Trial Outcomes & Findings for A Study of Abemaciclib (LY2835219) Plus Hormone Therapy in Participants With Early Breast Cancer (NCT NCT04752332)
NCT ID: NCT04752332
Last Updated: 2025-07-15
Results Overview
IDFS, as defined by the STEEP System, is measured from the date of randomization to the date of first occurrence of one of the following events: ipsilateral invasive breast tumor recurrence, regional invasive breast cancer recurrence, distant recurrence, contralateral invasive breast cancer, second primary non-breast invasive cancer, death attributable to any cause. Study was terminated early. Data was not collected for this outcome and outcome measures were not assessed.
Recruitment status
TERMINATED
Study phase
PHASE3
Target enrollment
111 participants
Primary outcome timeframe
Randomization to Recurrence or Death from Any Cause (up to 890 days)
Results posted on
2025-07-15
Participant Flow
The study was terminated early due to inability to enroll study participants. Data was not collected after termination and outcome measures were not assessed.
Completers were defined as participants who received abemaciclib and were allowed to stay on treatment in the study. Participants receiving placebo discontinued after the study was terminated.
Participant milestones
| Measure |
150 mg Abemaciclib + Endocrine Therapy (ET)
Participants received 150 milligrams (mg) of abemaciclib administered twice daily (BID) orally along with standard adjuvant endocrine therapy (ET).
|
Placebo + ET
Participants received placebo administered BID orally along with standard adjuvant ET.
|
|---|---|---|
|
Overall Study
STARTED
|
55
|
56
|
|
Overall Study
Received At Least One Dose of Study Drug
|
55
|
56
|
|
Overall Study
COMPLETED
|
25
|
0
|
|
Overall Study
NOT COMPLETED
|
30
|
56
|
Reasons for withdrawal
| Measure |
150 mg Abemaciclib + Endocrine Therapy (ET)
Participants received 150 milligrams (mg) of abemaciclib administered twice daily (BID) orally along with standard adjuvant endocrine therapy (ET).
|
Placebo + ET
Participants received placebo administered BID orally along with standard adjuvant ET.
|
|---|---|---|
|
Overall Study
Adverse Event
|
3
|
1
|
|
Overall Study
Disease Relapse
|
1
|
0
|
|
Overall Study
Non-compliance With Study Drug
|
2
|
0
|
|
Overall Study
Physician Decision
|
2
|
1
|
|
Overall Study
Protocol Violation
|
1
|
1
|
|
Overall Study
Study Terminated by IRB/ERB
|
0
|
2
|
|
Overall Study
Study Terminated by Sponsor
|
10
|
48
|
|
Overall Study
Withdrawal by Subject
|
11
|
3
|
Baseline Characteristics
A Study of Abemaciclib (LY2835219) Plus Hormone Therapy in Participants With Early Breast Cancer
Baseline characteristics by cohort
| Measure |
150 mg Abemaciclib + ET
n=55 Participants
Participants received 150 mg of abemaciclib administered BID orally along with standard adjuvant ET.
|
Placebo + ET
n=56 Participants
Participants received placebo administered BID orally along with standard adjuvant ET.
