Trial Outcomes & Findings for Study of Relacorilant in Combination With Nab-Paclitaxel for Patients With Recurrent Platinum-Resistant Ovarian, Fallopian Tube, or Primary Peritoneal Cancer (NCT NCT03776812)
NCT ID: NCT03776812
Last Updated: 2025-10-07
Results Overview
To assess time from randomization until the date of first documented progressive disease (PD) by RECIST v1.1 (as determined by the Investigator at the local site), or death due to any cause, whichever occurs first.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
178 participants
Primary outcome timeframe
Baseline and up to 15 months
Results posted on
2025-10-07
Participant Flow
The intent-to-treat (ITT) population included all randomized patients.
Participant milestones
| Measure |
Arm A: Continuous Relacorilant Dosing
Patients will receive relacorilant 100 mg (titrated up to 150 mg after Cycle 1 or 2) once daily in combination with nab-paclitaxel 80 mg/m\^2, on Days 1, 8, and 15 of each 28-day cycle.
|
Arm B: Intermittent Relacorilant Dosing
Patients will receive relacorilant 150 mg on the day before (excluding Cycle 1, Day -1), the day of, and the day after nab-paclitaxel, in combination with nab-paclitaxel 80 mg/m\^2, on Days 1, 8, and 15 of each 28-day cycle.
|
Arm C: Nab-paclitaxel Comparator
Patients will receive nab-paclitaxel 100 mg/m\^2 on Days 1, 8, and 15 of each 28-day cycle. Patients initially in Arm C who choose to cross over after disease progression will receive relacorilant 100 mg (titrated up to 150 mg) in combination with nab-paclitaxel 80 mg/m\^2 on Days 1, 8, and 15 of each 28-day cycle after cross over.
|
|---|---|---|---|
|
Overall Study
STARTED
|
58
|
60
|
60
|
|
Overall Study
Entered Crossover
|
0
|
0
|
28
|
|
Overall Study
COMPLETED
|
0
|
0
|
0
|
|
Overall Study
NOT COMPLETED
|
58
|
60
|
60
|
Reasons for withdrawal
| Measure |
Arm A: Continuous Relacorilant Dosing
Patients will receive relacorilant 100 mg (titrated up to 150 mg after Cycle 1 or 2) once daily in combination with nab-paclitaxel 80 mg/m\^2, on Days 1, 8, and 15 of each 28-day cycle.
|
Arm B: Intermittent Relacorilant Dosing
Patients will receive relacorilant 150 mg on the day before (excluding Cycle 1, Day -1), the day of, and the day after nab-paclitaxel, in combination with nab-paclitaxel 80 mg/m\^2, on Days 1, 8, and 15 of each 28-day cycle.
|
Arm C: Nab-paclitaxel Comparator
Patients will receive nab-paclitaxel 100 mg/m\^2 on Days 1, 8, and 15 of each 28-day cycle. Patients initially in Arm C who choose to cross over after disease progression will receive relacorilant 100 mg (titrated up to 150 mg) in combination with nab-paclitaxel 80 mg/m\^2 on Days 1, 8, and 15 of each 28-day cycle after cross over.
|
|---|---|---|---|
|
Overall Study
Death
|
53
|
49
|
56
|
|
Overall Study
Withdrawal by Subject
|
1
|
7
|
2
|
|
Overall Study
Lost to Follow-up
|
1
|
1
|
0
|
|
Overall Study
Did not enter long-term follow-up
|
3
|
3
|
2
|
Baseline Characteristics
Study of Relacorilant in Combination With Nab-Paclitaxel for Patients With Recurrent Platinum-Resistant Ovarian, Fallopian Tube, or Primary Peritoneal Cancer
Baseline characteristics by cohort
| Measure |
Arm A: Continuous Relacorilant Dosing
n=58 Participants
Patients will receive relacorilant 100 mg (titrated up to 150 mg after Cycle 1 or 2) once daily in combination with nab-paclitaxel 80 mg/m\^2, on Days 1, 8, and 15 of each 28-day cycle.
|
Arm B: Intermittent Relacorilant Dosing
n=60 Participants
Patients will receive relacorilant 150 mg on the day before (excluding Cycle 1, Day -1), the day of, and the day after nab-paclitaxel, in combination with nab-paclitaxel 80 mg/m\^2, on Days 1, 8, and 15 of each 28-day cycle.
|
Arm C: Nab-paclitaxel Comparator
n=60 Participants
Patients will receive nab-paclitaxel 100 mg/m\^2 on Days 1, 8, and 15 of each 28-day cycle. Patients initially in Arm C who choose to cross over after disease progression will receive relacorilant 100 mg (titrated up to 150 mg) in combination with nab-paclitaxel 80 mg/m\^2 on Days 1, 8, and 15 of each 28-day cycle after cross over.
|
Total
n=178 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
60.6 years
STANDARD_DEVIATION 8.8 • n=99 Participants
|
60.3 years
STANDARD_DEVIATION 9.7 • n=107 Participants
|
61.8 years
STANDARD_DEVIATION 8.8 • n=206 Participants
|
60.9 years
STANDARD_DEVIATION 9.1 • n=7 Participants
|
|
Sex: Female, Male
Female
|
58 Participants
n=99 Participants
|
60 Participants
n=107 Participants
|
60 Participants
n=206 Participants
|
178 Participants
n=7 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
3 Participants
n=99 Participants
|
3 Participants
n=107 Participants
|
6 Participants
n=206 Participants
|
12 Participants
n=7 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
53 Participants
n=99 Participants
|
54 Participants
n=107 Participants
|
49 Participants
n=206 Participants
|
156 Participants
n=7 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
2 Participants
n=99 Participants
|
3 Participants
n=107 Participants
|
5 Participants
n=206 Participants
|
10 Participants
n=7 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=99 Participants
|
3 Participants
n=107 Participants
|
3 Participants
n=206 Participants
|
6 Participants
n=7 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
1 Participants
n=7 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
2 Participants
n=7 Participants
|
|
Race (NIH/OMB)
White
|
57 Participants
n=99 Participants
|
52 Participants
n=107 Participants
|
50 Participants
n=206 Participants
|
159 Participants
n=7 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=99 Participants
|
4 Participants
n=107 Participants
|
5 Participants
n=206 Participants
|
10 Participants
n=7 Participants
|
PRIMARY outcome
Timeframe: Baseline and up to 15 monthsPopulation: The ITT population included all randomized patients.
To assess time from randomization until the date of first documented progressive disease (PD) by RECIST v1.1 (as determined by the Investigator at the local site), or death due to any cause, whichever occurs first.
Outcome measures
| Measure |
Arm A: Continuous Relacorilant Dosing
n=58 Participants
Patients will receive relacorilant 100 mg (titrated up to 150 mg after Cycle 1 or 2) once daily in combination with nab-paclitaxel 80 mg/m\^2, on Days 1, 8, and 15 of each 28-day cycle.
|
Arm B: Intermittent Relacorilant Dosing
n=60 Participants
Patients will receive relacorilant 150 mg on the day before (excluding Cycle 1, Day -1), the day of, and the day after nab-paclitaxel, in combination with nab-paclitaxel 80 mg/m\^2, on Days 1, 8, and 15 of each 28-day cycle.
|
Arm C: Nab-paclitaxel Comparator
n=60 Participants
Patients will receive nab-paclitaxel 100 mg/m\^2 on Days 1, 8, and 15 of each 28-day cycle. Patients initially in Arm C who choose to cross over after disease progression will receive relacorilant 100 mg (titrated up to 150 mg) in combination with nab-paclitaxel 80 mg/m\^2 on Days 1, 8, and 15 of each 28-day cycle after cross over.
|
|---|---|---|---|
|
Progression-free Survival (PFS)
|
5.29 months
Interval 3.84 to 5.55
|
5.55 months
Interval 3.68 to 7.2
|
3.76 months
Interval 3.52 to 5.36
|
SECONDARY outcome
Timeframe: Baseline and up to 15 monthsPopulation: Patients in the ITT population with measurable disease at Baseline
To assess the proportion of patients with measurable disease at Baseline who attain complete response (CR) or partial response (PR) by RECIST v1.1 (confirmation not required).
Outcome measures
| Measure |
Arm A: Continuous Relacorilant Dosing
n=54 Participants
Patients will receive relacorilant 100 mg (titrated up to 150 mg after Cycle 1 or 2) once daily in combination with nab-paclitaxel 80 mg/m\^2, on Days 1, 8, and 15 of each 28-day cycle.
|
Arm B: Intermittent Relacorilant Dosing
n=56 Participants
Patients will receive relacorilant 150 mg on the day before (excluding Cycle 1, Day -1), the day of, and the day after nab-paclitaxel, in combination with nab-paclitaxel 80 mg/m\^2, on Days 1, 8, and 15 of each 28-day cycle.
|
Arm C: Nab-paclitaxel Comparator
n=53 Participants
Patients will receive nab-paclitaxel 100 mg/m\^2 on Days 1, 8, and 15 of each 28-day cycle. Patients initially in Arm C who choose to cross over after disease progression will receive relacorilant 100 mg (titrated up to 150 mg) in combination with nab-paclitaxel 80 mg/m\^2 on Days 1, 8, and 15 of each 28-day cycle after cross over.
|
|---|---|---|---|
|
Objective Response Rate (ORR)
|
19 Participants
|
20 Participants
|
19 Participants
|
SECONDARY outcome
Timeframe: From first documented response up to 12 monthsPopulation: Patients in the ITT population with measurable disease at Baseline and who attain CR or PR by RECIST v1.1.
To assess the time from when response (CR or PR) was first documented to the first objectively documented PD or death (whichever occurs first)
Outcome measures
| Measure |
Arm A: Continuous Relacorilant Dosing
n=19 Participants
Patients will receive relacorilant 100 mg (titrated up to 150 mg after Cycle 1 or 2) once daily in combination with nab-paclitaxel 80 mg/m\^2, on Days 1, 8, and 15 of each 28-day cycle.
|
Arm B: Intermittent Relacorilant Dosing
n=20 Participants
Patients will receive relacorilant 150 mg on the day before (excluding Cycle 1, Day -1), the day of, and the day after nab-paclitaxel, in combination with nab-paclitaxel 80 mg/m\^2, on Days 1, 8, and 15 of each 28-day cycle.
|
Arm C: Nab-paclitaxel Comparator
n=19 Participants
Patients will receive nab-paclitaxel 100 mg/m\^2 on Days 1, 8, and 15 of each 28-day cycle. Patients initially in Arm C who choose to cross over after disease progression will receive relacorilant 100 mg (titrated up to 150 mg) in combination with nab-paclitaxel 80 mg/m\^2 on Days 1, 8, and 15 of each 28-day cycle after cross over.
|
|---|---|---|---|
|
Duration of Response (DOR)
|
3.79 months
Interval 2.33 to 5.55
|
5.55 months
Interval 3.75 to 5.88
|
3.65 months
Interval 2.89 to 5.09
|
SECONDARY outcome
Timeframe: Baseline and up to 15 monthsPopulation: Patients in the ITT population with an initial CA-125 level ≥ twice the upper limit of normal (ULN) of the reference range.
To assess the overall CA-125 response per GCIG criteria. Response was defined as ≥50% reduction in CA-125 from a pre-treatment sample. Patients whose CA-125 levels fall within the reference range are classified as complete responders.
Outcome measures
| Measure |
Arm A: Continuous Relacorilant Dosing
n=51 Participants
Patients will receive relacorilant 100 mg (titrated up to 150 mg after Cycle 1 or 2) once daily in combination with nab-paclitaxel 80 mg/m\^2, on Days 1, 8, and 15 of each 28-day cycle.
|
Arm B: Intermittent Relacorilant Dosing
n=53 Participants
Patients will receive relacorilant 150 mg on the day before (excluding Cycle 1, Day -1), the day of, and the day after nab-paclitaxel, in combination with nab-paclitaxel 80 mg/m\^2, on Days 1, 8, and 15 of each 28-day cycle.
|
Arm C: Nab-paclitaxel Comparator
n=52 Participants
Patients will receive nab-paclitaxel 100 mg/m\^2 on Days 1, 8, and 15 of each 28-day cycle. Patients initially in Arm C who choose to cross over after disease progression will receive relacorilant 100 mg (titrated up to 150 mg) in combination with nab-paclitaxel 80 mg/m\^2 on Days 1, 8, and 15 of each 28-day cycle after cross over.
|
|---|---|---|---|
|
Cancer Antigen 125 (CA-125) Response According to Gynecological Cancer Intergroup Criteria (GCIG)
|
32 Participants
|
34 Participants
|
28 Participants
|
SECONDARY outcome
Timeframe: Baseline and up to 15 monthsPopulation: Patients in the ITT population with measurable disease at Baseline
To assess the best response (CR, PR, stable disease \[SD\], or PD) recorded from the date of randomization until PD/recurrence (or death)
Outcome measures
| Measure |
Arm A: Continuous Relacorilant Dosing
n=54 Participants
Patients will receive relacorilant 100 mg (titrated up to 150 mg after Cycle 1 or 2) once daily in combination with nab-paclitaxel 80 mg/m\^2, on Days 1, 8, and 15 of each 28-day cycle.
|
Arm B: Intermittent Relacorilant Dosing
n=56 Participants
Patients will receive relacorilant 150 mg on the day before (excluding Cycle 1, Day -1), the day of, and the day after nab-paclitaxel, in combination with nab-paclitaxel 80 mg/m\^2, on Days 1, 8, and 15 of each 28-day cycle.
|
Arm C: Nab-paclitaxel Comparator
n=53 Participants
Patients will receive nab-paclitaxel 100 mg/m\^2 on Days 1, 8, and 15 of each 28-day cycle. Patients initially in Arm C who choose to cross over after disease progression will receive relacorilant 100 mg (titrated up to 150 mg) in combination with nab-paclitaxel 80 mg/m\^2 on Days 1, 8, and 15 of each 28-day cycle after cross over.
|
|---|---|---|---|
|
Best Overall Response (BOR)
Complete response
|
4 Participants
|
1 Participants
|
2 Participants
|
|
Best Overall Response (BOR)
Partial response
|
15 Participants
|
19 Participants
|
17 Participants
|
|
Best Overall Response (BOR)
Stable disease
|
23 Participants
|
20 Participants
|
21 Participants
|
|
Best Overall Response (BOR)
Progressive disease
|
9 Participants
|
14 Participants
|
12 Participants
|
|
Best Overall Response (BOR)
Not evaluable
|
3 Participants
|
2 Participants
|
1 Participants
|
SECONDARY outcome
Timeframe: 6 and 12 monthsPopulation: The ITT population included all randomized patients.
To assess the proportion of patients who have not progressed according to RECIST v1.1 criteria at 6 and 12 months. Values are Kaplan-Meier estimates of the patients progression-free at the time points specified.
Outcome measures
| Measure |
Arm A: Continuous Relacorilant Dosing
n=58 Participants
Patients will receive relacorilant 100 mg (titrated up to 150 mg after Cycle 1 or 2) once daily in combination with nab-paclitaxel 80 mg/m\^2, on Days 1, 8, and 15 of each 28-day cycle.
|
Arm B: Intermittent Relacorilant Dosing
n=60 Participants
Patients will receive relacorilant 150 mg on the day before (excluding Cycle 1, Day -1), the day of, and the day after nab-paclitaxel, in combination with nab-paclitaxel 80 mg/m\^2, on Days 1, 8, and 15 of each 28-day cycle.
|
Arm C: Nab-paclitaxel Comparator
n=60 Participants
Patients will receive nab-paclitaxel 100 mg/m\^2 on Days 1, 8, and 15 of each 28-day cycle. Patients initially in Arm C who choose to cross over after disease progression will receive relacorilant 100 mg (titrated up to 150 mg) in combination with nab-paclitaxel 80 mg/m\^2 on Days 1, 8, and 15 of each 28-day cycle after cross over.
|
|---|---|---|---|
|
PFS Rate at 6 and 12 Months
6 months
|
0.26 proportion of patients
Interval 0.15 to 0.38
|
0.40 proportion of patients
Interval 0.28 to 0.53
|
0.25 proportion of patients
Interval 0.15 to 0.36
|
|
PFS Rate at 6 and 12 Months
12 months
|
0.08 proportion of patients
Interval 0.02 to 0.18
|
0.11 proportion of patients
Interval 0.04 to 0.23
|
0.04 proportion of patients
Interval 0.01 to 0.12
|
SECONDARY outcome
Timeframe: Crossover Baseline (Day 50) up to Day 272Population: Patients in the ITT population initially in Arm C: Nab-paclitaxel Comparator, who choose to cross over after disease progression.
To assess the time from crossover Baseline (initial PD) until the earliest date of subsequent PD by RECIST v1.1, as determined by the Investigator at the local site, or death from any cause, whichever comes first.
Outcome measures
| Measure |
Arm A: Continuous Relacorilant Dosing
n=27 Participants
Patients will receive relacorilant 100 mg (titrated up to 150 mg after Cycle 1 or 2) once daily in combination with nab-paclitaxel 80 mg/m\^2, on Days 1, 8, and 15 of each 28-day cycle.
|
Arm B: Intermittent Relacorilant Dosing
Patients will receive relacorilant 150 mg on the day before (excluding Cycle 1, Day -1), the day of, and the day after nab-paclitaxel, in combination with nab-paclitaxel 80 mg/m\^2, on Days 1, 8, and 15 of each 28-day cycle.
|
Arm C: Nab-paclitaxel Comparator
Patients will receive nab-paclitaxel 100 mg/m\^2 on Days 1, 8, and 15 of each 28-day cycle. Patients initially in Arm C who choose to cross over after disease progression will receive relacorilant 100 mg (titrated up to 150 mg) in combination with nab-paclitaxel 80 mg/m\^2 on Days 1, 8, and 15 of each 28-day cycle after cross over.
|
|---|---|---|---|
|
PFS in Patients Who Cross Over to Continuous Treatment at Time of Initial PD
|
2.10 months
Interval 1.87 to 2.5
|
—
|
—
|
SECONDARY outcome
Timeframe: Crossover Baseline (Day 50) up to Day 272Population: Patients in the ITT population initially in Arm C: Nab-paclitaxel Comparator, who choose to cross over after disease progression and have measurable disease at the crossover Baseline.
