Trial Outcomes & Findings for Abemaciclib With or Without Atezolizumab for mCRPC (NCT NCT04751929)
NCT ID: NCT04751929
Last Updated: 2025-10-02
Results Overview
The percentage of participants alive and progression-free at 6 months, as assessed by RECIST 1.1 and PCWG3.
ACTIVE_NOT_RECRUITING
PHASE2
19 participants
6 months
2025-10-02
Participant Flow
Participant milestones
| Measure |
Biomarker-Unselected Abemaciclib Monotherapy (Randomized)
Participants in the Biomarker-Unselected Cohort, defined as those whose tumors are not known to have mutations in the CDK12 gene will be randomized to either receive Abemaciclib as monotherapy or in combination with Atezolizumab
* Monotherapy : Participants will receive Abemaciclib orally 2x daily
Abemaciclib: Taken orally 2x daily
|
Biomarker-Unselected Abemaciclib + Atezolizumab (Randomized)
Participants in the Biomarker-Unselected Cohort, defined as those whose tumors are not known to have mutations in the CDK12 gene will be randomized to either receive Abemaciclib as monotherapy or in combination with Atezolizumab
* Combination Therapy: Participants will receive Abemaciclib orally 2x daily and Atezolizumab intravenously Day 1 of each 21-Day cycle
Abemaciclib: Taken orally 2x daily
Atezolizumab: Intravenously Day 1 of 21 day cycle
|
CDK12 Mutation Atezolizumab Monotherapy (Non-Randomized)
Participants in the CDK12 Mutation Cohort defined as those whose tumors are known to have mutations in the CDK12 gene are not randomized but are assigned to receive either Atezolizumab monotherapy or in combination with Abemaciclib based on how many participants in this cohort previously received study treatment.
Atezolizumab monotherapy will be given to participants 1-5, these participants will receive Atezolizumab intravenously Day 1 of each 21-Day cycle
Atezolizumab: Intravenously Day 1 of 21 day cycle
|
CDK12 Mutation Abemaciclib + Atezolizumab (Non-Randomized)
Participants in the CDK12 Mutation Cohort defined as those whose tumors are known to have mutations in the CDK12 gene are not randomized but are assigned to receive either Atezolizumab monotherapy or in combination with Abemaciclib based on how many participants in this cohort previously received study treatment.
Combination Therapy will be given to participants 6-21, these participants will receive Abemaciclib orally 2x daily and Atezolizumab intravenously Day 1 of each 21-Day cycle
Abemaciclib: Taken orally 2x daily
Atezolizumab: Intravenously Day 1 of 21 day cycle
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
7
|
8
|
4
|
0
|
|
Overall Study
COMPLETED
|
0
|
0
|
0
|
0
|
|
Overall Study
NOT COMPLETED
|
7
|
8
|
4
|
0
|
Reasons for withdrawal
| Measure |
Biomarker-Unselected Abemaciclib Monotherapy (Randomized)
Participants in the Biomarker-Unselected Cohort, defined as those whose tumors are not known to have mutations in the CDK12 gene will be randomized to either receive Abemaciclib as monotherapy or in combination with Atezolizumab
* Monotherapy : Participants will receive Abemaciclib orally 2x daily
Abemaciclib: Taken orally 2x daily
|
Biomarker-Unselected Abemaciclib + Atezolizumab (Randomized)
Participants in the Biomarker-Unselected Cohort, defined as those whose tumors are not known to have mutations in the CDK12 gene will be randomized to either receive Abemaciclib as monotherapy or in combination with Atezolizumab
* Combination Therapy: Participants will receive Abemaciclib orally 2x daily and Atezolizumab intravenously Day 1 of each 21-Day cycle
Abemaciclib: Taken orally 2x daily
Atezolizumab: Intravenously Day 1 of 21 day cycle
|
CDK12 Mutation Atezolizumab Monotherapy (Non-Randomized)
Participants in the CDK12 Mutation Cohort defined as those whose tumors are known to have mutations in the CDK12 gene are not randomized but are assigned to receive either Atezolizumab monotherapy or in combination with Abemaciclib based on how many participants in this cohort previously received study treatment.
Atezolizumab monotherapy will be given to participants 1-5, these participants will receive Atezolizumab intravenously Day 1 of each 21-Day cycle
Atezolizumab: Intravenously Day 1 of 21 day cycle
|
CDK12 Mutation Abemaciclib + Atezolizumab (Non-Randomized)
Participants in the CDK12 Mutation Cohort defined as those whose tumors are known to have mutations in the CDK12 gene are not randomized but are assigned to receive either Atezolizumab monotherapy or in combination with Abemaciclib based on how many participants in this cohort previously received study treatment.
Combination Therapy will be given to participants 6-21, these participants will receive Abemaciclib orally 2x daily and Atezolizumab intravenously Day 1 of each 21-Day cycle
Abemaciclib: Taken orally 2x daily
Atezolizumab: Intravenously Day 1 of 21 day cycle
|
|---|---|---|---|---|
|
Overall Study
Withdrawal by Subject
|
2
|
0
|
0
|
0
|
|
Overall Study
Rising PSA
|
0
|
1
|
0
|
0
|
|
Overall Study
Adverse Event
|
1
|
2
|
0
|
0
|
|
Overall Study
Progressive Disease
|
3
|
4
|
4
|
0
|
|
Overall Study
Death
|
1
|
1
|
0
|
0
|
Baseline Characteristics
Abemaciclib With or Without Atezolizumab for mCRPC
Baseline characteristics by cohort
| Measure |
Biomarker-Unselected Abemaciclib Monotherapy (Randomized)
n=7 Participants
Participants in the Biomarker-Unselected Cohort, defined as those whose tumors are not known to have mutations in the CDK12 gene will be randomized to either receive Abemaciclib as monotherapy or in combination with Atezolizumab
* Monotherapy : Participants will receive Abemaciclib orally 2x daily
Abemaciclib: Taken orally 2x daily
|
Biomarker-Unselected Abemaciclib + Atezolizumab (Randomized)
n=8 Participants
Participants in the Biomarker-Unselected Cohort, defined as those whose tumors are not known to have mutations in the CDK12 gene will be randomized to either receive Abemaciclib as monotherapy or in combination with Atezolizumab
* Combination Therapy: Participants will receive Abemaciclib orally 2x daily and Atezolizumab intravenously Day 1 of each 21-Day cycle
Abemaciclib: Taken orally 2x daily
Atezolizumab: Intravenously Day 1 of 21 day cycle
|
CDK12 Mutation Atezolizumab Monotherapy (Non-Randomized)
n=4 Participants
Participants in the CDK12 Mutation Cohort defined as those whose tumors are known to have mutations in the CDK12 gene are not randomized but are assigned to receive either Atezolizumab monotherapy or in combination with Abemaciclib based on how many participants in this cohort previously received study treatment.