|
Total
n=111 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
48.60 years
STANDARD_DEVIATION 11.76 • n=5 Participants
|
49.70 years
STANDARD_DEVIATION 11.17 • n=7 Participants
|
49.20 years
STANDARD_DEVIATION 11.43 • n=5 Participants
|
|
Sex: Female, Male
Female
|
54 Participants
n=5 Participants
|
56 Participants
n=7 Participants
|
110 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
9 Participants
n=5 Participants
|
12 Participants
n=7 Participants
|
21 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
44 Participants
n=5 Participants
|
41 Participants
n=7 Participants
|
85 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
2 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
26 Participants
n=5 Participants
|
23 Participants
n=7 Participants
|
49 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
1 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
27 Participants
n=5 Participants
|
29 Participants
n=7 Participants
|
56 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Region of Enrollment
Argentina
|
4 participants
n=5 Participants
|
5 participants
n=7 Participants
|
9 participants
n=5 Participants
|
|
Region of Enrollment
Australia
|
1 participants
n=5 Participants
|
1 participants
n=7 Participants
|
2 participants
n=5 Participants
|
|
Region of Enrollment
Austria
|
0 participants
n=5 Participants
|
1 participants
n=7 Participants
|
1 participants
n=5 Participants
|
|
Region of Enrollment
Belgium
|
2 participants
n=5 Participants
|
2 participants
n=7 Participants
|
4 participants
n=5 Participants
|
|
Region of Enrollment
Brazil
|
3 participants
n=5 Participants
|
3 participants
n=7 Participants
|
6 participants
n=5 Participants
|
|
Region of Enrollment
China
|
12 participants
n=5 Participants
|
15 participants
n=7 Participants
|
27 participants
n=5 Participants
|
|
Region of Enrollment
France
|
2 participants
n=5 Participants
|
0 participants
n=7 Participants
|
2 participants
n=5 Participants
|
|
Region of Enrollment
Germany
|
2 participants
n=5 Participants
|
1 participants
n=7 Participants
|
3 participants
n=5 Participants
|
|
Region of Enrollment
Greece
|
4 participants
n=5 Participants
|
4 participants
n=7 Participants
|
8 participants
n=5 Participants
|
|
Region of Enrollment
Hungary
|
1 participants
n=5 Participants
|
0 participants
n=7 Participants
|
1 participants
n=5 Participants
|
|
Region of Enrollment
Israel
|
1 participants
n=5 Participants
|
0 participants
n=7 Participants
|
1 participants
n=5 Participants
|
|
Region of Enrollment
Italy
|
1 participants
n=5 Participants
|
1 participants
n=7 Participants
|
2 participants
n=5 Participants
|
|
Region of Enrollment
Japan
|
7 participants
n=5 Participants
|
3 participants
n=7 Participants
|
10 participants
n=5 Participants
|
|
Region of Enrollment
Mexico
|
1 participants
n=5 Participants
|
1 participants
n=7 Participants
|
2 participants
n=5 Participants
|
|
Region of Enrollment
South Korea
|
4 participants
n=5 Participants
|
2 participants
n=7 Participants
|
6 participants
n=5 Participants
|
|
Region of Enrollment
Spain
|
3 participants
n=5 Participants
|
5 participants
n=7 Participants
|
8 participants
n=5 Participants
|
|
Region of Enrollment
Switzerland
|
0 participants
n=5 Participants
|
2 participants
n=7 Participants
|
2 participants
n=5 Participants
|
|
Region of Enrollment
Taiwan
|
1 participants
n=5 Participants
|
3 participants
n=7 Participants
|
4 participants
n=5 Participants
|
|
Region of Enrollment
United Kingdom
|
1 participants
n=5 Participants
|
4 participants
n=7 Participants
|
5 participants
n=5 Participants
|
|
Region of Enrollment
United States
|
5 participants
n=5 Participants
|
3 participants
n=7 Participants
|
8 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Randomization to Recurrence or Death from Any Cause (up to 890 days)Population: Study was terminated early. Data was not collected for this outcome and outcome measures were not assessed.
IDFS, as defined by the STEEP System, is measured from the date of randomization to the date of first occurrence of one of the following events: ipsilateral invasive breast tumor recurrence, regional invasive breast cancer recurrence, distant recurrence, contralateral invasive breast cancer, second primary non-breast invasive cancer, death attributable to any cause. Study was terminated early. Data was not collected for this outcome and outcome measures were not assessed.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Randomization to Death from Any Cause (up to 890 days)Population: Study was terminated early. Data was not collected for this outcome and outcome measures were not assessed.
OS is defined as the time from randomization until death from any cause. Study was terminated early. Data was not collected for this outcome and outcome measures were not assessed.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Randomization to Distant Recurrence or Death from Any Cause (up to 890 days)Population: Study was terminated early. Data was not collected for this outcome and outcome measures were not assessed.
