Trial Outcomes & Findings for Study to Evaluate Exicorilant (CORT125281) in Combination With Enzalutamide in Patients With Metastatic Castration-Resistant Prostate Cancer (NCT NCT03437941)
NCT ID: NCT03437941
Last Updated: 2026-05-15
Results Overview
Assess the maximum tolerated dose (MTD) and/or biologically active doses of exicorilant in combination with enzalutamide to identify the recommended dose (RD) for Phase 2 studies based on the number of patients who experienced a DLT while receiving exicorilant in combination with enzalutamide. DLTs were defined as any of the protocol-specified toxicities that the Investigator considered possibly or probably related to study drug that occurred during the DLT-evaluation period. The MTD is defined as the highest dose at which the DLT rate was \<33%.
Recruitment status
TERMINATED
Study phase
PHASE1/PHASE2
Target enrollment
39 participants
Primary outcome timeframe
From first dose of exicorilant through completion of Cycle 1 (up to 28 days) for Segment 1 and from first dose of exicorilant through completion of Cycle 3 (up to 84 days) for Segment 2
Results posted on
2026-05-15
Participant Flow
By Sponsor decision, no patients were enrolled in the study after the Dose Determination Segment 2; thus, no patients were enrolled in the Dose Expansion arms.
Participant milestones
| Measure |
Enrolled But Not Allocated
Patients were enrolled in the study but discontinued before being allocated into a treatment group.
|
Dose Determination Segment 1 (Open-label) Cohort 1 - 360 mg Exicorilant
Patients will receive lead-in enzalutamide monotherapy once daily for 28 days. Patients will then receive combination treatment with twice-daily exicorilant 180 mg (total daily dose 360 mg) and enzalutamide once daily in 28-day dosing cycles.
|
Dose Determination Segment 1 (Open-label) Cohort 2 - 280 mg Exicorilant
Patients will receive lead-in enzalutamide monotherapy once daily for 28 days. Patients will then receive combination treatment with twice-daily exicorilant 140 mg (total daily dose 280 mg) and enzalutamide once daily in 28-day dosing cycles.
|
Dose Determination Segment 1 (Open-label) Cohort 3 - 280 mg Exicorilant
Patients will not receive lead-in enzalutamide monotherapy. Patients will receive combination treatment with twice-daily exicorilant 140 mg (total daily dose 280 mg) and enzalutamide once daily in 28-day dosing cycles.
|
Dose Determination Segment 2: Arm A - Maximum Dose 240 mg Exicorilant
Patients will receive treatment with once-daily exicorilant starting at 240 mg and titrating to 280 mg and then to 320 mg at 2-week intervals, as tolerated, in combination with enzalutamide once daily in 28-day dosing cycles. Patients in this arm are reported at the highest titrated dose of exicorilant achieved: 240 mg exicorilant.
|
Dose Determination Segment 2: Arm A - Maximum Dose 280 mg Exicorilant
Patients will receive treatment with once-daily exicorilant starting at 240 mg and titrating to 280 mg and then to 320 mg at 2-week intervals, as tolerated, in combination with enzalutamide once daily in 28-day dosing cycles. Patients in this arm are reported at the highest titrated dose of exicorilant achieved: 280 mg exicorilant.
|
Dose Determination Segment 2: Arm A - Maximum Dose 320 mg Exicorilant
Patients will receive treatment with once-daily exicorilant starting at 240 mg and titrating to 280 mg and then to 320 mg at 2-week intervals, as tolerated, in combination with enzalutamide once daily in 28-day dosing cycles. Patients in this arm are reported at the highest titrated dose of exicorilant achieved: 320 mg exicorilant.
|
Dose Determination Segment 2: Arm B - 240 mg Exicorilant
Patients will receive combination treatment with once-daily exicorilant 240 mg, enzalutamide once daily, and placebo in 28-day dosing cycles.
|
Dose Expansion - Abi-Resistant Cohort (Open-label)
Patients who have progressed during treatment with abiraterone and no other androgen receptor-blocking therapies will receive exicorilant and enzalutamide.
|
Dose Expansion - Abi-Resistant Cohort Food Effect (Open-label)
Subcohort (first 10 patients enrolled into Cohort A). Patients enrolled into this subcohort will receive a single dose of exicorilant at Cycle 1 Day -7 and a single dose of exicorilant at Cycle 1 Day 1 30 minutes after a standard breakfast to assess the effect of food on pharmacokinetic (PK)parameters. Patients will then begin exicorilant in combination with enzalutamide on Cycle 1 Day 2 and continue in 28-day dosing cycles.
|
Dose Expansion - ARant-Resistant Cohort (Open-label)
Patients who progressed during treatment with enzalutamide or second-generation androgen receptor-blocking therapies will receive a daily dose of exicorilant and enzalutamide.
|
|---|---|---|---|---|---|---|---|---|---|---|---|
|
Overall Study
STARTED
|
2
|
2
|
3
|
7
|
8
|
1
|
10
|
6
|
0
|
0
|
0
|
|
Overall Study
COMPLETED
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Overall Study
NOT COMPLETED
|
2
|
2
|
3
|
7
|
8
|
1
|
10
|
6
|
0
|
0
|
0
|
Reasons for withdrawal
| Measure |
Enrolled But Not Allocated
Patients were enrolled in the study but discontinued before being allocated into a treatment group.
|
Dose Determination Segment 1 (Open-label) Cohort 1 - 360 mg Exicorilant
Patients will receive lead-in enzalutamide monotherapy once daily for 28 days. Patients will then receive combination treatment with twice-daily exicorilant 180 mg (total daily dose 360 mg) and enzalutamide once daily in 28-day dosing cycles.
|
Dose Determination Segment 1 (Open-label) Cohort 2 - 280 mg Exicorilant
Patients will receive lead-in enzalutamide monotherapy once daily for 28 days. Patients will then receive combination treatment with twice-daily exicorilant 140 mg (total daily dose 280 mg) and enzalutamide once daily in 28-day dosing cycles.
|
Dose Determination Segment 1 (Open-label) Cohort 3 - 280 mg Exicorilant
Patients will not receive lead-in enzalutamide monotherapy. Patients will receive combination treatment with twice-daily exicorilant 140 mg (total daily dose 280 mg) and enzalutamide once daily in 28-day dosing cycles.
|
Dose Determination Segment 2: Arm A - Maximum Dose 240 mg Exicorilant
Patients will receive treatment with once-daily exicorilant starting at 240 mg and titrating to 280 mg and then to 320 mg at 2-week intervals, as tolerated, in combination with enzalutamide once daily in 28-day dosing cycles. Patients in this arm are reported at the highest titrated dose of exicorilant achieved: 240 mg exicorilant.
|
Dose Determination Segment 2: Arm A - Maximum Dose 280 mg Exicorilant
Patients will receive treatment with once-daily exicorilant starting at 240 mg and titrating to 280 mg and then to 320 mg at 2-week intervals, as tolerated, in combination with enzalutamide once daily in 28-day dosing cycles. Patients in this arm are reported at the highest titrated dose of exicorilant achieved: 280 mg exicorilant.
|
Dose Determination Segment 2: Arm A - Maximum Dose 320 mg Exicorilant
Patients will receive treatment with once-daily exicorilant starting at 240 mg and titrating to 280 mg and then to 320 mg at 2-week intervals, as tolerated, in combination with enzalutamide once daily in 28-day dosing cycles. Patients in this arm are reported at the highest titrated dose of exicorilant achieved: 320 mg exicorilant.
|
Dose Determination Segment 2: Arm B - 240 mg Exicorilant
Patients will receive combination treatment with once-daily exicorilant 240 mg, enzalutamide once daily, and placebo in 28-day dosing cycles.
|
Dose Expansion - Abi-Resistant Cohort (Open-label)
Patients who have progressed during treatment with abiraterone and no other androgen receptor-blocking therapies will receive exicorilant and enzalutamide.
|
Dose Expansion - Abi-Resistant Cohort Food Effect (Open-label)
Subcohort (first 10 patients enrolled into Cohort A). Patients enrolled into this subcohort will receive a single dose of exicorilant at Cycle 1 Day -7 and a single dose of exicorilant at Cycle 1 Day 1 30 minutes after a standard breakfast to assess the effect of food on pharmacokinetic (PK)parameters. Patients will then begin exicorilant in combination with enzalutamide on Cycle 1 Day 2 and continue in 28-day dosing cycles.
|
Dose Expansion - ARant-Resistant Cohort (Open-label)
Patients who progressed during treatment with enzalutamide or second-generation androgen receptor-blocking therapies will receive a daily dose of exicorilant and enzalutamide.
|
|---|---|---|---|---|---|---|---|---|---|---|---|
|
Overall Study
Death
|
1
|
1
|
1
|
5
|
1
|
0
|
5
|
4
|
0
|
0
|
0
|
|
Overall Study
Study terminated by Sponsor
|
0
|
0
|
2
|
2
|
7
|
1
|
3
|
2
|
0
|
0
|
0
|
|
Overall Study
Withdrawal by Subject
|
1
|
0
|
0
|
0
|
0
|
0
|
2
|
0
|
0
|
0
|
0
|
|
Overall Study
Investigator decision
|
0
|
1
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
Baseline Characteristics
Study to Evaluate Exicorilant (CORT125281) in Combination With Enzalutamide in Patients With Metastatic Castration-Resistant Prostate Cancer
Baseline characteristics by cohort
| Measure |
Dose Determination Segment 1 (Open-label) Cohort 1 - 360 mg Exicorilant
n=2 Participants
Patients will receive lead-in enzalutamide monotherapy once daily for 28 days. Patients will then receive combination treatment with twice-daily exicorilant 180 mg (total daily dose 360 mg) and enzalutamide once daily in 28-day dosing cycles.
|
Dose Determination Segment 1 (Open-label) Cohort 2 - 280 mg Exicorilant
n=3 Participants
Patients will receive lead-in enzalutamide monotherapy once daily for 28 days. Patients will then receive combination treatment with twice-daily exicorilant 140 mg (total daily dose 280 mg) and enzalutamide once daily in 28-day dosing cycles.
|
Dose Determination Segment 1 (Open-label) Cohort 3 - 280 mg Exicorilant
n=7 Participants
Patients will not receive lead-in enzalutamide monotherapy. Patients will receive combination treatment with twice-daily exicorilant 140 mg (total daily dose 280 mg) and enzalutamide once daily in 28-day dosing cycles.
|
Dose Determination Segment 2: Arm A - Maximum Dose 240 mg Exicorilant
n=8 Participants
Patients will receive treatment with once-daily exicorilant starting at 240 mg and titrating to 280 mg and then to 320 mg at 2-week intervals, as tolerated, in combination with enzalutamide once daily in 28-day dosing cycles. Patients in this arm are reported at the highest titrated dose of exicorilant achieved: 240 mg exicorilant.
|
Dose Determination Segment 2: Arm A - Maximum Dose 280 mg Exicorilant
n=1 Participants
Patients will receive treatment with once-daily exicorilant starting at 240 mg and titrating to 280 mg and then to 320 mg at 2-week intervals, as tolerated, in combination with enzalutamide once daily in 28-day dosing cycles. Patients in this arm are reported at the highest titrated dose of exicorilant achieved: 280 mg exicorilant.
|
Dose Determination Segment 2: Arm A - Maximum Dose 320 mg Exicorilant
n=10 Participants
Patients will receive treatment with once-daily exicorilant starting at 240 mg and titrating to 280 mg and then to 320 mg at 2-week intervals, as tolerated, in combination with enzalutamide once daily in 28-day dosing cycles. Patients in this arm are reported at the highest titrated dose of exicorilant achieved: 320 mg exicorilant.
|
Dose Determination Segment 2: Arm B - 240 mg Exicorilant
n=6 Participants
Patients will receive combination treatment with once-daily exicorilant 240 mg, enzalutamide once daily, and placebo in 28-day dosing cycles.
|
Total
n=37 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|---|---|
|
Age, Continuous
|
67.5 years
n=11 Participants
|
60.0 years
n=9 Participants
|
70.0 years
n=20 Participants
|
72.0 years
n=186 Participants
|
75.0 years
n=12 Participants
|
64.0 years
n=12 Participants
|
66.0 years
n=122 Participants
|
70.0 years
n=2 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=11 Participants
|
0 Participants
n=9 Participants
|
0 Participants
n=20 Participants
|
0 Participants
n=186 Participants
|
0 Participants
n=12 Participants
|
0 Participants
n=12 Participants
|
0 Participants
n=122 Participants
|
0 Participants
n=2 Participants
|
|
Sex: Female, Male
Male
|
2 Participants
n=11 Participants
|
3 Participants
n=9 Participants
|
7 Participants
n=20 Participants
|
8 Participants
n=186 Participants
|
1 Participants
n=12 Participants
|
10 Participants
n=12 Participants
|
6 Participants
n=122 Participants
|
37 Participants
n=2 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=11 Participants
|
0 Participants
n=9 Participants
|
0 Participants
n=20 Participants
|
0 Participants
n=186 Participants
|
0 Participants
n=12 Participants
|
0 Participants
n=12 Participants
|
0 Participants
n=122 Participants
|
0 Participants
n=2 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
1 Participants
n=11 Participants
|
3 Participants
n=9 Participants
|
7 Participants
n=20 Participants
|
7 Participants
n=186 Participants
|
1 Participants
n=12 Participants
|
8 Participants
n=12 Participants
|
5 Participants
n=122 Participants
|
32 Participants
n=2 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=11 Participants
|
0 Participants
n=9 Participants
|
0 Participants
n=20 Participants
|
1 Participants
n=186 Participants
|
0 Participants
n=12 Participants
|
2 Participants
n=12 Participants
|
1 Participants
n=122 Participants
|
5 Participants
n=2 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=11 Participants
|
0 Participants
n=9 Participants
|
0 Participants
n=20 Participants
|
0 Participants
n=186 Participants
|
0 Participants
n=12 Participants
|
0 Participants
n=12 Participants
|
0 Participants
n=122 Participants
|
0 Participants
n=2 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=11 Participants
|
0 Participants
n=9 Participants
|
0 Participants
n=20 Participants
|
0 Participants
n=186 Participants
|
0 Participants
n=12 Participants
|
1 Participants
n=12 Participants
|
1 Participants
n=122 Participants
|
2 Participants
n=2 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=11 Participants
|
0 Participants
n=9 Participants
|
0 Participants
n=20 Participants
|
0 Participants
n=186 Participants
|
0 Participants
n=12 Participants
|
0 Participants
n=12 Participants
|
0 Participants
n=122 Participants
|
0 Participants
n=2 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=11 Participants
|
1 Participants
n=9 Participants
|
0 Participants
n=20 Participants
|
1 Participants
n=186 Participants
|
0 Participants
n=12 Participants
|
2 Participants
n=12 Participants
|
0 Participants
n=122 Participants
|
4 Participants
n=2 Participants
|
|
Race (NIH/OMB)
White
|
2 Participants
n=11 Participants
|
2 Participants
n=9 Participants
|
7 Participants
n=20 Participants
|
4 Participants
n=186 Participants
|
1 Participants
n=12 Participants
|
5 Participants
n=12 Participants
|
5 Participants
n=122 Participants
|
26 Participants
n=2 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=11 Participants
|
0 Participants
n=9 Participants
|
0 Participants
n=20 Participants
|
0 Participants
n=186 Participants
|
0 Participants
n=12 Participants
|
0 Participants
n=12 Participants
|
0 Participants
n=122 Participants
|
0 Participants
n=2 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=11 Participants
|
0 Participants
n=9 Participants
|
0 Participants
n=20 Participants
|
3 Participants
n=186 Participants
|
0 Participants
n=12 Participants
|
2 Participants
n=12 Participants
|
0 Participants
n=122 Participants
|
5 Participants
n=2 Participants
|
PRIMARY outcome
Timeframe: From first dose of exicorilant through completion of Cycle 1 (up to 28 days) for Segment 1 and from first dose of exicorilant through completion of Cycle 3 (up to 84 days) for Segment 2Population: The DLT-Evaluable Population included all patients in the Dose-Determination cohorts who received at least 1 dose of exicorilant and fulfill at least 1 of the following: 1) received at least 75% of the study regimen; 2) experienced a DLT within the DLT-evaluation period.
Assess the maximum tolerated dose (MTD) and/or biologically active doses of exicorilant in combination with enzalutamide to identify the recommended dose (RD) for Phase 2 studies based on the number of patients who experienced a DLT while receiving exicorilant in combination with enzalutamide. DLTs were defined as any of the protocol-specified toxicities that the Investigator considered possibly or probably related to study drug that occurred during the DLT-evaluation period. The MTD is defined as the highest dose at which the DLT rate was \<33%.
Outcome measures
| Measure |
Dose Determination Segment 1 (Open-label): Cohort 2 - 280 mg Exicorilant
n=3 Participants
Patients will receive lead-in enzalutamide monotherapy once daily for 28 days. Patients will then receive combination treatment with twice-daily exicorilant 140 mg (total daily dose 280 mg) and enzalutamide once daily in 28-day dosing cycles.
|
Dose Determination Segment 1 (Open-label):Cohort 3 - 280 mg Exicorilant
n=6 Participants
Patients will not receive lead-in enzalutamide monotherapy. Patients will receive combination treatment with twice-daily exicorilant 140 mg (total daily dose 280 mg) and enzalutamide once daily in 28-day dosing cycles.
|
Dose Determination Segment 1 (Open-label): Cohort 1 - 360 mg Exicorilant
n=2 Participants
Patients will receive lead-in enzalutamide monotherapy once daily for 28 days. Patients will then receive combination treatment with twice-daily exicorilant 180 mg (total daily dose 360 mg) and enzalutamide once daily in 28-day dosing cycles.
|
Dose Determination Segment 2: Arm A - Maximum Dose 320 mg Exicorilant
n=5 Participants
Patients will receive treatment with once-daily exicorilant starting at 240 mg and titrating to 280 mg and then to 320 mg at 2-week intervals, as tolerated, in combination with enzalutamide once daily in 28-day dosing cycles. Patients in this arm are reported at the highest titrated dose of exicorilant achieved: 320 mg exicorilant.
|
Dose Determination Segment 2: Arm B - 240 mg Exicorilant
n=6 Participants
Patients will receive combination treatment with once-daily exicorilant 240 mg, enzalutamide once daily, and placebo in 28-day dosing cycles.
|
Dose Determination Segment 2: Arm A - Maximum Dose 240 mg Exicorilant
n=4 Participants
Patients will receive treatment with once-daily exicorilant starting at 240 mg and titrating to 280 mg and then to 320 mg at 2-week intervals, as tolerated, in combination with enzalutamide once daily in 28-day dosing cycles. Patients in this arm are reported at the highest titrated dose of exicorilant achieved: 240 mg exicorilant.
|
Dose Determination Segment 2: Arm A - Maximum Dose 280 mg Exicorilant
n=1 Participants
Patients will receive treatment with once-daily exicorilant starting at 240 mg and titrating to 280 mg and then to 320 mg at 2-week intervals, as tolerated, in combination with enzalutamide once daily in 28-day dosing cycles. Patients in this arm are reported at the highest titrated dose of exicorilant achieved: 280 mg exicorilant.
|
|---|---|---|---|---|---|---|---|
|
Number of Patients With One or More Dose-Limiting Toxicity (DLT)
|
1 Participants
|
0 Participants
|
2 Participants
|
0 Participants
|
1 Participants
|
4 Participants
|
1 Participants
|
SECONDARY outcome
Timeframe: Up to 27 months for Segment 1 and up to 19 months for Segment 2Population: The Safety Population included all patients who received ≥1 dose of exicorilant.
The safety of each treatment group will be assessed by evaluating the incidence of treatment-emergent adverse events.
Outcome measures
| Measure |
Dose Determination Segment 1 (Open-label): Cohort 2 - 280 mg Exicorilant
n=3 Participants
Patients will receive lead-in enzalutamide monotherapy once daily for 28 days. Patients will then receive combination treatment with twice-daily exicorilant 140 mg (total daily dose 280 mg) and enzalutamide once daily in 28-day dosing cycles.
|
Dose Determination Segment 1 (Open-label):Cohort 3 - 280 mg Exicorilant
n=7 Participants
Patients will not receive lead-in enzalutamide monotherapy. Patients will receive combination treatment with twice-daily exicorilant 140 mg (total daily dose 280 mg) and enzalutamide once daily in 28-day dosing cycles.
|
Dose Determination Segment 1 (Open-label): Cohort 1 - 360 mg Exicorilant
n=2 Participants
Patients will receive lead-in enzalutamide monotherapy once daily for 28 days. Patients will then receive combination treatment with twice-daily exicorilant 180 mg (total daily dose 360 mg) and enzalutamide once daily in 28-day dosing cycles.
|
Dose Determination Segment 2: Arm A - Maximum Dose 320 mg Exicorilant
n=10 Participants
Patients will receive treatment with once-daily exicorilant starting at 240 mg and titrating to 280 mg and then to 320 mg at 2-week intervals, as tolerated, in combination with enzalutamide once daily in 28-day dosing cycles. Patients in this arm are reported at the highest titrated dose of exicorilant achieved: 320 mg exicorilant.
|
Dose Determination Segment 2: Arm B - 240 mg Exicorilant
n=6 Participants
Patients will receive combination treatment with once-daily exicorilant 240 mg, enzalutamide once daily, and placebo in 28-day dosing cycles.
|
Dose Determination Segment 2: Arm A - Maximum Dose 240 mg Exicorilant
n=8 Participants
Patients will receive treatment with once-daily exicorilant starting at 240 mg and titrating to 280 mg and then to 320 mg at 2-week intervals, as tolerated, in combination with enzalutamide once daily in 28-day dosing cycles. Patients in this arm are reported at the highest titrated dose of exicorilant achieved: 240 mg exicorilant.
|
Dose Determination Segment 2: Arm A - Maximum Dose 280 mg Exicorilant
n=1 Participants
Patients will receive treatment with once-daily exicorilant starting at 240 mg and titrating to 280 mg and then to 320 mg at 2-week intervals, as tolerated, in combination with enzalutamide once daily in 28-day dosing cycles. Patients in this arm are reported at the highest titrated dose of exicorilant achieved: 280 mg exicorilant.
|
|---|---|---|---|---|---|---|---|
|
Number of Patients With One or More Treatment-Emergent Adverse Events
|
3 Participants
|
7 Participants
|
2 Participants
|
10 Participants
|
6 Participants
|
8 Participants
|
1 Participants
|
SECONDARY outcome
Timeframe: Predose and at time intervals up to 12 hours postdose on Cycle 1 Day 1 and Cycle 2 Day 1Population: The PK-Evaluable Population includes all patients who received active study treatment and had measurable plasma concentration of study treatment at any time point.
AUC from time zero to 12 hours postdose (AUC0-12) calculated using linear up and log down method.
Outcome measures
| Measure |
Dose Determination Segment 1 (Open-label): Cohort 2 - 280 mg Exicorilant
n=3 Participants
Patients will receive lead-in enzalutamide monotherapy once daily for 28 days. Patients will then receive combination treatment with twice-daily exicorilant 140 mg (total daily dose 280 mg) and enzalutamide once daily in 28-day dosing cycles.
|
Dose Determination Segment 1 (Open-label):Cohort 3 - 280 mg Exicorilant
n=7 Participants
Patients will not receive lead-in enzalutamide monotherapy. Patients will receive combination treatment with twice-daily exicorilant 140 mg (total daily dose 280 mg) and enzalutamide once daily in 28-day dosing cycles.
|
Dose Determination Segment 1 (Open-label): Cohort 1 - 360 mg Exicorilant
n=2 Participants
Patients will receive lead-in enzalutamide monotherapy once daily for 28 days. Patients will then receive combination treatment with twice-daily exicorilant 180 mg (total daily dose 360 mg) and enzalutamide once daily in 28-day dosing cycles.
|
Dose Determination Segment 2: Arm A - Maximum Dose 320 mg Exicorilant
Patients will receive treatment with once-daily exicorilant starting at 240 mg and titrating to 280 mg and then to 320 mg at 2-week intervals, as tolerated, in combination with enzalutamide once daily in 28-day dosing cycles. Patients in this arm are reported at the highest titrated dose of exicorilant achieved: 320 mg exicorilant.
|
Dose Determination Segment 2: Arm B - 240 mg Exicorilant
Patients will receive combination treatment with once-daily exicorilant 240 mg, enzalutamide once daily, and placebo in 28-day dosing cycles.
|
Dose Determination Segment 2: Arm A - Maximum Dose 240 mg Exicorilant
Patients will receive treatment with once-daily exicorilant starting at 240 mg and titrating to 280 mg and then to 320 mg at 2-week intervals, as tolerated, in combination with enzalutamide once daily in 28-day dosing cycles. Patients in this arm are reported at the highest titrated dose of exicorilant achieved: 240 mg exicorilant.
|
Dose Determination Segment 2: Arm A - Maximum Dose 280 mg Exicorilant
Patients will receive treatment with once-daily exicorilant starting at 240 mg and titrating to 280 mg and then to 320 mg at 2-week intervals, as tolerated, in combination with enzalutamide once daily in 28-day dosing cycles. Patients in this arm are reported at the highest titrated dose of exicorilant achieved: 280 mg exicorilant.
|
|---|---|---|---|---|---|---|---|
|
Area Under the Concentration Versus Time Curve (AUC) of Plasma Exicorilant: Segment 1
Cycle 2 Day 1
|
431 ng-hr/ml
Geometric Coefficient of Variation 29.0
|
747 ng-hr/ml
Geometric Coefficient of Variation 82.2
|
433 ng-hr/ml
Geometric Coefficient of Variation 14.8
|
—
|
—
|
—
|
—
|
|
Area Under the Concentration Versus Time Curve (AUC) of Plasma Exicorilant: Segment 1
Cycle 1 Day 1
|
275 ng-hr/ml
Geometric Coefficient of Variation 64.2
|
477 ng-hr/ml
Geometric Coefficient of Variation 82.4
|
387 ng-hr/ml
Geometric Coefficient of Variation 11.3
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Predose and at time intervals up to 12 hours postdose on Cycle 1 Day 1 and Cycle 2 Day 1Population: The PK-Evaluable population includes all patients who received active study treatment and had measurable plasma concentration of study treatment at any time point.
Maximum observed concentration over the dosing interval
Outcome measures
| Measure |
Dose Determination Segment 1 (Open-label): Cohort 2 - 280 mg Exicorilant
n=3 Participants
Patients will receive lead-in enzalutamide monotherapy once daily for 28 days. Patients will then receive combination treatment with twice-daily exicorilant 140 mg (total daily dose 280 mg) and enzalutamide once daily in 28-day dosing cycles.
|
Dose Determination Segment 1 (Open-label):Cohort 3 - 280 mg Exicorilant
n=7 Participants
Patients will not receive lead-in enzalutamide monotherapy. Patients will receive combination treatment with twice-daily exicorilant 140 mg (total daily dose 280 mg) and enzalutamide once daily in 28-day dosing cycles.
|
Dose Determination Segment 1 (Open-label): Cohort 1 - 360 mg Exicorilant
n=2 Participants
Patients will receive lead-in enzalutamide monotherapy once daily for 28 days. Patients will then receive combination treatment with twice-daily exicorilant 180 mg (total daily dose 360 mg) and enzalutamide once daily in 28-day dosing cycles.
|
Dose Determination Segment 2: Arm A - Maximum Dose 320 mg Exicorilant
Patients will receive treatment with once-daily exicorilant starting at 240 mg and titrating to 280 mg and then to 320 mg at 2-week intervals, as tolerated, in combination with enzalutamide once daily in 28-day dosing cycles. Patients in this arm are reported at the highest titrated dose of exicorilant achieved: 320 mg exicorilant.
|
Dose Determination Segment 2: Arm B - 240 mg Exicorilant
Patients will receive combination treatment with once-daily exicorilant 240 mg, enzalutamide once daily, and placebo in 28-day dosing cycles.
|
Dose Determination Segment 2: Arm A - Maximum Dose 240 mg Exicorilant
Patients will receive treatment with once-daily exicorilant starting at 240 mg and titrating to 280 mg and then to 320 mg at 2-week intervals, as tolerated, in combination with enzalutamide once daily in 28-day dosing cycles. Patients in this arm are reported at the highest titrated dose of exicorilant achieved: 240 mg exicorilant.
|
Dose Determination Segment 2: Arm A - Maximum Dose 280 mg Exicorilant
Patients will receive treatment with once-daily exicorilant starting at 240 mg and titrating to 280 mg and then to 320 mg at 2-week intervals, as tolerated, in combination with enzalutamide once daily in 28-day dosing cycles. Patients in this arm are reported at the highest titrated dose of exicorilant achieved: 280 mg exicorilant.
|
|---|---|---|---|---|---|---|---|
|
Maximum Observed Concentration (Cmax) of Plasma Exicorilant: Segment 1
Cycle 2 Day 1
|
125 ng/ml
Geometric Coefficient of Variation 15.4
|
174 ng/ml
Geometric Coefficient of Variation 68.7
|
108 ng/ml
Geometric Coefficient of Variation 59.2
|
—
|
—
|
—
|
—
|
|
Maximum Observed Concentration (Cmax) of Plasma Exicorilant: Segment 1
Cycle 1 Day 1
|
91.6 ng/ml
Geometric Coefficient of Variation 34.5
|
186.1 ng/ml
Geometric Coefficient of Variation 70.5
|
84.2 ng/ml
Geometric Coefficient of Variation 24.5
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Predose and at time intervals up to 24 hours postdose on Cycle 1 Day -1, Cycle 1 Day 1, and Cycle 2 Day 1Population: The PK-Evaluable Population includes all patients who received active study treatment and had measurable plasma concentration of study treatment at any time point.
AUC from time zero to 24 hours postdose (AUC0-24) calculated using linear up and log down method.
Outcome measures
| Measure |
Dose Determination Segment 1 (Open-label): Cohort 2 - 280 mg Exicorilant
n=3 Participants
Patients will receive lead-in enzalutamide monotherapy once daily for 28 days. Patients will then receive combination treatment with twice-daily exicorilant 140 mg (total daily dose 280 mg) and enzalutamide once daily in 28-day dosing cycles.
|
Dose Determination Segment 1 (Open-label):Cohort 3 - 280 mg Exicorilant
n=7 Participants
Patients will not receive lead-in enzalutamide monotherapy. Patients will receive combination treatment with twice-daily exicorilant 140 mg (total daily dose 280 mg) and enzalutamide once daily in 28-day dosing cycles.
|
Dose Determination Segment 1 (Open-label): Cohort 1 - 360 mg Exicorilant
n=2 Participants
Patients will receive lead-in enzalutamide monotherapy once daily for 28 days. Patients will then receive combination treatment with twice-daily exicorilant 180 mg (total daily dose 360 mg) and enzalutamide once daily in 28-day dosing cycles.
|
Dose Determination Segment 2: Arm A - Maximum Dose 320 mg Exicorilant
Patients will receive treatment with once-daily exicorilant starting at 240 mg and titrating to 280 mg and then to 320 mg at 2-week intervals, as tolerated, in combination with enzalutamide once daily in 28-day dosing cycles. Patients in this arm are reported at the highest titrated dose of exicorilant achieved: 320 mg exicorilant.
|
Dose Determination Segment 2: Arm B - 240 mg Exicorilant
Patients will receive combination treatment with once-daily exicorilant 240 mg, enzalutamide once daily, and placebo in 28-day dosing cycles.
|
Dose Determination Segment 2: Arm A - Maximum Dose 240 mg Exicorilant
Patients will receive treatment with once-daily exicorilant starting at 240 mg and titrating to 280 mg and then to 320 mg at 2-week intervals, as tolerated, in combination with enzalutamide once daily in 28-day dosing cycles. Patients in this arm are reported at the highest titrated dose of exicorilant achieved: 240 mg exicorilant.
|
Dose Determination Segment 2: Arm A - Maximum Dose 280 mg Exicorilant
Patients will receive treatment with once-daily exicorilant starting at 240 mg and titrating to 280 mg and then to 320 mg at 2-week intervals, as tolerated, in combination with enzalutamide once daily in 28-day dosing cycles. Patients in this arm are reported at the highest titrated dose of exicorilant achieved: 280 mg exicorilant.
|
|---|---|---|---|---|---|---|---|
|
AUC of Plasma Enzalutamide: Segment 1
Cycle 1 Day -1 lead-in
|
255623 ng-hr/ml
Geometric Coefficient of Variation 20.0
|
—
|
281499 ng-hr/ml
Geometric Coefficient of Variation 2.7
|
—
|
—
|
—
|
—
|
|
AUC of Plasma Enzalutamide: Segment 1
Cycle 1 Day 1
|
278573 ng-hr/ml
Geometric Coefficient of Variation 25.6
|
36979 ng-hr/ml
Geometric Coefficient of Variation 21.4
|
307849 ng-hr/ml
|
—
|
—
|
—
|
—
|
|
AUC of Plasma Enzalutamide: Segment 1
Cycle 2 Day 1
|
410557 ng-hr/ml
Geometric Coefficient of Variation 16.3
|
386651 ng-hr/ml
Geometric Coefficient of Variation 15.3
|
334761 ng-hr/ml
Geometric Coefficient of Variation 3.8
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Predose and at time intervals up to 24 hours postdose on Cycle 1 Day -1, Cycle 1 Day 1, and Cycle 2 Day 1Population: The PK-Evaluable Population includes all patients who received active study treatment and had measurable plasma concentration of study treatment at any time point.
Maximum observed concentration over the dosing interval
Outcome measures
| Measure |
Dose Determination Segment 1 (Open-label): Cohort 2 - 280 mg Exicorilant
n=3 Participants
Patients will receive lead-in enzalutamide monotherapy once daily for 28 days. Patients will then receive combination treatment with twice-daily exicorilant 140 mg (total daily dose 280 mg) and enzalutamide once daily in 28-day dosing cycles.
|
Dose Determination Segment 1 (Open-label):Cohort 3 - 280 mg Exicorilant
n=7 Participants
Patients will not receive lead-in enzalutamide monotherapy. Patients will receive combination treatment with twice-daily exicorilant 140 mg (total daily dose 280 mg) and enzalutamide once daily in 28-day dosing cycles.
|
Dose Determination Segment 1 (Open-label): Cohort 1 - 360 mg Exicorilant
n=2 Participants
Patients will receive lead-in enzalutamide monotherapy once daily for 28 days. Patients will then receive combination treatment with twice-daily exicorilant 180 mg (total daily dose 360 mg) and enzalutamide once daily in 28-day dosing cycles.
|
Dose Determination Segment 2: Arm A - Maximum Dose 320 mg Exicorilant
Patients will receive treatment with once-daily exicorilant starting at 240 mg and titrating to 280 mg and then to 320 mg at 2-week intervals, as tolerated, in combination with enzalutamide once daily in 28-day dosing cycles. Patients in this arm are reported at the highest titrated dose of exicorilant achieved: 320 mg exicorilant.
|
Dose Determination Segment 2: Arm B - 240 mg Exicorilant
Patients will receive combination treatment with once-daily exicorilant 240 mg, enzalutamide once daily, and placebo in 28-day dosing cycles.
|
Dose Determination Segment 2: Arm A - Maximum Dose 240 mg Exicorilant
Patients will receive treatment with once-daily exicorilant starting at 240 mg and titrating to 280 mg and then to 320 mg at 2-week intervals, as tolerated, in combination with enzalutamide once daily in 28-day dosing cycles. Patients in this arm are reported at the highest titrated dose of exicorilant achieved: 240 mg exicorilant.
|
Dose Determination Segment 2: Arm A - Maximum Dose 280 mg Exicorilant
Patients will receive treatment with once-daily exicorilant starting at 240 mg and titrating to 280 mg and then to 320 mg at 2-week intervals, as tolerated, in combination with enzalutamide once daily in 28-day dosing cycles. Patients in this arm are reported at the highest titrated dose of exicorilant achieved: 280 mg exicorilant.
|
|---|---|---|---|---|---|---|---|
|
Cmax of Plasma Enzalutamide: Segment 1
Cycle 1 Day -1 lead-in
|
12759 ng/ml
Geometric Coefficient of Variation 27.5
|
—
|
15112 ng/ml
Geometric Coefficient of Variation 15.5
|
—
|
—
|
—
|
—
|
|
Cmax of Plasma Enzalutamide: Segment 1
Cycle 1 Day 1
|
14186 ng/ml
Geometric Coefficient of Variation 13.0
|
4260 ng/ml
Geometric Coefficient of Variation 36.5
|
15500 ng/ml
Geometric Coefficient of Variation 0.9
|
—
|
—
|
—
|
—
|
|
Cmax of Plasma Enzalutamide: Segment 1
Cycle 2 Day 1
|
19669 ng/ml
Geometric Coefficient of Variation 7.9
|
19338 ng/ml
Geometric Coefficient of Variation 11.6
|
16497 ng/ml
Geometric Coefficient of Variation 2.6
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Predose and at time intervals up to 24 hours postdose on Cycle 1 Day -1, Cycle 1 Day 1, and Cycle 2 Day 1Population: The PK-Evaluable Population includes all patients who received active study treatment and had measurable plasma concentration of study treatment at any time point.
AUC0-24 calculated using linear up and log down method.
Outcome measures
| Measure |
Dose Determination Segment 1 (Open-label): Cohort 2 - 280 mg Exicorilant
n=3 Participants
Patients will receive lead-in enzalutamide monotherapy once daily for 28 days. Patients will then receive combination treatment with twice-daily exicorilant 140 mg (total daily dose 280 mg) and enzalutamide once daily in 28-day dosing cycles.
|
Dose Determination Segment 1 (Open-label):Cohort 3 - 280 mg Exicorilant
n=7 Participants
Patients will not receive lead-in enzalutamide monotherapy. Patients will receive combination treatment with twice-daily exicorilant 140 mg (total daily dose 280 mg) and enzalutamide once daily in 28-day dosing cycles.
|
Dose Determination Segment 1 (Open-label): Cohort 1 - 360 mg Exicorilant
n=2 Participants
Patients will receive lead-in enzalutamide monotherapy once daily for 28 days. Patients will then receive combination treatment with twice-daily exicorilant 180 mg (total daily dose 360 mg) and enzalutamide once daily in 28-day dosing cycles.
|
Dose Determination Segment 2: Arm A - Maximum Dose 320 mg Exicorilant
Patients will receive treatment with once-daily exicorilant starting at 240 mg and titrating to 280 mg and then to 320 mg at 2-week intervals, as tolerated, in combination with enzalutamide once daily in 28-day dosing cycles. Patients in this arm are reported at the highest titrated dose of exicorilant achieved: 320 mg exicorilant.
|
Dose Determination Segment 2: Arm B - 240 mg Exicorilant
Patients will receive combination treatment with once-daily exicorilant 240 mg, enzalutamide once daily, and placebo in 28-day dosing cycles.
|
Dose Determination Segment 2: Arm A - Maximum Dose 240 mg Exicorilant
Patients will receive treatment with once-daily exicorilant starting at 240 mg and titrating to 280 mg and then to 320 mg at 2-week intervals, as tolerated, in combination with enzalutamide once daily in 28-day dosing cycles. Patients in this arm are reported at the highest titrated dose of exicorilant achieved: 240 mg exicorilant.
|
Dose Determination Segment 2: Arm A - Maximum Dose 280 mg Exicorilant
Patients will receive treatment with once-daily exicorilant starting at 240 mg and titrating to 280 mg and then to 320 mg at 2-week intervals, as tolerated, in combination with enzalutamide once daily in 28-day dosing cycles. Patients in this arm are reported at the highest titrated dose of exicorilant achieved: 280 mg exicorilant.
|
|---|---|---|---|---|---|---|---|
|
AUC of Plasma N-Desmethyl Enzalutamide: Segment 1
Cycle 1 Day -1 lead-in
|
121320 ng-hr/ml
Geometric Coefficient of Variation 26.1
|
—
|
143300 ng-hr/ml
|
—
|
—
|
—
|
—
|
|
AUC of Plasma N-Desmethyl Enzalutamide: Segment 1
Cycle 1 Day 1
|
146225 ng-hr/ml
Geometric Coefficient of Variation 21.0
|
717 ng-hr/ml
|
—
|
—
|
—
|
—
|
—
|
|
AUC of Plasma N-Desmethyl Enzalutamide: Segment 1
Cycle 2 Day 1
|
181855 ng-hr/ml
Geometric Coefficient of Variation 7.8
|
146580 ng-hr/ml
Geometric Coefficient of Variation 42.7
|
180628 ng-hr/ml
Geometric Coefficient of Variation 21.5
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Predose and at time intervals up to 24 hours postdose on Cycle 1 Day -1, Cycle 1 Day 1, and Cycle 2 Day 1Population: The PK-Evaluable Population includes all patients who received active study treatment and had measurable plasma concentration of study treatment at any time point.
Maximum observed concentration over the dosing interval
Outcome measures
| Measure |
Dose Determination Segment 1 (Open-label): Cohort 2 - 280 mg Exicorilant
n=3 Participants
Patients will receive lead-in enzalutamide monotherapy once daily for 28 days. Patients will then receive combination treatment with twice-daily exicorilant 140 mg (total daily dose 280 mg) and enzalutamide once daily in 28-day dosing cycles.
|
Dose Determination Segment 1 (Open-label):Cohort 3 - 280 mg Exicorilant
n=7 Participants
Patients will not receive lead-in enzalutamide monotherapy. Patients will receive combination treatment with twice-daily exicorilant 140 mg (total daily dose 280 mg) and enzalutamide once daily in 28-day dosing cycles.
|
Dose Determination Segment 1 (Open-label): Cohort 1 - 360 mg Exicorilant
n=2 Participants
Patients will receive lead-in enzalutamide monotherapy once daily for 28 days. Patients will then receive combination treatment with twice-daily exicorilant 180 mg (total daily dose 360 mg) and enzalutamide once daily in 28-day dosing cycles.
|
Dose Determination Segment 2: Arm A - Maximum Dose 320 mg Exicorilant
Patients will receive treatment with once-daily exicorilant starting at 240 mg and titrating to 280 mg and then to 320 mg at 2-week intervals, as tolerated, in combination with enzalutamide once daily in 28-day dosing cycles. Patients in this arm are reported at the highest titrated dose of exicorilant achieved: 320 mg exicorilant.
|
Dose Determination Segment 2: Arm B - 240 mg Exicorilant
Patients will receive combination treatment with once-daily exicorilant 240 mg, enzalutamide once daily, and placebo in 28-day dosing cycles.
|
Dose Determination Segment 2: Arm A - Maximum Dose 240 mg Exicorilant
Patients will receive treatment with once-daily exicorilant starting at 240 mg and titrating to 280 mg and then to 320 mg at 2-week intervals, as tolerated, in combination with enzalutamide once daily in 28-day dosing cycles. Patients in this arm are reported at the highest titrated dose of exicorilant achieved: 240 mg exicorilant.
|
Dose Determination Segment 2: Arm A - Maximum Dose 280 mg Exicorilant
Patients will receive treatment with once-daily exicorilant starting at 240 mg and titrating to 280 mg and then to 320 mg at 2-week intervals, as tolerated, in combination with enzalutamide once daily in 28-day dosing cycles. Patients in this arm are reported at the highest titrated dose of exicorilant achieved: 280 mg exicorilant.
|
|---|---|---|---|---|---|---|---|
|
Cmax of Plasma N-Desmethyl Enzalutamide: Segment 1
Cycle 1 Day -1 lead-in
|
5812 ng/ml
Geometric Coefficient of Variation 12.6
|
—
|
7835 ng/ml
Geometric Coefficient of Variation 14.3
|
—
|
—
|
—
|
—
|
|
Cmax of Plasma N-Desmethyl Enzalutamide: Segment 1
Cycle 1 Day 1
|
7074 ng/ml
Geometric Coefficient of Variation 20.4
|
112 ng/ml
Geometric Coefficient of Variation 1152.2
|
8570 ng/ml
Geometric Coefficient of Variation 18.3
|
—
|
—
|
—
|
—
|
|
Cmax of Plasma N-Desmethyl Enzalutamide: Segment 1
Cycle 2 Day 1
|
7996 ng/ml
Geometric Coefficient of Variation 6.8
|
6742 ng/ml
Geometric Coefficient of Variation 46.1
|
7760 ng/ml
Geometric Coefficient of Variation 21.2
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Predose and at time intervals up to 24 hours postdose on Cycle 1 Day -1, Cycle 1 Day 1, and Cycle 2 Day 1Population: The PK-Evaluable Population includes all patients who received active study treatment and had measurable plasma concentration of study treatment at any time point.
AUC0-24 calculated using linear up and log down method.
Outcome measures
| Measure |
Dose Determination Segment 1 (Open-label): Cohort 2 - 280 mg Exicorilant
n=3 Participants
Patients will receive lead-in enzalutamide monotherapy once daily for 28 days. Patients will then receive combination treatment with twice-daily exicorilant 140 mg (total daily dose 280 mg) and enzalutamide once daily in 28-day dosing cycles.
|
Dose Determination Segment 1 (Open-label):Cohort 3 - 280 mg Exicorilant
n=7 Participants
Patients will not receive lead-in enzalutamide monotherapy. Patients will receive combination treatment with twice-daily exicorilant 140 mg (total daily dose 280 mg) and enzalutamide once daily in 28-day dosing cycles.
|
Dose Determination Segment 1 (Open-label): Cohort 1 - 360 mg Exicorilant
n=2 Participants
Patients will receive lead-in enzalutamide monotherapy once daily for 28 days. Patients will then receive combination treatment with twice-daily exicorilant 180 mg (total daily dose 360 mg) and enzalutamide once daily in 28-day dosing cycles.
|
Dose Determination Segment 2: Arm A - Maximum Dose 320 mg Exicorilant
Patients will receive treatment with once-daily exicorilant starting at 240 mg and titrating to 280 mg and then to 320 mg at 2-week intervals, as tolerated, in combination with enzalutamide once daily in 28-day dosing cycles. Patients in this arm are reported at the highest titrated dose of exicorilant achieved: 320 mg exicorilant.
|
Dose Determination Segment 2: Arm B - 240 mg Exicorilant
Patients will receive combination treatment with once-daily exicorilant 240 mg, enzalutamide once daily, and placebo in 28-day dosing cycles.
|
Dose Determination Segment 2: Arm A - Maximum Dose 240 mg Exicorilant
Patients will receive treatment with once-daily exicorilant starting at 240 mg and titrating to 280 mg and then to 320 mg at 2-week intervals, as tolerated, in combination with enzalutamide once daily in 28-day dosing cycles. Patients in this arm are reported at the highest titrated dose of exicorilant achieved: 240 mg exicorilant.
|
Dose Determination Segment 2: Arm A - Maximum Dose 280 mg Exicorilant
Patients will receive treatment with once-daily exicorilant starting at 240 mg and titrating to 280 mg and then to 320 mg at 2-week intervals, as tolerated, in combination with enzalutamide once daily in 28-day dosing cycles. Patients in this arm are reported at the highest titrated dose of exicorilant achieved: 280 mg exicorilant.
|
|---|---|---|---|---|---|---|---|
|
AUC of Plasma Enzalutamide Carboxylic Acid: Segment 1
Cycle 2 Day 1
|
52579 ng-hr/ml
Geometric Coefficient of Variation 23.1
|
63388 ng-hr/ml
Geometric Coefficient of Variation 93.3
|
80970 ng-hr/ml
Geometric Coefficient of Variation 219.0
|
—
|
—
|
—
|
—
|
|
AUC of Plasma Enzalutamide Carboxylic Acid: Segment 1
Cycle 1 Day -1 lead-in
|
34493 ng-hr/ml
|
—
|
19108 ng-hr/ml
|
—
|
—
|
—
|
—
|
|
AUC of Plasma Enzalutamide Carboxylic Acid: Segment 1
Cycle 1 Day 1
|
52471 ng-hr/ml
Geometric Coefficient of Variation 26.3
|
1287 ng-hr/ml
|
125786 ng-hr/ml
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Predose and at time intervals up to 24 hours postdose on Cycle 1 Day -1, Cycle 1 Day 1, and Cycle 2 Day 1Population: The PK-Evaluable Population includes all patients who received active study treatment and had measurable plasma concentration of study treatment at any time point.
Maximum observed concentration over the dosing interval
Outcome measures
| Measure |
Dose Determination Segment 1 (Open-label): Cohort 2 - 280 mg Exicorilant
n=3 Participants
Patients will receive lead-in enzalutamide monotherapy once daily for 28 days. Patients will then receive combination treatment with twice-daily exicorilant 140 mg (total daily dose 280 mg) and enzalutamide once daily in 28-day dosing cycles.
|
Dose Determination Segment 1 (Open-label):Cohort 3 - 280 mg Exicorilant
n=7 Participants
Patients will not receive lead-in enzalutamide monotherapy. Patients will receive combination treatment with twice-daily exicorilant 140 mg (total daily dose 280 mg) and enzalutamide once daily in 28-day dosing cycles.
|
Dose Determination Segment 1 (Open-label): Cohort 1 - 360 mg Exicorilant
n=2 Participants
Patients will receive lead-in enzalutamide monotherapy once daily for 28 days. Patients will then receive combination treatment with twice-daily exicorilant 180 mg (total daily dose 360 mg) and enzalutamide once daily in 28-day dosing cycles.
|
Dose Determination Segment 2: Arm A - Maximum Dose 320 mg Exicorilant
Patients will receive treatment with once-daily exicorilant starting at 240 mg and titrating to 280 mg and then to 320 mg at 2-week intervals, as tolerated, in combination with enzalutamide once daily in 28-day dosing cycles. Patients in this arm are reported at the highest titrated dose of exicorilant achieved: 320 mg exicorilant.
|
Dose Determination Segment 2: Arm B - 240 mg Exicorilant
Patients will receive combination treatment with once-daily exicorilant 240 mg, enzalutamide once daily, and placebo in 28-day dosing cycles.
|
Dose Determination Segment 2: Arm A - Maximum Dose 240 mg Exicorilant
Patients will receive treatment with once-daily exicorilant starting at 240 mg and titrating to 280 mg and then to 320 mg at 2-week intervals, as tolerated, in combination with enzalutamide once daily in 28-day dosing cycles. Patients in this arm are reported at the highest titrated dose of exicorilant achieved: 240 mg exicorilant.
|
Dose Determination Segment 2: Arm A - Maximum Dose 280 mg Exicorilant
Patients will receive treatment with once-daily exicorilant starting at 240 mg and titrating to 280 mg and then to 320 mg at 2-week intervals, as tolerated, in combination with enzalutamide once daily in 28-day dosing cycles. Patients in this arm are reported at the highest titrated dose of exicorilant achieved: 280 mg exicorilant.
|
|---|---|---|---|---|---|---|---|
|
Cmax of Plasma Enzalutamide Carboxylic Acid: Segment 1
Cycle 1 Day -1 lead-in
|
1930 ng/ml
Geometric Coefficient of Variation 39.5
|
—
|
2286 ng/ml
Geometric Coefficient of Variation 121.4
|
—
|
—
|
—
|
—
|
|
Cmax of Plasma Enzalutamide Carboxylic Acid: Segment 1
Cycle 1 Day 1
|
2554 ng/ml
Geometric Coefficient of Variation 26.6
|
127 ng/ml
Geometric Coefficient of Variation 180.0
|
3181 ng/ml
Geometric Coefficient of Variation 113.8
|
—
|
—
|
—
|
—
|
|
Cmax of Plasma Enzalutamide Carboxylic Acid: Segment 1
Cycle 2 Day 1
|
2862 ng/ml
Geometric Coefficient of Variation 31.6
|
3088 ng/ml
Geometric Coefficient of Variation 88.0
|
3719 ng/ml
Geometric Coefficient of Variation 235.9
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Predose and at time intervals up to 6 hours on Cycle 1 Day 15 (before dose escalation), and at 2 weeks after each dose escalation (Week 4 for escalation from 240 mg to 280 mg exicorilant and Week 6 for escalation from 280 mg to 320 mg exicorilant).Population: The PK-Evaluable Population includes all patients who received active study treatment and had measurable plasma concentration of study treatment at any time point.
AUC from time zero to 6 hours postdose (AUC0-6) calculated using linear up and log down method. Patients in Arm B did not receive dose escalations, but they were sampled for pharmacokinetic analysis on the same time frame as the Arm A patients: Cycle 1 Day 15, Week 4, and Week 6.
Outcome measures
| Measure |
Dose Determination Segment 1 (Open-label): Cohort 2 - 280 mg Exicorilant
n=1 Participants
Patients will receive lead-in enzalutamide monotherapy once daily for 28 days. Patients will then receive combination treatment with twice-daily exicorilant 140 mg (total daily dose 280 mg) and enzalutamide once daily in 28-day dosing cycles.
|
Dose Determination Segment 1 (Open-label):Cohort 3 - 280 mg Exicorilant
n=9 Participants
Patients will not receive lead-in enzalutamide monotherapy. Patients will receive combination treatment with twice-daily exicorilant 140 mg (total daily dose 280 mg) and enzalutamide once daily in 28-day dosing cycles.
|
Dose Determination Segment 1 (Open-label): Cohort 1 - 360 mg Exicorilant
n=5 Participants
Patients will receive lead-in enzalutamide monotherapy once daily for 28 days. Patients will then receive combination treatment with twice-daily exicorilant 180 mg (total daily dose 360 mg) and enzalutamide once daily in 28-day dosing cycles.
|
Dose Determination Segment 2: Arm A - Maximum Dose 320 mg Exicorilant
Patients will receive treatment with once-daily exicorilant starting at 240 mg and titrating to 280 mg and then to 320 mg at 2-week intervals, as tolerated, in combination with enzalutamide once daily in 28-day dosing cycles. Patients in this arm are reported at the highest titrated dose of exicorilant achieved: 320 mg exicorilant.
|
Dose Determination Segment 2: Arm B - 240 mg Exicorilant
Patients will receive combination treatment with once-daily exicorilant 240 mg, enzalutamide once daily, and placebo in 28-day dosing cycles.
|
Dose Determination Segment 2: Arm A - Maximum Dose 240 mg Exicorilant
n=5 Participants
Patients will receive treatment with once-daily exicorilant starting at 240 mg and titrating to 280 mg and then to 320 mg at 2-week intervals, as tolerated, in combination with enzalutamide once daily in 28-day dosing cycles. Patients in this arm are reported at the highest titrated dose of exicorilant achieved: 240 mg exicorilant.
|
Dose Determination Segment 2: Arm A - Maximum Dose 280 mg Exicorilant
Patients will receive treatment with once-daily exicorilant starting at 240 mg and titrating to 280 mg and then to 320 mg at 2-week intervals, as tolerated, in combination with enzalutamide once daily in 28-day dosing cycles. Patients in this arm are reported at the highest titrated dose of exicorilant achieved: 280 mg exicorilant.
|
|---|---|---|---|---|---|---|---|
|
AUC of Plasma Exicorilant: Segment 2
After dose escalation from 280 mg to 320 mg exicorilant.
|
—
|
1589 ng-hr/ml
Geometric Coefficient of Variation 38.8
|
—
|
—
|
—
|
1012 ng-hr/ml
Geometric Coefficient of Variation 48.3
|
—
|
|
AUC of Plasma Exicorilant: Segment 2
Cycle 1 Day 15 before dose escalation
|
511 ng-hr/ml
|
1125 ng-hr/ml
Geometric Coefficient of Variation 56.1
|
1086 ng-hr/ml
Geometric Coefficient of Variation 43.4
|
—
|
—
|
1201 ng-hr/ml
Geometric Coefficient of Variation 77.0
|
—
|
|
AUC of Plasma Exicorilant: Segment 2
After dose escalation from 240 mg to 280 mg exicorilant.
|
—
|
1424 ng-hr/ml
Geometric Coefficient of Variation 53.3
|
974 ng-hr/ml
|
—
|
—
|
990 ng-hr/ml
Geometric Coefficient of Variation 33.2
|
—
|
SECONDARY outcome
Timeframe: Predose and at time intervals up to 6 hours on Cycle 1 Day 15 (before dose escalation), and at 2 weeks after each dose escalation (Week 4 for escalation from 240 mg to 280 mg exicorilant and Week 6 for escalation from 280 mg to 320 mg exicorilant).Population: The PK-Evaluable Population includes all patients who received active study treatment and had measurable plasma concentration of study treatment at any time point.
Maximum observed concentration over the dosing interval. Patients in Arm B did not receive dose escalations, but they were sampled for pharmacokinetic analysis on the same time frame as the Arm A patients: Cycle 1 Day 15, Week 4, and Week 6.
Outcome measures
| Measure |
Dose Determination Segment 1 (Open-label): Cohort 2 - 280 mg Exicorilant
n=1 Participants
Patients will receive lead-in enzalutamide monotherapy once daily for 28 days. Patients will then receive combination treatment with twice-daily exicorilant 140 mg (total daily dose 280 mg) and enzalutamide once daily in 28-day dosing cycles.
|
Dose Determination Segment 1 (Open-label):Cohort 3 - 280 mg Exicorilant
n=9 Participants
Patients will not receive lead-in enzalutamide monotherapy. Patients will receive combination treatment with twice-daily exicorilant 140 mg (total daily dose 280 mg) and enzalutamide once daily in 28-day dosing cycles.
|
Dose Determination Segment 1 (Open-label): Cohort 1 - 360 mg Exicorilant
n=5 Participants
Patients will receive lead-in enzalutamide monotherapy once daily for 28 days. Patients will then receive combination treatment with twice-daily exicorilant 180 mg (total daily dose 360 mg) and enzalutamide once daily in 28-day dosing cycles.
|
Dose Determination Segment 2: Arm A - Maximum Dose 320 mg Exicorilant
Patients will receive treatment with once-daily exicorilant starting at 240 mg and titrating to 280 mg and then to 320 mg at 2-week intervals, as tolerated, in combination with enzalutamide once daily in 28-day dosing cycles. Patients in this arm are reported at the highest titrated dose of exicorilant achieved: 320 mg exicorilant.
|
Dose Determination Segment 2: Arm B - 240 mg Exicorilant
Patients will receive combination treatment with once-daily exicorilant 240 mg, enzalutamide once daily, and placebo in 28-day dosing cycles.
|
Dose Determination Segment 2: Arm A - Maximum Dose 240 mg Exicorilant
n=5 Participants
Patients will receive treatment with once-daily exicorilant starting at 240 mg and titrating to 280 mg and then to 320 mg at 2-week intervals, as tolerated, in combination with enzalutamide once daily in 28-day dosing cycles. Patients in this arm are reported at the highest titrated dose of exicorilant achieved: 240 mg exicorilant.
|
Dose Determination Segment 2: Arm A - Maximum Dose 280 mg Exicorilant
Patients will receive treatment with once-daily exicorilant starting at 240 mg and titrating to 280 mg and then to 320 mg at 2-week intervals, as tolerated, in combination with enzalutamide once daily in 28-day dosing cycles. Patients in this arm are reported at the highest titrated dose of exicorilant achieved: 280 mg exicorilant.
|
|---|---|---|---|---|---|---|---|
|
Cmax of Plasma Exicorilant: Segment 2
Cycle 1 Day 15 before dose escalation
|
157 ng/ml
|
418 ng/ml
Geometric Coefficient of Variation 61.7
|
402 ng/ml
Geometric Coefficient of Variation 34.7
|
—
|
—
|
495 ng/ml
Geometric Coefficient of Variation 80.7
|
—
|
|
Cmax of Plasma Exicorilant: Segment 2
After dose escalation from 240 mg to 280 mg exicorilant
|
—
|
528 ng/ml
Geometric Coefficient of Variation 58.6
|
247 ng/ml
|
—
|
—
|
398 ng/ml
Geometric Coefficient of Variation 63.8
|
—
|
|
Cmax of Plasma Exicorilant: Segment 2
After dose escalation from 280 mg to 320 mg exicorilant
|
—
|
534 ng/ml
Geometric Coefficient of Variation 56.8
|
—
|
—
|
—
|
374 ng/ml
Geometric Coefficient of Variation 65.9
|
—
|
SECONDARY outcome
Timeframe: Predose and at time intervals up to 6 hours on Cycle 1 Day 15 (before dose escalation), and at 2 weeks after each dose escalation (Week 4 for escalation from 240 mg to 280 mg exicorilant and Week 6 for escalation from 280 mg to 320 mg exicorilant).Population: The PK-Evaluable Population includes all patients who received active study treatment and had measurable plasma concentration of study treatment at any time point.
AUC from time zero to 6 hours postdose (AUC0-6) calculated using linear up and log down method. Patients in Arm B did not receive dose escalations, but they were sampled for pharmacokinetic analysis on the same time frame as the Arm A patients: Cycle 1 Day 15, Week 4, and Week 6.
Outcome measures
| Measure |
Dose Determination Segment 1 (Open-label): Cohort 2 - 280 mg Exicorilant
n=1 Participants
Patients will receive lead-in enzalutamide monotherapy once daily for 28 days. Patients will then receive combination treatment with twice-daily exicorilant 140 mg (total daily dose 280 mg) and enzalutamide once daily in 28-day dosing cycles.
|
Dose Determination Segment 1 (Open-label):Cohort 3 - 280 mg Exicorilant
n=9 Participants
Patients will not receive lead-in enzalutamide monotherapy. Patients will receive combination treatment with twice-daily exicorilant 140 mg (total daily dose 280 mg) and enzalutamide once daily in 28-day dosing cycles.
|
Dose Determination Segment 1 (Open-label): Cohort 1 - 360 mg Exicorilant
n=5 Participants
Patients will receive lead-in enzalutamide monotherapy once daily for 28 days. Patients will then receive combination treatment with twice-daily exicorilant 180 mg (total daily dose 360 mg) and enzalutamide once daily in 28-day dosing cycles.
|
Dose Determination Segment 2: Arm A - Maximum Dose 320 mg Exicorilant
Patients will receive treatment with once-daily exicorilant starting at 240 mg and titrating to 280 mg and then to 320 mg at 2-week intervals, as tolerated, in combination with enzalutamide once daily in 28-day dosing cycles. Patients in this arm are reported at the highest titrated dose of exicorilant achieved: 320 mg exicorilant.
|
Dose Determination Segment 2: Arm B - 240 mg Exicorilant
Patients will receive combination treatment with once-daily exicorilant 240 mg, enzalutamide once daily, and placebo in 28-day dosing cycles.
|
Dose Determination Segment 2: Arm A - Maximum Dose 240 mg Exicorilant
n=5 Participants
Patients will receive treatment with once-daily exicorilant starting at 240 mg and titrating to 280 mg and then to 320 mg at 2-week intervals, as tolerated, in combination with enzalutamide once daily in 28-day dosing cycles. Patients in this arm are reported at the highest titrated dose of exicorilant achieved: 240 mg exicorilant.
|
Dose Determination Segment 2: Arm A - Maximum Dose 280 mg Exicorilant
Patients will receive treatment with once-daily exicorilant starting at 240 mg and titrating to 280 mg and then to 320 mg at 2-week intervals, as tolerated, in combination with enzalutamide once daily in 28-day dosing cycles. Patients in this arm are reported at the highest titrated dose of exicorilant achieved: 280 mg exicorilant.
|
|---|---|---|---|---|---|---|---|
|
AUC of Plasma Enzalutamide: Segment 2
Cycle 1 Day 15 before dose escalation
|
90563 ng-hr/ml
|
98157 ng-hr/ml
Geometric Coefficient of Variation 26.1
|
93894 ng-hr/ml
Geometric Coefficient of Variation 27.5
|
—
|
—
|
95735 ng-hr/ml
Geometric Coefficient of Variation 8.5
|
—
|
|
AUC of Plasma Enzalutamide: Segment 2
After dose escalation from 240 mg to 280 mg exicorilant
|
—
|
102373 ng-hr/ml
Geometric Coefficient of Variation 20.3
|
150022 ng-hr/ml
|
—
|
—
|
96684 ng-hr/ml
Geometric Coefficient of Variation 17.6
|
—
|
|
AUC of Plasma Enzalutamide: Segment 2
After dose escalation from 280 mg to 320 mg exicorilant
|
—
|
111632 ng-hr/ml
Geometric Coefficient of Variation 12.4
|
—
|
—
|
—
|
95653 ng-hr/ml
Geometric Coefficient of Variation 11.8
|
—
|
SECONDARY outcome
Timeframe: Predose and at time intervals up to 6 hours on Cycle 1 Day 15 (before dose escalation), and at 2 weeks after each dose escalation (Week 4 for escalation from 240 mg to 280 mg exicorilant and Week 6 for escalation from 280 mg to 320 mg exicorilant).Population: The PK-Evaluable Population includes all patients who received active study treatment and had measurable plasma concentration of study treatment at any time point.
Maximum observed concentration over the dosing interval. Patients in Arm B did not receive dose escalations, but they were sampled for pharmacokinetic analysis on the same time frame as the Arm A patients: Cycle 1 Day 15, Week 4, and Week 6.
Outcome measures
| Measure |
Dose Determination Segment 1 (Open-label): Cohort 2 - 280 mg Exicorilant
n=1 Participants
Patients will receive lead-in enzalutamide monotherapy once daily for 28 days. Patients will then receive combination treatment with twice-daily exicorilant 140 mg (total daily dose 280 mg) and enzalutamide once daily in 28-day dosing cycles.
|
Dose Determination Segment 1 (Open-label):Cohort 3 - 280 mg Exicorilant
n=9 Participants
Patients will not receive lead-in enzalutamide monotherapy. Patients will receive combination treatment with twice-daily exicorilant 140 mg (total daily dose 280 mg) and enzalutamide once daily in 28-day dosing cycles.
|
Dose Determination Segment 1 (Open-label): Cohort 1 - 360 mg Exicorilant
n=5 Participants
Patients will receive lead-in enzalutamide monotherapy once daily for 28 days. Patients will then receive combination treatment with twice-daily exicorilant 180 mg (total daily dose 360 mg) and enzalutamide once daily in 28-day dosing cycles.
|
Dose Determination Segment 2: Arm A - Maximum Dose 320 mg Exicorilant
Patients will receive treatment with once-daily exicorilant starting at 240 mg and titrating to 280 mg and then to 320 mg at 2-week intervals, as tolerated, in combination with enzalutamide once daily in 28-day dosing cycles. Patients in this arm are reported at the highest titrated dose of exicorilant achieved: 320 mg exicorilant.
|
Dose Determination Segment 2: Arm B - 240 mg Exicorilant
Patients will receive combination treatment with once-daily exicorilant 240 mg, enzalutamide once daily, and placebo in 28-day dosing cycles.
|
Dose Determination Segment 2: Arm A - Maximum Dose 240 mg Exicorilant
n=5 Participants
Patients will receive treatment with once-daily exicorilant starting at 240 mg and titrating to 280 mg and then to 320 mg at 2-week intervals, as tolerated, in combination with enzalutamide once daily in 28-day dosing cycles. Patients in this arm are reported at the highest titrated dose of exicorilant achieved: 240 mg exicorilant.
|
Dose Determination Segment 2: Arm A - Maximum Dose 280 mg Exicorilant
Patients will receive treatment with once-daily exicorilant starting at 240 mg and titrating to 280 mg and then to 320 mg at 2-week intervals, as tolerated, in combination with enzalutamide once daily in 28-day dosing cycles. Patients in this arm are reported at the highest titrated dose of exicorilant achieved: 280 mg exicorilant.
|
|---|---|---|---|---|---|---|---|
|
Cmax of Plasma Enzalutamide: Segment 2
Cycle 1 Day 15 before dose escalation
|
16800 ng/ml
|
18004 ng/ml
Geometric Coefficient of Variation 25.6
|
17609 ng/ml
Geometric Coefficient of Variation 28.3
|
—
|
—
|
18440 ng/ml
Geometric Coefficient of Variation 15.2
|
—
|
|
Cmax of Plasma Enzalutamide: Segment 2
After dose escalation from 240 mg to 280 mg exicorilant
|
—
|
18899 ng/ml
Geometric Coefficient of Variation 17.9
|
27000 ng/ml
|
—
|
—
|
18408 ng/ml
Geometric Coefficient of Variation 22.8
|
—
|
|
Cmax of Plasma Enzalutamide: Segment 2
After dose escalation from 280 mg to 320 mg exicorilant
|
—
|
20235 ng/ml
Geometric Coefficient of Variation 13.2
|
—
|
—
|
—
|
18157 ng/ml
Geometric Coefficient of Variation 17.0
|
—
|
SECONDARY outcome
Timeframe: Predose and at time intervals up to 6 hours on Cycle 1 Day 15 (before dose escalation), and at 2 weeks after each dose escalation (Week 4 for escalation from 240 mg to 280 mg exicorilant and Week 6 for escalation from 280 mg to 320 mg exicorilant).Population: The PK-Evaluable Population includes all patients who received active study treatment and had measurable plasma concentration of study treatment at any time point.
AUC from time zero to 6 hours postdose (AUC0-6) calculated using linear up and log down method. Patients in Arm B did not receive dose escalations, but they were sampled for pharmacokinetic analysis on the same time frame as the Arm A patients: Cycle 1 Day 15, Week 4, and Week 6.
Outcome measures
| Measure |
Dose Determination Segment 1 (Open-label): Cohort 2 - 280 mg Exicorilant
n=1 Participants
Patients will receive lead-in enzalutamide monotherapy once daily for 28 days. Patients will then receive combination treatment with twice-daily exicorilant 140 mg (total daily dose 280 mg) and enzalutamide once daily in 28-day dosing cycles.
|
Dose Determination Segment 1 (Open-label):Cohort 3 - 280 mg Exicorilant
n=9 Participants
Patients will not receive lead-in enzalutamide monotherapy. Patients will receive combination treatment with twice-daily exicorilant 140 mg (total daily dose 280 mg) and enzalutamide once daily in 28-day dosing cycles.
|
Dose Determination Segment 1 (Open-label): Cohort 1 - 360 mg Exicorilant
n=5 Participants
Patients will receive lead-in enzalutamide monotherapy once daily for 28 days. Patients will then receive combination treatment with twice-daily exicorilant 180 mg (total daily dose 360 mg) and enzalutamide once daily in 28-day dosing cycles.
|
Dose Determination Segment 2: Arm A - Maximum Dose 320 mg Exicorilant
Patients will receive treatment with once-daily exicorilant starting at 240 mg and titrating to 280 mg and then to 320 mg at 2-week intervals, as tolerated, in combination with enzalutamide once daily in 28-day dosing cycles. Patients in this arm are reported at the highest titrated dose of exicorilant achieved: 320 mg exicorilant.
|
Dose Determination Segment 2: Arm B - 240 mg Exicorilant
Patients will receive combination treatment with once-daily exicorilant 240 mg, enzalutamide once daily, and placebo in 28-day dosing cycles.
|
Dose Determination Segment 2: Arm A - Maximum Dose 240 mg Exicorilant
n=5 Participants
Patients will receive treatment with once-daily exicorilant starting at 240 mg and titrating to 280 mg and then to 320 mg at 2-week intervals, as tolerated, in combination with enzalutamide once daily in 28-day dosing cycles. Patients in this arm are reported at the highest titrated dose of exicorilant achieved: 240 mg exicorilant.
|
Dose Determination Segment 2: Arm A - Maximum Dose 280 mg Exicorilant
Patients will receive treatment with once-daily exicorilant starting at 240 mg and titrating to 280 mg and then to 320 mg at 2-week intervals, as tolerated, in combination with enzalutamide once daily in 28-day dosing cycles. Patients in this arm are reported at the highest titrated dose of exicorilant achieved: 280 mg exicorilant.
|
|---|---|---|---|---|---|---|---|
|
AUC of Plasma N-Desmethyl Enzalutamide: Segment 2
After dose escalation from 240 mg to 280 mg exicorilant
|
—
|
51977 ng-hr/ml
Geometric Coefficient of Variation 22.0
|
49995 ng-hr/ml
|
—
|
—
|
50353 ng-hr/ml
Geometric Coefficient of Variation 28.2
|
—
|
|
AUC of Plasma N-Desmethyl Enzalutamide: Segment 2
Cycle 1 Day 15 before dose escalation
|
34131 ng-hr/ml
|
50752 ng-hr/ml
Geometric Coefficient of Variation 20.6
|
67872 ng-hr/ml
Geometric Coefficient of Variation 7.0
|
—
|
—
|
49744 ng-hr/ml
Geometric Coefficient of Variation 21.0
|
—
|
|
AUC of Plasma N-Desmethyl Enzalutamide: Segment 2
After dose escalation from 280 mg to 320 mg exicorilant
|
—
|
48255 ng-hr/ml
Geometric Coefficient of Variation 11.2
|
—
|
—
|
—
|
48411 ng-hr/ml
Geometric Coefficient of Variation 20.6
|
—
|
SECONDARY outcome
Timeframe: Predose and at time intervals up to 6 hours on Cycle 1 Day 15 (before dose escalation), and at 2 weeks after each dose escalation (Week 4 for escalation from 240 mg to 280 mg exicorilant and Week 6 for escalation from 280 mg to 320 mg exicorilant).Population: The PK-Evaluable Population includes all patients who received active study treatment and had measurable plasma concentration of study treatment at any time point.
Maximum observed concentration over the dosing interval. Patients in Arm B did not receive dose escalations, but they were sampled for pharmacokinetic analysis on the same time frame as the Arm A patients: Cycle 1 Day 15, Week 4, and Week 6.
Outcome measures
| Measure |
Dose Determination Segment 1 (Open-label): Cohort 2 - 280 mg Exicorilant
n=1 Participants
Patients will receive lead-in enzalutamide monotherapy once daily for 28 days. Patients will then receive combination treatment with twice-daily exicorilant 140 mg (total daily dose 280 mg) and enzalutamide once daily in 28-day dosing cycles.
|
Dose Determination Segment 1 (Open-label):Cohort 3 - 280 mg Exicorilant
n=9 Participants
Patients will not receive lead-in enzalutamide monotherapy. Patients will receive combination treatment with twice-daily exicorilant 140 mg (total daily dose 280 mg) and enzalutamide once daily in 28-day dosing cycles.
|
Dose Determination Segment 1 (Open-label): Cohort 1 - 360 mg Exicorilant
n=5 Participants
Patients will receive lead-in enzalutamide monotherapy once daily for 28 days. Patients will then receive combination treatment with twice-daily exicorilant 180 mg (total daily dose 360 mg) and enzalutamide once daily in 28-day dosing cycles.
|
Dose Determination Segment 2: Arm A - Maximum Dose 320 mg Exicorilant
Patients will receive treatment with once-daily exicorilant starting at 240 mg and titrating to 280 mg and then to 320 mg at 2-week intervals, as tolerated, in combination with enzalutamide once daily in 28-day dosing cycles. Patients in this arm are reported at the highest titrated dose of exicorilant achieved: 320 mg exicorilant.
|
Dose Determination Segment 2: Arm B - 240 mg Exicorilant
Patients will receive combination treatment with once-daily exicorilant 240 mg, enzalutamide once daily, and placebo in 28-day dosing cycles.
|
Dose Determination Segment 2: Arm A - Maximum Dose 240 mg Exicorilant
n=5 Participants
Patients will receive treatment with once-daily exicorilant starting at 240 mg and titrating to 280 mg and then to 320 mg at 2-week intervals, as tolerated, in combination with enzalutamide once daily in 28-day dosing cycles. Patients in this arm are reported at the highest titrated dose of exicorilant achieved: 240 mg exicorilant.
|
Dose Determination Segment 2: Arm A - Maximum Dose 280 mg Exicorilant
Patients will receive treatment with once-daily exicorilant starting at 240 mg and titrating to 280 mg and then to 320 mg at 2-week intervals, as tolerated, in combination with enzalutamide once daily in 28-day dosing cycles. Patients in this arm are reported at the highest titrated dose of exicorilant achieved: 280 mg exicorilant.
|
|---|---|---|---|---|---|---|---|
|
Cmax of Plasma N-Desmethyl Enzalutamide: Segment 2
Cycle 1 Day 15 before dose escalation
|
6520 ng/ml
|
9350 ng/ml
Geometric Coefficient of Variation 22.8
|
12448 ng/ml
Geometric Coefficient of Variation 7.7
|
—
|
—
|
10116 ng/ml
Geometric Coefficient of Variation 24.3
|
—
|
|
Cmax of Plasma N-Desmethyl Enzalutamide: Segment 2
After dose escalation from 240 mg to 280 mg exicorilant
|
—
|
9682 ng/ml
Geometric Coefficient of Variation 20.4
|
8600 ng/ml
|
—
|
—
|
9873 ng/ml
Geometric Coefficient of Variation 28.4
|
—
|
|
Cmax of Plasma N-Desmethyl Enzalutamide: Segment 2
After dose escalation from 280 mg to 320 mg exicorilant
|
—
|
8870 ng/ml
Geometric Coefficient of Variation 13.4
|
—
|
—
|
—
|
9185 ng/ml
Geometric Coefficient of Variation 23.8
|
—
|
SECONDARY outcome
Timeframe: Predose and at time intervals up to 6 hours on Cycle 1 Day 15 (before dose escalation), and at 2 weeks after each dose escalation (Week 4 for escalation from 240 mg to 280 mg exicorilant and Week 6 for escalation from 280 mg to 320 mg exicorilant).Population: The PK-Evaluable Population includes all patients who received active study treatment and had measurable plasma concentration of study treatment at any time point.