Atezolizumab monotherapy will be given to participants 1-5, these participants will receive Atezolizumab intravenously Day 1 of each 21-Day cycle
Atezolizumab: Intravenously Day 1 of 21 day cycle
|
CDK12 Mutation Abemaciclib + Atezolizumab (Non-Randomized)
Participants in the CDK12 Mutation Cohort defined as those whose tumors are known to have mutations in the CDK12 gene are not randomized but are assigned to receive either Atezolizumab monotherapy or in combination with Abemaciclib based on how many participants in this cohort previously received study treatment.
Combination Therapy will be given to participants 6-21, these participants will receive Abemaciclib orally 2x daily and Atezolizumab intravenously Day 1 of each 21-Day cycle
Abemaciclib: Taken orally 2x daily
Atezolizumab: Intravenously Day 1 of 21 day cycle
|
Total
n=19 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Continuous
|
71 years
n=5 Participants
|
70 years
n=7 Participants
|
69 years
n=5 Participants
|
—
|
70 years
n=21 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
—
|
0 Participants
n=21 Participants
|
|
Sex: Female, Male
Male
|
7 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
—
|
19 Participants
n=21 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
—
|
0 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
—
|
1 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
—
|
0 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Black or African American
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
—
|
2 Participants
n=21 Participants
|
|
Race (NIH/OMB)
White
|
6 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
—
|
16 Participants
n=21 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
—
|
0 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
—
|
0 Participants
n=21 Participants
|
|
ECOG performance status
0; Fully active, able to carry on all pre-disease activities without restriction (best outcome)
|
3 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
—
|
12 Participants
n=21 Participants
|
|
ECOG performance status
1; Restricted in physically strenuous activity but ambulatory and able to carry out light work
|
4 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
—
|
7 Participants
n=21 Participants
|
PRIMARY outcome
Timeframe: 6 monthsPopulation: No patients were enrolled in the Monotherapy (Non-Randomized) or the CDK12 Mutation Abemaciclib + Atezolizumab (Non-Randomized) arms. One patient in each of the following arms, Biomarker-Unselected Abemaciclib Monotherapy (Randomized) and CDK12 Mutation Atezolizumab Monotherapy (Non-Randomized), did not initiate study treatment and was therefore excluded from the analysis.
The percentage of participants alive and progression-free at 6 months, as assessed by RECIST 1.1 and PCWG3.
Outcome measures
| Measure |
Biomarker-Unselected Abemaciclib Monotherapy (Randomized)
n=7 Participants
Participants in the Biomarker-Unselected Cohort, defined as those whose tumors are not known to have mutations in the CDK12 gene will be randomized to either receive Abemaciclib as monotherapy or in combination with Atezolizumab
* Monotherapy : Participants will receive Abemaciclib orally 2x daily
Abemaciclib: Taken orally 2x daily
|
Biomarker-Unselected Abemaciclib + Atezolizumab (Randomized)
n=8 Participants
Participants in the Biomarker-Unselected Cohort, defined as those whose tumors are not known to have mutations in the CDK12 gene will be randomized to either receive Abemaciclib as monotherapy or in combination with Atezolizumab
* Combination Therapy: Participants will receive Abemaciclib orally 2x daily and Atezolizumab intravenously Day 1 of each 21-Day cycle
Abemaciclib: Taken orally 2x daily
Atezolizumab: Intravenously Day 1 of 21 day cycle
|
CDK12 Mutation Atezolizumab Monotherapy (Non-Randomized)
n=4 Participants
Participants in the CDK12 Mutation Cohort defined as those whose tumors are known to have mutations in the CDK12 gene are not randomized but are assigned to receive either Atezolizumab monotherapy or in combination with Abemaciclib based on how many participants in this cohort previously received study treatment.
Atezolizumab monotherapy will be given to participants 1-5, these participants will receive Atezolizumab intravenously Day 1 of each 21-Day cycle
Atezolizumab: Intravenously Day 1 of 21 day cycle
|
CDK12 Mutation Abemaciclib + Atezolizumab (Non-Randomized)
Participants in the CDK12 Mutation Cohort defined as those whose tumors are known to have mutations in the CDK12 gene are not randomized but are assigned to receive either Atezolizumab monotherapy or in combination with Abemaciclib based on how many participants in this cohort previously received study treatment.
Combination Therapy will be given to participants 6-21, these participants will receive Abemaciclib orally 2x daily and Atezolizumab intravenously Day 1 of each 21-Day cycle
Abemaciclib: Taken orally 2x daily
Atezolizumab: Intravenously Day 1 of 21 day cycle
|
|---|---|---|---|---|
|
6-month Progression Free Survival (PFS) Rate
|
100 percentage of participants
Interval 100.0 to 100.0
|
NA percentage of participants
The median and its 95% CI have not been reached, as the KM curve has not crossed the 50% point.
|
50 percentage of participants
Interval 10.0 to 81.0
|
—
|
PRIMARY outcome
Timeframe: 6 monthsPopulation: No patients were enrolled in the Monotherapy (Non-Randomized) or the CDK12 Mutation Abemaciclib + Atezolizumab (Non-Randomized) arms. One patient in each of the following arms, Biomarker-Unselected Abemaciclib Monotherapy (Randomized) and CDK12 Mutation Atezolizumab Monotherapy (Non-Randomized), did not initiate study treatment and was therefore excluded from the analysis.
The percentage of evaluable patients who had radiographic response (complete response or partial response) by RECIST 1.1 criteria OR 50% decline in PSA from pretreatment baseline per PCWG3 criteria.