DRFS is defined as the time from randomization to distant recurrence or death from any cause, whichever occurs first. Study was terminated early. Data was not collected for this outcome and outcome measures were not assessed.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Randomization to Distant Recurrence or Death from Any Cause (up to 890 days)Population: Study was terminated early. Data was not collected for this outcome and outcome measures were not assessed.
Study was terminated early. Data was not collected for this outcome and outcome measures were not assessed.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Cycle 1 up to 390 daysPopulation: Study was terminated early. Data was not collected for this outcome and outcome measures were not assessed.
The EORTC QLQ-C30 (v. 3.0) is a self-administered, cancer-specific questionnaire with multidimensional scales assessing 15 domains (5 functional domains, 9 symptoms, and global health status). A linear transformation will be applied to standardize the raw scores to range between 0 and 100 per developer guidelines. For the functional domains and global health status scale, higher scores represent a better level of functioning. For symptom scales, higher scores represent a greater degree of symptoms. Study was terminated early. Data was not collected for this outcome and outcome measures were not assessed.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Cycle 1 up to 390 daysPopulation: Study was terminated early. Data was not collected for this outcome and outcome measures were not assessed.
The EQ-5D-5L is a standardized instrument for use as a measure of self-reported health status. Participants completed the 5-level (no problem, slight problem, moderate problem, severe problem, and inability or extreme problem), 5-dimension (mobility, self-care, usual activities, pain/discomfort, and anxiety/depression) questionnaire concerning their current health state. Five dimensions of health status are each assessed with 5 response options and scored as a composite index which are anchored on a scale of 0 to 1 with a higher score representing better health status. Study was terminated early. Data was not collected for this outcome and outcome measures were not assessed.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Day 1 of Cycles 1-3 (Cycle = 28 days)Population: Study was terminated early. Data was not collected for this outcome and outcome measures were not assessed.
Study was terminated early. Data was not collected for this outcome and outcome measures were not assessed.
Outcome measures
Outcome data not reported
Adverse Events
150 mg Abemaciclib + ET
Serious events: 6 serious events
Other events: 53 other events
Deaths: 0 deaths
Placebo + ET
Serious events: 2 serious events
Other events: 40 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
150 mg Abemaciclib + ET
n=55 participants at risk
Participants received 150 mg of abemaciclib administered BID orally along with standard adjuvant ET.
|
Placebo + ET
n=56 participants at risk
Participants received placebo administered BID orally along with standard adjuvant ET.
|
|---|---|---|
|
Blood and lymphatic system disorders
Neutropenia
|
1.8%
1/55 • Number of events 1 • Baseline Up To 890 Days
All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly. Based on the planned safety analysis, adverse event analysis was planned as per the cohort's corresponding regimen received.
|
0.00%
0/56 • Baseline Up To 890 Days
All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly. Based on the planned safety analysis, adverse event analysis was planned as per the cohort's corresponding regimen received.
|
|
Infections and infestations
Anal abscess
|
1.8%
1/55 • Number of events 1 • Baseline Up To 890 Days
All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly. Based on the planned safety analysis, adverse event analysis was planned as per the cohort's corresponding regimen received.
|
0.00%
0/56 • Baseline Up To 890 Days
All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly. Based on the planned safety analysis, adverse event analysis was planned as per the cohort's corresponding regimen received.
|
|
Infections and infestations
Covid-19
|
1.8%
1/55 • Number of events 1 • Baseline Up To 890 Days
All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly. Based on the planned safety analysis, adverse event analysis was planned as per the cohort's corresponding regimen received.
|
0.00%
0/56 • Baseline Up To 890 Days
All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly. Based on the planned safety analysis, adverse event analysis was planned as per the cohort's corresponding regimen received.
|
|
Injury, poisoning and procedural complications
Radius fracture
|
1.8%
1/55 • Number of events 1 • Baseline Up To 890 Days
All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly. Based on the planned safety analysis, adverse event analysis was planned as per the cohort's corresponding regimen received.