AUC from time zero to 6 hours postdose (AUC0-6) calculated using linear up and log down method. Patients in Arm B did not receive dose escalations, but they were sampled for pharmacokinetic analysis on the same time frame as the Arm A patients: Cycle 1 Day 15, Week 4, and Week 6.
Outcome measures
| Measure |
Dose Determination Segment 1 (Open-label): Cohort 2 - 280 mg Exicorilant
n=1 Participants
Patients will receive lead-in enzalutamide monotherapy once daily for 28 days. Patients will then receive combination treatment with twice-daily exicorilant 140 mg (total daily dose 280 mg) and enzalutamide once daily in 28-day dosing cycles.
|
Dose Determination Segment 1 (Open-label):Cohort 3 - 280 mg Exicorilant
n=9 Participants
Patients will not receive lead-in enzalutamide monotherapy. Patients will receive combination treatment with twice-daily exicorilant 140 mg (total daily dose 280 mg) and enzalutamide once daily in 28-day dosing cycles.
|
Dose Determination Segment 1 (Open-label): Cohort 1 - 360 mg Exicorilant
n=5 Participants
Patients will receive lead-in enzalutamide monotherapy once daily for 28 days. Patients will then receive combination treatment with twice-daily exicorilant 180 mg (total daily dose 360 mg) and enzalutamide once daily in 28-day dosing cycles.
|
Dose Determination Segment 2: Arm A - Maximum Dose 320 mg Exicorilant
Patients will receive treatment with once-daily exicorilant starting at 240 mg and titrating to 280 mg and then to 320 mg at 2-week intervals, as tolerated, in combination with enzalutamide once daily in 28-day dosing cycles. Patients in this arm are reported at the highest titrated dose of exicorilant achieved: 320 mg exicorilant.
|
Dose Determination Segment 2: Arm B - 240 mg Exicorilant
Patients will receive combination treatment with once-daily exicorilant 240 mg, enzalutamide once daily, and placebo in 28-day dosing cycles.
|
Dose Determination Segment 2: Arm A - Maximum Dose 240 mg Exicorilant
n=5 Participants
Patients will receive treatment with once-daily exicorilant starting at 240 mg and titrating to 280 mg and then to 320 mg at 2-week intervals, as tolerated, in combination with enzalutamide once daily in 28-day dosing cycles. Patients in this arm are reported at the highest titrated dose of exicorilant achieved: 240 mg exicorilant.
|
Dose Determination Segment 2: Arm A - Maximum Dose 280 mg Exicorilant
Patients will receive treatment with once-daily exicorilant starting at 240 mg and titrating to 280 mg and then to 320 mg at 2-week intervals, as tolerated, in combination with enzalutamide once daily in 28-day dosing cycles. Patients in this arm are reported at the highest titrated dose of exicorilant achieved: 280 mg exicorilant.
|
|---|---|---|---|---|---|---|---|
|
AUC of Plasma Enzalutamide Carboxylic Acid: Segment 2
Cycle 1 Day 15 before dose escalation
|
14108 ng-hr/ml
|
24863 ng-hr/ml
Geometric Coefficient of Variation 41.6
|
25662 ng-hr/ml
Geometric Coefficient of Variation 55.7
|
—
|
—
|
19310 ng-hr/ml
Geometric Coefficient of Variation 56.9
|
—
|
|
AUC of Plasma Enzalutamide Carboxylic Acid: Segment 2
After dose escalation from 240 mg to 280 mg exicorilant
|
—
|
25995 ng-hr/ml
Geometric Coefficient of Variation 42.6
|
86613 ng-hr/ml
|
—
|
—
|
23393 ng-hr/ml
Geometric Coefficient of Variation 21.1
|
—
|
|
AUC of Plasma Enzalutamide Carboxylic Acid: Segment 2
After dose escalation from 280 mg to 320 mg exicorilant
|
—
|
31814 ng-hr/ml
Geometric Coefficient of Variation 20.8
|
—
|
—
|
—
|
18047 ng-hr/ml
Geometric Coefficient of Variation 43.6
|
—
|
SECONDARY outcome
Timeframe: Predose and at time intervals up to 6 hours on Cycle 1 Day 15 (before dose escalation), and at 2 weeks after each dose escalation (Week 4 for escalation from 240 mg to 280 mg exicorilant and Week 6 for escalation from 280 mg to 320 mg exicorilant).Population: The PK-Evaluable Population includes all patients who received active study treatment and had measurable plasma concentration of study treatment at any time point.
Maximum observed concentration over the dosing interval. Patients in Arm B did not receive dose escalations, but they were sampled for pharmacokinetic analysis on the same time frame as the Arm A patients: Cycle 1 Day 15, Week 4, and Week 6.
Outcome measures
| Measure |
Dose Determination Segment 1 (Open-label): Cohort 2 - 280 mg Exicorilant
n=1 Participants
Patients will receive lead-in enzalutamide monotherapy once daily for 28 days. Patients will then receive combination treatment with twice-daily exicorilant 140 mg (total daily dose 280 mg) and enzalutamide once daily in 28-day dosing cycles.
|
Dose Determination Segment 1 (Open-label):Cohort 3 - 280 mg Exicorilant
n=9 Participants
Patients will not receive lead-in enzalutamide monotherapy. Patients will receive combination treatment with twice-daily exicorilant 140 mg (total daily dose 280 mg) and enzalutamide once daily in 28-day dosing cycles.
|
Dose Determination Segment 1 (Open-label): Cohort 1 - 360 mg Exicorilant
n=5 Participants
Patients will receive lead-in enzalutamide monotherapy once daily for 28 days. Patients will then receive combination treatment with twice-daily exicorilant 180 mg (total daily dose 360 mg) and enzalutamide once daily in 28-day dosing cycles.
|
Dose Determination Segment 2: Arm A - Maximum Dose 320 mg Exicorilant
Patients will receive treatment with once-daily exicorilant starting at 240 mg and titrating to 280 mg and then to 320 mg at 2-week intervals, as tolerated, in combination with enzalutamide once daily in 28-day dosing cycles. Patients in this arm are reported at the highest titrated dose of exicorilant achieved: 320 mg exicorilant.
|
Dose Determination Segment 2: Arm B - 240 mg Exicorilant
Patients will receive combination treatment with once-daily exicorilant 240 mg, enzalutamide once daily, and placebo in 28-day dosing cycles.
|
Dose Determination Segment 2: Arm A - Maximum Dose 240 mg Exicorilant
n=5 Participants
Patients will receive treatment with once-daily exicorilant starting at 240 mg and titrating to 280 mg and then to 320 mg at 2-week intervals, as tolerated, in combination with enzalutamide once daily in 28-day dosing cycles. Patients in this arm are reported at the highest titrated dose of exicorilant achieved: 240 mg exicorilant.
|
Dose Determination Segment 2: Arm A - Maximum Dose 280 mg Exicorilant
Patients will receive treatment with once-daily exicorilant starting at 240 mg and titrating to 280 mg and then to 320 mg at 2-week intervals, as tolerated, in combination with enzalutamide once daily in 28-day dosing cycles. Patients in this arm are reported at the highest titrated dose of exicorilant achieved: 280 mg exicorilant.
|
|---|---|---|---|---|---|---|---|
|
Cmax of Plasma Enzalutamide Carboxylic Acid: Segment 2
After dose escalation from 240 mg to 280 mg exicorilant
|
—
|
4821 ng/ml
Geometric Coefficient of Variation 43.1
|
15400 ng/ml
|
—
|
—
|
4745 ng/ml
Geometric Coefficient of Variation 15.1
|
—
|
|
Cmax of Plasma Enzalutamide Carboxylic Acid: Segment 2
Cycle 1 Day 15 before dose escalation
|
2480 ng/ml
|
4572 ng/ml
Geometric Coefficient of Variation 40.8
|
4693 ng/ml
Geometric Coefficient of Variation 50.8
|
—
|
—
|
3713 ng/ml
Geometric Coefficient of Variation 58.3
|
—
|
|
Cmax of Plasma Enzalutamide Carboxylic Acid: Segment 2
After dose escalation from 280 mg to 320 mg exicorilant
|
—
|
6032 ng/ml
Geometric Coefficient of Variation 24.8
|
—
|
—
|
—
|
3524 ng/ml
Geometric Coefficient of Variation 44.1
|
—
|
SECONDARY outcome
Timeframe: Up to 22 monthsPopulation: The Response-Evaluable (RE) Population includes all patients who received ≥1 dose of the combination (exicorilant + enzalutamide) study treatment and had measurable disease at Baseline.
Confirmed ORR is defined as the proportion of patients with measurable disease at Baseline who achieve a complete regression (CR) or partial regression (PR) by Prostate Cancer Clinical Trials Working Group 3 (PCWG3) / Modified Response Evaluation Criteria in Solid Tumors v1.1 (mRECIST) criteria, after confirmation.
Outcome measures
| Measure |
Dose Determination Segment 1 (Open-label): Cohort 2 - 280 mg Exicorilant
Patients will receive lead-in enzalutamide monotherapy once daily for 28 days. Patients will then receive combination treatment with twice-daily exicorilant 140 mg (total daily dose 280 mg) and enzalutamide once daily in 28-day dosing cycles.
|
Dose Determination Segment 1 (Open-label):Cohort 3 - 280 mg Exicorilant
n=5 Participants
Patients will not receive lead-in enzalutamide monotherapy. Patients will receive combination treatment with twice-daily exicorilant 140 mg (total daily dose 280 mg) and enzalutamide once daily in 28-day dosing cycles.
|
Dose Determination Segment 1 (Open-label): Cohort 1 - 360 mg Exicorilant
n=2 Participants
Patients will receive lead-in enzalutamide monotherapy once daily for 28 days. Patients will then receive combination treatment with twice-daily exicorilant 180 mg (total daily dose 360 mg) and enzalutamide once daily in 28-day dosing cycles.
|
Dose Determination Segment 2: Arm A - Maximum Dose 320 mg Exicorilant
n=6 Participants
Patients will receive treatment with once-daily exicorilant starting at 240 mg and titrating to 280 mg and then to 320 mg at 2-week intervals, as tolerated, in combination with enzalutamide once daily in 28-day dosing cycles. Patients in this arm are reported at the highest titrated dose of exicorilant achieved: 320 mg exicorilant.
|
Dose Determination Segment 2: Arm B - 240 mg Exicorilant
n=1 Participants
Patients will receive combination treatment with once-daily exicorilant 240 mg, enzalutamide once daily, and placebo in 28-day dosing cycles.
|
Dose Determination Segment 2: Arm A - Maximum Dose 240 mg Exicorilant
n=3 Participants
Patients will receive treatment with once-daily exicorilant starting at 240 mg and titrating to 280 mg and then to 320 mg at 2-week intervals, as tolerated, in combination with enzalutamide once daily in 28-day dosing cycles. Patients in this arm are reported at the highest titrated dose of exicorilant achieved: 240 mg exicorilant.
|
Dose Determination Segment 2: Arm A - Maximum Dose 280 mg Exicorilant
Patients will receive treatment with once-daily exicorilant starting at 240 mg and titrating to 280 mg and then to 320 mg at 2-week intervals, as tolerated, in combination with enzalutamide once daily in 28-day dosing cycles. Patients in this arm are reported at the highest titrated dose of exicorilant achieved: 280 mg exicorilant.
|
|---|---|---|---|---|---|---|---|
|
Objective Response Rate (ORR)
|
0 Participants
|
1 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Up to 39 monthsPopulation: The Intent-to-treat (ITT) Population includes all patients who received at least 1 dose of the combination (exicorilant + enzalutamide) study treatment.
Outcome measures
| Measure |
Dose Determination Segment 1 (Open-label): Cohort 2 - 280 mg Exicorilant
n=3 Participants
Patients will receive lead-in enzalutamide monotherapy once daily for 28 days. Patients will then receive combination treatment with twice-daily exicorilant 140 mg (total daily dose 280 mg) and enzalutamide once daily in 28-day dosing cycles.
|
Dose Determination Segment 1 (Open-label):Cohort 3 - 280 mg Exicorilant
n=7 Participants
Patients will not receive lead-in enzalutamide monotherapy. Patients will receive combination treatment with twice-daily exicorilant 140 mg (total daily dose 280 mg) and enzalutamide once daily in 28-day dosing cycles.
|
Dose Determination Segment 1 (Open-label): Cohort 1 - 360 mg Exicorilant
n=2 Participants
Patients will receive lead-in enzalutamide monotherapy once daily for 28 days. Patients will then receive combination treatment with twice-daily exicorilant 180 mg (total daily dose 360 mg) and enzalutamide once daily in 28-day dosing cycles.
|
Dose Determination Segment 2: Arm A - Maximum Dose 320 mg Exicorilant
n=10 Participants
Patients will receive treatment with once-daily exicorilant starting at 240 mg and titrating to 280 mg and then to 320 mg at 2-week intervals, as tolerated, in combination with enzalutamide once daily in 28-day dosing cycles. Patients in this arm are reported at the highest titrated dose of exicorilant achieved: 320 mg exicorilant.
|
Dose Determination Segment 2: Arm B - 240 mg Exicorilant
n=6 Participants
Patients will receive combination treatment with once-daily exicorilant 240 mg, enzalutamide once daily, and placebo in 28-day dosing cycles.
|
Dose Determination Segment 2: Arm A - Maximum Dose 240 mg Exicorilant
n=8 Participants
Patients will receive treatment with once-daily exicorilant starting at 240 mg and titrating to 280 mg and then to 320 mg at 2-week intervals, as tolerated, in combination with enzalutamide once daily in 28-day dosing cycles. Patients in this arm are reported at the highest titrated dose of exicorilant achieved: 240 mg exicorilant.
|
Dose Determination Segment 2: Arm A - Maximum Dose 280 mg Exicorilant
n=1 Participants
Patients will receive treatment with once-daily exicorilant starting at 240 mg and titrating to 280 mg and then to 320 mg at 2-week intervals, as tolerated, in combination with enzalutamide once daily in 28-day dosing cycles. Patients in this arm are reported at the highest titrated dose of exicorilant achieved: 280 mg exicorilant.
|
|---|---|---|---|---|---|---|---|
|
Number of Patients With ≥50% Reduction in Prostate-Specific Antigen (PSA)
|
0 Participants
|
3 Participants
|
2 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Up to 39 monthsPopulation: The ITT Population includes all patients who received at least 1 dose of the combination (exicorilant + enzalutamide) study treatment.
Assess the time to PSA progression defined as the first occurrence of 50% or greater increase in PSA levels. Kaplan-Meier estimates of time to PSA progression were calculated as (earliest date of PSA progression or censoring - date of first study treatment + 1)/30.4375.
Outcome measures
| Measure |
Dose Determination Segment 1 (Open-label): Cohort 2 - 280 mg Exicorilant
n=3 Participants
Patients will receive lead-in enzalutamide monotherapy once daily for 28 days. Patients will then receive combination treatment with twice-daily exicorilant 140 mg (total daily dose 280 mg) and enzalutamide once daily in 28-day dosing cycles.
|
Dose Determination Segment 1 (Open-label):Cohort 3 - 280 mg Exicorilant
n=7 Participants
Patients will not receive lead-in enzalutamide monotherapy. Patients will receive combination treatment with twice-daily exicorilant 140 mg (total daily dose 280 mg) and enzalutamide once daily in 28-day dosing cycles.
|
Dose Determination Segment 1 (Open-label): Cohort 1 - 360 mg Exicorilant
n=2 Participants
Patients will receive lead-in enzalutamide monotherapy once daily for 28 days. Patients will then receive combination treatment with twice-daily exicorilant 180 mg (total daily dose 360 mg) and enzalutamide once daily in 28-day dosing cycles.
|
Dose Determination Segment 2: Arm A - Maximum Dose 320 mg Exicorilant
n=10 Participants
Patients will receive treatment with once-daily exicorilant starting at 240 mg and titrating to 280 mg and then to 320 mg at 2-week intervals, as tolerated, in combination with enzalutamide once daily in 28-day dosing cycles. Patients in this arm are reported at the highest titrated dose of exicorilant achieved: 320 mg exicorilant.
|
Dose Determination Segment 2: Arm B - 240 mg Exicorilant
n=6 Participants
Patients will receive combination treatment with once-daily exicorilant 240 mg, enzalutamide once daily, and placebo in 28-day dosing cycles.
|
Dose Determination Segment 2: Arm A - Maximum Dose 240 mg Exicorilant
n=8 Participants
Patients will receive treatment with once-daily exicorilant starting at 240 mg and titrating to 280 mg and then to 320 mg at 2-week intervals, as tolerated, in combination with enzalutamide once daily in 28-day dosing cycles. Patients in this arm are reported at the highest titrated dose of exicorilant achieved: 240 mg exicorilant.
|
Dose Determination Segment 2: Arm A - Maximum Dose 280 mg Exicorilant
n=1 Participants
Patients will receive treatment with once-daily exicorilant starting at 240 mg and titrating to 280 mg and then to 320 mg at 2-week intervals, as tolerated, in combination with enzalutamide once daily in 28-day dosing cycles. Patients in this arm are reported at the highest titrated dose of exicorilant achieved: 280 mg exicorilant.
|
|---|---|---|---|---|---|---|---|
|
Time to PSA Progression
|
NA months
Interval 0.99 to
The value was not estimable due to low number of patients with an event.
|
38.90 months
Interval 0.99 to
The value was not estimable due to low number of patients with an event.
|
NA months
The value was not estimable due to low number of patients with an event.
|
1.41 months
Interval 0.49 to
The value was not estimable due to low number of patients with an event.
|
3.25 months
Interval 0.95 to
The value was not estimable due to low number of patients with an event.
|
1.43 months
Interval 0.49 to
The value was not estimable due to low number of patients with an event.
|
1.41 months
|
SECONDARY outcome
Timeframe: 4, 6, and 12 monthsPopulation: The ITT Population includes all patients who received at least 1 dose of the combination (exicorilant + enzalutamide) study treatment.
Assess the percentage of patients who are progression-free by PSA criteria, or death. PSA progression was defined as the first occurrence of 50% or greater increase in PSA levels. Values are Kaplan-Meier estimates of the patients progression free at the time points specified.
Outcome measures
| Measure |
Dose Determination Segment 1 (Open-label): Cohort 2 - 280 mg Exicorilant
n=3 Participants
Patients will receive lead-in enzalutamide monotherapy once daily for 28 days. Patients will then receive combination treatment with twice-daily exicorilant 140 mg (total daily dose 280 mg) and enzalutamide once daily in 28-day dosing cycles.
|
Dose Determination Segment 1 (Open-label):Cohort 3 - 280 mg Exicorilant
n=7 Participants
Patients will not receive lead-in enzalutamide monotherapy. Patients will receive combination treatment with twice-daily exicorilant 140 mg (total daily dose 280 mg) and enzalutamide once daily in 28-day dosing cycles.
|
Dose Determination Segment 1 (Open-label): Cohort 1 - 360 mg Exicorilant
n=2 Participants
Patients will receive lead-in enzalutamide monotherapy once daily for 28 days. Patients will then receive combination treatment with twice-daily exicorilant 180 mg (total daily dose 360 mg) and enzalutamide once daily in 28-day dosing cycles.
|
Dose Determination Segment 2: Arm A - Maximum Dose 320 mg Exicorilant
n=10 Participants
Patients will receive treatment with once-daily exicorilant starting at 240 mg and titrating to 280 mg and then to 320 mg at 2-week intervals, as tolerated, in combination with enzalutamide once daily in 28-day dosing cycles. Patients in this arm are reported at the highest titrated dose of exicorilant achieved: 320 mg exicorilant.
|
Dose Determination Segment 2: Arm B - 240 mg Exicorilant
n=6 Participants
Patients will receive combination treatment with once-daily exicorilant 240 mg, enzalutamide once daily, and placebo in 28-day dosing cycles.
|
Dose Determination Segment 2: Arm A - Maximum Dose 240 mg Exicorilant
n=8 Participants
Patients will receive treatment with once-daily exicorilant starting at 240 mg and titrating to 280 mg and then to 320 mg at 2-week intervals, as tolerated, in combination with enzalutamide once daily in 28-day dosing cycles. Patients in this arm are reported at the highest titrated dose of exicorilant achieved: 240 mg exicorilant.
|
Dose Determination Segment 2: Arm A - Maximum Dose 280 mg Exicorilant
n=1 Participants
Patients will receive treatment with once-daily exicorilant starting at 240 mg and titrating to 280 mg and then to 320 mg at 2-week intervals, as tolerated, in combination with enzalutamide once daily in 28-day dosing cycles. Patients in this arm are reported at the highest titrated dose of exicorilant achieved: 280 mg exicorilant.
|
|---|---|---|---|---|---|---|---|
|
Percentage of Patients Who Are Progression-Free by PSA Criteria at 4, 6, and 12 Months
4 months
|
NA Percentage of patients
All patients progressed, died, or were censored before the time point.
|
85.71 Percentage of patients
Interval 33.41 to 97.86
|
0 Percentage of patients
All patients progressed, died, or were censored before the time point.
|
40.00 Percentage of patients
Interval 12.27 to 67.02
|
50.00 Percentage of patients
Interval 11.09 to 80.37
|
0 Percentage of patients
All patients progressed, died, or were censored before the time point.
|
0 Percentage of patients
|
|
Percentage of Patients Who Are Progression-Free by PSA Criteria at 4, 6, and 12 Months
6 months
|
NA Percentage of patients
All patients progressed, died, or were censored before the time point.
|
85.71 Percentage of patients
Interval 33.41 to 97.86
|
0 Percentage of patients
All patients progressed, died, or were censored before the time point.
|
40.00 Percentage of patients
Interval 12.27 to 67.02
|
33.33 Percentage of patients
Interval 4.61 to 67.56
|
0 Percentage of patients
All patients progressed, died, or were censored before the time point.
|
0 Percentage of patients
|
|
Percentage of Patients Who Are Progression-Free by PSA Criteria at 4, 6, and 12 Months
12 months
|
NA Percentage of patients
All patients progressed, died, or were censored before the time point.
|
85.71 Percentage of patients
Interval 33.41 to 97.86
|
0 Percentage of patients
All patients progressed, died, or were censored before the time point.
|
26.67 Percentage of patients
Interval 4.76 to 56.34
|
16.67 Percentage of patients
Interval 0.77 to 51.68
|
0 Percentage of patients
All patients progressed, died, or were censored before the time point.
|
0 Percentage of patients
|
SECONDARY outcome
Timeframe: Up to 39 monthsPopulation: The ITT Population includes all patients who received at least 1 dose of the combination (exicorilant + enzalutamide) study treatment.
Assess the time to first SSE defined as symptomatic fracture, radiation or surgery to bone, or spinal cord compression. Kaplan-Meier estimates of time to first SSE were calculated as (earliest date of SSE or censoring - date of first study treatment + 1)/30.4375.
Outcome measures
| Measure |
Dose Determination Segment 1 (Open-label): Cohort 2 - 280 mg Exicorilant
n=3 Participants
Patients will receive lead-in enzalutamide monotherapy once daily for 28 days. Patients will then receive combination treatment with twice-daily exicorilant 140 mg (total daily dose 280 mg) and enzalutamide once daily in 28-day dosing cycles.
|
Dose Determination Segment 1 (Open-label):Cohort 3 - 280 mg Exicorilant
n=7 Participants
Patients will not receive lead-in enzalutamide monotherapy. Patients will receive combination treatment with twice-daily exicorilant 140 mg (total daily dose 280 mg) and enzalutamide once daily in 28-day dosing cycles.
|
Dose Determination Segment 1 (Open-label): Cohort 1 - 360 mg Exicorilant
n=2 Participants
Patients will receive lead-in enzalutamide monotherapy once daily for 28 days. Patients will then receive combination treatment with twice-daily exicorilant 180 mg (total daily dose 360 mg) and enzalutamide once daily in 28-day dosing cycles.
|
Dose Determination Segment 2: Arm A - Maximum Dose 320 mg Exicorilant
n=10 Participants
Patients will receive treatment with once-daily exicorilant starting at 240 mg and titrating to 280 mg and then to 320 mg at 2-week intervals, as tolerated, in combination with enzalutamide once daily in 28-day dosing cycles. Patients in this arm are reported at the highest titrated dose of exicorilant achieved: 320 mg exicorilant.
|
Dose Determination Segment 2: Arm B - 240 mg Exicorilant
n=6 Participants
Patients will receive combination treatment with once-daily exicorilant 240 mg, enzalutamide once daily, and placebo in 28-day dosing cycles.
|
Dose Determination Segment 2: Arm A - Maximum Dose 240 mg Exicorilant
n=8 Participants
Patients will receive treatment with once-daily exicorilant starting at 240 mg and titrating to 280 mg and then to 320 mg at 2-week intervals, as tolerated, in combination with enzalutamide once daily in 28-day dosing cycles. Patients in this arm are reported at the highest titrated dose of exicorilant achieved: 240 mg exicorilant.
|
Dose Determination Segment 2: Arm A - Maximum Dose 280 mg Exicorilant
n=1 Participants
Patients will receive treatment with once-daily exicorilant starting at 240 mg and titrating to 280 mg and then to 320 mg at 2-week intervals, as tolerated, in combination with enzalutamide once daily in 28-day dosing cycles. Patients in this arm are reported at the highest titrated dose of exicorilant achieved: 280 mg exicorilant.
|
|---|---|---|---|---|---|---|---|
|
Time to First Symptomatic Skeletal Event (SSE)
|
NA months
Interval 2.83 to
The value was not estimable due to low number of patients with an event.
|
NA months
Interval 25.79 to
The value was not estimable due to low number of patients with an event.
|
0 months
The value was not estimable due to low number of patients with an event.
|
NA months
The value was not estimable due to low number of patients with an event.
|
NA months
The value was not estimable due to low number of patients with an event.
|
NA months
The value was not estimable due to low number of patients with an event.
|
NA months
The value was not estimable due to low number of patients with an event.
|
SECONDARY outcome
Timeframe: Up to 22 monthsPopulation: The ITT Population includes all patients who received at least 1 dose of the combination (exicorilant + enzalutamide) study treatment.
Assess radiographic progression free survival (PFS) defined as the time interval from first dose of study drug (exicorilant and/or enzalutamide) to the date when the first site of disease progression is found on computerized tomography (CT), magnetic resonance imaging (MRI), or radionucleotide bone scan per PCWG3/mRECIST v1.1, or death whichever occurs first. The data values are Kaplan-Meier estimates.
Outcome measures
| Measure |
Dose Determination Segment 1 (Open-label): Cohort 2 - 280 mg Exicorilant
n=3 Participants
Patients will receive lead-in enzalutamide monotherapy once daily for 28 days. Patients will then receive combination treatment with twice-daily exicorilant 140 mg (total daily dose 280 mg) and enzalutamide once daily in 28-day dosing cycles.
|
Dose Determination Segment 1 (Open-label):Cohort 3 - 280 mg Exicorilant
n=7 Participants
Patients will not receive lead-in enzalutamide monotherapy. Patients will receive combination treatment with twice-daily exicorilant 140 mg (total daily dose 280 mg) and enzalutamide once daily in 28-day dosing cycles.
|
Dose Determination Segment 1 (Open-label): Cohort 1 - 360 mg Exicorilant
n=2 Participants
Patients will receive lead-in enzalutamide monotherapy once daily for 28 days. Patients will then receive combination treatment with twice-daily exicorilant 180 mg (total daily dose 360 mg) and enzalutamide once daily in 28-day dosing cycles.
|
Dose Determination Segment 2: Arm A - Maximum Dose 320 mg Exicorilant
n=10 Participants
Patients will receive treatment with once-daily exicorilant starting at 240 mg and titrating to 280 mg and then to 320 mg at 2-week intervals, as tolerated, in combination with enzalutamide once daily in 28-day dosing cycles. Patients in this arm are reported at the highest titrated dose of exicorilant achieved: 320 mg exicorilant.
|
Dose Determination Segment 2: Arm B - 240 mg Exicorilant
n=6 Participants
Patients will receive combination treatment with once-daily exicorilant 240 mg, enzalutamide once daily, and placebo in 28-day dosing cycles.
|
Dose Determination Segment 2: Arm A - Maximum Dose 240 mg Exicorilant
n=8 Participants
Patients will receive treatment with once-daily exicorilant starting at 240 mg and titrating to 280 mg and then to 320 mg at 2-week intervals, as tolerated, in combination with enzalutamide once daily in 28-day dosing cycles. Patients in this arm are reported at the highest titrated dose of exicorilant achieved: 240 mg exicorilant.
|
Dose Determination Segment 2: Arm A - Maximum Dose 280 mg Exicorilant
n=1 Participants
Patients will receive treatment with once-daily exicorilant starting at 240 mg and titrating to 280 mg and then to 320 mg at 2-week intervals, as tolerated, in combination with enzalutamide once daily in 28-day dosing cycles. Patients in this arm are reported at the highest titrated dose of exicorilant achieved: 280 mg exicorilant.
|
|---|---|---|---|---|---|---|---|
|
Time to Progression by Radiographic Criteria
|
1.81 months
Interval 0.82 to
The value was not estimable due to low number of patients with an event.
|
6.21 months
Interval 0.49 to
The value was not estimable due to low number of patients with an event.
|
18.46 months
The value was not estimable due to low number of patients with an event.
|
5.08 months
Interval 1.02 to
The value was not estimable due to low number of patients with an event.
|
NA months
Interval 3.91 to
The value was not estimable due to low number of patients with an event.
|
5.55 months
Interval 1.02 to
The value was not estimable due to low number of patients with an event.
|
0 months
|
SECONDARY outcome
Timeframe: 4, 6, and 12 monthsPopulation: The ITT Population includes all patients who received at least 1 dose of the combination (exicorilant + enzalutamide) study treatment.
Assess the percentage of patients who are progression-free by radiographic criteria per PCWG3/RECIST v1.1, or death whichever occurs first. Values are Kaplan-Meier estimates of the patients progression free at the time points specified.
Outcome measures
| Measure |
Dose Determination Segment 1 (Open-label): Cohort 2 - 280 mg Exicorilant
n=3 Participants
Patients will receive lead-in enzalutamide monotherapy once daily for 28 days. Patients will then receive combination treatment with twice-daily exicorilant 140 mg (total daily dose 280 mg) and enzalutamide once daily in 28-day dosing cycles.
|
Dose Determination Segment 1 (Open-label):Cohort 3 - 280 mg Exicorilant
n=7 Participants
Patients will not receive lead-in enzalutamide monotherapy. Patients will receive combination treatment with twice-daily exicorilant 140 mg (total daily dose 280 mg) and enzalutamide once daily in 28-day dosing cycles.
|
Dose Determination Segment 1 (Open-label): Cohort 1 - 360 mg Exicorilant
n=2 Participants
Patients will receive lead-in enzalutamide monotherapy once daily for 28 days. Patients will then receive combination treatment with twice-daily exicorilant 180 mg (total daily dose 360 mg) and enzalutamide once daily in 28-day dosing cycles.
|
Dose Determination Segment 2: Arm A - Maximum Dose 320 mg Exicorilant
n=10 Participants
Patients will receive treatment with once-daily exicorilant starting at 240 mg and titrating to 280 mg and then to 320 mg at 2-week intervals, as tolerated, in combination with enzalutamide once daily in 28-day dosing cycles. Patients in this arm are reported at the highest titrated dose of exicorilant achieved: 320 mg exicorilant.
|
Dose Determination Segment 2: Arm B - 240 mg Exicorilant
n=6 Participants
Patients will receive combination treatment with once-daily exicorilant 240 mg, enzalutamide once daily, and placebo in 28-day dosing cycles.
|
Dose Determination Segment 2: Arm A - Maximum Dose 240 mg Exicorilant
n=8 Participants
Patients will receive treatment with once-daily exicorilant starting at 240 mg and titrating to 280 mg and then to 320 mg at 2-week intervals, as tolerated, in combination with enzalutamide once daily in 28-day dosing cycles. Patients in this arm are reported at the highest titrated dose of exicorilant achieved: 240 mg exicorilant.
|
Dose Determination Segment 2: Arm A - Maximum Dose 280 mg Exicorilant
n=1 Participants
Patients will receive treatment with once-daily exicorilant starting at 240 mg and titrating to 280 mg and then to 320 mg at 2-week intervals, as tolerated, in combination with enzalutamide once daily in 28-day dosing cycles. Patients in this arm are reported at the highest titrated dose of exicorilant achieved: 280 mg exicorilant.
|
|---|---|---|---|---|---|---|---|
|
Percentage of Patients Who Are Progression-Free by Radiographic Criteria at 4, 6, and 12 Months
4 months
|
0.00 Percentage of patients
All patients progressed, died, or were censored before the time point.
|
83.33 Percentage of patients
Interval 27.31 to 97.47
|
100.0 Percentage of patients
Interval 100.0 to 100.0
|
66.67 Percentage of patients
Interval 28.17 to 87.83
|
83.33 Percentage of patients
Interval 27.31 to 97.47
|
62.50 Percentage of patients
Interval 14.19 to 89.31
|
0 Percentage of patients
|
|
Percentage of Patients Who Are Progression-Free by Radiographic Criteria at 4, 6, and 12 Months
6 months
|
0.00 Percentage of patients
All patients progressed, died, or were censored before the time point.
|
62.50 Percentage of patients
Interval 14.19 to 89.31
|
100.0 Percentage of patients
Interval 100.0 to 100.0
|
33.33 Percentage of patients
Interval 5.26 to 66.38
|
62.50 Percentage of patients
Interval 14.19 to 89.31
|
0.00 Percentage of patients
All patients progressed, died, or were censored before the time point.
|
0 Percentage of patients
|
|
Percentage of Patients Who Are Progression-Free by Radiographic Criteria at 4, 6, and 12 Months
12 months
|
0.00 Percentage of patients
All patients progressed, died, or were censored before the time point.
|
41.67 Percentage of patients
Interval 5.6 to 76.65
|
100.0 Percentage of patients
Interval 100.0 to 100.0
|
33.33 Percentage of patients
Interval 5.26 to 66.38
|
62.50 Percentage of patients
Interval 14.19 to 89.31
|
0.00 Percentage of patients
All patients progressed, died, or were censored before the time point.
|
0 Percentage of patients
|
SECONDARY outcome
Timeframe: Up to 22 monthsPopulation: The ITT Population includes all patients who received at least 1 dose of the combination (exicorilant + enzalutamide) study treatment.
Determine PFS by clinical or radiographic criteria, or death, whichever occurs first. Clinical progression was defined as treatment discontinuation due to disease progression by investigator assessment per PCWG3/mRECIST v1.1, or by PSA criteria. The data values are Kaplan-Meier estimates.
Outcome measures
| Measure |
Dose Determination Segment 1 (Open-label): Cohort 2 - 280 mg Exicorilant
n=3 Participants
Patients will receive lead-in enzalutamide monotherapy once daily for 28 days. Patients will then receive combination treatment with twice-daily exicorilant 140 mg (total daily dose 280 mg) and enzalutamide once daily in 28-day dosing cycles.
|
Dose Determination Segment 1 (Open-label):Cohort 3 - 280 mg Exicorilant
n=7 Participants
Patients will not receive lead-in enzalutamide monotherapy. Patients will receive combination treatment with twice-daily exicorilant 140 mg (total daily dose 280 mg) and enzalutamide once daily in 28-day dosing cycles.
|
Dose Determination Segment 1 (Open-label): Cohort 1 - 360 mg Exicorilant
n=2 Participants
Patients will receive lead-in enzalutamide monotherapy once daily for 28 days. Patients will then receive combination treatment with twice-daily exicorilant 180 mg (total daily dose 360 mg) and enzalutamide once daily in 28-day dosing cycles.
|
Dose Determination Segment 2: Arm A - Maximum Dose 320 mg Exicorilant
n=10 Participants
Patients will receive treatment with once-daily exicorilant starting at 240 mg and titrating to 280 mg and then to 320 mg at 2-week intervals, as tolerated, in combination with enzalutamide once daily in 28-day dosing cycles. Patients in this arm are reported at the highest titrated dose of exicorilant achieved: 320 mg exicorilant.
|
Dose Determination Segment 2: Arm B - 240 mg Exicorilant
n=6 Participants
Patients will receive combination treatment with once-daily exicorilant 240 mg, enzalutamide once daily, and placebo in 28-day dosing cycles.
|
Dose Determination Segment 2: Arm A - Maximum Dose 240 mg Exicorilant
n=8 Participants
Patients will receive treatment with once-daily exicorilant starting at 240 mg and titrating to 280 mg and then to 320 mg at 2-week intervals, as tolerated, in combination with enzalutamide once daily in 28-day dosing cycles. Patients in this arm are reported at the highest titrated dose of exicorilant achieved: 240 mg exicorilant.
|
Dose Determination Segment 2: Arm A - Maximum Dose 280 mg Exicorilant
n=1 Participants
Patients will receive treatment with once-daily exicorilant starting at 240 mg and titrating to 280 mg and then to 320 mg at 2-week intervals, as tolerated, in combination with enzalutamide once daily in 28-day dosing cycles. Patients in this arm are reported at the highest titrated dose of exicorilant achieved: 280 mg exicorilant.
|
|---|---|---|---|---|---|---|---|
|
Time to Progression by Clinical or Radiographic Criteria
|
1.81 months
Interval 0.82 to
The value was not estimable due to low number of patients with an event.
|
6.21 months
Interval 0.49 to
The value was not estimable due to low number of patients with an event.
|
18.46 months
The value was not estimable due to low number of patients with an event.
|
3.68 months
Interval 1.02 to
The value was not estimable due to low number of patients with an event.
|
NA months
Interval 3.91 to
The value was not estimable due to low number of patients with an event.
|
1.84 months
Interval 0.99 to
The value was not estimable due to low number of patients with an event.
|
0 months
|
SECONDARY outcome
Timeframe: 4, 6, and 12 monthsPopulation: The ITT Population includes all patients who received at least 1 dose of the combination (exicorilant + enzalutamide) study treatment.
Assess the percentage of patients who are progression-free by clinical or radiographic measures at 4, 6, and 12 months. Values are Kaplan-Meier estimates of the patients progression free at the time points specified.
Outcome measures
| Measure |
Dose Determination Segment 1 (Open-label): Cohort 2 - 280 mg Exicorilant
n=3 Participants
Patients will receive lead-in enzalutamide monotherapy once daily for 28 days. Patients will then receive combination treatment with twice-daily exicorilant 140 mg (total daily dose 280 mg) and enzalutamide once daily in 28-day dosing cycles.
|
Dose Determination Segment 1 (Open-label):Cohort 3 - 280 mg Exicorilant
n=7 Participants
Patients will not receive lead-in enzalutamide monotherapy. Patients will receive combination treatment with twice-daily exicorilant 140 mg (total daily dose 280 mg) and enzalutamide once daily in 28-day dosing cycles.
|
Dose Determination Segment 1 (Open-label): Cohort 1 - 360 mg Exicorilant
n=2 Participants
Patients will receive lead-in enzalutamide monotherapy once daily for 28 days. Patients will then receive combination treatment with twice-daily exicorilant 180 mg (total daily dose 360 mg) and enzalutamide once daily in 28-day dosing cycles.
|
Dose Determination Segment 2: Arm A - Maximum Dose 320 mg Exicorilant
n=10 Participants
Patients will receive treatment with once-daily exicorilant starting at 240 mg and titrating to 280 mg and then to 320 mg at 2-week intervals, as tolerated, in combination with enzalutamide once daily in 28-day dosing cycles. Patients in this arm are reported at the highest titrated dose of exicorilant achieved: 320 mg exicorilant.
|
Dose Determination Segment 2: Arm B - 240 mg Exicorilant
n=6 Participants
Patients will receive combination treatment with once-daily exicorilant 240 mg, enzalutamide once daily, and placebo in 28-day dosing cycles.
|
Dose Determination Segment 2: Arm A - Maximum Dose 240 mg Exicorilant
n=8 Participants
Patients will receive treatment with once-daily exicorilant starting at 240 mg and titrating to 280 mg and then to 320 mg at 2-week intervals, as tolerated, in combination with enzalutamide once daily in 28-day dosing cycles. Patients in this arm are reported at the highest titrated dose of exicorilant achieved: 240 mg exicorilant.
|
Dose Determination Segment 2: Arm A - Maximum Dose 280 mg Exicorilant
n=1 Participants
Patients will receive treatment with once-daily exicorilant starting at 240 mg and titrating to 280 mg and then to 320 mg at 2-week intervals, as tolerated, in combination with enzalutamide once daily in 28-day dosing cycles. Patients in this arm are reported at the highest titrated dose of exicorilant achieved: 280 mg exicorilant.
|
|---|---|---|---|---|---|---|---|
|
Percentage of Patients Who Are Progression-Free by Clinical or Radiographic Criteria at 4, 6, and 12 Months
6 months
|
0.00 Percentage of patients
All patients progressed, died, or were censored before the time point.
|
62.50 Percentage of patients
Interval 14.19 to 89.31
|
100.0 Percentage of patients
Interval 100.0 to 100.0
|
33.33 Percentage of patients
Interval 6.33 to 64.58
|
62.50 Percentage of patients
Interval 14.19 to 89.31
|
0.00 Percentage of patients
All patients progressed, died, or were censored before the time point.
|
0 Percentage of patients
|
|
Percentage of Patients Who Are Progression-Free by Clinical or Radiographic Criteria at 4, 6, and 12 Months
12 months
|
0.00 Percentage of patients
All patients progressed, died, or were censored before the time point.
|
41.67 Percentage of patients
Interval 5.6 to 76.65
|
100.0 Percentage of patients
Interval 100.0 to 100.0
|
33.33 Percentage of patients
Interval 6.33 to 64.58
|
62.50 Percentage of patients
Interval 14.19 to 89.31
|
0.00 Percentage of patients
All patients progressed, died, or were censored before the time point.
|
0 Percentage of patients
|
|
Percentage of Patients Who Are Progression-Free by Clinical or Radiographic Criteria at 4, 6, and 12 Months
4 months
|
0.00 Percentage of patients
All patients progressed, died, or were censored before the time point.
|
83.33 Percentage of patients
Interval 27.31 to 97.47
|
100.0 Percentage of patients
Interval 100.0 to 100.0
|
50.00 Percentage of patients
Interval 18.36 to 75.32
|
83.33 Percentage of patients
Interval 27.31 to 97.47
|
44.44 Percentage of patients
Interval 6.62 to 78.49
|
0 Percentage of patients
|
SECONDARY outcome
Timeframe: Up to 33 monthsPopulation: The ITT Population includes all patients who received at least 1 dose of the combination (exicorilant + enzalutamide) study treatment.
Determine PFS by clinical criteria or biochemical criteria (defined as treatment discontinuation due to clinical progression by investigator assessment, or by PSA criteria) PCWG3/mRECIST v1.1, or death whichever occurs first. The data values are Kaplan-Meier estimates.
Outcome measures
| Measure |
Dose Determination Segment 1 (Open-label): Cohort 2 - 280 mg Exicorilant
n=3 Participants
Patients will receive lead-in enzalutamide monotherapy once daily for 28 days. Patients will then receive combination treatment with twice-daily exicorilant 140 mg (total daily dose 280 mg) and enzalutamide once daily in 28-day dosing cycles.
|
Dose Determination Segment 1 (Open-label):Cohort 3 - 280 mg Exicorilant
n=7 Participants
Patients will not receive lead-in enzalutamide monotherapy. Patients will receive combination treatment with twice-daily exicorilant 140 mg (total daily dose 280 mg) and enzalutamide once daily in 28-day dosing cycles.
|
Dose Determination Segment 1 (Open-label): Cohort 1 - 360 mg Exicorilant
n=2 Participants
Patients will receive lead-in enzalutamide monotherapy once daily for 28 days. Patients will then receive combination treatment with twice-daily exicorilant 180 mg (total daily dose 360 mg) and enzalutamide once daily in 28-day dosing cycles.
|
Dose Determination Segment 2: Arm A - Maximum Dose 320 mg Exicorilant
n=10 Participants
Patients will receive treatment with once-daily exicorilant starting at 240 mg and titrating to 280 mg and then to 320 mg at 2-week intervals, as tolerated, in combination with enzalutamide once daily in 28-day dosing cycles. Patients in this arm are reported at the highest titrated dose of exicorilant achieved: 320 mg exicorilant.
|
Dose Determination Segment 2: Arm B - 240 mg Exicorilant
n=6 Participants
Patients will receive combination treatment with once-daily exicorilant 240 mg, enzalutamide once daily, and placebo in 28-day dosing cycles.
|
Dose Determination Segment 2: Arm A - Maximum Dose 240 mg Exicorilant
n=8 Participants
Patients will receive treatment with once-daily exicorilant starting at 240 mg and titrating to 280 mg and then to 320 mg at 2-week intervals, as tolerated, in combination with enzalutamide once daily in 28-day dosing cycles. Patients in this arm are reported at the highest titrated dose of exicorilant achieved: 240 mg exicorilant.
|
Dose Determination Segment 2: Arm A - Maximum Dose 280 mg Exicorilant
n=1 Participants
Patients will receive treatment with once-daily exicorilant starting at 240 mg and titrating to 280 mg and then to 320 mg at 2-week intervals, as tolerated, in combination with enzalutamide once daily in 28-day dosing cycles. Patients in this arm are reported at the highest titrated dose of exicorilant achieved: 280 mg exicorilant.
|
|---|---|---|---|---|---|---|---|
|
Time to Progression by Clinical or Biochemical Criteria
|
5.85 months
The value was not estimable due to low number of patients with an event.
|
11.96 months
Interval 3.68 to
The value was not estimable due to low number of patients with an event.
|
32.72 months
The value was not estimable due to low number of patients with an event.
|
6.77 months
Interval 1.41 to 16.53
|
NA months
Interval 4.86 to
The value was not estimable due to low number of patients with an event.
|
3.55 months
Interval 0.99 to
The value was not estimable due to low number of patients with an event.
|
0 months
|
SECONDARY outcome
Timeframe: 4, 6, and 12 monthsPopulation: The ITT Population includes all patients who received at least 1 dose of the combination (exicorilant + enzalutamide) study treatment.
Assess the percentage of patients who are progression-free by clinical or biochemical criteria (defined as treatment discontinuation due to clinical progression by investigator assessment or by PSA criteria) PCWG3/mRECIST v1.1, or death whichever occurs first at 4, 6, and 12 months. Values are Kaplan-Meier estimates of the patients progression free at the time points specified.
Outcome measures
| Measure |
Dose Determination Segment 1 (Open-label): Cohort 2 - 280 mg Exicorilant
n=3 Participants
Patients will receive lead-in enzalutamide monotherapy once daily for 28 days. Patients will then receive combination treatment with twice-daily exicorilant 140 mg (total daily dose 280 mg) and enzalutamide once daily in 28-day dosing cycles.
|
Dose Determination Segment 1 (Open-label):Cohort 3 - 280 mg Exicorilant
n=7 Participants
Patients will not receive lead-in enzalutamide monotherapy. Patients will receive combination treatment with twice-daily exicorilant 140 mg (total daily dose 280 mg) and enzalutamide once daily in 28-day dosing cycles.
|
Dose Determination Segment 1 (Open-label): Cohort 1 - 360 mg Exicorilant
n=2 Participants
Patients will receive lead-in enzalutamide monotherapy once daily for 28 days. Patients will then receive combination treatment with twice-daily exicorilant 180 mg (total daily dose 360 mg) and enzalutamide once daily in 28-day dosing cycles.
|
Dose Determination Segment 2: Arm A - Maximum Dose 320 mg Exicorilant
n=10 Participants
Patients will receive treatment with once-daily exicorilant starting at 240 mg and titrating to 280 mg and then to 320 mg at 2-week intervals, as tolerated, in combination with enzalutamide once daily in 28-day dosing cycles. Patients in this arm are reported at the highest titrated dose of exicorilant achieved: 320 mg exicorilant.
|
Dose Determination Segment 2: Arm B - 240 mg Exicorilant
n=6 Participants
Patients will receive combination treatment with once-daily exicorilant 240 mg, enzalutamide once daily, and placebo in 28-day dosing cycles.
|
Dose Determination Segment 2: Arm A - Maximum Dose 240 mg Exicorilant
n=8 Participants
Patients will receive treatment with once-daily exicorilant starting at 240 mg and titrating to 280 mg and then to 320 mg at 2-week intervals, as tolerated, in combination with enzalutamide once daily in 28-day dosing cycles. Patients in this arm are reported at the highest titrated dose of exicorilant achieved: 240 mg exicorilant.
|
Dose Determination Segment 2: Arm A - Maximum Dose 280 mg Exicorilant
n=1 Participants
Patients will receive treatment with once-daily exicorilant starting at 240 mg and titrating to 280 mg and then to 320 mg at 2-week intervals, as tolerated, in combination with enzalutamide once daily in 28-day dosing cycles. Patients in this arm are reported at the highest titrated dose of exicorilant achieved: 280 mg exicorilant.
|
|---|---|---|---|---|---|---|---|
|
Percentage of Patients Who Are Progression-Free by Clinical or Biochemical Criteria at 4, 6, and 12 Months
4 months
|
100.0 Percentage of patients
Interval 100.0 to 100.0
|
80.00 Percentage of patients
Interval 20.38 to 96.92
|
100.0 Percentage of patients
Interval 100.0 to 100.0
|
70.00 Percentage of patients
Interval 32.87 to 89.19
|
100.0 Percentage of patients
Interval 100.0 to 100.0
|
41.67 Percentage of patients
Interval 1.12 to 84.31
|
0 Percentage of patients
|
|
Percentage of Patients Who Are Progression-Free by Clinical or Biochemical Criteria at 4, 6, and 12 Months
6 months
|
0.00 Percentage of patients
All patients progressed, died, or were censored before the time point.
|
60.00 Percentage of patients
Interval 12.57 to 88.18
|
100.0 Percentage of patients
Interval 100.0 to 100.0
|
58.33 Percentage of patients
Interval 22.98 to 82.07
|
75.00 Percentage of patients
Interval 12.79 to 96.05
|
NA Percentage of patients
All patients progressed, died, or were censored before the time point.
|
0 Percentage of patients
|
|
Percentage of Patients Who Are Progression-Free by Clinical or Biochemical Criteria at 4, 6, and 12 Months
12 months
|
0.00 Percentage of patients
All patients progressed, died, or were censored before the time point.
|
40.00 Percentage of patients
Interval 5.2 to 75.28
|
100.0 Percentage of patients
Interval 100.0 to 100.0
|
35.00 Percentage of patients
Interval 8.48 to 63.98
|
75.00 Percentage of patients
Interval 12.79 to 96.05
|
NA Percentage of patients
All patients progressed, died, or were censored before the time point.
|
0 Percentage of patients
|
SECONDARY outcome
Timeframe: Up to 11 monthsPopulation: The population analyzed includes all patients who received at least 1 dose of the combination (exicorilant + enzalutamide) study treatment (ITT population) and had an uncensored response (CR or PR).
Determine the DOR as defined as the time from the first occurrence of a documented objective tumor response to the time of radiographic progression (per investigator using PCWG3/mRECIST v1.1 criteria) or death from any cause on study, whichever occurs first. DOR was calculated as (earliest date of progression, death, or censoring - date of first documented objective response +1)/30.4375. The data values are Kaplan-Meier estimates.
Outcome measures
| Measure |
Dose Determination Segment 1 (Open-label): Cohort 2 - 280 mg Exicorilant
Patients will receive lead-in enzalutamide monotherapy once daily for 28 days. Patients will then receive combination treatment with twice-daily exicorilant 140 mg (total daily dose 280 mg) and enzalutamide once daily in 28-day dosing cycles.
|
Dose Determination Segment 1 (Open-label):Cohort 3 - 280 mg Exicorilant
n=1 Participants
Patients will not receive lead-in enzalutamide monotherapy. Patients will receive combination treatment with twice-daily exicorilant 140 mg (total daily dose 280 mg) and enzalutamide once daily in 28-day dosing cycles.
|
Dose Determination Segment 1 (Open-label): Cohort 1 - 360 mg Exicorilant
Patients will receive lead-in enzalutamide monotherapy once daily for 28 days. Patients will then receive combination treatment with twice-daily exicorilant 180 mg (total daily dose 360 mg) and enzalutamide once daily in 28-day dosing cycles.
|
Dose Determination Segment 2: Arm A - Maximum Dose 320 mg Exicorilant
Patients will receive treatment with once-daily exicorilant starting at 240 mg and titrating to 280 mg and then to 320 mg at 2-week intervals, as tolerated, in combination with enzalutamide once daily in 28-day dosing cycles. Patients in this arm are reported at the highest titrated dose of exicorilant achieved: 320 mg exicorilant.
|
Dose Determination Segment 2: Arm B - 240 mg Exicorilant
Patients will receive combination treatment with once-daily exicorilant 240 mg, enzalutamide once daily, and placebo in 28-day dosing cycles.
|
Dose Determination Segment 2: Arm A - Maximum Dose 240 mg Exicorilant
Patients will receive treatment with once-daily exicorilant starting at 240 mg and titrating to 280 mg and then to 320 mg at 2-week intervals, as tolerated, in combination with enzalutamide once daily in 28-day dosing cycles. Patients in this arm are reported at the highest titrated dose of exicorilant achieved: 240 mg exicorilant.
|
Dose Determination Segment 2: Arm A - Maximum Dose 280 mg Exicorilant
Patients will receive treatment with once-daily exicorilant starting at 240 mg and titrating to 280 mg and then to 320 mg at 2-week intervals, as tolerated, in combination with enzalutamide once daily in 28-day dosing cycles. Patients in this arm are reported at the highest titrated dose of exicorilant achieved: 280 mg exicorilant.
|
|---|---|---|---|---|---|---|---|
|
Duration of Response (DOR)
|
—
|
10.97 months
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Up to 52 monthsPopulation: The ITT Population includes all patients who received at least 1 dose of the combination (exicorilant + enzalutamide) study treatment.
Determine OS assessed as the time from the first dose of study drug (exicorilant and/or enzalutamide) to the date of death from any cause. The data values are Kaplan-Meier estimates.
Outcome measures
| Measure |
Dose Determination Segment 1 (Open-label): Cohort 2 - 280 mg Exicorilant
n=3 Participants
Patients will receive lead-in enzalutamide monotherapy once daily for 28 days. Patients will then receive combination treatment with twice-daily exicorilant 140 mg (total daily dose 280 mg) and enzalutamide once daily in 28-day dosing cycles.
|
Dose Determination Segment 1 (Open-label):Cohort 3 - 280 mg Exicorilant
n=7 Participants
Patients will not receive lead-in enzalutamide monotherapy. Patients will receive combination treatment with twice-daily exicorilant 140 mg (total daily dose 280 mg) and enzalutamide once daily in 28-day dosing cycles.
|
Dose Determination Segment 1 (Open-label): Cohort 1 - 360 mg Exicorilant
n=2 Participants
Patients will receive lead-in enzalutamide monotherapy once daily for 28 days. Patients will then receive combination treatment with twice-daily exicorilant 180 mg (total daily dose 360 mg) and enzalutamide once daily in 28-day dosing cycles.
|
Dose Determination Segment 2: Arm A - Maximum Dose 320 mg Exicorilant
n=10 Participants
Patients will receive treatment with once-daily exicorilant starting at 240 mg and titrating to 280 mg and then to 320 mg at 2-week intervals, as tolerated, in combination with enzalutamide once daily in 28-day dosing cycles. Patients in this arm are reported at the highest titrated dose of exicorilant achieved: 320 mg exicorilant.
|
Dose Determination Segment 2: Arm B - 240 mg Exicorilant
n=6 Participants
Patients will receive combination treatment with once-daily exicorilant 240 mg, enzalutamide once daily, and placebo in 28-day dosing cycles.
|
Dose Determination Segment 2: Arm A - Maximum Dose 240 mg Exicorilant
n=8 Participants
Patients will receive treatment with once-daily exicorilant starting at 240 mg and titrating to 280 mg and then to 320 mg at 2-week intervals, as tolerated, in combination with enzalutamide once daily in 28-day dosing cycles. Patients in this arm are reported at the highest titrated dose of exicorilant achieved: 240 mg exicorilant.
|
Dose Determination Segment 2: Arm A - Maximum Dose 280 mg Exicorilant
n=1 Participants
Patients will receive treatment with once-daily exicorilant starting at 240 mg and titrating to 280 mg and then to 320 mg at 2-week intervals, as tolerated, in combination with enzalutamide once daily in 28-day dosing cycles. Patients in this arm are reported at the highest titrated dose of exicorilant achieved: 280 mg exicorilant.
|
|---|---|---|---|---|---|---|---|
|
Overall Survival (OS)
|
NA months
Interval 5.85 to
The value was not estimable due to low number of patients with an event.
|
13.73 months
Interval 4.63 to
The value was not estimable due to low number of patients with an event.
|
32.72 months
The value was not estimable due to low number of patients with an event.
|
13.96 months
Interval 4.47 to
The value was not estimable due to low number of patients with an event.
|
17.23 months
Interval 10.02 to
The value was not estimable due to low number of patients with an event.
|
NA months
Interval 3.55 to
The value was not estimable due to low number of patients with an event.
|
NA months
The value was not estimable due to low number of patients with an event.
|
Adverse Events
Dose Determination Segment 1 (Open-label) Cohort 2 - 280 mg Exicorilant
Serious events: 1 serious events
Other events: 3 other events
Deaths: 1 deaths
Dose Determination Segment 1 (Open-label) Cohort 3 - 280 mg Exicorilant
Serious events: 2 serious events
Other events: 7 other events
Deaths: 5 deaths
Enrolled But Not Allocated
Serious events: 0 serious events
Other events: 0 other events
Deaths: 1 deaths
Dose Determination Segment 1 (Open-label) Cohort 1 - 360 mg Exicorilant
Serious events: 1 serious events
Other events: 2 other events
Deaths: 1 deaths
Dose Determination Segment 2: Arm A - Maximum Dose 240 mg Exicorilant
Serious events: 2 serious events
Other events: 8 other events
Deaths: 1 deaths
Dose Determination Segment 2: Arm A - Maximum Dose 280 mg Exicorilant
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Dose Determination Segment 2: Arm A - Maximum Dose 320 mg Exicorilant
Serious events: 2 serious events
Other events: 10 other events
Deaths: 5 deaths
Dose Determination Segment 2: Arm B - 240 mg Exicorilant
Serious events: 0 serious events
Other events: 6 other events
Deaths: 4 deaths
Serious adverse events
| Measure |
Dose Determination Segment 1 (Open-label) Cohort 2 - 280 mg Exicorilant
n=3 participants at risk
Patients will receive lead-in enzalutamide monotherapy once daily for 28 days. Patients will then receive combination treatment with twice-daily exicorilant 140 mg (total daily dose 280 mg) and enzalutamide once daily in 28-day dosing cycles.
|
Dose Determination Segment 1 (Open-label) Cohort 3 - 280 mg Exicorilant
n=7 participants at risk
Patients will not receive lead-in enzalutamide monotherapy. Patients will receive combination treatment with twice-daily exicorilant 140 mg (total daily dose 280 mg) and enzalutamide once daily in 28-day dosing cycles.
|
Enrolled But Not Allocated
Patients were enrolled in the study but discontinued before being allocated into a treatment group.
|
Dose Determination Segment 1 (Open-label) Cohort 1 - 360 mg Exicorilant
n=2 participants at risk
Patients will receive lead-in enzalutamide monotherapy once daily for 28 days. Patients will then receive combination treatment with twice-daily exicorilant 180 mg (total daily dose 360 mg) and enzalutamide once daily in 28-day dosing cycles.
|
Dose Determination Segment 2: Arm A - Maximum Dose 240 mg Exicorilant
n=8 participants at risk
Patients will receive treatment with once-daily exicorilant starting at 240 mg and titrating to 280 mg and then to 320 mg at 2-week intervals, as tolerated, in combination with enzalutamide once daily in 28-day dosing cycles. Patients in this arm are reported at the highest titrated dose of exicorilant achieved: 240 mg exicorilant.
|
Dose Determination Segment 2: Arm A - Maximum Dose 280 mg Exicorilant
n=1 participants at risk
Patients will receive treatment with once-daily exicorilant starting at 240 mg and titrating to 280 mg and then to 320 mg at 2-week intervals, as tolerated, in combination with enzalutamide once daily in 28-day dosing cycles.
Patients in this arm are reported at the highest titrated dose of exicorilant achieved: 280 mg exicorilant.
|
Dose Determination Segment 2: Arm A - Maximum Dose 320 mg Exicorilant
n=10 participants at risk
Patients will receive treatment with once-daily exicorilant starting at 240 mg and titrating to 280 mg and then to 320 mg at 2-week intervals, as tolerated, in combination with enzalutamide once daily in 28-day dosing cycles. Patients in this arm are reported at the highest titrated dose of exicorilant achieved: 320 mg exicorilant.
|
Dose Determination Segment 2: Arm B - 240 mg Exicorilant
n=6 participants at risk
Patients will receive combination treatment with once-daily exicorilant 240 mg, enzalutamide once daily, and placebo in 28-day dosing cycles.
|
|---|---|---|---|---|---|---|---|---|
|
Gastrointestinal disorders
Pancreatitis acute
|
33.3%
1/3 • Treatment-emergent adverse events were reported from randomization up to 27 months for Segment 1 and up to 19 months for Segment 2. All-cause mortality was reported from enrollment up to 52 months.
Patients in the Enrolled But Not Randomized group were enrolled in the study but discontinued before being allocated into a treatment group. They never received treatment with exicorilant. Thus, they were not at risk for a treatment-emergent adverse event.
|
0.00%
0/7 • Treatment-emergent adverse events were reported from randomization up to 27 months for Segment 1 and up to 19 months for Segment 2. All-cause mortality was reported from enrollment up to 52 months.
Patients in the Enrolled But Not Randomized group were enrolled in the study but discontinued before being allocated into a treatment group. They never received treatment with exicorilant. Thus, they were not at risk for a treatment-emergent adverse event.
|
—
0/0 • Treatment-emergent adverse events were reported from randomization up to 27 months for Segment 1 and up to 19 months for Segment 2. All-cause mortality was reported from enrollment up to 52 months.
Patients in the Enrolled But Not Randomized group were enrolled in the study but discontinued before being allocated into a treatment group. They never received treatment with exicorilant. Thus, they were not at risk for a treatment-emergent adverse event.
|
0.00%
0/2 • Treatment-emergent adverse events were reported from randomization up to 27 months for Segment 1 and up to 19 months for Segment 2. All-cause mortality was reported from enrollment up to 52 months.
Patients in the Enrolled But Not Randomized group were enrolled in the study but discontinued before being allocated into a treatment group. They never received treatment with exicorilant. Thus, they were not at risk for a treatment-emergent adverse event.
|
0.00%
0/8 • Treatment-emergent adverse events were reported from randomization up to 27 months for Segment 1 and up to 19 months for Segment 2. All-cause mortality was reported from enrollment up to 52 months.
Patients in the Enrolled But Not Randomized group were enrolled in the study but discontinued before being allocated into a treatment group. They never received treatment with exicorilant. Thus, they were not at risk for a treatment-emergent adverse event.
|
0.00%
0/1 • Treatment-emergent adverse events were reported from randomization up to 27 months for Segment 1 and up to 19 months for Segment 2. All-cause mortality was reported from enrollment up to 52 months.
Patients in the Enrolled But Not Randomized group were enrolled in the study but discontinued before being allocated into a treatment group. They never received treatment with exicorilant. Thus, they were not at risk for a treatment-emergent adverse event.
|
0.00%
0/10 • Treatment-emergent adverse events were reported from randomization up to 27 months for Segment 1 and up to 19 months for Segment 2. All-cause mortality was reported from enrollment up to 52 months.
Patients in the Enrolled But Not Randomized group were enrolled in the study but discontinued before being allocated into a treatment group. They never received treatment with exicorilant. Thus, they were not at risk for a treatment-emergent adverse event.
|
0.00%
0/6 • Treatment-emergent adverse events were reported from randomization up to 27 months for Segment 1 and up to 19 months for Segment 2. All-cause mortality was reported from enrollment up to 52 months.
Patients in the Enrolled But Not Randomized group were enrolled in the study but discontinued before being allocated into a treatment group. They never received treatment with exicorilant. Thus, they were not at risk for a treatment-emergent adverse event.
|
|
General disorders
Fatigue
|
0.00%
0/3 • Treatment-emergent adverse events were reported from randomization up to 27 months for Segment 1 and up to 19 months for Segment 2. All-cause mortality was reported from enrollment up to 52 months.
Patients in the Enrolled But Not Randomized group were enrolled in the study but discontinued before being allocated into a treatment group. They never received treatment with exicorilant. Thus, they were not at risk for a treatment-emergent adverse event.
|
0.00%
0/7 • Treatment-emergent adverse events were reported from randomization up to 27 months for Segment 1 and up to 19 months for Segment 2. All-cause mortality was reported from enrollment up to 52 months.
Patients in the Enrolled But Not Randomized group were enrolled in the study but discontinued before being allocated into a treatment group. They never received treatment with exicorilant. Thus, they were not at risk for a treatment-emergent adverse event.
|
—
0/0 • Treatment-emergent adverse events were reported from randomization up to 27 months for Segment 1 and up to 19 months for Segment 2. All-cause mortality was reported from enrollment up to 52 months.
Patients in the Enrolled But Not Randomized group were enrolled in the study but discontinued before being allocated into a treatment group. They never received treatment with exicorilant. Thus, they were not at risk for a treatment-emergent adverse event.
|
50.0%
1/2 • Treatment-emergent adverse events were reported from randomization up to 27 months for Segment 1 and up to 19 months for Segment 2. All-cause mortality was reported from enrollment up to 52 months.
Patients in the Enrolled But Not Randomized group were enrolled in the study but discontinued before being allocated into a treatment group. They never received treatment with exicorilant. Thus, they were not at risk for a treatment-emergent adverse event.
|
0.00%
0/8 • Treatment-emergent adverse events were reported from randomization up to 27 months for Segment 1 and up to 19 months for Segment 2. All-cause mortality was reported from enrollment up to 52 months.
Patients in the Enrolled But Not Randomized group were enrolled in the study but discontinued before being allocated into a treatment group. They never received treatment with exicorilant. Thus, they were not at risk for a treatment-emergent adverse event.
|
0.00%
0/1 • Treatment-emergent adverse events were reported from randomization up to 27 months for Segment 1 and up to 19 months for Segment 2. All-cause mortality was reported from enrollment up to 52 months.
Patients in the Enrolled But Not Randomized group were enrolled in the study but discontinued before being allocated into a treatment group. They never received treatment with exicorilant. Thus, they were not at risk for a treatment-emergent adverse event.
|
0.00%
0/10 • Treatment-emergent adverse events were reported from randomization up to 27 months for Segment 1 and up to 19 months for Segment 2. All-cause mortality was reported from enrollment up to 52 months.
Patients in the Enrolled But Not Randomized group were enrolled in the study but discontinued before being allocated into a treatment group. They never received treatment with exicorilant. Thus, they were not at risk for a treatment-emergent adverse event.
|
0.00%
0/6 • Treatment-emergent adverse events were reported from randomization up to 27 months for Segment 1 and up to 19 months for Segment 2. All-cause mortality was reported from enrollment up to 52 months.
Patients in the Enrolled But Not Randomized group were enrolled in the study but discontinued before being allocated into a treatment group. They never received treatment with exicorilant. Thus, they were not at risk for a treatment-emergent adverse event.
|
|
Infections and infestations
Sepsis
|
0.00%
0/3 • Treatment-emergent adverse events were reported from randomization up to 27 months for Segment 1 and up to 19 months for Segment 2. All-cause mortality was reported from enrollment up to 52 months.
Patients in the Enrolled But Not Randomized group were enrolled in the study but discontinued before being allocated into a treatment group. They never received treatment with exicorilant. Thus, they were not at risk for a treatment-emergent adverse event.
|
0.00%
0/7 • Treatment-emergent adverse events were reported from randomization up to 27 months for Segment 1 and up to 19 months for Segment 2. All-cause mortality was reported from enrollment up to 52 months.
Patients in the Enrolled But Not Randomized group were enrolled in the study but discontinued before being allocated into a treatment group. They never received treatment with exicorilant. Thus, they were not at risk for a treatment-emergent adverse event.
|
—
0/0 • Treatment-emergent adverse events were reported from randomization up to 27 months for Segment 1 and up to 19 months for Segment 2. All-cause mortality was reported from enrollment up to 52 months.
Patients in the Enrolled But Not Randomized group were enrolled in the study but discontinued before being allocated into a treatment group. They never received treatment with exicorilant. Thus, they were not at risk for a treatment-emergent adverse event.
|
0.00%
0/2 • Treatment-emergent adverse events were reported from randomization up to 27 months for Segment 1 and up to 19 months for Segment 2. All-cause mortality was reported from enrollment up to 52 months.
Patients in the Enrolled But Not Randomized group were enrolled in the study but discontinued before being allocated into a treatment group. They never received treatment with exicorilant. Thus, they were not at risk for a treatment-emergent adverse event.
|
0.00%
0/8 • Treatment-emergent adverse events were reported from randomization up to 27 months for Segment 1 and up to 19 months for Segment 2. All-cause mortality was reported from enrollment up to 52 months.
Patients in the Enrolled But Not Randomized group were enrolled in the study but discontinued before being allocated into a treatment group. They never received treatment with exicorilant. Thus, they were not at risk for a treatment-emergent adverse event.
|
0.00%
0/1 • Treatment-emergent adverse events were reported from randomization up to 27 months for Segment 1 and up to 19 months for Segment 2. All-cause mortality was reported from enrollment up to 52 months.
Patients in the Enrolled But Not Randomized group were enrolled in the study but discontinued before being allocated into a treatment group. They never received treatment with exicorilant. Thus, they were not at risk for a treatment-emergent adverse event.
|
10.0%
1/10 • Treatment-emergent adverse events were reported from randomization up to 27 months for Segment 1 and up to 19 months for Segment 2. All-cause mortality was reported from enrollment up to 52 months.
Patients in the Enrolled But Not Randomized group were enrolled in the study but discontinued before being allocated into a treatment group. They never received treatment with exicorilant. Thus, they were not at risk for a treatment-emergent adverse event.
|
0.00%
0/6 • Treatment-emergent adverse events were reported from randomization up to 27 months for Segment 1 and up to 19 months for Segment 2. All-cause mortality was reported from enrollment up to 52 months.
Patients in the Enrolled But Not Randomized group were enrolled in the study but discontinued before being allocated into a treatment group. They never received treatment with exicorilant. Thus, they were not at risk for a treatment-emergent adverse event.
|
|
Injury, poisoning and procedural complications
Spinal fracture
|
0.00%
0/3 • Treatment-emergent adverse events were reported from randomization up to 27 months for Segment 1 and up to 19 months for Segment 2. All-cause mortality was reported from enrollment up to 52 months.
Patients in the Enrolled But Not Randomized group were enrolled in the study but discontinued before being allocated into a treatment group. They never received treatment with exicorilant. Thus, they were not at risk for a treatment-emergent adverse event.
|
14.3%
1/7 • Treatment-emergent adverse events were reported from randomization up to 27 months for Segment 1 and up to 19 months for Segment 2. All-cause mortality was reported from enrollment up to 52 months.
Patients in the Enrolled But Not Randomized group were enrolled in the study but discontinued before being allocated into a treatment group. They never received treatment with exicorilant. Thus, they were not at risk for a treatment-emergent adverse event.
|
—
0/0 • Treatment-emergent adverse events were reported from randomization up to 27 months for Segment 1 and up to 19 months for Segment 2. All-cause mortality was reported from enrollment up to 52 months.
Patients in the Enrolled But Not Randomized group were enrolled in the study but discontinued before being allocated into a treatment group. They never received treatment with exicorilant. Thus, they were not at risk for a treatment-emergent adverse event.
|
0.00%
0/2 • Treatment-emergent adverse events were reported from randomization up to 27 months for Segment 1 and up to 19 months for Segment 2. All-cause mortality was reported from enrollment up to 52 months.
Patients in the Enrolled But Not Randomized group were enrolled in the study but discontinued before being allocated into a treatment group. They never received treatment with exicorilant. Thus, they were not at risk for a treatment-emergent adverse event.
|
0.00%
0/8 • Treatment-emergent adverse events were reported from randomization up to 27 months for Segment 1 and up to 19 months for Segment 2. All-cause mortality was reported from enrollment up to 52 months.
Patients in the Enrolled But Not Randomized group were enrolled in the study but discontinued before being allocated into a treatment group. They never received treatment with exicorilant. Thus, they were not at risk for a treatment-emergent adverse event.
|
0.00%
0/1 • Treatment-emergent adverse events were reported from randomization up to 27 months for Segment 1 and up to 19 months for Segment 2. All-cause mortality was reported from enrollment up to 52 months.
Patients in the Enrolled But Not Randomized group were enrolled in the study but discontinued before being allocated into a treatment group. They never received treatment with exicorilant. Thus, they were not at risk for a treatment-emergent adverse event.
|
0.00%
0/10 • Treatment-emergent adverse events were reported from randomization up to 27 months for Segment 1 and up to 19 months for Segment 2. All-cause mortality was reported from enrollment up to 52 months.
Patients in the Enrolled But Not Randomized group were enrolled in the study but discontinued before being allocated into a treatment group. They never received treatment with exicorilant. Thus, they were not at risk for a treatment-emergent adverse event.
|
0.00%
0/6 • Treatment-emergent adverse events were reported from randomization up to 27 months for Segment 1 and up to 19 months for Segment 2. All-cause mortality was reported from enrollment up to 52 months.
Patients in the Enrolled But Not Randomized group were enrolled in the study but discontinued before being allocated into a treatment group. They never received treatment with exicorilant. Thus, they were not at risk for a treatment-emergent adverse event.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.00%
0/3 • Treatment-emergent adverse events were reported from randomization up to 27 months for Segment 1 and up to 19 months for Segment 2. All-cause mortality was reported from enrollment up to 52 months.
Patients in the Enrolled But Not Randomized group were enrolled in the study but discontinued before being allocated into a treatment group. They never received treatment with exicorilant. Thus, they were not at risk for a treatment-emergent adverse event.
|
0.00%
0/7 • Treatment-emergent adverse events were reported from randomization up to 27 months for Segment 1 and up to 19 months for Segment 2. All-cause mortality was reported from enrollment up to 52 months.
Patients in the Enrolled But Not Randomized group were enrolled in the study but discontinued before being allocated into a treatment group. They never received treatment with exicorilant. Thus, they were not at risk for a treatment-emergent adverse event.
|
—
0/0 • Treatment-emergent adverse events were reported from randomization up to 27 months for Segment 1 and up to 19 months for Segment 2. All-cause mortality was reported from enrollment up to 52 months.