To assess the proportion of patients with measurable disease at the crossover Baseline who attain confirmed CR or PR by RECIST v1.1
Outcome measures
| Measure |
Arm A: Continuous Relacorilant Dosing
n=21 Participants
Patients will receive relacorilant 100 mg (titrated up to 150 mg after Cycle 1 or 2) once daily in combination with nab-paclitaxel 80 mg/m\^2, on Days 1, 8, and 15 of each 28-day cycle.
|
Arm B: Intermittent Relacorilant Dosing
Patients will receive relacorilant 150 mg on the day before (excluding Cycle 1, Day -1), the day of, and the day after nab-paclitaxel, in combination with nab-paclitaxel 80 mg/m\^2, on Days 1, 8, and 15 of each 28-day cycle.
|
Arm C: Nab-paclitaxel Comparator
Patients will receive nab-paclitaxel 100 mg/m\^2 on Days 1, 8, and 15 of each 28-day cycle. Patients initially in Arm C who choose to cross over after disease progression will receive relacorilant 100 mg (titrated up to 150 mg) in combination with nab-paclitaxel 80 mg/m\^2 on Days 1, 8, and 15 of each 28-day cycle after cross over.
|
|---|---|---|---|
|
ORR in Patients Who Cross Over to Continuous Treatment at Time of Initial PD
|
0 Participants
|
—
|
—
|
SECONDARY outcome
Timeframe: From the time of objective response in the crossover period to the time of subsequent PDPopulation: No crossover patients attained CR or PR, so duration of response could not be analyzed.
To assess the time from when the first objective response (CR or PR) in the crossover period to the first objectively documented subsequent PD, or death (whichever occurs first)
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Crossover Baseline (Day 50) up to Day 272Population: Patients in the ITT population initially in Arm C: Nab-paclitaxel Comparator, who choose to cross over after disease progression and have measurable disease at the crossover Baseline.
To assess the best overall response (CR, PR, SD, or PD) recorded in the crossover period
Outcome measures
| Measure |
Arm A: Continuous Relacorilant Dosing
n=21 Participants
Patients will receive relacorilant 100 mg (titrated up to 150 mg after Cycle 1 or 2) once daily in combination with nab-paclitaxel 80 mg/m\^2, on Days 1, 8, and 15 of each 28-day cycle.
|
Arm B: Intermittent Relacorilant Dosing
Patients will receive relacorilant 150 mg on the day before (excluding Cycle 1, Day -1), the day of, and the day after nab-paclitaxel, in combination with nab-paclitaxel 80 mg/m\^2, on Days 1, 8, and 15 of each 28-day cycle.
|
Arm C: Nab-paclitaxel Comparator
Patients will receive nab-paclitaxel 100 mg/m\^2 on Days 1, 8, and 15 of each 28-day cycle. Patients initially in Arm C who choose to cross over after disease progression will receive relacorilant 100 mg (titrated up to 150 mg) in combination with nab-paclitaxel 80 mg/m\^2 on Days 1, 8, and 15 of each 28-day cycle after cross over.
|
|---|---|---|---|
|
BOR in Patients Who Cross Over to Continuous Treatment at Time of Initial PD
Complete response
|
0 Participants
|
—
|
—
|
|
BOR in Patients Who Cross Over to Continuous Treatment at Time of Initial PD
Partial response
|
0 Participants
|
—
|
—
|
|
BOR in Patients Who Cross Over to Continuous Treatment at Time of Initial PD
Stable disease
|
3 Participants
|
—
|
—
|
|
BOR in Patients Who Cross Over to Continuous Treatment at Time of Initial PD
Progressive disease
|
18 Participants
|
—
|
—
|
|
BOR in Patients Who Cross Over to Continuous Treatment at Time of Initial PD
Not evaluable
|
0 Participants
|
—
|
—
|
SECONDARY outcome
Timeframe: Up to 31 monthsPopulation: The ITT population included all randomized patients.
To assess the time from randomization to death by any cause.
Outcome measures
| Measure |
Arm A: Continuous Relacorilant Dosing
n=58 Participants
Patients will receive relacorilant 100 mg (titrated up to 150 mg after Cycle 1 or 2) once daily in combination with nab-paclitaxel 80 mg/m\^2, on Days 1, 8, and 15 of each 28-day cycle.
|
Arm B: Intermittent Relacorilant Dosing
n=60 Participants
Patients will receive relacorilant 150 mg on the day before (excluding Cycle 1, Day -1), the day of, and the day after nab-paclitaxel, in combination with nab-paclitaxel 80 mg/m\^2, on Days 1, 8, and 15 of each 28-day cycle.
|
Arm C: Nab-paclitaxel Comparator
n=60 Participants
Patients will receive nab-paclitaxel 100 mg/m\^2 on Days 1, 8, and 15 of each 28-day cycle. Patients initially in Arm C who choose to cross over after disease progression will receive relacorilant 100 mg (titrated up to 150 mg) in combination with nab-paclitaxel 80 mg/m\^2 on Days 1, 8, and 15 of each 28-day cycle after cross over.
|
|---|---|---|---|
|
Overall Survival (OS)
|
11.30 months
Interval 7.52 to 16.39
|
13.90 months
Interval 11.07 to 18.43
|
12.19 months
Interval 7.72 to 15.28
|
SECONDARY outcome
Timeframe: Baseline and up to 15 monthsPopulation: Patients in the ITT population with an initial CA-125 level ≥ twice the ULN of the reference range within 2 weeks before starting treatment.
To assess the proportion of patients with measurable disease at Baseline who attain confirmed CR or PR by RECIST v1.1 and GCIG criteria. GCIG response was defined as ≥50% reduction in CA-125 from a pre-treatment sample.
Outcome measures
| Measure |
Arm A: Continuous Relacorilant Dosing
n=58 Participants
Patients will receive relacorilant 100 mg (titrated up to 150 mg after Cycle 1 or 2) once daily in combination with nab-paclitaxel 80 mg/m\^2, on Days 1, 8, and 15 of each 28-day cycle.
|
Arm B: Intermittent Relacorilant Dosing
n=60 Participants
Patients will receive relacorilant 150 mg on the day before (excluding Cycle 1, Day -1), the day of, and the day after nab-paclitaxel, in combination with nab-paclitaxel 80 mg/m\^2, on Days 1, 8, and 15 of each 28-day cycle.
|
Arm C: Nab-paclitaxel Comparator
n=60 Participants
Patients will receive nab-paclitaxel 100 mg/m\^2 on Days 1, 8, and 15 of each 28-day cycle. Patients initially in Arm C who choose to cross over after disease progression will receive relacorilant 100 mg (titrated up to 150 mg) in combination with nab-paclitaxel 80 mg/m\^2 on Days 1, 8, and 15 of each 28-day cycle after cross over.
|
|---|---|---|---|
|
Overall Response According to Combined RECIST v1.1 + GCIG Criteria
|
34 Participants
|
36 Participants
|
33 Participants
|
Adverse Events
Arm A: Continuous Relacorilant Dosing
Serious events: 30 serious events
Other events: 57 other events
Deaths: 53 deaths
Arm B: Intermittent Relacorilant Dosing
Serious events: 15 serious events
Other events: 59 other events
Deaths: 49 deaths
Arm C: Nab-paclitaxel Comparator
Serious events: 19 serious events
Other events: 60 other events
Deaths: 56 deaths
Serious adverse events
| Measure |
Arm A: Continuous Relacorilant Dosing
n=57 participants at risk
Patients will receive relacorilant 100 mg (titrated up to 150 mg after Cycle 1 or 2) once daily in combination with nab-paclitaxel 80 mg/m\^2, on Days 1, 8, and 15 of each 28-day cycle.
|
Arm B: Intermittent Relacorilant Dosing
n=60 participants at risk
Patients will receive relacorilant 150 mg on the day before (excluding Cycle 1, Day -1), the day of, and the day after nab-paclitaxel, in combination with nab-paclitaxel 80 mg/m\^2, on Days 1, 8, and 15 of each 28-day cycle.
|
Arm C: Nab-paclitaxel Comparator
n=60 participants at risk
Patients will receive nab-paclitaxel 100 mg/m\^2 on Days 1, 8, and 15 of each 28-day cycle. Patients initially in Arm C who choose to cross over after disease progression will receive relacorilant 100 mg (titrated up to 150 mg) in combination with nab-paclitaxel 80 mg/m\^2 on Days 1, 8, and 15 of each 28-day cycle after cross over.
|
|---|---|---|---|
|
Investigations
Electrocardiogram ST segment elevation
|
1.8%
1/57 • Up to 39 months
All-Cause Mortality: the ITT population. Serious Adverse Events and Other (not including serious) Adverse Events: the safety population included all randomized patients who received ≥1 dose of study treatment.
|
0.00%
0/60 • Up to 39 months
All-Cause Mortality: the ITT population. Serious Adverse Events and Other (not including serious) Adverse Events: the safety population included all randomized patients who received ≥1 dose of study treatment.
|
0.00%
0/60 • Up to 39 months
All-Cause Mortality: the ITT population. Serious Adverse Events and Other (not including serious) Adverse Events: the safety population included all randomized patients who received ≥1 dose of study treatment.
|
|
Blood and lymphatic system disorders
Anaemia
|
0.00%
0/57 • Up to 39 months
All-Cause Mortality: the ITT population. Serious Adverse Events and Other (not including serious) Adverse Events: the safety population included all randomized patients who received ≥1 dose of study treatment.
|
1.7%
1/60 • Up to 39 months
All-Cause Mortality: the ITT population. Serious Adverse Events and Other (not including serious) Adverse Events: the safety population included all randomized patients who received ≥1 dose of study treatment.
|
0.00%
0/60 • Up to 39 months
All-Cause Mortality: the ITT population. Serious Adverse Events and Other (not including serious) Adverse Events: the safety population included all randomized patients who received ≥1 dose of study treatment.
|
|
Cardiac disorders
Cardiac failure
|
0.00%
0/57 • Up to 39 months
All-Cause Mortality: the ITT population. Serious Adverse Events and Other (not including serious) Adverse Events: the safety population included all randomized patients who received ≥1 dose of study treatment.
|
0.00%
0/60 • Up to 39 months
All-Cause Mortality: the ITT population. Serious Adverse Events and Other (not including serious) Adverse Events: the safety population included all randomized patients who received ≥1 dose of study treatment.
|
1.7%
1/60 • Up to 39 months
All-Cause Mortality: the ITT population. Serious Adverse Events and Other (not including serious) Adverse Events: the safety population included all randomized patients who received ≥1 dose of study treatment.
|
|
Cardiac disorders
Coronary artery stenosis
|
1.8%
1/57 • Up to 39 months
All-Cause Mortality: the ITT population. Serious Adverse Events and Other (not including serious) Adverse Events: the safety population included all randomized patients who received ≥1 dose of study treatment.
|
0.00%
0/60 • Up to 39 months
All-Cause Mortality: the ITT population. Serious Adverse Events and Other (not including serious) Adverse Events: the safety population included all randomized patients who received ≥1 dose of study treatment.
|
0.00%
0/60 • Up to 39 months
All-Cause Mortality: the ITT population. Serious Adverse Events and Other (not including serious) Adverse Events: the safety population included all randomized patients who received ≥1 dose of study treatment.
|
|
Cardiac disorders
Myocardial infarction
|
1.8%
1/57 • Up to 39 months
All-Cause Mortality: the ITT population. Serious Adverse Events and Other (not including serious) Adverse Events: the safety population included all randomized patients who received ≥1 dose of study treatment.
|
0.00%
0/60 • Up to 39 months
All-Cause Mortality: the ITT population. Serious Adverse Events and Other (not including serious) Adverse Events: the safety population included all randomized patients who received ≥1 dose of study treatment.
|
0.00%
0/60 • Up to 39 months
All-Cause Mortality: the ITT population. Serious Adverse Events and Other (not including serious) Adverse Events: the safety population included all randomized patients who received ≥1 dose of study treatment.
|
|
Cardiac disorders
Pericardial effusion
|
1.8%
1/57 • Up to 39 months
All-Cause Mortality: the ITT population. Serious Adverse Events and Other (not including serious) Adverse Events: the safety population included all randomized patients who received ≥1 dose of study treatment.
|
0.00%
0/60 • Up to 39 months
All-Cause Mortality: the ITT population. Serious Adverse Events and Other (not including serious) Adverse Events: the safety population included all randomized patients who received ≥1 dose of study treatment.
|
0.00%
0/60 • Up to 39 months
All-Cause Mortality: the ITT population. Serious Adverse Events and Other (not including serious) Adverse Events: the safety population included all randomized patients who received ≥1 dose of study treatment.
|
|
Cardiac disorders
Pericarditis
|
1.8%
1/57 • Up to 39 months
All-Cause Mortality: the ITT population. Serious Adverse Events and Other (not including serious) Adverse Events: the safety population included all randomized patients who received ≥1 dose of study treatment.
|
0.00%
0/60 • Up to 39 months
All-Cause Mortality: the ITT population. Serious Adverse Events and Other (not including serious) Adverse Events: the safety population included all randomized patients who received ≥1 dose of study treatment.
|
0.00%
0/60 • Up to 39 months
All-Cause Mortality: the ITT population. Serious Adverse Events and Other (not including serious) Adverse Events: the safety population included all randomized patients who received ≥1 dose of study treatment.
|
|
Cardiac disorders
Tachycardia
|
1.8%
1/57 • Up to 39 months
All-Cause Mortality: the ITT population. Serious Adverse Events and Other (not including serious) Adverse Events: the safety population included all randomized patients who received ≥1 dose of study treatment.
|
0.00%
0/60 • Up to 39 months
All-Cause Mortality: the ITT population. Serious Adverse Events and Other (not including serious) Adverse Events: the safety population included all randomized patients who received ≥1 dose of study treatment.
|
0.00%
0/60 • Up to 39 months
All-Cause Mortality: the ITT population. Serious Adverse Events and Other (not including serious) Adverse Events: the safety population included all randomized patients who received ≥1 dose of study treatment.
|
|
Ear and labyrinth disorders
Vertigo
|
1.8%
1/57 • Up to 39 months
All-Cause Mortality: the ITT population. Serious Adverse Events and Other (not including serious) Adverse Events: the safety population included all randomized patients who received ≥1 dose of study treatment.
|
0.00%
0/60 • Up to 39 months
All-Cause Mortality: the ITT population. Serious Adverse Events and Other (not including serious) Adverse Events: the safety population included all randomized patients who received ≥1 dose of study treatment.
|
0.00%
0/60 • Up to 39 months
All-Cause Mortality: the ITT population. Serious Adverse Events and Other (not including serious) Adverse Events: the safety population included all randomized patients who received ≥1 dose of study treatment.
|
|
Gastrointestinal disorders
Intestinal obstruction
|
8.8%
5/57 • Up to 39 months
All-Cause Mortality: the ITT population. Serious Adverse Events and Other (not including serious) Adverse Events: the safety population included all randomized patients who received ≥1 dose of study treatment.
|
3.3%
2/60 • Up to 39 months
All-Cause Mortality: the ITT population. Serious Adverse Events and Other (not including serious) Adverse Events: the safety population included all randomized patients who received ≥1 dose of study treatment.
|
3.3%
2/60 • Up to 39 months
All-Cause Mortality: the ITT population. Serious Adverse Events and Other (not including serious) Adverse Events: the safety population included all randomized patients who received ≥1 dose of study treatment.
|
|
Gastrointestinal disorders
Abdominal pain
|
5.3%
3/57 • Up to 39 months
All-Cause Mortality: the ITT population. Serious Adverse Events and Other (not including serious) Adverse Events: the safety population included all randomized patients who received ≥1 dose of study treatment.
|
1.7%
1/60 • Up to 39 months
All-Cause Mortality: the ITT population. Serious Adverse Events and Other (not including serious) Adverse Events: the safety population included all randomized patients who received ≥1 dose of study treatment.
|
1.7%
1/60 • Up to 39 months
All-Cause Mortality: the ITT population. Serious Adverse Events and Other (not including serious) Adverse Events: the safety population included all randomized patients who received ≥1 dose of study treatment.
|
|
Gastrointestinal disorders
Small intestinal obstruction
|
5.3%
3/57 • Up to 39 months
All-Cause Mortality: the ITT population. Serious Adverse Events and Other (not including serious) Adverse Events: the safety population included all randomized patients who received ≥1 dose of study treatment.
|
1.7%
1/60 • Up to 39 months
All-Cause Mortality: the ITT population. Serious Adverse Events and Other (not including serious) Adverse Events: the safety population included all randomized patients who received ≥1 dose of study treatment.
|
1.7%
1/60 • Up to 39 months
All-Cause Mortality: the ITT population. Serious Adverse Events and Other (not including serious) Adverse Events: the safety population included all randomized patients who received ≥1 dose of study treatment.
|
|
Gastrointestinal disorders
Ascites
|
1.8%
1/57 • Up to 39 months
All-Cause Mortality: the ITT population. Serious Adverse Events and Other (not including serious) Adverse Events: the safety population included all randomized patients who received ≥1 dose of study treatment.
|
1.7%
1/60 • Up to 39 months
All-Cause Mortality: the ITT population. Serious Adverse Events and Other (not including serious) Adverse Events: the safety population included all randomized patients who received ≥1 dose of study treatment.
|
1.7%
1/60 • Up to 39 months
All-Cause Mortality: the ITT population. Serious Adverse Events and Other (not including serious) Adverse Events: the safety population included all randomized patients who received ≥1 dose of study treatment.
|
|
Gastrointestinal disorders
Constipation
|
3.5%
2/57 • Up to 39 months
All-Cause Mortality: the ITT population. Serious Adverse Events and Other (not including serious) Adverse Events: the safety population included all randomized patients who received ≥1 dose of study treatment.