|
1.8%
1/56 • Number of events 1 • Baseline Up To 890 Days
All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly. Based on the planned safety analysis, adverse event analysis was planned as per the cohort's corresponding regimen received.
|
|
Investigations
Alanine aminotransferase increased
|
1.8%
1/55 • Number of events 1 • Baseline Up To 890 Days
All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly. Based on the planned safety analysis, adverse event analysis was planned as per the cohort's corresponding regimen received.
|
0.00%
0/56 • Baseline Up To 890 Days
All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly. Based on the planned safety analysis, adverse event analysis was planned as per the cohort's corresponding regimen received.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Uterine leiomyoma
|
0.00%
0/54 • Baseline Up To 890 Days
All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly. Based on the planned safety analysis, adverse event analysis was planned as per the cohort's corresponding regimen received.
|
1.8%
1/56 • Number of events 1 • Baseline Up To 890 Days
All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly. Based on the planned safety analysis, adverse event analysis was planned as per the cohort's corresponding regimen received.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
1.8%
1/55 • Number of events 1 • Baseline Up To 890 Days
All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly. Based on the planned safety analysis, adverse event analysis was planned as per the cohort's corresponding regimen received.
|
0.00%
0/56 • Baseline Up To 890 Days
All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly. Based on the planned safety analysis, adverse event analysis was planned as per the cohort's corresponding regimen received.
|
Other adverse events
| Measure |
150 mg Abemaciclib + ET
n=55 participants at risk
Participants received 150 mg of abemaciclib administered BID orally along with standard adjuvant ET.
|
Placebo + ET
n=56 participants at risk
Participants received placebo administered BID orally along with standard adjuvant ET.
|
|---|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
23.6%
13/55 • Number of events 24 • Baseline Up To 890 Days
All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly. Based on the planned safety analysis, adverse event analysis was planned as per the cohort's corresponding regimen received.
|
1.8%
1/56 • Number of events 1 • Baseline Up To 890 Days
All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly. Based on the planned safety analysis, adverse event analysis was planned as per the cohort's corresponding regimen received.
|
|
Blood and lymphatic system disorders
Leukopenia
|
30.9%
17/55 • Number of events 31 • Baseline Up To 890 Days
All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly. Based on the planned safety analysis, adverse event analysis was planned as per the cohort's corresponding regimen received.
|
5.4%
3/56 • Number of events 3 • Baseline Up To 890 Days
All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly. Based on the planned safety analysis, adverse event analysis was planned as per the cohort's corresponding regimen received.
|
|
Blood and lymphatic system disorders
Lymphopenia
|
9.1%
5/55 • Number of events 8 • Baseline Up To 890 Days
All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly. Based on the planned safety analysis, adverse event analysis was planned as per the cohort's corresponding regimen received.
|
0.00%
0/56 • Baseline Up To 890 Days
All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly. Based on the planned safety analysis, adverse event analysis was planned as per the cohort's corresponding regimen received.
|
|
Blood and lymphatic system disorders
Neutropenia
|
50.9%
28/55 • Number of events 63 • Baseline Up To 890 Days
All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly. Based on the planned safety analysis, adverse event analysis was planned as per the cohort's corresponding regimen received.
|
7.1%
4/56 • Number of events 5 • Baseline Up To 890 Days
All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly. Based on the planned safety analysis, adverse event analysis was planned as per the cohort's corresponding regimen received.
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
21.8%
12/55 • Number of events 14 • Baseline Up To 890 Days
All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly. Based on the planned safety analysis, adverse event analysis was planned as per the cohort's corresponding regimen received.
|
0.00%
0/56 • Baseline Up To 890 Days
All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly. Based on the planned safety analysis, adverse event analysis was planned as per the cohort's corresponding regimen received.
|
|
Cardiac disorders
Palpitations
|
5.5%
3/55 • Number of events 3 • Baseline Up To 890 Days
All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly. Based on the planned safety analysis, adverse event analysis was planned as per the cohort's corresponding regimen received.