Patients in the Enrolled But Not Randomized group were enrolled in the study but discontinued before being allocated into a treatment group. They never received treatment with exicorilant. Thus, they were not at risk for a treatment-emergent adverse event.
|
0.00%
0/2 • Treatment-emergent adverse events were reported from randomization up to 27 months for Segment 1 and up to 19 months for Segment 2. All-cause mortality was reported from enrollment up to 52 months.
Patients in the Enrolled But Not Randomized group were enrolled in the study but discontinued before being allocated into a treatment group. They never received treatment with exicorilant. Thus, they were not at risk for a treatment-emergent adverse event.
|
12.5%
1/8 • Treatment-emergent adverse events were reported from randomization up to 27 months for Segment 1 and up to 19 months for Segment 2. All-cause mortality was reported from enrollment up to 52 months.
Patients in the Enrolled But Not Randomized group were enrolled in the study but discontinued before being allocated into a treatment group. They never received treatment with exicorilant. Thus, they were not at risk for a treatment-emergent adverse event.
|
0.00%
0/1 • Treatment-emergent adverse events were reported from randomization up to 27 months for Segment 1 and up to 19 months for Segment 2. All-cause mortality was reported from enrollment up to 52 months.
Patients in the Enrolled But Not Randomized group were enrolled in the study but discontinued before being allocated into a treatment group. They never received treatment with exicorilant. Thus, they were not at risk for a treatment-emergent adverse event.
|
0.00%
0/10 • Treatment-emergent adverse events were reported from randomization up to 27 months for Segment 1 and up to 19 months for Segment 2. All-cause mortality was reported from enrollment up to 52 months.
Patients in the Enrolled But Not Randomized group were enrolled in the study but discontinued before being allocated into a treatment group. They never received treatment with exicorilant. Thus, they were not at risk for a treatment-emergent adverse event.
|
0.00%
0/6 • Treatment-emergent adverse events were reported from randomization up to 27 months for Segment 1 and up to 19 months for Segment 2. All-cause mortality was reported from enrollment up to 52 months.
Patients in the Enrolled But Not Randomized group were enrolled in the study but discontinued before being allocated into a treatment group. They never received treatment with exicorilant. Thus, they were not at risk for a treatment-emergent adverse event.
|
|
Musculoskeletal and connective tissue disorders
Bone pain
|
0.00%
0/3 • Treatment-emergent adverse events were reported from randomization up to 27 months for Segment 1 and up to 19 months for Segment 2. All-cause mortality was reported from enrollment up to 52 months.
Patients in the Enrolled But Not Randomized group were enrolled in the study but discontinued before being allocated into a treatment group. They never received treatment with exicorilant. Thus, they were not at risk for a treatment-emergent adverse event.
|
0.00%
0/7 • Treatment-emergent adverse events were reported from randomization up to 27 months for Segment 1 and up to 19 months for Segment 2. All-cause mortality was reported from enrollment up to 52 months.
Patients in the Enrolled But Not Randomized group were enrolled in the study but discontinued before being allocated into a treatment group. They never received treatment with exicorilant. Thus, they were not at risk for a treatment-emergent adverse event.
|
—
0/0 • Treatment-emergent adverse events were reported from randomization up to 27 months for Segment 1 and up to 19 months for Segment 2. All-cause mortality was reported from enrollment up to 52 months.
Patients in the Enrolled But Not Randomized group were enrolled in the study but discontinued before being allocated into a treatment group. They never received treatment with exicorilant. Thus, they were not at risk for a treatment-emergent adverse event.
|
0.00%
0/2 • Treatment-emergent adverse events were reported from randomization up to 27 months for Segment 1 and up to 19 months for Segment 2. All-cause mortality was reported from enrollment up to 52 months.
Patients in the Enrolled But Not Randomized group were enrolled in the study but discontinued before being allocated into a treatment group. They never received treatment with exicorilant. Thus, they were not at risk for a treatment-emergent adverse event.
|
12.5%
1/8 • Treatment-emergent adverse events were reported from randomization up to 27 months for Segment 1 and up to 19 months for Segment 2. All-cause mortality was reported from enrollment up to 52 months.
Patients in the Enrolled But Not Randomized group were enrolled in the study but discontinued before being allocated into a treatment group. They never received treatment with exicorilant. Thus, they were not at risk for a treatment-emergent adverse event.
|
0.00%
0/1 • Treatment-emergent adverse events were reported from randomization up to 27 months for Segment 1 and up to 19 months for Segment 2. All-cause mortality was reported from enrollment up to 52 months.
Patients in the Enrolled But Not Randomized group were enrolled in the study but discontinued before being allocated into a treatment group. They never received treatment with exicorilant. Thus, they were not at risk for a treatment-emergent adverse event.
|
0.00%
0/10 • Treatment-emergent adverse events were reported from randomization up to 27 months for Segment 1 and up to 19 months for Segment 2. All-cause mortality was reported from enrollment up to 52 months.
Patients in the Enrolled But Not Randomized group were enrolled in the study but discontinued before being allocated into a treatment group. They never received treatment with exicorilant. Thus, they were not at risk for a treatment-emergent adverse event.
|
0.00%
0/6 • Treatment-emergent adverse events were reported from randomization up to 27 months for Segment 1 and up to 19 months for Segment 2. All-cause mortality was reported from enrollment up to 52 months.
Patients in the Enrolled But Not Randomized group were enrolled in the study but discontinued before being allocated into a treatment group. They never received treatment with exicorilant. Thus, they were not at risk for a treatment-emergent adverse event.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal pain
|
0.00%
0/3 • Treatment-emergent adverse events were reported from randomization up to 27 months for Segment 1 and up to 19 months for Segment 2. All-cause mortality was reported from enrollment up to 52 months.
Patients in the Enrolled But Not Randomized group were enrolled in the study but discontinued before being allocated into a treatment group. They never received treatment with exicorilant. Thus, they were not at risk for a treatment-emergent adverse event.
|
0.00%
0/7 • Treatment-emergent adverse events were reported from randomization up to 27 months for Segment 1 and up to 19 months for Segment 2. All-cause mortality was reported from enrollment up to 52 months.
Patients in the Enrolled But Not Randomized group were enrolled in the study but discontinued before being allocated into a treatment group. They never received treatment with exicorilant. Thus, they were not at risk for a treatment-emergent adverse event.
|
—
0/0 • Treatment-emergent adverse events were reported from randomization up to 27 months for Segment 1 and up to 19 months for Segment 2. All-cause mortality was reported from enrollment up to 52 months.
Patients in the Enrolled But Not Randomized group were enrolled in the study but discontinued before being allocated into a treatment group. They never received treatment with exicorilant. Thus, they were not at risk for a treatment-emergent adverse event.
|
50.0%
1/2 • Treatment-emergent adverse events were reported from randomization up to 27 months for Segment 1 and up to 19 months for Segment 2. All-cause mortality was reported from enrollment up to 52 months.
Patients in the Enrolled But Not Randomized group were enrolled in the study but discontinued before being allocated into a treatment group. They never received treatment with exicorilant. Thus, they were not at risk for a treatment-emergent adverse event.
|
0.00%
0/8 • Treatment-emergent adverse events were reported from randomization up to 27 months for Segment 1 and up to 19 months for Segment 2. All-cause mortality was reported from enrollment up to 52 months.
Patients in the Enrolled But Not Randomized group were enrolled in the study but discontinued before being allocated into a treatment group. They never received treatment with exicorilant. Thus, they were not at risk for a treatment-emergent adverse event.
|
0.00%
0/1 • Treatment-emergent adverse events were reported from randomization up to 27 months for Segment 1 and up to 19 months for Segment 2. All-cause mortality was reported from enrollment up to 52 months.
Patients in the Enrolled But Not Randomized group were enrolled in the study but discontinued before being allocated into a treatment group. They never received treatment with exicorilant. Thus, they were not at risk for a treatment-emergent adverse event.
|
0.00%
0/10 • Treatment-emergent adverse events were reported from randomization up to 27 months for Segment 1 and up to 19 months for Segment 2. All-cause mortality was reported from enrollment up to 52 months.
Patients in the Enrolled But Not Randomized group were enrolled in the study but discontinued before being allocated into a treatment group. They never received treatment with exicorilant. Thus, they were not at risk for a treatment-emergent adverse event.
|
0.00%
0/6 • Treatment-emergent adverse events were reported from randomization up to 27 months for Segment 1 and up to 19 months for Segment 2. All-cause mortality was reported from enrollment up to 52 months.
Patients in the Enrolled But Not Randomized group were enrolled in the study but discontinued before being allocated into a treatment group. They never received treatment with exicorilant. Thus, they were not at risk for a treatment-emergent adverse event.
|
|
Psychiatric disorders
Confusional state
|
0.00%
0/3 • Treatment-emergent adverse events were reported from randomization up to 27 months for Segment 1 and up to 19 months for Segment 2. All-cause mortality was reported from enrollment up to 52 months.
Patients in the Enrolled But Not Randomized group were enrolled in the study but discontinued before being allocated into a treatment group. They never received treatment with exicorilant. Thus, they were not at risk for a treatment-emergent adverse event.
|
0.00%
0/7 • Treatment-emergent adverse events were reported from randomization up to 27 months for Segment 1 and up to 19 months for Segment 2. All-cause mortality was reported from enrollment up to 52 months.
Patients in the Enrolled But Not Randomized group were enrolled in the study but discontinued before being allocated into a treatment group. They never received treatment with exicorilant. Thus, they were not at risk for a treatment-emergent adverse event.
|
—
0/0 • Treatment-emergent adverse events were reported from randomization up to 27 months for Segment 1 and up to 19 months for Segment 2. All-cause mortality was reported from enrollment up to 52 months.
Patients in the Enrolled But Not Randomized group were enrolled in the study but discontinued before being allocated into a treatment group. They never received treatment with exicorilant. Thus, they were not at risk for a treatment-emergent adverse event.
|
0.00%
0/2 • Treatment-emergent adverse events were reported from randomization up to 27 months for Segment 1 and up to 19 months for Segment 2. All-cause mortality was reported from enrollment up to 52 months.
Patients in the Enrolled But Not Randomized group were enrolled in the study but discontinued before being allocated into a treatment group. They never received treatment with exicorilant. Thus, they were not at risk for a treatment-emergent adverse event.
|
12.5%
1/8 • Treatment-emergent adverse events were reported from randomization up to 27 months for Segment 1 and up to 19 months for Segment 2. All-cause mortality was reported from enrollment up to 52 months.
Patients in the Enrolled But Not Randomized group were enrolled in the study but discontinued before being allocated into a treatment group. They never received treatment with exicorilant. Thus, they were not at risk for a treatment-emergent adverse event.
|
0.00%
0/1 • Treatment-emergent adverse events were reported from randomization up to 27 months for Segment 1 and up to 19 months for Segment 2. All-cause mortality was reported from enrollment up to 52 months.
Patients in the Enrolled But Not Randomized group were enrolled in the study but discontinued before being allocated into a treatment group. They never received treatment with exicorilant. Thus, they were not at risk for a treatment-emergent adverse event.
|
0.00%
0/10 • Treatment-emergent adverse events were reported from randomization up to 27 months for Segment 1 and up to 19 months for Segment 2. All-cause mortality was reported from enrollment up to 52 months.
Patients in the Enrolled But Not Randomized group were enrolled in the study but discontinued before being allocated into a treatment group. They never received treatment with exicorilant. Thus, they were not at risk for a treatment-emergent adverse event.
|
0.00%
0/6 • Treatment-emergent adverse events were reported from randomization up to 27 months for Segment 1 and up to 19 months for Segment 2. All-cause mortality was reported from enrollment up to 52 months.
Patients in the Enrolled But Not Randomized group were enrolled in the study but discontinued before being allocated into a treatment group. They never received treatment with exicorilant. Thus, they were not at risk for a treatment-emergent adverse event.
|
|
Renal and urinary disorders
Urinary retention
|
0.00%
0/3 • Treatment-emergent adverse events were reported from randomization up to 27 months for Segment 1 and up to 19 months for Segment 2. All-cause mortality was reported from enrollment up to 52 months.
Patients in the Enrolled But Not Randomized group were enrolled in the study but discontinued before being allocated into a treatment group. They never received treatment with exicorilant. Thus, they were not at risk for a treatment-emergent adverse event.
|
0.00%
0/7 • Treatment-emergent adverse events were reported from randomization up to 27 months for Segment 1 and up to 19 months for Segment 2. All-cause mortality was reported from enrollment up to 52 months.
Patients in the Enrolled But Not Randomized group were enrolled in the study but discontinued before being allocated into a treatment group. They never received treatment with exicorilant. Thus, they were not at risk for a treatment-emergent adverse event.
|
—
0/0 • Treatment-emergent adverse events were reported from randomization up to 27 months for Segment 1 and up to 19 months for Segment 2. All-cause mortality was reported from enrollment up to 52 months.
Patients in the Enrolled But Not Randomized group were enrolled in the study but discontinued before being allocated into a treatment group. They never received treatment with exicorilant. Thus, they were not at risk for a treatment-emergent adverse event.
|
0.00%
0/2 • Treatment-emergent adverse events were reported from randomization up to 27 months for Segment 1 and up to 19 months for Segment 2. All-cause mortality was reported from enrollment up to 52 months.
Patients in the Enrolled But Not Randomized group were enrolled in the study but discontinued before being allocated into a treatment group. They never received treatment with exicorilant. Thus, they were not at risk for a treatment-emergent adverse event.
|
0.00%
0/8 • Treatment-emergent adverse events were reported from randomization up to 27 months for Segment 1 and up to 19 months for Segment 2. All-cause mortality was reported from enrollment up to 52 months.
Patients in the Enrolled But Not Randomized group were enrolled in the study but discontinued before being allocated into a treatment group. They never received treatment with exicorilant. Thus, they were not at risk for a treatment-emergent adverse event.
|
0.00%
0/1 • Treatment-emergent adverse events were reported from randomization up to 27 months for Segment 1 and up to 19 months for Segment 2. All-cause mortality was reported from enrollment up to 52 months.
Patients in the Enrolled But Not Randomized group were enrolled in the study but discontinued before being allocated into a treatment group. They never received treatment with exicorilant. Thus, they were not at risk for a treatment-emergent adverse event.
|
10.0%
1/10 • Treatment-emergent adverse events were reported from randomization up to 27 months for Segment 1 and up to 19 months for Segment 2. All-cause mortality was reported from enrollment up to 52 months.
Patients in the Enrolled But Not Randomized group were enrolled in the study but discontinued before being allocated into a treatment group. They never received treatment with exicorilant. Thus, they were not at risk for a treatment-emergent adverse event.
|
0.00%
0/6 • Treatment-emergent adverse events were reported from randomization up to 27 months for Segment 1 and up to 19 months for Segment 2. All-cause mortality was reported from enrollment up to 52 months.
Patients in the Enrolled But Not Randomized group were enrolled in the study but discontinued before being allocated into a treatment group. They never received treatment with exicorilant. Thus, they were not at risk for a treatment-emergent adverse event.
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
0.00%
0/3 • Treatment-emergent adverse events were reported from randomization up to 27 months for Segment 1 and up to 19 months for Segment 2. All-cause mortality was reported from enrollment up to 52 months.
Patients in the Enrolled But Not Randomized group were enrolled in the study but discontinued before being allocated into a treatment group. They never received treatment with exicorilant. Thus, they were not at risk for a treatment-emergent adverse event.
|
14.3%
1/7 • Treatment-emergent adverse events were reported from randomization up to 27 months for Segment 1 and up to 19 months for Segment 2. All-cause mortality was reported from enrollment up to 52 months.
Patients in the Enrolled But Not Randomized group were enrolled in the study but discontinued before being allocated into a treatment group. They never received treatment with exicorilant. Thus, they were not at risk for a treatment-emergent adverse event.
|
—
0/0 • Treatment-emergent adverse events were reported from randomization up to 27 months for Segment 1 and up to 19 months for Segment 2. All-cause mortality was reported from enrollment up to 52 months.
Patients in the Enrolled But Not Randomized group were enrolled in the study but discontinued before being allocated into a treatment group. They never received treatment with exicorilant. Thus, they were not at risk for a treatment-emergent adverse event.
|
0.00%
0/2 • Treatment-emergent adverse events were reported from randomization up to 27 months for Segment 1 and up to 19 months for Segment 2. All-cause mortality was reported from enrollment up to 52 months.
Patients in the Enrolled But Not Randomized group were enrolled in the study but discontinued before being allocated into a treatment group. They never received treatment with exicorilant. Thus, they were not at risk for a treatment-emergent adverse event.
|
0.00%
0/8 • Treatment-emergent adverse events were reported from randomization up to 27 months for Segment 1 and up to 19 months for Segment 2. All-cause mortality was reported from enrollment up to 52 months.
Patients in the Enrolled But Not Randomized group were enrolled in the study but discontinued before being allocated into a treatment group. They never received treatment with exicorilant. Thus, they were not at risk for a treatment-emergent adverse event.
|
0.00%
0/1 • Treatment-emergent adverse events were reported from randomization up to 27 months for Segment 1 and up to 19 months for Segment 2. All-cause mortality was reported from enrollment up to 52 months.
Patients in the Enrolled But Not Randomized group were enrolled in the study but discontinued before being allocated into a treatment group. They never received treatment with exicorilant. Thus, they were not at risk for a treatment-emergent adverse event.
|
0.00%
0/10 • Treatment-emergent adverse events were reported from randomization up to 27 months for Segment 1 and up to 19 months for Segment 2. All-cause mortality was reported from enrollment up to 52 months.
Patients in the Enrolled But Not Randomized group were enrolled in the study but discontinued before being allocated into a treatment group. They never received treatment with exicorilant. Thus, they were not at risk for a treatment-emergent adverse event.
|
0.00%
0/6 • Treatment-emergent adverse events were reported from randomization up to 27 months for Segment 1 and up to 19 months for Segment 2. All-cause mortality was reported from enrollment up to 52 months.
Patients in the Enrolled But Not Randomized group were enrolled in the study but discontinued before being allocated into a treatment group. They never received treatment with exicorilant. Thus, they were not at risk for a treatment-emergent adverse event.
|
Other adverse events
| Measure |
Dose Determination Segment 1 (Open-label) Cohort 2 - 280 mg Exicorilant
n=3 participants at risk
Patients will receive lead-in enzalutamide monotherapy once daily for 28 days. Patients will then receive combination treatment with twice-daily exicorilant 140 mg (total daily dose 280 mg) and enzalutamide once daily in 28-day dosing cycles.
|
Dose Determination Segment 1 (Open-label) Cohort 3 - 280 mg Exicorilant
n=7 participants at risk
Patients will not receive lead-in enzalutamide monotherapy. Patients will receive combination treatment with twice-daily exicorilant 140 mg (total daily dose 280 mg) and enzalutamide once daily in 28-day dosing cycles.
|
Enrolled But Not Allocated
Patients were enrolled in the study but discontinued before being allocated into a treatment group.
|
Dose Determination Segment 1 (Open-label) Cohort 1 - 360 mg Exicorilant
n=2 participants at risk
Patients will receive lead-in enzalutamide monotherapy once daily for 28 days. Patients will then receive combination treatment with twice-daily exicorilant 180 mg (total daily dose 360 mg) and enzalutamide once daily in 28-day dosing cycles.
|
Dose Determination Segment 2: Arm A - Maximum Dose 240 mg Exicorilant
n=8 participants at risk
Patients will receive treatment with once-daily exicorilant starting at 240 mg and titrating to 280 mg and then to 320 mg at 2-week intervals, as tolerated, in combination with enzalutamide once daily in 28-day dosing cycles. Patients in this arm are reported at the highest titrated dose of exicorilant achieved: 240 mg exicorilant.
|
Dose Determination Segment 2: Arm A - Maximum Dose 280 mg Exicorilant
n=1 participants at risk
Patients will receive treatment with once-daily exicorilant starting at 240 mg and titrating to 280 mg and then to 320 mg at 2-week intervals, as tolerated, in combination with enzalutamide once daily in 28-day dosing cycles.
Patients in this arm are reported at the highest titrated dose of exicorilant achieved: 280 mg exicorilant.
|
Dose Determination Segment 2: Arm A - Maximum Dose 320 mg Exicorilant
n=10 participants at risk
Patients will receive treatment with once-daily exicorilant starting at 240 mg and titrating to 280 mg and then to 320 mg at 2-week intervals, as tolerated, in combination with enzalutamide once daily in 28-day dosing cycles. Patients in this arm are reported at the highest titrated dose of exicorilant achieved: 320 mg exicorilant.
|
Dose Determination Segment 2: Arm B - 240 mg Exicorilant
n=6 participants at risk
Patients will receive combination treatment with once-daily exicorilant 240 mg, enzalutamide once daily, and placebo in 28-day dosing cycles.
|
|---|---|---|---|---|---|---|---|---|
|
Cardiac disorders
Atrial fibrillation
|
0.00%
0/3 • Treatment-emergent adverse events were reported from randomization up to 27 months for Segment 1 and up to 19 months for Segment 2. All-cause mortality was reported from enrollment up to 52 months.
Patients in the Enrolled But Not Randomized group were enrolled in the study but discontinued before being allocated into a treatment group. They never received treatment with exicorilant. Thus, they were not at risk for a treatment-emergent adverse event.
|
14.3%
1/7 • Treatment-emergent adverse events were reported from randomization up to 27 months for Segment 1 and up to 19 months for Segment 2. All-cause mortality was reported from enrollment up to 52 months.
Patients in the Enrolled But Not Randomized group were enrolled in the study but discontinued before being allocated into a treatment group. They never received treatment with exicorilant. Thus, they were not at risk for a treatment-emergent adverse event.
|
—
0/0 • Treatment-emergent adverse events were reported from randomization up to 27 months for Segment 1 and up to 19 months for Segment 2. All-cause mortality was reported from enrollment up to 52 months.
Patients in the Enrolled But Not Randomized group were enrolled in the study but discontinued before being allocated into a treatment group. They never received treatment with exicorilant. Thus, they were not at risk for a treatment-emergent adverse event.
|
0.00%
0/2 • Treatment-emergent adverse events were reported from randomization up to 27 months for Segment 1 and up to 19 months for Segment 2. All-cause mortality was reported from enrollment up to 52 months.
Patients in the Enrolled But Not Randomized group were enrolled in the study but discontinued before being allocated into a treatment group. They never received treatment with exicorilant. Thus, they were not at risk for a treatment-emergent adverse event.
|
0.00%
0/8 • Treatment-emergent adverse events were reported from randomization up to 27 months for Segment 1 and up to 19 months for Segment 2. All-cause mortality was reported from enrollment up to 52 months.
Patients in the Enrolled But Not Randomized group were enrolled in the study but discontinued before being allocated into a treatment group. They never received treatment with exicorilant. Thus, they were not at risk for a treatment-emergent adverse event.
|
0.00%
0/1 • Treatment-emergent adverse events were reported from randomization up to 27 months for Segment 1 and up to 19 months for Segment 2. All-cause mortality was reported from enrollment up to 52 months.
Patients in the Enrolled But Not Randomized group were enrolled in the study but discontinued before being allocated into a treatment group. They never received treatment with exicorilant. Thus, they were not at risk for a treatment-emergent adverse event.
|
0.00%
0/10 • Treatment-emergent adverse events were reported from randomization up to 27 months for Segment 1 and up to 19 months for Segment 2. All-cause mortality was reported from enrollment up to 52 months.
Patients in the Enrolled But Not Randomized group were enrolled in the study but discontinued before being allocated into a treatment group. They never received treatment with exicorilant. Thus, they were not at risk for a treatment-emergent adverse event.
|
0.00%
0/6 • Treatment-emergent adverse events were reported from randomization up to 27 months for Segment 1 and up to 19 months for Segment 2. All-cause mortality was reported from enrollment up to 52 months.
Patients in the Enrolled But Not Randomized group were enrolled in the study but discontinued before being allocated into a treatment group. They never received treatment with exicorilant. Thus, they were not at risk for a treatment-emergent adverse event.
|
|
Blood and lymphatic system disorders
Anaemia
|
0.00%
0/3 • Treatment-emergent adverse events were reported from randomization up to 27 months for Segment 1 and up to 19 months for Segment 2. All-cause mortality was reported from enrollment up to 52 months.
Patients in the Enrolled But Not Randomized group were enrolled in the study but discontinued before being allocated into a treatment group. They never received treatment with exicorilant. Thus, they were not at risk for a treatment-emergent adverse event.
|
0.00%
0/7 • Treatment-emergent adverse events were reported from randomization up to 27 months for Segment 1 and up to 19 months for Segment 2. All-cause mortality was reported from enrollment up to 52 months.
Patients in the Enrolled But Not Randomized group were enrolled in the study but discontinued before being allocated into a treatment group. They never received treatment with exicorilant. Thus, they were not at risk for a treatment-emergent adverse event.
|
—
0/0 • Treatment-emergent adverse events were reported from randomization up to 27 months for Segment 1 and up to 19 months for Segment 2. All-cause mortality was reported from enrollment up to 52 months.
Patients in the Enrolled But Not Randomized group were enrolled in the study but discontinued before being allocated into a treatment group. They never received treatment with exicorilant. Thus, they were not at risk for a treatment-emergent adverse event.
|
0.00%
0/2 • Treatment-emergent adverse events were reported from randomization up to 27 months for Segment 1 and up to 19 months for Segment 2. All-cause mortality was reported from enrollment up to 52 months.
Patients in the Enrolled But Not Randomized group were enrolled in the study but discontinued before being allocated into a treatment group. They never received treatment with exicorilant. Thus, they were not at risk for a treatment-emergent adverse event.
|
25.0%
2/8 • Treatment-emergent adverse events were reported from randomization up to 27 months for Segment 1 and up to 19 months for Segment 2. All-cause mortality was reported from enrollment up to 52 months.
Patients in the Enrolled But Not Randomized group were enrolled in the study but discontinued before being allocated into a treatment group. They never received treatment with exicorilant. Thus, they were not at risk for a treatment-emergent adverse event.
|
100.0%
1/1 • Treatment-emergent adverse events were reported from randomization up to 27 months for Segment 1 and up to 19 months for Segment 2. All-cause mortality was reported from enrollment up to 52 months.
Patients in the Enrolled But Not Randomized group were enrolled in the study but discontinued before being allocated into a treatment group. They never received treatment with exicorilant. Thus, they were not at risk for a treatment-emergent adverse event.
|
30.0%
3/10 • Treatment-emergent adverse events were reported from randomization up to 27 months for Segment 1 and up to 19 months for Segment 2. All-cause mortality was reported from enrollment up to 52 months.
Patients in the Enrolled But Not Randomized group were enrolled in the study but discontinued before being allocated into a treatment group. They never received treatment with exicorilant. Thus, they were not at risk for a treatment-emergent adverse event.
|
33.3%
2/6 • Treatment-emergent adverse events were reported from randomization up to 27 months for Segment 1 and up to 19 months for Segment 2. All-cause mortality was reported from enrollment up to 52 months.
Patients in the Enrolled But Not Randomized group were enrolled in the study but discontinued before being allocated into a treatment group. They never received treatment with exicorilant. Thus, they were not at risk for a treatment-emergent adverse event.
|
|
Cardiac disorders
Palpitations
|
0.00%
0/3 • Treatment-emergent adverse events were reported from randomization up to 27 months for Segment 1 and up to 19 months for Segment 2. All-cause mortality was reported from enrollment up to 52 months.
Patients in the Enrolled But Not Randomized group were enrolled in the study but discontinued before being allocated into a treatment group. They never received treatment with exicorilant. Thus, they were not at risk for a treatment-emergent adverse event.
|
0.00%
0/7 • Treatment-emergent adverse events were reported from randomization up to 27 months for Segment 1 and up to 19 months for Segment 2. All-cause mortality was reported from enrollment up to 52 months.
Patients in the Enrolled But Not Randomized group were enrolled in the study but discontinued before being allocated into a treatment group. They never received treatment with exicorilant. Thus, they were not at risk for a treatment-emergent adverse event.
|
—
0/0 • Treatment-emergent adverse events were reported from randomization up to 27 months for Segment 1 and up to 19 months for Segment 2. All-cause mortality was reported from enrollment up to 52 months.
Patients in the Enrolled But Not Randomized group were enrolled in the study but discontinued before being allocated into a treatment group. They never received treatment with exicorilant. Thus, they were not at risk for a treatment-emergent adverse event.
|
0.00%
0/2 • Treatment-emergent adverse events were reported from randomization up to 27 months for Segment 1 and up to 19 months for Segment 2. All-cause mortality was reported from enrollment up to 52 months.
Patients in the Enrolled But Not Randomized group were enrolled in the study but discontinued before being allocated into a treatment group. They never received treatment with exicorilant. Thus, they were not at risk for a treatment-emergent adverse event.
|
0.00%
0/8 • Treatment-emergent adverse events were reported from randomization up to 27 months for Segment 1 and up to 19 months for Segment 2. All-cause mortality was reported from enrollment up to 52 months.
Patients in the Enrolled But Not Randomized group were enrolled in the study but discontinued before being allocated into a treatment group. They never received treatment with exicorilant. Thus, they were not at risk for a treatment-emergent adverse event.
|
0.00%
0/1 • Treatment-emergent adverse events were reported from randomization up to 27 months for Segment 1 and up to 19 months for Segment 2. All-cause mortality was reported from enrollment up to 52 months.
Patients in the Enrolled But Not Randomized group were enrolled in the study but discontinued before being allocated into a treatment group. They never received treatment with exicorilant. Thus, they were not at risk for a treatment-emergent adverse event.
|
10.0%
1/10 • Treatment-emergent adverse events were reported from randomization up to 27 months for Segment 1 and up to 19 months for Segment 2. All-cause mortality was reported from enrollment up to 52 months.
Patients in the Enrolled But Not Randomized group were enrolled in the study but discontinued before being allocated into a treatment group. They never received treatment with exicorilant. Thus, they were not at risk for a treatment-emergent adverse event.
|
0.00%
0/6 • Treatment-emergent adverse events were reported from randomization up to 27 months for Segment 1 and up to 19 months for Segment 2. All-cause mortality was reported from enrollment up to 52 months.
Patients in the Enrolled But Not Randomized group were enrolled in the study but discontinued before being allocated into a treatment group. They never received treatment with exicorilant. Thus, they were not at risk for a treatment-emergent adverse event.
|
|
Cardiac disorders
Tachycardia
|
0.00%
0/3 • Treatment-emergent adverse events were reported from randomization up to 27 months for Segment 1 and up to 19 months for Segment 2. All-cause mortality was reported from enrollment up to 52 months.
Patients in the Enrolled But Not Randomized group were enrolled in the study but discontinued before being allocated into a treatment group. They never received treatment with exicorilant. Thus, they were not at risk for a treatment-emergent adverse event.
|
14.3%
1/7 • Treatment-emergent adverse events were reported from randomization up to 27 months for Segment 1 and up to 19 months for Segment 2. All-cause mortality was reported from enrollment up to 52 months.
Patients in the Enrolled But Not Randomized group were enrolled in the study but discontinued before being allocated into a treatment group. They never received treatment with exicorilant. Thus, they were not at risk for a treatment-emergent adverse event.
|
—
0/0 • Treatment-emergent adverse events were reported from randomization up to 27 months for Segment 1 and up to 19 months for Segment 2. All-cause mortality was reported from enrollment up to 52 months.
Patients in the Enrolled But Not Randomized group were enrolled in the study but discontinued before being allocated into a treatment group. They never received treatment with exicorilant. Thus, they were not at risk for a treatment-emergent adverse event.
|
0.00%
0/2 • Treatment-emergent adverse events were reported from randomization up to 27 months for Segment 1 and up to 19 months for Segment 2. All-cause mortality was reported from enrollment up to 52 months.
Patients in the Enrolled But Not Randomized group were enrolled in the study but discontinued before being allocated into a treatment group. They never received treatment with exicorilant. Thus, they were not at risk for a treatment-emergent adverse event.
|
0.00%
0/8 • Treatment-emergent adverse events were reported from randomization up to 27 months for Segment 1 and up to 19 months for Segment 2. All-cause mortality was reported from enrollment up to 52 months.
Patients in the Enrolled But Not Randomized group were enrolled in the study but discontinued before being allocated into a treatment group. They never received treatment with exicorilant. Thus, they were not at risk for a treatment-emergent adverse event.
|
0.00%
0/1 • Treatment-emergent adverse events were reported from randomization up to 27 months for Segment 1 and up to 19 months for Segment 2. All-cause mortality was reported from enrollment up to 52 months.
Patients in the Enrolled But Not Randomized group were enrolled in the study but discontinued before being allocated into a treatment group. They never received treatment with exicorilant. Thus, they were not at risk for a treatment-emergent adverse event.
|
0.00%
0/10 • Treatment-emergent adverse events were reported from randomization up to 27 months for Segment 1 and up to 19 months for Segment 2. All-cause mortality was reported from enrollment up to 52 months.
Patients in the Enrolled But Not Randomized group were enrolled in the study but discontinued before being allocated into a treatment group. They never received treatment with exicorilant. Thus, they were not at risk for a treatment-emergent adverse event.
|
0.00%
0/6 • Treatment-emergent adverse events were reported from randomization up to 27 months for Segment 1 and up to 19 months for Segment 2. All-cause mortality was reported from enrollment up to 52 months.
Patients in the Enrolled But Not Randomized group were enrolled in the study but discontinued before being allocated into a treatment group. They never received treatment with exicorilant. Thus, they were not at risk for a treatment-emergent adverse event.
|
|
Ear and labyrinth disorders
Ear congestion
|
0.00%
0/3 • Treatment-emergent adverse events were reported from randomization up to 27 months for Segment 1 and up to 19 months for Segment 2. All-cause mortality was reported from enrollment up to 52 months.
Patients in the Enrolled But Not Randomized group were enrolled in the study but discontinued before being allocated into a treatment group. They never received treatment with exicorilant. Thus, they were not at risk for a treatment-emergent adverse event.
|
0.00%
0/7 • Treatment-emergent adverse events were reported from randomization up to 27 months for Segment 1 and up to 19 months for Segment 2. All-cause mortality was reported from enrollment up to 52 months.
Patients in the Enrolled But Not Randomized group were enrolled in the study but discontinued before being allocated into a treatment group. They never received treatment with exicorilant. Thus, they were not at risk for a treatment-emergent adverse event.
|
—
0/0 • Treatment-emergent adverse events were reported from randomization up to 27 months for Segment 1 and up to 19 months for Segment 2. All-cause mortality was reported from enrollment up to 52 months.
Patients in the Enrolled But Not Randomized group were enrolled in the study but discontinued before being allocated into a treatment group. They never received treatment with exicorilant. Thus, they were not at risk for a treatment-emergent adverse event.
|
0.00%
0/2 • Treatment-emergent adverse events were reported from randomization up to 27 months for Segment 1 and up to 19 months for Segment 2. All-cause mortality was reported from enrollment up to 52 months.
Patients in the Enrolled But Not Randomized group were enrolled in the study but discontinued before being allocated into a treatment group. They never received treatment with exicorilant. Thus, they were not at risk for a treatment-emergent adverse event.
|
0.00%
0/8 • Treatment-emergent adverse events were reported from randomization up to 27 months for Segment 1 and up to 19 months for Segment 2. All-cause mortality was reported from enrollment up to 52 months.
Patients in the Enrolled But Not Randomized group were enrolled in the study but discontinued before being allocated into a treatment group. They never received treatment with exicorilant. Thus, they were not at risk for a treatment-emergent adverse event.
|
0.00%
0/1 • Treatment-emergent adverse events were reported from randomization up to 27 months for Segment 1 and up to 19 months for Segment 2. All-cause mortality was reported from enrollment up to 52 months.
Patients in the Enrolled But Not Randomized group were enrolled in the study but discontinued before being allocated into a treatment group. They never received treatment with exicorilant. Thus, they were not at risk for a treatment-emergent adverse event.
|
0.00%
0/10 • Treatment-emergent adverse events were reported from randomization up to 27 months for Segment 1 and up to 19 months for Segment 2. All-cause mortality was reported from enrollment up to 52 months.
Patients in the Enrolled But Not Randomized group were enrolled in the study but discontinued before being allocated into a treatment group. They never received treatment with exicorilant. Thus, they were not at risk for a treatment-emergent adverse event.
|
16.7%
1/6 • Treatment-emergent adverse events were reported from randomization up to 27 months for Segment 1 and up to 19 months for Segment 2. All-cause mortality was reported from enrollment up to 52 months.
Patients in the Enrolled But Not Randomized group were enrolled in the study but discontinued before being allocated into a treatment group. They never received treatment with exicorilant. Thus, they were not at risk for a treatment-emergent adverse event.
|
|
Ear and labyrinth disorders
Ear discomfort
|
0.00%
0/3 • Treatment-emergent adverse events were reported from randomization up to 27 months for Segment 1 and up to 19 months for Segment 2. All-cause mortality was reported from enrollment up to 52 months.
Patients in the Enrolled But Not Randomized group were enrolled in the study but discontinued before being allocated into a treatment group. They never received treatment with exicorilant. Thus, they were not at risk for a treatment-emergent adverse event.
|
0.00%
0/7 • Treatment-emergent adverse events were reported from randomization up to 27 months for Segment 1 and up to 19 months for Segment 2. All-cause mortality was reported from enrollment up to 52 months.
Patients in the Enrolled But Not Randomized group were enrolled in the study but discontinued before being allocated into a treatment group. They never received treatment with exicorilant. Thus, they were not at risk for a treatment-emergent adverse event.
|
—
0/0 • Treatment-emergent adverse events were reported from randomization up to 27 months for Segment 1 and up to 19 months for Segment 2. All-cause mortality was reported from enrollment up to 52 months.
Patients in the Enrolled But Not Randomized group were enrolled in the study but discontinued before being allocated into a treatment group. They never received treatment with exicorilant. Thus, they were not at risk for a treatment-emergent adverse event.
|
0.00%
0/2 • Treatment-emergent adverse events were reported from randomization up to 27 months for Segment 1 and up to 19 months for Segment 2. All-cause mortality was reported from enrollment up to 52 months.
Patients in the Enrolled But Not Randomized group were enrolled in the study but discontinued before being allocated into a treatment group. They never received treatment with exicorilant. Thus, they were not at risk for a treatment-emergent adverse event.
|
0.00%
0/8 • Treatment-emergent adverse events were reported from randomization up to 27 months for Segment 1 and up to 19 months for Segment 2. All-cause mortality was reported from enrollment up to 52 months.
Patients in the Enrolled But Not Randomized group were enrolled in the study but discontinued before being allocated into a treatment group. They never received treatment with exicorilant. Thus, they were not at risk for a treatment-emergent adverse event.
|
0.00%
0/1 • Treatment-emergent adverse events were reported from randomization up to 27 months for Segment 1 and up to 19 months for Segment 2. All-cause mortality was reported from enrollment up to 52 months.
Patients in the Enrolled But Not Randomized group were enrolled in the study but discontinued before being allocated into a treatment group. They never received treatment with exicorilant. Thus, they were not at risk for a treatment-emergent adverse event.
|
10.0%
1/10 • Treatment-emergent adverse events were reported from randomization up to 27 months for Segment 1 and up to 19 months for Segment 2. All-cause mortality was reported from enrollment up to 52 months.
Patients in the Enrolled But Not Randomized group were enrolled in the study but discontinued before being allocated into a treatment group. They never received treatment with exicorilant. Thus, they were not at risk for a treatment-emergent adverse event.
|
0.00%
0/6 • Treatment-emergent adverse events were reported from randomization up to 27 months for Segment 1 and up to 19 months for Segment 2. All-cause mortality was reported from enrollment up to 52 months.
Patients in the Enrolled But Not Randomized group were enrolled in the study but discontinued before being allocated into a treatment group. They never received treatment with exicorilant. Thus, they were not at risk for a treatment-emergent adverse event.
|
|
Ear and labyrinth disorders
Ear pain
|
0.00%
0/3 • Treatment-emergent adverse events were reported from randomization up to 27 months for Segment 1 and up to 19 months for Segment 2. All-cause mortality was reported from enrollment up to 52 months.
Patients in the Enrolled But Not Randomized group were enrolled in the study but discontinued before being allocated into a treatment group. They never received treatment with exicorilant. Thus, they were not at risk for a treatment-emergent adverse event.
|
0.00%
0/7 • Treatment-emergent adverse events were reported from randomization up to 27 months for Segment 1 and up to 19 months for Segment 2. All-cause mortality was reported from enrollment up to 52 months.
Patients in the Enrolled But Not Randomized group were enrolled in the study but discontinued before being allocated into a treatment group. They never received treatment with exicorilant. Thus, they were not at risk for a treatment-emergent adverse event.
|
—
0/0 • Treatment-emergent adverse events were reported from randomization up to 27 months for Segment 1 and up to 19 months for Segment 2. All-cause mortality was reported from enrollment up to 52 months.
Patients in the Enrolled But Not Randomized group were enrolled in the study but discontinued before being allocated into a treatment group. They never received treatment with exicorilant. Thus, they were not at risk for a treatment-emergent adverse event.
|
0.00%
0/2 • Treatment-emergent adverse events were reported from randomization up to 27 months for Segment 1 and up to 19 months for Segment 2. All-cause mortality was reported from enrollment up to 52 months.
Patients in the Enrolled But Not Randomized group were enrolled in the study but discontinued before being allocated into a treatment group. They never received treatment with exicorilant. Thus, they were not at risk for a treatment-emergent adverse event.
|
12.5%
1/8 • Treatment-emergent adverse events were reported from randomization up to 27 months for Segment 1 and up to 19 months for Segment 2. All-cause mortality was reported from enrollment up to 52 months.
Patients in the Enrolled But Not Randomized group were enrolled in the study but discontinued before being allocated into a treatment group. They never received treatment with exicorilant. Thus, they were not at risk for a treatment-emergent adverse event.
|
0.00%
0/1 • Treatment-emergent adverse events were reported from randomization up to 27 months for Segment 1 and up to 19 months for Segment 2. All-cause mortality was reported from enrollment up to 52 months.
Patients in the Enrolled But Not Randomized group were enrolled in the study but discontinued before being allocated into a treatment group. They never received treatment with exicorilant. Thus, they were not at risk for a treatment-emergent adverse event.
|
0.00%
0/10 • Treatment-emergent adverse events were reported from randomization up to 27 months for Segment 1 and up to 19 months for Segment 2. All-cause mortality was reported from enrollment up to 52 months.
Patients in the Enrolled But Not Randomized group were enrolled in the study but discontinued before being allocated into a treatment group. They never received treatment with exicorilant. Thus, they were not at risk for a treatment-emergent adverse event.
|
0.00%
0/6 • Treatment-emergent adverse events were reported from randomization up to 27 months for Segment 1 and up to 19 months for Segment 2. All-cause mortality was reported from enrollment up to 52 months.
Patients in the Enrolled But Not Randomized group were enrolled in the study but discontinued before being allocated into a treatment group. They never received treatment with exicorilant. Thus, they were not at risk for a treatment-emergent adverse event.
|
|
Eye disorders
Dry eye
|
0.00%
0/3 • Treatment-emergent adverse events were reported from randomization up to 27 months for Segment 1 and up to 19 months for Segment 2. All-cause mortality was reported from enrollment up to 52 months.
Patients in the Enrolled But Not Randomized group were enrolled in the study but discontinued before being allocated into a treatment group. They never received treatment with exicorilant. Thus, they were not at risk for a treatment-emergent adverse event.
|
0.00%
0/7 • Treatment-emergent adverse events were reported from randomization up to 27 months for Segment 1 and up to 19 months for Segment 2. All-cause mortality was reported from enrollment up to 52 months.
Patients in the Enrolled But Not Randomized group were enrolled in the study but discontinued before being allocated into a treatment group. They never received treatment with exicorilant. Thus, they were not at risk for a treatment-emergent adverse event.
|
—
0/0 • Treatment-emergent adverse events were reported from randomization up to 27 months for Segment 1 and up to 19 months for Segment 2. All-cause mortality was reported from enrollment up to 52 months.
Patients in the Enrolled But Not Randomized group were enrolled in the study but discontinued before being allocated into a treatment group. They never received treatment with exicorilant. Thus, they were not at risk for a treatment-emergent adverse event.
|
50.0%
1/2 • Treatment-emergent adverse events were reported from randomization up to 27 months for Segment 1 and up to 19 months for Segment 2. All-cause mortality was reported from enrollment up to 52 months.
Patients in the Enrolled But Not Randomized group were enrolled in the study but discontinued before being allocated into a treatment group. They never received treatment with exicorilant. Thus, they were not at risk for a treatment-emergent adverse event.
|
0.00%
0/8 • Treatment-emergent adverse events were reported from randomization up to 27 months for Segment 1 and up to 19 months for Segment 2. All-cause mortality was reported from enrollment up to 52 months.
Patients in the Enrolled But Not Randomized group were enrolled in the study but discontinued before being allocated into a treatment group. They never received treatment with exicorilant. Thus, they were not at risk for a treatment-emergent adverse event.
|
0.00%
0/1 • Treatment-emergent adverse events were reported from randomization up to 27 months for Segment 1 and up to 19 months for Segment 2. All-cause mortality was reported from enrollment up to 52 months.
Patients in the Enrolled But Not Randomized group were enrolled in the study but discontinued before being allocated into a treatment group. They never received treatment with exicorilant. Thus, they were not at risk for a treatment-emergent adverse event.
|
0.00%
0/10 • Treatment-emergent adverse events were reported from randomization up to 27 months for Segment 1 and up to 19 months for Segment 2. All-cause mortality was reported from enrollment up to 52 months.
Patients in the Enrolled But Not Randomized group were enrolled in the study but discontinued before being allocated into a treatment group. They never received treatment with exicorilant. Thus, they were not at risk for a treatment-emergent adverse event.
|
0.00%
0/6 • Treatment-emergent adverse events were reported from randomization up to 27 months for Segment 1 and up to 19 months for Segment 2. All-cause mortality was reported from enrollment up to 52 months.
Patients in the Enrolled But Not Randomized group were enrolled in the study but discontinued before being allocated into a treatment group. They never received treatment with exicorilant. Thus, they were not at risk for a treatment-emergent adverse event.
|
|
Eye disorders
Ocular hyperaemia
|
0.00%
0/3 • Treatment-emergent adverse events were reported from randomization up to 27 months for Segment 1 and up to 19 months for Segment 2. All-cause mortality was reported from enrollment up to 52 months.
Patients in the Enrolled But Not Randomized group were enrolled in the study but discontinued before being allocated into a treatment group. They never received treatment with exicorilant. Thus, they were not at risk for a treatment-emergent adverse event.
|
0.00%
0/7 • Treatment-emergent adverse events were reported from randomization up to 27 months for Segment 1 and up to 19 months for Segment 2. All-cause mortality was reported from enrollment up to 52 months.
Patients in the Enrolled But Not Randomized group were enrolled in the study but discontinued before being allocated into a treatment group. They never received treatment with exicorilant. Thus, they were not at risk for a treatment-emergent adverse event.
|
—
0/0 • Treatment-emergent adverse events were reported from randomization up to 27 months for Segment 1 and up to 19 months for Segment 2. All-cause mortality was reported from enrollment up to 52 months.
Patients in the Enrolled But Not Randomized group were enrolled in the study but discontinued before being allocated into a treatment group. They never received treatment with exicorilant. Thus, they were not at risk for a treatment-emergent adverse event.
|
0.00%
0/2 • Treatment-emergent adverse events were reported from randomization up to 27 months for Segment 1 and up to 19 months for Segment 2. All-cause mortality was reported from enrollment up to 52 months.
Patients in the Enrolled But Not Randomized group were enrolled in the study but discontinued before being allocated into a treatment group. They never received treatment with exicorilant. Thus, they were not at risk for a treatment-emergent adverse event.
|
0.00%
0/8 • Treatment-emergent adverse events were reported from randomization up to 27 months for Segment 1 and up to 19 months for Segment 2. All-cause mortality was reported from enrollment up to 52 months.
Patients in the Enrolled But Not Randomized group were enrolled in the study but discontinued before being allocated into a treatment group. They never received treatment with exicorilant. Thus, they were not at risk for a treatment-emergent adverse event.
|
0.00%
0/1 • Treatment-emergent adverse events were reported from randomization up to 27 months for Segment 1 and up to 19 months for Segment 2. All-cause mortality was reported from enrollment up to 52 months.
Patients in the Enrolled But Not Randomized group were enrolled in the study but discontinued before being allocated into a treatment group. They never received treatment with exicorilant. Thus, they were not at risk for a treatment-emergent adverse event.
|
10.0%
1/10 • Treatment-emergent adverse events were reported from randomization up to 27 months for Segment 1 and up to 19 months for Segment 2. All-cause mortality was reported from enrollment up to 52 months.
Patients in the Enrolled But Not Randomized group were enrolled in the study but discontinued before being allocated into a treatment group. They never received treatment with exicorilant. Thus, they were not at risk for a treatment-emergent adverse event.
|
0.00%
0/6 • Treatment-emergent adverse events were reported from randomization up to 27 months for Segment 1 and up to 19 months for Segment 2. All-cause mortality was reported from enrollment up to 52 months.
Patients in the Enrolled But Not Randomized group were enrolled in the study but discontinued before being allocated into a treatment group. They never received treatment with exicorilant. Thus, they were not at risk for a treatment-emergent adverse event.
|
|
Eye disorders
Periorbital oedema
|
0.00%
0/3 • Treatment-emergent adverse events were reported from randomization up to 27 months for Segment 1 and up to 19 months for Segment 2. All-cause mortality was reported from enrollment up to 52 months.
Patients in the Enrolled But Not Randomized group were enrolled in the study but discontinued before being allocated into a treatment group. They never received treatment with exicorilant. Thus, they were not at risk for a treatment-emergent adverse event.
|
14.3%
1/7 • Treatment-emergent adverse events were reported from randomization up to 27 months for Segment 1 and up to 19 months for Segment 2. All-cause mortality was reported from enrollment up to 52 months.
Patients in the Enrolled But Not Randomized group were enrolled in the study but discontinued before being allocated into a treatment group. They never received treatment with exicorilant. Thus, they were not at risk for a treatment-emergent adverse event.
|
—
0/0 • Treatment-emergent adverse events were reported from randomization up to 27 months for Segment 1 and up to 19 months for Segment 2. All-cause mortality was reported from enrollment up to 52 months.
Patients in the Enrolled But Not Randomized group were enrolled in the study but discontinued before being allocated into a treatment group. They never received treatment with exicorilant. Thus, they were not at risk for a treatment-emergent adverse event.
|
0.00%
0/2 • Treatment-emergent adverse events were reported from randomization up to 27 months for Segment 1 and up to 19 months for Segment 2. All-cause mortality was reported from enrollment up to 52 months.
Patients in the Enrolled But Not Randomized group were enrolled in the study but discontinued before being allocated into a treatment group. They never received treatment with exicorilant. Thus, they were not at risk for a treatment-emergent adverse event.
|
0.00%
0/8 • Treatment-emergent adverse events were reported from randomization up to 27 months for Segment 1 and up to 19 months for Segment 2. All-cause mortality was reported from enrollment up to 52 months.
Patients in the Enrolled But Not Randomized group were enrolled in the study but discontinued before being allocated into a treatment group. They never received treatment with exicorilant. Thus, they were not at risk for a treatment-emergent adverse event.
|
0.00%
0/1 • Treatment-emergent adverse events were reported from randomization up to 27 months for Segment 1 and up to 19 months for Segment 2. All-cause mortality was reported from enrollment up to 52 months.
Patients in the Enrolled But Not Randomized group were enrolled in the study but discontinued before being allocated into a treatment group. They never received treatment with exicorilant. Thus, they were not at risk for a treatment-emergent adverse event.
|
0.00%
0/10 • Treatment-emergent adverse events were reported from randomization up to 27 months for Segment 1 and up to 19 months for Segment 2. All-cause mortality was reported from enrollment up to 52 months.
Patients in the Enrolled But Not Randomized group were enrolled in the study but discontinued before being allocated into a treatment group. They never received treatment with exicorilant. Thus, they were not at risk for a treatment-emergent adverse event.
|
0.00%
0/6 • Treatment-emergent adverse events were reported from randomization up to 27 months for Segment 1 and up to 19 months for Segment 2. All-cause mortality was reported from enrollment up to 52 months.
Patients in the Enrolled But Not Randomized group were enrolled in the study but discontinued before being allocated into a treatment group. They never received treatment with exicorilant. Thus, they were not at risk for a treatment-emergent adverse event.
|
|
Eye disorders
Vision blurred
|
0.00%
0/3 • Treatment-emergent adverse events were reported from randomization up to 27 months for Segment 1 and up to 19 months for Segment 2. All-cause mortality was reported from enrollment up to 52 months.
Patients in the Enrolled But Not Randomized group were enrolled in the study but discontinued before being allocated into a treatment group. They never received treatment with exicorilant. Thus, they were not at risk for a treatment-emergent adverse event.
|
14.3%
1/7 • Treatment-emergent adverse events were reported from randomization up to 27 months for Segment 1 and up to 19 months for Segment 2. All-cause mortality was reported from enrollment up to 52 months.
Patients in the Enrolled But Not Randomized group were enrolled in the study but discontinued before being allocated into a treatment group. They never received treatment with exicorilant. Thus, they were not at risk for a treatment-emergent adverse event.
|
—
0/0 • Treatment-emergent adverse events were reported from randomization up to 27 months for Segment 1 and up to 19 months for Segment 2. All-cause mortality was reported from enrollment up to 52 months.
Patients in the Enrolled But Not Randomized group were enrolled in the study but discontinued before being allocated into a treatment group. They never received treatment with exicorilant. Thus, they were not at risk for a treatment-emergent adverse event.
|
0.00%
0/2 • Treatment-emergent adverse events were reported from randomization up to 27 months for Segment 1 and up to 19 months for Segment 2. All-cause mortality was reported from enrollment up to 52 months.
Patients in the Enrolled But Not Randomized group were enrolled in the study but discontinued before being allocated into a treatment group. They never received treatment with exicorilant. Thus, they were not at risk for a treatment-emergent adverse event.
|
0.00%
0/8 • Treatment-emergent adverse events were reported from randomization up to 27 months for Segment 1 and up to 19 months for Segment 2. All-cause mortality was reported from enrollment up to 52 months.
Patients in the Enrolled But Not Randomized group were enrolled in the study but discontinued before being allocated into a treatment group. They never received treatment with exicorilant. Thus, they were not at risk for a treatment-emergent adverse event.
|
0.00%
0/1 • Treatment-emergent adverse events were reported from randomization up to 27 months for Segment 1 and up to 19 months for Segment 2. All-cause mortality was reported from enrollment up to 52 months.
Patients in the Enrolled But Not Randomized group were enrolled in the study but discontinued before being allocated into a treatment group. They never received treatment with exicorilant. Thus, they were not at risk for a treatment-emergent adverse event.
|
0.00%
0/10 • Treatment-emergent adverse events were reported from randomization up to 27 months for Segment 1 and up to 19 months for Segment 2. All-cause mortality was reported from enrollment up to 52 months.
Patients in the Enrolled But Not Randomized group were enrolled in the study but discontinued before being allocated into a treatment group. They never received treatment with exicorilant. Thus, they were not at risk for a treatment-emergent adverse event.
|
16.7%
1/6 • Treatment-emergent adverse events were reported from randomization up to 27 months for Segment 1 and up to 19 months for Segment 2. All-cause mortality was reported from enrollment up to 52 months.
Patients in the Enrolled But Not Randomized group were enrolled in the study but discontinued before being allocated into a treatment group. They never received treatment with exicorilant. Thus, they were not at risk for a treatment-emergent adverse event.
|
|
Eye disorders
Visual acuity reduced
|
0.00%
0/3 • Treatment-emergent adverse events were reported from randomization up to 27 months for Segment 1 and up to 19 months for Segment 2. All-cause mortality was reported from enrollment up to 52 months.
Patients in the Enrolled But Not Randomized group were enrolled in the study but discontinued before being allocated into a treatment group. They never received treatment with exicorilant. Thus, they were not at risk for a treatment-emergent adverse event.
|
0.00%
0/7 • Treatment-emergent adverse events were reported from randomization up to 27 months for Segment 1 and up to 19 months for Segment 2. All-cause mortality was reported from enrollment up to 52 months.
Patients in the Enrolled But Not Randomized group were enrolled in the study but discontinued before being allocated into a treatment group. They never received treatment with exicorilant. Thus, they were not at risk for a treatment-emergent adverse event.
|
—
0/0 • Treatment-emergent adverse events were reported from randomization up to 27 months for Segment 1 and up to 19 months for Segment 2. All-cause mortality was reported from enrollment up to 52 months.
Patients in the Enrolled But Not Randomized group were enrolled in the study but discontinued before being allocated into a treatment group. They never received treatment with exicorilant. Thus, they were not at risk for a treatment-emergent adverse event.
|
0.00%
0/2 • Treatment-emergent adverse events were reported from randomization up to 27 months for Segment 1 and up to 19 months for Segment 2. All-cause mortality was reported from enrollment up to 52 months.
Patients in the Enrolled But Not Randomized group were enrolled in the study but discontinued before being allocated into a treatment group. They never received treatment with exicorilant. Thus, they were not at risk for a treatment-emergent adverse event.
|
0.00%
0/8 • Treatment-emergent adverse events were reported from randomization up to 27 months for Segment 1 and up to 19 months for Segment 2. All-cause mortality was reported from enrollment up to 52 months.
Patients in the Enrolled But Not Randomized group were enrolled in the study but discontinued before being allocated into a treatment group. They never received treatment with exicorilant. Thus, they were not at risk for a treatment-emergent adverse event.
|
0.00%
0/1 • Treatment-emergent adverse events were reported from randomization up to 27 months for Segment 1 and up to 19 months for Segment 2. All-cause mortality was reported from enrollment up to 52 months.
Patients in the Enrolled But Not Randomized group were enrolled in the study but discontinued before being allocated into a treatment group. They never received treatment with exicorilant. Thus, they were not at risk for a treatment-emergent adverse event.
|
10.0%
1/10 • Treatment-emergent adverse events were reported from randomization up to 27 months for Segment 1 and up to 19 months for Segment 2. All-cause mortality was reported from enrollment up to 52 months.
Patients in the Enrolled But Not Randomized group were enrolled in the study but discontinued before being allocated into a treatment group. They never received treatment with exicorilant. Thus, they were not at risk for a treatment-emergent adverse event.
|
0.00%
0/6 • Treatment-emergent adverse events were reported from randomization up to 27 months for Segment 1 and up to 19 months for Segment 2. All-cause mortality was reported from enrollment up to 52 months.
Patients in the Enrolled But Not Randomized group were enrolled in the study but discontinued before being allocated into a treatment group. They never received treatment with exicorilant. Thus, they were not at risk for a treatment-emergent adverse event.
|
|
Gastrointestinal disorders
Abdominal discomfort
|
0.00%
0/3 • Treatment-emergent adverse events were reported from randomization up to 27 months for Segment 1 and up to 19 months for Segment 2. All-cause mortality was reported from enrollment up to 52 months.
Patients in the Enrolled But Not Randomized group were enrolled in the study but discontinued before being allocated into a treatment group. They never received treatment with exicorilant. Thus, they were not at risk for a treatment-emergent adverse event.
|
0.00%
0/7 • Treatment-emergent adverse events were reported from randomization up to 27 months for Segment 1 and up to 19 months for Segment 2. All-cause mortality was reported from enrollment up to 52 months.
Patients in the Enrolled But Not Randomized group were enrolled in the study but discontinued before being allocated into a treatment group. They never received treatment with exicorilant. Thus, they were not at risk for a treatment-emergent adverse event.
|
—
0/0 • Treatment-emergent adverse events were reported from randomization up to 27 months for Segment 1 and up to 19 months for Segment 2. All-cause mortality was reported from enrollment up to 52 months.
Patients in the Enrolled But Not Randomized group were enrolled in the study but discontinued before being allocated into a treatment group. They never received treatment with exicorilant. Thus, they were not at risk for a treatment-emergent adverse event.
|
50.0%
1/2 • Treatment-emergent adverse events were reported from randomization up to 27 months for Segment 1 and up to 19 months for Segment 2. All-cause mortality was reported from enrollment up to 52 months.
Patients in the Enrolled But Not Randomized group were enrolled in the study but discontinued before being allocated into a treatment group. They never received treatment with exicorilant. Thus, they were not at risk for a treatment-emergent adverse event.
|
0.00%
0/8 • Treatment-emergent adverse events were reported from randomization up to 27 months for Segment 1 and up to 19 months for Segment 2. All-cause mortality was reported from enrollment up to 52 months.
Patients in the Enrolled But Not Randomized group were enrolled in the study but discontinued before being allocated into a treatment group. They never received treatment with exicorilant. Thus, they were not at risk for a treatment-emergent adverse event.
|
0.00%
0/1 • Treatment-emergent adverse events were reported from randomization up to 27 months for Segment 1 and up to 19 months for Segment 2. All-cause mortality was reported from enrollment up to 52 months.
Patients in the Enrolled But Not Randomized group were enrolled in the study but discontinued before being allocated into a treatment group. They never received treatment with exicorilant. Thus, they were not at risk for a treatment-emergent adverse event.
|
0.00%
0/10 • Treatment-emergent adverse events were reported from randomization up to 27 months for Segment 1 and up to 19 months for Segment 2. All-cause mortality was reported from enrollment up to 52 months.
Patients in the Enrolled But Not Randomized group were enrolled in the study but discontinued before being allocated into a treatment group. They never received treatment with exicorilant. Thus, they were not at risk for a treatment-emergent adverse event.
|
0.00%
0/6 • Treatment-emergent adverse events were reported from randomization up to 27 months for Segment 1 and up to 19 months for Segment 2. All-cause mortality was reported from enrollment up to 52 months.
Patients in the Enrolled But Not Randomized group were enrolled in the study but discontinued before being allocated into a treatment group. They never received treatment with exicorilant. Thus, they were not at risk for a treatment-emergent adverse event.
|
|
Gastrointestinal disorders
Abdominal pain
|
33.3%
1/3 • Treatment-emergent adverse events were reported from randomization up to 27 months for Segment 1 and up to 19 months for Segment 2. All-cause mortality was reported from enrollment up to 52 months.
Patients in the Enrolled But Not Randomized group were enrolled in the study but discontinued before being allocated into a treatment group. They never received treatment with exicorilant. Thus, they were not at risk for a treatment-emergent adverse event.
|
14.3%
1/7 • Treatment-emergent adverse events were reported from randomization up to 27 months for Segment 1 and up to 19 months for Segment 2. All-cause mortality was reported from enrollment up to 52 months.
Patients in the Enrolled But Not Randomized group were enrolled in the study but discontinued before being allocated into a treatment group. They never received treatment with exicorilant. Thus, they were not at risk for a treatment-emergent adverse event.
|
—
0/0 • Treatment-emergent adverse events were reported from randomization up to 27 months for Segment 1 and up to 19 months for Segment 2. All-cause mortality was reported from enrollment up to 52 months.
Patients in the Enrolled But Not Randomized group were enrolled in the study but discontinued before being allocated into a treatment group. They never received treatment with exicorilant. Thus, they were not at risk for a treatment-emergent adverse event.
|
50.0%
1/2 • Treatment-emergent adverse events were reported from randomization up to 27 months for Segment 1 and up to 19 months for Segment 2. All-cause mortality was reported from enrollment up to 52 months.
Patients in the Enrolled But Not Randomized group were enrolled in the study but discontinued before being allocated into a treatment group. They never received treatment with exicorilant. Thus, they were not at risk for a treatment-emergent adverse event.
|
12.5%
1/8 • Treatment-emergent adverse events were reported from randomization up to 27 months for Segment 1 and up to 19 months for Segment 2. All-cause mortality was reported from enrollment up to 52 months.
Patients in the Enrolled But Not Randomized group were enrolled in the study but discontinued before being allocated into a treatment group. They never received treatment with exicorilant. Thus, they were not at risk for a treatment-emergent adverse event.
|
100.0%
1/1 • Treatment-emergent adverse events were reported from randomization up to 27 months for Segment 1 and up to 19 months for Segment 2. All-cause mortality was reported from enrollment up to 52 months.
Patients in the Enrolled But Not Randomized group were enrolled in the study but discontinued before being allocated into a treatment group. They never received treatment with exicorilant. Thus, they were not at risk for a treatment-emergent adverse event.
|
0.00%
0/10 • Treatment-emergent adverse events were reported from randomization up to 27 months for Segment 1 and up to 19 months for Segment 2. All-cause mortality was reported from enrollment up to 52 months.
Patients in the Enrolled But Not Randomized group were enrolled in the study but discontinued before being allocated into a treatment group. They never received treatment with exicorilant. Thus, they were not at risk for a treatment-emergent adverse event.
|
50.0%
3/6 • Treatment-emergent adverse events were reported from randomization up to 27 months for Segment 1 and up to 19 months for Segment 2. All-cause mortality was reported from enrollment up to 52 months.
Patients in the Enrolled But Not Randomized group were enrolled in the study but discontinued before being allocated into a treatment group. They never received treatment with exicorilant. Thus, they were not at risk for a treatment-emergent adverse event.
|
|
Gastrointestinal disorders
Abdominal pain upper
|
0.00%
0/3 • Treatment-emergent adverse events were reported from randomization up to 27 months for Segment 1 and up to 19 months for Segment 2. All-cause mortality was reported from enrollment up to 52 months.
Patients in the Enrolled But Not Randomized group were enrolled in the study but discontinued before being allocated into a treatment group. They never received treatment with exicorilant. Thus, they were not at risk for a treatment-emergent adverse event.
|
0.00%
0/7 • Treatment-emergent adverse events were reported from randomization up to 27 months for Segment 1 and up to 19 months for Segment 2. All-cause mortality was reported from enrollment up to 52 months.
Patients in the Enrolled But Not Randomized group were enrolled in the study but discontinued before being allocated into a treatment group. They never received treatment with exicorilant. Thus, they were not at risk for a treatment-emergent adverse event.
|
—
0/0 • Treatment-emergent adverse events were reported from randomization up to 27 months for Segment 1 and up to 19 months for Segment 2. All-cause mortality was reported from enrollment up to 52 months.
Patients in the Enrolled But Not Randomized group were enrolled in the study but discontinued before being allocated into a treatment group. They never received treatment with exicorilant. Thus, they were not at risk for a treatment-emergent adverse event.
|
50.0%
1/2 • Treatment-emergent adverse events were reported from randomization up to 27 months for Segment 1 and up to 19 months for Segment 2. All-cause mortality was reported from enrollment up to 52 months.
Patients in the Enrolled But Not Randomized group were enrolled in the study but discontinued before being allocated into a treatment group. They never received treatment with exicorilant. Thus, they were not at risk for a treatment-emergent adverse event.
|
0.00%
0/8 • Treatment-emergent adverse events were reported from randomization up to 27 months for Segment 1 and up to 19 months for Segment 2. All-cause mortality was reported from enrollment up to 52 months.
Patients in the Enrolled But Not Randomized group were enrolled in the study but discontinued before being allocated into a treatment group. They never received treatment with exicorilant. Thus, they were not at risk for a treatment-emergent adverse event.
|
0.00%
0/1 • Treatment-emergent adverse events were reported from randomization up to 27 months for Segment 1 and up to 19 months for Segment 2. All-cause mortality was reported from enrollment up to 52 months.
Patients in the Enrolled But Not Randomized group were enrolled in the study but discontinued before being allocated into a treatment group. They never received treatment with exicorilant. Thus, they were not at risk for a treatment-emergent adverse event.
|
0.00%
0/10 • Treatment-emergent adverse events were reported from randomization up to 27 months for Segment 1 and up to 19 months for Segment 2. All-cause mortality was reported from enrollment up to 52 months.
Patients in the Enrolled But Not Randomized group were enrolled in the study but discontinued before being allocated into a treatment group. They never received treatment with exicorilant. Thus, they were not at risk for a treatment-emergent adverse event.
|
0.00%
0/6 • Treatment-emergent adverse events were reported from randomization up to 27 months for Segment 1 and up to 19 months for Segment 2. All-cause mortality was reported from enrollment up to 52 months.
Patients in the Enrolled But Not Randomized group were enrolled in the study but discontinued before being allocated into a treatment group. They never received treatment with exicorilant. Thus, they were not at risk for a treatment-emergent adverse event.
|
|
Gastrointestinal disorders
Constipation
|
33.3%
1/3 • Treatment-emergent adverse events were reported from randomization up to 27 months for Segment 1 and up to 19 months for Segment 2. All-cause mortality was reported from enrollment up to 52 months.
Patients in the Enrolled But Not Randomized group were enrolled in the study but discontinued before being allocated into a treatment group. They never received treatment with exicorilant. Thus, they were not at risk for a treatment-emergent adverse event.
|
42.9%
3/7 • Treatment-emergent adverse events were reported from randomization up to 27 months for Segment 1 and up to 19 months for Segment 2. All-cause mortality was reported from enrollment up to 52 months.
Patients in the Enrolled But Not Randomized group were enrolled in the study but discontinued before being allocated into a treatment group. They never received treatment with exicorilant. Thus, they were not at risk for a treatment-emergent adverse event.
|
—
0/0 • Treatment-emergent adverse events were reported from randomization up to 27 months for Segment 1 and up to 19 months for Segment 2. All-cause mortality was reported from enrollment up to 52 months.
Patients in the Enrolled But Not Randomized group were enrolled in the study but discontinued before being allocated into a treatment group. They never received treatment with exicorilant. Thus, they were not at risk for a treatment-emergent adverse event.
|
0.00%
0/2 • Treatment-emergent adverse events were reported from randomization up to 27 months for Segment 1 and up to 19 months for Segment 2. All-cause mortality was reported from enrollment up to 52 months.
Patients in the Enrolled But Not Randomized group were enrolled in the study but discontinued before being allocated into a treatment group. They never received treatment with exicorilant. Thus, they were not at risk for a treatment-emergent adverse event.
|
25.0%
2/8 • Treatment-emergent adverse events were reported from randomization up to 27 months for Segment 1 and up to 19 months for Segment 2. All-cause mortality was reported from enrollment up to 52 months.
Patients in the Enrolled But Not Randomized group were enrolled in the study but discontinued before being allocated into a treatment group. They never received treatment with exicorilant. Thus, they were not at risk for a treatment-emergent adverse event.
|
0.00%
0/1 • Treatment-emergent adverse events were reported from randomization up to 27 months for Segment 1 and up to 19 months for Segment 2. All-cause mortality was reported from enrollment up to 52 months.
Patients in the Enrolled But Not Randomized group were enrolled in the study but discontinued before being allocated into a treatment group. They never received treatment with exicorilant. Thus, they were not at risk for a treatment-emergent adverse event.
|
40.0%
4/10 • Treatment-emergent adverse events were reported from randomization up to 27 months for Segment 1 and up to 19 months for Segment 2. All-cause mortality was reported from enrollment up to 52 months.
Patients in the Enrolled But Not Randomized group were enrolled in the study but discontinued before being allocated into a treatment group. They never received treatment with exicorilant. Thus, they were not at risk for a treatment-emergent adverse event.
|
66.7%
4/6 • Treatment-emergent adverse events were reported from randomization up to 27 months for Segment 1 and up to 19 months for Segment 2. All-cause mortality was reported from enrollment up to 52 months.
Patients in the Enrolled But Not Randomized group were enrolled in the study but discontinued before being allocated into a treatment group. They never received treatment with exicorilant. Thus, they were not at risk for a treatment-emergent adverse event.
|
|
Gastrointestinal disorders
Dental caries
|
0.00%
0/3 • Treatment-emergent adverse events were reported from randomization up to 27 months for Segment 1 and up to 19 months for Segment 2. All-cause mortality was reported from enrollment up to 52 months.
Patients in the Enrolled But Not Randomized group were enrolled in the study but discontinued before being allocated into a treatment group. They never received treatment with exicorilant. Thus, they were not at risk for a treatment-emergent adverse event.
|
14.3%
1/7 • Treatment-emergent adverse events were reported from randomization up to 27 months for Segment 1 and up to 19 months for Segment 2. All-cause mortality was reported from enrollment up to 52 months.
Patients in the Enrolled But Not Randomized group were enrolled in the study but discontinued before being allocated into a treatment group. They never received treatment with exicorilant. Thus, they were not at risk for a treatment-emergent adverse event.
|
—
0/0 • Treatment-emergent adverse events were reported from randomization up to 27 months for Segment 1 and up to 19 months for Segment 2. All-cause mortality was reported from enrollment up to 52 months.
Patients in the Enrolled But Not Randomized group were enrolled in the study but discontinued before being allocated into a treatment group. They never received treatment with exicorilant. Thus, they were not at risk for a treatment-emergent adverse event.
|
0.00%
0/2 • Treatment-emergent adverse events were reported from randomization up to 27 months for Segment 1 and up to 19 months for Segment 2. All-cause mortality was reported from enrollment up to 52 months.
Patients in the Enrolled But Not Randomized group were enrolled in the study but discontinued before being allocated into a treatment group. They never received treatment with exicorilant. Thus, they were not at risk for a treatment-emergent adverse event.
|
0.00%
0/8 • Treatment-emergent adverse events were reported from randomization up to 27 months for Segment 1 and up to 19 months for Segment 2. All-cause mortality was reported from enrollment up to 52 months.
Patients in the Enrolled But Not Randomized group were enrolled in the study but discontinued before being allocated into a treatment group. They never received treatment with exicorilant. Thus, they were not at risk for a treatment-emergent adverse event.
|
0.00%
0/1 • Treatment-emergent adverse events were reported from randomization up to 27 months for Segment 1 and up to 19 months for Segment 2. All-cause mortality was reported from enrollment up to 52 months.
Patients in the Enrolled But Not Randomized group were enrolled in the study but discontinued before being allocated into a treatment group. They never received treatment with exicorilant. Thus, they were not at risk for a treatment-emergent adverse event.
|
0.00%
0/10 • Treatment-emergent adverse events were reported from randomization up to 27 months for Segment 1 and up to 19 months for Segment 2. All-cause mortality was reported from enrollment up to 52 months.
Patients in the Enrolled But Not Randomized group were enrolled in the study but discontinued before being allocated into a treatment group. They never received treatment with exicorilant. Thus, they were not at risk for a treatment-emergent adverse event.
|
0.00%
0/6 • Treatment-emergent adverse events were reported from randomization up to 27 months for Segment 1 and up to 19 months for Segment 2. All-cause mortality was reported from enrollment up to 52 months.
Patients in the Enrolled But Not Randomized group were enrolled in the study but discontinued before being allocated into a treatment group. They never received treatment with exicorilant. Thus, they were not at risk for a treatment-emergent adverse event.
|
|
Gastrointestinal disorders
Dental necrosis
|
0.00%
0/3 • Treatment-emergent adverse events were reported from randomization up to 27 months for Segment 1 and up to 19 months for Segment 2. All-cause mortality was reported from enrollment up to 52 months.
Patients in the Enrolled But Not Randomized group were enrolled in the study but discontinued before being allocated into a treatment group. They never received treatment with exicorilant. Thus, they were not at risk for a treatment-emergent adverse event.
|
14.3%
1/7 • Treatment-emergent adverse events were reported from randomization up to 27 months for Segment 1 and up to 19 months for Segment 2. All-cause mortality was reported from enrollment up to 52 months.
Patients in the Enrolled But Not Randomized group were enrolled in the study but discontinued before being allocated into a treatment group. They never received treatment with exicorilant. Thus, they were not at risk for a treatment-emergent adverse event.
|
—
0/0 • Treatment-emergent adverse events were reported from randomization up to 27 months for Segment 1 and up to 19 months for Segment 2. All-cause mortality was reported from enrollment up to 52 months.