Outcome measures
| Measure |
Biomarker-Unselected Abemaciclib Monotherapy (Randomized)
n=7 Participants
Participants in the Biomarker-Unselected Cohort, defined as those whose tumors are not known to have mutations in the CDK12 gene will be randomized to either receive Abemaciclib as monotherapy or in combination with Atezolizumab
* Monotherapy : Participants will receive Abemaciclib orally 2x daily
Abemaciclib: Taken orally 2x daily
|
Biomarker-Unselected Abemaciclib + Atezolizumab (Randomized)
n=8 Participants
Participants in the Biomarker-Unselected Cohort, defined as those whose tumors are not known to have mutations in the CDK12 gene will be randomized to either receive Abemaciclib as monotherapy or in combination with Atezolizumab
* Combination Therapy: Participants will receive Abemaciclib orally 2x daily and Atezolizumab intravenously Day 1 of each 21-Day cycle
Abemaciclib: Taken orally 2x daily
Atezolizumab: Intravenously Day 1 of 21 day cycle
|
CDK12 Mutation Atezolizumab Monotherapy (Non-Randomized)
n=4 Participants
Participants in the CDK12 Mutation Cohort defined as those whose tumors are known to have mutations in the CDK12 gene are not randomized but are assigned to receive either Atezolizumab monotherapy or in combination with Abemaciclib based on how many participants in this cohort previously received study treatment.
Atezolizumab monotherapy will be given to participants 1-5, these participants will receive Atezolizumab intravenously Day 1 of each 21-Day cycle
Atezolizumab: Intravenously Day 1 of 21 day cycle
|
CDK12 Mutation Abemaciclib + Atezolizumab (Non-Randomized)
Participants in the CDK12 Mutation Cohort defined as those whose tumors are known to have mutations in the CDK12 gene are not randomized but are assigned to receive either Atezolizumab monotherapy or in combination with Abemaciclib based on how many participants in this cohort previously received study treatment.
Combination Therapy will be given to participants 6-21, these participants will receive Abemaciclib orally 2x daily and Atezolizumab intravenously Day 1 of each 21-Day cycle
Abemaciclib: Taken orally 2x daily
Atezolizumab: Intravenously Day 1 of 21 day cycle
|
|---|---|---|---|---|
|
Objective Response Rate (ORR)
|
0 percentage of participants
Interval 0.0 to 0.0
|
12.5 percentage of participants
Interval 0.6 to 47.0
|
0 percentage of participants
Interval 0.0 to 0.0
|
—
|
PRIMARY outcome
Timeframe: DLTs were collected while participants on treatment. Treatment duration up to 18 months.Population: Only for Biomarker-Unselected Abemaciclib + Atezolizumab (Randomized) and CDK12 Mutation Abemaciclib + Atezolizumab (Non-Randomized) arms
DLT was assessed by Bayesian Continuous Toxicity Monitoring in Biomarker-Unselected Abemaciclib + Atezolizumab (Randomized) and CDK12 Mutation Abemaciclib + Atezolizumab (Non-Randomized) arms.
Outcome measures
| Measure |
Biomarker-Unselected Abemaciclib Monotherapy (Randomized)
Participants in the Biomarker-Unselected Cohort, defined as those whose tumors are not known to have mutations in the CDK12 gene will be randomized to either receive Abemaciclib as monotherapy or in combination with Atezolizumab
* Monotherapy : Participants will receive Abemaciclib orally 2x daily
Abemaciclib: Taken orally 2x daily
|
Biomarker-Unselected Abemaciclib + Atezolizumab (Randomized)
n=8 Participants
Participants in the Biomarker-Unselected Cohort, defined as those whose tumors are not known to have mutations in the CDK12 gene will be randomized to either receive Abemaciclib as monotherapy or in combination with Atezolizumab
* Combination Therapy: Participants will receive Abemaciclib orally 2x daily and Atezolizumab intravenously Day 1 of each 21-Day cycle
Abemaciclib: Taken orally 2x daily
Atezolizumab: Intravenously Day 1 of 21 day cycle
|
CDK12 Mutation Atezolizumab Monotherapy (Non-Randomized)
Participants in the CDK12 Mutation Cohort defined as those whose tumors are known to have mutations in the CDK12 gene are not randomized but are assigned to receive either Atezolizumab monotherapy or in combination with Abemaciclib based on how many participants in this cohort previously received study treatment.
Atezolizumab monotherapy will be given to participants 1-5, these participants will receive Atezolizumab intravenously Day 1 of each 21-Day cycle
Atezolizumab: Intravenously Day 1 of 21 day cycle
|
CDK12 Mutation Abemaciclib + Atezolizumab (Non-Randomized)
Participants in the CDK12 Mutation Cohort defined as those whose tumors are known to have mutations in the CDK12 gene are not randomized but are assigned to receive either Atezolizumab monotherapy or in combination with Abemaciclib based on how many participants in this cohort previously received study treatment.
Combination Therapy will be given to participants 6-21, these participants will receive Abemaciclib orally 2x daily and Atezolizumab intravenously Day 1 of each 21-Day cycle
Abemaciclib: Taken orally 2x daily
Atezolizumab: Intravenously Day 1 of 21 day cycle
|
|---|---|---|---|---|
|
Number of Participants Experiencing Dose Limiting Toxicity (DLT) in Biomarker-Unselected Abemaciclib + Atezolizumab (Randomized) and CDK12 Mutation Abemaciclib + Atezolizumab (Non-Randomized) Arms
|
0 Participants
|
4 Participants
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: From treatment initiation to end of treatment, with follow-up for up to 2 years after treatment discontinuationProportion of evaluable patients who had complete response (CR), partial response (PR) or stable disease (SD) as their best response to treatment in arms biomarker-unselected abemaciclib monotherapy (randomized), biomarker-unselected abemaciclib + atezolizumab (randomized), and CDK12 mutation abemaciclib + atezolizumab (non-randomized)
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: From the date of first documented CR or PR until disease progression or death, or up to 2 yearsThe time from the first documented complete response (CR) or partial response (PR) to the earliest date of disease progression or death, whichever occurs first, as determined by PCWG3 criteria.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: From treatment initiation until treatment discontinuation for any reasonThe length of time from the first administration of study treatment to the date of treatment discontinuation for any reason
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: From treatment initiation until documented disease progression, or assessed up to 2 yearsThe duration of time from the first administration of study treatment to the date of first documented disease progression, as determined by Prostate Cancer Working Group 3 (PCWG3) criteria. Patients without documented progression are censored at the last tumor assessment date.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 12 monthsPopulation: No patients were enrolled in the Monotherapy (Non-Randomized) or the CDK12 Mutation Abemaciclib + Atezolizumab (Non-Randomized) arms. One patient in each of the following arms, Biomarker-Unselected Abemaciclib Monotherapy (Randomized) and CDK12 Mutation Atezolizumab Monotherapy (Non-Randomized), did not initiate study treatment and was therefore excluded from the analysis.