|
1.8%
1/56 • Number of events 1 • Baseline Up To 890 Days
All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly. Based on the planned safety analysis, adverse event analysis was planned as per the cohort's corresponding regimen received.
|
|
Gastrointestinal disorders
Abdominal distension
|
1.8%
1/55 • Number of events 1 • Baseline Up To 890 Days
All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly. Based on the planned safety analysis, adverse event analysis was planned as per the cohort's corresponding regimen received.
|
5.4%
3/56 • Number of events 3 • Baseline Up To 890 Days
All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly. Based on the planned safety analysis, adverse event analysis was planned as per the cohort's corresponding regimen received.
|
|
Gastrointestinal disorders
Abdominal pain
|
21.8%
12/55 • Number of events 18 • Baseline Up To 890 Days
All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly. Based on the planned safety analysis, adverse event analysis was planned as per the cohort's corresponding regimen received.
|
10.7%
6/56 • Number of events 11 • Baseline Up To 890 Days
All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly. Based on the planned safety analysis, adverse event analysis was planned as per the cohort's corresponding regimen received.
|
|
Gastrointestinal disorders
Constipation
|
5.5%
3/55 • Number of events 4 • Baseline Up To 890 Days
All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly. Based on the planned safety analysis, adverse event analysis was planned as per the cohort's corresponding regimen received.
|
10.7%
6/56 • Number of events 9 • Baseline Up To 890 Days
All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly. Based on the planned safety analysis, adverse event analysis was planned as per the cohort's corresponding regimen received.
|
|
Gastrointestinal disorders
Diarrhoea
|
80.0%
44/55 • Number of events 97 • Baseline Up To 890 Days
All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly. Based on the planned safety analysis, adverse event analysis was planned as per the cohort's corresponding regimen received.
|
8.9%
5/56 • Number of events 7 • Baseline Up To 890 Days
All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly. Based on the planned safety analysis, adverse event analysis was planned as per the cohort's corresponding regimen received.
|
|
Gastrointestinal disorders
Nausea
|
30.9%
17/55 • Number of events 24 • Baseline Up To 890 Days
All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly. Based on the planned safety analysis, adverse event analysis was planned as per the cohort's corresponding regimen received.
|
14.3%
8/56 • Number of events 8 • Baseline Up To 890 Days
All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly. Based on the planned safety analysis, adverse event analysis was planned as per the cohort's corresponding regimen received.
|
|
Gastrointestinal disorders
Stomatitis
|
9.1%
5/55 • Number of events 5 • Baseline Up To 890 Days
All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly. Based on the planned safety analysis, adverse event analysis was planned as per the cohort's corresponding regimen received.
|
0.00%
0/56 • Baseline Up To 890 Days
All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly. Based on the planned safety analysis, adverse event analysis was planned as per the cohort's corresponding regimen received.
|
|
Gastrointestinal disorders
Vomiting
|
20.0%
11/55 • Number of events 12 • Baseline Up To 890 Days
All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly. Based on the planned safety analysis, adverse event analysis was planned as per the cohort's corresponding regimen received.
|
1.8%
1/56 • Number of events 1 • Baseline Up To 890 Days
All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly. Based on the planned safety analysis, adverse event analysis was planned as per the cohort's corresponding regimen received.
|
|
General disorders
Fatigue
|
29.1%
16/55 • Number of events 24 • Baseline Up To 890 Days
All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly. Based on the planned safety analysis, adverse event analysis was planned as per the cohort's corresponding regimen received.
|
10.7%
6/56 • Number of events 7 • Baseline Up To 890 Days
All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly. Based on the planned safety analysis, adverse event analysis was planned as per the cohort's corresponding regimen received.
|
|
General disorders
Oedema peripheral
|
5.5%
3/55 • Number of events 3 • Baseline Up To 890 Days
All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly. Based on the planned safety analysis, adverse event analysis was planned as per the cohort's corresponding regimen received.