|
0.00%
0/60 • Up to 39 months
All-Cause Mortality: the ITT population. Serious Adverse Events and Other (not including serious) Adverse Events: the safety population included all randomized patients who received ≥1 dose of study treatment.
|
0.00%
0/60 • Up to 39 months
All-Cause Mortality: the ITT population. Serious Adverse Events and Other (not including serious) Adverse Events: the safety population included all randomized patients who received ≥1 dose of study treatment.
|
|
Gastrointestinal disorders
Large intestinal obstruction
|
3.5%
2/57 • Up to 39 months
All-Cause Mortality: the ITT population. Serious Adverse Events and Other (not including serious) Adverse Events: the safety population included all randomized patients who received ≥1 dose of study treatment.
|
0.00%
0/60 • Up to 39 months
All-Cause Mortality: the ITT population. Serious Adverse Events and Other (not including serious) Adverse Events: the safety population included all randomized patients who received ≥1 dose of study treatment.
|
0.00%
0/60 • Up to 39 months
All-Cause Mortality: the ITT population. Serious Adverse Events and Other (not including serious) Adverse Events: the safety population included all randomized patients who received ≥1 dose of study treatment.
|
|
Gastrointestinal disorders
Vomiting
|
3.5%
2/57 • Up to 39 months
All-Cause Mortality: the ITT population. Serious Adverse Events and Other (not including serious) Adverse Events: the safety population included all randomized patients who received ≥1 dose of study treatment.
|
0.00%
0/60 • Up to 39 months
All-Cause Mortality: the ITT population. Serious Adverse Events and Other (not including serious) Adverse Events: the safety population included all randomized patients who received ≥1 dose of study treatment.
|
0.00%
0/60 • Up to 39 months
All-Cause Mortality: the ITT population. Serious Adverse Events and Other (not including serious) Adverse Events: the safety population included all randomized patients who received ≥1 dose of study treatment.
|
|
Gastrointestinal disorders
Abdominal distension
|
1.8%
1/57 • Up to 39 months
All-Cause Mortality: the ITT population. Serious Adverse Events and Other (not including serious) Adverse Events: the safety population included all randomized patients who received ≥1 dose of study treatment.
|
0.00%
0/60 • Up to 39 months
All-Cause Mortality: the ITT population. Serious Adverse Events and Other (not including serious) Adverse Events: the safety population included all randomized patients who received ≥1 dose of study treatment.
|
0.00%
0/60 • Up to 39 months
All-Cause Mortality: the ITT population. Serious Adverse Events and Other (not including serious) Adverse Events: the safety population included all randomized patients who received ≥1 dose of study treatment.
|
|
Gastrointestinal disorders
Abdominal pain upper
|
1.8%
1/57 • Up to 39 months
All-Cause Mortality: the ITT population. Serious Adverse Events and Other (not including serious) Adverse Events: the safety population included all randomized patients who received ≥1 dose of study treatment.
|
0.00%
0/60 • Up to 39 months
All-Cause Mortality: the ITT population. Serious Adverse Events and Other (not including serious) Adverse Events: the safety population included all randomized patients who received ≥1 dose of study treatment.
|
0.00%
0/60 • Up to 39 months
All-Cause Mortality: the ITT population. Serious Adverse Events and Other (not including serious) Adverse Events: the safety population included all randomized patients who received ≥1 dose of study treatment.
|
|
Gastrointestinal disorders
Gastric ulcer
|
1.8%
1/57 • Up to 39 months
All-Cause Mortality: the ITT population. Serious Adverse Events and Other (not including serious) Adverse Events: the safety population included all randomized patients who received ≥1 dose of study treatment.
|
0.00%
0/60 • Up to 39 months
All-Cause Mortality: the ITT population. Serious Adverse Events and Other (not including serious) Adverse Events: the safety population included all randomized patients who received ≥1 dose of study treatment.
|
0.00%
0/60 • Up to 39 months
All-Cause Mortality: the ITT population. Serious Adverse Events and Other (not including serious) Adverse Events: the safety population included all randomized patients who received ≥1 dose of study treatment.
|
|
Gastrointestinal disorders
Intestinal pseudo-obstruction
|
0.00%
0/57 • Up to 39 months
All-Cause Mortality: the ITT population. Serious Adverse Events and Other (not including serious) Adverse Events: the safety population included all randomized patients who received ≥1 dose of study treatment.
|
0.00%
0/60 • Up to 39 months
All-Cause Mortality: the ITT population. Serious Adverse Events and Other (not including serious) Adverse Events: the safety population included all randomized patients who received ≥1 dose of study treatment.
|
1.7%
1/60 • Up to 39 months
All-Cause Mortality: the ITT population. Serious Adverse Events and Other (not including serious) Adverse Events: the safety population included all randomized patients who received ≥1 dose of study treatment.
|
|
Gastrointestinal disorders
Nausea
|
1.8%
1/57 • Up to 39 months
All-Cause Mortality: the ITT population. Serious Adverse Events and Other (not including serious) Adverse Events: the safety population included all randomized patients who received ≥1 dose of study treatment.
|
0.00%
0/60 • Up to 39 months
All-Cause Mortality: the ITT population. Serious Adverse Events and Other (not including serious) Adverse Events: the safety population included all randomized patients who received ≥1 dose of study treatment.
|
0.00%
0/60 • Up to 39 months
All-Cause Mortality: the ITT population. Serious Adverse Events and Other (not including serious) Adverse Events: the safety population included all randomized patients who received ≥1 dose of study treatment.
|
|
Gastrointestinal disorders
Subileus
|
1.8%
1/57 • Up to 39 months
All-Cause Mortality: the ITT population. Serious Adverse Events and Other (not including serious) Adverse Events: the safety population included all randomized patients who received ≥1 dose of study treatment.
|
0.00%
0/60 • Up to 39 months
All-Cause Mortality: the ITT population. Serious Adverse Events and Other (not including serious) Adverse Events: the safety population included all randomized patients who received ≥1 dose of study treatment.
|
0.00%
0/60 • Up to 39 months
All-Cause Mortality: the ITT population. Serious Adverse Events and Other (not including serious) Adverse Events: the safety population included all randomized patients who received ≥1 dose of study treatment.
|
|
Gastrointestinal disorders
Varices oesophageal
|
0.00%
0/57 • Up to 39 months
All-Cause Mortality: the ITT population. Serious Adverse Events and Other (not including serious) Adverse Events: the safety population included all randomized patients who received ≥1 dose of study treatment.
|
0.00%
0/60 • Up to 39 months
All-Cause Mortality: the ITT population. Serious Adverse Events and Other (not including serious) Adverse Events: the safety population included all randomized patients who received ≥1 dose of study treatment.
|
1.7%
1/60 • Up to 39 months
All-Cause Mortality: the ITT population. Serious Adverse Events and Other (not including serious) Adverse Events: the safety population included all randomized patients who received ≥1 dose of study treatment.
|
|
General disorders
General physical health deterioration
|
3.5%
2/57 • Up to 39 months
All-Cause Mortality: the ITT population. Serious Adverse Events and Other (not including serious) Adverse Events: the safety population included all randomized patients who received ≥1 dose of study treatment.
|
1.7%
1/60 • Up to 39 months
All-Cause Mortality: the ITT population. Serious Adverse Events and Other (not including serious) Adverse Events: the safety population included all randomized patients who received ≥1 dose of study treatment.
|
0.00%
0/60 • Up to 39 months
All-Cause Mortality: the ITT population. Serious Adverse Events and Other (not including serious) Adverse Events: the safety population included all randomized patients who received ≥1 dose of study treatment.
|
|
General disorders
Pyrexia
|
0.00%
0/57 • Up to 39 months
All-Cause Mortality: the ITT population. Serious Adverse Events and Other (not including serious) Adverse Events: the safety population included all randomized patients who received ≥1 dose of study treatment.
|
1.7%
1/60 • Up to 39 months
All-Cause Mortality: the ITT population. Serious Adverse Events and Other (not including serious) Adverse Events: the safety population included all randomized patients who received ≥1 dose of study treatment.
|
1.7%
1/60 • Up to 39 months
All-Cause Mortality: the ITT population. Serious Adverse Events and Other (not including serious) Adverse Events: the safety population included all randomized patients who received ≥1 dose of study treatment.
|
|
General disorders
Fatigue
|
1.8%
1/57 • Up to 39 months
All-Cause Mortality: the ITT population. Serious Adverse Events and Other (not including serious) Adverse Events: the safety population included all randomized patients who received ≥1 dose of study treatment.
|
0.00%
0/60 • Up to 39 months
All-Cause Mortality: the ITT population. Serious Adverse Events and Other (not including serious) Adverse Events: the safety population included all randomized patients who received ≥1 dose of study treatment.
|
0.00%
0/60 • Up to 39 months
All-Cause Mortality: the ITT population. Serious Adverse Events and Other (not including serious) Adverse Events: the safety population included all randomized patients who received ≥1 dose of study treatment.
|
|
Hepatobiliary disorders
Cholangitis
|
0.00%
0/57 • Up to 39 months
All-Cause Mortality: the ITT population. Serious Adverse Events and Other (not including serious) Adverse Events: the safety population included all randomized patients who received ≥1 dose of study treatment.
|
0.00%
0/60 • Up to 39 months
All-Cause Mortality: the ITT population. Serious Adverse Events and Other (not including serious) Adverse Events: the safety population included all randomized patients who received ≥1 dose of study treatment.
|
3.3%
2/60 • Up to 39 months
All-Cause Mortality: the ITT population. Serious Adverse Events and Other (not including serious) Adverse Events: the safety population included all randomized patients who received ≥1 dose of study treatment.
|
|
Infections and infestations
Pneumonia
|
3.5%
2/57 • Up to 39 months
All-Cause Mortality: the ITT population. Serious Adverse Events and Other (not including serious) Adverse Events: the safety population included all randomized patients who received ≥1 dose of study treatment.
|
0.00%
0/60 • Up to 39 months
All-Cause Mortality: the ITT population. Serious Adverse Events and Other (not including serious) Adverse Events: the safety population included all randomized patients who received ≥1 dose of study treatment.
|
1.7%
1/60 • Up to 39 months
All-Cause Mortality: the ITT population. Serious Adverse Events and Other (not including serious) Adverse Events: the safety population included all randomized patients who received ≥1 dose of study treatment.
|
|
Infections and infestations
Urinary tract infection
|
1.8%
1/57 • Up to 39 months
All-Cause Mortality: the ITT population. Serious Adverse Events and Other (not including serious) Adverse Events: the safety population included all randomized patients who received ≥1 dose of study treatment.
|
1.7%
1/60 • Up to 39 months
All-Cause Mortality: the ITT population. Serious Adverse Events and Other (not including serious) Adverse Events: the safety population included all randomized patients who received ≥1 dose of study treatment.
|
1.7%
1/60 • Up to 39 months
All-Cause Mortality: the ITT population. Serious Adverse Events and Other (not including serious) Adverse Events: the safety population included all randomized patients who received ≥1 dose of study treatment.
|
|
Infections and infestations
Upper respiratory tract infection
|
0.00%
0/57 • Up to 39 months
All-Cause Mortality: the ITT population. Serious Adverse Events and Other (not including serious) Adverse Events: the safety population included all randomized patients who received ≥1 dose of study treatment.
|
0.00%
0/60 • Up to 39 months
All-Cause Mortality: the ITT population. Serious Adverse Events and Other (not including serious) Adverse Events: the safety population included all randomized patients who received ≥1 dose of study treatment.
|
3.3%
2/60 • Up to 39 months
All-Cause Mortality: the ITT population. Serious Adverse Events and Other (not including serious) Adverse Events: the safety population included all randomized patients who received ≥1 dose of study treatment.
|
|
Infections and infestations
Biliary tract infection
|
0.00%
0/57 • Up to 39 months
All-Cause Mortality: the ITT population. Serious Adverse Events and Other (not including serious) Adverse Events: the safety population included all randomized patients who received ≥1 dose of study treatment.
|
0.00%
0/60 • Up to 39 months
All-Cause Mortality: the ITT population. Serious Adverse Events and Other (not including serious) Adverse Events: the safety population included all randomized patients who received ≥1 dose of study treatment.
|
1.7%
1/60 • Up to 39 months
All-Cause Mortality: the ITT population. Serious Adverse Events and Other (not including serious) Adverse Events: the safety population included all randomized patients who received ≥1 dose of study treatment.
|
|
Infections and infestations
Coronavirus infection
|
0.00%
0/57 • Up to 39 months
All-Cause Mortality: the ITT population. Serious Adverse Events and Other (not including serious) Adverse Events: the safety population included all randomized patients who received ≥1 dose of study treatment.
|
1.7%
1/60 • Up to 39 months
All-Cause Mortality: the ITT population. Serious Adverse Events and Other (not including serious) Adverse Events: the safety population included all randomized patients who received ≥1 dose of study treatment.
|
0.00%
0/60 • Up to 39 months
All-Cause Mortality: the ITT population. Serious Adverse Events and Other (not including serious) Adverse Events: the safety population included all randomized patients who received ≥1 dose of study treatment.
|
|
Infections and infestations
Escherichia pyelonephritis
|
1.8%
1/57 • Up to 39 months
All-Cause Mortality: the ITT population. Serious Adverse Events and Other (not including serious) Adverse Events: the safety population included all randomized patients who received ≥1 dose of study treatment.
|
0.00%
0/60 • Up to 39 months
All-Cause Mortality: the ITT population. Serious Adverse Events and Other (not including serious) Adverse Events: the safety population included all randomized patients who received ≥1 dose of study treatment.
|
0.00%
0/60 • Up to 39 months
All-Cause Mortality: the ITT population. Serious Adverse Events and Other (not including serious) Adverse Events: the safety population included all randomized patients who received ≥1 dose of study treatment.
|
|
Infections and infestations
Influenza
|
0.00%
0/57 • Up to 39 months
All-Cause Mortality: the ITT population. Serious Adverse Events and Other (not including serious) Adverse Events: the safety population included all randomized patients who received ≥1 dose of study treatment.
|
0.00%
0/60 • Up to 39 months
All-Cause Mortality: the ITT population. Serious Adverse Events and Other (not including serious) Adverse Events: the safety population included all randomized patients who received ≥1 dose of study treatment.
|
1.7%
1/60 • Up to 39 months
All-Cause Mortality: the ITT population. Serious Adverse Events and Other (not including serious) Adverse Events: the safety population included all randomized patients who received ≥1 dose of study treatment.
|
|
Infections and infestations
Pneumocystis jirovecii pneumonia
|
0.00%
0/57 • Up to 39 months
All-Cause Mortality: the ITT population. Serious Adverse Events and Other (not including serious) Adverse Events: the safety population included all randomized patients who received ≥1 dose of study treatment.
|
1.7%
1/60 • Up to 39 months
All-Cause Mortality: the ITT population. Serious Adverse Events and Other (not including serious) Adverse Events: the safety population included all randomized patients who received ≥1 dose of study treatment.
|
0.00%
0/60 • Up to 39 months
All-Cause Mortality: the ITT population. Serious Adverse Events and Other (not including serious) Adverse Events: the safety population included all randomized patients who received ≥1 dose of study treatment.
|
|
Infections and infestations
Stoma site abscess
|
0.00%
0/57 • Up to 39 months
All-Cause Mortality: the ITT population. Serious Adverse Events and Other (not including serious) Adverse Events: the safety population included all randomized patients who received ≥1 dose of study treatment.
|
0.00%
0/60 • Up to 39 months
All-Cause Mortality: the ITT population. Serious Adverse Events and Other (not including serious) Adverse Events: the safety population included all randomized patients who received ≥1 dose of study treatment.
|
1.7%
1/60 • Up to 39 months
All-Cause Mortality: the ITT population. Serious Adverse Events and Other (not including serious) Adverse Events: the safety population included all randomized patients who received ≥1 dose of study treatment.
|
|
Infections and infestations
Subperiosteal abscess
|
1.8%
1/57 • Up to 39 months
All-Cause Mortality: the ITT population. Serious Adverse Events and Other (not including serious) Adverse Events: the safety population included all randomized patients who received ≥1 dose of study treatment.
|
0.00%
0/60 • Up to 39 months
All-Cause Mortality: the ITT population. Serious Adverse Events and Other (not including serious) Adverse Events: the safety population included all randomized patients who received ≥1 dose of study treatment.
|
0.00%
0/60 • Up to 39 months
All-Cause Mortality: the ITT population. Serious Adverse Events and Other (not including serious) Adverse Events: the safety population included all randomized patients who received ≥1 dose of study treatment.
|
|
Infections and infestations
Wound infection
|
0.00%
0/57 • Up to 39 months
All-Cause Mortality: the ITT population. Serious Adverse Events and Other (not including serious) Adverse Events: the safety population included all randomized patients who received ≥1 dose of study treatment.
|
1.7%
1/60 • Up to 39 months
All-Cause Mortality: the ITT population. Serious Adverse Events and Other (not including serious) Adverse Events: the safety population included all randomized patients who received ≥1 dose of study treatment.
|
0.00%
0/60 • Up to 39 months
All-Cause Mortality: the ITT population. Serious Adverse Events and Other (not including serious) Adverse Events: the safety population included all randomized patients who received ≥1 dose of study treatment.
|
|
Injury, poisoning and procedural complications
Gastrointestinal stoma necrosis
|
1.8%
1/57 • Up to 39 months
All-Cause Mortality: the ITT population. Serious Adverse Events and Other (not including serious) Adverse Events: the safety population included all randomized patients who received ≥1 dose of study treatment.
|
0.00%
0/60 • Up to 39 months
All-Cause Mortality: the ITT population. Serious Adverse Events and Other (not including serious) Adverse Events: the safety population included all randomized patients who received ≥1 dose of study treatment.
|
0.00%
0/60 • Up to 39 months
All-Cause Mortality: the ITT population. Serious Adverse Events and Other (not including serious) Adverse Events: the safety population included all randomized patients who received ≥1 dose of study treatment.
|
|
Injury, poisoning and procedural complications
Pelvic fracture
|
0.00%
0/57 • Up to 39 months
All-Cause Mortality: the ITT population. Serious Adverse Events and Other (not including serious) Adverse Events: the safety population included all randomized patients who received ≥1 dose of study treatment.