The percentage of participants who are alive 12 months after the start of treatment
Outcome measures
| Measure |
Biomarker-Unselected Abemaciclib Monotherapy (Randomized)
n=7 Participants
Participants in the Biomarker-Unselected Cohort, defined as those whose tumors are not known to have mutations in the CDK12 gene will be randomized to either receive Abemaciclib as monotherapy or in combination with Atezolizumab
* Monotherapy : Participants will receive Abemaciclib orally 2x daily
Abemaciclib: Taken orally 2x daily
|
Biomarker-Unselected Abemaciclib + Atezolizumab (Randomized)
n=8 Participants
Participants in the Biomarker-Unselected Cohort, defined as those whose tumors are not known to have mutations in the CDK12 gene will be randomized to either receive Abemaciclib as monotherapy or in combination with Atezolizumab
* Combination Therapy: Participants will receive Abemaciclib orally 2x daily and Atezolizumab intravenously Day 1 of each 21-Day cycle
Abemaciclib: Taken orally 2x daily
Atezolizumab: Intravenously Day 1 of 21 day cycle
|
CDK12 Mutation Atezolizumab Monotherapy (Non-Randomized)
n=4 Participants
Participants in the CDK12 Mutation Cohort defined as those whose tumors are known to have mutations in the CDK12 gene are not randomized but are assigned to receive either Atezolizumab monotherapy or in combination with Abemaciclib based on how many participants in this cohort previously received study treatment.
Atezolizumab monotherapy will be given to participants 1-5, these participants will receive Atezolizumab intravenously Day 1 of each 21-Day cycle
Atezolizumab: Intravenously Day 1 of 21 day cycle
|
CDK12 Mutation Abemaciclib + Atezolizumab (Non-Randomized)
Participants in the CDK12 Mutation Cohort defined as those whose tumors are known to have mutations in the CDK12 gene are not randomized but are assigned to receive either Atezolizumab monotherapy or in combination with Abemaciclib based on how many participants in this cohort previously received study treatment.
Combination Therapy will be given to participants 6-21, these participants will receive Abemaciclib orally 2x daily and Atezolizumab intravenously Day 1 of each 21-Day cycle
Abemaciclib: Taken orally 2x daily
Atezolizumab: Intravenously Day 1 of 21 day cycle
|
|---|---|---|---|---|
|
12-month Overall Survival (OS)
|
83 percentage of patients
Interval 39.0 to 97.0
|
50 percentage of patients
Interval 20.0 to 74.0
|
75 percentage of patients
Interval 22.0 to 95.0
|
—
|
SECONDARY outcome
Timeframe: From treatment initiation through 100 days after last dose for treatment-emergent adverse events, and up to 2 years after last doseNumber of participants experiencing adverse events, categorized by the maximum grade according to CTCAE v5.0.
Outcome measures
Outcome data not reported
Adverse Events
Biomarker-Unselected Abemaciclib Monotherapy (Randomized)
Biomarker-Unselected Abemaciclib + Atezolizumab (Randomized)
CDK12 Mutation Atezolizumab Monotherapy (Non-Randomized)
CDK12 Mutation Abemaciclib + Atezolizumab (Non-Randomized)
Serious adverse events
| Measure |
Biomarker-Unselected Abemaciclib Monotherapy (Randomized)
n=7 participants at risk
Participants in the Biomarker-Unselected Cohort, defined as those whose tumors are not known to have mutations in the CDK12 gene will be randomized to either receive Abemaciclib as monotherapy or in combination with Atezolizumab
* Monotherapy : Participants will receive Abemaciclib orally 2x daily
Abemaciclib: Taken orally 2x daily
|
Biomarker-Unselected Abemaciclib + Atezolizumab (Randomized)
n=8 participants at risk
Participants in the Biomarker-Unselected Cohort, defined as those whose tumors are not known to have mutations in the CDK12 gene will be randomized to either receive Abemaciclib as monotherapy or in combination with Atezolizumab
* Combination Therapy: Participants will receive Abemaciclib orally 2x daily and Atezolizumab intravenously Day 1 of each 21-Day cycle
Abemaciclib: Taken orally 2x daily
Atezolizumab: Intravenously Day 1 of 21 day cycle
|
CDK12 Mutation Atezolizumab Monotherapy (Non-Randomized)
n=4 participants at risk
Participants in the CDK12 Mutation Cohort defined as those whose tumors are known to have mutations in the CDK12 gene are not randomized but are assigned to receive either Atezolizumab monotherapy or in combination with Abemaciclib based on how many participants in this cohort previously received study treatment.
Atezolizumab monotherapy will be given to participants 1-5, these participants will receive Atezolizumab intravenously Day 1 of each 21-Day cycle
Atezolizumab: Intravenously Day 1 of 21 day cycle
|
CDK12 Mutation Abemaciclib + Atezolizumab (Non-Randomized)
Participants in the CDK12 Mutation Cohort defined as those whose tumors are known to have mutations in the CDK12 gene are not randomized but are assigned to receive either Atezolizumab monotherapy or in combination with Abemaciclib based on how many participants in this cohort previously received study treatment.
Combination Therapy will be given to participants 6-21, these participants will receive Abemaciclib orally 2x daily and Atezolizumab intravenously Day 1 of each 21-Day cycle
Abemaciclib: Taken orally 2x daily
Atezolizumab: Intravenously Day 1 of 21 day cycle
|
|---|---|---|---|---|
|
Blood and lymphatic system disorders
Anemia
|
14.3%
1/7 • From treatment initiation through 100 days after last dose for treatment-emergent adverse events, and up to 2 years after last dose. Maximum treatment duration was 18 months.