|
5.4%
3/56 • Number of events 3 • Baseline Up To 890 Days
All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly. Based on the planned safety analysis, adverse event analysis was planned as per the cohort's corresponding regimen received.
|
|
General disorders
Pyrexia
|
7.3%
4/55 • Number of events 4 • Baseline Up To 890 Days
All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly. Based on the planned safety analysis, adverse event analysis was planned as per the cohort's corresponding regimen received.
|
0.00%
0/56 • Baseline Up To 890 Days
All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly. Based on the planned safety analysis, adverse event analysis was planned as per the cohort's corresponding regimen received.
|
|
Infections and infestations
Covid-19
|
23.6%
13/55 • Number of events 13 • Baseline Up To 890 Days
All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly. Based on the planned safety analysis, adverse event analysis was planned as per the cohort's corresponding regimen received.
|
14.3%
8/56 • Number of events 9 • Baseline Up To 890 Days
All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly. Based on the planned safety analysis, adverse event analysis was planned as per the cohort's corresponding regimen received.
|
|
Infections and infestations
Nasopharyngitis
|
7.3%
4/55 • Number of events 4 • Baseline Up To 890 Days
All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly. Based on the planned safety analysis, adverse event analysis was planned as per the cohort's corresponding regimen received.
|
1.8%
1/56 • Number of events 2 • Baseline Up To 890 Days
All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly. Based on the planned safety analysis, adverse event analysis was planned as per the cohort's corresponding regimen received.
|
|
Infections and infestations
Upper respiratory tract infection
|
5.5%
3/55 • Number of events 3 • Baseline Up To 890 Days
All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly. Based on the planned safety analysis, adverse event analysis was planned as per the cohort's corresponding regimen received.
|
1.8%
1/56 • Number of events 2 • Baseline Up To 890 Days
All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly. Based on the planned safety analysis, adverse event analysis was planned as per the cohort's corresponding regimen received.
|
|
Infections and infestations
Urinary tract infection
|
5.5%
3/55 • Number of events 4 • Baseline Up To 890 Days
All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly. Based on the planned safety analysis, adverse event analysis was planned as per the cohort's corresponding regimen received.
|
3.6%
2/56 • Number of events 2 • Baseline Up To 890 Days
All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly. Based on the planned safety analysis, adverse event analysis was planned as per the cohort's corresponding regimen received.
|
|
Investigations
Alanine aminotransferase increased
|
5.5%
3/55 • Number of events 3 • Baseline Up To 890 Days
All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly. Based on the planned safety analysis, adverse event analysis was planned as per the cohort's corresponding regimen received.
|
0.00%
0/56 • Baseline Up To 890 Days
All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly. Based on the planned safety analysis, adverse event analysis was planned as per the cohort's corresponding regimen received.
|
|
Investigations
Aspartate aminotransferase increased
|
5.5%
3/55 • Number of events 3 • Baseline Up To 890 Days
All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly. Based on the planned safety analysis, adverse event analysis was planned as per the cohort's corresponding regimen received.
|
1.8%
1/56 • Number of events 1 • Baseline Up To 890 Days
All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly. Based on the planned safety analysis, adverse event analysis was planned as per the cohort's corresponding regimen received.
|
|
Investigations
Blood creatinine increased
|
18.2%
10/55 • Number of events 13 • Baseline Up To 890 Days
All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly. Based on the planned safety analysis, adverse event analysis was planned as per the cohort's corresponding regimen received.
|
0.00%
0/56 • Baseline Up To 890 Days
All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly. Based on the planned safety analysis, adverse event analysis was planned as per the cohort's corresponding regimen received.
|
|
Metabolism and nutrition disorders
Decreased appetite
|
7.3%
4/55 • Number of events 7 • Baseline Up To 890 Days
All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly. Based on the planned safety analysis, adverse event analysis was planned as per the cohort's corresponding regimen received.
|
0.00%
0/56 • Baseline Up To 890 Days
All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly. Based on the planned safety analysis, adverse event analysis was planned as per the cohort's corresponding regimen received.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
10.9%
6/55 • Number of events 7 • Baseline Up To 890 Days
All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly. Based on the planned safety analysis, adverse event analysis was planned as per the cohort's corresponding regimen received.