|
0.00%
0/60 • Up to 39 months
All-Cause Mortality: the ITT population. Serious Adverse Events and Other (not including serious) Adverse Events: the safety population included all randomized patients who received ≥1 dose of study treatment.
|
1.7%
1/60 • Up to 39 months
All-Cause Mortality: the ITT population. Serious Adverse Events and Other (not including serious) Adverse Events: the safety population included all randomized patients who received ≥1 dose of study treatment.
|
|
Metabolism and nutrition disorders
Dehydration
|
0.00%
0/57 • Up to 39 months
All-Cause Mortality: the ITT population. Serious Adverse Events and Other (not including serious) Adverse Events: the safety population included all randomized patients who received ≥1 dose of study treatment.
|
1.7%
1/60 • Up to 39 months
All-Cause Mortality: the ITT population. Serious Adverse Events and Other (not including serious) Adverse Events: the safety population included all randomized patients who received ≥1 dose of study treatment.
|
0.00%
0/60 • Up to 39 months
All-Cause Mortality: the ITT population. Serious Adverse Events and Other (not including serious) Adverse Events: the safety population included all randomized patients who received ≥1 dose of study treatment.
|
|
Metabolism and nutrition disorders
Hypocalcaemia
|
0.00%
0/57 • Up to 39 months
All-Cause Mortality: the ITT population. Serious Adverse Events and Other (not including serious) Adverse Events: the safety population included all randomized patients who received ≥1 dose of study treatment.
|
0.00%
0/60 • Up to 39 months
All-Cause Mortality: the ITT population. Serious Adverse Events and Other (not including serious) Adverse Events: the safety population included all randomized patients who received ≥1 dose of study treatment.
|
1.7%
1/60 • Up to 39 months
All-Cause Mortality: the ITT population. Serious Adverse Events and Other (not including serious) Adverse Events: the safety population included all randomized patients who received ≥1 dose of study treatment.
|
|
Metabolism and nutrition disorders
Hypomagnesaemia
|
0.00%
0/57 • Up to 39 months
All-Cause Mortality: the ITT population. Serious Adverse Events and Other (not including serious) Adverse Events: the safety population included all randomized patients who received ≥1 dose of study treatment.
|
0.00%
0/60 • Up to 39 months
All-Cause Mortality: the ITT population. Serious Adverse Events and Other (not including serious) Adverse Events: the safety population included all randomized patients who received ≥1 dose of study treatment.
|
1.7%
1/60 • Up to 39 months
All-Cause Mortality: the ITT population. Serious Adverse Events and Other (not including serious) Adverse Events: the safety population included all randomized patients who received ≥1 dose of study treatment.
|
|
Metabolism and nutrition disorders
Hypophosphataemia
|
0.00%
0/57 • Up to 39 months
All-Cause Mortality: the ITT population. Serious Adverse Events and Other (not including serious) Adverse Events: the safety population included all randomized patients who received ≥1 dose of study treatment.
|
0.00%
0/60 • Up to 39 months
All-Cause Mortality: the ITT population. Serious Adverse Events and Other (not including serious) Adverse Events: the safety population included all randomized patients who received ≥1 dose of study treatment.
|
1.7%
1/60 • Up to 39 months
All-Cause Mortality: the ITT population. Serious Adverse Events and Other (not including serious) Adverse Events: the safety population included all randomized patients who received ≥1 dose of study treatment.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
1.8%
1/57 • Up to 39 months
All-Cause Mortality: the ITT population. Serious Adverse Events and Other (not including serious) Adverse Events: the safety population included all randomized patients who received ≥1 dose of study treatment.
|
0.00%
0/60 • Up to 39 months
All-Cause Mortality: the ITT population. Serious Adverse Events and Other (not including serious) Adverse Events: the safety population included all randomized patients who received ≥1 dose of study treatment.
|
0.00%
0/60 • Up to 39 months
All-Cause Mortality: the ITT population. Serious Adverse Events and Other (not including serious) Adverse Events: the safety population included all randomized patients who received ≥1 dose of study treatment.
|
|
Gastrointestinal disorders
Malignant ascites
|
1.8%
1/57 • Up to 39 months
All-Cause Mortality: the ITT population. Serious Adverse Events and Other (not including serious) Adverse Events: the safety population included all randomized patients who received ≥1 dose of study treatment.
|
3.3%
2/60 • Up to 39 months
All-Cause Mortality: the ITT population. Serious Adverse Events and Other (not including serious) Adverse Events: the safety population included all randomized patients who received ≥1 dose of study treatment.
|
0.00%
0/60 • Up to 39 months
All-Cause Mortality: the ITT population. Serious Adverse Events and Other (not including serious) Adverse Events: the safety population included all randomized patients who received ≥1 dose of study treatment.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Malignant pleural effusion
|
1.8%
1/57 • Up to 39 months
All-Cause Mortality: the ITT population. Serious Adverse Events and Other (not including serious) Adverse Events: the safety population included all randomized patients who received ≥1 dose of study treatment.
|
0.00%
0/60 • Up to 39 months
All-Cause Mortality: the ITT population. Serious Adverse Events and Other (not including serious) Adverse Events: the safety population included all randomized patients who received ≥1 dose of study treatment.
|
0.00%
0/60 • Up to 39 months
All-Cause Mortality: the ITT population. Serious Adverse Events and Other (not including serious) Adverse Events: the safety population included all randomized patients who received ≥1 dose of study treatment.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastases to central nervous system
|
0.00%
0/57 • Up to 39 months
All-Cause Mortality: the ITT population. Serious Adverse Events and Other (not including serious) Adverse Events: the safety population included all randomized patients who received ≥1 dose of study treatment.
|
3.3%
2/60 • Up to 39 months
All-Cause Mortality: the ITT population. Serious Adverse Events and Other (not including serious) Adverse Events: the safety population included all randomized patients who received ≥1 dose of study treatment.
|
0.00%
0/60 • Up to 39 months
All-Cause Mortality: the ITT population. Serious Adverse Events and Other (not including serious) Adverse Events: the safety population included all randomized patients who received ≥1 dose of study treatment.
|
|
Nervous system disorders
Monoparesis
|
1.8%
1/57 • Up to 39 months
All-Cause Mortality: the ITT population. Serious Adverse Events and Other (not including serious) Adverse Events: the safety population included all randomized patients who received ≥1 dose of study treatment.
|
0.00%
0/60 • Up to 39 months
All-Cause Mortality: the ITT population. Serious Adverse Events and Other (not including serious) Adverse Events: the safety population included all randomized patients who received ≥1 dose of study treatment.
|
0.00%
0/60 • Up to 39 months
All-Cause Mortality: the ITT population. Serious Adverse Events and Other (not including serious) Adverse Events: the safety population included all randomized patients who received ≥1 dose of study treatment.
|
|
Nervous system disorders
Paraneoplastic neurological syndrome
|
0.00%
0/57 • Up to 39 months
All-Cause Mortality: the ITT population. Serious Adverse Events and Other (not including serious) Adverse Events: the safety population included all randomized patients who received ≥1 dose of study treatment.
|
0.00%
0/60 • Up to 39 months
All-Cause Mortality: the ITT population. Serious Adverse Events and Other (not including serious) Adverse Events: the safety population included all randomized patients who received ≥1 dose of study treatment.
|
1.7%
1/60 • Up to 39 months
All-Cause Mortality: the ITT population. Serious Adverse Events and Other (not including serious) Adverse Events: the safety population included all randomized patients who received ≥1 dose of study treatment.
|
|
Nervous system disorders
Syncope
|
0.00%
0/57 • Up to 39 months
All-Cause Mortality: the ITT population. Serious Adverse Events and Other (not including serious) Adverse Events: the safety population included all randomized patients who received ≥1 dose of study treatment.
|
0.00%
0/60 • Up to 39 months
All-Cause Mortality: the ITT population. Serious Adverse Events and Other (not including serious) Adverse Events: the safety population included all randomized patients who received ≥1 dose of study treatment.
|
1.7%
1/60 • Up to 39 months
All-Cause Mortality: the ITT population. Serious Adverse Events and Other (not including serious) Adverse Events: the safety population included all randomized patients who received ≥1 dose of study treatment.
|
|
Renal and urinary disorders
Hydronephrosis
|
1.8%
1/57 • Up to 39 months
All-Cause Mortality: the ITT population. Serious Adverse Events and Other (not including serious) Adverse Events: the safety population included all randomized patients who received ≥1 dose of study treatment.
|
1.7%
1/60 • Up to 39 months
All-Cause Mortality: the ITT population. Serious Adverse Events and Other (not including serious) Adverse Events: the safety population included all randomized patients who received ≥1 dose of study treatment.
|
0.00%
0/60 • Up to 39 months
All-Cause Mortality: the ITT population. Serious Adverse Events and Other (not including serious) Adverse Events: the safety population included all randomized patients who received ≥1 dose of study treatment.
|
|
Renal and urinary disorders
Acute kidney injury
|
0.00%
0/57 • Up to 39 months
All-Cause Mortality: the ITT population. Serious Adverse Events and Other (not including serious) Adverse Events: the safety population included all randomized patients who received ≥1 dose of study treatment.
|
1.7%
1/60 • Up to 39 months
All-Cause Mortality: the ITT population. Serious Adverse Events and Other (not including serious) Adverse Events: the safety population included all randomized patients who received ≥1 dose of study treatment.
|
0.00%
0/60 • Up to 39 months
All-Cause Mortality: the ITT population. Serious Adverse Events and Other (not including serious) Adverse Events: the safety population included all randomized patients who received ≥1 dose of study treatment.
|
|
Renal and urinary disorders
Cystitis haemorrhagic
|
1.8%
1/57 • Up to 39 months
All-Cause Mortality: the ITT population. Serious Adverse Events and Other (not including serious) Adverse Events: the safety population included all randomized patients who received ≥1 dose of study treatment.
|
0.00%
0/60 • Up to 39 months
All-Cause Mortality: the ITT population. Serious Adverse Events and Other (not including serious) Adverse Events: the safety population included all randomized patients who received ≥1 dose of study treatment.
|
0.00%
0/60 • Up to 39 months
All-Cause Mortality: the ITT population. Serious Adverse Events and Other (not including serious) Adverse Events: the safety population included all randomized patients who received ≥1 dose of study treatment.
|
|
Reproductive system and breast disorders
Pelvic pain
|
0.00%
0/57 • Up to 39 months
All-Cause Mortality: the ITT population. Serious Adverse Events and Other (not including serious) Adverse Events: the safety population included all randomized patients who received ≥1 dose of study treatment.
|
0.00%
0/60 • Up to 39 months
All-Cause Mortality: the ITT population. Serious Adverse Events and Other (not including serious) Adverse Events: the safety population included all randomized patients who received ≥1 dose of study treatment.
|
1.7%
1/60 • Up to 39 months
All-Cause Mortality: the ITT population. Serious Adverse Events and Other (not including serious) Adverse Events: the safety population included all randomized patients who received ≥1 dose of study treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Pleural efffusion
|
5.3%
3/57 • Up to 39 months
All-Cause Mortality: the ITT population. Serious Adverse Events and Other (not including serious) Adverse Events: the safety population included all randomized patients who received ≥1 dose of study treatment.
|
1.7%
1/60 • Up to 39 months
All-Cause Mortality: the ITT population. Serious Adverse Events and Other (not including serious) Adverse Events: the safety population included all randomized patients who received ≥1 dose of study treatment.
|
1.7%
1/60 • Up to 39 months
All-Cause Mortality: the ITT population. Serious Adverse Events and Other (not including serious) Adverse Events: the safety population included all randomized patients who received ≥1 dose of study treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
3.5%
2/57 • Up to 39 months
All-Cause Mortality: the ITT population. Serious Adverse Events and Other (not including serious) Adverse Events: the safety population included all randomized patients who received ≥1 dose of study treatment.
|
1.7%
1/60 • Up to 39 months
All-Cause Mortality: the ITT population. Serious Adverse Events and Other (not including serious) Adverse Events: the safety population included all randomized patients who received ≥1 dose of study treatment.
|
1.7%
1/60 • Up to 39 months
All-Cause Mortality: the ITT population. Serious Adverse Events and Other (not including serious) Adverse Events: the safety population included all randomized patients who received ≥1 dose of study treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
1.8%
1/57 • Up to 39 months
All-Cause Mortality: the ITT population. Serious Adverse Events and Other (not including serious) Adverse Events: the safety population included all randomized patients who received ≥1 dose of study treatment.
|
1.7%
1/60 • Up to 39 months
All-Cause Mortality: the ITT population. Serious Adverse Events and Other (not including serious) Adverse Events: the safety population included all randomized patients who received ≥1 dose of study treatment.
|
0.00%
0/60 • Up to 39 months
All-Cause Mortality: the ITT population. Serious Adverse Events and Other (not including serious) Adverse Events: the safety population included all randomized patients who received ≥1 dose of study treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumothorax
|
1.8%
1/57 • Up to 39 months
All-Cause Mortality: the ITT population. Serious Adverse Events and Other (not including serious) Adverse Events: the safety population included all randomized patients who received ≥1 dose of study treatment.
|
0.00%
0/60 • Up to 39 months
All-Cause Mortality: the ITT population. Serious Adverse Events and Other (not including serious) Adverse Events: the safety population included all randomized patients who received ≥1 dose of study treatment.
|
0.00%
0/60 • Up to 39 months
All-Cause Mortality: the ITT population. Serious Adverse Events and Other (not including serious) Adverse Events: the safety population included all randomized patients who received ≥1 dose of study treatment.
|
|
Skin and subcutaneous tissue disorders
Melanocytic hyperplasia
|
1.8%
1/57 • Up to 39 months
All-Cause Mortality: the ITT population. Serious Adverse Events and Other (not including serious) Adverse Events: the safety population included all randomized patients who received ≥1 dose of study treatment.
|
0.00%
0/60 • Up to 39 months
All-Cause Mortality: the ITT population. Serious Adverse Events and Other (not including serious) Adverse Events: the safety population included all randomized patients who received ≥1 dose of study treatment.
|
0.00%
0/60 • Up to 39 months
All-Cause Mortality: the ITT population. Serious Adverse Events and Other (not including serious) Adverse Events: the safety population included all randomized patients who received ≥1 dose of study treatment.
|
|
Vascular disorders
Deep vein thrombosis
|
0.00%
0/57 • Up to 39 months
All-Cause Mortality: the ITT population. Serious Adverse Events and Other (not including serious) Adverse Events: the safety population included all randomized patients who received ≥1 dose of study treatment.
|
1.7%
1/60 • Up to 39 months
All-Cause Mortality: the ITT population. Serious Adverse Events and Other (not including serious) Adverse Events: the safety population included all randomized patients who received ≥1 dose of study treatment.
|
0.00%
0/60 • Up to 39 months
All-Cause Mortality: the ITT population. Serious Adverse Events and Other (not including serious) Adverse Events: the safety population included all randomized patients who received ≥1 dose of study treatment.
|
|
Infections and infestations
Bacterial diarrhoea
|
1.8%
1/57 • Up to 39 months
All-Cause Mortality: the ITT population. Serious Adverse Events and Other (not including serious) Adverse Events: the safety population included all randomized patients who received ≥1 dose of study treatment.
|
0.00%
0/60 • Up to 39 months
All-Cause Mortality: the ITT population. Serious Adverse Events and Other (not including serious) Adverse Events: the safety population included all randomized patients who received ≥1 dose of study treatment.
|
0.00%
0/60 • Up to 39 months
All-Cause Mortality: the ITT population. Serious Adverse Events and Other (not including serious) Adverse Events: the safety population included all randomized patients who received ≥1 dose of study treatment.
|
|
Infections and infestations
Infectious pleural effusion
|
1.8%
1/57 • Up to 39 months
All-Cause Mortality: the ITT population. Serious Adverse Events and Other (not including serious) Adverse Events: the safety population included all randomized patients who received ≥1 dose of study treatment.
|
0.00%
0/60 • Up to 39 months
All-Cause Mortality: the ITT population. Serious Adverse Events and Other (not including serious) Adverse Events: the safety population included all randomized patients who received ≥1 dose of study treatment.
|
0.00%
0/60 • Up to 39 months
All-Cause Mortality: the ITT population. Serious Adverse Events and Other (not including serious) Adverse Events: the safety population included all randomized patients who received ≥1 dose of study treatment.
|
|
Infections and infestations
Urosepsis
|
0.00%
0/57 • Up to 39 months
All-Cause Mortality: the ITT population. Serious Adverse Events and Other (not including serious) Adverse Events: the safety population included all randomized patients who received ≥1 dose of study treatment.
|
0.00%
0/60 • Up to 39 months
All-Cause Mortality: the ITT population. Serious Adverse Events and Other (not including serious) Adverse Events: the safety population included all randomized patients who received ≥1 dose of study treatment.
|
1.7%
1/60 • Up to 39 months
All-Cause Mortality: the ITT population. Serious Adverse Events and Other (not including serious) Adverse Events: the safety population included all randomized patients who received ≥1 dose of study treatment.
|
|
Injury, poisoning and procedural complications
Stoma prolapse
|
1.8%
1/57 • Up to 39 months
All-Cause Mortality: the ITT population. Serious Adverse Events and Other (not including serious) Adverse Events: the safety population included all randomized patients who received ≥1 dose of study treatment.
|
0.00%
0/60 • Up to 39 months
All-Cause Mortality: the ITT population. Serious Adverse Events and Other (not including serious) Adverse Events: the safety population included all randomized patients who received ≥1 dose of study treatment.
|
0.00%
0/60 • Up to 39 months
All-Cause Mortality: the ITT population. Serious Adverse Events and Other (not including serious) Adverse Events: the safety population included all randomized patients who received ≥1 dose of study treatment.
|
|
Nervous system disorders
Hydrocephalus
|
0.00%
0/57 • Up to 39 months
All-Cause Mortality: the ITT population. Serious Adverse Events and Other (not including serious) Adverse Events: the safety population included all randomized patients who received ≥1 dose of study treatment.