Patients in the Enrolled But Not Randomized group were enrolled in the study but discontinued before being allocated into a treatment group. They never received treatment with exicorilant. Thus, they were not at risk for a treatment-emergent adverse event.
|
0.00%
0/2 • Treatment-emergent adverse events were reported from randomization up to 27 months for Segment 1 and up to 19 months for Segment 2. All-cause mortality was reported from enrollment up to 52 months.
Patients in the Enrolled But Not Randomized group were enrolled in the study but discontinued before being allocated into a treatment group. They never received treatment with exicorilant. Thus, they were not at risk for a treatment-emergent adverse event.
|
0.00%
0/8 • Treatment-emergent adverse events were reported from randomization up to 27 months for Segment 1 and up to 19 months for Segment 2. All-cause mortality was reported from enrollment up to 52 months.
Patients in the Enrolled But Not Randomized group were enrolled in the study but discontinued before being allocated into a treatment group. They never received treatment with exicorilant. Thus, they were not at risk for a treatment-emergent adverse event.
|
0.00%
0/1 • Treatment-emergent adverse events were reported from randomization up to 27 months for Segment 1 and up to 19 months for Segment 2. All-cause mortality was reported from enrollment up to 52 months.
Patients in the Enrolled But Not Randomized group were enrolled in the study but discontinued before being allocated into a treatment group. They never received treatment with exicorilant. Thus, they were not at risk for a treatment-emergent adverse event.
|
0.00%
0/10 • Treatment-emergent adverse events were reported from randomization up to 27 months for Segment 1 and up to 19 months for Segment 2. All-cause mortality was reported from enrollment up to 52 months.
Patients in the Enrolled But Not Randomized group were enrolled in the study but discontinued before being allocated into a treatment group. They never received treatment with exicorilant. Thus, they were not at risk for a treatment-emergent adverse event.
|
0.00%
0/6 • Treatment-emergent adverse events were reported from randomization up to 27 months for Segment 1 and up to 19 months for Segment 2. All-cause mortality was reported from enrollment up to 52 months.
Patients in the Enrolled But Not Randomized group were enrolled in the study but discontinued before being allocated into a treatment group. They never received treatment with exicorilant. Thus, they were not at risk for a treatment-emergent adverse event.
|
|
Gastrointestinal disorders
Diarrhoea
|
0.00%
0/3 • Treatment-emergent adverse events were reported from randomization up to 27 months for Segment 1 and up to 19 months for Segment 2. All-cause mortality was reported from enrollment up to 52 months.
Patients in the Enrolled But Not Randomized group were enrolled in the study but discontinued before being allocated into a treatment group. They never received treatment with exicorilant. Thus, they were not at risk for a treatment-emergent adverse event.
|
0.00%
0/7 • Treatment-emergent adverse events were reported from randomization up to 27 months for Segment 1 and up to 19 months for Segment 2. All-cause mortality was reported from enrollment up to 52 months.
Patients in the Enrolled But Not Randomized group were enrolled in the study but discontinued before being allocated into a treatment group. They never received treatment with exicorilant. Thus, they were not at risk for a treatment-emergent adverse event.
|
—
0/0 • Treatment-emergent adverse events were reported from randomization up to 27 months for Segment 1 and up to 19 months for Segment 2. All-cause mortality was reported from enrollment up to 52 months.
Patients in the Enrolled But Not Randomized group were enrolled in the study but discontinued before being allocated into a treatment group. They never received treatment with exicorilant. Thus, they were not at risk for a treatment-emergent adverse event.
|
50.0%
1/2 • Treatment-emergent adverse events were reported from randomization up to 27 months for Segment 1 and up to 19 months for Segment 2. All-cause mortality was reported from enrollment up to 52 months.
Patients in the Enrolled But Not Randomized group were enrolled in the study but discontinued before being allocated into a treatment group. They never received treatment with exicorilant. Thus, they were not at risk for a treatment-emergent adverse event.
|
0.00%
0/8 • Treatment-emergent adverse events were reported from randomization up to 27 months for Segment 1 and up to 19 months for Segment 2. All-cause mortality was reported from enrollment up to 52 months.
Patients in the Enrolled But Not Randomized group were enrolled in the study but discontinued before being allocated into a treatment group. They never received treatment with exicorilant. Thus, they were not at risk for a treatment-emergent adverse event.
|
0.00%
0/1 • Treatment-emergent adverse events were reported from randomization up to 27 months for Segment 1 and up to 19 months for Segment 2. All-cause mortality was reported from enrollment up to 52 months.
Patients in the Enrolled But Not Randomized group were enrolled in the study but discontinued before being allocated into a treatment group. They never received treatment with exicorilant. Thus, they were not at risk for a treatment-emergent adverse event.
|
10.0%
1/10 • Treatment-emergent adverse events were reported from randomization up to 27 months for Segment 1 and up to 19 months for Segment 2. All-cause mortality was reported from enrollment up to 52 months.
Patients in the Enrolled But Not Randomized group were enrolled in the study but discontinued before being allocated into a treatment group. They never received treatment with exicorilant. Thus, they were not at risk for a treatment-emergent adverse event.
|
0.00%
0/6 • Treatment-emergent adverse events were reported from randomization up to 27 months for Segment 1 and up to 19 months for Segment 2. All-cause mortality was reported from enrollment up to 52 months.
Patients in the Enrolled But Not Randomized group were enrolled in the study but discontinued before being allocated into a treatment group. They never received treatment with exicorilant. Thus, they were not at risk for a treatment-emergent adverse event.
|
|
Gastrointestinal disorders
Dry mouth
|
0.00%
0/3 • Treatment-emergent adverse events were reported from randomization up to 27 months for Segment 1 and up to 19 months for Segment 2. All-cause mortality was reported from enrollment up to 52 months.
Patients in the Enrolled But Not Randomized group were enrolled in the study but discontinued before being allocated into a treatment group. They never received treatment with exicorilant. Thus, they were not at risk for a treatment-emergent adverse event.
|
14.3%
1/7 • Treatment-emergent adverse events were reported from randomization up to 27 months for Segment 1 and up to 19 months for Segment 2. All-cause mortality was reported from enrollment up to 52 months.
Patients in the Enrolled But Not Randomized group were enrolled in the study but discontinued before being allocated into a treatment group. They never received treatment with exicorilant. Thus, they were not at risk for a treatment-emergent adverse event.
|
—
0/0 • Treatment-emergent adverse events were reported from randomization up to 27 months for Segment 1 and up to 19 months for Segment 2. All-cause mortality was reported from enrollment up to 52 months.
Patients in the Enrolled But Not Randomized group were enrolled in the study but discontinued before being allocated into a treatment group. They never received treatment with exicorilant. Thus, they were not at risk for a treatment-emergent adverse event.
|
0.00%
0/2 • Treatment-emergent adverse events were reported from randomization up to 27 months for Segment 1 and up to 19 months for Segment 2. All-cause mortality was reported from enrollment up to 52 months.
Patients in the Enrolled But Not Randomized group were enrolled in the study but discontinued before being allocated into a treatment group. They never received treatment with exicorilant. Thus, they were not at risk for a treatment-emergent adverse event.
|
0.00%
0/8 • Treatment-emergent adverse events were reported from randomization up to 27 months for Segment 1 and up to 19 months for Segment 2. All-cause mortality was reported from enrollment up to 52 months.
Patients in the Enrolled But Not Randomized group were enrolled in the study but discontinued before being allocated into a treatment group. They never received treatment with exicorilant. Thus, they were not at risk for a treatment-emergent adverse event.
|
0.00%
0/1 • Treatment-emergent adverse events were reported from randomization up to 27 months for Segment 1 and up to 19 months for Segment 2. All-cause mortality was reported from enrollment up to 52 months.
Patients in the Enrolled But Not Randomized group were enrolled in the study but discontinued before being allocated into a treatment group. They never received treatment with exicorilant. Thus, they were not at risk for a treatment-emergent adverse event.
|
10.0%
1/10 • Treatment-emergent adverse events were reported from randomization up to 27 months for Segment 1 and up to 19 months for Segment 2. All-cause mortality was reported from enrollment up to 52 months.
Patients in the Enrolled But Not Randomized group were enrolled in the study but discontinued before being allocated into a treatment group. They never received treatment with exicorilant. Thus, they were not at risk for a treatment-emergent adverse event.
|
0.00%
0/6 • Treatment-emergent adverse events were reported from randomization up to 27 months for Segment 1 and up to 19 months for Segment 2. All-cause mortality was reported from enrollment up to 52 months.
Patients in the Enrolled But Not Randomized group were enrolled in the study but discontinued before being allocated into a treatment group. They never received treatment with exicorilant. Thus, they were not at risk for a treatment-emergent adverse event.
|
|
Gastrointestinal disorders
Dyspepsia
|
33.3%
1/3 • Treatment-emergent adverse events were reported from randomization up to 27 months for Segment 1 and up to 19 months for Segment 2. All-cause mortality was reported from enrollment up to 52 months.
Patients in the Enrolled But Not Randomized group were enrolled in the study but discontinued before being allocated into a treatment group. They never received treatment with exicorilant. Thus, they were not at risk for a treatment-emergent adverse event.
|
14.3%
1/7 • Treatment-emergent adverse events were reported from randomization up to 27 months for Segment 1 and up to 19 months for Segment 2. All-cause mortality was reported from enrollment up to 52 months.
Patients in the Enrolled But Not Randomized group were enrolled in the study but discontinued before being allocated into a treatment group. They never received treatment with exicorilant. Thus, they were not at risk for a treatment-emergent adverse event.
|
—
0/0 • Treatment-emergent adverse events were reported from randomization up to 27 months for Segment 1 and up to 19 months for Segment 2. All-cause mortality was reported from enrollment up to 52 months.
Patients in the Enrolled But Not Randomized group were enrolled in the study but discontinued before being allocated into a treatment group. They never received treatment with exicorilant. Thus, they were not at risk for a treatment-emergent adverse event.
|
0.00%
0/2 • Treatment-emergent adverse events were reported from randomization up to 27 months for Segment 1 and up to 19 months for Segment 2. All-cause mortality was reported from enrollment up to 52 months.
Patients in the Enrolled But Not Randomized group were enrolled in the study but discontinued before being allocated into a treatment group. They never received treatment with exicorilant. Thus, they were not at risk for a treatment-emergent adverse event.
|
0.00%
0/8 • Treatment-emergent adverse events were reported from randomization up to 27 months for Segment 1 and up to 19 months for Segment 2. All-cause mortality was reported from enrollment up to 52 months.
Patients in the Enrolled But Not Randomized group were enrolled in the study but discontinued before being allocated into a treatment group. They never received treatment with exicorilant. Thus, they were not at risk for a treatment-emergent adverse event.
|
0.00%
0/1 • Treatment-emergent adverse events were reported from randomization up to 27 months for Segment 1 and up to 19 months for Segment 2. All-cause mortality was reported from enrollment up to 52 months.
Patients in the Enrolled But Not Randomized group were enrolled in the study but discontinued before being allocated into a treatment group. They never received treatment with exicorilant. Thus, they were not at risk for a treatment-emergent adverse event.
|
0.00%
0/10 • Treatment-emergent adverse events were reported from randomization up to 27 months for Segment 1 and up to 19 months for Segment 2. All-cause mortality was reported from enrollment up to 52 months.
Patients in the Enrolled But Not Randomized group were enrolled in the study but discontinued before being allocated into a treatment group. They never received treatment with exicorilant. Thus, they were not at risk for a treatment-emergent adverse event.
|
0.00%
0/6 • Treatment-emergent adverse events were reported from randomization up to 27 months for Segment 1 and up to 19 months for Segment 2. All-cause mortality was reported from enrollment up to 52 months.
Patients in the Enrolled But Not Randomized group were enrolled in the study but discontinued before being allocated into a treatment group. They never received treatment with exicorilant. Thus, they were not at risk for a treatment-emergent adverse event.
|
|
Gastrointestinal disorders
Dysphagia
|
0.00%
0/3 • Treatment-emergent adverse events were reported from randomization up to 27 months for Segment 1 and up to 19 months for Segment 2. All-cause mortality was reported from enrollment up to 52 months.
Patients in the Enrolled But Not Randomized group were enrolled in the study but discontinued before being allocated into a treatment group. They never received treatment with exicorilant. Thus, they were not at risk for a treatment-emergent adverse event.
|
14.3%
1/7 • Treatment-emergent adverse events were reported from randomization up to 27 months for Segment 1 and up to 19 months for Segment 2. All-cause mortality was reported from enrollment up to 52 months.
Patients in the Enrolled But Not Randomized group were enrolled in the study but discontinued before being allocated into a treatment group. They never received treatment with exicorilant. Thus, they were not at risk for a treatment-emergent adverse event.
|
—
0/0 • Treatment-emergent adverse events were reported from randomization up to 27 months for Segment 1 and up to 19 months for Segment 2. All-cause mortality was reported from enrollment up to 52 months.
Patients in the Enrolled But Not Randomized group were enrolled in the study but discontinued before being allocated into a treatment group. They never received treatment with exicorilant. Thus, they were not at risk for a treatment-emergent adverse event.
|
0.00%
0/2 • Treatment-emergent adverse events were reported from randomization up to 27 months for Segment 1 and up to 19 months for Segment 2. All-cause mortality was reported from enrollment up to 52 months.
Patients in the Enrolled But Not Randomized group were enrolled in the study but discontinued before being allocated into a treatment group. They never received treatment with exicorilant. Thus, they were not at risk for a treatment-emergent adverse event.
|
0.00%
0/8 • Treatment-emergent adverse events were reported from randomization up to 27 months for Segment 1 and up to 19 months for Segment 2. All-cause mortality was reported from enrollment up to 52 months.
Patients in the Enrolled But Not Randomized group were enrolled in the study but discontinued before being allocated into a treatment group. They never received treatment with exicorilant. Thus, they were not at risk for a treatment-emergent adverse event.
|
0.00%
0/1 • Treatment-emergent adverse events were reported from randomization up to 27 months for Segment 1 and up to 19 months for Segment 2. All-cause mortality was reported from enrollment up to 52 months.
Patients in the Enrolled But Not Randomized group were enrolled in the study but discontinued before being allocated into a treatment group. They never received treatment with exicorilant. Thus, they were not at risk for a treatment-emergent adverse event.
|
0.00%
0/10 • Treatment-emergent adverse events were reported from randomization up to 27 months for Segment 1 and up to 19 months for Segment 2. All-cause mortality was reported from enrollment up to 52 months.
Patients in the Enrolled But Not Randomized group were enrolled in the study but discontinued before being allocated into a treatment group. They never received treatment with exicorilant. Thus, they were not at risk for a treatment-emergent adverse event.
|
0.00%
0/6 • Treatment-emergent adverse events were reported from randomization up to 27 months for Segment 1 and up to 19 months for Segment 2. All-cause mortality was reported from enrollment up to 52 months.
Patients in the Enrolled But Not Randomized group were enrolled in the study but discontinued before being allocated into a treatment group. They never received treatment with exicorilant. Thus, they were not at risk for a treatment-emergent adverse event.
|
|
Gastrointestinal disorders
Flatulence
|
0.00%
0/3 • Treatment-emergent adverse events were reported from randomization up to 27 months for Segment 1 and up to 19 months for Segment 2. All-cause mortality was reported from enrollment up to 52 months.
Patients in the Enrolled But Not Randomized group were enrolled in the study but discontinued before being allocated into a treatment group. They never received treatment with exicorilant. Thus, they were not at risk for a treatment-emergent adverse event.
|
0.00%
0/7 • Treatment-emergent adverse events were reported from randomization up to 27 months for Segment 1 and up to 19 months for Segment 2. All-cause mortality was reported from enrollment up to 52 months.
Patients in the Enrolled But Not Randomized group were enrolled in the study but discontinued before being allocated into a treatment group. They never received treatment with exicorilant. Thus, they were not at risk for a treatment-emergent adverse event.
|
—
0/0 • Treatment-emergent adverse events were reported from randomization up to 27 months for Segment 1 and up to 19 months for Segment 2. All-cause mortality was reported from enrollment up to 52 months.
Patients in the Enrolled But Not Randomized group were enrolled in the study but discontinued before being allocated into a treatment group. They never received treatment with exicorilant. Thus, they were not at risk for a treatment-emergent adverse event.
|
0.00%
0/2 • Treatment-emergent adverse events were reported from randomization up to 27 months for Segment 1 and up to 19 months for Segment 2. All-cause mortality was reported from enrollment up to 52 months.
Patients in the Enrolled But Not Randomized group were enrolled in the study but discontinued before being allocated into a treatment group. They never received treatment with exicorilant. Thus, they were not at risk for a treatment-emergent adverse event.
|
0.00%
0/8 • Treatment-emergent adverse events were reported from randomization up to 27 months for Segment 1 and up to 19 months for Segment 2. All-cause mortality was reported from enrollment up to 52 months.
Patients in the Enrolled But Not Randomized group were enrolled in the study but discontinued before being allocated into a treatment group. They never received treatment with exicorilant. Thus, they were not at risk for a treatment-emergent adverse event.
|
100.0%
1/1 • Treatment-emergent adverse events were reported from randomization up to 27 months for Segment 1 and up to 19 months for Segment 2. All-cause mortality was reported from enrollment up to 52 months.
Patients in the Enrolled But Not Randomized group were enrolled in the study but discontinued before being allocated into a treatment group. They never received treatment with exicorilant. Thus, they were not at risk for a treatment-emergent adverse event.
|
0.00%
0/10 • Treatment-emergent adverse events were reported from randomization up to 27 months for Segment 1 and up to 19 months for Segment 2. All-cause mortality was reported from enrollment up to 52 months.
Patients in the Enrolled But Not Randomized group were enrolled in the study but discontinued before being allocated into a treatment group. They never received treatment with exicorilant. Thus, they were not at risk for a treatment-emergent adverse event.
|
0.00%
0/6 • Treatment-emergent adverse events were reported from randomization up to 27 months for Segment 1 and up to 19 months for Segment 2. All-cause mortality was reported from enrollment up to 52 months.
Patients in the Enrolled But Not Randomized group were enrolled in the study but discontinued before being allocated into a treatment group. They never received treatment with exicorilant. Thus, they were not at risk for a treatment-emergent adverse event.
|
|
Gastrointestinal disorders
Gastrooesophageal reflux disease
|
0.00%
0/3 • Treatment-emergent adverse events were reported from randomization up to 27 months for Segment 1 and up to 19 months for Segment 2. All-cause mortality was reported from enrollment up to 52 months.
Patients in the Enrolled But Not Randomized group were enrolled in the study but discontinued before being allocated into a treatment group. They never received treatment with exicorilant. Thus, they were not at risk for a treatment-emergent adverse event.
|
0.00%
0/7 • Treatment-emergent adverse events were reported from randomization up to 27 months for Segment 1 and up to 19 months for Segment 2. All-cause mortality was reported from enrollment up to 52 months.
Patients in the Enrolled But Not Randomized group were enrolled in the study but discontinued before being allocated into a treatment group. They never received treatment with exicorilant. Thus, they were not at risk for a treatment-emergent adverse event.
|
—
0/0 • Treatment-emergent adverse events were reported from randomization up to 27 months for Segment 1 and up to 19 months for Segment 2. All-cause mortality was reported from enrollment up to 52 months.
Patients in the Enrolled But Not Randomized group were enrolled in the study but discontinued before being allocated into a treatment group. They never received treatment with exicorilant. Thus, they were not at risk for a treatment-emergent adverse event.
|
50.0%
1/2 • Treatment-emergent adverse events were reported from randomization up to 27 months for Segment 1 and up to 19 months for Segment 2. All-cause mortality was reported from enrollment up to 52 months.
Patients in the Enrolled But Not Randomized group were enrolled in the study but discontinued before being allocated into a treatment group. They never received treatment with exicorilant. Thus, they were not at risk for a treatment-emergent adverse event.
|
12.5%
1/8 • Treatment-emergent adverse events were reported from randomization up to 27 months for Segment 1 and up to 19 months for Segment 2. All-cause mortality was reported from enrollment up to 52 months.
Patients in the Enrolled But Not Randomized group were enrolled in the study but discontinued before being allocated into a treatment group. They never received treatment with exicorilant. Thus, they were not at risk for a treatment-emergent adverse event.
|
0.00%
0/1 • Treatment-emergent adverse events were reported from randomization up to 27 months for Segment 1 and up to 19 months for Segment 2. All-cause mortality was reported from enrollment up to 52 months.
Patients in the Enrolled But Not Randomized group were enrolled in the study but discontinued before being allocated into a treatment group. They never received treatment with exicorilant. Thus, they were not at risk for a treatment-emergent adverse event.
|
0.00%
0/10 • Treatment-emergent adverse events were reported from randomization up to 27 months for Segment 1 and up to 19 months for Segment 2. All-cause mortality was reported from enrollment up to 52 months.
Patients in the Enrolled But Not Randomized group were enrolled in the study but discontinued before being allocated into a treatment group. They never received treatment with exicorilant. Thus, they were not at risk for a treatment-emergent adverse event.
|
0.00%
0/6 • Treatment-emergent adverse events were reported from randomization up to 27 months for Segment 1 and up to 19 months for Segment 2. All-cause mortality was reported from enrollment up to 52 months.
Patients in the Enrolled But Not Randomized group were enrolled in the study but discontinued before being allocated into a treatment group. They never received treatment with exicorilant. Thus, they were not at risk for a treatment-emergent adverse event.
|
|
Gastrointestinal disorders
Nausea
|
33.3%
1/3 • Treatment-emergent adverse events were reported from randomization up to 27 months for Segment 1 and up to 19 months for Segment 2. All-cause mortality was reported from enrollment up to 52 months.
Patients in the Enrolled But Not Randomized group were enrolled in the study but discontinued before being allocated into a treatment group. They never received treatment with exicorilant. Thus, they were not at risk for a treatment-emergent adverse event.
|
14.3%
1/7 • Treatment-emergent adverse events were reported from randomization up to 27 months for Segment 1 and up to 19 months for Segment 2. All-cause mortality was reported from enrollment up to 52 months.
Patients in the Enrolled But Not Randomized group were enrolled in the study but discontinued before being allocated into a treatment group. They never received treatment with exicorilant. Thus, they were not at risk for a treatment-emergent adverse event.
|
—
0/0 • Treatment-emergent adverse events were reported from randomization up to 27 months for Segment 1 and up to 19 months for Segment 2. All-cause mortality was reported from enrollment up to 52 months.
Patients in the Enrolled But Not Randomized group were enrolled in the study but discontinued before being allocated into a treatment group. They never received treatment with exicorilant. Thus, they were not at risk for a treatment-emergent adverse event.
|
0.00%
0/2 • Treatment-emergent adverse events were reported from randomization up to 27 months for Segment 1 and up to 19 months for Segment 2. All-cause mortality was reported from enrollment up to 52 months.
Patients in the Enrolled But Not Randomized group were enrolled in the study but discontinued before being allocated into a treatment group. They never received treatment with exicorilant. Thus, they were not at risk for a treatment-emergent adverse event.
|
12.5%
1/8 • Treatment-emergent adverse events were reported from randomization up to 27 months for Segment 1 and up to 19 months for Segment 2. All-cause mortality was reported from enrollment up to 52 months.
Patients in the Enrolled But Not Randomized group were enrolled in the study but discontinued before being allocated into a treatment group. They never received treatment with exicorilant. Thus, they were not at risk for a treatment-emergent adverse event.
|
100.0%
1/1 • Treatment-emergent adverse events were reported from randomization up to 27 months for Segment 1 and up to 19 months for Segment 2. All-cause mortality was reported from enrollment up to 52 months.
Patients in the Enrolled But Not Randomized group were enrolled in the study but discontinued before being allocated into a treatment group. They never received treatment with exicorilant. Thus, they were not at risk for a treatment-emergent adverse event.
|
20.0%
2/10 • Treatment-emergent adverse events were reported from randomization up to 27 months for Segment 1 and up to 19 months for Segment 2. All-cause mortality was reported from enrollment up to 52 months.
Patients in the Enrolled But Not Randomized group were enrolled in the study but discontinued before being allocated into a treatment group. They never received treatment with exicorilant. Thus, they were not at risk for a treatment-emergent adverse event.
|
16.7%
1/6 • Treatment-emergent adverse events were reported from randomization up to 27 months for Segment 1 and up to 19 months for Segment 2. All-cause mortality was reported from enrollment up to 52 months.
Patients in the Enrolled But Not Randomized group were enrolled in the study but discontinued before being allocated into a treatment group. They never received treatment with exicorilant. Thus, they were not at risk for a treatment-emergent adverse event.
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/3 • Treatment-emergent adverse events were reported from randomization up to 27 months for Segment 1 and up to 19 months for Segment 2. All-cause mortality was reported from enrollment up to 52 months.
Patients in the Enrolled But Not Randomized group were enrolled in the study but discontinued before being allocated into a treatment group. They never received treatment with exicorilant. Thus, they were not at risk for a treatment-emergent adverse event.
|
0.00%
0/7 • Treatment-emergent adverse events were reported from randomization up to 27 months for Segment 1 and up to 19 months for Segment 2. All-cause mortality was reported from enrollment up to 52 months.
Patients in the Enrolled But Not Randomized group were enrolled in the study but discontinued before being allocated into a treatment group. They never received treatment with exicorilant. Thus, they were not at risk for a treatment-emergent adverse event.
|
—
0/0 • Treatment-emergent adverse events were reported from randomization up to 27 months for Segment 1 and up to 19 months for Segment 2. All-cause mortality was reported from enrollment up to 52 months.
Patients in the Enrolled But Not Randomized group were enrolled in the study but discontinued before being allocated into a treatment group. They never received treatment with exicorilant. Thus, they were not at risk for a treatment-emergent adverse event.
|
0.00%
0/2 • Treatment-emergent adverse events were reported from randomization up to 27 months for Segment 1 and up to 19 months for Segment 2. All-cause mortality was reported from enrollment up to 52 months.
Patients in the Enrolled But Not Randomized group were enrolled in the study but discontinued before being allocated into a treatment group. They never received treatment with exicorilant. Thus, they were not at risk for a treatment-emergent adverse event.
|
0.00%
0/8 • Treatment-emergent adverse events were reported from randomization up to 27 months for Segment 1 and up to 19 months for Segment 2. All-cause mortality was reported from enrollment up to 52 months.
Patients in the Enrolled But Not Randomized group were enrolled in the study but discontinued before being allocated into a treatment group. They never received treatment with exicorilant. Thus, they were not at risk for a treatment-emergent adverse event.
|
100.0%
1/1 • Treatment-emergent adverse events were reported from randomization up to 27 months for Segment 1 and up to 19 months for Segment 2. All-cause mortality was reported from enrollment up to 52 months.
Patients in the Enrolled But Not Randomized group were enrolled in the study but discontinued before being allocated into a treatment group. They never received treatment with exicorilant. Thus, they were not at risk for a treatment-emergent adverse event.
|
0.00%
0/10 • Treatment-emergent adverse events were reported from randomization up to 27 months for Segment 1 and up to 19 months for Segment 2. All-cause mortality was reported from enrollment up to 52 months.
Patients in the Enrolled But Not Randomized group were enrolled in the study but discontinued before being allocated into a treatment group. They never received treatment with exicorilant. Thus, they were not at risk for a treatment-emergent adverse event.
|
0.00%
0/6 • Treatment-emergent adverse events were reported from randomization up to 27 months for Segment 1 and up to 19 months for Segment 2. All-cause mortality was reported from enrollment up to 52 months.
Patients in the Enrolled But Not Randomized group were enrolled in the study but discontinued before being allocated into a treatment group. They never received treatment with exicorilant. Thus, they were not at risk for a treatment-emergent adverse event.
|
|
General disorders
Asthenia
|
0.00%
0/3 • Treatment-emergent adverse events were reported from randomization up to 27 months for Segment 1 and up to 19 months for Segment 2. All-cause mortality was reported from enrollment up to 52 months.
Patients in the Enrolled But Not Randomized group were enrolled in the study but discontinued before being allocated into a treatment group. They never received treatment with exicorilant. Thus, they were not at risk for a treatment-emergent adverse event.
|
0.00%
0/7 • Treatment-emergent adverse events were reported from randomization up to 27 months for Segment 1 and up to 19 months for Segment 2. All-cause mortality was reported from enrollment up to 52 months.
Patients in the Enrolled But Not Randomized group were enrolled in the study but discontinued before being allocated into a treatment group. They never received treatment with exicorilant. Thus, they were not at risk for a treatment-emergent adverse event.
|
—
0/0 • Treatment-emergent adverse events were reported from randomization up to 27 months for Segment 1 and up to 19 months for Segment 2. All-cause mortality was reported from enrollment up to 52 months.
Patients in the Enrolled But Not Randomized group were enrolled in the study but discontinued before being allocated into a treatment group. They never received treatment with exicorilant. Thus, they were not at risk for a treatment-emergent adverse event.
|
0.00%
0/2 • Treatment-emergent adverse events were reported from randomization up to 27 months for Segment 1 and up to 19 months for Segment 2. All-cause mortality was reported from enrollment up to 52 months.
Patients in the Enrolled But Not Randomized group were enrolled in the study but discontinued before being allocated into a treatment group. They never received treatment with exicorilant. Thus, they were not at risk for a treatment-emergent adverse event.
|
12.5%
1/8 • Treatment-emergent adverse events were reported from randomization up to 27 months for Segment 1 and up to 19 months for Segment 2. All-cause mortality was reported from enrollment up to 52 months.
Patients in the Enrolled But Not Randomized group were enrolled in the study but discontinued before being allocated into a treatment group. They never received treatment with exicorilant. Thus, they were not at risk for a treatment-emergent adverse event.
|
0.00%
0/1 • Treatment-emergent adverse events were reported from randomization up to 27 months for Segment 1 and up to 19 months for Segment 2. All-cause mortality was reported from enrollment up to 52 months.
Patients in the Enrolled But Not Randomized group were enrolled in the study but discontinued before being allocated into a treatment group. They never received treatment with exicorilant. Thus, they were not at risk for a treatment-emergent adverse event.
|
0.00%
0/10 • Treatment-emergent adverse events were reported from randomization up to 27 months for Segment 1 and up to 19 months for Segment 2. All-cause mortality was reported from enrollment up to 52 months.
Patients in the Enrolled But Not Randomized group were enrolled in the study but discontinued before being allocated into a treatment group. They never received treatment with exicorilant. Thus, they were not at risk for a treatment-emergent adverse event.
|
16.7%
1/6 • Treatment-emergent adverse events were reported from randomization up to 27 months for Segment 1 and up to 19 months for Segment 2. All-cause mortality was reported from enrollment up to 52 months.
Patients in the Enrolled But Not Randomized group were enrolled in the study but discontinued before being allocated into a treatment group. They never received treatment with exicorilant. Thus, they were not at risk for a treatment-emergent adverse event.
|
|
General disorders
Chills
|
0.00%
0/3 • Treatment-emergent adverse events were reported from randomization up to 27 months for Segment 1 and up to 19 months for Segment 2. All-cause mortality was reported from enrollment up to 52 months.
Patients in the Enrolled But Not Randomized group were enrolled in the study but discontinued before being allocated into a treatment group. They never received treatment with exicorilant. Thus, they were not at risk for a treatment-emergent adverse event.
|
0.00%
0/7 • Treatment-emergent adverse events were reported from randomization up to 27 months for Segment 1 and up to 19 months for Segment 2. All-cause mortality was reported from enrollment up to 52 months.
Patients in the Enrolled But Not Randomized group were enrolled in the study but discontinued before being allocated into a treatment group. They never received treatment with exicorilant. Thus, they were not at risk for a treatment-emergent adverse event.
|
—
0/0 • Treatment-emergent adverse events were reported from randomization up to 27 months for Segment 1 and up to 19 months for Segment 2. All-cause mortality was reported from enrollment up to 52 months.
Patients in the Enrolled But Not Randomized group were enrolled in the study but discontinued before being allocated into a treatment group. They never received treatment with exicorilant. Thus, they were not at risk for a treatment-emergent adverse event.
|
0.00%
0/2 • Treatment-emergent adverse events were reported from randomization up to 27 months for Segment 1 and up to 19 months for Segment 2. All-cause mortality was reported from enrollment up to 52 months.
Patients in the Enrolled But Not Randomized group were enrolled in the study but discontinued before being allocated into a treatment group. They never received treatment with exicorilant. Thus, they were not at risk for a treatment-emergent adverse event.
|
0.00%
0/8 • Treatment-emergent adverse events were reported from randomization up to 27 months for Segment 1 and up to 19 months for Segment 2. All-cause mortality was reported from enrollment up to 52 months.
Patients in the Enrolled But Not Randomized group were enrolled in the study but discontinued before being allocated into a treatment group. They never received treatment with exicorilant. Thus, they were not at risk for a treatment-emergent adverse event.
|
0.00%
0/1 • Treatment-emergent adverse events were reported from randomization up to 27 months for Segment 1 and up to 19 months for Segment 2. All-cause mortality was reported from enrollment up to 52 months.
Patients in the Enrolled But Not Randomized group were enrolled in the study but discontinued before being allocated into a treatment group. They never received treatment with exicorilant. Thus, they were not at risk for a treatment-emergent adverse event.
|
0.00%
0/10 • Treatment-emergent adverse events were reported from randomization up to 27 months for Segment 1 and up to 19 months for Segment 2. All-cause mortality was reported from enrollment up to 52 months.
Patients in the Enrolled But Not Randomized group were enrolled in the study but discontinued before being allocated into a treatment group. They never received treatment with exicorilant. Thus, they were not at risk for a treatment-emergent adverse event.
|
16.7%
1/6 • Treatment-emergent adverse events were reported from randomization up to 27 months for Segment 1 and up to 19 months for Segment 2. All-cause mortality was reported from enrollment up to 52 months.
Patients in the Enrolled But Not Randomized group were enrolled in the study but discontinued before being allocated into a treatment group. They never received treatment with exicorilant. Thus, they were not at risk for a treatment-emergent adverse event.
|
|
General disorders
Fatigue
|
0.00%
0/3 • Treatment-emergent adverse events were reported from randomization up to 27 months for Segment 1 and up to 19 months for Segment 2. All-cause mortality was reported from enrollment up to 52 months.
Patients in the Enrolled But Not Randomized group were enrolled in the study but discontinued before being allocated into a treatment group. They never received treatment with exicorilant. Thus, they were not at risk for a treatment-emergent adverse event.
|
57.1%
4/7 • Treatment-emergent adverse events were reported from randomization up to 27 months for Segment 1 and up to 19 months for Segment 2. All-cause mortality was reported from enrollment up to 52 months.
Patients in the Enrolled But Not Randomized group were enrolled in the study but discontinued before being allocated into a treatment group. They never received treatment with exicorilant. Thus, they were not at risk for a treatment-emergent adverse event.
|
—
0/0 • Treatment-emergent adverse events were reported from randomization up to 27 months for Segment 1 and up to 19 months for Segment 2. All-cause mortality was reported from enrollment up to 52 months.
Patients in the Enrolled But Not Randomized group were enrolled in the study but discontinued before being allocated into a treatment group. They never received treatment with exicorilant. Thus, they were not at risk for a treatment-emergent adverse event.
|
100.0%
2/2 • Treatment-emergent adverse events were reported from randomization up to 27 months for Segment 1 and up to 19 months for Segment 2. All-cause mortality was reported from enrollment up to 52 months.
Patients in the Enrolled But Not Randomized group were enrolled in the study but discontinued before being allocated into a treatment group. They never received treatment with exicorilant. Thus, they were not at risk for a treatment-emergent adverse event.
|
62.5%
5/8 • Treatment-emergent adverse events were reported from randomization up to 27 months for Segment 1 and up to 19 months for Segment 2. All-cause mortality was reported from enrollment up to 52 months.
Patients in the Enrolled But Not Randomized group were enrolled in the study but discontinued before being allocated into a treatment group. They never received treatment with exicorilant. Thus, they were not at risk for a treatment-emergent adverse event.
|
0.00%
0/1 • Treatment-emergent adverse events were reported from randomization up to 27 months for Segment 1 and up to 19 months for Segment 2. All-cause mortality was reported from enrollment up to 52 months.
Patients in the Enrolled But Not Randomized group were enrolled in the study but discontinued before being allocated into a treatment group. They never received treatment with exicorilant. Thus, they were not at risk for a treatment-emergent adverse event.
|
60.0%
6/10 • Treatment-emergent adverse events were reported from randomization up to 27 months for Segment 1 and up to 19 months for Segment 2. All-cause mortality was reported from enrollment up to 52 months.
Patients in the Enrolled But Not Randomized group were enrolled in the study but discontinued before being allocated into a treatment group. They never received treatment with exicorilant. Thus, they were not at risk for a treatment-emergent adverse event.
|
83.3%
5/6 • Treatment-emergent adverse events were reported from randomization up to 27 months for Segment 1 and up to 19 months for Segment 2. All-cause mortality was reported from enrollment up to 52 months.
Patients in the Enrolled But Not Randomized group were enrolled in the study but discontinued before being allocated into a treatment group. They never received treatment with exicorilant. Thus, they were not at risk for a treatment-emergent adverse event.
|
|
General disorders
Gait disturbance
|
0.00%
0/3 • Treatment-emergent adverse events were reported from randomization up to 27 months for Segment 1 and up to 19 months for Segment 2. All-cause mortality was reported from enrollment up to 52 months.
Patients in the Enrolled But Not Randomized group were enrolled in the study but discontinued before being allocated into a treatment group. They never received treatment with exicorilant. Thus, they were not at risk for a treatment-emergent adverse event.
|
0.00%
0/7 • Treatment-emergent adverse events were reported from randomization up to 27 months for Segment 1 and up to 19 months for Segment 2. All-cause mortality was reported from enrollment up to 52 months.
Patients in the Enrolled But Not Randomized group were enrolled in the study but discontinued before being allocated into a treatment group. They never received treatment with exicorilant. Thus, they were not at risk for a treatment-emergent adverse event.
|
—
0/0 • Treatment-emergent adverse events were reported from randomization up to 27 months for Segment 1 and up to 19 months for Segment 2. All-cause mortality was reported from enrollment up to 52 months.
Patients in the Enrolled But Not Randomized group were enrolled in the study but discontinued before being allocated into a treatment group. They never received treatment with exicorilant. Thus, they were not at risk for a treatment-emergent adverse event.
|
0.00%
0/2 • Treatment-emergent adverse events were reported from randomization up to 27 months for Segment 1 and up to 19 months for Segment 2. All-cause mortality was reported from enrollment up to 52 months.
Patients in the Enrolled But Not Randomized group were enrolled in the study but discontinued before being allocated into a treatment group. They never received treatment with exicorilant. Thus, they were not at risk for a treatment-emergent adverse event.
|
0.00%
0/8 • Treatment-emergent adverse events were reported from randomization up to 27 months for Segment 1 and up to 19 months for Segment 2. All-cause mortality was reported from enrollment up to 52 months.
Patients in the Enrolled But Not Randomized group were enrolled in the study but discontinued before being allocated into a treatment group. They never received treatment with exicorilant. Thus, they were not at risk for a treatment-emergent adverse event.
|
0.00%
0/1 • Treatment-emergent adverse events were reported from randomization up to 27 months for Segment 1 and up to 19 months for Segment 2. All-cause mortality was reported from enrollment up to 52 months.
Patients in the Enrolled But Not Randomized group were enrolled in the study but discontinued before being allocated into a treatment group. They never received treatment with exicorilant. Thus, they were not at risk for a treatment-emergent adverse event.
|
0.00%
0/10 • Treatment-emergent adverse events were reported from randomization up to 27 months for Segment 1 and up to 19 months for Segment 2. All-cause mortality was reported from enrollment up to 52 months.
Patients in the Enrolled But Not Randomized group were enrolled in the study but discontinued before being allocated into a treatment group. They never received treatment with exicorilant. Thus, they were not at risk for a treatment-emergent adverse event.
|
16.7%
1/6 • Treatment-emergent adverse events were reported from randomization up to 27 months for Segment 1 and up to 19 months for Segment 2. All-cause mortality was reported from enrollment up to 52 months.
Patients in the Enrolled But Not Randomized group were enrolled in the study but discontinued before being allocated into a treatment group. They never received treatment with exicorilant. Thus, they were not at risk for a treatment-emergent adverse event.
|
|
General disorders
Influenza like illness
|
0.00%
0/3 • Treatment-emergent adverse events were reported from randomization up to 27 months for Segment 1 and up to 19 months for Segment 2. All-cause mortality was reported from enrollment up to 52 months.
Patients in the Enrolled But Not Randomized group were enrolled in the study but discontinued before being allocated into a treatment group. They never received treatment with exicorilant. Thus, they were not at risk for a treatment-emergent adverse event.
|
0.00%
0/7 • Treatment-emergent adverse events were reported from randomization up to 27 months for Segment 1 and up to 19 months for Segment 2. All-cause mortality was reported from enrollment up to 52 months.
Patients in the Enrolled But Not Randomized group were enrolled in the study but discontinued before being allocated into a treatment group. They never received treatment with exicorilant. Thus, they were not at risk for a treatment-emergent adverse event.
|
—
0/0 • Treatment-emergent adverse events were reported from randomization up to 27 months for Segment 1 and up to 19 months for Segment 2. All-cause mortality was reported from enrollment up to 52 months.
Patients in the Enrolled But Not Randomized group were enrolled in the study but discontinued before being allocated into a treatment group. They never received treatment with exicorilant. Thus, they were not at risk for a treatment-emergent adverse event.
|
0.00%
0/2 • Treatment-emergent adverse events were reported from randomization up to 27 months for Segment 1 and up to 19 months for Segment 2. All-cause mortality was reported from enrollment up to 52 months.
Patients in the Enrolled But Not Randomized group were enrolled in the study but discontinued before being allocated into a treatment group. They never received treatment with exicorilant. Thus, they were not at risk for a treatment-emergent adverse event.
|
0.00%
0/8 • Treatment-emergent adverse events were reported from randomization up to 27 months for Segment 1 and up to 19 months for Segment 2. All-cause mortality was reported from enrollment up to 52 months.
Patients in the Enrolled But Not Randomized group were enrolled in the study but discontinued before being allocated into a treatment group. They never received treatment with exicorilant. Thus, they were not at risk for a treatment-emergent adverse event.
|
0.00%
0/1 • Treatment-emergent adverse events were reported from randomization up to 27 months for Segment 1 and up to 19 months for Segment 2. All-cause mortality was reported from enrollment up to 52 months.
Patients in the Enrolled But Not Randomized group were enrolled in the study but discontinued before being allocated into a treatment group. They never received treatment with exicorilant. Thus, they were not at risk for a treatment-emergent adverse event.
|
0.00%
0/10 • Treatment-emergent adverse events were reported from randomization up to 27 months for Segment 1 and up to 19 months for Segment 2. All-cause mortality was reported from enrollment up to 52 months.
Patients in the Enrolled But Not Randomized group were enrolled in the study but discontinued before being allocated into a treatment group. They never received treatment with exicorilant. Thus, they were not at risk for a treatment-emergent adverse event.
|
16.7%
1/6 • Treatment-emergent adverse events were reported from randomization up to 27 months for Segment 1 and up to 19 months for Segment 2. All-cause mortality was reported from enrollment up to 52 months.
Patients in the Enrolled But Not Randomized group were enrolled in the study but discontinued before being allocated into a treatment group. They never received treatment with exicorilant. Thus, they were not at risk for a treatment-emergent adverse event.
|
|
General disorders
Malaise
|
0.00%
0/3 • Treatment-emergent adverse events were reported from randomization up to 27 months for Segment 1 and up to 19 months for Segment 2. All-cause mortality was reported from enrollment up to 52 months.
Patients in the Enrolled But Not Randomized group were enrolled in the study but discontinued before being allocated into a treatment group. They never received treatment with exicorilant. Thus, they were not at risk for a treatment-emergent adverse event.
|
14.3%
1/7 • Treatment-emergent adverse events were reported from randomization up to 27 months for Segment 1 and up to 19 months for Segment 2. All-cause mortality was reported from enrollment up to 52 months.
Patients in the Enrolled But Not Randomized group were enrolled in the study but discontinued before being allocated into a treatment group. They never received treatment with exicorilant. Thus, they were not at risk for a treatment-emergent adverse event.
|
—
0/0 • Treatment-emergent adverse events were reported from randomization up to 27 months for Segment 1 and up to 19 months for Segment 2. All-cause mortality was reported from enrollment up to 52 months.
Patients in the Enrolled But Not Randomized group were enrolled in the study but discontinued before being allocated into a treatment group. They never received treatment with exicorilant. Thus, they were not at risk for a treatment-emergent adverse event.
|
0.00%
0/2 • Treatment-emergent adverse events were reported from randomization up to 27 months for Segment 1 and up to 19 months for Segment 2. All-cause mortality was reported from enrollment up to 52 months.
Patients in the Enrolled But Not Randomized group were enrolled in the study but discontinued before being allocated into a treatment group. They never received treatment with exicorilant. Thus, they were not at risk for a treatment-emergent adverse event.
|
0.00%
0/8 • Treatment-emergent adverse events were reported from randomization up to 27 months for Segment 1 and up to 19 months for Segment 2. All-cause mortality was reported from enrollment up to 52 months.
Patients in the Enrolled But Not Randomized group were enrolled in the study but discontinued before being allocated into a treatment group. They never received treatment with exicorilant. Thus, they were not at risk for a treatment-emergent adverse event.
|
0.00%
0/1 • Treatment-emergent adverse events were reported from randomization up to 27 months for Segment 1 and up to 19 months for Segment 2. All-cause mortality was reported from enrollment up to 52 months.
Patients in the Enrolled But Not Randomized group were enrolled in the study but discontinued before being allocated into a treatment group. They never received treatment with exicorilant. Thus, they were not at risk for a treatment-emergent adverse event.
|
0.00%
0/10 • Treatment-emergent adverse events were reported from randomization up to 27 months for Segment 1 and up to 19 months for Segment 2. All-cause mortality was reported from enrollment up to 52 months.
Patients in the Enrolled But Not Randomized group were enrolled in the study but discontinued before being allocated into a treatment group. They never received treatment with exicorilant. Thus, they were not at risk for a treatment-emergent adverse event.
|
0.00%
0/6 • Treatment-emergent adverse events were reported from randomization up to 27 months for Segment 1 and up to 19 months for Segment 2. All-cause mortality was reported from enrollment up to 52 months.
Patients in the Enrolled But Not Randomized group were enrolled in the study but discontinued before being allocated into a treatment group. They never received treatment with exicorilant. Thus, they were not at risk for a treatment-emergent adverse event.
|
|
General disorders
Non-cardiac chest pain
|
0.00%
0/3 • Treatment-emergent adverse events were reported from randomization up to 27 months for Segment 1 and up to 19 months for Segment 2. All-cause mortality was reported from enrollment up to 52 months.
Patients in the Enrolled But Not Randomized group were enrolled in the study but discontinued before being allocated into a treatment group. They never received treatment with exicorilant. Thus, they were not at risk for a treatment-emergent adverse event.
|
0.00%
0/7 • Treatment-emergent adverse events were reported from randomization up to 27 months for Segment 1 and up to 19 months for Segment 2. All-cause mortality was reported from enrollment up to 52 months.
Patients in the Enrolled But Not Randomized group were enrolled in the study but discontinued before being allocated into a treatment group. They never received treatment with exicorilant. Thus, they were not at risk for a treatment-emergent adverse event.
|
—
0/0 • Treatment-emergent adverse events were reported from randomization up to 27 months for Segment 1 and up to 19 months for Segment 2. All-cause mortality was reported from enrollment up to 52 months.
Patients in the Enrolled But Not Randomized group were enrolled in the study but discontinued before being allocated into a treatment group. They never received treatment with exicorilant. Thus, they were not at risk for a treatment-emergent adverse event.
|
50.0%
1/2 • Treatment-emergent adverse events were reported from randomization up to 27 months for Segment 1 and up to 19 months for Segment 2. All-cause mortality was reported from enrollment up to 52 months.
Patients in the Enrolled But Not Randomized group were enrolled in the study but discontinued before being allocated into a treatment group. They never received treatment with exicorilant. Thus, they were not at risk for a treatment-emergent adverse event.
|
12.5%
1/8 • Treatment-emergent adverse events were reported from randomization up to 27 months for Segment 1 and up to 19 months for Segment 2. All-cause mortality was reported from enrollment up to 52 months.
Patients in the Enrolled But Not Randomized group were enrolled in the study but discontinued before being allocated into a treatment group. They never received treatment with exicorilant. Thus, they were not at risk for a treatment-emergent adverse event.
|
0.00%
0/1 • Treatment-emergent adverse events were reported from randomization up to 27 months for Segment 1 and up to 19 months for Segment 2. All-cause mortality was reported from enrollment up to 52 months.
Patients in the Enrolled But Not Randomized group were enrolled in the study but discontinued before being allocated into a treatment group. They never received treatment with exicorilant. Thus, they were not at risk for a treatment-emergent adverse event.
|
10.0%
1/10 • Treatment-emergent adverse events were reported from randomization up to 27 months for Segment 1 and up to 19 months for Segment 2. All-cause mortality was reported from enrollment up to 52 months.
Patients in the Enrolled But Not Randomized group were enrolled in the study but discontinued before being allocated into a treatment group. They never received treatment with exicorilant. Thus, they were not at risk for a treatment-emergent adverse event.
|
16.7%
1/6 • Treatment-emergent adverse events were reported from randomization up to 27 months for Segment 1 and up to 19 months for Segment 2. All-cause mortality was reported from enrollment up to 52 months.
Patients in the Enrolled But Not Randomized group were enrolled in the study but discontinued before being allocated into a treatment group. They never received treatment with exicorilant. Thus, they were not at risk for a treatment-emergent adverse event.
|
|
General disorders
Oedema peripheral
|
33.3%
1/3 • Treatment-emergent adverse events were reported from randomization up to 27 months for Segment 1 and up to 19 months for Segment 2. All-cause mortality was reported from enrollment up to 52 months.
Patients in the Enrolled But Not Randomized group were enrolled in the study but discontinued before being allocated into a treatment group. They never received treatment with exicorilant. Thus, they were not at risk for a treatment-emergent adverse event.
|
0.00%
0/7 • Treatment-emergent adverse events were reported from randomization up to 27 months for Segment 1 and up to 19 months for Segment 2. All-cause mortality was reported from enrollment up to 52 months.
Patients in the Enrolled But Not Randomized group were enrolled in the study but discontinued before being allocated into a treatment group. They never received treatment with exicorilant. Thus, they were not at risk for a treatment-emergent adverse event.
|
—
0/0 • Treatment-emergent adverse events were reported from randomization up to 27 months for Segment 1 and up to 19 months for Segment 2. All-cause mortality was reported from enrollment up to 52 months.
Patients in the Enrolled But Not Randomized group were enrolled in the study but discontinued before being allocated into a treatment group. They never received treatment with exicorilant. Thus, they were not at risk for a treatment-emergent adverse event.
|
50.0%
1/2 • Treatment-emergent adverse events were reported from randomization up to 27 months for Segment 1 and up to 19 months for Segment 2. All-cause mortality was reported from enrollment up to 52 months.
Patients in the Enrolled But Not Randomized group were enrolled in the study but discontinued before being allocated into a treatment group. They never received treatment with exicorilant. Thus, they were not at risk for a treatment-emergent adverse event.
|
0.00%
0/8 • Treatment-emergent adverse events were reported from randomization up to 27 months for Segment 1 and up to 19 months for Segment 2. All-cause mortality was reported from enrollment up to 52 months.
Patients in the Enrolled But Not Randomized group were enrolled in the study but discontinued before being allocated into a treatment group. They never received treatment with exicorilant. Thus, they were not at risk for a treatment-emergent adverse event.
|
0.00%
0/1 • Treatment-emergent adverse events were reported from randomization up to 27 months for Segment 1 and up to 19 months for Segment 2. All-cause mortality was reported from enrollment up to 52 months.
Patients in the Enrolled But Not Randomized group were enrolled in the study but discontinued before being allocated into a treatment group. They never received treatment with exicorilant. Thus, they were not at risk for a treatment-emergent adverse event.
|
10.0%
1/10 • Treatment-emergent adverse events were reported from randomization up to 27 months for Segment 1 and up to 19 months for Segment 2. All-cause mortality was reported from enrollment up to 52 months.
Patients in the Enrolled But Not Randomized group were enrolled in the study but discontinued before being allocated into a treatment group. They never received treatment with exicorilant. Thus, they were not at risk for a treatment-emergent adverse event.
|
0.00%
0/6 • Treatment-emergent adverse events were reported from randomization up to 27 months for Segment 1 and up to 19 months for Segment 2. All-cause mortality was reported from enrollment up to 52 months.
Patients in the Enrolled But Not Randomized group were enrolled in the study but discontinued before being allocated into a treatment group. They never received treatment with exicorilant. Thus, they were not at risk for a treatment-emergent adverse event.
|
|
General disorders
Peripheral swelling
|
0.00%
0/3 • Treatment-emergent adverse events were reported from randomization up to 27 months for Segment 1 and up to 19 months for Segment 2. All-cause mortality was reported from enrollment up to 52 months.
Patients in the Enrolled But Not Randomized group were enrolled in the study but discontinued before being allocated into a treatment group. They never received treatment with exicorilant. Thus, they were not at risk for a treatment-emergent adverse event.
|
14.3%
1/7 • Treatment-emergent adverse events were reported from randomization up to 27 months for Segment 1 and up to 19 months for Segment 2. All-cause mortality was reported from enrollment up to 52 months.
Patients in the Enrolled But Not Randomized group were enrolled in the study but discontinued before being allocated into a treatment group. They never received treatment with exicorilant. Thus, they were not at risk for a treatment-emergent adverse event.
|
—
0/0 • Treatment-emergent adverse events were reported from randomization up to 27 months for Segment 1 and up to 19 months for Segment 2. All-cause mortality was reported from enrollment up to 52 months.
Patients in the Enrolled But Not Randomized group were enrolled in the study but discontinued before being allocated into a treatment group. They never received treatment with exicorilant. Thus, they were not at risk for a treatment-emergent adverse event.
|
0.00%
0/2 • Treatment-emergent adverse events were reported from randomization up to 27 months for Segment 1 and up to 19 months for Segment 2. All-cause mortality was reported from enrollment up to 52 months.
Patients in the Enrolled But Not Randomized group were enrolled in the study but discontinued before being allocated into a treatment group. They never received treatment with exicorilant. Thus, they were not at risk for a treatment-emergent adverse event.
|
0.00%
0/8 • Treatment-emergent adverse events were reported from randomization up to 27 months for Segment 1 and up to 19 months for Segment 2. All-cause mortality was reported from enrollment up to 52 months.
Patients in the Enrolled But Not Randomized group were enrolled in the study but discontinued before being allocated into a treatment group. They never received treatment with exicorilant. Thus, they were not at risk for a treatment-emergent adverse event.
|
0.00%
0/1 • Treatment-emergent adverse events were reported from randomization up to 27 months for Segment 1 and up to 19 months for Segment 2. All-cause mortality was reported from enrollment up to 52 months.
Patients in the Enrolled But Not Randomized group were enrolled in the study but discontinued before being allocated into a treatment group. They never received treatment with exicorilant. Thus, they were not at risk for a treatment-emergent adverse event.
|
0.00%
0/10 • Treatment-emergent adverse events were reported from randomization up to 27 months for Segment 1 and up to 19 months for Segment 2. All-cause mortality was reported from enrollment up to 52 months.
Patients in the Enrolled But Not Randomized group were enrolled in the study but discontinued before being allocated into a treatment group. They never received treatment with exicorilant. Thus, they were not at risk for a treatment-emergent adverse event.
|
0.00%
0/6 • Treatment-emergent adverse events were reported from randomization up to 27 months for Segment 1 and up to 19 months for Segment 2. All-cause mortality was reported from enrollment up to 52 months.
Patients in the Enrolled But Not Randomized group were enrolled in the study but discontinued before being allocated into a treatment group. They never received treatment with exicorilant. Thus, they were not at risk for a treatment-emergent adverse event.
|
|
General disorders
Pyrexia
|
0.00%
0/3 • Treatment-emergent adverse events were reported from randomization up to 27 months for Segment 1 and up to 19 months for Segment 2. All-cause mortality was reported from enrollment up to 52 months.
Patients in the Enrolled But Not Randomized group were enrolled in the study but discontinued before being allocated into a treatment group. They never received treatment with exicorilant. Thus, they were not at risk for a treatment-emergent adverse event.
|
0.00%
0/7 • Treatment-emergent adverse events were reported from randomization up to 27 months for Segment 1 and up to 19 months for Segment 2. All-cause mortality was reported from enrollment up to 52 months.
Patients in the Enrolled But Not Randomized group were enrolled in the study but discontinued before being allocated into a treatment group. They never received treatment with exicorilant. Thus, they were not at risk for a treatment-emergent adverse event.
|
—
0/0 • Treatment-emergent adverse events were reported from randomization up to 27 months for Segment 1 and up to 19 months for Segment 2. All-cause mortality was reported from enrollment up to 52 months.
Patients in the Enrolled But Not Randomized group were enrolled in the study but discontinued before being allocated into a treatment group. They never received treatment with exicorilant. Thus, they were not at risk for a treatment-emergent adverse event.
|
0.00%
0/2 • Treatment-emergent adverse events were reported from randomization up to 27 months for Segment 1 and up to 19 months for Segment 2. All-cause mortality was reported from enrollment up to 52 months.
Patients in the Enrolled But Not Randomized group were enrolled in the study but discontinued before being allocated into a treatment group. They never received treatment with exicorilant. Thus, they were not at risk for a treatment-emergent adverse event.
|
12.5%
1/8 • Treatment-emergent adverse events were reported from randomization up to 27 months for Segment 1 and up to 19 months for Segment 2. All-cause mortality was reported from enrollment up to 52 months.
Patients in the Enrolled But Not Randomized group were enrolled in the study but discontinued before being allocated into a treatment group. They never received treatment with exicorilant. Thus, they were not at risk for a treatment-emergent adverse event.
|
0.00%
0/1 • Treatment-emergent adverse events were reported from randomization up to 27 months for Segment 1 and up to 19 months for Segment 2. All-cause mortality was reported from enrollment up to 52 months.
Patients in the Enrolled But Not Randomized group were enrolled in the study but discontinued before being allocated into a treatment group. They never received treatment with exicorilant. Thus, they were not at risk for a treatment-emergent adverse event.
|
0.00%
0/10 • Treatment-emergent adverse events were reported from randomization up to 27 months for Segment 1 and up to 19 months for Segment 2. All-cause mortality was reported from enrollment up to 52 months.
Patients in the Enrolled But Not Randomized group were enrolled in the study but discontinued before being allocated into a treatment group. They never received treatment with exicorilant. Thus, they were not at risk for a treatment-emergent adverse event.
|
0.00%
0/6 • Treatment-emergent adverse events were reported from randomization up to 27 months for Segment 1 and up to 19 months for Segment 2. All-cause mortality was reported from enrollment up to 52 months.
Patients in the Enrolled But Not Randomized group were enrolled in the study but discontinued before being allocated into a treatment group. They never received treatment with exicorilant. Thus, they were not at risk for a treatment-emergent adverse event.
|
|
Infections and infestations
COVID-19
|
0.00%
0/3 • Treatment-emergent adverse events were reported from randomization up to 27 months for Segment 1 and up to 19 months for Segment 2. All-cause mortality was reported from enrollment up to 52 months.
Patients in the Enrolled But Not Randomized group were enrolled in the study but discontinued before being allocated into a treatment group. They never received treatment with exicorilant. Thus, they were not at risk for a treatment-emergent adverse event.
|
0.00%
0/7 • Treatment-emergent adverse events were reported from randomization up to 27 months for Segment 1 and up to 19 months for Segment 2. All-cause mortality was reported from enrollment up to 52 months.
Patients in the Enrolled But Not Randomized group were enrolled in the study but discontinued before being allocated into a treatment group. They never received treatment with exicorilant. Thus, they were not at risk for a treatment-emergent adverse event.
|
—
0/0 • Treatment-emergent adverse events were reported from randomization up to 27 months for Segment 1 and up to 19 months for Segment 2. All-cause mortality was reported from enrollment up to 52 months.
Patients in the Enrolled But Not Randomized group were enrolled in the study but discontinued before being allocated into a treatment group. They never received treatment with exicorilant. Thus, they were not at risk for a treatment-emergent adverse event.
|
0.00%
0/2 • Treatment-emergent adverse events were reported from randomization up to 27 months for Segment 1 and up to 19 months for Segment 2. All-cause mortality was reported from enrollment up to 52 months.
Patients in the Enrolled But Not Randomized group were enrolled in the study but discontinued before being allocated into a treatment group. They never received treatment with exicorilant. Thus, they were not at risk for a treatment-emergent adverse event.
|
0.00%
0/8 • Treatment-emergent adverse events were reported from randomization up to 27 months for Segment 1 and up to 19 months for Segment 2. All-cause mortality was reported from enrollment up to 52 months.
Patients in the Enrolled But Not Randomized group were enrolled in the study but discontinued before being allocated into a treatment group. They never received treatment with exicorilant. Thus, they were not at risk for a treatment-emergent adverse event.
|
0.00%
0/1 • Treatment-emergent adverse events were reported from randomization up to 27 months for Segment 1 and up to 19 months for Segment 2. All-cause mortality was reported from enrollment up to 52 months.
Patients in the Enrolled But Not Randomized group were enrolled in the study but discontinued before being allocated into a treatment group. They never received treatment with exicorilant. Thus, they were not at risk for a treatment-emergent adverse event.
|
10.0%
1/10 • Treatment-emergent adverse events were reported from randomization up to 27 months for Segment 1 and up to 19 months for Segment 2. All-cause mortality was reported from enrollment up to 52 months.
Patients in the Enrolled But Not Randomized group were enrolled in the study but discontinued before being allocated into a treatment group. They never received treatment with exicorilant. Thus, they were not at risk for a treatment-emergent adverse event.
|
0.00%
0/6 • Treatment-emergent adverse events were reported from randomization up to 27 months for Segment 1 and up to 19 months for Segment 2. All-cause mortality was reported from enrollment up to 52 months.
Patients in the Enrolled But Not Randomized group were enrolled in the study but discontinued before being allocated into a treatment group. They never received treatment with exicorilant. Thus, they were not at risk for a treatment-emergent adverse event.
|
|
Infections and infestations
Furuncle
|
0.00%
0/3 • Treatment-emergent adverse events were reported from randomization up to 27 months for Segment 1 and up to 19 months for Segment 2. All-cause mortality was reported from enrollment up to 52 months.
Patients in the Enrolled But Not Randomized group were enrolled in the study but discontinued before being allocated into a treatment group. They never received treatment with exicorilant. Thus, they were not at risk for a treatment-emergent adverse event.
|
14.3%
1/7 • Treatment-emergent adverse events were reported from randomization up to 27 months for Segment 1 and up to 19 months for Segment 2. All-cause mortality was reported from enrollment up to 52 months.
Patients in the Enrolled But Not Randomized group were enrolled in the study but discontinued before being allocated into a treatment group. They never received treatment with exicorilant. Thus, they were not at risk for a treatment-emergent adverse event.
|
—
0/0 • Treatment-emergent adverse events were reported from randomization up to 27 months for Segment 1 and up to 19 months for Segment 2. All-cause mortality was reported from enrollment up to 52 months.
Patients in the Enrolled But Not Randomized group were enrolled in the study but discontinued before being allocated into a treatment group. They never received treatment with exicorilant. Thus, they were not at risk for a treatment-emergent adverse event.
|
0.00%
0/2 • Treatment-emergent adverse events were reported from randomization up to 27 months for Segment 1 and up to 19 months for Segment 2. All-cause mortality was reported from enrollment up to 52 months.
Patients in the Enrolled But Not Randomized group were enrolled in the study but discontinued before being allocated into a treatment group. They never received treatment with exicorilant. Thus, they were not at risk for a treatment-emergent adverse event.
|
0.00%
0/8 • Treatment-emergent adverse events were reported from randomization up to 27 months for Segment 1 and up to 19 months for Segment 2. All-cause mortality was reported from enrollment up to 52 months.
Patients in the Enrolled But Not Randomized group were enrolled in the study but discontinued before being allocated into a treatment group. They never received treatment with exicorilant. Thus, they were not at risk for a treatment-emergent adverse event.
|
0.00%
0/1 • Treatment-emergent adverse events were reported from randomization up to 27 months for Segment 1 and up to 19 months for Segment 2. All-cause mortality was reported from enrollment up to 52 months.
Patients in the Enrolled But Not Randomized group were enrolled in the study but discontinued before being allocated into a treatment group. They never received treatment with exicorilant. Thus, they were not at risk for a treatment-emergent adverse event.
|
0.00%
0/10 • Treatment-emergent adverse events were reported from randomization up to 27 months for Segment 1 and up to 19 months for Segment 2. All-cause mortality was reported from enrollment up to 52 months.
Patients in the Enrolled But Not Randomized group were enrolled in the study but discontinued before being allocated into a treatment group. They never received treatment with exicorilant. Thus, they were not at risk for a treatment-emergent adverse event.
|
0.00%
0/6 • Treatment-emergent adverse events were reported from randomization up to 27 months for Segment 1 and up to 19 months for Segment 2. All-cause mortality was reported from enrollment up to 52 months.
Patients in the Enrolled But Not Randomized group were enrolled in the study but discontinued before being allocated into a treatment group. They never received treatment with exicorilant. Thus, they were not at risk for a treatment-emergent adverse event.
|
|
Infections and infestations
Gastroenteritis viral
|
0.00%
0/3 • Treatment-emergent adverse events were reported from randomization up to 27 months for Segment 1 and up to 19 months for Segment 2. All-cause mortality was reported from enrollment up to 52 months.
Patients in the Enrolled But Not Randomized group were enrolled in the study but discontinued before being allocated into a treatment group. They never received treatment with exicorilant. Thus, they were not at risk for a treatment-emergent adverse event.
|
0.00%
0/7 • Treatment-emergent adverse events were reported from randomization up to 27 months for Segment 1 and up to 19 months for Segment 2. All-cause mortality was reported from enrollment up to 52 months.
Patients in the Enrolled But Not Randomized group were enrolled in the study but discontinued before being allocated into a treatment group. They never received treatment with exicorilant. Thus, they were not at risk for a treatment-emergent adverse event.
|
—
0/0 • Treatment-emergent adverse events were reported from randomization up to 27 months for Segment 1 and up to 19 months for Segment 2. All-cause mortality was reported from enrollment up to 52 months.
Patients in the Enrolled But Not Randomized group were enrolled in the study but discontinued before being allocated into a treatment group. They never received treatment with exicorilant. Thus, they were not at risk for a treatment-emergent adverse event.
|
50.0%
1/2 • Treatment-emergent adverse events were reported from randomization up to 27 months for Segment 1 and up to 19 months for Segment 2. All-cause mortality was reported from enrollment up to 52 months.
Patients in the Enrolled But Not Randomized group were enrolled in the study but discontinued before being allocated into a treatment group. They never received treatment with exicorilant. Thus, they were not at risk for a treatment-emergent adverse event.
|
0.00%
0/8 • Treatment-emergent adverse events were reported from randomization up to 27 months for Segment 1 and up to 19 months for Segment 2. All-cause mortality was reported from enrollment up to 52 months.
Patients in the Enrolled But Not Randomized group were enrolled in the study but discontinued before being allocated into a treatment group. They never received treatment with exicorilant. Thus, they were not at risk for a treatment-emergent adverse event.
|
0.00%
0/1 • Treatment-emergent adverse events were reported from randomization up to 27 months for Segment 1 and up to 19 months for Segment 2. All-cause mortality was reported from enrollment up to 52 months.
Patients in the Enrolled But Not Randomized group were enrolled in the study but discontinued before being allocated into a treatment group. They never received treatment with exicorilant. Thus, they were not at risk for a treatment-emergent adverse event.
|
0.00%
0/10 • Treatment-emergent adverse events were reported from randomization up to 27 months for Segment 1 and up to 19 months for Segment 2. All-cause mortality was reported from enrollment up to 52 months.
Patients in the Enrolled But Not Randomized group were enrolled in the study but discontinued before being allocated into a treatment group. They never received treatment with exicorilant. Thus, they were not at risk for a treatment-emergent adverse event.
|
0.00%
0/6 • Treatment-emergent adverse events were reported from randomization up to 27 months for Segment 1 and up to 19 months for Segment 2. All-cause mortality was reported from enrollment up to 52 months.
Patients in the Enrolled But Not Randomized group were enrolled in the study but discontinued before being allocated into a treatment group. They never received treatment with exicorilant. Thus, they were not at risk for a treatment-emergent adverse event.
|
|
Infections and infestations
Laryngitis
|
0.00%
0/3 • Treatment-emergent adverse events were reported from randomization up to 27 months for Segment 1 and up to 19 months for Segment 2. All-cause mortality was reported from enrollment up to 52 months.
Patients in the Enrolled But Not Randomized group were enrolled in the study but discontinued before being allocated into a treatment group. They never received treatment with exicorilant. Thus, they were not at risk for a treatment-emergent adverse event.
|
0.00%
0/7 • Treatment-emergent adverse events were reported from randomization up to 27 months for Segment 1 and up to 19 months for Segment 2. All-cause mortality was reported from enrollment up to 52 months.
Patients in the Enrolled But Not Randomized group were enrolled in the study but discontinued before being allocated into a treatment group. They never received treatment with exicorilant. Thus, they were not at risk for a treatment-emergent adverse event.
|
—
0/0 • Treatment-emergent adverse events were reported from randomization up to 27 months for Segment 1 and up to 19 months for Segment 2. All-cause mortality was reported from enrollment up to 52 months.
Patients in the Enrolled But Not Randomized group were enrolled in the study but discontinued before being allocated into a treatment group. They never received treatment with exicorilant. Thus, they were not at risk for a treatment-emergent adverse event.
|
0.00%
0/2 • Treatment-emergent adverse events were reported from randomization up to 27 months for Segment 1 and up to 19 months for Segment 2. All-cause mortality was reported from enrollment up to 52 months.
Patients in the Enrolled But Not Randomized group were enrolled in the study but discontinued before being allocated into a treatment group. They never received treatment with exicorilant. Thus, they were not at risk for a treatment-emergent adverse event.
|
0.00%
0/8 • Treatment-emergent adverse events were reported from randomization up to 27 months for Segment 1 and up to 19 months for Segment 2. All-cause mortality was reported from enrollment up to 52 months.
Patients in the Enrolled But Not Randomized group were enrolled in the study but discontinued before being allocated into a treatment group. They never received treatment with exicorilant. Thus, they were not at risk for a treatment-emergent adverse event.
|
0.00%
0/1 • Treatment-emergent adverse events were reported from randomization up to 27 months for Segment 1 and up to 19 months for Segment 2. All-cause mortality was reported from enrollment up to 52 months.
Patients in the Enrolled But Not Randomized group were enrolled in the study but discontinued before being allocated into a treatment group. They never received treatment with exicorilant. Thus, they were not at risk for a treatment-emergent adverse event.
|
10.0%
1/10 • Treatment-emergent adverse events were reported from randomization up to 27 months for Segment 1 and up to 19 months for Segment 2. All-cause mortality was reported from enrollment up to 52 months.
Patients in the Enrolled But Not Randomized group were enrolled in the study but discontinued before being allocated into a treatment group. They never received treatment with exicorilant. Thus, they were not at risk for a treatment-emergent adverse event.
|
0.00%
0/6 • Treatment-emergent adverse events were reported from randomization up to 27 months for Segment 1 and up to 19 months for Segment 2. All-cause mortality was reported from enrollment up to 52 months.
Patients in the Enrolled But Not Randomized group were enrolled in the study but discontinued before being allocated into a treatment group. They never received treatment with exicorilant. Thus, they were not at risk for a treatment-emergent adverse event.
|
|
Infections and infestations
Sinusitis
|
0.00%
0/3 • Treatment-emergent adverse events were reported from randomization up to 27 months for Segment 1 and up to 19 months for Segment 2. All-cause mortality was reported from enrollment up to 52 months.
Patients in the Enrolled But Not Randomized group were enrolled in the study but discontinued before being allocated into a treatment group. They never received treatment with exicorilant. Thus, they were not at risk for a treatment-emergent adverse event.
|
0.00%
0/7 • Treatment-emergent adverse events were reported from randomization up to 27 months for Segment 1 and up to 19 months for Segment 2. All-cause mortality was reported from enrollment up to 52 months.
Patients in the Enrolled But Not Randomized group were enrolled in the study but discontinued before being allocated into a treatment group. They never received treatment with exicorilant. Thus, they were not at risk for a treatment-emergent adverse event.
|
—
0/0 • Treatment-emergent adverse events were reported from randomization up to 27 months for Segment 1 and up to 19 months for Segment 2. All-cause mortality was reported from enrollment up to 52 months.
Patients in the Enrolled But Not Randomized group were enrolled in the study but discontinued before being allocated into a treatment group. They never received treatment with exicorilant. Thus, they were not at risk for a treatment-emergent adverse event.
|
0.00%
0/2 • Treatment-emergent adverse events were reported from randomization up to 27 months for Segment 1 and up to 19 months for Segment 2. All-cause mortality was reported from enrollment up to 52 months.
Patients in the Enrolled But Not Randomized group were enrolled in the study but discontinued before being allocated into a treatment group. They never received treatment with exicorilant. Thus, they were not at risk for a treatment-emergent adverse event.
|
0.00%
0/8 • Treatment-emergent adverse events were reported from randomization up to 27 months for Segment 1 and up to 19 months for Segment 2. All-cause mortality was reported from enrollment up to 52 months.
Patients in the Enrolled But Not Randomized group were enrolled in the study but discontinued before being allocated into a treatment group. They never received treatment with exicorilant. Thus, they were not at risk for a treatment-emergent adverse event.
|
0.00%
0/1 • Treatment-emergent adverse events were reported from randomization up to 27 months for Segment 1 and up to 19 months for Segment 2. All-cause mortality was reported from enrollment up to 52 months.
Patients in the Enrolled But Not Randomized group were enrolled in the study but discontinued before being allocated into a treatment group. They never received treatment with exicorilant. Thus, they were not at risk for a treatment-emergent adverse event.
|
10.0%
1/10 • Treatment-emergent adverse events were reported from randomization up to 27 months for Segment 1 and up to 19 months for Segment 2. All-cause mortality was reported from enrollment up to 52 months.
Patients in the Enrolled But Not Randomized group were enrolled in the study but discontinued before being allocated into a treatment group. They never received treatment with exicorilant. Thus, they were not at risk for a treatment-emergent adverse event.
|
0.00%
0/6 • Treatment-emergent adverse events were reported from randomization up to 27 months for Segment 1 and up to 19 months for Segment 2. All-cause mortality was reported from enrollment up to 52 months.
Patients in the Enrolled But Not Randomized group were enrolled in the study but discontinued before being allocated into a treatment group. They never received treatment with exicorilant. Thus, they were not at risk for a treatment-emergent adverse event.
|
|
Infections and infestations
Upper respiratory tract infection
|
33.3%
1/3 • Treatment-emergent adverse events were reported from randomization up to 27 months for Segment 1 and up to 19 months for Segment 2. All-cause mortality was reported from enrollment up to 52 months.
Patients in the Enrolled But Not Randomized group were enrolled in the study but discontinued before being allocated into a treatment group. They never received treatment with exicorilant. Thus, they were not at risk for a treatment-emergent adverse event.
|
0.00%
0/7 • Treatment-emergent adverse events were reported from randomization up to 27 months for Segment 1 and up to 19 months for Segment 2. All-cause mortality was reported from enrollment up to 52 months.
Patients in the Enrolled But Not Randomized group were enrolled in the study but discontinued before being allocated into a treatment group. They never received treatment with exicorilant. Thus, they were not at risk for a treatment-emergent adverse event.
|
—
0/0 • Treatment-emergent adverse events were reported from randomization up to 27 months for Segment 1 and up to 19 months for Segment 2. All-cause mortality was reported from enrollment up to 52 months.