A serious adverse event is classified using physician's discretion. All adverse events resulting in death, life threatening events, significant disability, prolonged hospitalization, congenital abnormality/birth defect, or new cancer will be considered a serious adverse event. No patients were accrued in the CDK12 Mutation Abemaciclib + Atezolizumab (Non-Randomized) arm.
|
0.00%
0/8 • From treatment initiation through 100 days after last dose for treatment-emergent adverse events, and up to 2 years after last dose. Maximum treatment duration was 18 months.
A serious adverse event is classified using physician's discretion. All adverse events resulting in death, life threatening events, significant disability, prolonged hospitalization, congenital abnormality/birth defect, or new cancer will be considered a serious adverse event. No patients were accrued in the CDK12 Mutation Abemaciclib + Atezolizumab (Non-Randomized) arm.
|
—
0/0 • From treatment initiation through 100 days after last dose for treatment-emergent adverse events, and up to 2 years after last dose. Maximum treatment duration was 18 months.
A serious adverse event is classified using physician's discretion. All adverse events resulting in death, life threatening events, significant disability, prolonged hospitalization, congenital abnormality/birth defect, or new cancer will be considered a serious adverse event. No patients were accrued in the CDK12 Mutation Abemaciclib + Atezolizumab (Non-Randomized) arm.
|
—
0/0 • From treatment initiation through 100 days after last dose for treatment-emergent adverse events, and up to 2 years after last dose. Maximum treatment duration was 18 months.
A serious adverse event is classified using physician's discretion. All adverse events resulting in death, life threatening events, significant disability, prolonged hospitalization, congenital abnormality/birth defect, or new cancer will be considered a serious adverse event. No patients were accrued in the CDK12 Mutation Abemaciclib + Atezolizumab (Non-Randomized) arm.
|
|
Cardiac disorders
Atrial fibrillation
|
0.00%
0/7 • From treatment initiation through 100 days after last dose for treatment-emergent adverse events, and up to 2 years after last dose. Maximum treatment duration was 18 months.
A serious adverse event is classified using physician's discretion. All adverse events resulting in death, life threatening events, significant disability, prolonged hospitalization, congenital abnormality/birth defect, or new cancer will be considered a serious adverse event. No patients were accrued in the CDK12 Mutation Abemaciclib + Atezolizumab (Non-Randomized) arm.
|
12.5%
1/8 • From treatment initiation through 100 days after last dose for treatment-emergent adverse events, and up to 2 years after last dose. Maximum treatment duration was 18 months.
A serious adverse event is classified using physician's discretion. All adverse events resulting in death, life threatening events, significant disability, prolonged hospitalization, congenital abnormality/birth defect, or new cancer will be considered a serious adverse event. No patients were accrued in the CDK12 Mutation Abemaciclib + Atezolizumab (Non-Randomized) arm.
|
—
0/0 • From treatment initiation through 100 days after last dose for treatment-emergent adverse events, and up to 2 years after last dose. Maximum treatment duration was 18 months.
A serious adverse event is classified using physician's discretion. All adverse events resulting in death, life threatening events, significant disability, prolonged hospitalization, congenital abnormality/birth defect, or new cancer will be considered a serious adverse event. No patients were accrued in the CDK12 Mutation Abemaciclib + Atezolizumab (Non-Randomized) arm.
|
—
0/0 • From treatment initiation through 100 days after last dose for treatment-emergent adverse events, and up to 2 years after last dose. Maximum treatment duration was 18 months.
A serious adverse event is classified using physician's discretion. All adverse events resulting in death, life threatening events, significant disability, prolonged hospitalization, congenital abnormality/birth defect, or new cancer will be considered a serious adverse event. No patients were accrued in the CDK12 Mutation Abemaciclib + Atezolizumab (Non-Randomized) arm.
|
|
Gastrointestinal disorders
Abdominal pain
|
14.3%
1/7 • From treatment initiation through 100 days after last dose for treatment-emergent adverse events, and up to 2 years after last dose. Maximum treatment duration was 18 months.
A serious adverse event is classified using physician's discretion. All adverse events resulting in death, life threatening events, significant disability, prolonged hospitalization, congenital abnormality/birth defect, or new cancer will be considered a serious adverse event. No patients were accrued in the CDK12 Mutation Abemaciclib + Atezolizumab (Non-Randomized) arm.
|
0.00%
0/8 • From treatment initiation through 100 days after last dose for treatment-emergent adverse events, and up to 2 years after last dose. Maximum treatment duration was 18 months.
A serious adverse event is classified using physician's discretion. All adverse events resulting in death, life threatening events, significant disability, prolonged hospitalization, congenital abnormality/birth defect, or new cancer will be considered a serious adverse event. No patients were accrued in the CDK12 Mutation Abemaciclib + Atezolizumab (Non-Randomized) arm.
|
—
0/0 • From treatment initiation through 100 days after last dose for treatment-emergent adverse events, and up to 2 years after last dose. Maximum treatment duration was 18 months.
A serious adverse event is classified using physician's discretion. All adverse events resulting in death, life threatening events, significant disability, prolonged hospitalization, congenital abnormality/birth defect, or new cancer will be considered a serious adverse event. No patients were accrued in the CDK12 Mutation Abemaciclib + Atezolizumab (Non-Randomized) arm.
|
—
0/0 • From treatment initiation through 100 days after last dose for treatment-emergent adverse events, and up to 2 years after last dose. Maximum treatment duration was 18 months.
A serious adverse event is classified using physician's discretion. All adverse events resulting in death, life threatening events, significant disability, prolonged hospitalization, congenital abnormality/birth defect, or new cancer will be considered a serious adverse event. No patients were accrued in the CDK12 Mutation Abemaciclib + Atezolizumab (Non-Randomized) arm.
|
|
Gastrointestinal disorders
Small intestinal obstruction
|
0.00%
0/7 • From treatment initiation through 100 days after last dose for treatment-emergent adverse events, and up to 2 years after last dose. Maximum treatment duration was 18 months.
A serious adverse event is classified using physician's discretion. All adverse events resulting in death, life threatening events, significant disability, prolonged hospitalization, congenital abnormality/birth defect, or new cancer will be considered a serious adverse event. No patients were accrued in the CDK12 Mutation Abemaciclib + Atezolizumab (Non-Randomized) arm.
|
12.5%
1/8 • From treatment initiation through 100 days after last dose for treatment-emergent adverse events, and up to 2 years after last dose. Maximum treatment duration was 18 months.