|
1.7%
1/60 • Up to 39 months
All-Cause Mortality: the ITT population. Serious Adverse Events and Other (not including serious) Adverse Events: the safety population included all randomized patients who received ≥1 dose of study treatment.
|
0.00%
0/60 • Up to 39 months
All-Cause Mortality: the ITT population. Serious Adverse Events and Other (not including serious) Adverse Events: the safety population included all randomized patients who received ≥1 dose of study treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea exertional
|
0.00%
0/57 • Up to 39 months
All-Cause Mortality: the ITT population. Serious Adverse Events and Other (not including serious) Adverse Events: the safety population included all randomized patients who received ≥1 dose of study treatment.
|
0.00%
0/60 • Up to 39 months
All-Cause Mortality: the ITT population. Serious Adverse Events and Other (not including serious) Adverse Events: the safety population included all randomized patients who received ≥1 dose of study treatment.
|
1.7%
1/60 • Up to 39 months
All-Cause Mortality: the ITT population. Serious Adverse Events and Other (not including serious) Adverse Events: the safety population included all randomized patients who received ≥1 dose of study treatment.
|
Other adverse events
| Measure |
Arm A: Continuous Relacorilant Dosing
n=57 participants at risk
Patients will receive relacorilant 100 mg (titrated up to 150 mg after Cycle 1 or 2) once daily in combination with nab-paclitaxel 80 mg/m\^2, on Days 1, 8, and 15 of each 28-day cycle.
|
Arm B: Intermittent Relacorilant Dosing
n=60 participants at risk
Patients will receive relacorilant 150 mg on the day before (excluding Cycle 1, Day -1), the day of, and the day after nab-paclitaxel, in combination with nab-paclitaxel 80 mg/m\^2, on Days 1, 8, and 15 of each 28-day cycle.
|
Arm C: Nab-paclitaxel Comparator
n=60 participants at risk
Patients will receive nab-paclitaxel 100 mg/m\^2 on Days 1, 8, and 15 of each 28-day cycle. Patients initially in Arm C who choose to cross over after disease progression will receive relacorilant 100 mg (titrated up to 150 mg) in combination with nab-paclitaxel 80 mg/m\^2 on Days 1, 8, and 15 of each 28-day cycle after cross over.
|
|---|---|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
68.4%
39/57 • Up to 39 months
All-Cause Mortality: the ITT population. Serious Adverse Events and Other (not including serious) Adverse Events: the safety population included all randomized patients who received ≥1 dose of study treatment.
|
48.3%
29/60 • Up to 39 months
All-Cause Mortality: the ITT population. Serious Adverse Events and Other (not including serious) Adverse Events: the safety population included all randomized patients who received ≥1 dose of study treatment.
|
56.7%
34/60 • Up to 39 months
All-Cause Mortality: the ITT population. Serious Adverse Events and Other (not including serious) Adverse Events: the safety population included all randomized patients who received ≥1 dose of study treatment.
|
|
Blood and lymphatic system disorders
Neutropenia
|
35.1%
20/57 • Up to 39 months
All-Cause Mortality: the ITT population. Serious Adverse Events and Other (not including serious) Adverse Events: the safety population included all randomized patients who received ≥1 dose of study treatment.
|
18.3%
11/60 • Up to 39 months
All-Cause Mortality: the ITT population. Serious Adverse Events and Other (not including serious) Adverse Events: the safety population included all randomized patients who received ≥1 dose of study treatment.
|
33.3%
20/60 • Up to 39 months
All-Cause Mortality: the ITT population. Serious Adverse Events and Other (not including serious) Adverse Events: the safety population included all randomized patients who received ≥1 dose of study treatment.
|
|
Blood and lymphatic system disorders
Leukopenia
|
12.3%
7/57 • Up to 39 months
All-Cause Mortality: the ITT population. Serious Adverse Events and Other (not including serious) Adverse Events: the safety population included all randomized patients who received ≥1 dose of study treatment.
|
5.0%
3/60 • Up to 39 months
All-Cause Mortality: the ITT population. Serious Adverse Events and Other (not including serious) Adverse Events: the safety population included all randomized patients who received ≥1 dose of study treatment.
|
10.0%
6/60 • Up to 39 months
All-Cause Mortality: the ITT population. Serious Adverse Events and Other (not including serious) Adverse Events: the safety population included all randomized patients who received ≥1 dose of study treatment.
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
12.3%
7/57 • Up to 39 months
All-Cause Mortality: the ITT population. Serious Adverse Events and Other (not including serious) Adverse Events: the safety population included all randomized patients who received ≥1 dose of study treatment.
|
3.3%
2/60 • Up to 39 months
All-Cause Mortality: the ITT population. Serious Adverse Events and Other (not including serious) Adverse Events: the safety population included all randomized patients who received ≥1 dose of study treatment.
|
8.3%
5/60 • Up to 39 months
All-Cause Mortality: the ITT population. Serious Adverse Events and Other (not including serious) Adverse Events: the safety population included all randomized patients who received ≥1 dose of study treatment.
|
|
Cardiac disorders
Tachycardia
|
8.8%
5/57 • Up to 39 months
All-Cause Mortality: the ITT population. Serious Adverse Events and Other (not including serious) Adverse Events: the safety population included all randomized patients who received ≥1 dose of study treatment.
|
1.7%
1/60 • Up to 39 months
All-Cause Mortality: the ITT population. Serious Adverse Events and Other (not including serious) Adverse Events: the safety population included all randomized patients who received ≥1 dose of study treatment.
|
1.7%
1/60 • Up to 39 months
All-Cause Mortality: the ITT population. Serious Adverse Events and Other (not including serious) Adverse Events: the safety population included all randomized patients who received ≥1 dose of study treatment.
|
|
Cardiac disorders
Palpitations
|
7.0%
4/57 • Up to 39 months
All-Cause Mortality: the ITT population. Serious Adverse Events and Other (not including serious) Adverse Events: the safety population included all randomized patients who received ≥1 dose of study treatment.
|
1.7%
1/60 • Up to 39 months
All-Cause Mortality: the ITT population. Serious Adverse Events and Other (not including serious) Adverse Events: the safety population included all randomized patients who received ≥1 dose of study treatment.
|
0.00%
0/60 • Up to 39 months
All-Cause Mortality: the ITT population. Serious Adverse Events and Other (not including serious) Adverse Events: the safety population included all randomized patients who received ≥1 dose of study treatment.
|
|
Cardiac disorders
Sinus tachycardia
|
1.8%
1/57 • Up to 39 months
All-Cause Mortality: the ITT population. Serious Adverse Events and Other (not including serious) Adverse Events: the safety population included all randomized patients who received ≥1 dose of study treatment.
|
5.0%
3/60 • Up to 39 months
All-Cause Mortality: the ITT population. Serious Adverse Events and Other (not including serious) Adverse Events: the safety population included all randomized patients who received ≥1 dose of study treatment.
|
1.7%
1/60 • Up to 39 months
All-Cause Mortality: the ITT population. Serious Adverse Events and Other (not including serious) Adverse Events: the safety population included all randomized patients who received ≥1 dose of study treatment.
|
|
Eye disorders
Lacrimation increased
|
14.0%
8/57 • Up to 39 months
All-Cause Mortality: the ITT population. Serious Adverse Events and Other (not including serious) Adverse Events: the safety population included all randomized patients who received ≥1 dose of study treatment.
|
10.0%
6/60 • Up to 39 months
All-Cause Mortality: the ITT population. Serious Adverse Events and Other (not including serious) Adverse Events: the safety population included all randomized patients who received ≥1 dose of study treatment.
|
3.3%
2/60 • Up to 39 months
All-Cause Mortality: the ITT population. Serious Adverse Events and Other (not including serious) Adverse Events: the safety population included all randomized patients who received ≥1 dose of study treatment.
|
|
Eye disorders
Visual impairment
|
7.0%
4/57 • Up to 39 months
All-Cause Mortality: the ITT population. Serious Adverse Events and Other (not including serious) Adverse Events: the safety population included all randomized patients who received ≥1 dose of study treatment.
|
0.00%
0/60 • Up to 39 months
All-Cause Mortality: the ITT population. Serious Adverse Events and Other (not including serious) Adverse Events: the safety population included all randomized patients who received ≥1 dose of study treatment.
|
5.0%
3/60 • Up to 39 months
All-Cause Mortality: the ITT population. Serious Adverse Events and Other (not including serious) Adverse Events: the safety population included all randomized patients who received ≥1 dose of study treatment.
|
|
Eye disorders
Dry eye
|
3.5%
2/57 • Up to 39 months
All-Cause Mortality: the ITT population. Serious Adverse Events and Other (not including serious) Adverse Events: the safety population included all randomized patients who received ≥1 dose of study treatment.
|
5.0%
3/60 • Up to 39 months
All-Cause Mortality: the ITT population. Serious Adverse Events and Other (not including serious) Adverse Events: the safety population included all randomized patients who received ≥1 dose of study treatment.
|
1.7%
1/60 • Up to 39 months
All-Cause Mortality: the ITT population. Serious Adverse Events and Other (not including serious) Adverse Events: the safety population included all randomized patients who received ≥1 dose of study treatment.
|
|
Gastrointestinal disorders
Nausea
|
71.9%
41/57 • Up to 39 months
All-Cause Mortality: the ITT population. Serious Adverse Events and Other (not including serious) Adverse Events: the safety population included all randomized patients who received ≥1 dose of study treatment.
|
50.0%
30/60 • Up to 39 months
All-Cause Mortality: the ITT population. Serious Adverse Events and Other (not including serious) Adverse Events: the safety population included all randomized patients who received ≥1 dose of study treatment.
|
45.0%
27/60 • Up to 39 months
All-Cause Mortality: the ITT population. Serious Adverse Events and Other (not including serious) Adverse Events: the safety population included all randomized patients who received ≥1 dose of study treatment.
|
|
Gastrointestinal disorders
Constipation
|
43.9%
25/57 • Up to 39 months
All-Cause Mortality: the ITT population. Serious Adverse Events and Other (not including serious) Adverse Events: the safety population included all randomized patients who received ≥1 dose of study treatment.
|
31.7%
19/60 • Up to 39 months
All-Cause Mortality: the ITT population. Serious Adverse Events and Other (not including serious) Adverse Events: the safety population included all randomized patients who received ≥1 dose of study treatment.
|
28.3%
17/60 • Up to 39 months
All-Cause Mortality: the ITT population. Serious Adverse Events and Other (not including serious) Adverse Events: the safety population included all randomized patients who received ≥1 dose of study treatment.
|
|
Gastrointestinal disorders
Abdominal pain
|
36.8%
21/57 • Up to 39 months
All-Cause Mortality: the ITT population. Serious Adverse Events and Other (not including serious) Adverse Events: the safety population included all randomized patients who received ≥1 dose of study treatment.
|
26.7%
16/60 • Up to 39 months
All-Cause Mortality: the ITT population. Serious Adverse Events and Other (not including serious) Adverse Events: the safety population included all randomized patients who received ≥1 dose of study treatment.
|
33.3%
20/60 • Up to 39 months
All-Cause Mortality: the ITT population. Serious Adverse Events and Other (not including serious) Adverse Events: the safety population included all randomized patients who received ≥1 dose of study treatment.
|
|
Gastrointestinal disorders
Vomiting
|
47.4%
27/57 • Up to 39 months
All-Cause Mortality: the ITT population. Serious Adverse Events and Other (not including serious) Adverse Events: the safety population included all randomized patients who received ≥1 dose of study treatment.
|
30.0%
18/60 • Up to 39 months
All-Cause Mortality: the ITT population. Serious Adverse Events and Other (not including serious) Adverse Events: the safety population included all randomized patients who received ≥1 dose of study treatment.
|
25.0%
15/60 • Up to 39 months
All-Cause Mortality: the ITT population. Serious Adverse Events and Other (not including serious) Adverse Events: the safety population included all randomized patients who received ≥1 dose of study treatment.
|
|
Gastrointestinal disorders
Diarrhoea
|
38.6%
22/57 • Up to 39 months
All-Cause Mortality: the ITT population. Serious Adverse Events and Other (not including serious) Adverse Events: the safety population included all randomized patients who received ≥1 dose of study treatment.
|
26.7%
16/60 • Up to 39 months
All-Cause Mortality: the ITT population. Serious Adverse Events and Other (not including serious) Adverse Events: the safety population included all randomized patients who received ≥1 dose of study treatment.
|
25.0%
15/60 • Up to 39 months
All-Cause Mortality: the ITT population. Serious Adverse Events and Other (not including serious) Adverse Events: the safety population included all randomized patients who received ≥1 dose of study treatment.
|
|
Gastrointestinal disorders
Abdominal pain upper
|
12.3%
7/57 • Up to 39 months
All-Cause Mortality: the ITT population. Serious Adverse Events and Other (not including serious) Adverse Events: the safety population included all randomized patients who received ≥1 dose of study treatment.
|
15.0%
9/60 • Up to 39 months
All-Cause Mortality: the ITT population. Serious Adverse Events and Other (not including serious) Adverse Events: the safety population included all randomized patients who received ≥1 dose of study treatment.
|
10.0%
6/60 • Up to 39 months
All-Cause Mortality: the ITT population. Serious Adverse Events and Other (not including serious) Adverse Events: the safety population included all randomized patients who received ≥1 dose of study treatment.
|
|
Gastrointestinal disorders
Stomatitis
|
26.3%
15/57 • Up to 39 months
All-Cause Mortality: the ITT population. Serious Adverse Events and Other (not including serious) Adverse Events: the safety population included all randomized patients who received ≥1 dose of study treatment.
|
5.0%
3/60 • Up to 39 months
All-Cause Mortality: the ITT population. Serious Adverse Events and Other (not including serious) Adverse Events: the safety population included all randomized patients who received ≥1 dose of study treatment.
|
5.0%
3/60 • Up to 39 months
All-Cause Mortality: the ITT population. Serious Adverse Events and Other (not including serious) Adverse Events: the safety population included all randomized patients who received ≥1 dose of study treatment.
|
|
Gastrointestinal disorders
Abdominal distension
|
15.8%
9/57 • Up to 39 months
All-Cause Mortality: the ITT population. Serious Adverse Events and Other (not including serious) Adverse Events: the safety population included all randomized patients who received ≥1 dose of study treatment.
|
10.0%
6/60 • Up to 39 months
All-Cause Mortality: the ITT population. Serious Adverse Events and Other (not including serious) Adverse Events: the safety population included all randomized patients who received ≥1 dose of study treatment.
|
6.7%
4/60 • Up to 39 months
All-Cause Mortality: the ITT population. Serious Adverse Events and Other (not including serious) Adverse Events: the safety population included all randomized patients who received ≥1 dose of study treatment.
|
|
Gastrointestinal disorders
Dyspepsia
|
12.3%
7/57 • Up to 39 months
All-Cause Mortality: the ITT population. Serious Adverse Events and Other (not including serious) Adverse Events: the safety population included all randomized patients who received ≥1 dose of study treatment.
|
6.7%
4/60 • Up to 39 months
All-Cause Mortality: the ITT population. Serious Adverse Events and Other (not including serious) Adverse Events: the safety population included all randomized patients who received ≥1 dose of study treatment.
|
6.7%
4/60 • Up to 39 months
All-Cause Mortality: the ITT population. Serious Adverse Events and Other (not including serious) Adverse Events: the safety population included all randomized patients who received ≥1 dose of study treatment.
|
|
Gastrointestinal disorders
Ascites
|
10.5%
6/57 • Up to 39 months
All-Cause Mortality: the ITT population. Serious Adverse Events and Other (not including serious) Adverse Events: the safety population included all randomized patients who received ≥1 dose of study treatment.
|
8.3%
5/60 • Up to 39 months
All-Cause Mortality: the ITT population. Serious Adverse Events and Other (not including serious) Adverse Events: the safety population included all randomized patients who received ≥1 dose of study treatment.
|
6.7%
4/60 • Up to 39 months
All-Cause Mortality: the ITT population. Serious Adverse Events and Other (not including serious) Adverse Events: the safety population included all randomized patients who received ≥1 dose of study treatment.
|
|
Gastrointestinal disorders
Abdominal discomfort
|
5.3%
3/57 • Up to 39 months
All-Cause Mortality: the ITT population. Serious Adverse Events and Other (not including serious) Adverse Events: the safety population included all randomized patients who received ≥1 dose of study treatment.
|
5.0%
3/60 • Up to 39 months
All-Cause Mortality: the ITT population. Serious Adverse Events and Other (not including serious) Adverse Events: the safety population included all randomized patients who received ≥1 dose of study treatment.
|
3.3%
2/60 • Up to 39 months
All-Cause Mortality: the ITT population. Serious Adverse Events and Other (not including serious) Adverse Events: the safety population included all randomized patients who received ≥1 dose of study treatment.
|
|
Gastrointestinal disorders
Dry mouth
|
3.5%
2/57 • Up to 39 months
All-Cause Mortality: the ITT population. Serious Adverse Events and Other (not including serious) Adverse Events: the safety population included all randomized patients who received ≥1 dose of study treatment.
|
5.0%
3/60 • Up to 39 months
All-Cause Mortality: the ITT population. Serious Adverse Events and Other (not including serious) Adverse Events: the safety population included all randomized patients who received ≥1 dose of study treatment.
|
3.3%
2/60 • Up to 39 months
All-Cause Mortality: the ITT population. Serious Adverse Events and Other (not including serious) Adverse Events: the safety population included all randomized patients who received ≥1 dose of study treatment.
|
|
Gastrointestinal disorders
Abdominal pain lower
|
0.00%
0/57 • Up to 39 months
All-Cause Mortality: the ITT population. Serious Adverse Events and Other (not including serious) Adverse Events: the safety population included all randomized patients who received ≥1 dose of study treatment.
|
6.7%
4/60 • Up to 39 months
All-Cause Mortality: the ITT population. Serious Adverse Events and Other (not including serious) Adverse Events: the safety population included all randomized patients who received ≥1 dose of study treatment.