Patients in the Enrolled But Not Randomized group were enrolled in the study but discontinued before being allocated into a treatment group. They never received treatment with exicorilant. Thus, they were not at risk for a treatment-emergent adverse event.
|
50.0%
1/2 • Treatment-emergent adverse events were reported from randomization up to 27 months for Segment 1 and up to 19 months for Segment 2. All-cause mortality was reported from enrollment up to 52 months.
Patients in the Enrolled But Not Randomized group were enrolled in the study but discontinued before being allocated into a treatment group. They never received treatment with exicorilant. Thus, they were not at risk for a treatment-emergent adverse event.
|
0.00%
0/8 • Treatment-emergent adverse events were reported from randomization up to 27 months for Segment 1 and up to 19 months for Segment 2. All-cause mortality was reported from enrollment up to 52 months.
Patients in the Enrolled But Not Randomized group were enrolled in the study but discontinued before being allocated into a treatment group. They never received treatment with exicorilant. Thus, they were not at risk for a treatment-emergent adverse event.
|
0.00%
0/1 • Treatment-emergent adverse events were reported from randomization up to 27 months for Segment 1 and up to 19 months for Segment 2. All-cause mortality was reported from enrollment up to 52 months.
Patients in the Enrolled But Not Randomized group were enrolled in the study but discontinued before being allocated into a treatment group. They never received treatment with exicorilant. Thus, they were not at risk for a treatment-emergent adverse event.
|
0.00%
0/10 • Treatment-emergent adverse events were reported from randomization up to 27 months for Segment 1 and up to 19 months for Segment 2. All-cause mortality was reported from enrollment up to 52 months.
Patients in the Enrolled But Not Randomized group were enrolled in the study but discontinued before being allocated into a treatment group. They never received treatment with exicorilant. Thus, they were not at risk for a treatment-emergent adverse event.
|
0.00%
0/6 • Treatment-emergent adverse events were reported from randomization up to 27 months for Segment 1 and up to 19 months for Segment 2. All-cause mortality was reported from enrollment up to 52 months.
Patients in the Enrolled But Not Randomized group were enrolled in the study but discontinued before being allocated into a treatment group. They never received treatment with exicorilant. Thus, they were not at risk for a treatment-emergent adverse event.
|
|
Infections and infestations
Urinary tract infection
|
0.00%
0/3 • Treatment-emergent adverse events were reported from randomization up to 27 months for Segment 1 and up to 19 months for Segment 2. All-cause mortality was reported from enrollment up to 52 months.
Patients in the Enrolled But Not Randomized group were enrolled in the study but discontinued before being allocated into a treatment group. They never received treatment with exicorilant. Thus, they were not at risk for a treatment-emergent adverse event.
|
0.00%
0/7 • Treatment-emergent adverse events were reported from randomization up to 27 months for Segment 1 and up to 19 months for Segment 2. All-cause mortality was reported from enrollment up to 52 months.
Patients in the Enrolled But Not Randomized group were enrolled in the study but discontinued before being allocated into a treatment group. They never received treatment with exicorilant. Thus, they were not at risk for a treatment-emergent adverse event.
|
—
0/0 • Treatment-emergent adverse events were reported from randomization up to 27 months for Segment 1 and up to 19 months for Segment 2. All-cause mortality was reported from enrollment up to 52 months.
Patients in the Enrolled But Not Randomized group were enrolled in the study but discontinued before being allocated into a treatment group. They never received treatment with exicorilant. Thus, they were not at risk for a treatment-emergent adverse event.
|
0.00%
0/2 • Treatment-emergent adverse events were reported from randomization up to 27 months for Segment 1 and up to 19 months for Segment 2. All-cause mortality was reported from enrollment up to 52 months.
Patients in the Enrolled But Not Randomized group were enrolled in the study but discontinued before being allocated into a treatment group. They never received treatment with exicorilant. Thus, they were not at risk for a treatment-emergent adverse event.
|
25.0%
2/8 • Treatment-emergent adverse events were reported from randomization up to 27 months for Segment 1 and up to 19 months for Segment 2. All-cause mortality was reported from enrollment up to 52 months.
Patients in the Enrolled But Not Randomized group were enrolled in the study but discontinued before being allocated into a treatment group. They never received treatment with exicorilant. Thus, they were not at risk for a treatment-emergent adverse event.
|
0.00%
0/1 • Treatment-emergent adverse events were reported from randomization up to 27 months for Segment 1 and up to 19 months for Segment 2. All-cause mortality was reported from enrollment up to 52 months.
Patients in the Enrolled But Not Randomized group were enrolled in the study but discontinued before being allocated into a treatment group. They never received treatment with exicorilant. Thus, they were not at risk for a treatment-emergent adverse event.
|
0.00%
0/10 • Treatment-emergent adverse events were reported from randomization up to 27 months for Segment 1 and up to 19 months for Segment 2. All-cause mortality was reported from enrollment up to 52 months.
Patients in the Enrolled But Not Randomized group were enrolled in the study but discontinued before being allocated into a treatment group. They never received treatment with exicorilant. Thus, they were not at risk for a treatment-emergent adverse event.
|
0.00%
0/6 • Treatment-emergent adverse events were reported from randomization up to 27 months for Segment 1 and up to 19 months for Segment 2. All-cause mortality was reported from enrollment up to 52 months.
Patients in the Enrolled But Not Randomized group were enrolled in the study but discontinued before being allocated into a treatment group. They never received treatment with exicorilant. Thus, they were not at risk for a treatment-emergent adverse event.
|
|
Injury, poisoning and procedural complications
Fall
|
0.00%
0/3 • Treatment-emergent adverse events were reported from randomization up to 27 months for Segment 1 and up to 19 months for Segment 2. All-cause mortality was reported from enrollment up to 52 months.
Patients in the Enrolled But Not Randomized group were enrolled in the study but discontinued before being allocated into a treatment group. They never received treatment with exicorilant. Thus, they were not at risk for a treatment-emergent adverse event.
|
0.00%
0/7 • Treatment-emergent adverse events were reported from randomization up to 27 months for Segment 1 and up to 19 months for Segment 2. All-cause mortality was reported from enrollment up to 52 months.
Patients in the Enrolled But Not Randomized group were enrolled in the study but discontinued before being allocated into a treatment group. They never received treatment with exicorilant. Thus, they were not at risk for a treatment-emergent adverse event.
|
—
0/0 • Treatment-emergent adverse events were reported from randomization up to 27 months for Segment 1 and up to 19 months for Segment 2. All-cause mortality was reported from enrollment up to 52 months.
Patients in the Enrolled But Not Randomized group were enrolled in the study but discontinued before being allocated into a treatment group. They never received treatment with exicorilant. Thus, they were not at risk for a treatment-emergent adverse event.
|
0.00%
0/2 • Treatment-emergent adverse events were reported from randomization up to 27 months for Segment 1 and up to 19 months for Segment 2. All-cause mortality was reported from enrollment up to 52 months.
Patients in the Enrolled But Not Randomized group were enrolled in the study but discontinued before being allocated into a treatment group. They never received treatment with exicorilant. Thus, they were not at risk for a treatment-emergent adverse event.
|
0.00%
0/8 • Treatment-emergent adverse events were reported from randomization up to 27 months for Segment 1 and up to 19 months for Segment 2. All-cause mortality was reported from enrollment up to 52 months.
Patients in the Enrolled But Not Randomized group were enrolled in the study but discontinued before being allocated into a treatment group. They never received treatment with exicorilant. Thus, they were not at risk for a treatment-emergent adverse event.
|
0.00%
0/1 • Treatment-emergent adverse events were reported from randomization up to 27 months for Segment 1 and up to 19 months for Segment 2. All-cause mortality was reported from enrollment up to 52 months.
Patients in the Enrolled But Not Randomized group were enrolled in the study but discontinued before being allocated into a treatment group. They never received treatment with exicorilant. Thus, they were not at risk for a treatment-emergent adverse event.
|
10.0%
1/10 • Treatment-emergent adverse events were reported from randomization up to 27 months for Segment 1 and up to 19 months for Segment 2. All-cause mortality was reported from enrollment up to 52 months.
Patients in the Enrolled But Not Randomized group were enrolled in the study but discontinued before being allocated into a treatment group. They never received treatment with exicorilant. Thus, they were not at risk for a treatment-emergent adverse event.
|
0.00%
0/6 • Treatment-emergent adverse events were reported from randomization up to 27 months for Segment 1 and up to 19 months for Segment 2. All-cause mortality was reported from enrollment up to 52 months.
Patients in the Enrolled But Not Randomized group were enrolled in the study but discontinued before being allocated into a treatment group. They never received treatment with exicorilant. Thus, they were not at risk for a treatment-emergent adverse event.
|
|
Injury, poisoning and procedural complications
Incision site pain
|
0.00%
0/3 • Treatment-emergent adverse events were reported from randomization up to 27 months for Segment 1 and up to 19 months for Segment 2. All-cause mortality was reported from enrollment up to 52 months.
Patients in the Enrolled But Not Randomized group were enrolled in the study but discontinued before being allocated into a treatment group. They never received treatment with exicorilant. Thus, they were not at risk for a treatment-emergent adverse event.
|
14.3%
1/7 • Treatment-emergent adverse events were reported from randomization up to 27 months for Segment 1 and up to 19 months for Segment 2. All-cause mortality was reported from enrollment up to 52 months.
Patients in the Enrolled But Not Randomized group were enrolled in the study but discontinued before being allocated into a treatment group. They never received treatment with exicorilant. Thus, they were not at risk for a treatment-emergent adverse event.
|
—
0/0 • Treatment-emergent adverse events were reported from randomization up to 27 months for Segment 1 and up to 19 months for Segment 2. All-cause mortality was reported from enrollment up to 52 months.
Patients in the Enrolled But Not Randomized group were enrolled in the study but discontinued before being allocated into a treatment group. They never received treatment with exicorilant. Thus, they were not at risk for a treatment-emergent adverse event.
|
0.00%
0/2 • Treatment-emergent adverse events were reported from randomization up to 27 months for Segment 1 and up to 19 months for Segment 2. All-cause mortality was reported from enrollment up to 52 months.
Patients in the Enrolled But Not Randomized group were enrolled in the study but discontinued before being allocated into a treatment group. They never received treatment with exicorilant. Thus, they were not at risk for a treatment-emergent adverse event.
|
0.00%
0/8 • Treatment-emergent adverse events were reported from randomization up to 27 months for Segment 1 and up to 19 months for Segment 2. All-cause mortality was reported from enrollment up to 52 months.
Patients in the Enrolled But Not Randomized group were enrolled in the study but discontinued before being allocated into a treatment group. They never received treatment with exicorilant. Thus, they were not at risk for a treatment-emergent adverse event.
|
0.00%
0/1 • Treatment-emergent adverse events were reported from randomization up to 27 months for Segment 1 and up to 19 months for Segment 2. All-cause mortality was reported from enrollment up to 52 months.
Patients in the Enrolled But Not Randomized group were enrolled in the study but discontinued before being allocated into a treatment group. They never received treatment with exicorilant. Thus, they were not at risk for a treatment-emergent adverse event.
|
0.00%
0/10 • Treatment-emergent adverse events were reported from randomization up to 27 months for Segment 1 and up to 19 months for Segment 2. All-cause mortality was reported from enrollment up to 52 months.
Patients in the Enrolled But Not Randomized group were enrolled in the study but discontinued before being allocated into a treatment group. They never received treatment with exicorilant. Thus, they were not at risk for a treatment-emergent adverse event.
|
0.00%
0/6 • Treatment-emergent adverse events were reported from randomization up to 27 months for Segment 1 and up to 19 months for Segment 2. All-cause mortality was reported from enrollment up to 52 months.
Patients in the Enrolled But Not Randomized group were enrolled in the study but discontinued before being allocated into a treatment group. They never received treatment with exicorilant. Thus, they were not at risk for a treatment-emergent adverse event.
|
|
Injury, poisoning and procedural complications
Meniscus injury
|
0.00%
0/3 • Treatment-emergent adverse events were reported from randomization up to 27 months for Segment 1 and up to 19 months for Segment 2. All-cause mortality was reported from enrollment up to 52 months.
Patients in the Enrolled But Not Randomized group were enrolled in the study but discontinued before being allocated into a treatment group. They never received treatment with exicorilant. Thus, they were not at risk for a treatment-emergent adverse event.
|
0.00%
0/7 • Treatment-emergent adverse events were reported from randomization up to 27 months for Segment 1 and up to 19 months for Segment 2. All-cause mortality was reported from enrollment up to 52 months.
Patients in the Enrolled But Not Randomized group were enrolled in the study but discontinued before being allocated into a treatment group. They never received treatment with exicorilant. Thus, they were not at risk for a treatment-emergent adverse event.
|
—
0/0 • Treatment-emergent adverse events were reported from randomization up to 27 months for Segment 1 and up to 19 months for Segment 2. All-cause mortality was reported from enrollment up to 52 months.
Patients in the Enrolled But Not Randomized group were enrolled in the study but discontinued before being allocated into a treatment group. They never received treatment with exicorilant. Thus, they were not at risk for a treatment-emergent adverse event.
|
0.00%
0/2 • Treatment-emergent adverse events were reported from randomization up to 27 months for Segment 1 and up to 19 months for Segment 2. All-cause mortality was reported from enrollment up to 52 months.
Patients in the Enrolled But Not Randomized group were enrolled in the study but discontinued before being allocated into a treatment group. They never received treatment with exicorilant. Thus, they were not at risk for a treatment-emergent adverse event.
|
0.00%
0/8 • Treatment-emergent adverse events were reported from randomization up to 27 months for Segment 1 and up to 19 months for Segment 2. All-cause mortality was reported from enrollment up to 52 months.
Patients in the Enrolled But Not Randomized group were enrolled in the study but discontinued before being allocated into a treatment group. They never received treatment with exicorilant. Thus, they were not at risk for a treatment-emergent adverse event.
|
0.00%
0/1 • Treatment-emergent adverse events were reported from randomization up to 27 months for Segment 1 and up to 19 months for Segment 2. All-cause mortality was reported from enrollment up to 52 months.
Patients in the Enrolled But Not Randomized group were enrolled in the study but discontinued before being allocated into a treatment group. They never received treatment with exicorilant. Thus, they were not at risk for a treatment-emergent adverse event.
|
0.00%
0/10 • Treatment-emergent adverse events were reported from randomization up to 27 months for Segment 1 and up to 19 months for Segment 2. All-cause mortality was reported from enrollment up to 52 months.
Patients in the Enrolled But Not Randomized group were enrolled in the study but discontinued before being allocated into a treatment group. They never received treatment with exicorilant. Thus, they were not at risk for a treatment-emergent adverse event.
|
16.7%
1/6 • Treatment-emergent adverse events were reported from randomization up to 27 months for Segment 1 and up to 19 months for Segment 2. All-cause mortality was reported from enrollment up to 52 months.
Patients in the Enrolled But Not Randomized group were enrolled in the study but discontinued before being allocated into a treatment group. They never received treatment with exicorilant. Thus, they were not at risk for a treatment-emergent adverse event.
|
|
Injury, poisoning and procedural complications
Procedural pain
|
0.00%
0/3 • Treatment-emergent adverse events were reported from randomization up to 27 months for Segment 1 and up to 19 months for Segment 2. All-cause mortality was reported from enrollment up to 52 months.
Patients in the Enrolled But Not Randomized group were enrolled in the study but discontinued before being allocated into a treatment group. They never received treatment with exicorilant. Thus, they were not at risk for a treatment-emergent adverse event.
|
14.3%
1/7 • Treatment-emergent adverse events were reported from randomization up to 27 months for Segment 1 and up to 19 months for Segment 2. All-cause mortality was reported from enrollment up to 52 months.
Patients in the Enrolled But Not Randomized group were enrolled in the study but discontinued before being allocated into a treatment group. They never received treatment with exicorilant. Thus, they were not at risk for a treatment-emergent adverse event.
|
—
0/0 • Treatment-emergent adverse events were reported from randomization up to 27 months for Segment 1 and up to 19 months for Segment 2. All-cause mortality was reported from enrollment up to 52 months.
Patients in the Enrolled But Not Randomized group were enrolled in the study but discontinued before being allocated into a treatment group. They never received treatment with exicorilant. Thus, they were not at risk for a treatment-emergent adverse event.
|
0.00%
0/2 • Treatment-emergent adverse events were reported from randomization up to 27 months for Segment 1 and up to 19 months for Segment 2. All-cause mortality was reported from enrollment up to 52 months.
Patients in the Enrolled But Not Randomized group were enrolled in the study but discontinued before being allocated into a treatment group. They never received treatment with exicorilant. Thus, they were not at risk for a treatment-emergent adverse event.
|
0.00%
0/8 • Treatment-emergent adverse events were reported from randomization up to 27 months for Segment 1 and up to 19 months for Segment 2. All-cause mortality was reported from enrollment up to 52 months.
Patients in the Enrolled But Not Randomized group were enrolled in the study but discontinued before being allocated into a treatment group. They never received treatment with exicorilant. Thus, they were not at risk for a treatment-emergent adverse event.
|
0.00%
0/1 • Treatment-emergent adverse events were reported from randomization up to 27 months for Segment 1 and up to 19 months for Segment 2. All-cause mortality was reported from enrollment up to 52 months.
Patients in the Enrolled But Not Randomized group were enrolled in the study but discontinued before being allocated into a treatment group. They never received treatment with exicorilant. Thus, they were not at risk for a treatment-emergent adverse event.
|
0.00%
0/10 • Treatment-emergent adverse events were reported from randomization up to 27 months for Segment 1 and up to 19 months for Segment 2. All-cause mortality was reported from enrollment up to 52 months.
Patients in the Enrolled But Not Randomized group were enrolled in the study but discontinued before being allocated into a treatment group. They never received treatment with exicorilant. Thus, they were not at risk for a treatment-emergent adverse event.
|
0.00%
0/6 • Treatment-emergent adverse events were reported from randomization up to 27 months for Segment 1 and up to 19 months for Segment 2. All-cause mortality was reported from enrollment up to 52 months.
Patients in the Enrolled But Not Randomized group were enrolled in the study but discontinued before being allocated into a treatment group. They never received treatment with exicorilant. Thus, they were not at risk for a treatment-emergent adverse event.
|
|
Injury, poisoning and procedural complications
Radiation skin injury
|
0.00%
0/3 • Treatment-emergent adverse events were reported from randomization up to 27 months for Segment 1 and up to 19 months for Segment 2. All-cause mortality was reported from enrollment up to 52 months.
Patients in the Enrolled But Not Randomized group were enrolled in the study but discontinued before being allocated into a treatment group. They never received treatment with exicorilant. Thus, they were not at risk for a treatment-emergent adverse event.
|
0.00%
0/7 • Treatment-emergent adverse events were reported from randomization up to 27 months for Segment 1 and up to 19 months for Segment 2. All-cause mortality was reported from enrollment up to 52 months.
Patients in the Enrolled But Not Randomized group were enrolled in the study but discontinued before being allocated into a treatment group. They never received treatment with exicorilant. Thus, they were not at risk for a treatment-emergent adverse event.
|
—
0/0 • Treatment-emergent adverse events were reported from randomization up to 27 months for Segment 1 and up to 19 months for Segment 2. All-cause mortality was reported from enrollment up to 52 months.
Patients in the Enrolled But Not Randomized group were enrolled in the study but discontinued before being allocated into a treatment group. They never received treatment with exicorilant. Thus, they were not at risk for a treatment-emergent adverse event.
|
0.00%
0/2 • Treatment-emergent adverse events were reported from randomization up to 27 months for Segment 1 and up to 19 months for Segment 2. All-cause mortality was reported from enrollment up to 52 months.
Patients in the Enrolled But Not Randomized group were enrolled in the study but discontinued before being allocated into a treatment group. They never received treatment with exicorilant. Thus, they were not at risk for a treatment-emergent adverse event.
|
0.00%
0/8 • Treatment-emergent adverse events were reported from randomization up to 27 months for Segment 1 and up to 19 months for Segment 2. All-cause mortality was reported from enrollment up to 52 months.
Patients in the Enrolled But Not Randomized group were enrolled in the study but discontinued before being allocated into a treatment group. They never received treatment with exicorilant. Thus, they were not at risk for a treatment-emergent adverse event.
|
0.00%
0/1 • Treatment-emergent adverse events were reported from randomization up to 27 months for Segment 1 and up to 19 months for Segment 2. All-cause mortality was reported from enrollment up to 52 months.
Patients in the Enrolled But Not Randomized group were enrolled in the study but discontinued before being allocated into a treatment group. They never received treatment with exicorilant. Thus, they were not at risk for a treatment-emergent adverse event.
|
0.00%
0/10 • Treatment-emergent adverse events were reported from randomization up to 27 months for Segment 1 and up to 19 months for Segment 2. All-cause mortality was reported from enrollment up to 52 months.
Patients in the Enrolled But Not Randomized group were enrolled in the study but discontinued before being allocated into a treatment group. They never received treatment with exicorilant. Thus, they were not at risk for a treatment-emergent adverse event.
|
16.7%
1/6 • Treatment-emergent adverse events were reported from randomization up to 27 months for Segment 1 and up to 19 months for Segment 2. All-cause mortality was reported from enrollment up to 52 months.
Patients in the Enrolled But Not Randomized group were enrolled in the study but discontinued before being allocated into a treatment group. They never received treatment with exicorilant. Thus, they were not at risk for a treatment-emergent adverse event.
|
|
Injury, poisoning and procedural complications
Spinal fracture
|
0.00%
0/3 • Treatment-emergent adverse events were reported from randomization up to 27 months for Segment 1 and up to 19 months for Segment 2. All-cause mortality was reported from enrollment up to 52 months.
Patients in the Enrolled But Not Randomized group were enrolled in the study but discontinued before being allocated into a treatment group. They never received treatment with exicorilant. Thus, they were not at risk for a treatment-emergent adverse event.
|
0.00%
0/7 • Treatment-emergent adverse events were reported from randomization up to 27 months for Segment 1 and up to 19 months for Segment 2. All-cause mortality was reported from enrollment up to 52 months.
Patients in the Enrolled But Not Randomized group were enrolled in the study but discontinued before being allocated into a treatment group. They never received treatment with exicorilant. Thus, they were not at risk for a treatment-emergent adverse event.
|
—
0/0 • Treatment-emergent adverse events were reported from randomization up to 27 months for Segment 1 and up to 19 months for Segment 2. All-cause mortality was reported from enrollment up to 52 months.
Patients in the Enrolled But Not Randomized group were enrolled in the study but discontinued before being allocated into a treatment group. They never received treatment with exicorilant. Thus, they were not at risk for a treatment-emergent adverse event.
|
0.00%
0/2 • Treatment-emergent adverse events were reported from randomization up to 27 months for Segment 1 and up to 19 months for Segment 2. All-cause mortality was reported from enrollment up to 52 months.
Patients in the Enrolled But Not Randomized group were enrolled in the study but discontinued before being allocated into a treatment group. They never received treatment with exicorilant. Thus, they were not at risk for a treatment-emergent adverse event.
|
0.00%
0/8 • Treatment-emergent adverse events were reported from randomization up to 27 months for Segment 1 and up to 19 months for Segment 2. All-cause mortality was reported from enrollment up to 52 months.
Patients in the Enrolled But Not Randomized group were enrolled in the study but discontinued before being allocated into a treatment group. They never received treatment with exicorilant. Thus, they were not at risk for a treatment-emergent adverse event.
|
0.00%
0/1 • Treatment-emergent adverse events were reported from randomization up to 27 months for Segment 1 and up to 19 months for Segment 2. All-cause mortality was reported from enrollment up to 52 months.
Patients in the Enrolled But Not Randomized group were enrolled in the study but discontinued before being allocated into a treatment group. They never received treatment with exicorilant. Thus, they were not at risk for a treatment-emergent adverse event.
|
0.00%
0/10 • Treatment-emergent adverse events were reported from randomization up to 27 months for Segment 1 and up to 19 months for Segment 2. All-cause mortality was reported from enrollment up to 52 months.
Patients in the Enrolled But Not Randomized group were enrolled in the study but discontinued before being allocated into a treatment group. They never received treatment with exicorilant. Thus, they were not at risk for a treatment-emergent adverse event.
|
16.7%
1/6 • Treatment-emergent adverse events were reported from randomization up to 27 months for Segment 1 and up to 19 months for Segment 2. All-cause mortality was reported from enrollment up to 52 months.
Patients in the Enrolled But Not Randomized group were enrolled in the study but discontinued before being allocated into a treatment group. They never received treatment with exicorilant. Thus, they were not at risk for a treatment-emergent adverse event.
|
|
Investigations
Activated partial thromboplastin time prolonged
|
33.3%
1/3 • Treatment-emergent adverse events were reported from randomization up to 27 months for Segment 1 and up to 19 months for Segment 2. All-cause mortality was reported from enrollment up to 52 months.
Patients in the Enrolled But Not Randomized group were enrolled in the study but discontinued before being allocated into a treatment group. They never received treatment with exicorilant. Thus, they were not at risk for a treatment-emergent adverse event.
|
0.00%
0/7 • Treatment-emergent adverse events were reported from randomization up to 27 months for Segment 1 and up to 19 months for Segment 2. All-cause mortality was reported from enrollment up to 52 months.
Patients in the Enrolled But Not Randomized group were enrolled in the study but discontinued before being allocated into a treatment group. They never received treatment with exicorilant. Thus, they were not at risk for a treatment-emergent adverse event.
|
—
0/0 • Treatment-emergent adverse events were reported from randomization up to 27 months for Segment 1 and up to 19 months for Segment 2. All-cause mortality was reported from enrollment up to 52 months.
Patients in the Enrolled But Not Randomized group were enrolled in the study but discontinued before being allocated into a treatment group. They never received treatment with exicorilant. Thus, they were not at risk for a treatment-emergent adverse event.
|
0.00%
0/2 • Treatment-emergent adverse events were reported from randomization up to 27 months for Segment 1 and up to 19 months for Segment 2. All-cause mortality was reported from enrollment up to 52 months.
Patients in the Enrolled But Not Randomized group were enrolled in the study but discontinued before being allocated into a treatment group. They never received treatment with exicorilant. Thus, they were not at risk for a treatment-emergent adverse event.
|
0.00%
0/8 • Treatment-emergent adverse events were reported from randomization up to 27 months for Segment 1 and up to 19 months for Segment 2. All-cause mortality was reported from enrollment up to 52 months.
Patients in the Enrolled But Not Randomized group were enrolled in the study but discontinued before being allocated into a treatment group. They never received treatment with exicorilant. Thus, they were not at risk for a treatment-emergent adverse event.
|
0.00%
0/1 • Treatment-emergent adverse events were reported from randomization up to 27 months for Segment 1 and up to 19 months for Segment 2. All-cause mortality was reported from enrollment up to 52 months.
Patients in the Enrolled But Not Randomized group were enrolled in the study but discontinued before being allocated into a treatment group. They never received treatment with exicorilant. Thus, they were not at risk for a treatment-emergent adverse event.
|
0.00%
0/10 • Treatment-emergent adverse events were reported from randomization up to 27 months for Segment 1 and up to 19 months for Segment 2. All-cause mortality was reported from enrollment up to 52 months.
Patients in the Enrolled But Not Randomized group were enrolled in the study but discontinued before being allocated into a treatment group. They never received treatment with exicorilant. Thus, they were not at risk for a treatment-emergent adverse event.
|
0.00%
0/6 • Treatment-emergent adverse events were reported from randomization up to 27 months for Segment 1 and up to 19 months for Segment 2. All-cause mortality was reported from enrollment up to 52 months.
Patients in the Enrolled But Not Randomized group were enrolled in the study but discontinued before being allocated into a treatment group. They never received treatment with exicorilant. Thus, they were not at risk for a treatment-emergent adverse event.
|
|
Investigations
Alanine aminotransferase increased
|
0.00%
0/3 • Treatment-emergent adverse events were reported from randomization up to 27 months for Segment 1 and up to 19 months for Segment 2. All-cause mortality was reported from enrollment up to 52 months.
Patients in the Enrolled But Not Randomized group were enrolled in the study but discontinued before being allocated into a treatment group. They never received treatment with exicorilant. Thus, they were not at risk for a treatment-emergent adverse event.
|
14.3%
1/7 • Treatment-emergent adverse events were reported from randomization up to 27 months for Segment 1 and up to 19 months for Segment 2. All-cause mortality was reported from enrollment up to 52 months.
Patients in the Enrolled But Not Randomized group were enrolled in the study but discontinued before being allocated into a treatment group. They never received treatment with exicorilant. Thus, they were not at risk for a treatment-emergent adverse event.
|
—
0/0 • Treatment-emergent adverse events were reported from randomization up to 27 months for Segment 1 and up to 19 months for Segment 2. All-cause mortality was reported from enrollment up to 52 months.
Patients in the Enrolled But Not Randomized group were enrolled in the study but discontinued before being allocated into a treatment group. They never received treatment with exicorilant. Thus, they were not at risk for a treatment-emergent adverse event.
|
0.00%
0/2 • Treatment-emergent adverse events were reported from randomization up to 27 months for Segment 1 and up to 19 months for Segment 2. All-cause mortality was reported from enrollment up to 52 months.
Patients in the Enrolled But Not Randomized group were enrolled in the study but discontinued before being allocated into a treatment group. They never received treatment with exicorilant. Thus, they were not at risk for a treatment-emergent adverse event.
|
37.5%
3/8 • Treatment-emergent adverse events were reported from randomization up to 27 months for Segment 1 and up to 19 months for Segment 2. All-cause mortality was reported from enrollment up to 52 months.
Patients in the Enrolled But Not Randomized group were enrolled in the study but discontinued before being allocated into a treatment group. They never received treatment with exicorilant. Thus, they were not at risk for a treatment-emergent adverse event.
|
0.00%
0/1 • Treatment-emergent adverse events were reported from randomization up to 27 months for Segment 1 and up to 19 months for Segment 2. All-cause mortality was reported from enrollment up to 52 months.
Patients in the Enrolled But Not Randomized group were enrolled in the study but discontinued before being allocated into a treatment group. They never received treatment with exicorilant. Thus, they were not at risk for a treatment-emergent adverse event.
|
0.00%
0/10 • Treatment-emergent adverse events were reported from randomization up to 27 months for Segment 1 and up to 19 months for Segment 2. All-cause mortality was reported from enrollment up to 52 months.
Patients in the Enrolled But Not Randomized group were enrolled in the study but discontinued before being allocated into a treatment group. They never received treatment with exicorilant. Thus, they were not at risk for a treatment-emergent adverse event.
|
0.00%
0/6 • Treatment-emergent adverse events were reported from randomization up to 27 months for Segment 1 and up to 19 months for Segment 2. All-cause mortality was reported from enrollment up to 52 months.
Patients in the Enrolled But Not Randomized group were enrolled in the study but discontinued before being allocated into a treatment group. They never received treatment with exicorilant. Thus, they were not at risk for a treatment-emergent adverse event.
|
|
Investigations
Amylase increased
|
0.00%
0/3 • Treatment-emergent adverse events were reported from randomization up to 27 months for Segment 1 and up to 19 months for Segment 2. All-cause mortality was reported from enrollment up to 52 months.
Patients in the Enrolled But Not Randomized group were enrolled in the study but discontinued before being allocated into a treatment group. They never received treatment with exicorilant. Thus, they were not at risk for a treatment-emergent adverse event.
|
0.00%
0/7 • Treatment-emergent adverse events were reported from randomization up to 27 months for Segment 1 and up to 19 months for Segment 2. All-cause mortality was reported from enrollment up to 52 months.
Patients in the Enrolled But Not Randomized group were enrolled in the study but discontinued before being allocated into a treatment group. They never received treatment with exicorilant. Thus, they were not at risk for a treatment-emergent adverse event.
|
—
0/0 • Treatment-emergent adverse events were reported from randomization up to 27 months for Segment 1 and up to 19 months for Segment 2. All-cause mortality was reported from enrollment up to 52 months.
Patients in the Enrolled But Not Randomized group were enrolled in the study but discontinued before being allocated into a treatment group. They never received treatment with exicorilant. Thus, they were not at risk for a treatment-emergent adverse event.
|
0.00%
0/2 • Treatment-emergent adverse events were reported from randomization up to 27 months for Segment 1 and up to 19 months for Segment 2. All-cause mortality was reported from enrollment up to 52 months.
Patients in the Enrolled But Not Randomized group were enrolled in the study but discontinued before being allocated into a treatment group. They never received treatment with exicorilant. Thus, they were not at risk for a treatment-emergent adverse event.
|
25.0%
2/8 • Treatment-emergent adverse events were reported from randomization up to 27 months for Segment 1 and up to 19 months for Segment 2. All-cause mortality was reported from enrollment up to 52 months.
Patients in the Enrolled But Not Randomized group were enrolled in the study but discontinued before being allocated into a treatment group. They never received treatment with exicorilant. Thus, they were not at risk for a treatment-emergent adverse event.
|
0.00%
0/1 • Treatment-emergent adverse events were reported from randomization up to 27 months for Segment 1 and up to 19 months for Segment 2. All-cause mortality was reported from enrollment up to 52 months.
Patients in the Enrolled But Not Randomized group were enrolled in the study but discontinued before being allocated into a treatment group. They never received treatment with exicorilant. Thus, they were not at risk for a treatment-emergent adverse event.
|
0.00%
0/10 • Treatment-emergent adverse events were reported from randomization up to 27 months for Segment 1 and up to 19 months for Segment 2. All-cause mortality was reported from enrollment up to 52 months.
Patients in the Enrolled But Not Randomized group were enrolled in the study but discontinued before being allocated into a treatment group. They never received treatment with exicorilant. Thus, they were not at risk for a treatment-emergent adverse event.
|
0.00%
0/6 • Treatment-emergent adverse events were reported from randomization up to 27 months for Segment 1 and up to 19 months for Segment 2. All-cause mortality was reported from enrollment up to 52 months.
Patients in the Enrolled But Not Randomized group were enrolled in the study but discontinued before being allocated into a treatment group. They never received treatment with exicorilant. Thus, they were not at risk for a treatment-emergent adverse event.
|
|
Investigations
Aspartate aminotransferase increased
|
0.00%
0/3 • Treatment-emergent adverse events were reported from randomization up to 27 months for Segment 1 and up to 19 months for Segment 2. All-cause mortality was reported from enrollment up to 52 months.
Patients in the Enrolled But Not Randomized group were enrolled in the study but discontinued before being allocated into a treatment group. They never received treatment with exicorilant. Thus, they were not at risk for a treatment-emergent adverse event.
|
14.3%
1/7 • Treatment-emergent adverse events were reported from randomization up to 27 months for Segment 1 and up to 19 months for Segment 2. All-cause mortality was reported from enrollment up to 52 months.
Patients in the Enrolled But Not Randomized group were enrolled in the study but discontinued before being allocated into a treatment group. They never received treatment with exicorilant. Thus, they were not at risk for a treatment-emergent adverse event.
|
—
0/0 • Treatment-emergent adverse events were reported from randomization up to 27 months for Segment 1 and up to 19 months for Segment 2. All-cause mortality was reported from enrollment up to 52 months.
Patients in the Enrolled But Not Randomized group were enrolled in the study but discontinued before being allocated into a treatment group. They never received treatment with exicorilant. Thus, they were not at risk for a treatment-emergent adverse event.
|
0.00%
0/2 • Treatment-emergent adverse events were reported from randomization up to 27 months for Segment 1 and up to 19 months for Segment 2. All-cause mortality was reported from enrollment up to 52 months.
Patients in the Enrolled But Not Randomized group were enrolled in the study but discontinued before being allocated into a treatment group. They never received treatment with exicorilant. Thus, they were not at risk for a treatment-emergent adverse event.
|
25.0%
2/8 • Treatment-emergent adverse events were reported from randomization up to 27 months for Segment 1 and up to 19 months for Segment 2. All-cause mortality was reported from enrollment up to 52 months.
Patients in the Enrolled But Not Randomized group were enrolled in the study but discontinued before being allocated into a treatment group. They never received treatment with exicorilant. Thus, they were not at risk for a treatment-emergent adverse event.
|
0.00%
0/1 • Treatment-emergent adverse events were reported from randomization up to 27 months for Segment 1 and up to 19 months for Segment 2. All-cause mortality was reported from enrollment up to 52 months.
Patients in the Enrolled But Not Randomized group were enrolled in the study but discontinued before being allocated into a treatment group. They never received treatment with exicorilant. Thus, they were not at risk for a treatment-emergent adverse event.
|
0.00%
0/10 • Treatment-emergent adverse events were reported from randomization up to 27 months for Segment 1 and up to 19 months for Segment 2. All-cause mortality was reported from enrollment up to 52 months.
Patients in the Enrolled But Not Randomized group were enrolled in the study but discontinued before being allocated into a treatment group. They never received treatment with exicorilant. Thus, they were not at risk for a treatment-emergent adverse event.
|
0.00%
0/6 • Treatment-emergent adverse events were reported from randomization up to 27 months for Segment 1 and up to 19 months for Segment 2. All-cause mortality was reported from enrollment up to 52 months.
Patients in the Enrolled But Not Randomized group were enrolled in the study but discontinued before being allocated into a treatment group. They never received treatment with exicorilant. Thus, they were not at risk for a treatment-emergent adverse event.
|
|
Investigations
Blood alkaline phosphatase increased
|
0.00%
0/3 • Treatment-emergent adverse events were reported from randomization up to 27 months for Segment 1 and up to 19 months for Segment 2. All-cause mortality was reported from enrollment up to 52 months.
Patients in the Enrolled But Not Randomized group were enrolled in the study but discontinued before being allocated into a treatment group. They never received treatment with exicorilant. Thus, they were not at risk for a treatment-emergent adverse event.
|
14.3%
1/7 • Treatment-emergent adverse events were reported from randomization up to 27 months for Segment 1 and up to 19 months for Segment 2. All-cause mortality was reported from enrollment up to 52 months.
Patients in the Enrolled But Not Randomized group were enrolled in the study but discontinued before being allocated into a treatment group. They never received treatment with exicorilant. Thus, they were not at risk for a treatment-emergent adverse event.
|
—
0/0 • Treatment-emergent adverse events were reported from randomization up to 27 months for Segment 1 and up to 19 months for Segment 2. All-cause mortality was reported from enrollment up to 52 months.
Patients in the Enrolled But Not Randomized group were enrolled in the study but discontinued before being allocated into a treatment group. They never received treatment with exicorilant. Thus, they were not at risk for a treatment-emergent adverse event.
|
0.00%
0/2 • Treatment-emergent adverse events were reported from randomization up to 27 months for Segment 1 and up to 19 months for Segment 2. All-cause mortality was reported from enrollment up to 52 months.
Patients in the Enrolled But Not Randomized group were enrolled in the study but discontinued before being allocated into a treatment group. They never received treatment with exicorilant. Thus, they were not at risk for a treatment-emergent adverse event.
|
37.5%
3/8 • Treatment-emergent adverse events were reported from randomization up to 27 months for Segment 1 and up to 19 months for Segment 2. All-cause mortality was reported from enrollment up to 52 months.
Patients in the Enrolled But Not Randomized group were enrolled in the study but discontinued before being allocated into a treatment group. They never received treatment with exicorilant. Thus, they were not at risk for a treatment-emergent adverse event.
|
0.00%
0/1 • Treatment-emergent adverse events were reported from randomization up to 27 months for Segment 1 and up to 19 months for Segment 2. All-cause mortality was reported from enrollment up to 52 months.
Patients in the Enrolled But Not Randomized group were enrolled in the study but discontinued before being allocated into a treatment group. They never received treatment with exicorilant. Thus, they were not at risk for a treatment-emergent adverse event.
|
0.00%
0/10 • Treatment-emergent adverse events were reported from randomization up to 27 months for Segment 1 and up to 19 months for Segment 2. All-cause mortality was reported from enrollment up to 52 months.
Patients in the Enrolled But Not Randomized group were enrolled in the study but discontinued before being allocated into a treatment group. They never received treatment with exicorilant. Thus, they were not at risk for a treatment-emergent adverse event.
|
16.7%
1/6 • Treatment-emergent adverse events were reported from randomization up to 27 months for Segment 1 and up to 19 months for Segment 2. All-cause mortality was reported from enrollment up to 52 months.
Patients in the Enrolled But Not Randomized group were enrolled in the study but discontinued before being allocated into a treatment group. They never received treatment with exicorilant. Thus, they were not at risk for a treatment-emergent adverse event.
|
|
Investigations
Blood bilirubin increased
|
0.00%
0/3 • Treatment-emergent adverse events were reported from randomization up to 27 months for Segment 1 and up to 19 months for Segment 2. All-cause mortality was reported from enrollment up to 52 months.
Patients in the Enrolled But Not Randomized group were enrolled in the study but discontinued before being allocated into a treatment group. They never received treatment with exicorilant. Thus, they were not at risk for a treatment-emergent adverse event.
|
0.00%
0/7 • Treatment-emergent adverse events were reported from randomization up to 27 months for Segment 1 and up to 19 months for Segment 2. All-cause mortality was reported from enrollment up to 52 months.
Patients in the Enrolled But Not Randomized group were enrolled in the study but discontinued before being allocated into a treatment group. They never received treatment with exicorilant. Thus, they were not at risk for a treatment-emergent adverse event.
|
—
0/0 • Treatment-emergent adverse events were reported from randomization up to 27 months for Segment 1 and up to 19 months for Segment 2. All-cause mortality was reported from enrollment up to 52 months.
Patients in the Enrolled But Not Randomized group were enrolled in the study but discontinued before being allocated into a treatment group. They never received treatment with exicorilant. Thus, they were not at risk for a treatment-emergent adverse event.
|
0.00%
0/2 • Treatment-emergent adverse events were reported from randomization up to 27 months for Segment 1 and up to 19 months for Segment 2. All-cause mortality was reported from enrollment up to 52 months.
Patients in the Enrolled But Not Randomized group were enrolled in the study but discontinued before being allocated into a treatment group. They never received treatment with exicorilant. Thus, they were not at risk for a treatment-emergent adverse event.
|
12.5%
1/8 • Treatment-emergent adverse events were reported from randomization up to 27 months for Segment 1 and up to 19 months for Segment 2. All-cause mortality was reported from enrollment up to 52 months.
Patients in the Enrolled But Not Randomized group were enrolled in the study but discontinued before being allocated into a treatment group. They never received treatment with exicorilant. Thus, they were not at risk for a treatment-emergent adverse event.
|
0.00%
0/1 • Treatment-emergent adverse events were reported from randomization up to 27 months for Segment 1 and up to 19 months for Segment 2. All-cause mortality was reported from enrollment up to 52 months.
Patients in the Enrolled But Not Randomized group were enrolled in the study but discontinued before being allocated into a treatment group. They never received treatment with exicorilant. Thus, they were not at risk for a treatment-emergent adverse event.
|
0.00%
0/10 • Treatment-emergent adverse events were reported from randomization up to 27 months for Segment 1 and up to 19 months for Segment 2. All-cause mortality was reported from enrollment up to 52 months.
Patients in the Enrolled But Not Randomized group were enrolled in the study but discontinued before being allocated into a treatment group. They never received treatment with exicorilant. Thus, they were not at risk for a treatment-emergent adverse event.
|
0.00%
0/6 • Treatment-emergent adverse events were reported from randomization up to 27 months for Segment 1 and up to 19 months for Segment 2. All-cause mortality was reported from enrollment up to 52 months.
Patients in the Enrolled But Not Randomized group were enrolled in the study but discontinued before being allocated into a treatment group. They never received treatment with exicorilant. Thus, they were not at risk for a treatment-emergent adverse event.
|
|
Investigations
Blood creatinine increased
|
0.00%
0/3 • Treatment-emergent adverse events were reported from randomization up to 27 months for Segment 1 and up to 19 months for Segment 2. All-cause mortality was reported from enrollment up to 52 months.
Patients in the Enrolled But Not Randomized group were enrolled in the study but discontinued before being allocated into a treatment group. They never received treatment with exicorilant. Thus, they were not at risk for a treatment-emergent adverse event.
|
0.00%
0/7 • Treatment-emergent adverse events were reported from randomization up to 27 months for Segment 1 and up to 19 months for Segment 2. All-cause mortality was reported from enrollment up to 52 months.
Patients in the Enrolled But Not Randomized group were enrolled in the study but discontinued before being allocated into a treatment group. They never received treatment with exicorilant. Thus, they were not at risk for a treatment-emergent adverse event.
|
—
0/0 • Treatment-emergent adverse events were reported from randomization up to 27 months for Segment 1 and up to 19 months for Segment 2. All-cause mortality was reported from enrollment up to 52 months.
Patients in the Enrolled But Not Randomized group were enrolled in the study but discontinued before being allocated into a treatment group. They never received treatment with exicorilant. Thus, they were not at risk for a treatment-emergent adverse event.
|
0.00%
0/2 • Treatment-emergent adverse events were reported from randomization up to 27 months for Segment 1 and up to 19 months for Segment 2. All-cause mortality was reported from enrollment up to 52 months.
Patients in the Enrolled But Not Randomized group were enrolled in the study but discontinued before being allocated into a treatment group. They never received treatment with exicorilant. Thus, they were not at risk for a treatment-emergent adverse event.
|
0.00%
0/8 • Treatment-emergent adverse events were reported from randomization up to 27 months for Segment 1 and up to 19 months for Segment 2. All-cause mortality was reported from enrollment up to 52 months.
Patients in the Enrolled But Not Randomized group were enrolled in the study but discontinued before being allocated into a treatment group. They never received treatment with exicorilant. Thus, they were not at risk for a treatment-emergent adverse event.
|
0.00%
0/1 • Treatment-emergent adverse events were reported from randomization up to 27 months for Segment 1 and up to 19 months for Segment 2. All-cause mortality was reported from enrollment up to 52 months.
Patients in the Enrolled But Not Randomized group were enrolled in the study but discontinued before being allocated into a treatment group. They never received treatment with exicorilant. Thus, they were not at risk for a treatment-emergent adverse event.
|
10.0%
1/10 • Treatment-emergent adverse events were reported from randomization up to 27 months for Segment 1 and up to 19 months for Segment 2. All-cause mortality was reported from enrollment up to 52 months.
Patients in the Enrolled But Not Randomized group were enrolled in the study but discontinued before being allocated into a treatment group. They never received treatment with exicorilant. Thus, they were not at risk for a treatment-emergent adverse event.
|
0.00%
0/6 • Treatment-emergent adverse events were reported from randomization up to 27 months for Segment 1 and up to 19 months for Segment 2. All-cause mortality was reported from enrollment up to 52 months.
Patients in the Enrolled But Not Randomized group were enrolled in the study but discontinued before being allocated into a treatment group. They never received treatment with exicorilant. Thus, they were not at risk for a treatment-emergent adverse event.
|
|
Investigations
Blood lactate dehydrogenase increased
|
0.00%
0/3 • Treatment-emergent adverse events were reported from randomization up to 27 months for Segment 1 and up to 19 months for Segment 2. All-cause mortality was reported from enrollment up to 52 months.
Patients in the Enrolled But Not Randomized group were enrolled in the study but discontinued before being allocated into a treatment group. They never received treatment with exicorilant. Thus, they were not at risk for a treatment-emergent adverse event.
|
0.00%
0/7 • Treatment-emergent adverse events were reported from randomization up to 27 months for Segment 1 and up to 19 months for Segment 2. All-cause mortality was reported from enrollment up to 52 months.
Patients in the Enrolled But Not Randomized group were enrolled in the study but discontinued before being allocated into a treatment group. They never received treatment with exicorilant. Thus, they were not at risk for a treatment-emergent adverse event.
|
—
0/0 • Treatment-emergent adverse events were reported from randomization up to 27 months for Segment 1 and up to 19 months for Segment 2. All-cause mortality was reported from enrollment up to 52 months.
Patients in the Enrolled But Not Randomized group were enrolled in the study but discontinued before being allocated into a treatment group. They never received treatment with exicorilant. Thus, they were not at risk for a treatment-emergent adverse event.
|
0.00%
0/2 • Treatment-emergent adverse events were reported from randomization up to 27 months for Segment 1 and up to 19 months for Segment 2. All-cause mortality was reported from enrollment up to 52 months.
Patients in the Enrolled But Not Randomized group were enrolled in the study but discontinued before being allocated into a treatment group. They never received treatment with exicorilant. Thus, they were not at risk for a treatment-emergent adverse event.
|
12.5%
1/8 • Treatment-emergent adverse events were reported from randomization up to 27 months for Segment 1 and up to 19 months for Segment 2. All-cause mortality was reported from enrollment up to 52 months.
Patients in the Enrolled But Not Randomized group were enrolled in the study but discontinued before being allocated into a treatment group. They never received treatment with exicorilant. Thus, they were not at risk for a treatment-emergent adverse event.
|
0.00%
0/1 • Treatment-emergent adverse events were reported from randomization up to 27 months for Segment 1 and up to 19 months for Segment 2. All-cause mortality was reported from enrollment up to 52 months.
Patients in the Enrolled But Not Randomized group were enrolled in the study but discontinued before being allocated into a treatment group. They never received treatment with exicorilant. Thus, they were not at risk for a treatment-emergent adverse event.
|
0.00%
0/10 • Treatment-emergent adverse events were reported from randomization up to 27 months for Segment 1 and up to 19 months for Segment 2. All-cause mortality was reported from enrollment up to 52 months.
Patients in the Enrolled But Not Randomized group were enrolled in the study but discontinued before being allocated into a treatment group. They never received treatment with exicorilant. Thus, they were not at risk for a treatment-emergent adverse event.
|
0.00%
0/6 • Treatment-emergent adverse events were reported from randomization up to 27 months for Segment 1 and up to 19 months for Segment 2. All-cause mortality was reported from enrollment up to 52 months.
Patients in the Enrolled But Not Randomized group were enrolled in the study but discontinued before being allocated into a treatment group. They never received treatment with exicorilant. Thus, they were not at risk for a treatment-emergent adverse event.
|
|
Investigations
Blood phosphorus decreased
|
33.3%
1/3 • Treatment-emergent adverse events were reported from randomization up to 27 months for Segment 1 and up to 19 months for Segment 2. All-cause mortality was reported from enrollment up to 52 months.
Patients in the Enrolled But Not Randomized group were enrolled in the study but discontinued before being allocated into a treatment group. They never received treatment with exicorilant. Thus, they were not at risk for a treatment-emergent adverse event.
|
0.00%
0/7 • Treatment-emergent adverse events were reported from randomization up to 27 months for Segment 1 and up to 19 months for Segment 2. All-cause mortality was reported from enrollment up to 52 months.
Patients in the Enrolled But Not Randomized group were enrolled in the study but discontinued before being allocated into a treatment group. They never received treatment with exicorilant. Thus, they were not at risk for a treatment-emergent adverse event.
|
—
0/0 • Treatment-emergent adverse events were reported from randomization up to 27 months for Segment 1 and up to 19 months for Segment 2. All-cause mortality was reported from enrollment up to 52 months.
Patients in the Enrolled But Not Randomized group were enrolled in the study but discontinued before being allocated into a treatment group. They never received treatment with exicorilant. Thus, they were not at risk for a treatment-emergent adverse event.
|
0.00%
0/2 • Treatment-emergent adverse events were reported from randomization up to 27 months for Segment 1 and up to 19 months for Segment 2. All-cause mortality was reported from enrollment up to 52 months.
Patients in the Enrolled But Not Randomized group were enrolled in the study but discontinued before being allocated into a treatment group. They never received treatment with exicorilant. Thus, they were not at risk for a treatment-emergent adverse event.
|
0.00%
0/8 • Treatment-emergent adverse events were reported from randomization up to 27 months for Segment 1 and up to 19 months for Segment 2. All-cause mortality was reported from enrollment up to 52 months.
Patients in the Enrolled But Not Randomized group were enrolled in the study but discontinued before being allocated into a treatment group. They never received treatment with exicorilant. Thus, they were not at risk for a treatment-emergent adverse event.
|
0.00%
0/1 • Treatment-emergent adverse events were reported from randomization up to 27 months for Segment 1 and up to 19 months for Segment 2. All-cause mortality was reported from enrollment up to 52 months.
Patients in the Enrolled But Not Randomized group were enrolled in the study but discontinued before being allocated into a treatment group. They never received treatment with exicorilant. Thus, they were not at risk for a treatment-emergent adverse event.
|
0.00%
0/10 • Treatment-emergent adverse events were reported from randomization up to 27 months for Segment 1 and up to 19 months for Segment 2. All-cause mortality was reported from enrollment up to 52 months.
Patients in the Enrolled But Not Randomized group were enrolled in the study but discontinued before being allocated into a treatment group. They never received treatment with exicorilant. Thus, they were not at risk for a treatment-emergent adverse event.
|
0.00%
0/6 • Treatment-emergent adverse events were reported from randomization up to 27 months for Segment 1 and up to 19 months for Segment 2. All-cause mortality was reported from enrollment up to 52 months.
Patients in the Enrolled But Not Randomized group were enrolled in the study but discontinued before being allocated into a treatment group. They never received treatment with exicorilant. Thus, they were not at risk for a treatment-emergent adverse event.
|
|
Investigations
Gamma-glutamyltransferase increased
|
0.00%
0/3 • Treatment-emergent adverse events were reported from randomization up to 27 months for Segment 1 and up to 19 months for Segment 2. All-cause mortality was reported from enrollment up to 52 months.
Patients in the Enrolled But Not Randomized group were enrolled in the study but discontinued before being allocated into a treatment group. They never received treatment with exicorilant. Thus, they were not at risk for a treatment-emergent adverse event.
|
14.3%
1/7 • Treatment-emergent adverse events were reported from randomization up to 27 months for Segment 1 and up to 19 months for Segment 2. All-cause mortality was reported from enrollment up to 52 months.
Patients in the Enrolled But Not Randomized group were enrolled in the study but discontinued before being allocated into a treatment group. They never received treatment with exicorilant. Thus, they were not at risk for a treatment-emergent adverse event.
|
—
0/0 • Treatment-emergent adverse events were reported from randomization up to 27 months for Segment 1 and up to 19 months for Segment 2. All-cause mortality was reported from enrollment up to 52 months.
Patients in the Enrolled But Not Randomized group were enrolled in the study but discontinued before being allocated into a treatment group. They never received treatment with exicorilant. Thus, they were not at risk for a treatment-emergent adverse event.
|
0.00%
0/2 • Treatment-emergent adverse events were reported from randomization up to 27 months for Segment 1 and up to 19 months for Segment 2. All-cause mortality was reported from enrollment up to 52 months.
Patients in the Enrolled But Not Randomized group were enrolled in the study but discontinued before being allocated into a treatment group. They never received treatment with exicorilant. Thus, they were not at risk for a treatment-emergent adverse event.
|
12.5%
1/8 • Treatment-emergent adverse events were reported from randomization up to 27 months for Segment 1 and up to 19 months for Segment 2. All-cause mortality was reported from enrollment up to 52 months.
Patients in the Enrolled But Not Randomized group were enrolled in the study but discontinued before being allocated into a treatment group. They never received treatment with exicorilant. Thus, they were not at risk for a treatment-emergent adverse event.
|
0.00%
0/1 • Treatment-emergent adverse events were reported from randomization up to 27 months for Segment 1 and up to 19 months for Segment 2. All-cause mortality was reported from enrollment up to 52 months.
Patients in the Enrolled But Not Randomized group were enrolled in the study but discontinued before being allocated into a treatment group. They never received treatment with exicorilant. Thus, they were not at risk for a treatment-emergent adverse event.
|
0.00%
0/10 • Treatment-emergent adverse events were reported from randomization up to 27 months for Segment 1 and up to 19 months for Segment 2. All-cause mortality was reported from enrollment up to 52 months.
Patients in the Enrolled But Not Randomized group were enrolled in the study but discontinued before being allocated into a treatment group. They never received treatment with exicorilant. Thus, they were not at risk for a treatment-emergent adverse event.
|
0.00%
0/6 • Treatment-emergent adverse events were reported from randomization up to 27 months for Segment 1 and up to 19 months for Segment 2. All-cause mortality was reported from enrollment up to 52 months.
Patients in the Enrolled But Not Randomized group were enrolled in the study but discontinued before being allocated into a treatment group. They never received treatment with exicorilant. Thus, they were not at risk for a treatment-emergent adverse event.
|
|
Investigations
Lipase increased
|
0.00%
0/3 • Treatment-emergent adverse events were reported from randomization up to 27 months for Segment 1 and up to 19 months for Segment 2. All-cause mortality was reported from enrollment up to 52 months.
Patients in the Enrolled But Not Randomized group were enrolled in the study but discontinued before being allocated into a treatment group. They never received treatment with exicorilant. Thus, they were not at risk for a treatment-emergent adverse event.
|
0.00%
0/7 • Treatment-emergent adverse events were reported from randomization up to 27 months for Segment 1 and up to 19 months for Segment 2. All-cause mortality was reported from enrollment up to 52 months.
Patients in the Enrolled But Not Randomized group were enrolled in the study but discontinued before being allocated into a treatment group. They never received treatment with exicorilant. Thus, they were not at risk for a treatment-emergent adverse event.
|
—
0/0 • Treatment-emergent adverse events were reported from randomization up to 27 months for Segment 1 and up to 19 months for Segment 2. All-cause mortality was reported from enrollment up to 52 months.
Patients in the Enrolled But Not Randomized group were enrolled in the study but discontinued before being allocated into a treatment group. They never received treatment with exicorilant. Thus, they were not at risk for a treatment-emergent adverse event.
|
0.00%
0/2 • Treatment-emergent adverse events were reported from randomization up to 27 months for Segment 1 and up to 19 months for Segment 2. All-cause mortality was reported from enrollment up to 52 months.
Patients in the Enrolled But Not Randomized group were enrolled in the study but discontinued before being allocated into a treatment group. They never received treatment with exicorilant. Thus, they were not at risk for a treatment-emergent adverse event.
|
37.5%
3/8 • Treatment-emergent adverse events were reported from randomization up to 27 months for Segment 1 and up to 19 months for Segment 2. All-cause mortality was reported from enrollment up to 52 months.
Patients in the Enrolled But Not Randomized group were enrolled in the study but discontinued before being allocated into a treatment group. They never received treatment with exicorilant. Thus, they were not at risk for a treatment-emergent adverse event.
|
100.0%
1/1 • Treatment-emergent adverse events were reported from randomization up to 27 months for Segment 1 and up to 19 months for Segment 2. All-cause mortality was reported from enrollment up to 52 months.
Patients in the Enrolled But Not Randomized group were enrolled in the study but discontinued before being allocated into a treatment group. They never received treatment with exicorilant. Thus, they were not at risk for a treatment-emergent adverse event.
|
0.00%
0/10 • Treatment-emergent adverse events were reported from randomization up to 27 months for Segment 1 and up to 19 months for Segment 2. All-cause mortality was reported from enrollment up to 52 months.
Patients in the Enrolled But Not Randomized group were enrolled in the study but discontinued before being allocated into a treatment group. They never received treatment with exicorilant. Thus, they were not at risk for a treatment-emergent adverse event.
|
66.7%
4/6 • Treatment-emergent adverse events were reported from randomization up to 27 months for Segment 1 and up to 19 months for Segment 2. All-cause mortality was reported from enrollment up to 52 months.
Patients in the Enrolled But Not Randomized group were enrolled in the study but discontinued before being allocated into a treatment group. They never received treatment with exicorilant. Thus, they were not at risk for a treatment-emergent adverse event.
|
|
Investigations
Lymphocyte count decreased
|
0.00%
0/3 • Treatment-emergent adverse events were reported from randomization up to 27 months for Segment 1 and up to 19 months for Segment 2. All-cause mortality was reported from enrollment up to 52 months.
Patients in the Enrolled But Not Randomized group were enrolled in the study but discontinued before being allocated into a treatment group. They never received treatment with exicorilant. Thus, they were not at risk for a treatment-emergent adverse event.
|
0.00%
0/7 • Treatment-emergent adverse events were reported from randomization up to 27 months for Segment 1 and up to 19 months for Segment 2. All-cause mortality was reported from enrollment up to 52 months.
Patients in the Enrolled But Not Randomized group were enrolled in the study but discontinued before being allocated into a treatment group. They never received treatment with exicorilant. Thus, they were not at risk for a treatment-emergent adverse event.
|
—
0/0 • Treatment-emergent adverse events were reported from randomization up to 27 months for Segment 1 and up to 19 months for Segment 2. All-cause mortality was reported from enrollment up to 52 months.
Patients in the Enrolled But Not Randomized group were enrolled in the study but discontinued before being allocated into a treatment group. They never received treatment with exicorilant. Thus, they were not at risk for a treatment-emergent adverse event.
|
0.00%
0/2 • Treatment-emergent adverse events were reported from randomization up to 27 months for Segment 1 and up to 19 months for Segment 2. All-cause mortality was reported from enrollment up to 52 months.
Patients in the Enrolled But Not Randomized group were enrolled in the study but discontinued before being allocated into a treatment group. They never received treatment with exicorilant. Thus, they were not at risk for a treatment-emergent adverse event.
|
0.00%
0/8 • Treatment-emergent adverse events were reported from randomization up to 27 months for Segment 1 and up to 19 months for Segment 2. All-cause mortality was reported from enrollment up to 52 months.
Patients in the Enrolled But Not Randomized group were enrolled in the study but discontinued before being allocated into a treatment group. They never received treatment with exicorilant. Thus, they were not at risk for a treatment-emergent adverse event.
|
100.0%
1/1 • Treatment-emergent adverse events were reported from randomization up to 27 months for Segment 1 and up to 19 months for Segment 2. All-cause mortality was reported from enrollment up to 52 months.
Patients in the Enrolled But Not Randomized group were enrolled in the study but discontinued before being allocated into a treatment group. They never received treatment with exicorilant. Thus, they were not at risk for a treatment-emergent adverse event.
|
10.0%
1/10 • Treatment-emergent adverse events were reported from randomization up to 27 months for Segment 1 and up to 19 months for Segment 2. All-cause mortality was reported from enrollment up to 52 months.
Patients in the Enrolled But Not Randomized group were enrolled in the study but discontinued before being allocated into a treatment group. They never received treatment with exicorilant. Thus, they were not at risk for a treatment-emergent adverse event.
|
33.3%
2/6 • Treatment-emergent adverse events were reported from randomization up to 27 months for Segment 1 and up to 19 months for Segment 2. All-cause mortality was reported from enrollment up to 52 months.
Patients in the Enrolled But Not Randomized group were enrolled in the study but discontinued before being allocated into a treatment group. They never received treatment with exicorilant. Thus, they were not at risk for a treatment-emergent adverse event.
|
|
Investigations
Platelet count decreased
|
0.00%
0/3 • Treatment-emergent adverse events were reported from randomization up to 27 months for Segment 1 and up to 19 months for Segment 2. All-cause mortality was reported from enrollment up to 52 months.
Patients in the Enrolled But Not Randomized group were enrolled in the study but discontinued before being allocated into a treatment group. They never received treatment with exicorilant. Thus, they were not at risk for a treatment-emergent adverse event.
|
0.00%
0/7 • Treatment-emergent adverse events were reported from randomization up to 27 months for Segment 1 and up to 19 months for Segment 2. All-cause mortality was reported from enrollment up to 52 months.
Patients in the Enrolled But Not Randomized group were enrolled in the study but discontinued before being allocated into a treatment group. They never received treatment with exicorilant. Thus, they were not at risk for a treatment-emergent adverse event.
|
—
0/0 • Treatment-emergent adverse events were reported from randomization up to 27 months for Segment 1 and up to 19 months for Segment 2. All-cause mortality was reported from enrollment up to 52 months.
Patients in the Enrolled But Not Randomized group were enrolled in the study but discontinued before being allocated into a treatment group. They never received treatment with exicorilant. Thus, they were not at risk for a treatment-emergent adverse event.
|
0.00%
0/2 • Treatment-emergent adverse events were reported from randomization up to 27 months for Segment 1 and up to 19 months for Segment 2. All-cause mortality was reported from enrollment up to 52 months.
Patients in the Enrolled But Not Randomized group were enrolled in the study but discontinued before being allocated into a treatment group. They never received treatment with exicorilant. Thus, they were not at risk for a treatment-emergent adverse event.
|
0.00%
0/8 • Treatment-emergent adverse events were reported from randomization up to 27 months for Segment 1 and up to 19 months for Segment 2. All-cause mortality was reported from enrollment up to 52 months.
Patients in the Enrolled But Not Randomized group were enrolled in the study but discontinued before being allocated into a treatment group. They never received treatment with exicorilant. Thus, they were not at risk for a treatment-emergent adverse event.
|
0.00%
0/1 • Treatment-emergent adverse events were reported from randomization up to 27 months for Segment 1 and up to 19 months for Segment 2. All-cause mortality was reported from enrollment up to 52 months.
Patients in the Enrolled But Not Randomized group were enrolled in the study but discontinued before being allocated into a treatment group. They never received treatment with exicorilant. Thus, they were not at risk for a treatment-emergent adverse event.
|
10.0%
1/10 • Treatment-emergent adverse events were reported from randomization up to 27 months for Segment 1 and up to 19 months for Segment 2. All-cause mortality was reported from enrollment up to 52 months.
Patients in the Enrolled But Not Randomized group were enrolled in the study but discontinued before being allocated into a treatment group. They never received treatment with exicorilant. Thus, they were not at risk for a treatment-emergent adverse event.
|
16.7%
1/6 • Treatment-emergent adverse events were reported from randomization up to 27 months for Segment 1 and up to 19 months for Segment 2. All-cause mortality was reported from enrollment up to 52 months.
Patients in the Enrolled But Not Randomized group were enrolled in the study but discontinued before being allocated into a treatment group. They never received treatment with exicorilant. Thus, they were not at risk for a treatment-emergent adverse event.
|
|
Investigations
Troponin increased
|
0.00%
0/3 • Treatment-emergent adverse events were reported from randomization up to 27 months for Segment 1 and up to 19 months for Segment 2. All-cause mortality was reported from enrollment up to 52 months.
Patients in the Enrolled But Not Randomized group were enrolled in the study but discontinued before being allocated into a treatment group. They never received treatment with exicorilant. Thus, they were not at risk for a treatment-emergent adverse event.
|
14.3%
1/7 • Treatment-emergent adverse events were reported from randomization up to 27 months for Segment 1 and up to 19 months for Segment 2. All-cause mortality was reported from enrollment up to 52 months.
Patients in the Enrolled But Not Randomized group were enrolled in the study but discontinued before being allocated into a treatment group. They never received treatment with exicorilant. Thus, they were not at risk for a treatment-emergent adverse event.
|
—
0/0 • Treatment-emergent adverse events were reported from randomization up to 27 months for Segment 1 and up to 19 months for Segment 2. All-cause mortality was reported from enrollment up to 52 months.
Patients in the Enrolled But Not Randomized group were enrolled in the study but discontinued before being allocated into a treatment group. They never received treatment with exicorilant. Thus, they were not at risk for a treatment-emergent adverse event.
|
0.00%
0/2 • Treatment-emergent adverse events were reported from randomization up to 27 months for Segment 1 and up to 19 months for Segment 2. All-cause mortality was reported from enrollment up to 52 months.
Patients in the Enrolled But Not Randomized group were enrolled in the study but discontinued before being allocated into a treatment group. They never received treatment with exicorilant. Thus, they were not at risk for a treatment-emergent adverse event.
|
0.00%
0/8 • Treatment-emergent adverse events were reported from randomization up to 27 months for Segment 1 and up to 19 months for Segment 2. All-cause mortality was reported from enrollment up to 52 months.
Patients in the Enrolled But Not Randomized group were enrolled in the study but discontinued before being allocated into a treatment group. They never received treatment with exicorilant. Thus, they were not at risk for a treatment-emergent adverse event.
|
0.00%
0/1 • Treatment-emergent adverse events were reported from randomization up to 27 months for Segment 1 and up to 19 months for Segment 2. All-cause mortality was reported from enrollment up to 52 months.
Patients in the Enrolled But Not Randomized group were enrolled in the study but discontinued before being allocated into a treatment group. They never received treatment with exicorilant. Thus, they were not at risk for a treatment-emergent adverse event.
|
0.00%
0/10 • Treatment-emergent adverse events were reported from randomization up to 27 months for Segment 1 and up to 19 months for Segment 2. All-cause mortality was reported from enrollment up to 52 months.
Patients in the Enrolled But Not Randomized group were enrolled in the study but discontinued before being allocated into a treatment group. They never received treatment with exicorilant. Thus, they were not at risk for a treatment-emergent adverse event.
|
0.00%
0/6 • Treatment-emergent adverse events were reported from randomization up to 27 months for Segment 1 and up to 19 months for Segment 2. All-cause mortality was reported from enrollment up to 52 months.
Patients in the Enrolled But Not Randomized group were enrolled in the study but discontinued before being allocated into a treatment group. They never received treatment with exicorilant. Thus, they were not at risk for a treatment-emergent adverse event.
|
|
Investigations
Weight decreased
|
0.00%
0/3 • Treatment-emergent adverse events were reported from randomization up to 27 months for Segment 1 and up to 19 months for Segment 2. All-cause mortality was reported from enrollment up to 52 months.
Patients in the Enrolled But Not Randomized group were enrolled in the study but discontinued before being allocated into a treatment group. They never received treatment with exicorilant. Thus, they were not at risk for a treatment-emergent adverse event.
|
28.6%
2/7 • Treatment-emergent adverse events were reported from randomization up to 27 months for Segment 1 and up to 19 months for Segment 2. All-cause mortality was reported from enrollment up to 52 months.
Patients in the Enrolled But Not Randomized group were enrolled in the study but discontinued before being allocated into a treatment group. They never received treatment with exicorilant. Thus, they were not at risk for a treatment-emergent adverse event.
|
—
0/0 • Treatment-emergent adverse events were reported from randomization up to 27 months for Segment 1 and up to 19 months for Segment 2. All-cause mortality was reported from enrollment up to 52 months.
Patients in the Enrolled But Not Randomized group were enrolled in the study but discontinued before being allocated into a treatment group. They never received treatment with exicorilant. Thus, they were not at risk for a treatment-emergent adverse event.
|
50.0%
1/2 • Treatment-emergent adverse events were reported from randomization up to 27 months for Segment 1 and up to 19 months for Segment 2. All-cause mortality was reported from enrollment up to 52 months.
Patients in the Enrolled But Not Randomized group were enrolled in the study but discontinued before being allocated into a treatment group. They never received treatment with exicorilant. Thus, they were not at risk for a treatment-emergent adverse event.
|
12.5%
1/8 • Treatment-emergent adverse events were reported from randomization up to 27 months for Segment 1 and up to 19 months for Segment 2. All-cause mortality was reported from enrollment up to 52 months.
Patients in the Enrolled But Not Randomized group were enrolled in the study but discontinued before being allocated into a treatment group. They never received treatment with exicorilant. Thus, they were not at risk for a treatment-emergent adverse event.
|
0.00%
0/1 • Treatment-emergent adverse events were reported from randomization up to 27 months for Segment 1 and up to 19 months for Segment 2. All-cause mortality was reported from enrollment up to 52 months.
Patients in the Enrolled But Not Randomized group were enrolled in the study but discontinued before being allocated into a treatment group. They never received treatment with exicorilant. Thus, they were not at risk for a treatment-emergent adverse event.
|
10.0%
1/10 • Treatment-emergent adverse events were reported from randomization up to 27 months for Segment 1 and up to 19 months for Segment 2. All-cause mortality was reported from enrollment up to 52 months.
Patients in the Enrolled But Not Randomized group were enrolled in the study but discontinued before being allocated into a treatment group. They never received treatment with exicorilant. Thus, they were not at risk for a treatment-emergent adverse event.
|
16.7%
1/6 • Treatment-emergent adverse events were reported from randomization up to 27 months for Segment 1 and up to 19 months for Segment 2. All-cause mortality was reported from enrollment up to 52 months.
Patients in the Enrolled But Not Randomized group were enrolled in the study but discontinued before being allocated into a treatment group. They never received treatment with exicorilant. Thus, they were not at risk for a treatment-emergent adverse event.
|
|
Metabolism and nutrition disorders
Decreased appetite
|
66.7%
2/3 • Treatment-emergent adverse events were reported from randomization up to 27 months for Segment 1 and up to 19 months for Segment 2. All-cause mortality was reported from enrollment up to 52 months.
Patients in the Enrolled But Not Randomized group were enrolled in the study but discontinued before being allocated into a treatment group. They never received treatment with exicorilant. Thus, they were not at risk for a treatment-emergent adverse event.
|
14.3%
1/7 • Treatment-emergent adverse events were reported from randomization up to 27 months for Segment 1 and up to 19 months for Segment 2. All-cause mortality was reported from enrollment up to 52 months.
Patients in the Enrolled But Not Randomized group were enrolled in the study but discontinued before being allocated into a treatment group. They never received treatment with exicorilant. Thus, they were not at risk for a treatment-emergent adverse event.
|
—
0/0 • Treatment-emergent adverse events were reported from randomization up to 27 months for Segment 1 and up to 19 months for Segment 2. All-cause mortality was reported from enrollment up to 52 months.
Patients in the Enrolled But Not Randomized group were enrolled in the study but discontinued before being allocated into a treatment group. They never received treatment with exicorilant. Thus, they were not at risk for a treatment-emergent adverse event.
|
50.0%
1/2 • Treatment-emergent adverse events were reported from randomization up to 27 months for Segment 1 and up to 19 months for Segment 2. All-cause mortality was reported from enrollment up to 52 months.
Patients in the Enrolled But Not Randomized group were enrolled in the study but discontinued before being allocated into a treatment group. They never received treatment with exicorilant. Thus, they were not at risk for a treatment-emergent adverse event.
|
12.5%
1/8 • Treatment-emergent adverse events were reported from randomization up to 27 months for Segment 1 and up to 19 months for Segment 2. All-cause mortality was reported from enrollment up to 52 months.
Patients in the Enrolled But Not Randomized group were enrolled in the study but discontinued before being allocated into a treatment group. They never received treatment with exicorilant. Thus, they were not at risk for a treatment-emergent adverse event.
|
0.00%
0/1 • Treatment-emergent adverse events were reported from randomization up to 27 months for Segment 1 and up to 19 months for Segment 2. All-cause mortality was reported from enrollment up to 52 months.
Patients in the Enrolled But Not Randomized group were enrolled in the study but discontinued before being allocated into a treatment group. They never received treatment with exicorilant. Thus, they were not at risk for a treatment-emergent adverse event.
|
30.0%
3/10 • Treatment-emergent adverse events were reported from randomization up to 27 months for Segment 1 and up to 19 months for Segment 2. All-cause mortality was reported from enrollment up to 52 months.
Patients in the Enrolled But Not Randomized group were enrolled in the study but discontinued before being allocated into a treatment group. They never received treatment with exicorilant. Thus, they were not at risk for a treatment-emergent adverse event.
|
50.0%
3/6 • Treatment-emergent adverse events were reported from randomization up to 27 months for Segment 1 and up to 19 months for Segment 2. All-cause mortality was reported from enrollment up to 52 months.
Patients in the Enrolled But Not Randomized group were enrolled in the study but discontinued before being allocated into a treatment group. They never received treatment with exicorilant. Thus, they were not at risk for a treatment-emergent adverse event.
|
|
Metabolism and nutrition disorders
Gout
|
0.00%
0/3 • Treatment-emergent adverse events were reported from randomization up to 27 months for Segment 1 and up to 19 months for Segment 2. All-cause mortality was reported from enrollment up to 52 months.
Patients in the Enrolled But Not Randomized group were enrolled in the study but discontinued before being allocated into a treatment group. They never received treatment with exicorilant. Thus, they were not at risk for a treatment-emergent adverse event.
|
0.00%
0/7 • Treatment-emergent adverse events were reported from randomization up to 27 months for Segment 1 and up to 19 months for Segment 2. All-cause mortality was reported from enrollment up to 52 months.