A serious adverse event is classified using physician's discretion. All adverse events resulting in death, life threatening events, significant disability, prolonged hospitalization, congenital abnormality/birth defect, or new cancer will be considered a serious adverse event. No patients were accrued in the CDK12 Mutation Abemaciclib + Atezolizumab (Non-Randomized) arm.
|
—
0/0 • From treatment initiation through 100 days after last dose for treatment-emergent adverse events, and up to 2 years after last dose. Maximum treatment duration was 18 months.
A serious adverse event is classified using physician's discretion. All adverse events resulting in death, life threatening events, significant disability, prolonged hospitalization, congenital abnormality/birth defect, or new cancer will be considered a serious adverse event. No patients were accrued in the CDK12 Mutation Abemaciclib + Atezolizumab (Non-Randomized) arm.
|
—
0/0 • From treatment initiation through 100 days after last dose for treatment-emergent adverse events, and up to 2 years after last dose. Maximum treatment duration was 18 months.
A serious adverse event is classified using physician's discretion. All adverse events resulting in death, life threatening events, significant disability, prolonged hospitalization, congenital abnormality/birth defect, or new cancer will be considered a serious adverse event. No patients were accrued in the CDK12 Mutation Abemaciclib + Atezolizumab (Non-Randomized) arm.
|
|
Hepatobiliary disorders
Hepatic failure
|
0.00%
0/7 • From treatment initiation through 100 days after last dose for treatment-emergent adverse events, and up to 2 years after last dose. Maximum treatment duration was 18 months.
A serious adverse event is classified using physician's discretion. All adverse events resulting in death, life threatening events, significant disability, prolonged hospitalization, congenital abnormality/birth defect, or new cancer will be considered a serious adverse event. No patients were accrued in the CDK12 Mutation Abemaciclib + Atezolizumab (Non-Randomized) arm.
|
12.5%
1/8 • From treatment initiation through 100 days after last dose for treatment-emergent adverse events, and up to 2 years after last dose. Maximum treatment duration was 18 months.
A serious adverse event is classified using physician's discretion. All adverse events resulting in death, life threatening events, significant disability, prolonged hospitalization, congenital abnormality/birth defect, or new cancer will be considered a serious adverse event. No patients were accrued in the CDK12 Mutation Abemaciclib + Atezolizumab (Non-Randomized) arm.
|
—
0/0 • From treatment initiation through 100 days after last dose for treatment-emergent adverse events, and up to 2 years after last dose. Maximum treatment duration was 18 months.
A serious adverse event is classified using physician's discretion. All adverse events resulting in death, life threatening events, significant disability, prolonged hospitalization, congenital abnormality/birth defect, or new cancer will be considered a serious adverse event. No patients were accrued in the CDK12 Mutation Abemaciclib + Atezolizumab (Non-Randomized) arm.
|
—
0/0 • From treatment initiation through 100 days after last dose for treatment-emergent adverse events, and up to 2 years after last dose. Maximum treatment duration was 18 months.
A serious adverse event is classified using physician's discretion. All adverse events resulting in death, life threatening events, significant disability, prolonged hospitalization, congenital abnormality/birth defect, or new cancer will be considered a serious adverse event. No patients were accrued in the CDK12 Mutation Abemaciclib + Atezolizumab (Non-Randomized) arm.
|
|
Infections and infestations
Joint infection
|
14.3%
1/7 • From treatment initiation through 100 days after last dose for treatment-emergent adverse events, and up to 2 years after last dose. Maximum treatment duration was 18 months.
A serious adverse event is classified using physician's discretion. All adverse events resulting in death, life threatening events, significant disability, prolonged hospitalization, congenital abnormality/birth defect, or new cancer will be considered a serious adverse event. No patients were accrued in the CDK12 Mutation Abemaciclib + Atezolizumab (Non-Randomized) arm.
|
0.00%
0/8 • From treatment initiation through 100 days after last dose for treatment-emergent adverse events, and up to 2 years after last dose. Maximum treatment duration was 18 months.
A serious adverse event is classified using physician's discretion. All adverse events resulting in death, life threatening events, significant disability, prolonged hospitalization, congenital abnormality/birth defect, or new cancer will be considered a serious adverse event. No patients were accrued in the CDK12 Mutation Abemaciclib + Atezolizumab (Non-Randomized) arm.
|
—
0/0 • From treatment initiation through 100 days after last dose for treatment-emergent adverse events, and up to 2 years after last dose. Maximum treatment duration was 18 months.
A serious adverse event is classified using physician's discretion. All adverse events resulting in death, life threatening events, significant disability, prolonged hospitalization, congenital abnormality/birth defect, or new cancer will be considered a serious adverse event. No patients were accrued in the CDK12 Mutation Abemaciclib + Atezolizumab (Non-Randomized) arm.
|
—
0/0 • From treatment initiation through 100 days after last dose for treatment-emergent adverse events, and up to 2 years after last dose. Maximum treatment duration was 18 months.
A serious adverse event is classified using physician's discretion. All adverse events resulting in death, life threatening events, significant disability, prolonged hospitalization, congenital abnormality/birth defect, or new cancer will be considered a serious adverse event. No patients were accrued in the CDK12 Mutation Abemaciclib + Atezolizumab (Non-Randomized) arm.
|
|
Infections and infestations
Sepsis
|
0.00%
0/7 • From treatment initiation through 100 days after last dose for treatment-emergent adverse events, and up to 2 years after last dose. Maximum treatment duration was 18 months.
A serious adverse event is classified using physician's discretion. All adverse events resulting in death, life threatening events, significant disability, prolonged hospitalization, congenital abnormality/birth defect, or new cancer will be considered a serious adverse event. No patients were accrued in the CDK12 Mutation Abemaciclib + Atezolizumab (Non-Randomized) arm.
|
25.0%
2/8 • From treatment initiation through 100 days after last dose for treatment-emergent adverse events, and up to 2 years after last dose. Maximum treatment duration was 18 months.