|
5.0%
3/60 • Up to 39 months
All-Cause Mortality: the ITT population. Serious Adverse Events and Other (not including serious) Adverse Events: the safety population included all randomized patients who received ≥1 dose of study treatment.
|
|
Gastrointestinal disorders
Gastrooesophageal reflux disease
|
7.0%
4/57 • Up to 39 months
All-Cause Mortality: the ITT population. Serious Adverse Events and Other (not including serious) Adverse Events: the safety population included all randomized patients who received ≥1 dose of study treatment.
|
0.00%
0/60 • Up to 39 months
All-Cause Mortality: the ITT population. Serious Adverse Events and Other (not including serious) Adverse Events: the safety population included all randomized patients who received ≥1 dose of study treatment.
|
3.3%
2/60 • Up to 39 months
All-Cause Mortality: the ITT population. Serious Adverse Events and Other (not including serious) Adverse Events: the safety population included all randomized patients who received ≥1 dose of study treatment.
|
|
Gastrointestinal disorders
Intestinal obstruction
|
1.8%
1/57 • Up to 39 months
All-Cause Mortality: the ITT population. Serious Adverse Events and Other (not including serious) Adverse Events: the safety population included all randomized patients who received ≥1 dose of study treatment.
|
0.00%
0/60 • Up to 39 months
All-Cause Mortality: the ITT population. Serious Adverse Events and Other (not including serious) Adverse Events: the safety population included all randomized patients who received ≥1 dose of study treatment.
|
6.7%
4/60 • Up to 39 months
All-Cause Mortality: the ITT population. Serious Adverse Events and Other (not including serious) Adverse Events: the safety population included all randomized patients who received ≥1 dose of study treatment.
|
|
General disorders
Fatigue
|
33.3%
19/57 • Up to 39 months
All-Cause Mortality: the ITT population. Serious Adverse Events and Other (not including serious) Adverse Events: the safety population included all randomized patients who received ≥1 dose of study treatment.
|
31.7%
19/60 • Up to 39 months
All-Cause Mortality: the ITT population. Serious Adverse Events and Other (not including serious) Adverse Events: the safety population included all randomized patients who received ≥1 dose of study treatment.
|
35.0%
21/60 • Up to 39 months
All-Cause Mortality: the ITT population. Serious Adverse Events and Other (not including serious) Adverse Events: the safety population included all randomized patients who received ≥1 dose of study treatment.
|
|
General disorders
Asthenia
|
42.1%
24/57 • Up to 39 months
All-Cause Mortality: the ITT population. Serious Adverse Events and Other (not including serious) Adverse Events: the safety population included all randomized patients who received ≥1 dose of study treatment.
|
25.0%
15/60 • Up to 39 months
All-Cause Mortality: the ITT population. Serious Adverse Events and Other (not including serious) Adverse Events: the safety population included all randomized patients who received ≥1 dose of study treatment.
|
31.7%
19/60 • Up to 39 months
All-Cause Mortality: the ITT population. Serious Adverse Events and Other (not including serious) Adverse Events: the safety population included all randomized patients who received ≥1 dose of study treatment.
|
|
General disorders
Oedema peripheral
|
14.0%
8/57 • Up to 39 months
All-Cause Mortality: the ITT population. Serious Adverse Events and Other (not including serious) Adverse Events: the safety population included all randomized patients who received ≥1 dose of study treatment.
|
16.7%
10/60 • Up to 39 months
All-Cause Mortality: the ITT population. Serious Adverse Events and Other (not including serious) Adverse Events: the safety population included all randomized patients who received ≥1 dose of study treatment.
|
20.0%
12/60 • Up to 39 months
All-Cause Mortality: the ITT population. Serious Adverse Events and Other (not including serious) Adverse Events: the safety population included all randomized patients who received ≥1 dose of study treatment.
|
|
General disorders
Pyrexia
|
8.8%
5/57 • Up to 39 months
All-Cause Mortality: the ITT population. Serious Adverse Events and Other (not including serious) Adverse Events: the safety population included all randomized patients who received ≥1 dose of study treatment.
|
10.0%
6/60 • Up to 39 months
All-Cause Mortality: the ITT population. Serious Adverse Events and Other (not including serious) Adverse Events: the safety population included all randomized patients who received ≥1 dose of study treatment.
|
16.7%
10/60 • Up to 39 months
All-Cause Mortality: the ITT population. Serious Adverse Events and Other (not including serious) Adverse Events: the safety population included all randomized patients who received ≥1 dose of study treatment.
|
|
General disorders
Peripheral swelling
|
7.0%
4/57 • Up to 39 months
All-Cause Mortality: the ITT population. Serious Adverse Events and Other (not including serious) Adverse Events: the safety population included all randomized patients who received ≥1 dose of study treatment.
|
5.0%
3/60 • Up to 39 months
All-Cause Mortality: the ITT population. Serious Adverse Events and Other (not including serious) Adverse Events: the safety population included all randomized patients who received ≥1 dose of study treatment.
|
5.0%
3/60 • Up to 39 months
All-Cause Mortality: the ITT population. Serious Adverse Events and Other (not including serious) Adverse Events: the safety population included all randomized patients who received ≥1 dose of study treatment.
|
|
General disorders
Malaise
|
8.8%
5/57 • Up to 39 months
All-Cause Mortality: the ITT population. Serious Adverse Events and Other (not including serious) Adverse Events: the safety population included all randomized patients who received ≥1 dose of study treatment.
|
1.7%
1/60 • Up to 39 months
All-Cause Mortality: the ITT population. Serious Adverse Events and Other (not including serious) Adverse Events: the safety population included all randomized patients who received ≥1 dose of study treatment.
|
3.3%
2/60 • Up to 39 months
All-Cause Mortality: the ITT population. Serious Adverse Events and Other (not including serious) Adverse Events: the safety population included all randomized patients who received ≥1 dose of study treatment.
|
|
Hepatobiliary disorders
Hypertransaminasaemia
|
5.3%
3/57 • Up to 39 months
All-Cause Mortality: the ITT population. Serious Adverse Events and Other (not including serious) Adverse Events: the safety population included all randomized patients who received ≥1 dose of study treatment.
|
0.00%
0/60 • Up to 39 months
All-Cause Mortality: the ITT population. Serious Adverse Events and Other (not including serious) Adverse Events: the safety population included all randomized patients who received ≥1 dose of study treatment.
|
1.7%
1/60 • Up to 39 months
All-Cause Mortality: the ITT population. Serious Adverse Events and Other (not including serious) Adverse Events: the safety population included all randomized patients who received ≥1 dose of study treatment.
|
|
Infections and infestations
Urinary tract infection
|
14.0%
8/57 • Up to 39 months
All-Cause Mortality: the ITT population. Serious Adverse Events and Other (not including serious) Adverse Events: the safety population included all randomized patients who received ≥1 dose of study treatment.
|
6.7%
4/60 • Up to 39 months
All-Cause Mortality: the ITT population. Serious Adverse Events and Other (not including serious) Adverse Events: the safety population included all randomized patients who received ≥1 dose of study treatment.
|
5.0%
3/60 • Up to 39 months
All-Cause Mortality: the ITT population. Serious Adverse Events and Other (not including serious) Adverse Events: the safety population included all randomized patients who received ≥1 dose of study treatment.
|
|
Infections and infestations
Upper respiratory tract infection
|
3.5%
2/57 • Up to 39 months
All-Cause Mortality: the ITT population. Serious Adverse Events and Other (not including serious) Adverse Events: the safety population included all randomized patients who received ≥1 dose of study treatment.
|
1.7%
1/60 • Up to 39 months
All-Cause Mortality: the ITT population. Serious Adverse Events and Other (not including serious) Adverse Events: the safety population included all randomized patients who received ≥1 dose of study treatment.
|
10.0%
6/60 • Up to 39 months
All-Cause Mortality: the ITT population. Serious Adverse Events and Other (not including serious) Adverse Events: the safety population included all randomized patients who received ≥1 dose of study treatment.
|
|
Infections and infestations
Cystitis
|
1.8%
1/57 • Up to 39 months
All-Cause Mortality: the ITT population. Serious Adverse Events and Other (not including serious) Adverse Events: the safety population included all randomized patients who received ≥1 dose of study treatment.
|
1.7%
1/60 • Up to 39 months
All-Cause Mortality: the ITT population. Serious Adverse Events and Other (not including serious) Adverse Events: the safety population included all randomized patients who received ≥1 dose of study treatment.
|
5.0%
3/60 • Up to 39 months
All-Cause Mortality: the ITT population. Serious Adverse Events and Other (not including serious) Adverse Events: the safety population included all randomized patients who received ≥1 dose of study treatment.
|
|
Investigations
Blood alkaline phosphatase increased
|
8.8%
5/57 • Up to 39 months
All-Cause Mortality: the ITT population. Serious Adverse Events and Other (not including serious) Adverse Events: the safety population included all randomized patients who received ≥1 dose of study treatment.
|
5.0%
3/60 • Up to 39 months
All-Cause Mortality: the ITT population. Serious Adverse Events and Other (not including serious) Adverse Events: the safety population included all randomized patients who received ≥1 dose of study treatment.
|
11.7%
7/60 • Up to 39 months
All-Cause Mortality: the ITT population. Serious Adverse Events and Other (not including serious) Adverse Events: the safety population included all randomized patients who received ≥1 dose of study treatment.
|
|
Investigations
Weight decreased
|
10.5%
6/57 • Up to 39 months
All-Cause Mortality: the ITT population. Serious Adverse Events and Other (not including serious) Adverse Events: the safety population included all randomized patients who received ≥1 dose of study treatment.
|
5.0%
3/60 • Up to 39 months
All-Cause Mortality: the ITT population. Serious Adverse Events and Other (not including serious) Adverse Events: the safety population included all randomized patients who received ≥1 dose of study treatment.
|
5.0%
3/60 • Up to 39 months
All-Cause Mortality: the ITT population. Serious Adverse Events and Other (not including serious) Adverse Events: the safety population included all randomized patients who received ≥1 dose of study treatment.
|
|
Investigations
Alanine aminotransferase increased
|
7.0%
4/57 • Up to 39 months
All-Cause Mortality: the ITT population. Serious Adverse Events and Other (not including serious) Adverse Events: the safety population included all randomized patients who received ≥1 dose of study treatment.
|
1.7%
1/60 • Up to 39 months
All-Cause Mortality: the ITT population. Serious Adverse Events and Other (not including serious) Adverse Events: the safety population included all randomized patients who received ≥1 dose of study treatment.
|
10.0%
6/60 • Up to 39 months
All-Cause Mortality: the ITT population. Serious Adverse Events and Other (not including serious) Adverse Events: the safety population included all randomized patients who received ≥1 dose of study treatment.
|
|
Investigations
Aspartate aminotransferase increased
|
7.0%
4/57 • Up to 39 months
All-Cause Mortality: the ITT population. Serious Adverse Events and Other (not including serious) Adverse Events: the safety population included all randomized patients who received ≥1 dose of study treatment.
|
1.7%
1/60 • Up to 39 months
All-Cause Mortality: the ITT population. Serious Adverse Events and Other (not including serious) Adverse Events: the safety population included all randomized patients who received ≥1 dose of study treatment.
|
10.0%
6/60 • Up to 39 months
All-Cause Mortality: the ITT population. Serious Adverse Events and Other (not including serious) Adverse Events: the safety population included all randomized patients who received ≥1 dose of study treatment.
|
|
Investigations
Gamma-glutamyltransferase increased
|
7.0%
4/57 • Up to 39 months
All-Cause Mortality: the ITT population. Serious Adverse Events and Other (not including serious) Adverse Events: the safety population included all randomized patients who received ≥1 dose of study treatment.
|
0.00%
0/60 • Up to 39 months
All-Cause Mortality: the ITT population. Serious Adverse Events and Other (not including serious) Adverse Events: the safety population included all randomized patients who received ≥1 dose of study treatment.
|
10.0%
6/60 • Up to 39 months
All-Cause Mortality: the ITT population. Serious Adverse Events and Other (not including serious) Adverse Events: the safety population included all randomized patients who received ≥1 dose of study treatment.
|
|
Investigations
Neutrophil count decreased
|
5.3%
3/57 • Up to 39 months
All-Cause Mortality: the ITT population. Serious Adverse Events and Other (not including serious) Adverse Events: the safety population included all randomized patients who received ≥1 dose of study treatment.
|
1.7%
1/60 • Up to 39 months
All-Cause Mortality: the ITT population. Serious Adverse Events and Other (not including serious) Adverse Events: the safety population included all randomized patients who received ≥1 dose of study treatment.
|
6.7%
4/60 • Up to 39 months
All-Cause Mortality: the ITT population. Serious Adverse Events and Other (not including serious) Adverse Events: the safety population included all randomized patients who received ≥1 dose of study treatment.
|
|
Investigations
Blood creatine phosphokinase increased
|
1.8%
1/57 • Up to 39 months
All-Cause Mortality: the ITT population. Serious Adverse Events and Other (not including serious) Adverse Events: the safety population included all randomized patients who received ≥1 dose of study treatment.
|
0.00%
0/60 • Up to 39 months
All-Cause Mortality: the ITT population. Serious Adverse Events and Other (not including serious) Adverse Events: the safety population included all randomized patients who received ≥1 dose of study treatment.
|
5.0%
3/60 • Up to 39 months
All-Cause Mortality: the ITT population. Serious Adverse Events and Other (not including serious) Adverse Events: the safety population included all randomized patients who received ≥1 dose of study treatment.
|
|
Investigations
White blood cell count decreased
|
5.3%
3/57 • Up to 39 months
All-Cause Mortality: the ITT population. Serious Adverse Events and Other (not including serious) Adverse Events: the safety population included all randomized patients who received ≥1 dose of study treatment.
|
1.7%
1/60 • Up to 39 months
All-Cause Mortality: the ITT population. Serious Adverse Events and Other (not including serious) Adverse Events: the safety population included all randomized patients who received ≥1 dose of study treatment.
|
0.00%
0/60 • Up to 39 months
All-Cause Mortality: the ITT population. Serious Adverse Events and Other (not including serious) Adverse Events: the safety population included all randomized patients who received ≥1 dose of study treatment.
|
|
Metabolism and nutrition disorders
Decreased appetite
|
35.1%
20/57 • Up to 39 months
All-Cause Mortality: the ITT population. Serious Adverse Events and Other (not including serious) Adverse Events: the safety population included all randomized patients who received ≥1 dose of study treatment.
|
21.7%
13/60 • Up to 39 months
All-Cause Mortality: the ITT population. Serious Adverse Events and Other (not including serious) Adverse Events: the safety population included all randomized patients who received ≥1 dose of study treatment.
|
16.7%
10/60 • Up to 39 months
All-Cause Mortality: the ITT population. Serious Adverse Events and Other (not including serious) Adverse Events: the safety population included all randomized patients who received ≥1 dose of study treatment.
|
|
Metabolism and nutrition disorders
Hypomagnesaemia
|
15.8%
9/57 • Up to 39 months
All-Cause Mortality: the ITT population. Serious Adverse Events and Other (not including serious) Adverse Events: the safety population included all randomized patients who received ≥1 dose of study treatment.
|
8.3%
5/60 • Up to 39 months
All-Cause Mortality: the ITT population. Serious Adverse Events and Other (not including serious) Adverse Events: the safety population included all randomized patients who received ≥1 dose of study treatment.
|
18.3%
11/60 • Up to 39 months
All-Cause Mortality: the ITT population. Serious Adverse Events and Other (not including serious) Adverse Events: the safety population included all randomized patients who received ≥1 dose of study treatment.
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
24.6%
14/57 • Up to 39 months
All-Cause Mortality: the ITT population. Serious Adverse Events and Other (not including serious) Adverse Events: the safety population included all randomized patients who received ≥1 dose of study treatment.
|
5.0%
3/60 • Up to 39 months
All-Cause Mortality: the ITT population. Serious Adverse Events and Other (not including serious) Adverse Events: the safety population included all randomized patients who received ≥1 dose of study treatment.
|
8.3%
5/60 • Up to 39 months
All-Cause Mortality: the ITT population. Serious Adverse Events and Other (not including serious) Adverse Events: the safety population included all randomized patients who received ≥1 dose of study treatment.
|
|
Metabolism and nutrition disorders
Hypoalbuminaemia
|
5.3%
3/57 • Up to 39 months
All-Cause Mortality: the ITT population. Serious Adverse Events and Other (not including serious) Adverse Events: the safety population included all randomized patients who received ≥1 dose of study treatment.
|
5.0%
3/60 • Up to 39 months
All-Cause Mortality: the ITT population. Serious Adverse Events and Other (not including serious) Adverse Events: the safety population included all randomized patients who received ≥1 dose of study treatment.
|
6.7%
4/60 • Up to 39 months
All-Cause Mortality: the ITT population. Serious Adverse Events and Other (not including serious) Adverse Events: the safety population included all randomized patients who received ≥1 dose of study treatment.