Patients in the Enrolled But Not Randomized group were enrolled in the study but discontinued before being allocated into a treatment group. They never received treatment with exicorilant. Thus, they were not at risk for a treatment-emergent adverse event.
|
—
0/0 • Treatment-emergent adverse events were reported from randomization up to 27 months for Segment 1 and up to 19 months for Segment 2. All-cause mortality was reported from enrollment up to 52 months.
Patients in the Enrolled But Not Randomized group were enrolled in the study but discontinued before being allocated into a treatment group. They never received treatment with exicorilant. Thus, they were not at risk for a treatment-emergent adverse event.
|
0.00%
0/2 • Treatment-emergent adverse events were reported from randomization up to 27 months for Segment 1 and up to 19 months for Segment 2. All-cause mortality was reported from enrollment up to 52 months.
Patients in the Enrolled But Not Randomized group were enrolled in the study but discontinued before being allocated into a treatment group. They never received treatment with exicorilant. Thus, they were not at risk for a treatment-emergent adverse event.
|
0.00%
0/8 • Treatment-emergent adverse events were reported from randomization up to 27 months for Segment 1 and up to 19 months for Segment 2. All-cause mortality was reported from enrollment up to 52 months.
Patients in the Enrolled But Not Randomized group were enrolled in the study but discontinued before being allocated into a treatment group. They never received treatment with exicorilant. Thus, they were not at risk for a treatment-emergent adverse event.
|
0.00%
0/1 • Treatment-emergent adverse events were reported from randomization up to 27 months for Segment 1 and up to 19 months for Segment 2. All-cause mortality was reported from enrollment up to 52 months.
Patients in the Enrolled But Not Randomized group were enrolled in the study but discontinued before being allocated into a treatment group. They never received treatment with exicorilant. Thus, they were not at risk for a treatment-emergent adverse event.
|
10.0%
1/10 • Treatment-emergent adverse events were reported from randomization up to 27 months for Segment 1 and up to 19 months for Segment 2. All-cause mortality was reported from enrollment up to 52 months.
Patients in the Enrolled But Not Randomized group were enrolled in the study but discontinued before being allocated into a treatment group. They never received treatment with exicorilant. Thus, they were not at risk for a treatment-emergent adverse event.
|
0.00%
0/6 • Treatment-emergent adverse events were reported from randomization up to 27 months for Segment 1 and up to 19 months for Segment 2. All-cause mortality was reported from enrollment up to 52 months.
Patients in the Enrolled But Not Randomized group were enrolled in the study but discontinued before being allocated into a treatment group. They never received treatment with exicorilant. Thus, they were not at risk for a treatment-emergent adverse event.
|
|
Metabolism and nutrition disorders
Hypercalcaemia
|
0.00%
0/3 • Treatment-emergent adverse events were reported from randomization up to 27 months for Segment 1 and up to 19 months for Segment 2. All-cause mortality was reported from enrollment up to 52 months.
Patients in the Enrolled But Not Randomized group were enrolled in the study but discontinued before being allocated into a treatment group. They never received treatment with exicorilant. Thus, they were not at risk for a treatment-emergent adverse event.
|
0.00%
0/7 • Treatment-emergent adverse events were reported from randomization up to 27 months for Segment 1 and up to 19 months for Segment 2. All-cause mortality was reported from enrollment up to 52 months.
Patients in the Enrolled But Not Randomized group were enrolled in the study but discontinued before being allocated into a treatment group. They never received treatment with exicorilant. Thus, they were not at risk for a treatment-emergent adverse event.
|
—
0/0 • Treatment-emergent adverse events were reported from randomization up to 27 months for Segment 1 and up to 19 months for Segment 2. All-cause mortality was reported from enrollment up to 52 months.
Patients in the Enrolled But Not Randomized group were enrolled in the study but discontinued before being allocated into a treatment group. They never received treatment with exicorilant. Thus, they were not at risk for a treatment-emergent adverse event.
|
0.00%
0/2 • Treatment-emergent adverse events were reported from randomization up to 27 months for Segment 1 and up to 19 months for Segment 2. All-cause mortality was reported from enrollment up to 52 months.
Patients in the Enrolled But Not Randomized group were enrolled in the study but discontinued before being allocated into a treatment group. They never received treatment with exicorilant. Thus, they were not at risk for a treatment-emergent adverse event.
|
0.00%
0/8 • Treatment-emergent adverse events were reported from randomization up to 27 months for Segment 1 and up to 19 months for Segment 2. All-cause mortality was reported from enrollment up to 52 months.
Patients in the Enrolled But Not Randomized group were enrolled in the study but discontinued before being allocated into a treatment group. They never received treatment with exicorilant. Thus, they were not at risk for a treatment-emergent adverse event.
|
0.00%
0/1 • Treatment-emergent adverse events were reported from randomization up to 27 months for Segment 1 and up to 19 months for Segment 2. All-cause mortality was reported from enrollment up to 52 months.
Patients in the Enrolled But Not Randomized group were enrolled in the study but discontinued before being allocated into a treatment group. They never received treatment with exicorilant. Thus, they were not at risk for a treatment-emergent adverse event.
|
0.00%
0/10 • Treatment-emergent adverse events were reported from randomization up to 27 months for Segment 1 and up to 19 months for Segment 2. All-cause mortality was reported from enrollment up to 52 months.
Patients in the Enrolled But Not Randomized group were enrolled in the study but discontinued before being allocated into a treatment group. They never received treatment with exicorilant. Thus, they were not at risk for a treatment-emergent adverse event.
|
33.3%
2/6 • Treatment-emergent adverse events were reported from randomization up to 27 months for Segment 1 and up to 19 months for Segment 2. All-cause mortality was reported from enrollment up to 52 months.
Patients in the Enrolled But Not Randomized group were enrolled in the study but discontinued before being allocated into a treatment group. They never received treatment with exicorilant. Thus, they were not at risk for a treatment-emergent adverse event.
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
0.00%
0/3 • Treatment-emergent adverse events were reported from randomization up to 27 months for Segment 1 and up to 19 months for Segment 2. All-cause mortality was reported from enrollment up to 52 months.
Patients in the Enrolled But Not Randomized group were enrolled in the study but discontinued before being allocated into a treatment group. They never received treatment with exicorilant. Thus, they were not at risk for a treatment-emergent adverse event.
|
14.3%
1/7 • Treatment-emergent adverse events were reported from randomization up to 27 months for Segment 1 and up to 19 months for Segment 2. All-cause mortality was reported from enrollment up to 52 months.
Patients in the Enrolled But Not Randomized group were enrolled in the study but discontinued before being allocated into a treatment group. They never received treatment with exicorilant. Thus, they were not at risk for a treatment-emergent adverse event.
|
—
0/0 • Treatment-emergent adverse events were reported from randomization up to 27 months for Segment 1 and up to 19 months for Segment 2. All-cause mortality was reported from enrollment up to 52 months.
Patients in the Enrolled But Not Randomized group were enrolled in the study but discontinued before being allocated into a treatment group. They never received treatment with exicorilant. Thus, they were not at risk for a treatment-emergent adverse event.
|
0.00%
0/2 • Treatment-emergent adverse events were reported from randomization up to 27 months for Segment 1 and up to 19 months for Segment 2. All-cause mortality was reported from enrollment up to 52 months.
Patients in the Enrolled But Not Randomized group were enrolled in the study but discontinued before being allocated into a treatment group. They never received treatment with exicorilant. Thus, they were not at risk for a treatment-emergent adverse event.
|
0.00%
0/8 • Treatment-emergent adverse events were reported from randomization up to 27 months for Segment 1 and up to 19 months for Segment 2. All-cause mortality was reported from enrollment up to 52 months.
Patients in the Enrolled But Not Randomized group were enrolled in the study but discontinued before being allocated into a treatment group. They never received treatment with exicorilant. Thus, they were not at risk for a treatment-emergent adverse event.
|
0.00%
0/1 • Treatment-emergent adverse events were reported from randomization up to 27 months for Segment 1 and up to 19 months for Segment 2. All-cause mortality was reported from enrollment up to 52 months.
Patients in the Enrolled But Not Randomized group were enrolled in the study but discontinued before being allocated into a treatment group. They never received treatment with exicorilant. Thus, they were not at risk for a treatment-emergent adverse event.
|
10.0%
1/10 • Treatment-emergent adverse events were reported from randomization up to 27 months for Segment 1 and up to 19 months for Segment 2. All-cause mortality was reported from enrollment up to 52 months.
Patients in the Enrolled But Not Randomized group were enrolled in the study but discontinued before being allocated into a treatment group. They never received treatment with exicorilant. Thus, they were not at risk for a treatment-emergent adverse event.
|
16.7%
1/6 • Treatment-emergent adverse events were reported from randomization up to 27 months for Segment 1 and up to 19 months for Segment 2. All-cause mortality was reported from enrollment up to 52 months.
Patients in the Enrolled But Not Randomized group were enrolled in the study but discontinued before being allocated into a treatment group. They never received treatment with exicorilant. Thus, they were not at risk for a treatment-emergent adverse event.
|
|
Metabolism and nutrition disorders
Hypermagnesaemia
|
0.00%
0/3 • Treatment-emergent adverse events were reported from randomization up to 27 months for Segment 1 and up to 19 months for Segment 2. All-cause mortality was reported from enrollment up to 52 months.
Patients in the Enrolled But Not Randomized group were enrolled in the study but discontinued before being allocated into a treatment group. They never received treatment with exicorilant. Thus, they were not at risk for a treatment-emergent adverse event.
|
0.00%
0/7 • Treatment-emergent adverse events were reported from randomization up to 27 months for Segment 1 and up to 19 months for Segment 2. All-cause mortality was reported from enrollment up to 52 months.
Patients in the Enrolled But Not Randomized group were enrolled in the study but discontinued before being allocated into a treatment group. They never received treatment with exicorilant. Thus, they were not at risk for a treatment-emergent adverse event.
|
—
0/0 • Treatment-emergent adverse events were reported from randomization up to 27 months for Segment 1 and up to 19 months for Segment 2. All-cause mortality was reported from enrollment up to 52 months.
Patients in the Enrolled But Not Randomized group were enrolled in the study but discontinued before being allocated into a treatment group. They never received treatment with exicorilant. Thus, they were not at risk for a treatment-emergent adverse event.
|
0.00%
0/2 • Treatment-emergent adverse events were reported from randomization up to 27 months for Segment 1 and up to 19 months for Segment 2. All-cause mortality was reported from enrollment up to 52 months.
Patients in the Enrolled But Not Randomized group were enrolled in the study but discontinued before being allocated into a treatment group. They never received treatment with exicorilant. Thus, they were not at risk for a treatment-emergent adverse event.
|
0.00%
0/8 • Treatment-emergent adverse events were reported from randomization up to 27 months for Segment 1 and up to 19 months for Segment 2. All-cause mortality was reported from enrollment up to 52 months.
Patients in the Enrolled But Not Randomized group were enrolled in the study but discontinued before being allocated into a treatment group. They never received treatment with exicorilant. Thus, they were not at risk for a treatment-emergent adverse event.
|
0.00%
0/1 • Treatment-emergent adverse events were reported from randomization up to 27 months for Segment 1 and up to 19 months for Segment 2. All-cause mortality was reported from enrollment up to 52 months.
Patients in the Enrolled But Not Randomized group were enrolled in the study but discontinued before being allocated into a treatment group. They never received treatment with exicorilant. Thus, they were not at risk for a treatment-emergent adverse event.
|
10.0%
1/10 • Treatment-emergent adverse events were reported from randomization up to 27 months for Segment 1 and up to 19 months for Segment 2. All-cause mortality was reported from enrollment up to 52 months.
Patients in the Enrolled But Not Randomized group were enrolled in the study but discontinued before being allocated into a treatment group. They never received treatment with exicorilant. Thus, they were not at risk for a treatment-emergent adverse event.
|
0.00%
0/6 • Treatment-emergent adverse events were reported from randomization up to 27 months for Segment 1 and up to 19 months for Segment 2. All-cause mortality was reported from enrollment up to 52 months.
Patients in the Enrolled But Not Randomized group were enrolled in the study but discontinued before being allocated into a treatment group. They never received treatment with exicorilant. Thus, they were not at risk for a treatment-emergent adverse event.
|
|
Metabolism and nutrition disorders
Hypoalbuminaemia
|
0.00%
0/3 • Treatment-emergent adverse events were reported from randomization up to 27 months for Segment 1 and up to 19 months for Segment 2. All-cause mortality was reported from enrollment up to 52 months.
Patients in the Enrolled But Not Randomized group were enrolled in the study but discontinued before being allocated into a treatment group. They never received treatment with exicorilant. Thus, they were not at risk for a treatment-emergent adverse event.
|
0.00%
0/7 • Treatment-emergent adverse events were reported from randomization up to 27 months for Segment 1 and up to 19 months for Segment 2. All-cause mortality was reported from enrollment up to 52 months.
Patients in the Enrolled But Not Randomized group were enrolled in the study but discontinued before being allocated into a treatment group. They never received treatment with exicorilant. Thus, they were not at risk for a treatment-emergent adverse event.
|
—
0/0 • Treatment-emergent adverse events were reported from randomization up to 27 months for Segment 1 and up to 19 months for Segment 2. All-cause mortality was reported from enrollment up to 52 months.
Patients in the Enrolled But Not Randomized group were enrolled in the study but discontinued before being allocated into a treatment group. They never received treatment with exicorilant. Thus, they were not at risk for a treatment-emergent adverse event.
|
0.00%
0/2 • Treatment-emergent adverse events were reported from randomization up to 27 months for Segment 1 and up to 19 months for Segment 2. All-cause mortality was reported from enrollment up to 52 months.
Patients in the Enrolled But Not Randomized group were enrolled in the study but discontinued before being allocated into a treatment group. They never received treatment with exicorilant. Thus, they were not at risk for a treatment-emergent adverse event.
|
0.00%
0/8 • Treatment-emergent adverse events were reported from randomization up to 27 months for Segment 1 and up to 19 months for Segment 2. All-cause mortality was reported from enrollment up to 52 months.
Patients in the Enrolled But Not Randomized group were enrolled in the study but discontinued before being allocated into a treatment group. They never received treatment with exicorilant. Thus, they were not at risk for a treatment-emergent adverse event.
|
0.00%
0/1 • Treatment-emergent adverse events were reported from randomization up to 27 months for Segment 1 and up to 19 months for Segment 2. All-cause mortality was reported from enrollment up to 52 months.
Patients in the Enrolled But Not Randomized group were enrolled in the study but discontinued before being allocated into a treatment group. They never received treatment with exicorilant. Thus, they were not at risk for a treatment-emergent adverse event.
|
10.0%
1/10 • Treatment-emergent adverse events were reported from randomization up to 27 months for Segment 1 and up to 19 months for Segment 2. All-cause mortality was reported from enrollment up to 52 months.
Patients in the Enrolled But Not Randomized group were enrolled in the study but discontinued before being allocated into a treatment group. They never received treatment with exicorilant. Thus, they were not at risk for a treatment-emergent adverse event.
|
16.7%
1/6 • Treatment-emergent adverse events were reported from randomization up to 27 months for Segment 1 and up to 19 months for Segment 2. All-cause mortality was reported from enrollment up to 52 months.
Patients in the Enrolled But Not Randomized group were enrolled in the study but discontinued before being allocated into a treatment group. They never received treatment with exicorilant. Thus, they were not at risk for a treatment-emergent adverse event.
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
0.00%
0/3 • Treatment-emergent adverse events were reported from randomization up to 27 months for Segment 1 and up to 19 months for Segment 2. All-cause mortality was reported from enrollment up to 52 months.
Patients in the Enrolled But Not Randomized group were enrolled in the study but discontinued before being allocated into a treatment group. They never received treatment with exicorilant. Thus, they were not at risk for a treatment-emergent adverse event.
|
14.3%
1/7 • Treatment-emergent adverse events were reported from randomization up to 27 months for Segment 1 and up to 19 months for Segment 2. All-cause mortality was reported from enrollment up to 52 months.
Patients in the Enrolled But Not Randomized group were enrolled in the study but discontinued before being allocated into a treatment group. They never received treatment with exicorilant. Thus, they were not at risk for a treatment-emergent adverse event.
|
—
0/0 • Treatment-emergent adverse events were reported from randomization up to 27 months for Segment 1 and up to 19 months for Segment 2. All-cause mortality was reported from enrollment up to 52 months.
Patients in the Enrolled But Not Randomized group were enrolled in the study but discontinued before being allocated into a treatment group. They never received treatment with exicorilant. Thus, they were not at risk for a treatment-emergent adverse event.
|
0.00%
0/2 • Treatment-emergent adverse events were reported from randomization up to 27 months for Segment 1 and up to 19 months for Segment 2. All-cause mortality was reported from enrollment up to 52 months.
Patients in the Enrolled But Not Randomized group were enrolled in the study but discontinued before being allocated into a treatment group. They never received treatment with exicorilant. Thus, they were not at risk for a treatment-emergent adverse event.
|
0.00%
0/8 • Treatment-emergent adverse events were reported from randomization up to 27 months for Segment 1 and up to 19 months for Segment 2. All-cause mortality was reported from enrollment up to 52 months.
Patients in the Enrolled But Not Randomized group were enrolled in the study but discontinued before being allocated into a treatment group. They never received treatment with exicorilant. Thus, they were not at risk for a treatment-emergent adverse event.
|
0.00%
0/1 • Treatment-emergent adverse events were reported from randomization up to 27 months for Segment 1 and up to 19 months for Segment 2. All-cause mortality was reported from enrollment up to 52 months.
Patients in the Enrolled But Not Randomized group were enrolled in the study but discontinued before being allocated into a treatment group. They never received treatment with exicorilant. Thus, they were not at risk for a treatment-emergent adverse event.
|
0.00%
0/10 • Treatment-emergent adverse events were reported from randomization up to 27 months for Segment 1 and up to 19 months for Segment 2. All-cause mortality was reported from enrollment up to 52 months.
Patients in the Enrolled But Not Randomized group were enrolled in the study but discontinued before being allocated into a treatment group. They never received treatment with exicorilant. Thus, they were not at risk for a treatment-emergent adverse event.
|
0.00%
0/6 • Treatment-emergent adverse events were reported from randomization up to 27 months for Segment 1 and up to 19 months for Segment 2. All-cause mortality was reported from enrollment up to 52 months.
Patients in the Enrolled But Not Randomized group were enrolled in the study but discontinued before being allocated into a treatment group. They never received treatment with exicorilant. Thus, they were not at risk for a treatment-emergent adverse event.
|
|
Metabolism and nutrition disorders
Hypophosphataemia
|
0.00%
0/3 • Treatment-emergent adverse events were reported from randomization up to 27 months for Segment 1 and up to 19 months for Segment 2. All-cause mortality was reported from enrollment up to 52 months.
Patients in the Enrolled But Not Randomized group were enrolled in the study but discontinued before being allocated into a treatment group. They never received treatment with exicorilant. Thus, they were not at risk for a treatment-emergent adverse event.
|
0.00%
0/7 • Treatment-emergent adverse events were reported from randomization up to 27 months for Segment 1 and up to 19 months for Segment 2. All-cause mortality was reported from enrollment up to 52 months.
Patients in the Enrolled But Not Randomized group were enrolled in the study but discontinued before being allocated into a treatment group. They never received treatment with exicorilant. Thus, they were not at risk for a treatment-emergent adverse event.
|
—
0/0 • Treatment-emergent adverse events were reported from randomization up to 27 months for Segment 1 and up to 19 months for Segment 2. All-cause mortality was reported from enrollment up to 52 months.
Patients in the Enrolled But Not Randomized group were enrolled in the study but discontinued before being allocated into a treatment group. They never received treatment with exicorilant. Thus, they were not at risk for a treatment-emergent adverse event.
|
0.00%
0/2 • Treatment-emergent adverse events were reported from randomization up to 27 months for Segment 1 and up to 19 months for Segment 2. All-cause mortality was reported from enrollment up to 52 months.
Patients in the Enrolled But Not Randomized group were enrolled in the study but discontinued before being allocated into a treatment group. They never received treatment with exicorilant. Thus, they were not at risk for a treatment-emergent adverse event.
|
12.5%
1/8 • Treatment-emergent adverse events were reported from randomization up to 27 months for Segment 1 and up to 19 months for Segment 2. All-cause mortality was reported from enrollment up to 52 months.
Patients in the Enrolled But Not Randomized group were enrolled in the study but discontinued before being allocated into a treatment group. They never received treatment with exicorilant. Thus, they were not at risk for a treatment-emergent adverse event.
|
0.00%
0/1 • Treatment-emergent adverse events were reported from randomization up to 27 months for Segment 1 and up to 19 months for Segment 2. All-cause mortality was reported from enrollment up to 52 months.
Patients in the Enrolled But Not Randomized group were enrolled in the study but discontinued before being allocated into a treatment group. They never received treatment with exicorilant. Thus, they were not at risk for a treatment-emergent adverse event.
|
0.00%
0/10 • Treatment-emergent adverse events were reported from randomization up to 27 months for Segment 1 and up to 19 months for Segment 2. All-cause mortality was reported from enrollment up to 52 months.
Patients in the Enrolled But Not Randomized group were enrolled in the study but discontinued before being allocated into a treatment group. They never received treatment with exicorilant. Thus, they were not at risk for a treatment-emergent adverse event.
|
0.00%
0/6 • Treatment-emergent adverse events were reported from randomization up to 27 months for Segment 1 and up to 19 months for Segment 2. All-cause mortality was reported from enrollment up to 52 months.
Patients in the Enrolled But Not Randomized group were enrolled in the study but discontinued before being allocated into a treatment group. They never received treatment with exicorilant. Thus, they were not at risk for a treatment-emergent adverse event.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
33.3%
1/3 • Treatment-emergent adverse events were reported from randomization up to 27 months for Segment 1 and up to 19 months for Segment 2. All-cause mortality was reported from enrollment up to 52 months.
Patients in the Enrolled But Not Randomized group were enrolled in the study but discontinued before being allocated into a treatment group. They never received treatment with exicorilant. Thus, they were not at risk for a treatment-emergent adverse event.
|
14.3%
1/7 • Treatment-emergent adverse events were reported from randomization up to 27 months for Segment 1 and up to 19 months for Segment 2. All-cause mortality was reported from enrollment up to 52 months.
Patients in the Enrolled But Not Randomized group were enrolled in the study but discontinued before being allocated into a treatment group. They never received treatment with exicorilant. Thus, they were not at risk for a treatment-emergent adverse event.
|
—
0/0 • Treatment-emergent adverse events were reported from randomization up to 27 months for Segment 1 and up to 19 months for Segment 2. All-cause mortality was reported from enrollment up to 52 months.
Patients in the Enrolled But Not Randomized group were enrolled in the study but discontinued before being allocated into a treatment group. They never received treatment with exicorilant. Thus, they were not at risk for a treatment-emergent adverse event.
|
0.00%
0/2 • Treatment-emergent adverse events were reported from randomization up to 27 months for Segment 1 and up to 19 months for Segment 2. All-cause mortality was reported from enrollment up to 52 months.
Patients in the Enrolled But Not Randomized group were enrolled in the study but discontinued before being allocated into a treatment group. They never received treatment with exicorilant. Thus, they were not at risk for a treatment-emergent adverse event.
|
25.0%
2/8 • Treatment-emergent adverse events were reported from randomization up to 27 months for Segment 1 and up to 19 months for Segment 2. All-cause mortality was reported from enrollment up to 52 months.
Patients in the Enrolled But Not Randomized group were enrolled in the study but discontinued before being allocated into a treatment group. They never received treatment with exicorilant. Thus, they were not at risk for a treatment-emergent adverse event.
|
0.00%
0/1 • Treatment-emergent adverse events were reported from randomization up to 27 months for Segment 1 and up to 19 months for Segment 2. All-cause mortality was reported from enrollment up to 52 months.
Patients in the Enrolled But Not Randomized group were enrolled in the study but discontinued before being allocated into a treatment group. They never received treatment with exicorilant. Thus, they were not at risk for a treatment-emergent adverse event.
|
10.0%
1/10 • Treatment-emergent adverse events were reported from randomization up to 27 months for Segment 1 and up to 19 months for Segment 2. All-cause mortality was reported from enrollment up to 52 months.
Patients in the Enrolled But Not Randomized group were enrolled in the study but discontinued before being allocated into a treatment group. They never received treatment with exicorilant. Thus, they were not at risk for a treatment-emergent adverse event.
|
50.0%
3/6 • Treatment-emergent adverse events were reported from randomization up to 27 months for Segment 1 and up to 19 months for Segment 2. All-cause mortality was reported from enrollment up to 52 months.
Patients in the Enrolled But Not Randomized group were enrolled in the study but discontinued before being allocated into a treatment group. They never received treatment with exicorilant. Thus, they were not at risk for a treatment-emergent adverse event.
|
|
Musculoskeletal and connective tissue disorders
Arthritis
|
0.00%
0/3 • Treatment-emergent adverse events were reported from randomization up to 27 months for Segment 1 and up to 19 months for Segment 2. All-cause mortality was reported from enrollment up to 52 months.
Patients in the Enrolled But Not Randomized group were enrolled in the study but discontinued before being allocated into a treatment group. They never received treatment with exicorilant. Thus, they were not at risk for a treatment-emergent adverse event.
|
0.00%
0/7 • Treatment-emergent adverse events were reported from randomization up to 27 months for Segment 1 and up to 19 months for Segment 2. All-cause mortality was reported from enrollment up to 52 months.
Patients in the Enrolled But Not Randomized group were enrolled in the study but discontinued before being allocated into a treatment group. They never received treatment with exicorilant. Thus, they were not at risk for a treatment-emergent adverse event.
|
—
0/0 • Treatment-emergent adverse events were reported from randomization up to 27 months for Segment 1 and up to 19 months for Segment 2. All-cause mortality was reported from enrollment up to 52 months.
Patients in the Enrolled But Not Randomized group were enrolled in the study but discontinued before being allocated into a treatment group. They never received treatment with exicorilant. Thus, they were not at risk for a treatment-emergent adverse event.
|
0.00%
0/2 • Treatment-emergent adverse events were reported from randomization up to 27 months for Segment 1 and up to 19 months for Segment 2. All-cause mortality was reported from enrollment up to 52 months.
Patients in the Enrolled But Not Randomized group were enrolled in the study but discontinued before being allocated into a treatment group. They never received treatment with exicorilant. Thus, they were not at risk for a treatment-emergent adverse event.
|
0.00%
0/8 • Treatment-emergent adverse events were reported from randomization up to 27 months for Segment 1 and up to 19 months for Segment 2. All-cause mortality was reported from enrollment up to 52 months.
Patients in the Enrolled But Not Randomized group were enrolled in the study but discontinued before being allocated into a treatment group. They never received treatment with exicorilant. Thus, they were not at risk for a treatment-emergent adverse event.
|
0.00%
0/1 • Treatment-emergent adverse events were reported from randomization up to 27 months for Segment 1 and up to 19 months for Segment 2. All-cause mortality was reported from enrollment up to 52 months.
Patients in the Enrolled But Not Randomized group were enrolled in the study but discontinued before being allocated into a treatment group. They never received treatment with exicorilant. Thus, they were not at risk for a treatment-emergent adverse event.
|
10.0%
1/10 • Treatment-emergent adverse events were reported from randomization up to 27 months for Segment 1 and up to 19 months for Segment 2. All-cause mortality was reported from enrollment up to 52 months.
Patients in the Enrolled But Not Randomized group were enrolled in the study but discontinued before being allocated into a treatment group. They never received treatment with exicorilant. Thus, they were not at risk for a treatment-emergent adverse event.
|
0.00%
0/6 • Treatment-emergent adverse events were reported from randomization up to 27 months for Segment 1 and up to 19 months for Segment 2. All-cause mortality was reported from enrollment up to 52 months.
Patients in the Enrolled But Not Randomized group were enrolled in the study but discontinued before being allocated into a treatment group. They never received treatment with exicorilant. Thus, they were not at risk for a treatment-emergent adverse event.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
33.3%
1/3 • Treatment-emergent adverse events were reported from randomization up to 27 months for Segment 1 and up to 19 months for Segment 2. All-cause mortality was reported from enrollment up to 52 months.
Patients in the Enrolled But Not Randomized group were enrolled in the study but discontinued before being allocated into a treatment group. They never received treatment with exicorilant. Thus, they were not at risk for a treatment-emergent adverse event.
|
57.1%
4/7 • Treatment-emergent adverse events were reported from randomization up to 27 months for Segment 1 and up to 19 months for Segment 2. All-cause mortality was reported from enrollment up to 52 months.
Patients in the Enrolled But Not Randomized group were enrolled in the study but discontinued before being allocated into a treatment group. They never received treatment with exicorilant. Thus, they were not at risk for a treatment-emergent adverse event.
|
—
0/0 • Treatment-emergent adverse events were reported from randomization up to 27 months for Segment 1 and up to 19 months for Segment 2. All-cause mortality was reported from enrollment up to 52 months.
Patients in the Enrolled But Not Randomized group were enrolled in the study but discontinued before being allocated into a treatment group. They never received treatment with exicorilant. Thus, they were not at risk for a treatment-emergent adverse event.
|
100.0%
2/2 • Treatment-emergent adverse events were reported from randomization up to 27 months for Segment 1 and up to 19 months for Segment 2. All-cause mortality was reported from enrollment up to 52 months.
Patients in the Enrolled But Not Randomized group were enrolled in the study but discontinued before being allocated into a treatment group. They never received treatment with exicorilant. Thus, they were not at risk for a treatment-emergent adverse event.
|
50.0%
4/8 • Treatment-emergent adverse events were reported from randomization up to 27 months for Segment 1 and up to 19 months for Segment 2. All-cause mortality was reported from enrollment up to 52 months.
Patients in the Enrolled But Not Randomized group were enrolled in the study but discontinued before being allocated into a treatment group. They never received treatment with exicorilant. Thus, they were not at risk for a treatment-emergent adverse event.
|
100.0%
1/1 • Treatment-emergent adverse events were reported from randomization up to 27 months for Segment 1 and up to 19 months for Segment 2. All-cause mortality was reported from enrollment up to 52 months.
Patients in the Enrolled But Not Randomized group were enrolled in the study but discontinued before being allocated into a treatment group. They never received treatment with exicorilant. Thus, they were not at risk for a treatment-emergent adverse event.
|
50.0%
5/10 • Treatment-emergent adverse events were reported from randomization up to 27 months for Segment 1 and up to 19 months for Segment 2. All-cause mortality was reported from enrollment up to 52 months.
Patients in the Enrolled But Not Randomized group were enrolled in the study but discontinued before being allocated into a treatment group. They never received treatment with exicorilant. Thus, they were not at risk for a treatment-emergent adverse event.
|
83.3%
5/6 • Treatment-emergent adverse events were reported from randomization up to 27 months for Segment 1 and up to 19 months for Segment 2. All-cause mortality was reported from enrollment up to 52 months.
Patients in the Enrolled But Not Randomized group were enrolled in the study but discontinued before being allocated into a treatment group. They never received treatment with exicorilant. Thus, they were not at risk for a treatment-emergent adverse event.
|
|
Musculoskeletal and connective tissue disorders
Flank pain
|
0.00%
0/3 • Treatment-emergent adverse events were reported from randomization up to 27 months for Segment 1 and up to 19 months for Segment 2. All-cause mortality was reported from enrollment up to 52 months.
Patients in the Enrolled But Not Randomized group were enrolled in the study but discontinued before being allocated into a treatment group. They never received treatment with exicorilant. Thus, they were not at risk for a treatment-emergent adverse event.
|
0.00%
0/7 • Treatment-emergent adverse events were reported from randomization up to 27 months for Segment 1 and up to 19 months for Segment 2. All-cause mortality was reported from enrollment up to 52 months.
Patients in the Enrolled But Not Randomized group were enrolled in the study but discontinued before being allocated into a treatment group. They never received treatment with exicorilant. Thus, they were not at risk for a treatment-emergent adverse event.
|
—
0/0 • Treatment-emergent adverse events were reported from randomization up to 27 months for Segment 1 and up to 19 months for Segment 2. All-cause mortality was reported from enrollment up to 52 months.
Patients in the Enrolled But Not Randomized group were enrolled in the study but discontinued before being allocated into a treatment group. They never received treatment with exicorilant. Thus, they were not at risk for a treatment-emergent adverse event.
|
0.00%
0/2 • Treatment-emergent adverse events were reported from randomization up to 27 months for Segment 1 and up to 19 months for Segment 2. All-cause mortality was reported from enrollment up to 52 months.
Patients in the Enrolled But Not Randomized group were enrolled in the study but discontinued before being allocated into a treatment group. They never received treatment with exicorilant. Thus, they were not at risk for a treatment-emergent adverse event.
|
12.5%
1/8 • Treatment-emergent adverse events were reported from randomization up to 27 months for Segment 1 and up to 19 months for Segment 2. All-cause mortality was reported from enrollment up to 52 months.
Patients in the Enrolled But Not Randomized group were enrolled in the study but discontinued before being allocated into a treatment group. They never received treatment with exicorilant. Thus, they were not at risk for a treatment-emergent adverse event.
|
0.00%
0/1 • Treatment-emergent adverse events were reported from randomization up to 27 months for Segment 1 and up to 19 months for Segment 2. All-cause mortality was reported from enrollment up to 52 months.
Patients in the Enrolled But Not Randomized group were enrolled in the study but discontinued before being allocated into a treatment group. They never received treatment with exicorilant. Thus, they were not at risk for a treatment-emergent adverse event.
|
0.00%
0/10 • Treatment-emergent adverse events were reported from randomization up to 27 months for Segment 1 and up to 19 months for Segment 2. All-cause mortality was reported from enrollment up to 52 months.
Patients in the Enrolled But Not Randomized group were enrolled in the study but discontinued before being allocated into a treatment group. They never received treatment with exicorilant. Thus, they were not at risk for a treatment-emergent adverse event.
|
16.7%
1/6 • Treatment-emergent adverse events were reported from randomization up to 27 months for Segment 1 and up to 19 months for Segment 2. All-cause mortality was reported from enrollment up to 52 months.
Patients in the Enrolled But Not Randomized group were enrolled in the study but discontinued before being allocated into a treatment group. They never received treatment with exicorilant. Thus, they were not at risk for a treatment-emergent adverse event.
|
|
Musculoskeletal and connective tissue disorders
Groin pain
|
0.00%
0/3 • Treatment-emergent adverse events were reported from randomization up to 27 months for Segment 1 and up to 19 months for Segment 2. All-cause mortality was reported from enrollment up to 52 months.
Patients in the Enrolled But Not Randomized group were enrolled in the study but discontinued before being allocated into a treatment group. They never received treatment with exicorilant. Thus, they were not at risk for a treatment-emergent adverse event.
|
0.00%
0/7 • Treatment-emergent adverse events were reported from randomization up to 27 months for Segment 1 and up to 19 months for Segment 2. All-cause mortality was reported from enrollment up to 52 months.
Patients in the Enrolled But Not Randomized group were enrolled in the study but discontinued before being allocated into a treatment group. They never received treatment with exicorilant. Thus, they were not at risk for a treatment-emergent adverse event.
|
—
0/0 • Treatment-emergent adverse events were reported from randomization up to 27 months for Segment 1 and up to 19 months for Segment 2. All-cause mortality was reported from enrollment up to 52 months.
Patients in the Enrolled But Not Randomized group were enrolled in the study but discontinued before being allocated into a treatment group. They never received treatment with exicorilant. Thus, they were not at risk for a treatment-emergent adverse event.
|
0.00%
0/2 • Treatment-emergent adverse events were reported from randomization up to 27 months for Segment 1 and up to 19 months for Segment 2. All-cause mortality was reported from enrollment up to 52 months.
Patients in the Enrolled But Not Randomized group were enrolled in the study but discontinued before being allocated into a treatment group. They never received treatment with exicorilant. Thus, they were not at risk for a treatment-emergent adverse event.
|
12.5%
1/8 • Treatment-emergent adverse events were reported from randomization up to 27 months for Segment 1 and up to 19 months for Segment 2. All-cause mortality was reported from enrollment up to 52 months.
Patients in the Enrolled But Not Randomized group were enrolled in the study but discontinued before being allocated into a treatment group. They never received treatment with exicorilant. Thus, they were not at risk for a treatment-emergent adverse event.
|
0.00%
0/1 • Treatment-emergent adverse events were reported from randomization up to 27 months for Segment 1 and up to 19 months for Segment 2. All-cause mortality was reported from enrollment up to 52 months.
Patients in the Enrolled But Not Randomized group were enrolled in the study but discontinued before being allocated into a treatment group. They never received treatment with exicorilant. Thus, they were not at risk for a treatment-emergent adverse event.
|
0.00%
0/10 • Treatment-emergent adverse events were reported from randomization up to 27 months for Segment 1 and up to 19 months for Segment 2. All-cause mortality was reported from enrollment up to 52 months.
Patients in the Enrolled But Not Randomized group were enrolled in the study but discontinued before being allocated into a treatment group. They never received treatment with exicorilant. Thus, they were not at risk for a treatment-emergent adverse event.
|
0.00%
0/6 • Treatment-emergent adverse events were reported from randomization up to 27 months for Segment 1 and up to 19 months for Segment 2. All-cause mortality was reported from enrollment up to 52 months.
Patients in the Enrolled But Not Randomized group were enrolled in the study but discontinued before being allocated into a treatment group. They never received treatment with exicorilant. Thus, they were not at risk for a treatment-emergent adverse event.
|
|
Musculoskeletal and connective tissue disorders
Muscular weakness
|
0.00%
0/3 • Treatment-emergent adverse events were reported from randomization up to 27 months for Segment 1 and up to 19 months for Segment 2. All-cause mortality was reported from enrollment up to 52 months.
Patients in the Enrolled But Not Randomized group were enrolled in the study but discontinued before being allocated into a treatment group. They never received treatment with exicorilant. Thus, they were not at risk for a treatment-emergent adverse event.
|
0.00%
0/7 • Treatment-emergent adverse events were reported from randomization up to 27 months for Segment 1 and up to 19 months for Segment 2. All-cause mortality was reported from enrollment up to 52 months.
Patients in the Enrolled But Not Randomized group were enrolled in the study but discontinued before being allocated into a treatment group. They never received treatment with exicorilant. Thus, they were not at risk for a treatment-emergent adverse event.
|
—
0/0 • Treatment-emergent adverse events were reported from randomization up to 27 months for Segment 1 and up to 19 months for Segment 2. All-cause mortality was reported from enrollment up to 52 months.
Patients in the Enrolled But Not Randomized group were enrolled in the study but discontinued before being allocated into a treatment group. They never received treatment with exicorilant. Thus, they were not at risk for a treatment-emergent adverse event.
|
0.00%
0/2 • Treatment-emergent adverse events were reported from randomization up to 27 months for Segment 1 and up to 19 months for Segment 2. All-cause mortality was reported from enrollment up to 52 months.
Patients in the Enrolled But Not Randomized group were enrolled in the study but discontinued before being allocated into a treatment group. They never received treatment with exicorilant. Thus, they were not at risk for a treatment-emergent adverse event.
|
12.5%
1/8 • Treatment-emergent adverse events were reported from randomization up to 27 months for Segment 1 and up to 19 months for Segment 2. All-cause mortality was reported from enrollment up to 52 months.
Patients in the Enrolled But Not Randomized group were enrolled in the study but discontinued before being allocated into a treatment group. They never received treatment with exicorilant. Thus, they were not at risk for a treatment-emergent adverse event.
|
0.00%
0/1 • Treatment-emergent adverse events were reported from randomization up to 27 months for Segment 1 and up to 19 months for Segment 2. All-cause mortality was reported from enrollment up to 52 months.
Patients in the Enrolled But Not Randomized group were enrolled in the study but discontinued before being allocated into a treatment group. They never received treatment with exicorilant. Thus, they were not at risk for a treatment-emergent adverse event.
|
10.0%
1/10 • Treatment-emergent adverse events were reported from randomization up to 27 months for Segment 1 and up to 19 months for Segment 2. All-cause mortality was reported from enrollment up to 52 months.
Patients in the Enrolled But Not Randomized group were enrolled in the study but discontinued before being allocated into a treatment group. They never received treatment with exicorilant. Thus, they were not at risk for a treatment-emergent adverse event.
|
16.7%
1/6 • Treatment-emergent adverse events were reported from randomization up to 27 months for Segment 1 and up to 19 months for Segment 2. All-cause mortality was reported from enrollment up to 52 months.
Patients in the Enrolled But Not Randomized group were enrolled in the study but discontinued before being allocated into a treatment group. They never received treatment with exicorilant. Thus, they were not at risk for a treatment-emergent adverse event.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal chest pain
|
0.00%
0/3 • Treatment-emergent adverse events were reported from randomization up to 27 months for Segment 1 and up to 19 months for Segment 2. All-cause mortality was reported from enrollment up to 52 months.
Patients in the Enrolled But Not Randomized group were enrolled in the study but discontinued before being allocated into a treatment group. They never received treatment with exicorilant. Thus, they were not at risk for a treatment-emergent adverse event.
|
14.3%
1/7 • Treatment-emergent adverse events were reported from randomization up to 27 months for Segment 1 and up to 19 months for Segment 2. All-cause mortality was reported from enrollment up to 52 months.
Patients in the Enrolled But Not Randomized group were enrolled in the study but discontinued before being allocated into a treatment group. They never received treatment with exicorilant. Thus, they were not at risk for a treatment-emergent adverse event.
|
—
0/0 • Treatment-emergent adverse events were reported from randomization up to 27 months for Segment 1 and up to 19 months for Segment 2. All-cause mortality was reported from enrollment up to 52 months.
Patients in the Enrolled But Not Randomized group were enrolled in the study but discontinued before being allocated into a treatment group. They never received treatment with exicorilant. Thus, they were not at risk for a treatment-emergent adverse event.
|
50.0%
1/2 • Treatment-emergent adverse events were reported from randomization up to 27 months for Segment 1 and up to 19 months for Segment 2. All-cause mortality was reported from enrollment up to 52 months.
Patients in the Enrolled But Not Randomized group were enrolled in the study but discontinued before being allocated into a treatment group. They never received treatment with exicorilant. Thus, they were not at risk for a treatment-emergent adverse event.
|
0.00%
0/8 • Treatment-emergent adverse events were reported from randomization up to 27 months for Segment 1 and up to 19 months for Segment 2. All-cause mortality was reported from enrollment up to 52 months.
Patients in the Enrolled But Not Randomized group were enrolled in the study but discontinued before being allocated into a treatment group. They never received treatment with exicorilant. Thus, they were not at risk for a treatment-emergent adverse event.
|
0.00%
0/1 • Treatment-emergent adverse events were reported from randomization up to 27 months for Segment 1 and up to 19 months for Segment 2. All-cause mortality was reported from enrollment up to 52 months.
Patients in the Enrolled But Not Randomized group were enrolled in the study but discontinued before being allocated into a treatment group. They never received treatment with exicorilant. Thus, they were not at risk for a treatment-emergent adverse event.
|
20.0%
2/10 • Treatment-emergent adverse events were reported from randomization up to 27 months for Segment 1 and up to 19 months for Segment 2. All-cause mortality was reported from enrollment up to 52 months.
Patients in the Enrolled But Not Randomized group were enrolled in the study but discontinued before being allocated into a treatment group. They never received treatment with exicorilant. Thus, they were not at risk for a treatment-emergent adverse event.
|
16.7%
1/6 • Treatment-emergent adverse events were reported from randomization up to 27 months for Segment 1 and up to 19 months for Segment 2. All-cause mortality was reported from enrollment up to 52 months.
Patients in the Enrolled But Not Randomized group were enrolled in the study but discontinued before being allocated into a treatment group. They never received treatment with exicorilant. Thus, they were not at risk for a treatment-emergent adverse event.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal pain
|
0.00%
0/3 • Treatment-emergent adverse events were reported from randomization up to 27 months for Segment 1 and up to 19 months for Segment 2. All-cause mortality was reported from enrollment up to 52 months.
Patients in the Enrolled But Not Randomized group were enrolled in the study but discontinued before being allocated into a treatment group. They never received treatment with exicorilant. Thus, they were not at risk for a treatment-emergent adverse event.
|
0.00%
0/7 • Treatment-emergent adverse events were reported from randomization up to 27 months for Segment 1 and up to 19 months for Segment 2. All-cause mortality was reported from enrollment up to 52 months.
Patients in the Enrolled But Not Randomized group were enrolled in the study but discontinued before being allocated into a treatment group. They never received treatment with exicorilant. Thus, they were not at risk for a treatment-emergent adverse event.
|
—
0/0 • Treatment-emergent adverse events were reported from randomization up to 27 months for Segment 1 and up to 19 months for Segment 2. All-cause mortality was reported from enrollment up to 52 months.
Patients in the Enrolled But Not Randomized group were enrolled in the study but discontinued before being allocated into a treatment group. They never received treatment with exicorilant. Thus, they were not at risk for a treatment-emergent adverse event.
|
100.0%
2/2 • Treatment-emergent adverse events were reported from randomization up to 27 months for Segment 1 and up to 19 months for Segment 2. All-cause mortality was reported from enrollment up to 52 months.
Patients in the Enrolled But Not Randomized group were enrolled in the study but discontinued before being allocated into a treatment group. They never received treatment with exicorilant. Thus, they were not at risk for a treatment-emergent adverse event.
|
37.5%
3/8 • Treatment-emergent adverse events were reported from randomization up to 27 months for Segment 1 and up to 19 months for Segment 2. All-cause mortality was reported from enrollment up to 52 months.
Patients in the Enrolled But Not Randomized group were enrolled in the study but discontinued before being allocated into a treatment group. They never received treatment with exicorilant. Thus, they were not at risk for a treatment-emergent adverse event.
|
0.00%
0/1 • Treatment-emergent adverse events were reported from randomization up to 27 months for Segment 1 and up to 19 months for Segment 2. All-cause mortality was reported from enrollment up to 52 months.
Patients in the Enrolled But Not Randomized group were enrolled in the study but discontinued before being allocated into a treatment group. They never received treatment with exicorilant. Thus, they were not at risk for a treatment-emergent adverse event.
|
0.00%
0/10 • Treatment-emergent adverse events were reported from randomization up to 27 months for Segment 1 and up to 19 months for Segment 2. All-cause mortality was reported from enrollment up to 52 months.
Patients in the Enrolled But Not Randomized group were enrolled in the study but discontinued before being allocated into a treatment group. They never received treatment with exicorilant. Thus, they were not at risk for a treatment-emergent adverse event.
|
0.00%
0/6 • Treatment-emergent adverse events were reported from randomization up to 27 months for Segment 1 and up to 19 months for Segment 2. All-cause mortality was reported from enrollment up to 52 months.
Patients in the Enrolled But Not Randomized group were enrolled in the study but discontinued before being allocated into a treatment group. They never received treatment with exicorilant. Thus, they were not at risk for a treatment-emergent adverse event.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
0.00%
0/3 • Treatment-emergent adverse events were reported from randomization up to 27 months for Segment 1 and up to 19 months for Segment 2. All-cause mortality was reported from enrollment up to 52 months.
Patients in the Enrolled But Not Randomized group were enrolled in the study but discontinued before being allocated into a treatment group. They never received treatment with exicorilant. Thus, they were not at risk for a treatment-emergent adverse event.
|
0.00%
0/7 • Treatment-emergent adverse events were reported from randomization up to 27 months for Segment 1 and up to 19 months for Segment 2. All-cause mortality was reported from enrollment up to 52 months.
Patients in the Enrolled But Not Randomized group were enrolled in the study but discontinued before being allocated into a treatment group. They never received treatment with exicorilant. Thus, they were not at risk for a treatment-emergent adverse event.
|
—
0/0 • Treatment-emergent adverse events were reported from randomization up to 27 months for Segment 1 and up to 19 months for Segment 2. All-cause mortality was reported from enrollment up to 52 months.
Patients in the Enrolled But Not Randomized group were enrolled in the study but discontinued before being allocated into a treatment group. They never received treatment with exicorilant. Thus, they were not at risk for a treatment-emergent adverse event.
|
0.00%
0/2 • Treatment-emergent adverse events were reported from randomization up to 27 months for Segment 1 and up to 19 months for Segment 2. All-cause mortality was reported from enrollment up to 52 months.
Patients in the Enrolled But Not Randomized group were enrolled in the study but discontinued before being allocated into a treatment group. They never received treatment with exicorilant. Thus, they were not at risk for a treatment-emergent adverse event.
|
0.00%
0/8 • Treatment-emergent adverse events were reported from randomization up to 27 months for Segment 1 and up to 19 months for Segment 2. All-cause mortality was reported from enrollment up to 52 months.
Patients in the Enrolled But Not Randomized group were enrolled in the study but discontinued before being allocated into a treatment group. They never received treatment with exicorilant. Thus, they were not at risk for a treatment-emergent adverse event.
|
0.00%
0/1 • Treatment-emergent adverse events were reported from randomization up to 27 months for Segment 1 and up to 19 months for Segment 2. All-cause mortality was reported from enrollment up to 52 months.
Patients in the Enrolled But Not Randomized group were enrolled in the study but discontinued before being allocated into a treatment group. They never received treatment with exicorilant. Thus, they were not at risk for a treatment-emergent adverse event.
|
20.0%
2/10 • Treatment-emergent adverse events were reported from randomization up to 27 months for Segment 1 and up to 19 months for Segment 2. All-cause mortality was reported from enrollment up to 52 months.
Patients in the Enrolled But Not Randomized group were enrolled in the study but discontinued before being allocated into a treatment group. They never received treatment with exicorilant. Thus, they were not at risk for a treatment-emergent adverse event.
|
16.7%
1/6 • Treatment-emergent adverse events were reported from randomization up to 27 months for Segment 1 and up to 19 months for Segment 2. All-cause mortality was reported from enrollment up to 52 months.
Patients in the Enrolled But Not Randomized group were enrolled in the study but discontinued before being allocated into a treatment group. They never received treatment with exicorilant. Thus, they were not at risk for a treatment-emergent adverse event.
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
0.00%
0/3 • Treatment-emergent adverse events were reported from randomization up to 27 months for Segment 1 and up to 19 months for Segment 2. All-cause mortality was reported from enrollment up to 52 months.
Patients in the Enrolled But Not Randomized group were enrolled in the study but discontinued before being allocated into a treatment group. They never received treatment with exicorilant. Thus, they were not at risk for a treatment-emergent adverse event.
|
14.3%
1/7 • Treatment-emergent adverse events were reported from randomization up to 27 months for Segment 1 and up to 19 months for Segment 2. All-cause mortality was reported from enrollment up to 52 months.
Patients in the Enrolled But Not Randomized group were enrolled in the study but discontinued before being allocated into a treatment group. They never received treatment with exicorilant. Thus, they were not at risk for a treatment-emergent adverse event.
|
—
0/0 • Treatment-emergent adverse events were reported from randomization up to 27 months for Segment 1 and up to 19 months for Segment 2. All-cause mortality was reported from enrollment up to 52 months.
Patients in the Enrolled But Not Randomized group were enrolled in the study but discontinued before being allocated into a treatment group. They never received treatment with exicorilant. Thus, they were not at risk for a treatment-emergent adverse event.
|
0.00%
0/2 • Treatment-emergent adverse events were reported from randomization up to 27 months for Segment 1 and up to 19 months for Segment 2. All-cause mortality was reported from enrollment up to 52 months.
Patients in the Enrolled But Not Randomized group were enrolled in the study but discontinued before being allocated into a treatment group. They never received treatment with exicorilant. Thus, they were not at risk for a treatment-emergent adverse event.
|
12.5%
1/8 • Treatment-emergent adverse events were reported from randomization up to 27 months for Segment 1 and up to 19 months for Segment 2. All-cause mortality was reported from enrollment up to 52 months.
Patients in the Enrolled But Not Randomized group were enrolled in the study but discontinued before being allocated into a treatment group. They never received treatment with exicorilant. Thus, they were not at risk for a treatment-emergent adverse event.
|
0.00%
0/1 • Treatment-emergent adverse events were reported from randomization up to 27 months for Segment 1 and up to 19 months for Segment 2. All-cause mortality was reported from enrollment up to 52 months.
Patients in the Enrolled But Not Randomized group were enrolled in the study but discontinued before being allocated into a treatment group. They never received treatment with exicorilant. Thus, they were not at risk for a treatment-emergent adverse event.
|
0.00%
0/10 • Treatment-emergent adverse events were reported from randomization up to 27 months for Segment 1 and up to 19 months for Segment 2. All-cause mortality was reported from enrollment up to 52 months.
Patients in the Enrolled But Not Randomized group were enrolled in the study but discontinued before being allocated into a treatment group. They never received treatment with exicorilant. Thus, they were not at risk for a treatment-emergent adverse event.
|
0.00%
0/6 • Treatment-emergent adverse events were reported from randomization up to 27 months for Segment 1 and up to 19 months for Segment 2. All-cause mortality was reported from enrollment up to 52 months.
Patients in the Enrolled But Not Randomized group were enrolled in the study but discontinued before being allocated into a treatment group. They never received treatment with exicorilant. Thus, they were not at risk for a treatment-emergent adverse event.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
33.3%
1/3 • Treatment-emergent adverse events were reported from randomization up to 27 months for Segment 1 and up to 19 months for Segment 2. All-cause mortality was reported from enrollment up to 52 months.
Patients in the Enrolled But Not Randomized group were enrolled in the study but discontinued before being allocated into a treatment group. They never received treatment with exicorilant. Thus, they were not at risk for a treatment-emergent adverse event.
|
0.00%
0/7 • Treatment-emergent adverse events were reported from randomization up to 27 months for Segment 1 and up to 19 months for Segment 2. All-cause mortality was reported from enrollment up to 52 months.
Patients in the Enrolled But Not Randomized group were enrolled in the study but discontinued before being allocated into a treatment group. They never received treatment with exicorilant. Thus, they were not at risk for a treatment-emergent adverse event.
|
—
0/0 • Treatment-emergent adverse events were reported from randomization up to 27 months for Segment 1 and up to 19 months for Segment 2. All-cause mortality was reported from enrollment up to 52 months.
Patients in the Enrolled But Not Randomized group were enrolled in the study but discontinued before being allocated into a treatment group. They never received treatment with exicorilant. Thus, they were not at risk for a treatment-emergent adverse event.
|
100.0%
2/2 • Treatment-emergent adverse events were reported from randomization up to 27 months for Segment 1 and up to 19 months for Segment 2. All-cause mortality was reported from enrollment up to 52 months.
Patients in the Enrolled But Not Randomized group were enrolled in the study but discontinued before being allocated into a treatment group. They never received treatment with exicorilant. Thus, they were not at risk for a treatment-emergent adverse event.
|
50.0%
4/8 • Treatment-emergent adverse events were reported from randomization up to 27 months for Segment 1 and up to 19 months for Segment 2. All-cause mortality was reported from enrollment up to 52 months.
Patients in the Enrolled But Not Randomized group were enrolled in the study but discontinued before being allocated into a treatment group. They never received treatment with exicorilant. Thus, they were not at risk for a treatment-emergent adverse event.
|
0.00%
0/1 • Treatment-emergent adverse events were reported from randomization up to 27 months for Segment 1 and up to 19 months for Segment 2. All-cause mortality was reported from enrollment up to 52 months.
Patients in the Enrolled But Not Randomized group were enrolled in the study but discontinued before being allocated into a treatment group. They never received treatment with exicorilant. Thus, they were not at risk for a treatment-emergent adverse event.
|
10.0%
1/10 • Treatment-emergent adverse events were reported from randomization up to 27 months for Segment 1 and up to 19 months for Segment 2. All-cause mortality was reported from enrollment up to 52 months.
Patients in the Enrolled But Not Randomized group were enrolled in the study but discontinued before being allocated into a treatment group. They never received treatment with exicorilant. Thus, they were not at risk for a treatment-emergent adverse event.
|
16.7%
1/6 • Treatment-emergent adverse events were reported from randomization up to 27 months for Segment 1 and up to 19 months for Segment 2. All-cause mortality was reported from enrollment up to 52 months.
Patients in the Enrolled But Not Randomized group were enrolled in the study but discontinued before being allocated into a treatment group. They never received treatment with exicorilant. Thus, they were not at risk for a treatment-emergent adverse event.
|
|
Musculoskeletal and connective tissue disorders
Pain in jaw
|
33.3%
1/3 • Treatment-emergent adverse events were reported from randomization up to 27 months for Segment 1 and up to 19 months for Segment 2. All-cause mortality was reported from enrollment up to 52 months.
Patients in the Enrolled But Not Randomized group were enrolled in the study but discontinued before being allocated into a treatment group. They never received treatment with exicorilant. Thus, they were not at risk for a treatment-emergent adverse event.
|
0.00%
0/7 • Treatment-emergent adverse events were reported from randomization up to 27 months for Segment 1 and up to 19 months for Segment 2. All-cause mortality was reported from enrollment up to 52 months.
Patients in the Enrolled But Not Randomized group were enrolled in the study but discontinued before being allocated into a treatment group. They never received treatment with exicorilant. Thus, they were not at risk for a treatment-emergent adverse event.
|
—
0/0 • Treatment-emergent adverse events were reported from randomization up to 27 months for Segment 1 and up to 19 months for Segment 2. All-cause mortality was reported from enrollment up to 52 months.
Patients in the Enrolled But Not Randomized group were enrolled in the study but discontinued before being allocated into a treatment group. They never received treatment with exicorilant. Thus, they were not at risk for a treatment-emergent adverse event.
|
0.00%
0/2 • Treatment-emergent adverse events were reported from randomization up to 27 months for Segment 1 and up to 19 months for Segment 2. All-cause mortality was reported from enrollment up to 52 months.
Patients in the Enrolled But Not Randomized group were enrolled in the study but discontinued before being allocated into a treatment group. They never received treatment with exicorilant. Thus, they were not at risk for a treatment-emergent adverse event.
|
0.00%
0/8 • Treatment-emergent adverse events were reported from randomization up to 27 months for Segment 1 and up to 19 months for Segment 2. All-cause mortality was reported from enrollment up to 52 months.
Patients in the Enrolled But Not Randomized group were enrolled in the study but discontinued before being allocated into a treatment group. They never received treatment with exicorilant. Thus, they were not at risk for a treatment-emergent adverse event.
|
0.00%
0/1 • Treatment-emergent adverse events were reported from randomization up to 27 months for Segment 1 and up to 19 months for Segment 2. All-cause mortality was reported from enrollment up to 52 months.
Patients in the Enrolled But Not Randomized group were enrolled in the study but discontinued before being allocated into a treatment group. They never received treatment with exicorilant. Thus, they were not at risk for a treatment-emergent adverse event.
|
0.00%
0/10 • Treatment-emergent adverse events were reported from randomization up to 27 months for Segment 1 and up to 19 months for Segment 2. All-cause mortality was reported from enrollment up to 52 months.
Patients in the Enrolled But Not Randomized group were enrolled in the study but discontinued before being allocated into a treatment group. They never received treatment with exicorilant. Thus, they were not at risk for a treatment-emergent adverse event.
|
0.00%
0/6 • Treatment-emergent adverse events were reported from randomization up to 27 months for Segment 1 and up to 19 months for Segment 2. All-cause mortality was reported from enrollment up to 52 months.
Patients in the Enrolled But Not Randomized group were enrolled in the study but discontinued before being allocated into a treatment group. They never received treatment with exicorilant. Thus, they were not at risk for a treatment-emergent adverse event.
|
|
Musculoskeletal and connective tissue disorders
Synovitis
|
0.00%
0/3 • Treatment-emergent adverse events were reported from randomization up to 27 months for Segment 1 and up to 19 months for Segment 2. All-cause mortality was reported from enrollment up to 52 months.
Patients in the Enrolled But Not Randomized group were enrolled in the study but discontinued before being allocated into a treatment group. They never received treatment with exicorilant. Thus, they were not at risk for a treatment-emergent adverse event.
|
0.00%
0/7 • Treatment-emergent adverse events were reported from randomization up to 27 months for Segment 1 and up to 19 months for Segment 2. All-cause mortality was reported from enrollment up to 52 months.
Patients in the Enrolled But Not Randomized group were enrolled in the study but discontinued before being allocated into a treatment group. They never received treatment with exicorilant. Thus, they were not at risk for a treatment-emergent adverse event.
|
—
0/0 • Treatment-emergent adverse events were reported from randomization up to 27 months for Segment 1 and up to 19 months for Segment 2. All-cause mortality was reported from enrollment up to 52 months.
Patients in the Enrolled But Not Randomized group were enrolled in the study but discontinued before being allocated into a treatment group. They never received treatment with exicorilant. Thus, they were not at risk for a treatment-emergent adverse event.
|
0.00%
0/2 • Treatment-emergent adverse events were reported from randomization up to 27 months for Segment 1 and up to 19 months for Segment 2. All-cause mortality was reported from enrollment up to 52 months.
Patients in the Enrolled But Not Randomized group were enrolled in the study but discontinued before being allocated into a treatment group. They never received treatment with exicorilant. Thus, they were not at risk for a treatment-emergent adverse event.
|
0.00%
0/8 • Treatment-emergent adverse events were reported from randomization up to 27 months for Segment 1 and up to 19 months for Segment 2. All-cause mortality was reported from enrollment up to 52 months.
Patients in the Enrolled But Not Randomized group were enrolled in the study but discontinued before being allocated into a treatment group. They never received treatment with exicorilant. Thus, they were not at risk for a treatment-emergent adverse event.
|
0.00%
0/1 • Treatment-emergent adverse events were reported from randomization up to 27 months for Segment 1 and up to 19 months for Segment 2. All-cause mortality was reported from enrollment up to 52 months.
Patients in the Enrolled But Not Randomized group were enrolled in the study but discontinued before being allocated into a treatment group. They never received treatment with exicorilant. Thus, they were not at risk for a treatment-emergent adverse event.
|
0.00%
0/10 • Treatment-emergent adverse events were reported from randomization up to 27 months for Segment 1 and up to 19 months for Segment 2. All-cause mortality was reported from enrollment up to 52 months.
Patients in the Enrolled But Not Randomized group were enrolled in the study but discontinued before being allocated into a treatment group. They never received treatment with exicorilant. Thus, they were not at risk for a treatment-emergent adverse event.
|
16.7%
1/6 • Treatment-emergent adverse events were reported from randomization up to 27 months for Segment 1 and up to 19 months for Segment 2. All-cause mortality was reported from enrollment up to 52 months.
Patients in the Enrolled But Not Randomized group were enrolled in the study but discontinued before being allocated into a treatment group. They never received treatment with exicorilant. Thus, they were not at risk for a treatment-emergent adverse event.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Cancer pain
|
0.00%
0/3 • Treatment-emergent adverse events were reported from randomization up to 27 months for Segment 1 and up to 19 months for Segment 2. All-cause mortality was reported from enrollment up to 52 months.
Patients in the Enrolled But Not Randomized group were enrolled in the study but discontinued before being allocated into a treatment group. They never received treatment with exicorilant. Thus, they were not at risk for a treatment-emergent adverse event.
|
0.00%
0/7 • Treatment-emergent adverse events were reported from randomization up to 27 months for Segment 1 and up to 19 months for Segment 2. All-cause mortality was reported from enrollment up to 52 months.
Patients in the Enrolled But Not Randomized group were enrolled in the study but discontinued before being allocated into a treatment group. They never received treatment with exicorilant. Thus, they were not at risk for a treatment-emergent adverse event.
|
—
0/0 • Treatment-emergent adverse events were reported from randomization up to 27 months for Segment 1 and up to 19 months for Segment 2. All-cause mortality was reported from enrollment up to 52 months.
Patients in the Enrolled But Not Randomized group were enrolled in the study but discontinued before being allocated into a treatment group. They never received treatment with exicorilant. Thus, they were not at risk for a treatment-emergent adverse event.
|
0.00%
0/2 • Treatment-emergent adverse events were reported from randomization up to 27 months for Segment 1 and up to 19 months for Segment 2. All-cause mortality was reported from enrollment up to 52 months.
Patients in the Enrolled But Not Randomized group were enrolled in the study but discontinued before being allocated into a treatment group. They never received treatment with exicorilant. Thus, they were not at risk for a treatment-emergent adverse event.
|
0.00%
0/8 • Treatment-emergent adverse events were reported from randomization up to 27 months for Segment 1 and up to 19 months for Segment 2. All-cause mortality was reported from enrollment up to 52 months.
Patients in the Enrolled But Not Randomized group were enrolled in the study but discontinued before being allocated into a treatment group. They never received treatment with exicorilant. Thus, they were not at risk for a treatment-emergent adverse event.
|
0.00%
0/1 • Treatment-emergent adverse events were reported from randomization up to 27 months for Segment 1 and up to 19 months for Segment 2. All-cause mortality was reported from enrollment up to 52 months.
Patients in the Enrolled But Not Randomized group were enrolled in the study but discontinued before being allocated into a treatment group. They never received treatment with exicorilant. Thus, they were not at risk for a treatment-emergent adverse event.
|
10.0%
1/10 • Treatment-emergent adverse events were reported from randomization up to 27 months for Segment 1 and up to 19 months for Segment 2. All-cause mortality was reported from enrollment up to 52 months.
Patients in the Enrolled But Not Randomized group were enrolled in the study but discontinued before being allocated into a treatment group. They never received treatment with exicorilant. Thus, they were not at risk for a treatment-emergent adverse event.
|
0.00%
0/6 • Treatment-emergent adverse events were reported from randomization up to 27 months for Segment 1 and up to 19 months for Segment 2. All-cause mortality was reported from enrollment up to 52 months.
Patients in the Enrolled But Not Randomized group were enrolled in the study but discontinued before being allocated into a treatment group. They never received treatment with exicorilant. Thus, they were not at risk for a treatment-emergent adverse event.
|
|
Nervous system disorders
Aphasia
|
0.00%
0/3 • Treatment-emergent adverse events were reported from randomization up to 27 months for Segment 1 and up to 19 months for Segment 2. All-cause mortality was reported from enrollment up to 52 months.
Patients in the Enrolled But Not Randomized group were enrolled in the study but discontinued before being allocated into a treatment group. They never received treatment with exicorilant. Thus, they were not at risk for a treatment-emergent adverse event.
|
14.3%
1/7 • Treatment-emergent adverse events were reported from randomization up to 27 months for Segment 1 and up to 19 months for Segment 2. All-cause mortality was reported from enrollment up to 52 months.
Patients in the Enrolled But Not Randomized group were enrolled in the study but discontinued before being allocated into a treatment group. They never received treatment with exicorilant. Thus, they were not at risk for a treatment-emergent adverse event.
|
—
0/0 • Treatment-emergent adverse events were reported from randomization up to 27 months for Segment 1 and up to 19 months for Segment 2. All-cause mortality was reported from enrollment up to 52 months.
Patients in the Enrolled But Not Randomized group were enrolled in the study but discontinued before being allocated into a treatment group. They never received treatment with exicorilant. Thus, they were not at risk for a treatment-emergent adverse event.
|
0.00%
0/2 • Treatment-emergent adverse events were reported from randomization up to 27 months for Segment 1 and up to 19 months for Segment 2. All-cause mortality was reported from enrollment up to 52 months.
Patients in the Enrolled But Not Randomized group were enrolled in the study but discontinued before being allocated into a treatment group. They never received treatment with exicorilant. Thus, they were not at risk for a treatment-emergent adverse event.
|
0.00%
0/8 • Treatment-emergent adverse events were reported from randomization up to 27 months for Segment 1 and up to 19 months for Segment 2. All-cause mortality was reported from enrollment up to 52 months.
Patients in the Enrolled But Not Randomized group were enrolled in the study but discontinued before being allocated into a treatment group. They never received treatment with exicorilant. Thus, they were not at risk for a treatment-emergent adverse event.
|
0.00%
0/1 • Treatment-emergent adverse events were reported from randomization up to 27 months for Segment 1 and up to 19 months for Segment 2. All-cause mortality was reported from enrollment up to 52 months.
Patients in the Enrolled But Not Randomized group were enrolled in the study but discontinued before being allocated into a treatment group. They never received treatment with exicorilant. Thus, they were not at risk for a treatment-emergent adverse event.
|
0.00%
0/10 • Treatment-emergent adverse events were reported from randomization up to 27 months for Segment 1 and up to 19 months for Segment 2. All-cause mortality was reported from enrollment up to 52 months.
Patients in the Enrolled But Not Randomized group were enrolled in the study but discontinued before being allocated into a treatment group. They never received treatment with exicorilant. Thus, they were not at risk for a treatment-emergent adverse event.
|
0.00%
0/6 • Treatment-emergent adverse events were reported from randomization up to 27 months for Segment 1 and up to 19 months for Segment 2. All-cause mortality was reported from enrollment up to 52 months.
Patients in the Enrolled But Not Randomized group were enrolled in the study but discontinued before being allocated into a treatment group. They never received treatment with exicorilant. Thus, they were not at risk for a treatment-emergent adverse event.
|
|
Nervous system disorders
Dizziness
|
0.00%
0/3 • Treatment-emergent adverse events were reported from randomization up to 27 months for Segment 1 and up to 19 months for Segment 2. All-cause mortality was reported from enrollment up to 52 months.
Patients in the Enrolled But Not Randomized group were enrolled in the study but discontinued before being allocated into a treatment group. They never received treatment with exicorilant. Thus, they were not at risk for a treatment-emergent adverse event.
|
14.3%
1/7 • Treatment-emergent adverse events were reported from randomization up to 27 months for Segment 1 and up to 19 months for Segment 2. All-cause mortality was reported from enrollment up to 52 months.
Patients in the Enrolled But Not Randomized group were enrolled in the study but discontinued before being allocated into a treatment group. They never received treatment with exicorilant. Thus, they were not at risk for a treatment-emergent adverse event.
|
—
0/0 • Treatment-emergent adverse events were reported from randomization up to 27 months for Segment 1 and up to 19 months for Segment 2. All-cause mortality was reported from enrollment up to 52 months.
Patients in the Enrolled But Not Randomized group were enrolled in the study but discontinued before being allocated into a treatment group. They never received treatment with exicorilant. Thus, they were not at risk for a treatment-emergent adverse event.
|
0.00%
0/2 • Treatment-emergent adverse events were reported from randomization up to 27 months for Segment 1 and up to 19 months for Segment 2. All-cause mortality was reported from enrollment up to 52 months.
Patients in the Enrolled But Not Randomized group were enrolled in the study but discontinued before being allocated into a treatment group. They never received treatment with exicorilant. Thus, they were not at risk for a treatment-emergent adverse event.
|
0.00%
0/8 • Treatment-emergent adverse events were reported from randomization up to 27 months for Segment 1 and up to 19 months for Segment 2. All-cause mortality was reported from enrollment up to 52 months.
Patients in the Enrolled But Not Randomized group were enrolled in the study but discontinued before being allocated into a treatment group. They never received treatment with exicorilant. Thus, they were not at risk for a treatment-emergent adverse event.
|
0.00%
0/1 • Treatment-emergent adverse events were reported from randomization up to 27 months for Segment 1 and up to 19 months for Segment 2. All-cause mortality was reported from enrollment up to 52 months.
Patients in the Enrolled But Not Randomized group were enrolled in the study but discontinued before being allocated into a treatment group. They never received treatment with exicorilant. Thus, they were not at risk for a treatment-emergent adverse event.
|
10.0%
1/10 • Treatment-emergent adverse events were reported from randomization up to 27 months for Segment 1 and up to 19 months for Segment 2. All-cause mortality was reported from enrollment up to 52 months.
Patients in the Enrolled But Not Randomized group were enrolled in the study but discontinued before being allocated into a treatment group. They never received treatment with exicorilant. Thus, they were not at risk for a treatment-emergent adverse event.
|
16.7%
1/6 • Treatment-emergent adverse events were reported from randomization up to 27 months for Segment 1 and up to 19 months for Segment 2. All-cause mortality was reported from enrollment up to 52 months.
Patients in the Enrolled But Not Randomized group were enrolled in the study but discontinued before being allocated into a treatment group. They never received treatment with exicorilant. Thus, they were not at risk for a treatment-emergent adverse event.
|
|
Nervous system disorders
Dysarthria
|
0.00%
0/3 • Treatment-emergent adverse events were reported from randomization up to 27 months for Segment 1 and up to 19 months for Segment 2. All-cause mortality was reported from enrollment up to 52 months.
Patients in the Enrolled But Not Randomized group were enrolled in the study but discontinued before being allocated into a treatment group. They never received treatment with exicorilant. Thus, they were not at risk for a treatment-emergent adverse event.
|
14.3%
1/7 • Treatment-emergent adverse events were reported from randomization up to 27 months for Segment 1 and up to 19 months for Segment 2. All-cause mortality was reported from enrollment up to 52 months.
Patients in the Enrolled But Not Randomized group were enrolled in the study but discontinued before being allocated into a treatment group. They never received treatment with exicorilant. Thus, they were not at risk for a treatment-emergent adverse event.
|
—
0/0 • Treatment-emergent adverse events were reported from randomization up to 27 months for Segment 1 and up to 19 months for Segment 2. All-cause mortality was reported from enrollment up to 52 months.
Patients in the Enrolled But Not Randomized group were enrolled in the study but discontinued before being allocated into a treatment group. They never received treatment with exicorilant. Thus, they were not at risk for a treatment-emergent adverse event.
|
0.00%
0/2 • Treatment-emergent adverse events were reported from randomization up to 27 months for Segment 1 and up to 19 months for Segment 2. All-cause mortality was reported from enrollment up to 52 months.
Patients in the Enrolled But Not Randomized group were enrolled in the study but discontinued before being allocated into a treatment group. They never received treatment with exicorilant. Thus, they were not at risk for a treatment-emergent adverse event.
|
0.00%
0/8 • Treatment-emergent adverse events were reported from randomization up to 27 months for Segment 1 and up to 19 months for Segment 2. All-cause mortality was reported from enrollment up to 52 months.
Patients in the Enrolled But Not Randomized group were enrolled in the study but discontinued before being allocated into a treatment group. They never received treatment with exicorilant. Thus, they were not at risk for a treatment-emergent adverse event.
|
0.00%
0/1 • Treatment-emergent adverse events were reported from randomization up to 27 months for Segment 1 and up to 19 months for Segment 2. All-cause mortality was reported from enrollment up to 52 months.
Patients in the Enrolled But Not Randomized group were enrolled in the study but discontinued before being allocated into a treatment group. They never received treatment with exicorilant. Thus, they were not at risk for a treatment-emergent adverse event.
|
0.00%
0/10 • Treatment-emergent adverse events were reported from randomization up to 27 months for Segment 1 and up to 19 months for Segment 2. All-cause mortality was reported from enrollment up to 52 months.
Patients in the Enrolled But Not Randomized group were enrolled in the study but discontinued before being allocated into a treatment group. They never received treatment with exicorilant. Thus, they were not at risk for a treatment-emergent adverse event.
|
0.00%
0/6 • Treatment-emergent adverse events were reported from randomization up to 27 months for Segment 1 and up to 19 months for Segment 2. All-cause mortality was reported from enrollment up to 52 months.
Patients in the Enrolled But Not Randomized group were enrolled in the study but discontinued before being allocated into a treatment group. They never received treatment with exicorilant. Thus, they were not at risk for a treatment-emergent adverse event.
|
|
Nervous system disorders
Dysgeusia
|
0.00%
0/3 • Treatment-emergent adverse events were reported from randomization up to 27 months for Segment 1 and up to 19 months for Segment 2. All-cause mortality was reported from enrollment up to 52 months.
Patients in the Enrolled But Not Randomized group were enrolled in the study but discontinued before being allocated into a treatment group. They never received treatment with exicorilant. Thus, they were not at risk for a treatment-emergent adverse event.
|
0.00%
0/7 • Treatment-emergent adverse events were reported from randomization up to 27 months for Segment 1 and up to 19 months for Segment 2. All-cause mortality was reported from enrollment up to 52 months.