A serious adverse event is classified using physician's discretion. All adverse events resulting in death, life threatening events, significant disability, prolonged hospitalization, congenital abnormality/birth defect, or new cancer will be considered a serious adverse event. No patients were accrued in the CDK12 Mutation Abemaciclib + Atezolizumab (Non-Randomized) arm.
|
—
0/0 • From treatment initiation through 100 days after last dose for treatment-emergent adverse events, and up to 2 years after last dose. Maximum treatment duration was 18 months.
A serious adverse event is classified using physician's discretion. All adverse events resulting in death, life threatening events, significant disability, prolonged hospitalization, congenital abnormality/birth defect, or new cancer will be considered a serious adverse event. No patients were accrued in the CDK12 Mutation Abemaciclib + Atezolizumab (Non-Randomized) arm.
|
—
0/0 • From treatment initiation through 100 days after last dose for treatment-emergent adverse events, and up to 2 years after last dose. Maximum treatment duration was 18 months.
A serious adverse event is classified using physician's discretion. All adverse events resulting in death, life threatening events, significant disability, prolonged hospitalization, congenital abnormality/birth defect, or new cancer will be considered a serious adverse event. No patients were accrued in the CDK12 Mutation Abemaciclib + Atezolizumab (Non-Randomized) arm.
|
|
Infections and infestations
Skin infection
|
0.00%
0/7 • From treatment initiation through 100 days after last dose for treatment-emergent adverse events, and up to 2 years after last dose. Maximum treatment duration was 18 months.
A serious adverse event is classified using physician's discretion. All adverse events resulting in death, life threatening events, significant disability, prolonged hospitalization, congenital abnormality/birth defect, or new cancer will be considered a serious adverse event. No patients were accrued in the CDK12 Mutation Abemaciclib + Atezolizumab (Non-Randomized) arm.
|
12.5%
1/8 • From treatment initiation through 100 days after last dose for treatment-emergent adverse events, and up to 2 years after last dose. Maximum treatment duration was 18 months.
A serious adverse event is classified using physician's discretion. All adverse events resulting in death, life threatening events, significant disability, prolonged hospitalization, congenital abnormality/birth defect, or new cancer will be considered a serious adverse event. No patients were accrued in the CDK12 Mutation Abemaciclib + Atezolizumab (Non-Randomized) arm.
|
—
0/0 • From treatment initiation through 100 days after last dose for treatment-emergent adverse events, and up to 2 years after last dose. Maximum treatment duration was 18 months.
A serious adverse event is classified using physician's discretion. All adverse events resulting in death, life threatening events, significant disability, prolonged hospitalization, congenital abnormality/birth defect, or new cancer will be considered a serious adverse event. No patients were accrued in the CDK12 Mutation Abemaciclib + Atezolizumab (Non-Randomized) arm.
|
—
0/0 • From treatment initiation through 100 days after last dose for treatment-emergent adverse events, and up to 2 years after last dose. Maximum treatment duration was 18 months.
A serious adverse event is classified using physician's discretion. All adverse events resulting in death, life threatening events, significant disability, prolonged hospitalization, congenital abnormality/birth defect, or new cancer will be considered a serious adverse event. No patients were accrued in the CDK12 Mutation Abemaciclib + Atezolizumab (Non-Randomized) arm.
|
|
Infections and infestations
Urinary tract infection
|
0.00%
0/7 • From treatment initiation through 100 days after last dose for treatment-emergent adverse events, and up to 2 years after last dose. Maximum treatment duration was 18 months.
A serious adverse event is classified using physician's discretion. All adverse events resulting in death, life threatening events, significant disability, prolonged hospitalization, congenital abnormality/birth defect, or new cancer will be considered a serious adverse event. No patients were accrued in the CDK12 Mutation Abemaciclib + Atezolizumab (Non-Randomized) arm.
|
12.5%
1/8 • From treatment initiation through 100 days after last dose for treatment-emergent adverse events, and up to 2 years after last dose. Maximum treatment duration was 18 months.
A serious adverse event is classified using physician's discretion. All adverse events resulting in death, life threatening events, significant disability, prolonged hospitalization, congenital abnormality/birth defect, or new cancer will be considered a serious adverse event. No patients were accrued in the CDK12 Mutation Abemaciclib + Atezolizumab (Non-Randomized) arm.
|
—
0/0 • From treatment initiation through 100 days after last dose for treatment-emergent adverse events, and up to 2 years after last dose. Maximum treatment duration was 18 months.
A serious adverse event is classified using physician's discretion. All adverse events resulting in death, life threatening events, significant disability, prolonged hospitalization, congenital abnormality/birth defect, or new cancer will be considered a serious adverse event. No patients were accrued in the CDK12 Mutation Abemaciclib + Atezolizumab (Non-Randomized) arm.
|
—
0/0 • From treatment initiation through 100 days after last dose for treatment-emergent adverse events, and up to 2 years after last dose. Maximum treatment duration was 18 months.
A serious adverse event is classified using physician's discretion. All adverse events resulting in death, life threatening events, significant disability, prolonged hospitalization, congenital abnormality/birth defect, or new cancer will be considered a serious adverse event. No patients were accrued in the CDK12 Mutation Abemaciclib + Atezolizumab (Non-Randomized) arm.
|
|
Investigations
Alkaline phosphatase increased
|
0.00%
0/7 • From treatment initiation through 100 days after last dose for treatment-emergent adverse events, and up to 2 years after last dose. Maximum treatment duration was 18 months.
A serious adverse event is classified using physician's discretion. All adverse events resulting in death, life threatening events, significant disability, prolonged hospitalization, congenital abnormality/birth defect, or new cancer will be considered a serious adverse event. No patients were accrued in the CDK12 Mutation Abemaciclib + Atezolizumab (Non-Randomized) arm.
|
12.5%
1/8 • From treatment initiation through 100 days after last dose for treatment-emergent adverse events, and up to 2 years after last dose. Maximum treatment duration was 18 months.
A serious adverse event is classified using physician's discretion. All adverse events resulting in death, life threatening events, significant disability, prolonged hospitalization, congenital abnormality/birth defect, or new cancer will be considered a serious adverse event. No patients were accrued in the CDK12 Mutation Abemaciclib + Atezolizumab (Non-Randomized) arm.
|
—
0/0 • From treatment initiation through 100 days after last dose for treatment-emergent adverse events, and up to 2 years after last dose. Maximum treatment duration was 18 months.