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
5.3%
3/57 • Up to 39 months
All-Cause Mortality: the ITT population. Serious Adverse Events and Other (not including serious) Adverse Events: the safety population included all randomized patients who received ≥1 dose of study treatment.
|
5.0%
3/60 • Up to 39 months
All-Cause Mortality: the ITT population. Serious Adverse Events and Other (not including serious) Adverse Events: the safety population included all randomized patients who received ≥1 dose of study treatment.
|
3.3%
2/60 • Up to 39 months
All-Cause Mortality: the ITT population. Serious Adverse Events and Other (not including serious) Adverse Events: the safety population included all randomized patients who received ≥1 dose of study treatment.
|
|
Metabolism and nutrition disorders
Hypophosphataemia
|
7.0%
4/57 • Up to 39 months
All-Cause Mortality: the ITT population. Serious Adverse Events and Other (not including serious) Adverse Events: the safety population included all randomized patients who received ≥1 dose of study treatment.
|
1.7%
1/60 • Up to 39 months
All-Cause Mortality: the ITT population. Serious Adverse Events and Other (not including serious) Adverse Events: the safety population included all randomized patients who received ≥1 dose of study treatment.
|
3.3%
2/60 • Up to 39 months
All-Cause Mortality: the ITT population. Serious Adverse Events and Other (not including serious) Adverse Events: the safety population included all randomized patients who received ≥1 dose of study treatment.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
24.6%
14/57 • Up to 39 months
All-Cause Mortality: the ITT population. Serious Adverse Events and Other (not including serious) Adverse Events: the safety population included all randomized patients who received ≥1 dose of study treatment.
|
15.0%
9/60 • Up to 39 months
All-Cause Mortality: the ITT population. Serious Adverse Events and Other (not including serious) Adverse Events: the safety population included all randomized patients who received ≥1 dose of study treatment.
|
11.7%
7/60 • Up to 39 months
All-Cause Mortality: the ITT population. Serious Adverse Events and Other (not including serious) Adverse Events: the safety population included all randomized patients who received ≥1 dose of study treatment.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
17.5%
10/57 • Up to 39 months
All-Cause Mortality: the ITT population. Serious Adverse Events and Other (not including serious) Adverse Events: the safety population included all randomized patients who received ≥1 dose of study treatment.
|
11.7%
7/60 • Up to 39 months
All-Cause Mortality: the ITT population. Serious Adverse Events and Other (not including serious) Adverse Events: the safety population included all randomized patients who received ≥1 dose of study treatment.
|
15.0%
9/60 • Up to 39 months
All-Cause Mortality: the ITT population. Serious Adverse Events and Other (not including serious) Adverse Events: the safety population included all randomized patients who received ≥1 dose of study treatment.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
21.1%
12/57 • Up to 39 months
All-Cause Mortality: the ITT population. Serious Adverse Events and Other (not including serious) Adverse Events: the safety population included all randomized patients who received ≥1 dose of study treatment.
|
6.7%
4/60 • Up to 39 months
All-Cause Mortality: the ITT population. Serious Adverse Events and Other (not including serious) Adverse Events: the safety population included all randomized patients who received ≥1 dose of study treatment.
|
16.7%
10/60 • Up to 39 months
All-Cause Mortality: the ITT population. Serious Adverse Events and Other (not including serious) Adverse Events: the safety population included all randomized patients who received ≥1 dose of study treatment.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
14.0%
8/57 • Up to 39 months
All-Cause Mortality: the ITT population. Serious Adverse Events and Other (not including serious) Adverse Events: the safety population included all randomized patients who received ≥1 dose of study treatment.
|
16.7%
10/60 • Up to 39 months
All-Cause Mortality: the ITT population. Serious Adverse Events and Other (not including serious) Adverse Events: the safety population included all randomized patients who received ≥1 dose of study treatment.
|
13.3%
8/60 • Up to 39 months
All-Cause Mortality: the ITT population. Serious Adverse Events and Other (not including serious) Adverse Events: the safety population included all randomized patients who received ≥1 dose of study treatment.
|
|
Musculoskeletal and connective tissue disorders
Bone pain
|
10.5%
6/57 • Up to 39 months
All-Cause Mortality: the ITT population. Serious Adverse Events and Other (not including serious) Adverse Events: the safety population included all randomized patients who received ≥1 dose of study treatment.
|
6.7%
4/60 • Up to 39 months
All-Cause Mortality: the ITT population. Serious Adverse Events and Other (not including serious) Adverse Events: the safety population included all randomized patients who received ≥1 dose of study treatment.
|
10.0%
6/60 • Up to 39 months
All-Cause Mortality: the ITT population. Serious Adverse Events and Other (not including serious) Adverse Events: the safety population included all randomized patients who received ≥1 dose of study treatment.
|
|
Musculoskeletal and connective tissue disorders
Muscular weakness
|
5.3%
3/57 • Up to 39 months
All-Cause Mortality: the ITT population. Serious Adverse Events and Other (not including serious) Adverse Events: the safety population included all randomized patients who received ≥1 dose of study treatment.
|
10.0%
6/60 • Up to 39 months
All-Cause Mortality: the ITT population. Serious Adverse Events and Other (not including serious) Adverse Events: the safety population included all randomized patients who received ≥1 dose of study treatment.
|
5.0%
3/60 • Up to 39 months
All-Cause Mortality: the ITT population. Serious Adverse Events and Other (not including serious) Adverse Events: the safety population included all randomized patients who received ≥1 dose of study treatment.
|
|
Musculoskeletal and connective tissue disorders
Muscle spasms
|
1.8%
1/57 • Up to 39 months
All-Cause Mortality: the ITT population. Serious Adverse Events and Other (not including serious) Adverse Events: the safety population included all randomized patients who received ≥1 dose of study treatment.
|
1.7%
1/60 • Up to 39 months
All-Cause Mortality: the ITT population. Serious Adverse Events and Other (not including serious) Adverse Events: the safety population included all randomized patients who received ≥1 dose of study treatment.
|
13.3%
8/60 • Up to 39 months
All-Cause Mortality: the ITT population. Serious Adverse Events and Other (not including serious) Adverse Events: the safety population included all randomized patients who received ≥1 dose of study treatment.
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
5.3%
3/57 • Up to 39 months
All-Cause Mortality: the ITT population. Serious Adverse Events and Other (not including serious) Adverse Events: the safety population included all randomized patients who received ≥1 dose of study treatment.
|
6.7%
4/60 • Up to 39 months
All-Cause Mortality: the ITT population. Serious Adverse Events and Other (not including serious) Adverse Events: the safety population included all randomized patients who received ≥1 dose of study treatment.
|
3.3%
2/60 • Up to 39 months
All-Cause Mortality: the ITT population. Serious Adverse Events and Other (not including serious) Adverse Events: the safety population included all randomized patients who received ≥1 dose of study treatment.
|
|
Nervous system disorders
Peripheral sensory neuropathy
|
45.6%
26/57 • Up to 39 months
All-Cause Mortality: the ITT population. Serious Adverse Events and Other (not including serious) Adverse Events: the safety population included all randomized patients who received ≥1 dose of study treatment.
|
30.0%
18/60 • Up to 39 months
All-Cause Mortality: the ITT population. Serious Adverse Events and Other (not including serious) Adverse Events: the safety population included all randomized patients who received ≥1 dose of study treatment.
|
23.3%
14/60 • Up to 39 months
All-Cause Mortality: the ITT population. Serious Adverse Events and Other (not including serious) Adverse Events: the safety population included all randomized patients who received ≥1 dose of study treatment.
|
|
Nervous system disorders
Headache
|
14.0%
8/57 • Up to 39 months
All-Cause Mortality: the ITT population. Serious Adverse Events and Other (not including serious) Adverse Events: the safety population included all randomized patients who received ≥1 dose of study treatment.
|
11.7%
7/60 • Up to 39 months
All-Cause Mortality: the ITT population. Serious Adverse Events and Other (not including serious) Adverse Events: the safety population included all randomized patients who received ≥1 dose of study treatment.
|
11.7%
7/60 • Up to 39 months
All-Cause Mortality: the ITT population. Serious Adverse Events and Other (not including serious) Adverse Events: the safety population included all randomized patients who received ≥1 dose of study treatment.
|
|
Nervous system disorders
Dysgeusia
|
12.3%
7/57 • Up to 39 months
All-Cause Mortality: the ITT population. Serious Adverse Events and Other (not including serious) Adverse Events: the safety population included all randomized patients who received ≥1 dose of study treatment.
|
11.7%
7/60 • Up to 39 months
All-Cause Mortality: the ITT population. Serious Adverse Events and Other (not including serious) Adverse Events: the safety population included all randomized patients who received ≥1 dose of study treatment.
|
8.3%
5/60 • Up to 39 months
All-Cause Mortality: the ITT population. Serious Adverse Events and Other (not including serious) Adverse Events: the safety population included all randomized patients who received ≥1 dose of study treatment.
|
|
Nervous system disorders
Paraesthesia
|
8.8%
5/57 • Up to 39 months
All-Cause Mortality: the ITT population. Serious Adverse Events and Other (not including serious) Adverse Events: the safety population included all randomized patients who received ≥1 dose of study treatment.
|
8.3%
5/60 • Up to 39 months
All-Cause Mortality: the ITT population. Serious Adverse Events and Other (not including serious) Adverse Events: the safety population included all randomized patients who received ≥1 dose of study treatment.
|
11.7%
7/60 • Up to 39 months
All-Cause Mortality: the ITT population. Serious Adverse Events and Other (not including serious) Adverse Events: the safety population included all randomized patients who received ≥1 dose of study treatment.
|
|
Nervous system disorders
Dizziness
|
10.5%
6/57 • Up to 39 months
All-Cause Mortality: the ITT population. Serious Adverse Events and Other (not including serious) Adverse Events: the safety population included all randomized patients who received ≥1 dose of study treatment.
|
10.0%
6/60 • Up to 39 months
All-Cause Mortality: the ITT population. Serious Adverse Events and Other (not including serious) Adverse Events: the safety population included all randomized patients who received ≥1 dose of study treatment.
|
5.0%
3/60 • Up to 39 months
All-Cause Mortality: the ITT population. Serious Adverse Events and Other (not including serious) Adverse Events: the safety population included all randomized patients who received ≥1 dose of study treatment.
|
|
Nervous system disorders
Neuropathy peripheral
|
7.0%
4/57 • Up to 39 months
All-Cause Mortality: the ITT population. Serious Adverse Events and Other (not including serious) Adverse Events: the safety population included all randomized patients who received ≥1 dose of study treatment.
|
5.0%
3/60 • Up to 39 months
All-Cause Mortality: the ITT population. Serious Adverse Events and Other (not including serious) Adverse Events: the safety population included all randomized patients who received ≥1 dose of study treatment.
|
6.7%
4/60 • Up to 39 months
All-Cause Mortality: the ITT population. Serious Adverse Events and Other (not including serious) Adverse Events: the safety population included all randomized patients who received ≥1 dose of study treatment.
|
|
Nervous system disorders
Hypoaesthesia
|
1.8%
1/57 • Up to 39 months
All-Cause Mortality: the ITT population. Serious Adverse Events and Other (not including serious) Adverse Events: the safety population included all randomized patients who received ≥1 dose of study treatment.
|
3.3%
2/60 • Up to 39 months
All-Cause Mortality: the ITT population. Serious Adverse Events and Other (not including serious) Adverse Events: the safety population included all randomized patients who received ≥1 dose of study treatment.
|
5.0%
3/60 • Up to 39 months
All-Cause Mortality: the ITT population. Serious Adverse Events and Other (not including serious) Adverse Events: the safety population included all randomized patients who received ≥1 dose of study treatment.
|
|
Psychiatric disorders
Insomnia
|
10.5%
6/57 • Up to 39 months
All-Cause Mortality: the ITT population. Serious Adverse Events and Other (not including serious) Adverse Events: the safety population included all randomized patients who received ≥1 dose of study treatment.
|
6.7%
4/60 • Up to 39 months
All-Cause Mortality: the ITT population. Serious Adverse Events and Other (not including serious) Adverse Events: the safety population included all randomized patients who received ≥1 dose of study treatment.
|
6.7%
4/60 • Up to 39 months
All-Cause Mortality: the ITT population. Serious Adverse Events and Other (not including serious) Adverse Events: the safety population included all randomized patients who received ≥1 dose of study treatment.
|
|
Renal and urinary disorders
Dysuria
|
3.5%
2/57 • Up to 39 months
All-Cause Mortality: the ITT population. Serious Adverse Events and Other (not including serious) Adverse Events: the safety population included all randomized patients who received ≥1 dose of study treatment.
|
5.0%
3/60 • Up to 39 months
All-Cause Mortality: the ITT population. Serious Adverse Events and Other (not including serious) Adverse Events: the safety population included all randomized patients who received ≥1 dose of study treatment.
|
6.7%
4/60 • Up to 39 months
All-Cause Mortality: the ITT population. Serious Adverse Events and Other (not including serious) Adverse Events: the safety population included all randomized patients who received ≥1 dose of study treatment.
|
|
Renal and urinary disorders
Pollakiuria
|
1.8%
1/57 • Up to 39 months
All-Cause Mortality: the ITT population. Serious Adverse Events and Other (not including serious) Adverse Events: the safety population included all randomized patients who received ≥1 dose of study treatment.
|
5.0%
3/60 • Up to 39 months
All-Cause Mortality: the ITT population. Serious Adverse Events and Other (not including serious) Adverse Events: the safety population included all randomized patients who received ≥1 dose of study treatment.
|
6.7%
4/60 • Up to 39 months
All-Cause Mortality: the ITT population. Serious Adverse Events and Other (not including serious) Adverse Events: the safety population included all randomized patients who received ≥1 dose of study treatment.
|
|
Renal and urinary disorders
Urinary incontinence
|
5.3%
3/57 • Up to 39 months
All-Cause Mortality: the ITT population. Serious Adverse Events and Other (not including serious) Adverse Events: the safety population included all randomized patients who received ≥1 dose of study treatment.
|
1.7%
1/60 • Up to 39 months
All-Cause Mortality: the ITT population. Serious Adverse Events and Other (not including serious) Adverse Events: the safety population included all randomized patients who received ≥1 dose of study treatment.
|
5.0%
3/60 • Up to 39 months
All-Cause Mortality: the ITT population. Serious Adverse Events and Other (not including serious) Adverse Events: the safety population included all randomized patients who received ≥1 dose of study treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
21.1%
12/57 • Up to 39 months
All-Cause Mortality: the ITT population. Serious Adverse Events and Other (not including serious) Adverse Events: the safety population included all randomized patients who received ≥1 dose of study treatment.
|
6.7%
4/60 • Up to 39 months
All-Cause Mortality: the ITT population. Serious Adverse Events and Other (not including serious) Adverse Events: the safety population included all randomized patients who received ≥1 dose of study treatment.
|
25.0%
15/60 • Up to 39 months
All-Cause Mortality: the ITT population. Serious Adverse Events and Other (not including serious) Adverse Events: the safety population included all randomized patients who received ≥1 dose of study treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
10.5%
6/57 • Up to 39 months
All-Cause Mortality: the ITT population. Serious Adverse Events and Other (not including serious) Adverse Events: the safety population included all randomized patients who received ≥1 dose of study treatment.
|
15.0%
9/60 • Up to 39 months
All-Cause Mortality: the ITT population. Serious Adverse Events and Other (not including serious) Adverse Events: the safety population included all randomized patients who received ≥1 dose of study treatment.
|
16.7%
10/60 • Up to 39 months
All-Cause Mortality: the ITT population. Serious Adverse Events and Other (not including serious) Adverse Events: the safety population included all randomized patients who received ≥1 dose of study treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
0.00%
0/57 • Up to 39 months
All-Cause Mortality: the ITT population. Serious Adverse Events and Other (not including serious) Adverse Events: the safety population included all randomized patients who received ≥1 dose of study treatment.
|
8.3%
5/60 • Up to 39 months
All-Cause Mortality: the ITT population. Serious Adverse Events and Other (not including serious) Adverse Events: the safety population included all randomized patients who received ≥1 dose of study treatment.
|
11.7%
7/60 • Up to 39 months
All-Cause Mortality: the ITT population. Serious Adverse Events and Other (not including serious) Adverse Events: the safety population included all randomized patients who received ≥1 dose of study treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
3.5%
2/57 • Up to 39 months
All-Cause Mortality: the ITT population. Serious Adverse Events and Other (not including serious) Adverse Events: the safety population included all randomized patients who received ≥1 dose of study treatment.
|
10.0%
6/60 • Up to 39 months
All-Cause Mortality: the ITT population. Serious Adverse Events and Other (not including serious) Adverse Events: the safety population included all randomized patients who received ≥1 dose of study treatment.
|
3.3%
2/60 • Up to 39 months
All-Cause Mortality: the ITT population. Serious Adverse Events and Other (not including serious) Adverse Events: the safety population included all randomized patients who received ≥1 dose of study treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
7.0%
4/57 • Up to 39 months
All-Cause Mortality: the ITT population. Serious Adverse Events and Other (not including serious) Adverse Events: the safety population included all randomized patients who received ≥1 dose of study treatment.
|
1.7%
1/60 • Up to 39 months
All-Cause Mortality: the ITT population. Serious Adverse Events and Other (not including serious) Adverse Events: the safety population included all randomized patients who received ≥1 dose of study treatment.
|
1.7%
1/60 • Up to 39 months
All-Cause Mortality: the ITT population. Serious Adverse Events and Other (not including serious) Adverse Events: the safety population included all randomized patients who received ≥1 dose of study treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea exertional
|
1.8%
1/57 • Up to 39 months
All-Cause Mortality: the ITT population. Serious Adverse Events and Other (not including serious) Adverse Events: the safety population included all randomized patients who received ≥1 dose of study treatment.
|
5.0%
3/60 • Up to 39 months
All-Cause Mortality: the ITT population. Serious Adverse Events and Other (not including serious) Adverse Events: the safety population included all randomized patients who received ≥1 dose of study treatment.
|
3.3%
2/60 • Up to 39 months
All-Cause Mortality: the ITT population. Serious Adverse Events and Other (not including serious) Adverse Events: the safety population included all randomized patients who received ≥1 dose of study treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
7.0%
4/57 • Up to 39 months
All-Cause Mortality: the ITT population. Serious Adverse Events and Other (not including serious) Adverse Events: the safety population included all randomized patients who received ≥1 dose of study treatment.
|
0.00%
0/60 • Up to 39 months
All-Cause Mortality: the ITT population. Serious Adverse Events and Other (not including serious) Adverse Events: the safety population included all randomized patients who received ≥1 dose of study treatment.
|
3.3%
2/60 • Up to 39 months
All-Cause Mortality: the ITT population. Serious Adverse Events and Other (not including serious) Adverse Events: the safety population included all randomized patients who received ≥1 dose of study treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Dysphonia
|
1.8%
1/57 • Up to 39 months
All-Cause Mortality: the ITT population. Serious Adverse Events and Other (not including serious) Adverse Events: the safety population included all randomized patients who received ≥1 dose of study treatment.
|
1.7%
1/60 • Up to 39 months
All-Cause Mortality: the ITT population. Serious Adverse Events and Other (not including serious) Adverse Events: the safety population included all randomized patients who received ≥1 dose of study treatment.
|
5.0%
3/60 • Up to 39 months
All-Cause Mortality: the ITT population. Serious Adverse Events and Other (not including serious) Adverse Events: the safety population included all randomized patients who received ≥1 dose of study treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Upper-airway cough syndrome
|
1.8%
1/57 • Up to 39 months
All-Cause Mortality: the ITT population. Serious Adverse Events and Other (not including serious) Adverse Events: the safety population included all randomized patients who received ≥1 dose of study treatment.
|
0.00%
0/60 • Up to 39 months
All-Cause Mortality: the ITT population. Serious Adverse Events and Other (not including serious) Adverse Events: the safety population included all randomized patients who received ≥1 dose of study treatment.
|
6.7%
4/60 • Up to 39 months
All-Cause Mortality: the ITT population. Serious Adverse Events and Other (not including serious) Adverse Events: the safety population included all randomized patients who received ≥1 dose of study treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Rhinorrhoea
|
0.00%
0/57 • Up to 39 months
All-Cause Mortality: the ITT population. Serious Adverse Events and Other (not including serious) Adverse Events: the safety population included all randomized patients who received ≥1 dose of study treatment.
|
5.0%
3/60 • Up to 39 months
All-Cause Mortality: the ITT population. Serious Adverse Events and Other (not including serious) Adverse Events: the safety population included all randomized patients who received ≥1 dose of study treatment.
|
0.00%
0/60 • Up to 39 months
All-Cause Mortality: the ITT population. Serious Adverse Events and Other (not including serious) Adverse Events: the safety population included all randomized patients who received ≥1 dose of study treatment.