Patients in the Enrolled But Not Randomized group were enrolled in the study but discontinued before being allocated into a treatment group. They never received treatment with exicorilant. Thus, they were not at risk for a treatment-emergent adverse event.
|
—
0/0 • Treatment-emergent adverse events were reported from randomization up to 27 months for Segment 1 and up to 19 months for Segment 2. All-cause mortality was reported from enrollment up to 52 months.
Patients in the Enrolled But Not Randomized group were enrolled in the study but discontinued before being allocated into a treatment group. They never received treatment with exicorilant. Thus, they were not at risk for a treatment-emergent adverse event.
|
50.0%
1/2 • Treatment-emergent adverse events were reported from randomization up to 27 months for Segment 1 and up to 19 months for Segment 2. All-cause mortality was reported from enrollment up to 52 months.
Patients in the Enrolled But Not Randomized group were enrolled in the study but discontinued before being allocated into a treatment group. They never received treatment with exicorilant. Thus, they were not at risk for a treatment-emergent adverse event.
|
0.00%
0/8 • Treatment-emergent adverse events were reported from randomization up to 27 months for Segment 1 and up to 19 months for Segment 2. All-cause mortality was reported from enrollment up to 52 months.
Patients in the Enrolled But Not Randomized group were enrolled in the study but discontinued before being allocated into a treatment group. They never received treatment with exicorilant. Thus, they were not at risk for a treatment-emergent adverse event.
|
0.00%
0/1 • Treatment-emergent adverse events were reported from randomization up to 27 months for Segment 1 and up to 19 months for Segment 2. All-cause mortality was reported from enrollment up to 52 months.
Patients in the Enrolled But Not Randomized group were enrolled in the study but discontinued before being allocated into a treatment group. They never received treatment with exicorilant. Thus, they were not at risk for a treatment-emergent adverse event.
|
0.00%
0/10 • Treatment-emergent adverse events were reported from randomization up to 27 months for Segment 1 and up to 19 months for Segment 2. All-cause mortality was reported from enrollment up to 52 months.
Patients in the Enrolled But Not Randomized group were enrolled in the study but discontinued before being allocated into a treatment group. They never received treatment with exicorilant. Thus, they were not at risk for a treatment-emergent adverse event.
|
16.7%
1/6 • Treatment-emergent adverse events were reported from randomization up to 27 months for Segment 1 and up to 19 months for Segment 2. All-cause mortality was reported from enrollment up to 52 months.
Patients in the Enrolled But Not Randomized group were enrolled in the study but discontinued before being allocated into a treatment group. They never received treatment with exicorilant. Thus, they were not at risk for a treatment-emergent adverse event.
|
|
Nervous system disorders
Dysmetria
|
0.00%
0/3 • Treatment-emergent adverse events were reported from randomization up to 27 months for Segment 1 and up to 19 months for Segment 2. All-cause mortality was reported from enrollment up to 52 months.
Patients in the Enrolled But Not Randomized group were enrolled in the study but discontinued before being allocated into a treatment group. They never received treatment with exicorilant. Thus, they were not at risk for a treatment-emergent adverse event.
|
14.3%
1/7 • Treatment-emergent adverse events were reported from randomization up to 27 months for Segment 1 and up to 19 months for Segment 2. All-cause mortality was reported from enrollment up to 52 months.
Patients in the Enrolled But Not Randomized group were enrolled in the study but discontinued before being allocated into a treatment group. They never received treatment with exicorilant. Thus, they were not at risk for a treatment-emergent adverse event.
|
—
0/0 • Treatment-emergent adverse events were reported from randomization up to 27 months for Segment 1 and up to 19 months for Segment 2. All-cause mortality was reported from enrollment up to 52 months.
Patients in the Enrolled But Not Randomized group were enrolled in the study but discontinued before being allocated into a treatment group. They never received treatment with exicorilant. Thus, they were not at risk for a treatment-emergent adverse event.
|
0.00%
0/2 • Treatment-emergent adverse events were reported from randomization up to 27 months for Segment 1 and up to 19 months for Segment 2. All-cause mortality was reported from enrollment up to 52 months.
Patients in the Enrolled But Not Randomized group were enrolled in the study but discontinued before being allocated into a treatment group. They never received treatment with exicorilant. Thus, they were not at risk for a treatment-emergent adverse event.
|
0.00%
0/8 • Treatment-emergent adverse events were reported from randomization up to 27 months for Segment 1 and up to 19 months for Segment 2. All-cause mortality was reported from enrollment up to 52 months.
Patients in the Enrolled But Not Randomized group were enrolled in the study but discontinued before being allocated into a treatment group. They never received treatment with exicorilant. Thus, they were not at risk for a treatment-emergent adverse event.
|
0.00%
0/1 • Treatment-emergent adverse events were reported from randomization up to 27 months for Segment 1 and up to 19 months for Segment 2. All-cause mortality was reported from enrollment up to 52 months.
Patients in the Enrolled But Not Randomized group were enrolled in the study but discontinued before being allocated into a treatment group. They never received treatment with exicorilant. Thus, they were not at risk for a treatment-emergent adverse event.
|
0.00%
0/10 • Treatment-emergent adverse events were reported from randomization up to 27 months for Segment 1 and up to 19 months for Segment 2. All-cause mortality was reported from enrollment up to 52 months.
Patients in the Enrolled But Not Randomized group were enrolled in the study but discontinued before being allocated into a treatment group. They never received treatment with exicorilant. Thus, they were not at risk for a treatment-emergent adverse event.
|
0.00%
0/6 • Treatment-emergent adverse events were reported from randomization up to 27 months for Segment 1 and up to 19 months for Segment 2. All-cause mortality was reported from enrollment up to 52 months.
Patients in the Enrolled But Not Randomized group were enrolled in the study but discontinued before being allocated into a treatment group. They never received treatment with exicorilant. Thus, they were not at risk for a treatment-emergent adverse event.
|
|
Nervous system disorders
Headache
|
0.00%
0/3 • Treatment-emergent adverse events were reported from randomization up to 27 months for Segment 1 and up to 19 months for Segment 2. All-cause mortality was reported from enrollment up to 52 months.
Patients in the Enrolled But Not Randomized group were enrolled in the study but discontinued before being allocated into a treatment group. They never received treatment with exicorilant. Thus, they were not at risk for a treatment-emergent adverse event.
|
28.6%
2/7 • Treatment-emergent adverse events were reported from randomization up to 27 months for Segment 1 and up to 19 months for Segment 2. All-cause mortality was reported from enrollment up to 52 months.
Patients in the Enrolled But Not Randomized group were enrolled in the study but discontinued before being allocated into a treatment group. They never received treatment with exicorilant. Thus, they were not at risk for a treatment-emergent adverse event.
|
—
0/0 • Treatment-emergent adverse events were reported from randomization up to 27 months for Segment 1 and up to 19 months for Segment 2. All-cause mortality was reported from enrollment up to 52 months.
Patients in the Enrolled But Not Randomized group were enrolled in the study but discontinued before being allocated into a treatment group. They never received treatment with exicorilant. Thus, they were not at risk for a treatment-emergent adverse event.
|
50.0%
1/2 • Treatment-emergent adverse events were reported from randomization up to 27 months for Segment 1 and up to 19 months for Segment 2. All-cause mortality was reported from enrollment up to 52 months.
Patients in the Enrolled But Not Randomized group were enrolled in the study but discontinued before being allocated into a treatment group. They never received treatment with exicorilant. Thus, they were not at risk for a treatment-emergent adverse event.
|
0.00%
0/8 • Treatment-emergent adverse events were reported from randomization up to 27 months for Segment 1 and up to 19 months for Segment 2. All-cause mortality was reported from enrollment up to 52 months.
Patients in the Enrolled But Not Randomized group were enrolled in the study but discontinued before being allocated into a treatment group. They never received treatment with exicorilant. Thus, they were not at risk for a treatment-emergent adverse event.
|
0.00%
0/1 • Treatment-emergent adverse events were reported from randomization up to 27 months for Segment 1 and up to 19 months for Segment 2. All-cause mortality was reported from enrollment up to 52 months.
Patients in the Enrolled But Not Randomized group were enrolled in the study but discontinued before being allocated into a treatment group. They never received treatment with exicorilant. Thus, they were not at risk for a treatment-emergent adverse event.
|
10.0%
1/10 • Treatment-emergent adverse events were reported from randomization up to 27 months for Segment 1 and up to 19 months for Segment 2. All-cause mortality was reported from enrollment up to 52 months.
Patients in the Enrolled But Not Randomized group were enrolled in the study but discontinued before being allocated into a treatment group. They never received treatment with exicorilant. Thus, they were not at risk for a treatment-emergent adverse event.
|
16.7%
1/6 • Treatment-emergent adverse events were reported from randomization up to 27 months for Segment 1 and up to 19 months for Segment 2. All-cause mortality was reported from enrollment up to 52 months.
Patients in the Enrolled But Not Randomized group were enrolled in the study but discontinued before being allocated into a treatment group. They never received treatment with exicorilant. Thus, they were not at risk for a treatment-emergent adverse event.
|
|
Nervous system disorders
Hypoaesthesia
|
0.00%
0/3 • Treatment-emergent adverse events were reported from randomization up to 27 months for Segment 1 and up to 19 months for Segment 2. All-cause mortality was reported from enrollment up to 52 months.
Patients in the Enrolled But Not Randomized group were enrolled in the study but discontinued before being allocated into a treatment group. They never received treatment with exicorilant. Thus, they were not at risk for a treatment-emergent adverse event.
|
0.00%
0/7 • Treatment-emergent adverse events were reported from randomization up to 27 months for Segment 1 and up to 19 months for Segment 2. All-cause mortality was reported from enrollment up to 52 months.
Patients in the Enrolled But Not Randomized group were enrolled in the study but discontinued before being allocated into a treatment group. They never received treatment with exicorilant. Thus, they were not at risk for a treatment-emergent adverse event.
|
—
0/0 • Treatment-emergent adverse events were reported from randomization up to 27 months for Segment 1 and up to 19 months for Segment 2. All-cause mortality was reported from enrollment up to 52 months.
Patients in the Enrolled But Not Randomized group were enrolled in the study but discontinued before being allocated into a treatment group. They never received treatment with exicorilant. Thus, they were not at risk for a treatment-emergent adverse event.
|
0.00%
0/2 • Treatment-emergent adverse events were reported from randomization up to 27 months for Segment 1 and up to 19 months for Segment 2. All-cause mortality was reported from enrollment up to 52 months.
Patients in the Enrolled But Not Randomized group were enrolled in the study but discontinued before being allocated into a treatment group. They never received treatment with exicorilant. Thus, they were not at risk for a treatment-emergent adverse event.
|
0.00%
0/8 • Treatment-emergent adverse events were reported from randomization up to 27 months for Segment 1 and up to 19 months for Segment 2. All-cause mortality was reported from enrollment up to 52 months.
Patients in the Enrolled But Not Randomized group were enrolled in the study but discontinued before being allocated into a treatment group. They never received treatment with exicorilant. Thus, they were not at risk for a treatment-emergent adverse event.
|
0.00%
0/1 • Treatment-emergent adverse events were reported from randomization up to 27 months for Segment 1 and up to 19 months for Segment 2. All-cause mortality was reported from enrollment up to 52 months.
Patients in the Enrolled But Not Randomized group were enrolled in the study but discontinued before being allocated into a treatment group. They never received treatment with exicorilant. Thus, they were not at risk for a treatment-emergent adverse event.
|
10.0%
1/10 • Treatment-emergent adverse events were reported from randomization up to 27 months for Segment 1 and up to 19 months for Segment 2. All-cause mortality was reported from enrollment up to 52 months.
Patients in the Enrolled But Not Randomized group were enrolled in the study but discontinued before being allocated into a treatment group. They never received treatment with exicorilant. Thus, they were not at risk for a treatment-emergent adverse event.
|
0.00%
0/6 • Treatment-emergent adverse events were reported from randomization up to 27 months for Segment 1 and up to 19 months for Segment 2. All-cause mortality was reported from enrollment up to 52 months.
Patients in the Enrolled But Not Randomized group were enrolled in the study but discontinued before being allocated into a treatment group. They never received treatment with exicorilant. Thus, they were not at risk for a treatment-emergent adverse event.
|
|
Nervous system disorders
Lethargy
|
0.00%
0/3 • Treatment-emergent adverse events were reported from randomization up to 27 months for Segment 1 and up to 19 months for Segment 2. All-cause mortality was reported from enrollment up to 52 months.
Patients in the Enrolled But Not Randomized group were enrolled in the study but discontinued before being allocated into a treatment group. They never received treatment with exicorilant. Thus, they were not at risk for a treatment-emergent adverse event.
|
28.6%
2/7 • Treatment-emergent adverse events were reported from randomization up to 27 months for Segment 1 and up to 19 months for Segment 2. All-cause mortality was reported from enrollment up to 52 months.
Patients in the Enrolled But Not Randomized group were enrolled in the study but discontinued before being allocated into a treatment group. They never received treatment with exicorilant. Thus, they were not at risk for a treatment-emergent adverse event.
|
—
0/0 • Treatment-emergent adverse events were reported from randomization up to 27 months for Segment 1 and up to 19 months for Segment 2. All-cause mortality was reported from enrollment up to 52 months.
Patients in the Enrolled But Not Randomized group were enrolled in the study but discontinued before being allocated into a treatment group. They never received treatment with exicorilant. Thus, they were not at risk for a treatment-emergent adverse event.
|
0.00%
0/2 • Treatment-emergent adverse events were reported from randomization up to 27 months for Segment 1 and up to 19 months for Segment 2. All-cause mortality was reported from enrollment up to 52 months.
Patients in the Enrolled But Not Randomized group were enrolled in the study but discontinued before being allocated into a treatment group. They never received treatment with exicorilant. Thus, they were not at risk for a treatment-emergent adverse event.
|
0.00%
0/8 • Treatment-emergent adverse events were reported from randomization up to 27 months for Segment 1 and up to 19 months for Segment 2. All-cause mortality was reported from enrollment up to 52 months.
Patients in the Enrolled But Not Randomized group were enrolled in the study but discontinued before being allocated into a treatment group. They never received treatment with exicorilant. Thus, they were not at risk for a treatment-emergent adverse event.
|
0.00%
0/1 • Treatment-emergent adverse events were reported from randomization up to 27 months for Segment 1 and up to 19 months for Segment 2. All-cause mortality was reported from enrollment up to 52 months.
Patients in the Enrolled But Not Randomized group were enrolled in the study but discontinued before being allocated into a treatment group. They never received treatment with exicorilant. Thus, they were not at risk for a treatment-emergent adverse event.
|
0.00%
0/10 • Treatment-emergent adverse events were reported from randomization up to 27 months for Segment 1 and up to 19 months for Segment 2. All-cause mortality was reported from enrollment up to 52 months.
Patients in the Enrolled But Not Randomized group were enrolled in the study but discontinued before being allocated into a treatment group. They never received treatment with exicorilant. Thus, they were not at risk for a treatment-emergent adverse event.
|
0.00%
0/6 • Treatment-emergent adverse events were reported from randomization up to 27 months for Segment 1 and up to 19 months for Segment 2. All-cause mortality was reported from enrollment up to 52 months.
Patients in the Enrolled But Not Randomized group were enrolled in the study but discontinued before being allocated into a treatment group. They never received treatment with exicorilant. Thus, they were not at risk for a treatment-emergent adverse event.
|
|
Nervous system disorders
Memory impairment
|
0.00%
0/3 • Treatment-emergent adverse events were reported from randomization up to 27 months for Segment 1 and up to 19 months for Segment 2. All-cause mortality was reported from enrollment up to 52 months.
Patients in the Enrolled But Not Randomized group were enrolled in the study but discontinued before being allocated into a treatment group. They never received treatment with exicorilant. Thus, they were not at risk for a treatment-emergent adverse event.
|
0.00%
0/7 • Treatment-emergent adverse events were reported from randomization up to 27 months for Segment 1 and up to 19 months for Segment 2. All-cause mortality was reported from enrollment up to 52 months.
Patients in the Enrolled But Not Randomized group were enrolled in the study but discontinued before being allocated into a treatment group. They never received treatment with exicorilant. Thus, they were not at risk for a treatment-emergent adverse event.
|
—
0/0 • Treatment-emergent adverse events were reported from randomization up to 27 months for Segment 1 and up to 19 months for Segment 2. All-cause mortality was reported from enrollment up to 52 months.
Patients in the Enrolled But Not Randomized group were enrolled in the study but discontinued before being allocated into a treatment group. They never received treatment with exicorilant. Thus, they were not at risk for a treatment-emergent adverse event.
|
0.00%
0/2 • Treatment-emergent adverse events were reported from randomization up to 27 months for Segment 1 and up to 19 months for Segment 2. All-cause mortality was reported from enrollment up to 52 months.
Patients in the Enrolled But Not Randomized group were enrolled in the study but discontinued before being allocated into a treatment group. They never received treatment with exicorilant. Thus, they were not at risk for a treatment-emergent adverse event.
|
0.00%
0/8 • Treatment-emergent adverse events were reported from randomization up to 27 months for Segment 1 and up to 19 months for Segment 2. All-cause mortality was reported from enrollment up to 52 months.
Patients in the Enrolled But Not Randomized group were enrolled in the study but discontinued before being allocated into a treatment group. They never received treatment with exicorilant. Thus, they were not at risk for a treatment-emergent adverse event.
|
0.00%
0/1 • Treatment-emergent adverse events were reported from randomization up to 27 months for Segment 1 and up to 19 months for Segment 2. All-cause mortality was reported from enrollment up to 52 months.
Patients in the Enrolled But Not Randomized group were enrolled in the study but discontinued before being allocated into a treatment group. They never received treatment with exicorilant. Thus, they were not at risk for a treatment-emergent adverse event.
|
0.00%
0/10 • Treatment-emergent adverse events were reported from randomization up to 27 months for Segment 1 and up to 19 months for Segment 2. All-cause mortality was reported from enrollment up to 52 months.
Patients in the Enrolled But Not Randomized group were enrolled in the study but discontinued before being allocated into a treatment group. They never received treatment with exicorilant. Thus, they were not at risk for a treatment-emergent adverse event.
|
16.7%
1/6 • Treatment-emergent adverse events were reported from randomization up to 27 months for Segment 1 and up to 19 months for Segment 2. All-cause mortality was reported from enrollment up to 52 months.
Patients in the Enrolled But Not Randomized group were enrolled in the study but discontinued before being allocated into a treatment group. They never received treatment with exicorilant. Thus, they were not at risk for a treatment-emergent adverse event.
|
|
Nervous system disorders
Neuralgia
|
0.00%
0/3 • Treatment-emergent adverse events were reported from randomization up to 27 months for Segment 1 and up to 19 months for Segment 2. All-cause mortality was reported from enrollment up to 52 months.
Patients in the Enrolled But Not Randomized group were enrolled in the study but discontinued before being allocated into a treatment group. They never received treatment with exicorilant. Thus, they were not at risk for a treatment-emergent adverse event.
|
0.00%
0/7 • Treatment-emergent adverse events were reported from randomization up to 27 months for Segment 1 and up to 19 months for Segment 2. All-cause mortality was reported from enrollment up to 52 months.
Patients in the Enrolled But Not Randomized group were enrolled in the study but discontinued before being allocated into a treatment group. They never received treatment with exicorilant. Thus, they were not at risk for a treatment-emergent adverse event.
|
—
0/0 • Treatment-emergent adverse events were reported from randomization up to 27 months for Segment 1 and up to 19 months for Segment 2. All-cause mortality was reported from enrollment up to 52 months.
Patients in the Enrolled But Not Randomized group were enrolled in the study but discontinued before being allocated into a treatment group. They never received treatment with exicorilant. Thus, they were not at risk for a treatment-emergent adverse event.
|
50.0%
1/2 • Treatment-emergent adverse events were reported from randomization up to 27 months for Segment 1 and up to 19 months for Segment 2. All-cause mortality was reported from enrollment up to 52 months.
Patients in the Enrolled But Not Randomized group were enrolled in the study but discontinued before being allocated into a treatment group. They never received treatment with exicorilant. Thus, they were not at risk for a treatment-emergent adverse event.
|
0.00%
0/8 • Treatment-emergent adverse events were reported from randomization up to 27 months for Segment 1 and up to 19 months for Segment 2. All-cause mortality was reported from enrollment up to 52 months.
Patients in the Enrolled But Not Randomized group were enrolled in the study but discontinued before being allocated into a treatment group. They never received treatment with exicorilant. Thus, they were not at risk for a treatment-emergent adverse event.
|
0.00%
0/1 • Treatment-emergent adverse events were reported from randomization up to 27 months for Segment 1 and up to 19 months for Segment 2. All-cause mortality was reported from enrollment up to 52 months.
Patients in the Enrolled But Not Randomized group were enrolled in the study but discontinued before being allocated into a treatment group. They never received treatment with exicorilant. Thus, they were not at risk for a treatment-emergent adverse event.
|
10.0%
1/10 • Treatment-emergent adverse events were reported from randomization up to 27 months for Segment 1 and up to 19 months for Segment 2. All-cause mortality was reported from enrollment up to 52 months.
Patients in the Enrolled But Not Randomized group were enrolled in the study but discontinued before being allocated into a treatment group. They never received treatment with exicorilant. Thus, they were not at risk for a treatment-emergent adverse event.
|
0.00%
0/6 • Treatment-emergent adverse events were reported from randomization up to 27 months for Segment 1 and up to 19 months for Segment 2. All-cause mortality was reported from enrollment up to 52 months.
Patients in the Enrolled But Not Randomized group were enrolled in the study but discontinued before being allocated into a treatment group. They never received treatment with exicorilant. Thus, they were not at risk for a treatment-emergent adverse event.
|
|
Nervous system disorders
Paraesthesia
|
0.00%
0/3 • Treatment-emergent adverse events were reported from randomization up to 27 months for Segment 1 and up to 19 months for Segment 2. All-cause mortality was reported from enrollment up to 52 months.
Patients in the Enrolled But Not Randomized group were enrolled in the study but discontinued before being allocated into a treatment group. They never received treatment with exicorilant. Thus, they were not at risk for a treatment-emergent adverse event.
|
14.3%
1/7 • Treatment-emergent adverse events were reported from randomization up to 27 months for Segment 1 and up to 19 months for Segment 2. All-cause mortality was reported from enrollment up to 52 months.
Patients in the Enrolled But Not Randomized group were enrolled in the study but discontinued before being allocated into a treatment group. They never received treatment with exicorilant. Thus, they were not at risk for a treatment-emergent adverse event.
|
—
0/0 • Treatment-emergent adverse events were reported from randomization up to 27 months for Segment 1 and up to 19 months for Segment 2. All-cause mortality was reported from enrollment up to 52 months.
Patients in the Enrolled But Not Randomized group were enrolled in the study but discontinued before being allocated into a treatment group. They never received treatment with exicorilant. Thus, they were not at risk for a treatment-emergent adverse event.
|
0.00%
0/2 • Treatment-emergent adverse events were reported from randomization up to 27 months for Segment 1 and up to 19 months for Segment 2. All-cause mortality was reported from enrollment up to 52 months.
Patients in the Enrolled But Not Randomized group were enrolled in the study but discontinued before being allocated into a treatment group. They never received treatment with exicorilant. Thus, they were not at risk for a treatment-emergent adverse event.
|
0.00%
0/8 • Treatment-emergent adverse events were reported from randomization up to 27 months for Segment 1 and up to 19 months for Segment 2. All-cause mortality was reported from enrollment up to 52 months.
Patients in the Enrolled But Not Randomized group were enrolled in the study but discontinued before being allocated into a treatment group. They never received treatment with exicorilant. Thus, they were not at risk for a treatment-emergent adverse event.
|
0.00%
0/1 • Treatment-emergent adverse events were reported from randomization up to 27 months for Segment 1 and up to 19 months for Segment 2. All-cause mortality was reported from enrollment up to 52 months.
Patients in the Enrolled But Not Randomized group were enrolled in the study but discontinued before being allocated into a treatment group. They never received treatment with exicorilant. Thus, they were not at risk for a treatment-emergent adverse event.
|
20.0%
2/10 • Treatment-emergent adverse events were reported from randomization up to 27 months for Segment 1 and up to 19 months for Segment 2. All-cause mortality was reported from enrollment up to 52 months.
Patients in the Enrolled But Not Randomized group were enrolled in the study but discontinued before being allocated into a treatment group. They never received treatment with exicorilant. Thus, they were not at risk for a treatment-emergent adverse event.
|
0.00%
0/6 • Treatment-emergent adverse events were reported from randomization up to 27 months for Segment 1 and up to 19 months for Segment 2. All-cause mortality was reported from enrollment up to 52 months.
Patients in the Enrolled But Not Randomized group were enrolled in the study but discontinued before being allocated into a treatment group. They never received treatment with exicorilant. Thus, they were not at risk for a treatment-emergent adverse event.
|
|
Nervous system disorders
Peripheral sensory neuropathy
|
0.00%
0/3 • Treatment-emergent adverse events were reported from randomization up to 27 months for Segment 1 and up to 19 months for Segment 2. All-cause mortality was reported from enrollment up to 52 months.
Patients in the Enrolled But Not Randomized group were enrolled in the study but discontinued before being allocated into a treatment group. They never received treatment with exicorilant. Thus, they were not at risk for a treatment-emergent adverse event.
|
14.3%
1/7 • Treatment-emergent adverse events were reported from randomization up to 27 months for Segment 1 and up to 19 months for Segment 2. All-cause mortality was reported from enrollment up to 52 months.
Patients in the Enrolled But Not Randomized group were enrolled in the study but discontinued before being allocated into a treatment group. They never received treatment with exicorilant. Thus, they were not at risk for a treatment-emergent adverse event.
|
—
0/0 • Treatment-emergent adverse events were reported from randomization up to 27 months for Segment 1 and up to 19 months for Segment 2. All-cause mortality was reported from enrollment up to 52 months.
Patients in the Enrolled But Not Randomized group were enrolled in the study but discontinued before being allocated into a treatment group. They never received treatment with exicorilant. Thus, they were not at risk for a treatment-emergent adverse event.
|
50.0%
1/2 • Treatment-emergent adverse events were reported from randomization up to 27 months for Segment 1 and up to 19 months for Segment 2. All-cause mortality was reported from enrollment up to 52 months.
Patients in the Enrolled But Not Randomized group were enrolled in the study but discontinued before being allocated into a treatment group. They never received treatment with exicorilant. Thus, they were not at risk for a treatment-emergent adverse event.
|
12.5%
1/8 • Treatment-emergent adverse events were reported from randomization up to 27 months for Segment 1 and up to 19 months for Segment 2. All-cause mortality was reported from enrollment up to 52 months.
Patients in the Enrolled But Not Randomized group were enrolled in the study but discontinued before being allocated into a treatment group. They never received treatment with exicorilant. Thus, they were not at risk for a treatment-emergent adverse event.
|
0.00%
0/1 • Treatment-emergent adverse events were reported from randomization up to 27 months for Segment 1 and up to 19 months for Segment 2. All-cause mortality was reported from enrollment up to 52 months.
Patients in the Enrolled But Not Randomized group were enrolled in the study but discontinued before being allocated into a treatment group. They never received treatment with exicorilant. Thus, they were not at risk for a treatment-emergent adverse event.
|
10.0%
1/10 • Treatment-emergent adverse events were reported from randomization up to 27 months for Segment 1 and up to 19 months for Segment 2. All-cause mortality was reported from enrollment up to 52 months.
Patients in the Enrolled But Not Randomized group were enrolled in the study but discontinued before being allocated into a treatment group. They never received treatment with exicorilant. Thus, they were not at risk for a treatment-emergent adverse event.
|
16.7%
1/6 • Treatment-emergent adverse events were reported from randomization up to 27 months for Segment 1 and up to 19 months for Segment 2. All-cause mortality was reported from enrollment up to 52 months.
Patients in the Enrolled But Not Randomized group were enrolled in the study but discontinued before being allocated into a treatment group. They never received treatment with exicorilant. Thus, they were not at risk for a treatment-emergent adverse event.
|
|
Nervous system disorders
Presyncope
|
0.00%
0/3 • Treatment-emergent adverse events were reported from randomization up to 27 months for Segment 1 and up to 19 months for Segment 2. All-cause mortality was reported from enrollment up to 52 months.
Patients in the Enrolled But Not Randomized group were enrolled in the study but discontinued before being allocated into a treatment group. They never received treatment with exicorilant. Thus, they were not at risk for a treatment-emergent adverse event.
|
0.00%
0/7 • Treatment-emergent adverse events were reported from randomization up to 27 months for Segment 1 and up to 19 months for Segment 2. All-cause mortality was reported from enrollment up to 52 months.
Patients in the Enrolled But Not Randomized group were enrolled in the study but discontinued before being allocated into a treatment group. They never received treatment with exicorilant. Thus, they were not at risk for a treatment-emergent adverse event.
|
—
0/0 • Treatment-emergent adverse events were reported from randomization up to 27 months for Segment 1 and up to 19 months for Segment 2. All-cause mortality was reported from enrollment up to 52 months.
Patients in the Enrolled But Not Randomized group were enrolled in the study but discontinued before being allocated into a treatment group. They never received treatment with exicorilant. Thus, they were not at risk for a treatment-emergent adverse event.
|
0.00%
0/2 • Treatment-emergent adverse events were reported from randomization up to 27 months for Segment 1 and up to 19 months for Segment 2. All-cause mortality was reported from enrollment up to 52 months.
Patients in the Enrolled But Not Randomized group were enrolled in the study but discontinued before being allocated into a treatment group. They never received treatment with exicorilant. Thus, they were not at risk for a treatment-emergent adverse event.
|
12.5%
1/8 • Treatment-emergent adverse events were reported from randomization up to 27 months for Segment 1 and up to 19 months for Segment 2. All-cause mortality was reported from enrollment up to 52 months.
Patients in the Enrolled But Not Randomized group were enrolled in the study but discontinued before being allocated into a treatment group. They never received treatment with exicorilant. Thus, they were not at risk for a treatment-emergent adverse event.
|
0.00%
0/1 • Treatment-emergent adverse events were reported from randomization up to 27 months for Segment 1 and up to 19 months for Segment 2. All-cause mortality was reported from enrollment up to 52 months.
Patients in the Enrolled But Not Randomized group were enrolled in the study but discontinued before being allocated into a treatment group. They never received treatment with exicorilant. Thus, they were not at risk for a treatment-emergent adverse event.
|
0.00%
0/10 • Treatment-emergent adverse events were reported from randomization up to 27 months for Segment 1 and up to 19 months for Segment 2. All-cause mortality was reported from enrollment up to 52 months.
Patients in the Enrolled But Not Randomized group were enrolled in the study but discontinued before being allocated into a treatment group. They never received treatment with exicorilant. Thus, they were not at risk for a treatment-emergent adverse event.
|
0.00%
0/6 • Treatment-emergent adverse events were reported from randomization up to 27 months for Segment 1 and up to 19 months for Segment 2. All-cause mortality was reported from enrollment up to 52 months.
Patients in the Enrolled But Not Randomized group were enrolled in the study but discontinued before being allocated into a treatment group. They never received treatment with exicorilant. Thus, they were not at risk for a treatment-emergent adverse event.
|
|
Nervous system disorders
Restless legs syndrome
|
0.00%
0/3 • Treatment-emergent adverse events were reported from randomization up to 27 months for Segment 1 and up to 19 months for Segment 2. All-cause mortality was reported from enrollment up to 52 months.
Patients in the Enrolled But Not Randomized group were enrolled in the study but discontinued before being allocated into a treatment group. They never received treatment with exicorilant. Thus, they were not at risk for a treatment-emergent adverse event.
|
0.00%
0/7 • Treatment-emergent adverse events were reported from randomization up to 27 months for Segment 1 and up to 19 months for Segment 2. All-cause mortality was reported from enrollment up to 52 months.
Patients in the Enrolled But Not Randomized group were enrolled in the study but discontinued before being allocated into a treatment group. They never received treatment with exicorilant. Thus, they were not at risk for a treatment-emergent adverse event.
|
—
0/0 • Treatment-emergent adverse events were reported from randomization up to 27 months for Segment 1 and up to 19 months for Segment 2. All-cause mortality was reported from enrollment up to 52 months.
Patients in the Enrolled But Not Randomized group were enrolled in the study but discontinued before being allocated into a treatment group. They never received treatment with exicorilant. Thus, they were not at risk for a treatment-emergent adverse event.
|
50.0%
1/2 • Treatment-emergent adverse events were reported from randomization up to 27 months for Segment 1 and up to 19 months for Segment 2. All-cause mortality was reported from enrollment up to 52 months.
Patients in the Enrolled But Not Randomized group were enrolled in the study but discontinued before being allocated into a treatment group. They never received treatment with exicorilant. Thus, they were not at risk for a treatment-emergent adverse event.
|
0.00%
0/8 • Treatment-emergent adverse events were reported from randomization up to 27 months for Segment 1 and up to 19 months for Segment 2. All-cause mortality was reported from enrollment up to 52 months.
Patients in the Enrolled But Not Randomized group were enrolled in the study but discontinued before being allocated into a treatment group. They never received treatment with exicorilant. Thus, they were not at risk for a treatment-emergent adverse event.
|
0.00%
0/1 • Treatment-emergent adverse events were reported from randomization up to 27 months for Segment 1 and up to 19 months for Segment 2. All-cause mortality was reported from enrollment up to 52 months.
Patients in the Enrolled But Not Randomized group were enrolled in the study but discontinued before being allocated into a treatment group. They never received treatment with exicorilant. Thus, they were not at risk for a treatment-emergent adverse event.
|
0.00%
0/10 • Treatment-emergent adverse events were reported from randomization up to 27 months for Segment 1 and up to 19 months for Segment 2. All-cause mortality was reported from enrollment up to 52 months.
Patients in the Enrolled But Not Randomized group were enrolled in the study but discontinued before being allocated into a treatment group. They never received treatment with exicorilant. Thus, they were not at risk for a treatment-emergent adverse event.
|
16.7%
1/6 • Treatment-emergent adverse events were reported from randomization up to 27 months for Segment 1 and up to 19 months for Segment 2. All-cause mortality was reported from enrollment up to 52 months.
Patients in the Enrolled But Not Randomized group were enrolled in the study but discontinued before being allocated into a treatment group. They never received treatment with exicorilant. Thus, they were not at risk for a treatment-emergent adverse event.
|
|
Nervous system disorders
Sciatica
|
0.00%
0/3 • Treatment-emergent adverse events were reported from randomization up to 27 months for Segment 1 and up to 19 months for Segment 2. All-cause mortality was reported from enrollment up to 52 months.
Patients in the Enrolled But Not Randomized group were enrolled in the study but discontinued before being allocated into a treatment group. They never received treatment with exicorilant. Thus, they were not at risk for a treatment-emergent adverse event.
|
0.00%
0/7 • Treatment-emergent adverse events were reported from randomization up to 27 months for Segment 1 and up to 19 months for Segment 2. All-cause mortality was reported from enrollment up to 52 months.
Patients in the Enrolled But Not Randomized group were enrolled in the study but discontinued before being allocated into a treatment group. They never received treatment with exicorilant. Thus, they were not at risk for a treatment-emergent adverse event.
|
—
0/0 • Treatment-emergent adverse events were reported from randomization up to 27 months for Segment 1 and up to 19 months for Segment 2. All-cause mortality was reported from enrollment up to 52 months.
Patients in the Enrolled But Not Randomized group were enrolled in the study but discontinued before being allocated into a treatment group. They never received treatment with exicorilant. Thus, they were not at risk for a treatment-emergent adverse event.
|
0.00%
0/2 • Treatment-emergent adverse events were reported from randomization up to 27 months for Segment 1 and up to 19 months for Segment 2. All-cause mortality was reported from enrollment up to 52 months.
Patients in the Enrolled But Not Randomized group were enrolled in the study but discontinued before being allocated into a treatment group. They never received treatment with exicorilant. Thus, they were not at risk for a treatment-emergent adverse event.
|
0.00%
0/8 • Treatment-emergent adverse events were reported from randomization up to 27 months for Segment 1 and up to 19 months for Segment 2. All-cause mortality was reported from enrollment up to 52 months.
Patients in the Enrolled But Not Randomized group were enrolled in the study but discontinued before being allocated into a treatment group. They never received treatment with exicorilant. Thus, they were not at risk for a treatment-emergent adverse event.
|
0.00%
0/1 • Treatment-emergent adverse events were reported from randomization up to 27 months for Segment 1 and up to 19 months for Segment 2. All-cause mortality was reported from enrollment up to 52 months.
Patients in the Enrolled But Not Randomized group were enrolled in the study but discontinued before being allocated into a treatment group. They never received treatment with exicorilant. Thus, they were not at risk for a treatment-emergent adverse event.
|
0.00%
0/10 • Treatment-emergent adverse events were reported from randomization up to 27 months for Segment 1 and up to 19 months for Segment 2. All-cause mortality was reported from enrollment up to 52 months.
Patients in the Enrolled But Not Randomized group were enrolled in the study but discontinued before being allocated into a treatment group. They never received treatment with exicorilant. Thus, they were not at risk for a treatment-emergent adverse event.
|
16.7%
1/6 • Treatment-emergent adverse events were reported from randomization up to 27 months for Segment 1 and up to 19 months for Segment 2. All-cause mortality was reported from enrollment up to 52 months.
Patients in the Enrolled But Not Randomized group were enrolled in the study but discontinued before being allocated into a treatment group. They never received treatment with exicorilant. Thus, they were not at risk for a treatment-emergent adverse event.
|
|
Nervous system disorders
Sensory disturbance
|
0.00%
0/3 • Treatment-emergent adverse events were reported from randomization up to 27 months for Segment 1 and up to 19 months for Segment 2. All-cause mortality was reported from enrollment up to 52 months.
Patients in the Enrolled But Not Randomized group were enrolled in the study but discontinued before being allocated into a treatment group. They never received treatment with exicorilant. Thus, they were not at risk for a treatment-emergent adverse event.
|
0.00%
0/7 • Treatment-emergent adverse events were reported from randomization up to 27 months for Segment 1 and up to 19 months for Segment 2. All-cause mortality was reported from enrollment up to 52 months.
Patients in the Enrolled But Not Randomized group were enrolled in the study but discontinued before being allocated into a treatment group. They never received treatment with exicorilant. Thus, they were not at risk for a treatment-emergent adverse event.
|
—
0/0 • Treatment-emergent adverse events were reported from randomization up to 27 months for Segment 1 and up to 19 months for Segment 2. All-cause mortality was reported from enrollment up to 52 months.
Patients in the Enrolled But Not Randomized group were enrolled in the study but discontinued before being allocated into a treatment group. They never received treatment with exicorilant. Thus, they were not at risk for a treatment-emergent adverse event.
|
0.00%
0/2 • Treatment-emergent adverse events were reported from randomization up to 27 months for Segment 1 and up to 19 months for Segment 2. All-cause mortality was reported from enrollment up to 52 months.
Patients in the Enrolled But Not Randomized group were enrolled in the study but discontinued before being allocated into a treatment group. They never received treatment with exicorilant. Thus, they were not at risk for a treatment-emergent adverse event.
|
0.00%
0/8 • Treatment-emergent adverse events were reported from randomization up to 27 months for Segment 1 and up to 19 months for Segment 2. All-cause mortality was reported from enrollment up to 52 months.
Patients in the Enrolled But Not Randomized group were enrolled in the study but discontinued before being allocated into a treatment group. They never received treatment with exicorilant. Thus, they were not at risk for a treatment-emergent adverse event.
|
100.0%
1/1 • Treatment-emergent adverse events were reported from randomization up to 27 months for Segment 1 and up to 19 months for Segment 2. All-cause mortality was reported from enrollment up to 52 months.
Patients in the Enrolled But Not Randomized group were enrolled in the study but discontinued before being allocated into a treatment group. They never received treatment with exicorilant. Thus, they were not at risk for a treatment-emergent adverse event.
|
0.00%
0/10 • Treatment-emergent adverse events were reported from randomization up to 27 months for Segment 1 and up to 19 months for Segment 2. All-cause mortality was reported from enrollment up to 52 months.
Patients in the Enrolled But Not Randomized group were enrolled in the study but discontinued before being allocated into a treatment group. They never received treatment with exicorilant. Thus, they were not at risk for a treatment-emergent adverse event.
|
0.00%
0/6 • Treatment-emergent adverse events were reported from randomization up to 27 months for Segment 1 and up to 19 months for Segment 2. All-cause mortality was reported from enrollment up to 52 months.
Patients in the Enrolled But Not Randomized group were enrolled in the study but discontinued before being allocated into a treatment group. They never received treatment with exicorilant. Thus, they were not at risk for a treatment-emergent adverse event.
|
|
Nervous system disorders
Syncope
|
0.00%
0/3 • Treatment-emergent adverse events were reported from randomization up to 27 months for Segment 1 and up to 19 months for Segment 2. All-cause mortality was reported from enrollment up to 52 months.
Patients in the Enrolled But Not Randomized group were enrolled in the study but discontinued before being allocated into a treatment group. They never received treatment with exicorilant. Thus, they were not at risk for a treatment-emergent adverse event.
|
14.3%
1/7 • Treatment-emergent adverse events were reported from randomization up to 27 months for Segment 1 and up to 19 months for Segment 2. All-cause mortality was reported from enrollment up to 52 months.
Patients in the Enrolled But Not Randomized group were enrolled in the study but discontinued before being allocated into a treatment group. They never received treatment with exicorilant. Thus, they were not at risk for a treatment-emergent adverse event.
|
—
0/0 • Treatment-emergent adverse events were reported from randomization up to 27 months for Segment 1 and up to 19 months for Segment 2. All-cause mortality was reported from enrollment up to 52 months.
Patients in the Enrolled But Not Randomized group were enrolled in the study but discontinued before being allocated into a treatment group. They never received treatment with exicorilant. Thus, they were not at risk for a treatment-emergent adverse event.
|
0.00%
0/2 • Treatment-emergent adverse events were reported from randomization up to 27 months for Segment 1 and up to 19 months for Segment 2. All-cause mortality was reported from enrollment up to 52 months.
Patients in the Enrolled But Not Randomized group were enrolled in the study but discontinued before being allocated into a treatment group. They never received treatment with exicorilant. Thus, they were not at risk for a treatment-emergent adverse event.
|
0.00%
0/8 • Treatment-emergent adverse events were reported from randomization up to 27 months for Segment 1 and up to 19 months for Segment 2. All-cause mortality was reported from enrollment up to 52 months.
Patients in the Enrolled But Not Randomized group were enrolled in the study but discontinued before being allocated into a treatment group. They never received treatment with exicorilant. Thus, they were not at risk for a treatment-emergent adverse event.
|
0.00%
0/1 • Treatment-emergent adverse events were reported from randomization up to 27 months for Segment 1 and up to 19 months for Segment 2. All-cause mortality was reported from enrollment up to 52 months.
Patients in the Enrolled But Not Randomized group were enrolled in the study but discontinued before being allocated into a treatment group. They never received treatment with exicorilant. Thus, they were not at risk for a treatment-emergent adverse event.
|
0.00%
0/10 • Treatment-emergent adverse events were reported from randomization up to 27 months for Segment 1 and up to 19 months for Segment 2. All-cause mortality was reported from enrollment up to 52 months.
Patients in the Enrolled But Not Randomized group were enrolled in the study but discontinued before being allocated into a treatment group. They never received treatment with exicorilant. Thus, they were not at risk for a treatment-emergent adverse event.
|
0.00%
0/6 • Treatment-emergent adverse events were reported from randomization up to 27 months for Segment 1 and up to 19 months for Segment 2. All-cause mortality was reported from enrollment up to 52 months.
Patients in the Enrolled But Not Randomized group were enrolled in the study but discontinued before being allocated into a treatment group. They never received treatment with exicorilant. Thus, they were not at risk for a treatment-emergent adverse event.
|
|
Nervous system disorders
Transient ischaemic attack
|
0.00%
0/3 • Treatment-emergent adverse events were reported from randomization up to 27 months for Segment 1 and up to 19 months for Segment 2. All-cause mortality was reported from enrollment up to 52 months.
Patients in the Enrolled But Not Randomized group were enrolled in the study but discontinued before being allocated into a treatment group. They never received treatment with exicorilant. Thus, they were not at risk for a treatment-emergent adverse event.
|
0.00%
0/7 • Treatment-emergent adverse events were reported from randomization up to 27 months for Segment 1 and up to 19 months for Segment 2. All-cause mortality was reported from enrollment up to 52 months.
Patients in the Enrolled But Not Randomized group were enrolled in the study but discontinued before being allocated into a treatment group. They never received treatment with exicorilant. Thus, they were not at risk for a treatment-emergent adverse event.
|
—
0/0 • Treatment-emergent adverse events were reported from randomization up to 27 months for Segment 1 and up to 19 months for Segment 2. All-cause mortality was reported from enrollment up to 52 months.
Patients in the Enrolled But Not Randomized group were enrolled in the study but discontinued before being allocated into a treatment group. They never received treatment with exicorilant. Thus, they were not at risk for a treatment-emergent adverse event.
|
0.00%
0/2 • Treatment-emergent adverse events were reported from randomization up to 27 months for Segment 1 and up to 19 months for Segment 2. All-cause mortality was reported from enrollment up to 52 months.
Patients in the Enrolled But Not Randomized group were enrolled in the study but discontinued before being allocated into a treatment group. They never received treatment with exicorilant. Thus, they were not at risk for a treatment-emergent adverse event.
|
0.00%
0/8 • Treatment-emergent adverse events were reported from randomization up to 27 months for Segment 1 and up to 19 months for Segment 2. All-cause mortality was reported from enrollment up to 52 months.
Patients in the Enrolled But Not Randomized group were enrolled in the study but discontinued before being allocated into a treatment group. They never received treatment with exicorilant. Thus, they were not at risk for a treatment-emergent adverse event.
|
0.00%
0/1 • Treatment-emergent adverse events were reported from randomization up to 27 months for Segment 1 and up to 19 months for Segment 2. All-cause mortality was reported from enrollment up to 52 months.
Patients in the Enrolled But Not Randomized group were enrolled in the study but discontinued before being allocated into a treatment group. They never received treatment with exicorilant. Thus, they were not at risk for a treatment-emergent adverse event.
|
10.0%
1/10 • Treatment-emergent adverse events were reported from randomization up to 27 months for Segment 1 and up to 19 months for Segment 2. All-cause mortality was reported from enrollment up to 52 months.
Patients in the Enrolled But Not Randomized group were enrolled in the study but discontinued before being allocated into a treatment group. They never received treatment with exicorilant. Thus, they were not at risk for a treatment-emergent adverse event.
|
0.00%
0/6 • Treatment-emergent adverse events were reported from randomization up to 27 months for Segment 1 and up to 19 months for Segment 2. All-cause mortality was reported from enrollment up to 52 months.
Patients in the Enrolled But Not Randomized group were enrolled in the study but discontinued before being allocated into a treatment group. They never received treatment with exicorilant. Thus, they were not at risk for a treatment-emergent adverse event.
|
|
Nervous system disorders
Tremor
|
0.00%
0/3 • Treatment-emergent adverse events were reported from randomization up to 27 months for Segment 1 and up to 19 months for Segment 2. All-cause mortality was reported from enrollment up to 52 months.
Patients in the Enrolled But Not Randomized group were enrolled in the study but discontinued before being allocated into a treatment group. They never received treatment with exicorilant. Thus, they were not at risk for a treatment-emergent adverse event.
|
14.3%
1/7 • Treatment-emergent adverse events were reported from randomization up to 27 months for Segment 1 and up to 19 months for Segment 2. All-cause mortality was reported from enrollment up to 52 months.
Patients in the Enrolled But Not Randomized group were enrolled in the study but discontinued before being allocated into a treatment group. They never received treatment with exicorilant. Thus, they were not at risk for a treatment-emergent adverse event.
|
—
0/0 • Treatment-emergent adverse events were reported from randomization up to 27 months for Segment 1 and up to 19 months for Segment 2. All-cause mortality was reported from enrollment up to 52 months.
Patients in the Enrolled But Not Randomized group were enrolled in the study but discontinued before being allocated into a treatment group. They never received treatment with exicorilant. Thus, they were not at risk for a treatment-emergent adverse event.
|
0.00%
0/2 • Treatment-emergent adverse events were reported from randomization up to 27 months for Segment 1 and up to 19 months for Segment 2. All-cause mortality was reported from enrollment up to 52 months.
Patients in the Enrolled But Not Randomized group were enrolled in the study but discontinued before being allocated into a treatment group. They never received treatment with exicorilant. Thus, they were not at risk for a treatment-emergent adverse event.
|
0.00%
0/8 • Treatment-emergent adverse events were reported from randomization up to 27 months for Segment 1 and up to 19 months for Segment 2. All-cause mortality was reported from enrollment up to 52 months.
Patients in the Enrolled But Not Randomized group were enrolled in the study but discontinued before being allocated into a treatment group. They never received treatment with exicorilant. Thus, they were not at risk for a treatment-emergent adverse event.
|
0.00%
0/1 • Treatment-emergent adverse events were reported from randomization up to 27 months for Segment 1 and up to 19 months for Segment 2. All-cause mortality was reported from enrollment up to 52 months.
Patients in the Enrolled But Not Randomized group were enrolled in the study but discontinued before being allocated into a treatment group. They never received treatment with exicorilant. Thus, they were not at risk for a treatment-emergent adverse event.
|
0.00%
0/10 • Treatment-emergent adverse events were reported from randomization up to 27 months for Segment 1 and up to 19 months for Segment 2. All-cause mortality was reported from enrollment up to 52 months.
Patients in the Enrolled But Not Randomized group were enrolled in the study but discontinued before being allocated into a treatment group. They never received treatment with exicorilant. Thus, they were not at risk for a treatment-emergent adverse event.
|
0.00%
0/6 • Treatment-emergent adverse events were reported from randomization up to 27 months for Segment 1 and up to 19 months for Segment 2. All-cause mortality was reported from enrollment up to 52 months.
Patients in the Enrolled But Not Randomized group were enrolled in the study but discontinued before being allocated into a treatment group. They never received treatment with exicorilant. Thus, they were not at risk for a treatment-emergent adverse event.
|
|
Nervous system disorders
Visual field defect
|
0.00%
0/3 • Treatment-emergent adverse events were reported from randomization up to 27 months for Segment 1 and up to 19 months for Segment 2. All-cause mortality was reported from enrollment up to 52 months.
Patients in the Enrolled But Not Randomized group were enrolled in the study but discontinued before being allocated into a treatment group. They never received treatment with exicorilant. Thus, they were not at risk for a treatment-emergent adverse event.
|
14.3%
1/7 • Treatment-emergent adverse events were reported from randomization up to 27 months for Segment 1 and up to 19 months for Segment 2. All-cause mortality was reported from enrollment up to 52 months.
Patients in the Enrolled But Not Randomized group were enrolled in the study but discontinued before being allocated into a treatment group. They never received treatment with exicorilant. Thus, they were not at risk for a treatment-emergent adverse event.
|
—
0/0 • Treatment-emergent adverse events were reported from randomization up to 27 months for Segment 1 and up to 19 months for Segment 2. All-cause mortality was reported from enrollment up to 52 months.
Patients in the Enrolled But Not Randomized group were enrolled in the study but discontinued before being allocated into a treatment group. They never received treatment with exicorilant. Thus, they were not at risk for a treatment-emergent adverse event.
|
0.00%
0/2 • Treatment-emergent adverse events were reported from randomization up to 27 months for Segment 1 and up to 19 months for Segment 2. All-cause mortality was reported from enrollment up to 52 months.
Patients in the Enrolled But Not Randomized group were enrolled in the study but discontinued before being allocated into a treatment group. They never received treatment with exicorilant. Thus, they were not at risk for a treatment-emergent adverse event.
|
0.00%
0/8 • Treatment-emergent adverse events were reported from randomization up to 27 months for Segment 1 and up to 19 months for Segment 2. All-cause mortality was reported from enrollment up to 52 months.
Patients in the Enrolled But Not Randomized group were enrolled in the study but discontinued before being allocated into a treatment group. They never received treatment with exicorilant. Thus, they were not at risk for a treatment-emergent adverse event.
|
0.00%
0/1 • Treatment-emergent adverse events were reported from randomization up to 27 months for Segment 1 and up to 19 months for Segment 2. All-cause mortality was reported from enrollment up to 52 months.
Patients in the Enrolled But Not Randomized group were enrolled in the study but discontinued before being allocated into a treatment group. They never received treatment with exicorilant. Thus, they were not at risk for a treatment-emergent adverse event.
|
0.00%
0/10 • Treatment-emergent adverse events were reported from randomization up to 27 months for Segment 1 and up to 19 months for Segment 2. All-cause mortality was reported from enrollment up to 52 months.
Patients in the Enrolled But Not Randomized group were enrolled in the study but discontinued before being allocated into a treatment group. They never received treatment with exicorilant. Thus, they were not at risk for a treatment-emergent adverse event.
|
0.00%
0/6 • Treatment-emergent adverse events were reported from randomization up to 27 months for Segment 1 and up to 19 months for Segment 2. All-cause mortality was reported from enrollment up to 52 months.
Patients in the Enrolled But Not Randomized group were enrolled in the study but discontinued before being allocated into a treatment group. They never received treatment with exicorilant. Thus, they were not at risk for a treatment-emergent adverse event.
|
|
Psychiatric disorders
Insomnia
|
0.00%
0/3 • Treatment-emergent adverse events were reported from randomization up to 27 months for Segment 1 and up to 19 months for Segment 2. All-cause mortality was reported from enrollment up to 52 months.
Patients in the Enrolled But Not Randomized group were enrolled in the study but discontinued before being allocated into a treatment group. They never received treatment with exicorilant. Thus, they were not at risk for a treatment-emergent adverse event.
|
0.00%
0/7 • Treatment-emergent adverse events were reported from randomization up to 27 months for Segment 1 and up to 19 months for Segment 2. All-cause mortality was reported from enrollment up to 52 months.
Patients in the Enrolled But Not Randomized group were enrolled in the study but discontinued before being allocated into a treatment group. They never received treatment with exicorilant. Thus, they were not at risk for a treatment-emergent adverse event.
|
—
0/0 • Treatment-emergent adverse events were reported from randomization up to 27 months for Segment 1 and up to 19 months for Segment 2. All-cause mortality was reported from enrollment up to 52 months.
Patients in the Enrolled But Not Randomized group were enrolled in the study but discontinued before being allocated into a treatment group. They never received treatment with exicorilant. Thus, they were not at risk for a treatment-emergent adverse event.
|
0.00%
0/2 • Treatment-emergent adverse events were reported from randomization up to 27 months for Segment 1 and up to 19 months for Segment 2. All-cause mortality was reported from enrollment up to 52 months.
Patients in the Enrolled But Not Randomized group were enrolled in the study but discontinued before being allocated into a treatment group. They never received treatment with exicorilant. Thus, they were not at risk for a treatment-emergent adverse event.
|
12.5%
1/8 • Treatment-emergent adverse events were reported from randomization up to 27 months for Segment 1 and up to 19 months for Segment 2. All-cause mortality was reported from enrollment up to 52 months.
Patients in the Enrolled But Not Randomized group were enrolled in the study but discontinued before being allocated into a treatment group. They never received treatment with exicorilant. Thus, they were not at risk for a treatment-emergent adverse event.
|
0.00%
0/1 • Treatment-emergent adverse events were reported from randomization up to 27 months for Segment 1 and up to 19 months for Segment 2. All-cause mortality was reported from enrollment up to 52 months.
Patients in the Enrolled But Not Randomized group were enrolled in the study but discontinued before being allocated into a treatment group. They never received treatment with exicorilant. Thus, they were not at risk for a treatment-emergent adverse event.
|
10.0%
1/10 • Treatment-emergent adverse events were reported from randomization up to 27 months for Segment 1 and up to 19 months for Segment 2. All-cause mortality was reported from enrollment up to 52 months.
Patients in the Enrolled But Not Randomized group were enrolled in the study but discontinued before being allocated into a treatment group. They never received treatment with exicorilant. Thus, they were not at risk for a treatment-emergent adverse event.
|
0.00%
0/6 • Treatment-emergent adverse events were reported from randomization up to 27 months for Segment 1 and up to 19 months for Segment 2. All-cause mortality was reported from enrollment up to 52 months.
Patients in the Enrolled But Not Randomized group were enrolled in the study but discontinued before being allocated into a treatment group. They never received treatment with exicorilant. Thus, they were not at risk for a treatment-emergent adverse event.
|
|
Psychiatric disorders
Irritability
|
0.00%
0/3 • Treatment-emergent adverse events were reported from randomization up to 27 months for Segment 1 and up to 19 months for Segment 2. All-cause mortality was reported from enrollment up to 52 months.
Patients in the Enrolled But Not Randomized group were enrolled in the study but discontinued before being allocated into a treatment group. They never received treatment with exicorilant. Thus, they were not at risk for a treatment-emergent adverse event.
|
0.00%
0/7 • Treatment-emergent adverse events were reported from randomization up to 27 months for Segment 1 and up to 19 months for Segment 2. All-cause mortality was reported from enrollment up to 52 months.
Patients in the Enrolled But Not Randomized group were enrolled in the study but discontinued before being allocated into a treatment group. They never received treatment with exicorilant. Thus, they were not at risk for a treatment-emergent adverse event.
|
—
0/0 • Treatment-emergent adverse events were reported from randomization up to 27 months for Segment 1 and up to 19 months for Segment 2. All-cause mortality was reported from enrollment up to 52 months.
Patients in the Enrolled But Not Randomized group were enrolled in the study but discontinued before being allocated into a treatment group. They never received treatment with exicorilant. Thus, they were not at risk for a treatment-emergent adverse event.
|
0.00%
0/2 • Treatment-emergent adverse events were reported from randomization up to 27 months for Segment 1 and up to 19 months for Segment 2. All-cause mortality was reported from enrollment up to 52 months.
Patients in the Enrolled But Not Randomized group were enrolled in the study but discontinued before being allocated into a treatment group. They never received treatment with exicorilant. Thus, they were not at risk for a treatment-emergent adverse event.
|
0.00%
0/8 • Treatment-emergent adverse events were reported from randomization up to 27 months for Segment 1 and up to 19 months for Segment 2. All-cause mortality was reported from enrollment up to 52 months.
Patients in the Enrolled But Not Randomized group were enrolled in the study but discontinued before being allocated into a treatment group. They never received treatment with exicorilant. Thus, they were not at risk for a treatment-emergent adverse event.
|
0.00%
0/1 • Treatment-emergent adverse events were reported from randomization up to 27 months for Segment 1 and up to 19 months for Segment 2. All-cause mortality was reported from enrollment up to 52 months.
Patients in the Enrolled But Not Randomized group were enrolled in the study but discontinued before being allocated into a treatment group. They never received treatment with exicorilant. Thus, they were not at risk for a treatment-emergent adverse event.
|
0.00%
0/10 • Treatment-emergent adverse events were reported from randomization up to 27 months for Segment 1 and up to 19 months for Segment 2. All-cause mortality was reported from enrollment up to 52 months.
Patients in the Enrolled But Not Randomized group were enrolled in the study but discontinued before being allocated into a treatment group. They never received treatment with exicorilant. Thus, they were not at risk for a treatment-emergent adverse event.
|
16.7%
1/6 • Treatment-emergent adverse events were reported from randomization up to 27 months for Segment 1 and up to 19 months for Segment 2. All-cause mortality was reported from enrollment up to 52 months.
Patients in the Enrolled But Not Randomized group were enrolled in the study but discontinued before being allocated into a treatment group. They never received treatment with exicorilant. Thus, they were not at risk for a treatment-emergent adverse event.
|
|
Renal and urinary disorders
Haematuria
|
0.00%
0/3 • Treatment-emergent adverse events were reported from randomization up to 27 months for Segment 1 and up to 19 months for Segment 2. All-cause mortality was reported from enrollment up to 52 months.
Patients in the Enrolled But Not Randomized group were enrolled in the study but discontinued before being allocated into a treatment group. They never received treatment with exicorilant. Thus, they were not at risk for a treatment-emergent adverse event.
|
0.00%
0/7 • Treatment-emergent adverse events were reported from randomization up to 27 months for Segment 1 and up to 19 months for Segment 2. All-cause mortality was reported from enrollment up to 52 months.
Patients in the Enrolled But Not Randomized group were enrolled in the study but discontinued before being allocated into a treatment group. They never received treatment with exicorilant. Thus, they were not at risk for a treatment-emergent adverse event.
|
—
0/0 • Treatment-emergent adverse events were reported from randomization up to 27 months for Segment 1 and up to 19 months for Segment 2. All-cause mortality was reported from enrollment up to 52 months.
Patients in the Enrolled But Not Randomized group were enrolled in the study but discontinued before being allocated into a treatment group. They never received treatment with exicorilant. Thus, they were not at risk for a treatment-emergent adverse event.
|
0.00%
0/2 • Treatment-emergent adverse events were reported from randomization up to 27 months for Segment 1 and up to 19 months for Segment 2. All-cause mortality was reported from enrollment up to 52 months.
Patients in the Enrolled But Not Randomized group were enrolled in the study but discontinued before being allocated into a treatment group. They never received treatment with exicorilant. Thus, they were not at risk for a treatment-emergent adverse event.
|
0.00%
0/8 • Treatment-emergent adverse events were reported from randomization up to 27 months for Segment 1 and up to 19 months for Segment 2. All-cause mortality was reported from enrollment up to 52 months.
Patients in the Enrolled But Not Randomized group were enrolled in the study but discontinued before being allocated into a treatment group. They never received treatment with exicorilant. Thus, they were not at risk for a treatment-emergent adverse event.
|
0.00%
0/1 • Treatment-emergent adverse events were reported from randomization up to 27 months for Segment 1 and up to 19 months for Segment 2. All-cause mortality was reported from enrollment up to 52 months.
Patients in the Enrolled But Not Randomized group were enrolled in the study but discontinued before being allocated into a treatment group. They never received treatment with exicorilant. Thus, they were not at risk for a treatment-emergent adverse event.
|
20.0%
2/10 • Treatment-emergent adverse events were reported from randomization up to 27 months for Segment 1 and up to 19 months for Segment 2. All-cause mortality was reported from enrollment up to 52 months.
Patients in the Enrolled But Not Randomized group were enrolled in the study but discontinued before being allocated into a treatment group. They never received treatment with exicorilant. Thus, they were not at risk for a treatment-emergent adverse event.
|
16.7%
1/6 • Treatment-emergent adverse events were reported from randomization up to 27 months for Segment 1 and up to 19 months for Segment 2. All-cause mortality was reported from enrollment up to 52 months.
Patients in the Enrolled But Not Randomized group were enrolled in the study but discontinued before being allocated into a treatment group. They never received treatment with exicorilant. Thus, they were not at risk for a treatment-emergent adverse event.
|
|
Renal and urinary disorders
Micturition frequency decreased
|
0.00%
0/3 • Treatment-emergent adverse events were reported from randomization up to 27 months for Segment 1 and up to 19 months for Segment 2. All-cause mortality was reported from enrollment up to 52 months.
Patients in the Enrolled But Not Randomized group were enrolled in the study but discontinued before being allocated into a treatment group. They never received treatment with exicorilant. Thus, they were not at risk for a treatment-emergent adverse event.
|
0.00%
0/7 • Treatment-emergent adverse events were reported from randomization up to 27 months for Segment 1 and up to 19 months for Segment 2. All-cause mortality was reported from enrollment up to 52 months.
Patients in the Enrolled But Not Randomized group were enrolled in the study but discontinued before being allocated into a treatment group. They never received treatment with exicorilant. Thus, they were not at risk for a treatment-emergent adverse event.
|
—
0/0 • Treatment-emergent adverse events were reported from randomization up to 27 months for Segment 1 and up to 19 months for Segment 2. All-cause mortality was reported from enrollment up to 52 months.
Patients in the Enrolled But Not Randomized group were enrolled in the study but discontinued before being allocated into a treatment group. They never received treatment with exicorilant. Thus, they were not at risk for a treatment-emergent adverse event.
|
0.00%
0/2 • Treatment-emergent adverse events were reported from randomization up to 27 months for Segment 1 and up to 19 months for Segment 2. All-cause mortality was reported from enrollment up to 52 months.
Patients in the Enrolled But Not Randomized group were enrolled in the study but discontinued before being allocated into a treatment group. They never received treatment with exicorilant. Thus, they were not at risk for a treatment-emergent adverse event.
|
0.00%
0/8 • Treatment-emergent adverse events were reported from randomization up to 27 months for Segment 1 and up to 19 months for Segment 2. All-cause mortality was reported from enrollment up to 52 months.
Patients in the Enrolled But Not Randomized group were enrolled in the study but discontinued before being allocated into a treatment group. They never received treatment with exicorilant. Thus, they were not at risk for a treatment-emergent adverse event.
|
0.00%
0/1 • Treatment-emergent adverse events were reported from randomization up to 27 months for Segment 1 and up to 19 months for Segment 2. All-cause mortality was reported from enrollment up to 52 months.
Patients in the Enrolled But Not Randomized group were enrolled in the study but discontinued before being allocated into a treatment group. They never received treatment with exicorilant. Thus, they were not at risk for a treatment-emergent adverse event.
|
0.00%
0/10 • Treatment-emergent adverse events were reported from randomization up to 27 months for Segment 1 and up to 19 months for Segment 2. All-cause mortality was reported from enrollment up to 52 months.
Patients in the Enrolled But Not Randomized group were enrolled in the study but discontinued before being allocated into a treatment group. They never received treatment with exicorilant. Thus, they were not at risk for a treatment-emergent adverse event.
|
16.7%
1/6 • Treatment-emergent adverse events were reported from randomization up to 27 months for Segment 1 and up to 19 months for Segment 2. All-cause mortality was reported from enrollment up to 52 months.
Patients in the Enrolled But Not Randomized group were enrolled in the study but discontinued before being allocated into a treatment group. They never received treatment with exicorilant. Thus, they were not at risk for a treatment-emergent adverse event.
|
|
Renal and urinary disorders
Nocturia
|
0.00%
0/3 • Treatment-emergent adverse events were reported from randomization up to 27 months for Segment 1 and up to 19 months for Segment 2. All-cause mortality was reported from enrollment up to 52 months.
Patients in the Enrolled But Not Randomized group were enrolled in the study but discontinued before being allocated into a treatment group. They never received treatment with exicorilant. Thus, they were not at risk for a treatment-emergent adverse event.
|
0.00%
0/7 • Treatment-emergent adverse events were reported from randomization up to 27 months for Segment 1 and up to 19 months for Segment 2. All-cause mortality was reported from enrollment up to 52 months.
Patients in the Enrolled But Not Randomized group were enrolled in the study but discontinued before being allocated into a treatment group. They never received treatment with exicorilant. Thus, they were not at risk for a treatment-emergent adverse event.
|
—
0/0 • Treatment-emergent adverse events were reported from randomization up to 27 months for Segment 1 and up to 19 months for Segment 2. All-cause mortality was reported from enrollment up to 52 months.
Patients in the Enrolled But Not Randomized group were enrolled in the study but discontinued before being allocated into a treatment group. They never received treatment with exicorilant. Thus, they were not at risk for a treatment-emergent adverse event.
|
50.0%
1/2 • Treatment-emergent adverse events were reported from randomization up to 27 months for Segment 1 and up to 19 months for Segment 2. All-cause mortality was reported from enrollment up to 52 months.
Patients in the Enrolled But Not Randomized group were enrolled in the study but discontinued before being allocated into a treatment group. They never received treatment with exicorilant. Thus, they were not at risk for a treatment-emergent adverse event.
|
0.00%
0/8 • Treatment-emergent adverse events were reported from randomization up to 27 months for Segment 1 and up to 19 months for Segment 2. All-cause mortality was reported from enrollment up to 52 months.
Patients in the Enrolled But Not Randomized group were enrolled in the study but discontinued before being allocated into a treatment group. They never received treatment with exicorilant. Thus, they were not at risk for a treatment-emergent adverse event.
|
0.00%
0/1 • Treatment-emergent adverse events were reported from randomization up to 27 months for Segment 1 and up to 19 months for Segment 2. All-cause mortality was reported from enrollment up to 52 months.
Patients in the Enrolled But Not Randomized group were enrolled in the study but discontinued before being allocated into a treatment group. They never received treatment with exicorilant. Thus, they were not at risk for a treatment-emergent adverse event.
|
0.00%
0/10 • Treatment-emergent adverse events were reported from randomization up to 27 months for Segment 1 and up to 19 months for Segment 2. All-cause mortality was reported from enrollment up to 52 months.
Patients in the Enrolled But Not Randomized group were enrolled in the study but discontinued before being allocated into a treatment group. They never received treatment with exicorilant. Thus, they were not at risk for a treatment-emergent adverse event.
|
0.00%
0/6 • Treatment-emergent adverse events were reported from randomization up to 27 months for Segment 1 and up to 19 months for Segment 2. All-cause mortality was reported from enrollment up to 52 months.
Patients in the Enrolled But Not Randomized group were enrolled in the study but discontinued before being allocated into a treatment group. They never received treatment with exicorilant. Thus, they were not at risk for a treatment-emergent adverse event.
|
|
Renal and urinary disorders
Pollakiuria
|
0.00%
0/3 • Treatment-emergent adverse events were reported from randomization up to 27 months for Segment 1 and up to 19 months for Segment 2. All-cause mortality was reported from enrollment up to 52 months.
Patients in the Enrolled But Not Randomized group were enrolled in the study but discontinued before being allocated into a treatment group. They never received treatment with exicorilant. Thus, they were not at risk for a treatment-emergent adverse event.
|
0.00%
0/7 • Treatment-emergent adverse events were reported from randomization up to 27 months for Segment 1 and up to 19 months for Segment 2. All-cause mortality was reported from enrollment up to 52 months.
Patients in the Enrolled But Not Randomized group were enrolled in the study but discontinued before being allocated into a treatment group. They never received treatment with exicorilant. Thus, they were not at risk for a treatment-emergent adverse event.
|
—
0/0 • Treatment-emergent adverse events were reported from randomization up to 27 months for Segment 1 and up to 19 months for Segment 2. All-cause mortality was reported from enrollment up to 52 months.
Patients in the Enrolled But Not Randomized group were enrolled in the study but discontinued before being allocated into a treatment group. They never received treatment with exicorilant. Thus, they were not at risk for a treatment-emergent adverse event.
|
0.00%
0/2 • Treatment-emergent adverse events were reported from randomization up to 27 months for Segment 1 and up to 19 months for Segment 2. All-cause mortality was reported from enrollment up to 52 months.
Patients in the Enrolled But Not Randomized group were enrolled in the study but discontinued before being allocated into a treatment group. They never received treatment with exicorilant. Thus, they were not at risk for a treatment-emergent adverse event.
|
0.00%
0/8 • Treatment-emergent adverse events were reported from randomization up to 27 months for Segment 1 and up to 19 months for Segment 2. All-cause mortality was reported from enrollment up to 52 months.
Patients in the Enrolled But Not Randomized group were enrolled in the study but discontinued before being allocated into a treatment group. They never received treatment with exicorilant. Thus, they were not at risk for a treatment-emergent adverse event.
|
0.00%
0/1 • Treatment-emergent adverse events were reported from randomization up to 27 months for Segment 1 and up to 19 months for Segment 2. All-cause mortality was reported from enrollment up to 52 months.
Patients in the Enrolled But Not Randomized group were enrolled in the study but discontinued before being allocated into a treatment group. They never received treatment with exicorilant. Thus, they were not at risk for a treatment-emergent adverse event.
|
20.0%
2/10 • Treatment-emergent adverse events were reported from randomization up to 27 months for Segment 1 and up to 19 months for Segment 2. All-cause mortality was reported from enrollment up to 52 months.
Patients in the Enrolled But Not Randomized group were enrolled in the study but discontinued before being allocated into a treatment group. They never received treatment with exicorilant. Thus, they were not at risk for a treatment-emergent adverse event.
|
0.00%
0/6 • Treatment-emergent adverse events were reported from randomization up to 27 months for Segment 1 and up to 19 months for Segment 2. All-cause mortality was reported from enrollment up to 52 months.
Patients in the Enrolled But Not Randomized group were enrolled in the study but discontinued before being allocated into a treatment group. They never received treatment with exicorilant. Thus, they were not at risk for a treatment-emergent adverse event.
|
|
Renal and urinary disorders
Proteinuria
|
0.00%
0/3 • Treatment-emergent adverse events were reported from randomization up to 27 months for Segment 1 and up to 19 months for Segment 2. All-cause mortality was reported from enrollment up to 52 months.
Patients in the Enrolled But Not Randomized group were enrolled in the study but discontinued before being allocated into a treatment group. They never received treatment with exicorilant. Thus, they were not at risk for a treatment-emergent adverse event.
|
0.00%
0/7 • Treatment-emergent adverse events were reported from randomization up to 27 months for Segment 1 and up to 19 months for Segment 2. All-cause mortality was reported from enrollment up to 52 months.
Patients in the Enrolled But Not Randomized group were enrolled in the study but discontinued before being allocated into a treatment group. They never received treatment with exicorilant. Thus, they were not at risk for a treatment-emergent adverse event.
|
—
0/0 • Treatment-emergent adverse events were reported from randomization up to 27 months for Segment 1 and up to 19 months for Segment 2. All-cause mortality was reported from enrollment up to 52 months.
Patients in the Enrolled But Not Randomized group were enrolled in the study but discontinued before being allocated into a treatment group. They never received treatment with exicorilant. Thus, they were not at risk for a treatment-emergent adverse event.
|
0.00%
0/2 • Treatment-emergent adverse events were reported from randomization up to 27 months for Segment 1 and up to 19 months for Segment 2. All-cause mortality was reported from enrollment up to 52 months.
Patients in the Enrolled But Not Randomized group were enrolled in the study but discontinued before being allocated into a treatment group. They never received treatment with exicorilant. Thus, they were not at risk for a treatment-emergent adverse event.
|
0.00%
0/8 • Treatment-emergent adverse events were reported from randomization up to 27 months for Segment 1 and up to 19 months for Segment 2. All-cause mortality was reported from enrollment up to 52 months.
Patients in the Enrolled But Not Randomized group were enrolled in the study but discontinued before being allocated into a treatment group. They never received treatment with exicorilant. Thus, they were not at risk for a treatment-emergent adverse event.
|
0.00%
0/1 • Treatment-emergent adverse events were reported from randomization up to 27 months for Segment 1 and up to 19 months for Segment 2. All-cause mortality was reported from enrollment up to 52 months.
Patients in the Enrolled But Not Randomized group were enrolled in the study but discontinued before being allocated into a treatment group. They never received treatment with exicorilant. Thus, they were not at risk for a treatment-emergent adverse event.
|
10.0%
1/10 • Treatment-emergent adverse events were reported from randomization up to 27 months for Segment 1 and up to 19 months for Segment 2. All-cause mortality was reported from enrollment up to 52 months.
Patients in the Enrolled But Not Randomized group were enrolled in the study but discontinued before being allocated into a treatment group. They never received treatment with exicorilant. Thus, they were not at risk for a treatment-emergent adverse event.
|
16.7%
1/6 • Treatment-emergent adverse events were reported from randomization up to 27 months for Segment 1 and up to 19 months for Segment 2. All-cause mortality was reported from enrollment up to 52 months.
Patients in the Enrolled But Not Randomized group were enrolled in the study but discontinued before being allocated into a treatment group. They never received treatment with exicorilant. Thus, they were not at risk for a treatment-emergent adverse event.
|
|
Renal and urinary disorders
Urinary hesitation
|
0.00%
0/3 • Treatment-emergent adverse events were reported from randomization up to 27 months for Segment 1 and up to 19 months for Segment 2. All-cause mortality was reported from enrollment up to 52 months.
Patients in the Enrolled But Not Randomized group were enrolled in the study but discontinued before being allocated into a treatment group. They never received treatment with exicorilant. Thus, they were not at risk for a treatment-emergent adverse event.
|
0.00%
0/7 • Treatment-emergent adverse events were reported from randomization up to 27 months for Segment 1 and up to 19 months for Segment 2. All-cause mortality was reported from enrollment up to 52 months.