|
19.6%
11/56 • Number of events 13 • Baseline Up To 890 Days
All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly. Based on the planned safety analysis, adverse event analysis was planned as per the cohort's corresponding regimen received.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
7.3%
4/55 • Number of events 4 • Baseline Up To 890 Days
All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly. Based on the planned safety analysis, adverse event analysis was planned as per the cohort's corresponding regimen received.
|
1.8%
1/56 • Number of events 1 • Baseline Up To 890 Days
All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly. Based on the planned safety analysis, adverse event analysis was planned as per the cohort's corresponding regimen received.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
5.5%
3/55 • Number of events 3 • Baseline Up To 890 Days
All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly. Based on the planned safety analysis, adverse event analysis was planned as per the cohort's corresponding regimen received.
|
1.8%
1/56 • Number of events 1 • Baseline Up To 890 Days
All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly. Based on the planned safety analysis, adverse event analysis was planned as per the cohort's corresponding regimen received.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
1.8%
1/55 • Number of events 2 • Baseline Up To 890 Days
All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly. Based on the planned safety analysis, adverse event analysis was planned as per the cohort's corresponding regimen received.
|
7.1%
4/56 • Number of events 4 • Baseline Up To 890 Days
All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly. Based on the planned safety analysis, adverse event analysis was planned as per the cohort's corresponding regimen received.
|
|
Nervous system disorders
Dizziness
|
12.7%
7/55 • Number of events 8 • Baseline Up To 890 Days
All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly. Based on the planned safety analysis, adverse event analysis was planned as per the cohort's corresponding regimen received.
|
8.9%
5/56 • Number of events 8 • Baseline Up To 890 Days
All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly. Based on the planned safety analysis, adverse event analysis was planned as per the cohort's corresponding regimen received.
|
|
Nervous system disorders
Headache
|
9.1%
5/55 • Number of events 7 • Baseline Up To 890 Days
All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly. Based on the planned safety analysis, adverse event analysis was planned as per the cohort's corresponding regimen received.
|
10.7%
6/56 • Number of events 6 • Baseline Up To 890 Days
All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly. Based on the planned safety analysis, adverse event analysis was planned as per the cohort's corresponding regimen received.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
7.3%
4/55 • Number of events 4 • Baseline Up To 890 Days
All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly. Based on the planned safety analysis, adverse event analysis was planned as per the cohort's corresponding regimen received.
|
3.6%
2/56 • Number of events 2 • Baseline Up To 890 Days
All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly. Based on the planned safety analysis, adverse event analysis was planned as per the cohort's corresponding regimen received.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
10.9%
6/55 • Number of events 9 • Baseline Up To 890 Days
All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly. Based on the planned safety analysis, adverse event analysis was planned as per the cohort's corresponding regimen received.
|
3.6%
2/56 • Number of events 2 • Baseline Up To 890 Days
All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly. Based on the planned safety analysis, adverse event analysis was planned as per the cohort's corresponding regimen received.
|
|
Skin and subcutaneous tissue disorders
Rash
|
5.5%
3/55 • Number of events 7 • Baseline Up To 890 Days
All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly. Based on the planned safety analysis, adverse event analysis was planned as per the cohort's corresponding regimen received.
|
0.00%
0/56 • Baseline Up To 890 Days
All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly. Based on the planned safety analysis, adverse event analysis was planned as per the cohort's corresponding regimen received.
|
|
Vascular disorders
Hot flush
|
0.00%
0/55 • Baseline Up To 890 Days
All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly. Based on the planned safety analysis, adverse event analysis was planned as per the cohort's corresponding regimen received.
|
14.3%
8/56 • Number of events 8 • Baseline Up To 890 Days
All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly. Based on the planned safety analysis, adverse event analysis was planned as per the cohort's corresponding regimen received.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: GT60