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
36.8%
21/57 • Up to 39 months
All-Cause Mortality: the ITT population. Serious Adverse Events and Other (not including serious) Adverse Events: the safety population included all randomized patients who received ≥1 dose of study treatment.
|
36.7%
22/60 • Up to 39 months
All-Cause Mortality: the ITT population. Serious Adverse Events and Other (not including serious) Adverse Events: the safety population included all randomized patients who received ≥1 dose of study treatment.
|
40.0%
24/60 • Up to 39 months
All-Cause Mortality: the ITT population. Serious Adverse Events and Other (not including serious) Adverse Events: the safety population included all randomized patients who received ≥1 dose of study treatment.
|
|
Skin and subcutaneous tissue disorders
Rash
|
19.3%
11/57 • Up to 39 months
All-Cause Mortality: the ITT population. Serious Adverse Events and Other (not including serious) Adverse Events: the safety population included all randomized patients who received ≥1 dose of study treatment.
|
6.7%
4/60 • Up to 39 months
All-Cause Mortality: the ITT population. Serious Adverse Events and Other (not including serious) Adverse Events: the safety population included all randomized patients who received ≥1 dose of study treatment.
|
3.3%
2/60 • Up to 39 months
All-Cause Mortality: the ITT population. Serious Adverse Events and Other (not including serious) Adverse Events: the safety population included all randomized patients who received ≥1 dose of study treatment.
|
|
Skin and subcutaneous tissue disorders
Onycholysis
|
14.0%
8/57 • Up to 39 months
All-Cause Mortality: the ITT population. Serious Adverse Events and Other (not including serious) Adverse Events: the safety population included all randomized patients who received ≥1 dose of study treatment.
|
10.0%
6/60 • Up to 39 months
All-Cause Mortality: the ITT population. Serious Adverse Events and Other (not including serious) Adverse Events: the safety population included all randomized patients who received ≥1 dose of study treatment.
|
5.0%
3/60 • Up to 39 months
All-Cause Mortality: the ITT population. Serious Adverse Events and Other (not including serious) Adverse Events: the safety population included all randomized patients who received ≥1 dose of study treatment.
|
|
Skin and subcutaneous tissue disorders
Nail discolouration
|
8.8%
5/57 • Up to 39 months
All-Cause Mortality: the ITT population. Serious Adverse Events and Other (not including serious) Adverse Events: the safety population included all randomized patients who received ≥1 dose of study treatment.
|
8.3%
5/60 • Up to 39 months
All-Cause Mortality: the ITT population. Serious Adverse Events and Other (not including serious) Adverse Events: the safety population included all randomized patients who received ≥1 dose of study treatment.
|
6.7%
4/60 • Up to 39 months
All-Cause Mortality: the ITT population. Serious Adverse Events and Other (not including serious) Adverse Events: the safety population included all randomized patients who received ≥1 dose of study treatment.
|
|
Skin and subcutaneous tissue disorders
Nail disorder
|
15.8%
9/57 • Up to 39 months
All-Cause Mortality: the ITT population. Serious Adverse Events and Other (not including serious) Adverse Events: the safety population included all randomized patients who received ≥1 dose of study treatment.
|
6.7%
4/60 • Up to 39 months
All-Cause Mortality: the ITT population. Serious Adverse Events and Other (not including serious) Adverse Events: the safety population included all randomized patients who received ≥1 dose of study treatment.
|
1.7%
1/60 • Up to 39 months
All-Cause Mortality: the ITT population. Serious Adverse Events and Other (not including serious) Adverse Events: the safety population included all randomized patients who received ≥1 dose of study treatment.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
7.0%
4/57 • Up to 39 months
All-Cause Mortality: the ITT population. Serious Adverse Events and Other (not including serious) Adverse Events: the safety population included all randomized patients who received ≥1 dose of study treatment.
|
5.0%
3/60 • Up to 39 months
All-Cause Mortality: the ITT population. Serious Adverse Events and Other (not including serious) Adverse Events: the safety population included all randomized patients who received ≥1 dose of study treatment.
|
11.7%
7/60 • Up to 39 months
All-Cause Mortality: the ITT population. Serious Adverse Events and Other (not including serious) Adverse Events: the safety population included all randomized patients who received ≥1 dose of study treatment.
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
5.3%
3/57 • Up to 39 months
All-Cause Mortality: the ITT population. Serious Adverse Events and Other (not including serious) Adverse Events: the safety population included all randomized patients who received ≥1 dose of study treatment.
|
5.0%
3/60 • Up to 39 months
All-Cause Mortality: the ITT population. Serious Adverse Events and Other (not including serious) Adverse Events: the safety population included all randomized patients who received ≥1 dose of study treatment.
|
3.3%
2/60 • Up to 39 months
All-Cause Mortality: the ITT population. Serious Adverse Events and Other (not including serious) Adverse Events: the safety population included all randomized patients who received ≥1 dose of study treatment.
|
|
Skin and subcutaneous tissue disorders
Dermatitis acneiform
|
12.3%
7/57 • Up to 39 months
All-Cause Mortality: the ITT population. Serious Adverse Events and Other (not including serious) Adverse Events: the safety population included all randomized patients who received ≥1 dose of study treatment.
|
3.3%
2/60 • Up to 39 months
All-Cause Mortality: the ITT population. Serious Adverse Events and Other (not including serious) Adverse Events: the safety population included all randomized patients who received ≥1 dose of study treatment.
|
1.7%
1/60 • Up to 39 months
All-Cause Mortality: the ITT population. Serious Adverse Events and Other (not including serious) Adverse Events: the safety population included all randomized patients who received ≥1 dose of study treatment.
|
|
Skin and subcutaneous tissue disorders
Palmar-plantar erythrodysaesthesia syndrome
|
8.8%
5/57 • Up to 39 months
All-Cause Mortality: the ITT population. Serious Adverse Events and Other (not including serious) Adverse Events: the safety population included all randomized patients who received ≥1 dose of study treatment.
|
5.0%
3/60 • Up to 39 months
All-Cause Mortality: the ITT population. Serious Adverse Events and Other (not including serious) Adverse Events: the safety population included all randomized patients who received ≥1 dose of study treatment.
|
1.7%
1/60 • Up to 39 months
All-Cause Mortality: the ITT population. Serious Adverse Events and Other (not including serious) Adverse Events: the safety population included all randomized patients who received ≥1 dose of study treatment.
|
|
Skin and subcutaneous tissue disorders
Skin toxicity
|
8.8%
5/57 • Up to 39 months
All-Cause Mortality: the ITT population. Serious Adverse Events and Other (not including serious) Adverse Events: the safety population included all randomized patients who received ≥1 dose of study treatment.
|
1.7%
1/60 • Up to 39 months
All-Cause Mortality: the ITT population. Serious Adverse Events and Other (not including serious) Adverse Events: the safety population included all randomized patients who received ≥1 dose of study treatment.
|
3.3%
2/60 • Up to 39 months
All-Cause Mortality: the ITT population. Serious Adverse Events and Other (not including serious) Adverse Events: the safety population included all randomized patients who received ≥1 dose of study treatment.
|
|
Skin and subcutaneous tissue disorders
Erythema
|
3.5%
2/57 • Up to 39 months
All-Cause Mortality: the ITT population. Serious Adverse Events and Other (not including serious) Adverse Events: the safety population included all randomized patients who received ≥1 dose of study treatment.
|
6.7%
4/60 • Up to 39 months
All-Cause Mortality: the ITT population. Serious Adverse Events and Other (not including serious) Adverse Events: the safety population included all randomized patients who received ≥1 dose of study treatment.
|
0.00%
0/60 • Up to 39 months
All-Cause Mortality: the ITT population. Serious Adverse Events and Other (not including serious) Adverse Events: the safety population included all randomized patients who received ≥1 dose of study treatment.
|
|
Skin and subcutaneous tissue disorders
Skin hyperpigmentation
|
7.0%
4/57 • Up to 39 months
All-Cause Mortality: the ITT population. Serious Adverse Events and Other (not including serious) Adverse Events: the safety population included all randomized patients who received ≥1 dose of study treatment.
|
5.0%
3/60 • Up to 39 months
All-Cause Mortality: the ITT population. Serious Adverse Events and Other (not including serious) Adverse Events: the safety population included all randomized patients who received ≥1 dose of study treatment.
|
1.7%
1/60 • Up to 39 months
All-Cause Mortality: the ITT population. Serious Adverse Events and Other (not including serious) Adverse Events: the safety population included all randomized patients who received ≥1 dose of study treatment.
|
|
Skin and subcutaneous tissue disorders
Nail pigmentation
|
3.5%
2/57 • Up to 39 months
All-Cause Mortality: the ITT population. Serious Adverse Events and Other (not including serious) Adverse Events: the safety population included all randomized patients who received ≥1 dose of study treatment.
|
5.0%
3/60 • Up to 39 months
All-Cause Mortality: the ITT population. Serious Adverse Events and Other (not including serious) Adverse Events: the safety population included all randomized patients who received ≥1 dose of study treatment.
|
0.00%
0/60 • Up to 39 months
All-Cause Mortality: the ITT population. Serious Adverse Events and Other (not including serious) Adverse Events: the safety population included all randomized patients who received ≥1 dose of study treatment.
|
|
Skin and subcutaneous tissue disorders
Nail ridging
|
1.8%
1/57 • Up to 39 months
All-Cause Mortality: the ITT population. Serious Adverse Events and Other (not including serious) Adverse Events: the safety population included all randomized patients who received ≥1 dose of study treatment.
|
6.7%
4/60 • Up to 39 months
All-Cause Mortality: the ITT population. Serious Adverse Events and Other (not including serious) Adverse Events: the safety population included all randomized patients who received ≥1 dose of study treatment.
|
0.00%
0/60 • Up to 39 months
All-Cause Mortality: the ITT population. Serious Adverse Events and Other (not including serious) Adverse Events: the safety population included all randomized patients who received ≥1 dose of study treatment.
|
|
Skin and subcutaneous tissue disorders
Onychalgia
|
7.0%
4/57 • Up to 39 months
All-Cause Mortality: the ITT population. Serious Adverse Events and Other (not including serious) Adverse Events: the safety population included all randomized patients who received ≥1 dose of study treatment.
|
1.7%
1/60 • Up to 39 months
All-Cause Mortality: the ITT population. Serious Adverse Events and Other (not including serious) Adverse Events: the safety population included all randomized patients who received ≥1 dose of study treatment.
|
0.00%
0/60 • Up to 39 months
All-Cause Mortality: the ITT population. Serious Adverse Events and Other (not including serious) Adverse Events: the safety population included all randomized patients who received ≥1 dose of study treatment.
|
|
Skin and subcutaneous tissue disorders
Eczema
|
5.3%
3/57 • Up to 39 months
All-Cause Mortality: the ITT population. Serious Adverse Events and Other (not including serious) Adverse Events: the safety population included all randomized patients who received ≥1 dose of study treatment.
|
1.7%
1/60 • Up to 39 months
All-Cause Mortality: the ITT population. Serious Adverse Events and Other (not including serious) Adverse Events: the safety population included all randomized patients who received ≥1 dose of study treatment.
|
0.00%
0/60 • Up to 39 months
All-Cause Mortality: the ITT population. Serious Adverse Events and Other (not including serious) Adverse Events: the safety population included all randomized patients who received ≥1 dose of study treatment.
|
|
Skin and subcutaneous tissue disorders
Nail dystrophy
|
5.3%
3/57 • Up to 39 months
All-Cause Mortality: the ITT population. Serious Adverse Events and Other (not including serious) Adverse Events: the safety population included all randomized patients who received ≥1 dose of study treatment.
|
0.00%
0/60 • Up to 39 months
All-Cause Mortality: the ITT population. Serious Adverse Events and Other (not including serious) Adverse Events: the safety population included all randomized patients who received ≥1 dose of study treatment.
|
1.7%
1/60 • Up to 39 months
All-Cause Mortality: the ITT population. Serious Adverse Events and Other (not including serious) Adverse Events: the safety population included all randomized patients who received ≥1 dose of study treatment.
|
|
Vascular disorders
Hypertension
|
10.5%
6/57 • Up to 39 months
All-Cause Mortality: the ITT population. Serious Adverse Events and Other (not including serious) Adverse Events: the safety population included all randomized patients who received ≥1 dose of study treatment.
|
8.3%
5/60 • Up to 39 months
All-Cause Mortality: the ITT population. Serious Adverse Events and Other (not including serious) Adverse Events: the safety population included all randomized patients who received ≥1 dose of study treatment.
|
3.3%
2/60 • Up to 39 months
All-Cause Mortality: the ITT population. Serious Adverse Events and Other (not including serious) Adverse Events: the safety population included all randomized patients who received ≥1 dose of study treatment.
|
|
Ear and labyrinth disorders
Vertigo
|
5.3%
3/57 • Up to 39 months
All-Cause Mortality: the ITT population. Serious Adverse Events and Other (not including serious) Adverse Events: the safety population included all randomized patients who received ≥1 dose of study treatment.
|
1.7%
1/60 • Up to 39 months
All-Cause Mortality: the ITT population. Serious Adverse Events and Other (not including serious) Adverse Events: the safety population included all randomized patients who received ≥1 dose of study treatment.
|
1.7%
1/60 • Up to 39 months
All-Cause Mortality: the ITT population. Serious Adverse Events and Other (not including serious) Adverse Events: the safety population included all randomized patients who received ≥1 dose of study treatment.
|
|
General disorders
Influenza like illness
|
5.3%
3/57 • Up to 39 months
All-Cause Mortality: the ITT population. Serious Adverse Events and Other (not including serious) Adverse Events: the safety population included all randomized patients who received ≥1 dose of study treatment.
|
0.00%
0/60 • Up to 39 months
All-Cause Mortality: the ITT population. Serious Adverse Events and Other (not including serious) Adverse Events: the safety population included all randomized patients who received ≥1 dose of study treatment.
|
0.00%
0/60 • Up to 39 months
All-Cause Mortality: the ITT population. Serious Adverse Events and Other (not including serious) Adverse Events: the safety population included all randomized patients who received ≥1 dose of study treatment.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Skin papilloma
|
5.3%
3/57 • Up to 39 months
All-Cause Mortality: the ITT population. Serious Adverse Events and Other (not including serious) Adverse Events: the safety population included all randomized patients who received ≥1 dose of study treatment.
|
0.00%
0/60 • Up to 39 months
All-Cause Mortality: the ITT population. Serious Adverse Events and Other (not including serious) Adverse Events: the safety population included all randomized patients who received ≥1 dose of study treatment.
|
0.00%
0/60 • Up to 39 months
All-Cause Mortality: the ITT population. Serious Adverse Events and Other (not including serious) Adverse Events: the safety population included all randomized patients who received ≥1 dose of study treatment.
|
|
Nervous system disorders
Peripheral motor neuropathy
|
1.8%
1/57 • Up to 39 months
All-Cause Mortality: the ITT population. Serious Adverse Events and Other (not including serious) Adverse Events: the safety population included all randomized patients who received ≥1 dose of study treatment.
|
5.0%
3/60 • Up to 39 months
All-Cause Mortality: the ITT population. Serious Adverse Events and Other (not including serious) Adverse Events: the safety population included all randomized patients who received ≥1 dose of study treatment.
|
0.00%
0/60 • Up to 39 months
All-Cause Mortality: the ITT population. Serious Adverse Events and Other (not including serious) Adverse Events: the safety population included all randomized patients who received ≥1 dose of study treatment.
|
|
Renal and urinary disorders
Hydronephrosis
|
5.3%
3/57 • Up to 39 months
All-Cause Mortality: the ITT population. Serious Adverse Events and Other (not including serious) Adverse Events: the safety population included all randomized patients who received ≥1 dose of study treatment.
|
1.7%
1/60 • Up to 39 months
All-Cause Mortality: the ITT population. Serious Adverse Events and Other (not including serious) Adverse Events: the safety population included all randomized patients who received ≥1 dose of study treatment.
|
0.00%
0/60 • Up to 39 months
All-Cause Mortality: the ITT population. Serious Adverse Events and Other (not including serious) Adverse Events: the safety population included all randomized patients who received ≥1 dose of study treatment.
|
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 Corcept. The Investigator agrees to submit all manuscripts or abstracts to Corcept for review before submission to the publisher.
- Publication restrictions are in place
Restriction type: OTHER