Patients in the Enrolled But Not Randomized group were enrolled in the study but discontinued before being allocated into a treatment group. They never received treatment with exicorilant. Thus, they were not at risk for a treatment-emergent adverse event.
|
—
0/0 • Treatment-emergent adverse events were reported from randomization up to 27 months for Segment 1 and up to 19 months for Segment 2. All-cause mortality was reported from enrollment up to 52 months.
Patients in the Enrolled But Not Randomized group were enrolled in the study but discontinued before being allocated into a treatment group. They never received treatment with exicorilant. Thus, they were not at risk for a treatment-emergent adverse event.
|
0.00%
0/2 • Treatment-emergent adverse events were reported from randomization up to 27 months for Segment 1 and up to 19 months for Segment 2. All-cause mortality was reported from enrollment up to 52 months.
Patients in the Enrolled But Not Randomized group were enrolled in the study but discontinued before being allocated into a treatment group. They never received treatment with exicorilant. Thus, they were not at risk for a treatment-emergent adverse event.
|
0.00%
0/8 • Treatment-emergent adverse events were reported from randomization up to 27 months for Segment 1 and up to 19 months for Segment 2. All-cause mortality was reported from enrollment up to 52 months.
Patients in the Enrolled But Not Randomized group were enrolled in the study but discontinued before being allocated into a treatment group. They never received treatment with exicorilant. Thus, they were not at risk for a treatment-emergent adverse event.
|
0.00%
0/1 • Treatment-emergent adverse events were reported from randomization up to 27 months for Segment 1 and up to 19 months for Segment 2. All-cause mortality was reported from enrollment up to 52 months.
Patients in the Enrolled But Not Randomized group were enrolled in the study but discontinued before being allocated into a treatment group. They never received treatment with exicorilant. Thus, they were not at risk for a treatment-emergent adverse event.
|
10.0%
1/10 • Treatment-emergent adverse events were reported from randomization up to 27 months for Segment 1 and up to 19 months for Segment 2. All-cause mortality was reported from enrollment up to 52 months.
Patients in the Enrolled But Not Randomized group were enrolled in the study but discontinued before being allocated into a treatment group. They never received treatment with exicorilant. Thus, they were not at risk for a treatment-emergent adverse event.
|
0.00%
0/6 • Treatment-emergent adverse events were reported from randomization up to 27 months for Segment 1 and up to 19 months for Segment 2. All-cause mortality was reported from enrollment up to 52 months.
Patients in the Enrolled But Not Randomized group were enrolled in the study but discontinued before being allocated into a treatment group. They never received treatment with exicorilant. Thus, they were not at risk for a treatment-emergent adverse event.
|
|
Reproductive system and breast disorders
Pelvic pain
|
0.00%
0/3 • Treatment-emergent adverse events were reported from randomization up to 27 months for Segment 1 and up to 19 months for Segment 2. All-cause mortality was reported from enrollment up to 52 months.
Patients in the Enrolled But Not Randomized group were enrolled in the study but discontinued before being allocated into a treatment group. They never received treatment with exicorilant. Thus, they were not at risk for a treatment-emergent adverse event.
|
0.00%
0/7 • Treatment-emergent adverse events were reported from randomization up to 27 months for Segment 1 and up to 19 months for Segment 2. All-cause mortality was reported from enrollment up to 52 months.
Patients in the Enrolled But Not Randomized group were enrolled in the study but discontinued before being allocated into a treatment group. They never received treatment with exicorilant. Thus, they were not at risk for a treatment-emergent adverse event.
|
—
0/0 • Treatment-emergent adverse events were reported from randomization up to 27 months for Segment 1 and up to 19 months for Segment 2. All-cause mortality was reported from enrollment up to 52 months.
Patients in the Enrolled But Not Randomized group were enrolled in the study but discontinued before being allocated into a treatment group. They never received treatment with exicorilant. Thus, they were not at risk for a treatment-emergent adverse event.
|
0.00%
0/2 • Treatment-emergent adverse events were reported from randomization up to 27 months for Segment 1 and up to 19 months for Segment 2. All-cause mortality was reported from enrollment up to 52 months.
Patients in the Enrolled But Not Randomized group were enrolled in the study but discontinued before being allocated into a treatment group. They never received treatment with exicorilant. Thus, they were not at risk for a treatment-emergent adverse event.
|
0.00%
0/8 • Treatment-emergent adverse events were reported from randomization up to 27 months for Segment 1 and up to 19 months for Segment 2. All-cause mortality was reported from enrollment up to 52 months.
Patients in the Enrolled But Not Randomized group were enrolled in the study but discontinued before being allocated into a treatment group. They never received treatment with exicorilant. Thus, they were not at risk for a treatment-emergent adverse event.
|
0.00%
0/1 • Treatment-emergent adverse events were reported from randomization up to 27 months for Segment 1 and up to 19 months for Segment 2. All-cause mortality was reported from enrollment up to 52 months.
Patients in the Enrolled But Not Randomized group were enrolled in the study but discontinued before being allocated into a treatment group. They never received treatment with exicorilant. Thus, they were not at risk for a treatment-emergent adverse event.
|
20.0%
2/10 • Treatment-emergent adverse events were reported from randomization up to 27 months for Segment 1 and up to 19 months for Segment 2. All-cause mortality was reported from enrollment up to 52 months.
Patients in the Enrolled But Not Randomized group were enrolled in the study but discontinued before being allocated into a treatment group. They never received treatment with exicorilant. Thus, they were not at risk for a treatment-emergent adverse event.
|
16.7%
1/6 • Treatment-emergent adverse events were reported from randomization up to 27 months for Segment 1 and up to 19 months for Segment 2. All-cause mortality was reported from enrollment up to 52 months.
Patients in the Enrolled But Not Randomized group were enrolled in the study but discontinued before being allocated into a treatment group. They never received treatment with exicorilant. Thus, they were not at risk for a treatment-emergent adverse event.
|
|
Respiratory, thoracic and mediastinal disorders
Bronchospasm
|
0.00%
0/3 • Treatment-emergent adverse events were reported from randomization up to 27 months for Segment 1 and up to 19 months for Segment 2. All-cause mortality was reported from enrollment up to 52 months.
Patients in the Enrolled But Not Randomized group were enrolled in the study but discontinued before being allocated into a treatment group. They never received treatment with exicorilant. Thus, they were not at risk for a treatment-emergent adverse event.
|
14.3%
1/7 • Treatment-emergent adverse events were reported from randomization up to 27 months for Segment 1 and up to 19 months for Segment 2. All-cause mortality was reported from enrollment up to 52 months.
Patients in the Enrolled But Not Randomized group were enrolled in the study but discontinued before being allocated into a treatment group. They never received treatment with exicorilant. Thus, they were not at risk for a treatment-emergent adverse event.
|
—
0/0 • Treatment-emergent adverse events were reported from randomization up to 27 months for Segment 1 and up to 19 months for Segment 2. All-cause mortality was reported from enrollment up to 52 months.
Patients in the Enrolled But Not Randomized group were enrolled in the study but discontinued before being allocated into a treatment group. They never received treatment with exicorilant. Thus, they were not at risk for a treatment-emergent adverse event.
|
0.00%
0/2 • Treatment-emergent adverse events were reported from randomization up to 27 months for Segment 1 and up to 19 months for Segment 2. All-cause mortality was reported from enrollment up to 52 months.
Patients in the Enrolled But Not Randomized group were enrolled in the study but discontinued before being allocated into a treatment group. They never received treatment with exicorilant. Thus, they were not at risk for a treatment-emergent adverse event.
|
0.00%
0/8 • Treatment-emergent adverse events were reported from randomization up to 27 months for Segment 1 and up to 19 months for Segment 2. All-cause mortality was reported from enrollment up to 52 months.
Patients in the Enrolled But Not Randomized group were enrolled in the study but discontinued before being allocated into a treatment group. They never received treatment with exicorilant. Thus, they were not at risk for a treatment-emergent adverse event.
|
0.00%
0/1 • Treatment-emergent adverse events were reported from randomization up to 27 months for Segment 1 and up to 19 months for Segment 2. All-cause mortality was reported from enrollment up to 52 months.
Patients in the Enrolled But Not Randomized group were enrolled in the study but discontinued before being allocated into a treatment group. They never received treatment with exicorilant. Thus, they were not at risk for a treatment-emergent adverse event.
|
0.00%
0/10 • Treatment-emergent adverse events were reported from randomization up to 27 months for Segment 1 and up to 19 months for Segment 2. All-cause mortality was reported from enrollment up to 52 months.
Patients in the Enrolled But Not Randomized group were enrolled in the study but discontinued before being allocated into a treatment group. They never received treatment with exicorilant. Thus, they were not at risk for a treatment-emergent adverse event.
|
0.00%
0/6 • Treatment-emergent adverse events were reported from randomization up to 27 months for Segment 1 and up to 19 months for Segment 2. All-cause mortality was reported from enrollment up to 52 months.
Patients in the Enrolled But Not Randomized group were enrolled in the study but discontinued before being allocated into a treatment group. They never received treatment with exicorilant. Thus, they were not at risk for a treatment-emergent adverse event.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.00%
0/3 • Treatment-emergent adverse events were reported from randomization up to 27 months for Segment 1 and up to 19 months for Segment 2. All-cause mortality was reported from enrollment up to 52 months.
Patients in the Enrolled But Not Randomized group were enrolled in the study but discontinued before being allocated into a treatment group. They never received treatment with exicorilant. Thus, they were not at risk for a treatment-emergent adverse event.
|
14.3%
1/7 • Treatment-emergent adverse events were reported from randomization up to 27 months for Segment 1 and up to 19 months for Segment 2. All-cause mortality was reported from enrollment up to 52 months.
Patients in the Enrolled But Not Randomized group were enrolled in the study but discontinued before being allocated into a treatment group. They never received treatment with exicorilant. Thus, they were not at risk for a treatment-emergent adverse event.
|
—
0/0 • Treatment-emergent adverse events were reported from randomization up to 27 months for Segment 1 and up to 19 months for Segment 2. All-cause mortality was reported from enrollment up to 52 months.
Patients in the Enrolled But Not Randomized group were enrolled in the study but discontinued before being allocated into a treatment group. They never received treatment with exicorilant. Thus, they were not at risk for a treatment-emergent adverse event.
|
0.00%
0/2 • Treatment-emergent adverse events were reported from randomization up to 27 months for Segment 1 and up to 19 months for Segment 2. All-cause mortality was reported from enrollment up to 52 months.
Patients in the Enrolled But Not Randomized group were enrolled in the study but discontinued before being allocated into a treatment group. They never received treatment with exicorilant. Thus, they were not at risk for a treatment-emergent adverse event.
|
0.00%
0/8 • Treatment-emergent adverse events were reported from randomization up to 27 months for Segment 1 and up to 19 months for Segment 2. All-cause mortality was reported from enrollment up to 52 months.
Patients in the Enrolled But Not Randomized group were enrolled in the study but discontinued before being allocated into a treatment group. They never received treatment with exicorilant. Thus, they were not at risk for a treatment-emergent adverse event.
|
0.00%
0/1 • Treatment-emergent adverse events were reported from randomization up to 27 months for Segment 1 and up to 19 months for Segment 2. All-cause mortality was reported from enrollment up to 52 months.
Patients in the Enrolled But Not Randomized group were enrolled in the study but discontinued before being allocated into a treatment group. They never received treatment with exicorilant. Thus, they were not at risk for a treatment-emergent adverse event.
|
20.0%
2/10 • Treatment-emergent adverse events were reported from randomization up to 27 months for Segment 1 and up to 19 months for Segment 2. All-cause mortality was reported from enrollment up to 52 months.
Patients in the Enrolled But Not Randomized group were enrolled in the study but discontinued before being allocated into a treatment group. They never received treatment with exicorilant. Thus, they were not at risk for a treatment-emergent adverse event.
|
0.00%
0/6 • Treatment-emergent adverse events were reported from randomization up to 27 months for Segment 1 and up to 19 months for Segment 2. All-cause mortality was reported from enrollment up to 52 months.
Patients in the Enrolled But Not Randomized group were enrolled in the study but discontinued before being allocated into a treatment group. They never received treatment with exicorilant. Thus, they were not at risk for a treatment-emergent adverse event.
|
|
Respiratory, thoracic and mediastinal disorders
Dysphonia
|
0.00%
0/3 • Treatment-emergent adverse events were reported from randomization up to 27 months for Segment 1 and up to 19 months for Segment 2. All-cause mortality was reported from enrollment up to 52 months.
Patients in the Enrolled But Not Randomized group were enrolled in the study but discontinued before being allocated into a treatment group. They never received treatment with exicorilant. Thus, they were not at risk for a treatment-emergent adverse event.
|
0.00%
0/7 • Treatment-emergent adverse events were reported from randomization up to 27 months for Segment 1 and up to 19 months for Segment 2. All-cause mortality was reported from enrollment up to 52 months.
Patients in the Enrolled But Not Randomized group were enrolled in the study but discontinued before being allocated into a treatment group. They never received treatment with exicorilant. Thus, they were not at risk for a treatment-emergent adverse event.
|
—
0/0 • Treatment-emergent adverse events were reported from randomization up to 27 months for Segment 1 and up to 19 months for Segment 2. All-cause mortality was reported from enrollment up to 52 months.
Patients in the Enrolled But Not Randomized group were enrolled in the study but discontinued before being allocated into a treatment group. They never received treatment with exicorilant. Thus, they were not at risk for a treatment-emergent adverse event.
|
0.00%
0/2 • Treatment-emergent adverse events were reported from randomization up to 27 months for Segment 1 and up to 19 months for Segment 2. All-cause mortality was reported from enrollment up to 52 months.
Patients in the Enrolled But Not Randomized group were enrolled in the study but discontinued before being allocated into a treatment group. They never received treatment with exicorilant. Thus, they were not at risk for a treatment-emergent adverse event.
|
0.00%
0/8 • Treatment-emergent adverse events were reported from randomization up to 27 months for Segment 1 and up to 19 months for Segment 2. All-cause mortality was reported from enrollment up to 52 months.
Patients in the Enrolled But Not Randomized group were enrolled in the study but discontinued before being allocated into a treatment group. They never received treatment with exicorilant. Thus, they were not at risk for a treatment-emergent adverse event.
|
0.00%
0/1 • Treatment-emergent adverse events were reported from randomization up to 27 months for Segment 1 and up to 19 months for Segment 2. All-cause mortality was reported from enrollment up to 52 months.
Patients in the Enrolled But Not Randomized group were enrolled in the study but discontinued before being allocated into a treatment group. They never received treatment with exicorilant. Thus, they were not at risk for a treatment-emergent adverse event.
|
10.0%
1/10 • Treatment-emergent adverse events were reported from randomization up to 27 months for Segment 1 and up to 19 months for Segment 2. All-cause mortality was reported from enrollment up to 52 months.
Patients in the Enrolled But Not Randomized group were enrolled in the study but discontinued before being allocated into a treatment group. They never received treatment with exicorilant. Thus, they were not at risk for a treatment-emergent adverse event.
|
0.00%
0/6 • Treatment-emergent adverse events were reported from randomization up to 27 months for Segment 1 and up to 19 months for Segment 2. All-cause mortality was reported from enrollment up to 52 months.
Patients in the Enrolled But Not Randomized group were enrolled in the study but discontinued before being allocated into a treatment group. They never received treatment with exicorilant. Thus, they were not at risk for a treatment-emergent adverse event.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.00%
0/3 • Treatment-emergent adverse events were reported from randomization up to 27 months for Segment 1 and up to 19 months for Segment 2. All-cause mortality was reported from enrollment up to 52 months.
Patients in the Enrolled But Not Randomized group were enrolled in the study but discontinued before being allocated into a treatment group. They never received treatment with exicorilant. Thus, they were not at risk for a treatment-emergent adverse event.
|
14.3%
1/7 • Treatment-emergent adverse events were reported from randomization up to 27 months for Segment 1 and up to 19 months for Segment 2. All-cause mortality was reported from enrollment up to 52 months.
Patients in the Enrolled But Not Randomized group were enrolled in the study but discontinued before being allocated into a treatment group. They never received treatment with exicorilant. Thus, they were not at risk for a treatment-emergent adverse event.
|
—
0/0 • Treatment-emergent adverse events were reported from randomization up to 27 months for Segment 1 and up to 19 months for Segment 2. All-cause mortality was reported from enrollment up to 52 months.
Patients in the Enrolled But Not Randomized group were enrolled in the study but discontinued before being allocated into a treatment group. They never received treatment with exicorilant. Thus, they were not at risk for a treatment-emergent adverse event.
|
50.0%
1/2 • Treatment-emergent adverse events were reported from randomization up to 27 months for Segment 1 and up to 19 months for Segment 2. All-cause mortality was reported from enrollment up to 52 months.
Patients in the Enrolled But Not Randomized group were enrolled in the study but discontinued before being allocated into a treatment group. They never received treatment with exicorilant. Thus, they were not at risk for a treatment-emergent adverse event.
|
0.00%
0/8 • Treatment-emergent adverse events were reported from randomization up to 27 months for Segment 1 and up to 19 months for Segment 2. All-cause mortality was reported from enrollment up to 52 months.
Patients in the Enrolled But Not Randomized group were enrolled in the study but discontinued before being allocated into a treatment group. They never received treatment with exicorilant. Thus, they were not at risk for a treatment-emergent adverse event.
|
0.00%
0/1 • Treatment-emergent adverse events were reported from randomization up to 27 months for Segment 1 and up to 19 months for Segment 2. All-cause mortality was reported from enrollment up to 52 months.
Patients in the Enrolled But Not Randomized group were enrolled in the study but discontinued before being allocated into a treatment group. They never received treatment with exicorilant. Thus, they were not at risk for a treatment-emergent adverse event.
|
0.00%
0/10 • Treatment-emergent adverse events were reported from randomization up to 27 months for Segment 1 and up to 19 months for Segment 2. All-cause mortality was reported from enrollment up to 52 months.
Patients in the Enrolled But Not Randomized group were enrolled in the study but discontinued before being allocated into a treatment group. They never received treatment with exicorilant. Thus, they were not at risk for a treatment-emergent adverse event.
|
16.7%
1/6 • Treatment-emergent adverse events were reported from randomization up to 27 months for Segment 1 and up to 19 months for Segment 2. All-cause mortality was reported from enrollment up to 52 months.
Patients in the Enrolled But Not Randomized group were enrolled in the study but discontinued before being allocated into a treatment group. They never received treatment with exicorilant. Thus, they were not at risk for a treatment-emergent adverse event.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea exertional
|
0.00%
0/3 • Treatment-emergent adverse events were reported from randomization up to 27 months for Segment 1 and up to 19 months for Segment 2. All-cause mortality was reported from enrollment up to 52 months.
Patients in the Enrolled But Not Randomized group were enrolled in the study but discontinued before being allocated into a treatment group. They never received treatment with exicorilant. Thus, they were not at risk for a treatment-emergent adverse event.
|
0.00%
0/7 • Treatment-emergent adverse events were reported from randomization up to 27 months for Segment 1 and up to 19 months for Segment 2. All-cause mortality was reported from enrollment up to 52 months.
Patients in the Enrolled But Not Randomized group were enrolled in the study but discontinued before being allocated into a treatment group. They never received treatment with exicorilant. Thus, they were not at risk for a treatment-emergent adverse event.
|
—
0/0 • Treatment-emergent adverse events were reported from randomization up to 27 months for Segment 1 and up to 19 months for Segment 2. All-cause mortality was reported from enrollment up to 52 months.
Patients in the Enrolled But Not Randomized group were enrolled in the study but discontinued before being allocated into a treatment group. They never received treatment with exicorilant. Thus, they were not at risk for a treatment-emergent adverse event.
|
50.0%
1/2 • Treatment-emergent adverse events were reported from randomization up to 27 months for Segment 1 and up to 19 months for Segment 2. All-cause mortality was reported from enrollment up to 52 months.
Patients in the Enrolled But Not Randomized group were enrolled in the study but discontinued before being allocated into a treatment group. They never received treatment with exicorilant. Thus, they were not at risk for a treatment-emergent adverse event.
|
0.00%
0/8 • Treatment-emergent adverse events were reported from randomization up to 27 months for Segment 1 and up to 19 months for Segment 2. All-cause mortality was reported from enrollment up to 52 months.
Patients in the Enrolled But Not Randomized group were enrolled in the study but discontinued before being allocated into a treatment group. They never received treatment with exicorilant. Thus, they were not at risk for a treatment-emergent adverse event.
|
0.00%
0/1 • Treatment-emergent adverse events were reported from randomization up to 27 months for Segment 1 and up to 19 months for Segment 2. All-cause mortality was reported from enrollment up to 52 months.
Patients in the Enrolled But Not Randomized group were enrolled in the study but discontinued before being allocated into a treatment group. They never received treatment with exicorilant. Thus, they were not at risk for a treatment-emergent adverse event.
|
0.00%
0/10 • Treatment-emergent adverse events were reported from randomization up to 27 months for Segment 1 and up to 19 months for Segment 2. All-cause mortality was reported from enrollment up to 52 months.
Patients in the Enrolled But Not Randomized group were enrolled in the study but discontinued before being allocated into a treatment group. They never received treatment with exicorilant. Thus, they were not at risk for a treatment-emergent adverse event.
|
0.00%
0/6 • Treatment-emergent adverse events were reported from randomization up to 27 months for Segment 1 and up to 19 months for Segment 2. All-cause mortality was reported from enrollment up to 52 months.
Patients in the Enrolled But Not Randomized group were enrolled in the study but discontinued before being allocated into a treatment group. They never received treatment with exicorilant. Thus, they were not at risk for a treatment-emergent adverse event.
|
|
Respiratory, thoracic and mediastinal disorders
Lower respiratory tract congestion
|
0.00%
0/3 • Treatment-emergent adverse events were reported from randomization up to 27 months for Segment 1 and up to 19 months for Segment 2. All-cause mortality was reported from enrollment up to 52 months.
Patients in the Enrolled But Not Randomized group were enrolled in the study but discontinued before being allocated into a treatment group. They never received treatment with exicorilant. Thus, they were not at risk for a treatment-emergent adverse event.
|
0.00%
0/7 • Treatment-emergent adverse events were reported from randomization up to 27 months for Segment 1 and up to 19 months for Segment 2. All-cause mortality was reported from enrollment up to 52 months.
Patients in the Enrolled But Not Randomized group were enrolled in the study but discontinued before being allocated into a treatment group. They never received treatment with exicorilant. Thus, they were not at risk for a treatment-emergent adverse event.
|
—
0/0 • Treatment-emergent adverse events were reported from randomization up to 27 months for Segment 1 and up to 19 months for Segment 2. All-cause mortality was reported from enrollment up to 52 months.
Patients in the Enrolled But Not Randomized group were enrolled in the study but discontinued before being allocated into a treatment group. They never received treatment with exicorilant. Thus, they were not at risk for a treatment-emergent adverse event.
|
0.00%
0/2 • Treatment-emergent adverse events were reported from randomization up to 27 months for Segment 1 and up to 19 months for Segment 2. All-cause mortality was reported from enrollment up to 52 months.
Patients in the Enrolled But Not Randomized group were enrolled in the study but discontinued before being allocated into a treatment group. They never received treatment with exicorilant. Thus, they were not at risk for a treatment-emergent adverse event.
|
0.00%
0/8 • Treatment-emergent adverse events were reported from randomization up to 27 months for Segment 1 and up to 19 months for Segment 2. All-cause mortality was reported from enrollment up to 52 months.
Patients in the Enrolled But Not Randomized group were enrolled in the study but discontinued before being allocated into a treatment group. They never received treatment with exicorilant. Thus, they were not at risk for a treatment-emergent adverse event.
|
0.00%
0/1 • Treatment-emergent adverse events were reported from randomization up to 27 months for Segment 1 and up to 19 months for Segment 2. All-cause mortality was reported from enrollment up to 52 months.
Patients in the Enrolled But Not Randomized group were enrolled in the study but discontinued before being allocated into a treatment group. They never received treatment with exicorilant. Thus, they were not at risk for a treatment-emergent adverse event.
|
0.00%
0/10 • Treatment-emergent adverse events were reported from randomization up to 27 months for Segment 1 and up to 19 months for Segment 2. All-cause mortality was reported from enrollment up to 52 months.
Patients in the Enrolled But Not Randomized group were enrolled in the study but discontinued before being allocated into a treatment group. They never received treatment with exicorilant. Thus, they were not at risk for a treatment-emergent adverse event.
|
16.7%
1/6 • Treatment-emergent adverse events were reported from randomization up to 27 months for Segment 1 and up to 19 months for Segment 2. All-cause mortality was reported from enrollment up to 52 months.
Patients in the Enrolled But Not Randomized group were enrolled in the study but discontinued before being allocated into a treatment group. They never received treatment with exicorilant. Thus, they were not at risk for a treatment-emergent adverse event.
|
|
Respiratory, thoracic and mediastinal disorders
Productive cough
|
0.00%
0/3 • Treatment-emergent adverse events were reported from randomization up to 27 months for Segment 1 and up to 19 months for Segment 2. All-cause mortality was reported from enrollment up to 52 months.
Patients in the Enrolled But Not Randomized group were enrolled in the study but discontinued before being allocated into a treatment group. They never received treatment with exicorilant. Thus, they were not at risk for a treatment-emergent adverse event.
|
0.00%
0/7 • Treatment-emergent adverse events were reported from randomization up to 27 months for Segment 1 and up to 19 months for Segment 2. All-cause mortality was reported from enrollment up to 52 months.
Patients in the Enrolled But Not Randomized group were enrolled in the study but discontinued before being allocated into a treatment group. They never received treatment with exicorilant. Thus, they were not at risk for a treatment-emergent adverse event.
|
—
0/0 • Treatment-emergent adverse events were reported from randomization up to 27 months for Segment 1 and up to 19 months for Segment 2. All-cause mortality was reported from enrollment up to 52 months.
Patients in the Enrolled But Not Randomized group were enrolled in the study but discontinued before being allocated into a treatment group. They never received treatment with exicorilant. Thus, they were not at risk for a treatment-emergent adverse event.
|
0.00%
0/2 • Treatment-emergent adverse events were reported from randomization up to 27 months for Segment 1 and up to 19 months for Segment 2. All-cause mortality was reported from enrollment up to 52 months.
Patients in the Enrolled But Not Randomized group were enrolled in the study but discontinued before being allocated into a treatment group. They never received treatment with exicorilant. Thus, they were not at risk for a treatment-emergent adverse event.
|
0.00%
0/8 • Treatment-emergent adverse events were reported from randomization up to 27 months for Segment 1 and up to 19 months for Segment 2. All-cause mortality was reported from enrollment up to 52 months.
Patients in the Enrolled But Not Randomized group were enrolled in the study but discontinued before being allocated into a treatment group. They never received treatment with exicorilant. Thus, they were not at risk for a treatment-emergent adverse event.
|
0.00%
0/1 • Treatment-emergent adverse events were reported from randomization up to 27 months for Segment 1 and up to 19 months for Segment 2. All-cause mortality was reported from enrollment up to 52 months.
Patients in the Enrolled But Not Randomized group were enrolled in the study but discontinued before being allocated into a treatment group. They never received treatment with exicorilant. Thus, they were not at risk for a treatment-emergent adverse event.
|
0.00%
0/10 • Treatment-emergent adverse events were reported from randomization up to 27 months for Segment 1 and up to 19 months for Segment 2. All-cause mortality was reported from enrollment up to 52 months.
Patients in the Enrolled But Not Randomized group were enrolled in the study but discontinued before being allocated into a treatment group. They never received treatment with exicorilant. Thus, they were not at risk for a treatment-emergent adverse event.
|
16.7%
1/6 • Treatment-emergent adverse events were reported from randomization up to 27 months for Segment 1 and up to 19 months for Segment 2. All-cause mortality was reported from enrollment up to 52 months.
Patients in the Enrolled But Not Randomized group were enrolled in the study but discontinued before being allocated into a treatment group. They never received treatment with exicorilant. Thus, they were not at risk for a treatment-emergent adverse event.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary fibrosis
|
0.00%
0/3 • Treatment-emergent adverse events were reported from randomization up to 27 months for Segment 1 and up to 19 months for Segment 2. All-cause mortality was reported from enrollment up to 52 months.
Patients in the Enrolled But Not Randomized group were enrolled in the study but discontinued before being allocated into a treatment group. They never received treatment with exicorilant. Thus, they were not at risk for a treatment-emergent adverse event.
|
0.00%
0/7 • Treatment-emergent adverse events were reported from randomization up to 27 months for Segment 1 and up to 19 months for Segment 2. All-cause mortality was reported from enrollment up to 52 months.
Patients in the Enrolled But Not Randomized group were enrolled in the study but discontinued before being allocated into a treatment group. They never received treatment with exicorilant. Thus, they were not at risk for a treatment-emergent adverse event.
|
—
0/0 • Treatment-emergent adverse events were reported from randomization up to 27 months for Segment 1 and up to 19 months for Segment 2. All-cause mortality was reported from enrollment up to 52 months.
Patients in the Enrolled But Not Randomized group were enrolled in the study but discontinued before being allocated into a treatment group. They never received treatment with exicorilant. Thus, they were not at risk for a treatment-emergent adverse event.
|
0.00%
0/2 • Treatment-emergent adverse events were reported from randomization up to 27 months for Segment 1 and up to 19 months for Segment 2. All-cause mortality was reported from enrollment up to 52 months.
Patients in the Enrolled But Not Randomized group were enrolled in the study but discontinued before being allocated into a treatment group. They never received treatment with exicorilant. Thus, they were not at risk for a treatment-emergent adverse event.
|
12.5%
1/8 • Treatment-emergent adverse events were reported from randomization up to 27 months for Segment 1 and up to 19 months for Segment 2. All-cause mortality was reported from enrollment up to 52 months.
Patients in the Enrolled But Not Randomized group were enrolled in the study but discontinued before being allocated into a treatment group. They never received treatment with exicorilant. Thus, they were not at risk for a treatment-emergent adverse event.
|
0.00%
0/1 • Treatment-emergent adverse events were reported from randomization up to 27 months for Segment 1 and up to 19 months for Segment 2. All-cause mortality was reported from enrollment up to 52 months.
Patients in the Enrolled But Not Randomized group were enrolled in the study but discontinued before being allocated into a treatment group. They never received treatment with exicorilant. Thus, they were not at risk for a treatment-emergent adverse event.
|
0.00%
0/10 • Treatment-emergent adverse events were reported from randomization up to 27 months for Segment 1 and up to 19 months for Segment 2. All-cause mortality was reported from enrollment up to 52 months.
Patients in the Enrolled But Not Randomized group were enrolled in the study but discontinued before being allocated into a treatment group. They never received treatment with exicorilant. Thus, they were not at risk for a treatment-emergent adverse event.
|
0.00%
0/6 • Treatment-emergent adverse events were reported from randomization up to 27 months for Segment 1 and up to 19 months for Segment 2. All-cause mortality was reported from enrollment up to 52 months.
Patients in the Enrolled But Not Randomized group were enrolled in the study but discontinued before being allocated into a treatment group. They never received treatment with exicorilant. Thus, they were not at risk for a treatment-emergent adverse event.
|
|
Respiratory, thoracic and mediastinal disorders
Rhinorrhoea
|
0.00%
0/3 • Treatment-emergent adverse events were reported from randomization up to 27 months for Segment 1 and up to 19 months for Segment 2. All-cause mortality was reported from enrollment up to 52 months.
Patients in the Enrolled But Not Randomized group were enrolled in the study but discontinued before being allocated into a treatment group. They never received treatment with exicorilant. Thus, they were not at risk for a treatment-emergent adverse event.
|
0.00%
0/7 • Treatment-emergent adverse events were reported from randomization up to 27 months for Segment 1 and up to 19 months for Segment 2. All-cause mortality was reported from enrollment up to 52 months.
Patients in the Enrolled But Not Randomized group were enrolled in the study but discontinued before being allocated into a treatment group. They never received treatment with exicorilant. Thus, they were not at risk for a treatment-emergent adverse event.
|
—
0/0 • Treatment-emergent adverse events were reported from randomization up to 27 months for Segment 1 and up to 19 months for Segment 2. All-cause mortality was reported from enrollment up to 52 months.
Patients in the Enrolled But Not Randomized group were enrolled in the study but discontinued before being allocated into a treatment group. They never received treatment with exicorilant. Thus, they were not at risk for a treatment-emergent adverse event.
|
0.00%
0/2 • Treatment-emergent adverse events were reported from randomization up to 27 months for Segment 1 and up to 19 months for Segment 2. All-cause mortality was reported from enrollment up to 52 months.
Patients in the Enrolled But Not Randomized group were enrolled in the study but discontinued before being allocated into a treatment group. They never received treatment with exicorilant. Thus, they were not at risk for a treatment-emergent adverse event.
|
12.5%
1/8 • Treatment-emergent adverse events were reported from randomization up to 27 months for Segment 1 and up to 19 months for Segment 2. All-cause mortality was reported from enrollment up to 52 months.
Patients in the Enrolled But Not Randomized group were enrolled in the study but discontinued before being allocated into a treatment group. They never received treatment with exicorilant. Thus, they were not at risk for a treatment-emergent adverse event.
|
0.00%
0/1 • Treatment-emergent adverse events were reported from randomization up to 27 months for Segment 1 and up to 19 months for Segment 2. All-cause mortality was reported from enrollment up to 52 months.
Patients in the Enrolled But Not Randomized group were enrolled in the study but discontinued before being allocated into a treatment group. They never received treatment with exicorilant. Thus, they were not at risk for a treatment-emergent adverse event.
|
0.00%
0/10 • Treatment-emergent adverse events were reported from randomization up to 27 months for Segment 1 and up to 19 months for Segment 2. All-cause mortality was reported from enrollment up to 52 months.
Patients in the Enrolled But Not Randomized group were enrolled in the study but discontinued before being allocated into a treatment group. They never received treatment with exicorilant. Thus, they were not at risk for a treatment-emergent adverse event.
|
0.00%
0/6 • Treatment-emergent adverse events were reported from randomization up to 27 months for Segment 1 and up to 19 months for Segment 2. All-cause mortality was reported from enrollment up to 52 months.
Patients in the Enrolled But Not Randomized group were enrolled in the study but discontinued before being allocated into a treatment group. They never received treatment with exicorilant. Thus, they were not at risk for a treatment-emergent adverse event.
|
|
Respiratory, thoracic and mediastinal disorders
Wheezing
|
0.00%
0/3 • Treatment-emergent adverse events were reported from randomization up to 27 months for Segment 1 and up to 19 months for Segment 2. All-cause mortality was reported from enrollment up to 52 months.
Patients in the Enrolled But Not Randomized group were enrolled in the study but discontinued before being allocated into a treatment group. They never received treatment with exicorilant. Thus, they were not at risk for a treatment-emergent adverse event.
|
14.3%
1/7 • Treatment-emergent adverse events were reported from randomization up to 27 months for Segment 1 and up to 19 months for Segment 2. All-cause mortality was reported from enrollment up to 52 months.
Patients in the Enrolled But Not Randomized group were enrolled in the study but discontinued before being allocated into a treatment group. They never received treatment with exicorilant. Thus, they were not at risk for a treatment-emergent adverse event.
|
—
0/0 • Treatment-emergent adverse events were reported from randomization up to 27 months for Segment 1 and up to 19 months for Segment 2. All-cause mortality was reported from enrollment up to 52 months.
Patients in the Enrolled But Not Randomized group were enrolled in the study but discontinued before being allocated into a treatment group. They never received treatment with exicorilant. Thus, they were not at risk for a treatment-emergent adverse event.
|
0.00%
0/2 • Treatment-emergent adverse events were reported from randomization up to 27 months for Segment 1 and up to 19 months for Segment 2. All-cause mortality was reported from enrollment up to 52 months.
Patients in the Enrolled But Not Randomized group were enrolled in the study but discontinued before being allocated into a treatment group. They never received treatment with exicorilant. Thus, they were not at risk for a treatment-emergent adverse event.
|
0.00%
0/8 • Treatment-emergent adverse events were reported from randomization up to 27 months for Segment 1 and up to 19 months for Segment 2. All-cause mortality was reported from enrollment up to 52 months.
Patients in the Enrolled But Not Randomized group were enrolled in the study but discontinued before being allocated into a treatment group. They never received treatment with exicorilant. Thus, they were not at risk for a treatment-emergent adverse event.
|
0.00%
0/1 • Treatment-emergent adverse events were reported from randomization up to 27 months for Segment 1 and up to 19 months for Segment 2. All-cause mortality was reported from enrollment up to 52 months.
Patients in the Enrolled But Not Randomized group were enrolled in the study but discontinued before being allocated into a treatment group. They never received treatment with exicorilant. Thus, they were not at risk for a treatment-emergent adverse event.
|
10.0%
1/10 • Treatment-emergent adverse events were reported from randomization up to 27 months for Segment 1 and up to 19 months for Segment 2. All-cause mortality was reported from enrollment up to 52 months.
Patients in the Enrolled But Not Randomized group were enrolled in the study but discontinued before being allocated into a treatment group. They never received treatment with exicorilant. Thus, they were not at risk for a treatment-emergent adverse event.
|
0.00%
0/6 • Treatment-emergent adverse events were reported from randomization up to 27 months for Segment 1 and up to 19 months for Segment 2. All-cause mortality was reported from enrollment up to 52 months.
Patients in the Enrolled But Not Randomized group were enrolled in the study but discontinued before being allocated into a treatment group. They never received treatment with exicorilant. Thus, they were not at risk for a treatment-emergent adverse event.
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
0.00%
0/3 • Treatment-emergent adverse events were reported from randomization up to 27 months for Segment 1 and up to 19 months for Segment 2. All-cause mortality was reported from enrollment up to 52 months.
Patients in the Enrolled But Not Randomized group were enrolled in the study but discontinued before being allocated into a treatment group. They never received treatment with exicorilant. Thus, they were not at risk for a treatment-emergent adverse event.
|
14.3%
1/7 • Treatment-emergent adverse events were reported from randomization up to 27 months for Segment 1 and up to 19 months for Segment 2. All-cause mortality was reported from enrollment up to 52 months.
Patients in the Enrolled But Not Randomized group were enrolled in the study but discontinued before being allocated into a treatment group. They never received treatment with exicorilant. Thus, they were not at risk for a treatment-emergent adverse event.
|
—
0/0 • Treatment-emergent adverse events were reported from randomization up to 27 months for Segment 1 and up to 19 months for Segment 2. All-cause mortality was reported from enrollment up to 52 months.
Patients in the Enrolled But Not Randomized group were enrolled in the study but discontinued before being allocated into a treatment group. They never received treatment with exicorilant. Thus, they were not at risk for a treatment-emergent adverse event.
|
0.00%
0/2 • Treatment-emergent adverse events were reported from randomization up to 27 months for Segment 1 and up to 19 months for Segment 2. All-cause mortality was reported from enrollment up to 52 months.
Patients in the Enrolled But Not Randomized group were enrolled in the study but discontinued before being allocated into a treatment group. They never received treatment with exicorilant. Thus, they were not at risk for a treatment-emergent adverse event.
|
0.00%
0/8 • Treatment-emergent adverse events were reported from randomization up to 27 months for Segment 1 and up to 19 months for Segment 2. All-cause mortality was reported from enrollment up to 52 months.
Patients in the Enrolled But Not Randomized group were enrolled in the study but discontinued before being allocated into a treatment group. They never received treatment with exicorilant. Thus, they were not at risk for a treatment-emergent adverse event.
|
0.00%
0/1 • Treatment-emergent adverse events were reported from randomization up to 27 months for Segment 1 and up to 19 months for Segment 2. All-cause mortality was reported from enrollment up to 52 months.
Patients in the Enrolled But Not Randomized group were enrolled in the study but discontinued before being allocated into a treatment group. They never received treatment with exicorilant. Thus, they were not at risk for a treatment-emergent adverse event.
|
0.00%
0/10 • Treatment-emergent adverse events were reported from randomization up to 27 months for Segment 1 and up to 19 months for Segment 2. All-cause mortality was reported from enrollment up to 52 months.
Patients in the Enrolled But Not Randomized group were enrolled in the study but discontinued before being allocated into a treatment group. They never received treatment with exicorilant. Thus, they were not at risk for a treatment-emergent adverse event.
|
0.00%
0/6 • Treatment-emergent adverse events were reported from randomization up to 27 months for Segment 1 and up to 19 months for Segment 2. All-cause mortality was reported from enrollment up to 52 months.
Patients in the Enrolled But Not Randomized group were enrolled in the study but discontinued before being allocated into a treatment group. They never received treatment with exicorilant. Thus, they were not at risk for a treatment-emergent adverse event.
|
|
Skin and subcutaneous tissue disorders
Hyperhidrosis
|
0.00%
0/3 • Treatment-emergent adverse events were reported from randomization up to 27 months for Segment 1 and up to 19 months for Segment 2. All-cause mortality was reported from enrollment up to 52 months.
Patients in the Enrolled But Not Randomized group were enrolled in the study but discontinued before being allocated into a treatment group. They never received treatment with exicorilant. Thus, they were not at risk for a treatment-emergent adverse event.
|
0.00%
0/7 • Treatment-emergent adverse events were reported from randomization up to 27 months for Segment 1 and up to 19 months for Segment 2. All-cause mortality was reported from enrollment up to 52 months.
Patients in the Enrolled But Not Randomized group were enrolled in the study but discontinued before being allocated into a treatment group. They never received treatment with exicorilant. Thus, they were not at risk for a treatment-emergent adverse event.
|
—
0/0 • Treatment-emergent adverse events were reported from randomization up to 27 months for Segment 1 and up to 19 months for Segment 2. All-cause mortality was reported from enrollment up to 52 months.
Patients in the Enrolled But Not Randomized group were enrolled in the study but discontinued before being allocated into a treatment group. They never received treatment with exicorilant. Thus, they were not at risk for a treatment-emergent adverse event.
|
0.00%
0/2 • Treatment-emergent adverse events were reported from randomization up to 27 months for Segment 1 and up to 19 months for Segment 2. All-cause mortality was reported from enrollment up to 52 months.
Patients in the Enrolled But Not Randomized group were enrolled in the study but discontinued before being allocated into a treatment group. They never received treatment with exicorilant. Thus, they were not at risk for a treatment-emergent adverse event.
|
0.00%
0/8 • Treatment-emergent adverse events were reported from randomization up to 27 months for Segment 1 and up to 19 months for Segment 2. All-cause mortality was reported from enrollment up to 52 months.
Patients in the Enrolled But Not Randomized group were enrolled in the study but discontinued before being allocated into a treatment group. They never received treatment with exicorilant. Thus, they were not at risk for a treatment-emergent adverse event.
|
0.00%
0/1 • Treatment-emergent adverse events were reported from randomization up to 27 months for Segment 1 and up to 19 months for Segment 2. All-cause mortality was reported from enrollment up to 52 months.
Patients in the Enrolled But Not Randomized group were enrolled in the study but discontinued before being allocated into a treatment group. They never received treatment with exicorilant. Thus, they were not at risk for a treatment-emergent adverse event.
|
10.0%
1/10 • Treatment-emergent adverse events were reported from randomization up to 27 months for Segment 1 and up to 19 months for Segment 2. All-cause mortality was reported from enrollment up to 52 months.
Patients in the Enrolled But Not Randomized group were enrolled in the study but discontinued before being allocated into a treatment group. They never received treatment with exicorilant. Thus, they were not at risk for a treatment-emergent adverse event.
|
0.00%
0/6 • Treatment-emergent adverse events were reported from randomization up to 27 months for Segment 1 and up to 19 months for Segment 2. All-cause mortality was reported from enrollment up to 52 months.
Patients in the Enrolled But Not Randomized group were enrolled in the study but discontinued before being allocated into a treatment group. They never received treatment with exicorilant. Thus, they were not at risk for a treatment-emergent adverse event.
|
|
Skin and subcutaneous tissue disorders
Milia
|
0.00%
0/3 • Treatment-emergent adverse events were reported from randomization up to 27 months for Segment 1 and up to 19 months for Segment 2. All-cause mortality was reported from enrollment up to 52 months.
Patients in the Enrolled But Not Randomized group were enrolled in the study but discontinued before being allocated into a treatment group. They never received treatment with exicorilant. Thus, they were not at risk for a treatment-emergent adverse event.
|
0.00%
0/7 • Treatment-emergent adverse events were reported from randomization up to 27 months for Segment 1 and up to 19 months for Segment 2. All-cause mortality was reported from enrollment up to 52 months.
Patients in the Enrolled But Not Randomized group were enrolled in the study but discontinued before being allocated into a treatment group. They never received treatment with exicorilant. Thus, they were not at risk for a treatment-emergent adverse event.
|
—
0/0 • Treatment-emergent adverse events were reported from randomization up to 27 months for Segment 1 and up to 19 months for Segment 2. All-cause mortality was reported from enrollment up to 52 months.
Patients in the Enrolled But Not Randomized group were enrolled in the study but discontinued before being allocated into a treatment group. They never received treatment with exicorilant. Thus, they were not at risk for a treatment-emergent adverse event.
|
0.00%
0/2 • Treatment-emergent adverse events were reported from randomization up to 27 months for Segment 1 and up to 19 months for Segment 2. All-cause mortality was reported from enrollment up to 52 months.
Patients in the Enrolled But Not Randomized group were enrolled in the study but discontinued before being allocated into a treatment group. They never received treatment with exicorilant. Thus, they were not at risk for a treatment-emergent adverse event.
|
0.00%
0/8 • Treatment-emergent adverse events were reported from randomization up to 27 months for Segment 1 and up to 19 months for Segment 2. All-cause mortality was reported from enrollment up to 52 months.
Patients in the Enrolled But Not Randomized group were enrolled in the study but discontinued before being allocated into a treatment group. They never received treatment with exicorilant. Thus, they were not at risk for a treatment-emergent adverse event.
|
0.00%
0/1 • Treatment-emergent adverse events were reported from randomization up to 27 months for Segment 1 and up to 19 months for Segment 2. All-cause mortality was reported from enrollment up to 52 months.
Patients in the Enrolled But Not Randomized group were enrolled in the study but discontinued before being allocated into a treatment group. They never received treatment with exicorilant. Thus, they were not at risk for a treatment-emergent adverse event.
|
10.0%
1/10 • Treatment-emergent adverse events were reported from randomization up to 27 months for Segment 1 and up to 19 months for Segment 2. All-cause mortality was reported from enrollment up to 52 months.
Patients in the Enrolled But Not Randomized group were enrolled in the study but discontinued before being allocated into a treatment group. They never received treatment with exicorilant. Thus, they were not at risk for a treatment-emergent adverse event.
|
0.00%
0/6 • Treatment-emergent adverse events were reported from randomization up to 27 months for Segment 1 and up to 19 months for Segment 2. All-cause mortality was reported from enrollment up to 52 months.
Patients in the Enrolled But Not Randomized group were enrolled in the study but discontinued before being allocated into a treatment group. They never received treatment with exicorilant. Thus, they were not at risk for a treatment-emergent adverse event.
|
|
Skin and subcutaneous tissue disorders
Nail disorder
|
0.00%
0/3 • Treatment-emergent adverse events were reported from randomization up to 27 months for Segment 1 and up to 19 months for Segment 2. All-cause mortality was reported from enrollment up to 52 months.
Patients in the Enrolled But Not Randomized group were enrolled in the study but discontinued before being allocated into a treatment group. They never received treatment with exicorilant. Thus, they were not at risk for a treatment-emergent adverse event.
|
0.00%
0/7 • Treatment-emergent adverse events were reported from randomization up to 27 months for Segment 1 and up to 19 months for Segment 2. All-cause mortality was reported from enrollment up to 52 months.
Patients in the Enrolled But Not Randomized group were enrolled in the study but discontinued before being allocated into a treatment group. They never received treatment with exicorilant. Thus, they were not at risk for a treatment-emergent adverse event.
|
—
0/0 • Treatment-emergent adverse events were reported from randomization up to 27 months for Segment 1 and up to 19 months for Segment 2. All-cause mortality was reported from enrollment up to 52 months.
Patients in the Enrolled But Not Randomized group were enrolled in the study but discontinued before being allocated into a treatment group. They never received treatment with exicorilant. Thus, they were not at risk for a treatment-emergent adverse event.
|
0.00%
0/2 • Treatment-emergent adverse events were reported from randomization up to 27 months for Segment 1 and up to 19 months for Segment 2. All-cause mortality was reported from enrollment up to 52 months.
Patients in the Enrolled But Not Randomized group were enrolled in the study but discontinued before being allocated into a treatment group. They never received treatment with exicorilant. Thus, they were not at risk for a treatment-emergent adverse event.
|
12.5%
1/8 • Treatment-emergent adverse events were reported from randomization up to 27 months for Segment 1 and up to 19 months for Segment 2. All-cause mortality was reported from enrollment up to 52 months.
Patients in the Enrolled But Not Randomized group were enrolled in the study but discontinued before being allocated into a treatment group. They never received treatment with exicorilant. Thus, they were not at risk for a treatment-emergent adverse event.
|
0.00%
0/1 • Treatment-emergent adverse events were reported from randomization up to 27 months for Segment 1 and up to 19 months for Segment 2. All-cause mortality was reported from enrollment up to 52 months.
Patients in the Enrolled But Not Randomized group were enrolled in the study but discontinued before being allocated into a treatment group. They never received treatment with exicorilant. Thus, they were not at risk for a treatment-emergent adverse event.
|
0.00%
0/10 • Treatment-emergent adverse events were reported from randomization up to 27 months for Segment 1 and up to 19 months for Segment 2. All-cause mortality was reported from enrollment up to 52 months.
Patients in the Enrolled But Not Randomized group were enrolled in the study but discontinued before being allocated into a treatment group. They never received treatment with exicorilant. Thus, they were not at risk for a treatment-emergent adverse event.
|
0.00%
0/6 • Treatment-emergent adverse events were reported from randomization up to 27 months for Segment 1 and up to 19 months for Segment 2. All-cause mortality was reported from enrollment up to 52 months.
Patients in the Enrolled But Not Randomized group were enrolled in the study but discontinued before being allocated into a treatment group. They never received treatment with exicorilant. Thus, they were not at risk for a treatment-emergent adverse event.
|
|
Skin and subcutaneous tissue disorders
Nail ridging
|
0.00%
0/3 • Treatment-emergent adverse events were reported from randomization up to 27 months for Segment 1 and up to 19 months for Segment 2. All-cause mortality was reported from enrollment up to 52 months.
Patients in the Enrolled But Not Randomized group were enrolled in the study but discontinued before being allocated into a treatment group. They never received treatment with exicorilant. Thus, they were not at risk for a treatment-emergent adverse event.
|
0.00%
0/7 • Treatment-emergent adverse events were reported from randomization up to 27 months for Segment 1 and up to 19 months for Segment 2. All-cause mortality was reported from enrollment up to 52 months.
Patients in the Enrolled But Not Randomized group were enrolled in the study but discontinued before being allocated into a treatment group. They never received treatment with exicorilant. Thus, they were not at risk for a treatment-emergent adverse event.
|
—
0/0 • Treatment-emergent adverse events were reported from randomization up to 27 months for Segment 1 and up to 19 months for Segment 2. All-cause mortality was reported from enrollment up to 52 months.
Patients in the Enrolled But Not Randomized group were enrolled in the study but discontinued before being allocated into a treatment group. They never received treatment with exicorilant. Thus, they were not at risk for a treatment-emergent adverse event.
|
0.00%
0/2 • Treatment-emergent adverse events were reported from randomization up to 27 months for Segment 1 and up to 19 months for Segment 2. All-cause mortality was reported from enrollment up to 52 months.
Patients in the Enrolled But Not Randomized group were enrolled in the study but discontinued before being allocated into a treatment group. They never received treatment with exicorilant. Thus, they were not at risk for a treatment-emergent adverse event.
|
0.00%
0/8 • Treatment-emergent adverse events were reported from randomization up to 27 months for Segment 1 and up to 19 months for Segment 2. All-cause mortality was reported from enrollment up to 52 months.
Patients in the Enrolled But Not Randomized group were enrolled in the study but discontinued before being allocated into a treatment group. They never received treatment with exicorilant. Thus, they were not at risk for a treatment-emergent adverse event.
|
0.00%
0/1 • Treatment-emergent adverse events were reported from randomization up to 27 months for Segment 1 and up to 19 months for Segment 2. All-cause mortality was reported from enrollment up to 52 months.
Patients in the Enrolled But Not Randomized group were enrolled in the study but discontinued before being allocated into a treatment group. They never received treatment with exicorilant. Thus, they were not at risk for a treatment-emergent adverse event.
|
10.0%
1/10 • Treatment-emergent adverse events were reported from randomization up to 27 months for Segment 1 and up to 19 months for Segment 2. All-cause mortality was reported from enrollment up to 52 months.
Patients in the Enrolled But Not Randomized group were enrolled in the study but discontinued before being allocated into a treatment group. They never received treatment with exicorilant. Thus, they were not at risk for a treatment-emergent adverse event.
|
0.00%
0/6 • Treatment-emergent adverse events were reported from randomization up to 27 months for Segment 1 and up to 19 months for Segment 2. All-cause mortality was reported from enrollment up to 52 months.
Patients in the Enrolled But Not Randomized group were enrolled in the study but discontinued before being allocated into a treatment group. They never received treatment with exicorilant. Thus, they were not at risk for a treatment-emergent adverse event.
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
33.3%
1/3 • Treatment-emergent adverse events were reported from randomization up to 27 months for Segment 1 and up to 19 months for Segment 2. All-cause mortality was reported from enrollment up to 52 months.
Patients in the Enrolled But Not Randomized group were enrolled in the study but discontinued before being allocated into a treatment group. They never received treatment with exicorilant. Thus, they were not at risk for a treatment-emergent adverse event.
|
14.3%
1/7 • Treatment-emergent adverse events were reported from randomization up to 27 months for Segment 1 and up to 19 months for Segment 2. All-cause mortality was reported from enrollment up to 52 months.
Patients in the Enrolled But Not Randomized group were enrolled in the study but discontinued before being allocated into a treatment group. They never received treatment with exicorilant. Thus, they were not at risk for a treatment-emergent adverse event.
|
—
0/0 • Treatment-emergent adverse events were reported from randomization up to 27 months for Segment 1 and up to 19 months for Segment 2. All-cause mortality was reported from enrollment up to 52 months.
Patients in the Enrolled But Not Randomized group were enrolled in the study but discontinued before being allocated into a treatment group. They never received treatment with exicorilant. Thus, they were not at risk for a treatment-emergent adverse event.
|
0.00%
0/2 • Treatment-emergent adverse events were reported from randomization up to 27 months for Segment 1 and up to 19 months for Segment 2. All-cause mortality was reported from enrollment up to 52 months.
Patients in the Enrolled But Not Randomized group were enrolled in the study but discontinued before being allocated into a treatment group. They never received treatment with exicorilant. Thus, they were not at risk for a treatment-emergent adverse event.
|
12.5%
1/8 • Treatment-emergent adverse events were reported from randomization up to 27 months for Segment 1 and up to 19 months for Segment 2. All-cause mortality was reported from enrollment up to 52 months.
Patients in the Enrolled But Not Randomized group were enrolled in the study but discontinued before being allocated into a treatment group. They never received treatment with exicorilant. Thus, they were not at risk for a treatment-emergent adverse event.
|
0.00%
0/1 • Treatment-emergent adverse events were reported from randomization up to 27 months for Segment 1 and up to 19 months for Segment 2. All-cause mortality was reported from enrollment up to 52 months.
Patients in the Enrolled But Not Randomized group were enrolled in the study but discontinued before being allocated into a treatment group. They never received treatment with exicorilant. Thus, they were not at risk for a treatment-emergent adverse event.
|
0.00%
0/10 • Treatment-emergent adverse events were reported from randomization up to 27 months for Segment 1 and up to 19 months for Segment 2. All-cause mortality was reported from enrollment up to 52 months.
Patients in the Enrolled But Not Randomized group were enrolled in the study but discontinued before being allocated into a treatment group. They never received treatment with exicorilant. Thus, they were not at risk for a treatment-emergent adverse event.
|
16.7%
1/6 • Treatment-emergent adverse events were reported from randomization up to 27 months for Segment 1 and up to 19 months for Segment 2. All-cause mortality was reported from enrollment up to 52 months.
Patients in the Enrolled But Not Randomized group were enrolled in the study but discontinued before being allocated into a treatment group. They never received treatment with exicorilant. Thus, they were not at risk for a treatment-emergent adverse event.
|
|
Skin and subcutaneous tissue disorders
Skin lesion
|
0.00%
0/3 • Treatment-emergent adverse events were reported from randomization up to 27 months for Segment 1 and up to 19 months for Segment 2. All-cause mortality was reported from enrollment up to 52 months.
Patients in the Enrolled But Not Randomized group were enrolled in the study but discontinued before being allocated into a treatment group. They never received treatment with exicorilant. Thus, they were not at risk for a treatment-emergent adverse event.
|
0.00%
0/7 • Treatment-emergent adverse events were reported from randomization up to 27 months for Segment 1 and up to 19 months for Segment 2. All-cause mortality was reported from enrollment up to 52 months.
Patients in the Enrolled But Not Randomized group were enrolled in the study but discontinued before being allocated into a treatment group. They never received treatment with exicorilant. Thus, they were not at risk for a treatment-emergent adverse event.
|
—
0/0 • Treatment-emergent adverse events were reported from randomization up to 27 months for Segment 1 and up to 19 months for Segment 2. All-cause mortality was reported from enrollment up to 52 months.
Patients in the Enrolled But Not Randomized group were enrolled in the study but discontinued before being allocated into a treatment group. They never received treatment with exicorilant. Thus, they were not at risk for a treatment-emergent adverse event.
|
50.0%
1/2 • Treatment-emergent adverse events were reported from randomization up to 27 months for Segment 1 and up to 19 months for Segment 2. All-cause mortality was reported from enrollment up to 52 months.
Patients in the Enrolled But Not Randomized group were enrolled in the study but discontinued before being allocated into a treatment group. They never received treatment with exicorilant. Thus, they were not at risk for a treatment-emergent adverse event.
|
0.00%
0/8 • Treatment-emergent adverse events were reported from randomization up to 27 months for Segment 1 and up to 19 months for Segment 2. All-cause mortality was reported from enrollment up to 52 months.
Patients in the Enrolled But Not Randomized group were enrolled in the study but discontinued before being allocated into a treatment group. They never received treatment with exicorilant. Thus, they were not at risk for a treatment-emergent adverse event.
|
0.00%
0/1 • Treatment-emergent adverse events were reported from randomization up to 27 months for Segment 1 and up to 19 months for Segment 2. All-cause mortality was reported from enrollment up to 52 months.
Patients in the Enrolled But Not Randomized group were enrolled in the study but discontinued before being allocated into a treatment group. They never received treatment with exicorilant. Thus, they were not at risk for a treatment-emergent adverse event.
|
0.00%
0/10 • Treatment-emergent adverse events were reported from randomization up to 27 months for Segment 1 and up to 19 months for Segment 2. All-cause mortality was reported from enrollment up to 52 months.
Patients in the Enrolled But Not Randomized group were enrolled in the study but discontinued before being allocated into a treatment group. They never received treatment with exicorilant. Thus, they were not at risk for a treatment-emergent adverse event.
|
0.00%
0/6 • Treatment-emergent adverse events were reported from randomization up to 27 months for Segment 1 and up to 19 months for Segment 2. All-cause mortality was reported from enrollment up to 52 months.
Patients in the Enrolled But Not Randomized group were enrolled in the study but discontinued before being allocated into a treatment group. They never received treatment with exicorilant. Thus, they were not at risk for a treatment-emergent adverse event.
|
|
Vascular disorders
Deep vein thrombosis
|
0.00%
0/3 • Treatment-emergent adverse events were reported from randomization up to 27 months for Segment 1 and up to 19 months for Segment 2. All-cause mortality was reported from enrollment up to 52 months.
Patients in the Enrolled But Not Randomized group were enrolled in the study but discontinued before being allocated into a treatment group. They never received treatment with exicorilant. Thus, they were not at risk for a treatment-emergent adverse event.
|
14.3%
1/7 • Treatment-emergent adverse events were reported from randomization up to 27 months for Segment 1 and up to 19 months for Segment 2. All-cause mortality was reported from enrollment up to 52 months.
Patients in the Enrolled But Not Randomized group were enrolled in the study but discontinued before being allocated into a treatment group. They never received treatment with exicorilant. Thus, they were not at risk for a treatment-emergent adverse event.
|
—
0/0 • Treatment-emergent adverse events were reported from randomization up to 27 months for Segment 1 and up to 19 months for Segment 2. All-cause mortality was reported from enrollment up to 52 months.
Patients in the Enrolled But Not Randomized group were enrolled in the study but discontinued before being allocated into a treatment group. They never received treatment with exicorilant. Thus, they were not at risk for a treatment-emergent adverse event.
|
0.00%
0/2 • Treatment-emergent adverse events were reported from randomization up to 27 months for Segment 1 and up to 19 months for Segment 2. All-cause mortality was reported from enrollment up to 52 months.
Patients in the Enrolled But Not Randomized group were enrolled in the study but discontinued before being allocated into a treatment group. They never received treatment with exicorilant. Thus, they were not at risk for a treatment-emergent adverse event.
|
0.00%
0/8 • Treatment-emergent adverse events were reported from randomization up to 27 months for Segment 1 and up to 19 months for Segment 2. All-cause mortality was reported from enrollment up to 52 months.
Patients in the Enrolled But Not Randomized group were enrolled in the study but discontinued before being allocated into a treatment group. They never received treatment with exicorilant. Thus, they were not at risk for a treatment-emergent adverse event.
|
0.00%
0/1 • Treatment-emergent adverse events were reported from randomization up to 27 months for Segment 1 and up to 19 months for Segment 2. All-cause mortality was reported from enrollment up to 52 months.
Patients in the Enrolled But Not Randomized group were enrolled in the study but discontinued before being allocated into a treatment group. They never received treatment with exicorilant. Thus, they were not at risk for a treatment-emergent adverse event.
|
0.00%
0/10 • Treatment-emergent adverse events were reported from randomization up to 27 months for Segment 1 and up to 19 months for Segment 2. All-cause mortality was reported from enrollment up to 52 months.
Patients in the Enrolled But Not Randomized group were enrolled in the study but discontinued before being allocated into a treatment group. They never received treatment with exicorilant. Thus, they were not at risk for a treatment-emergent adverse event.
|
0.00%
0/6 • Treatment-emergent adverse events were reported from randomization up to 27 months for Segment 1 and up to 19 months for Segment 2. All-cause mortality was reported from enrollment up to 52 months.
Patients in the Enrolled But Not Randomized group were enrolled in the study but discontinued before being allocated into a treatment group. They never received treatment with exicorilant. Thus, they were not at risk for a treatment-emergent adverse event.
|
|
Vascular disorders
Hot flush
|
0.00%
0/3 • Treatment-emergent adverse events were reported from randomization up to 27 months for Segment 1 and up to 19 months for Segment 2. All-cause mortality was reported from enrollment up to 52 months.
Patients in the Enrolled But Not Randomized group were enrolled in the study but discontinued before being allocated into a treatment group. They never received treatment with exicorilant. Thus, they were not at risk for a treatment-emergent adverse event.
|
0.00%
0/7 • Treatment-emergent adverse events were reported from randomization up to 27 months for Segment 1 and up to 19 months for Segment 2. All-cause mortality was reported from enrollment up to 52 months.
Patients in the Enrolled But Not Randomized group were enrolled in the study but discontinued before being allocated into a treatment group. They never received treatment with exicorilant. Thus, they were not at risk for a treatment-emergent adverse event.
|
—
0/0 • Treatment-emergent adverse events were reported from randomization up to 27 months for Segment 1 and up to 19 months for Segment 2. All-cause mortality was reported from enrollment up to 52 months.
Patients in the Enrolled But Not Randomized group were enrolled in the study but discontinued before being allocated into a treatment group. They never received treatment with exicorilant. Thus, they were not at risk for a treatment-emergent adverse event.
|
0.00%
0/2 • Treatment-emergent adverse events were reported from randomization up to 27 months for Segment 1 and up to 19 months for Segment 2. All-cause mortality was reported from enrollment up to 52 months.
Patients in the Enrolled But Not Randomized group were enrolled in the study but discontinued before being allocated into a treatment group. They never received treatment with exicorilant. Thus, they were not at risk for a treatment-emergent adverse event.
|
0.00%
0/8 • Treatment-emergent adverse events were reported from randomization up to 27 months for Segment 1 and up to 19 months for Segment 2. All-cause mortality was reported from enrollment up to 52 months.
Patients in the Enrolled But Not Randomized group were enrolled in the study but discontinued before being allocated into a treatment group. They never received treatment with exicorilant. Thus, they were not at risk for a treatment-emergent adverse event.
|
0.00%
0/1 • Treatment-emergent adverse events were reported from randomization up to 27 months for Segment 1 and up to 19 months for Segment 2. All-cause mortality was reported from enrollment up to 52 months.
Patients in the Enrolled But Not Randomized group were enrolled in the study but discontinued before being allocated into a treatment group. They never received treatment with exicorilant. Thus, they were not at risk for a treatment-emergent adverse event.
|
10.0%
1/10 • Treatment-emergent adverse events were reported from randomization up to 27 months for Segment 1 and up to 19 months for Segment 2. All-cause mortality was reported from enrollment up to 52 months.
Patients in the Enrolled But Not Randomized group were enrolled in the study but discontinued before being allocated into a treatment group. They never received treatment with exicorilant. Thus, they were not at risk for a treatment-emergent adverse event.
|
0.00%
0/6 • Treatment-emergent adverse events were reported from randomization up to 27 months for Segment 1 and up to 19 months for Segment 2. All-cause mortality was reported from enrollment up to 52 months.
Patients in the Enrolled But Not Randomized group were enrolled in the study but discontinued before being allocated into a treatment group. They never received treatment with exicorilant. Thus, they were not at risk for a treatment-emergent adverse event.
|
|
Vascular disorders
Hypertension
|
33.3%
1/3 • Treatment-emergent adverse events were reported from randomization up to 27 months for Segment 1 and up to 19 months for Segment 2. All-cause mortality was reported from enrollment up to 52 months.
Patients in the Enrolled But Not Randomized group were enrolled in the study but discontinued before being allocated into a treatment group. They never received treatment with exicorilant. Thus, they were not at risk for a treatment-emergent adverse event.
|
14.3%
1/7 • Treatment-emergent adverse events were reported from randomization up to 27 months for Segment 1 and up to 19 months for Segment 2. All-cause mortality was reported from enrollment up to 52 months.
Patients in the Enrolled But Not Randomized group were enrolled in the study but discontinued before being allocated into a treatment group. They never received treatment with exicorilant. Thus, they were not at risk for a treatment-emergent adverse event.
|
—
0/0 • Treatment-emergent adverse events were reported from randomization up to 27 months for Segment 1 and up to 19 months for Segment 2. All-cause mortality was reported from enrollment up to 52 months.
Patients in the Enrolled But Not Randomized group were enrolled in the study but discontinued before being allocated into a treatment group. They never received treatment with exicorilant. Thus, they were not at risk for a treatment-emergent adverse event.
|
0.00%
0/2 • Treatment-emergent adverse events were reported from randomization up to 27 months for Segment 1 and up to 19 months for Segment 2. All-cause mortality was reported from enrollment up to 52 months.
Patients in the Enrolled But Not Randomized group were enrolled in the study but discontinued before being allocated into a treatment group. They never received treatment with exicorilant. Thus, they were not at risk for a treatment-emergent adverse event.
|
12.5%
1/8 • Treatment-emergent adverse events were reported from randomization up to 27 months for Segment 1 and up to 19 months for Segment 2. All-cause mortality was reported from enrollment up to 52 months.
Patients in the Enrolled But Not Randomized group were enrolled in the study but discontinued before being allocated into a treatment group. They never received treatment with exicorilant. Thus, they were not at risk for a treatment-emergent adverse event.
|
0.00%
0/1 • Treatment-emergent adverse events were reported from randomization up to 27 months for Segment 1 and up to 19 months for Segment 2. All-cause mortality was reported from enrollment up to 52 months.
Patients in the Enrolled But Not Randomized group were enrolled in the study but discontinued before being allocated into a treatment group. They never received treatment with exicorilant. Thus, they were not at risk for a treatment-emergent adverse event.
|
0.00%
0/10 • Treatment-emergent adverse events were reported from randomization up to 27 months for Segment 1 and up to 19 months for Segment 2. All-cause mortality was reported from enrollment up to 52 months.
Patients in the Enrolled But Not Randomized group were enrolled in the study but discontinued before being allocated into a treatment group. They never received treatment with exicorilant. Thus, they were not at risk for a treatment-emergent adverse event.
|
33.3%
2/6 • Treatment-emergent adverse events were reported from randomization up to 27 months for Segment 1 and up to 19 months for Segment 2. All-cause mortality was reported from enrollment up to 52 months.
Patients in the Enrolled But Not Randomized group were enrolled in the study but discontinued before being allocated into a treatment group. They never received treatment with exicorilant. Thus, they were not at risk for a treatment-emergent adverse event.
|
|
Vascular disorders
Hypotension
|
0.00%
0/3 • Treatment-emergent adverse events were reported from randomization up to 27 months for Segment 1 and up to 19 months for Segment 2. All-cause mortality was reported from enrollment up to 52 months.
Patients in the Enrolled But Not Randomized group were enrolled in the study but discontinued before being allocated into a treatment group. They never received treatment with exicorilant. Thus, they were not at risk for a treatment-emergent adverse event.
|
0.00%
0/7 • Treatment-emergent adverse events were reported from randomization up to 27 months for Segment 1 and up to 19 months for Segment 2. All-cause mortality was reported from enrollment up to 52 months.
Patients in the Enrolled But Not Randomized group were enrolled in the study but discontinued before being allocated into a treatment group. They never received treatment with exicorilant. Thus, they were not at risk for a treatment-emergent adverse event.
|
—
0/0 • Treatment-emergent adverse events were reported from randomization up to 27 months for Segment 1 and up to 19 months for Segment 2. All-cause mortality was reported from enrollment up to 52 months.
Patients in the Enrolled But Not Randomized group were enrolled in the study but discontinued before being allocated into a treatment group. They never received treatment with exicorilant. Thus, they were not at risk for a treatment-emergent adverse event.
|
0.00%
0/2 • Treatment-emergent adverse events were reported from randomization up to 27 months for Segment 1 and up to 19 months for Segment 2. All-cause mortality was reported from enrollment up to 52 months.
Patients in the Enrolled But Not Randomized group were enrolled in the study but discontinued before being allocated into a treatment group. They never received treatment with exicorilant. Thus, they were not at risk for a treatment-emergent adverse event.
|
0.00%
0/8 • Treatment-emergent adverse events were reported from randomization up to 27 months for Segment 1 and up to 19 months for Segment 2. All-cause mortality was reported from enrollment up to 52 months.
Patients in the Enrolled But Not Randomized group were enrolled in the study but discontinued before being allocated into a treatment group. They never received treatment with exicorilant. Thus, they were not at risk for a treatment-emergent adverse event.
|
0.00%
0/1 • Treatment-emergent adverse events were reported from randomization up to 27 months for Segment 1 and up to 19 months for Segment 2. All-cause mortality was reported from enrollment up to 52 months.
Patients in the Enrolled But Not Randomized group were enrolled in the study but discontinued before being allocated into a treatment group. They never received treatment with exicorilant. Thus, they were not at risk for a treatment-emergent adverse event.
|
0.00%
0/10 • Treatment-emergent adverse events were reported from randomization up to 27 months for Segment 1 and up to 19 months for Segment 2. All-cause mortality was reported from enrollment up to 52 months.
Patients in the Enrolled But Not Randomized group were enrolled in the study but discontinued before being allocated into a treatment group. They never received treatment with exicorilant. Thus, they were not at risk for a treatment-emergent adverse event.
|
16.7%
1/6 • Treatment-emergent adverse events were reported from randomization up to 27 months for Segment 1 and up to 19 months for Segment 2. All-cause mortality was reported from enrollment up to 52 months.
Patients in the Enrolled But Not Randomized group were enrolled in the study but discontinued before being allocated into a treatment group. They never received treatment with exicorilant. Thus, they were not at risk for a treatment-emergent adverse event.
|
|
Vascular disorders
Lymphoedema
|
0.00%
0/3 • Treatment-emergent adverse events were reported from randomization up to 27 months for Segment 1 and up to 19 months for Segment 2. All-cause mortality was reported from enrollment up to 52 months.
Patients in the Enrolled But Not Randomized group were enrolled in the study but discontinued before being allocated into a treatment group. They never received treatment with exicorilant. Thus, they were not at risk for a treatment-emergent adverse event.
|
0.00%
0/7 • Treatment-emergent adverse events were reported from randomization up to 27 months for Segment 1 and up to 19 months for Segment 2. All-cause mortality was reported from enrollment up to 52 months.
Patients in the Enrolled But Not Randomized group were enrolled in the study but discontinued before being allocated into a treatment group. They never received treatment with exicorilant. Thus, they were not at risk for a treatment-emergent adverse event.
|
—
0/0 • Treatment-emergent adverse events were reported from randomization up to 27 months for Segment 1 and up to 19 months for Segment 2. All-cause mortality was reported from enrollment up to 52 months.
Patients in the Enrolled But Not Randomized group were enrolled in the study but discontinued before being allocated into a treatment group. They never received treatment with exicorilant. Thus, they were not at risk for a treatment-emergent adverse event.
|
0.00%
0/2 • Treatment-emergent adverse events were reported from randomization up to 27 months for Segment 1 and up to 19 months for Segment 2. All-cause mortality was reported from enrollment up to 52 months.
Patients in the Enrolled But Not Randomized group were enrolled in the study but discontinued before being allocated into a treatment group. They never received treatment with exicorilant. Thus, they were not at risk for a treatment-emergent adverse event.
|
0.00%
0/8 • Treatment-emergent adverse events were reported from randomization up to 27 months for Segment 1 and up to 19 months for Segment 2. All-cause mortality was reported from enrollment up to 52 months.
Patients in the Enrolled But Not Randomized group were enrolled in the study but discontinued before being allocated into a treatment group. They never received treatment with exicorilant. Thus, they were not at risk for a treatment-emergent adverse event.
|
0.00%
0/1 • Treatment-emergent adverse events were reported from randomization up to 27 months for Segment 1 and up to 19 months for Segment 2. All-cause mortality was reported from enrollment up to 52 months.
Patients in the Enrolled But Not Randomized group were enrolled in the study but discontinued before being allocated into a treatment group. They never received treatment with exicorilant. Thus, they were not at risk for a treatment-emergent adverse event.
|
10.0%
1/10 • Treatment-emergent adverse events were reported from randomization up to 27 months for Segment 1 and up to 19 months for Segment 2. All-cause mortality was reported from enrollment up to 52 months.
Patients in the Enrolled But Not Randomized group were enrolled in the study but discontinued before being allocated into a treatment group. They never received treatment with exicorilant. Thus, they were not at risk for a treatment-emergent adverse event.
|
0.00%
0/6 • Treatment-emergent adverse events were reported from randomization up to 27 months for Segment 1 and up to 19 months for Segment 2. All-cause mortality was reported from enrollment up to 52 months.
Patients in the Enrolled But Not Randomized group were enrolled in the study but discontinued before being allocated into a treatment group. They never received treatment with exicorilant. Thus, they were not at risk for a treatment-emergent adverse event.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee No individual publications will be allowed before publication of the multicenter results except as agreed with the Sponsor. The Investigator agrees to submit all manuscripts or abstracts to the Sponsor for review before submission to the publisher.
- Publication restrictions are in place
Restriction type: OTHER