A serious adverse event is classified using physician's discretion. All adverse events resulting in death, life threatening events, significant disability, prolonged hospitalization, congenital abnormality/birth defect, or new cancer will be considered a serious adverse event. No patients were accrued in the CDK12 Mutation Abemaciclib + Atezolizumab (Non-Randomized) arm.
|
—
0/0 • From treatment initiation through 100 days after last dose for treatment-emergent adverse events, and up to 2 years after last dose. Maximum treatment duration was 18 months.
A serious adverse event is classified using physician's discretion. All adverse events resulting in death, life threatening events, significant disability, prolonged hospitalization, congenital abnormality/birth defect, or new cancer will be considered a serious adverse event. No patients were accrued in the CDK12 Mutation Abemaciclib + Atezolizumab (Non-Randomized) arm.
|
|
Investigations
Blood bilirubin increased
|
0.00%
0/7 • From treatment initiation through 100 days after last dose for treatment-emergent adverse events, and up to 2 years after last dose. Maximum treatment duration was 18 months.
A serious adverse event is classified using physician's discretion. All adverse events resulting in death, life threatening events, significant disability, prolonged hospitalization, congenital abnormality/birth defect, or new cancer will be considered a serious adverse event. No patients were accrued in the CDK12 Mutation Abemaciclib + Atezolizumab (Non-Randomized) arm.
|
12.5%
1/8 • From treatment initiation through 100 days after last dose for treatment-emergent adverse events, and up to 2 years after last dose. Maximum treatment duration was 18 months.
A serious adverse event is classified using physician's discretion. All adverse events resulting in death, life threatening events, significant disability, prolonged hospitalization, congenital abnormality/birth defect, or new cancer will be considered a serious adverse event. No patients were accrued in the CDK12 Mutation Abemaciclib + Atezolizumab (Non-Randomized) arm.
|
—
0/0 • From treatment initiation through 100 days after last dose for treatment-emergent adverse events, and up to 2 years after last dose. Maximum treatment duration was 18 months.
A serious adverse event is classified using physician's discretion. All adverse events resulting in death, life threatening events, significant disability, prolonged hospitalization, congenital abnormality/birth defect, or new cancer will be considered a serious adverse event. No patients were accrued in the CDK12 Mutation Abemaciclib + Atezolizumab (Non-Randomized) arm.
|
—
0/0 • From treatment initiation through 100 days after last dose for treatment-emergent adverse events, and up to 2 years after last dose. Maximum treatment duration was 18 months.
A serious adverse event is classified using physician's discretion. All adverse events resulting in death, life threatening events, significant disability, prolonged hospitalization, congenital abnormality/birth defect, or new cancer will be considered a serious adverse event. No patients were accrued in the CDK12 Mutation Abemaciclib + Atezolizumab (Non-Randomized) arm.
|
|
Investigations
Creatinine increased
|
14.3%
1/7 • From treatment initiation through 100 days after last dose for treatment-emergent adverse events, and up to 2 years after last dose. Maximum treatment duration was 18 months.
A serious adverse event is classified using physician's discretion. All adverse events resulting in death, life threatening events, significant disability, prolonged hospitalization, congenital abnormality/birth defect, or new cancer will be considered a serious adverse event. No patients were accrued in the CDK12 Mutation Abemaciclib + Atezolizumab (Non-Randomized) arm.
|
0.00%
0/8 • From treatment initiation through 100 days after last dose for treatment-emergent adverse events, and up to 2 years after last dose. Maximum treatment duration was 18 months.
A serious adverse event is classified using physician's discretion. All adverse events resulting in death, life threatening events, significant disability, prolonged hospitalization, congenital abnormality/birth defect, or new cancer will be considered a serious adverse event. No patients were accrued in the CDK12 Mutation Abemaciclib + Atezolizumab (Non-Randomized) arm.
|
—
0/0 • From treatment initiation through 100 days after last dose for treatment-emergent adverse events, and up to 2 years after last dose. Maximum treatment duration was 18 months.
A serious adverse event is classified using physician's discretion. All adverse events resulting in death, life threatening events, significant disability, prolonged hospitalization, congenital abnormality/birth defect, or new cancer will be considered a serious adverse event. No patients were accrued in the CDK12 Mutation Abemaciclib + Atezolizumab (Non-Randomized) arm.
|
—
0/0 • From treatment initiation through 100 days after last dose for treatment-emergent adverse events, and up to 2 years after last dose. Maximum treatment duration was 18 months.
A serious adverse event is classified using physician's discretion. All adverse events resulting in death, life threatening events, significant disability, prolonged hospitalization, congenital abnormality/birth defect, or new cancer will be considered a serious adverse event. No patients were accrued in the CDK12 Mutation Abemaciclib + Atezolizumab (Non-Randomized) arm.
|
|
Investigations
Platelet count decreased
|
14.3%
1/7 • From treatment initiation through 100 days after last dose for treatment-emergent adverse events, and up to 2 years after last dose. Maximum treatment duration was 18 months.
A serious adverse event is classified using physician's discretion. All adverse events resulting in death, life threatening events, significant disability, prolonged hospitalization, congenital abnormality/birth defect, or new cancer will be considered a serious adverse event. No patients were accrued in the CDK12 Mutation Abemaciclib + Atezolizumab (Non-Randomized) arm.
|
0.00%
0/8 • From treatment initiation through 100 days after last dose for treatment-emergent adverse events, and up to 2 years after last dose. Maximum treatment duration was 18 months.
A serious adverse event is classified using physician's discretion. All adverse events resulting in death, life threatening events, significant disability, prolonged hospitalization, congenital abnormality/birth defect, or new cancer will be considered a serious adverse event. No patients were accrued in the CDK12 Mutation Abemaciclib + Atezolizumab (Non-Randomized) arm.
|
—
0/0 • From treatment initiation through 100 days after last dose for treatment-emergent adverse events, and up to 2 years after last dose. Maximum treatment duration was 18 months.
A serious adverse event is classified using physician's discretion. All adverse events resulting in death, life threatening events, significant disability, prolonged hospitalization, congenital abnormality/birth defect, or new cancer will be considered a serious adverse event. No patients were accrued in the CDK12 Mutation Abemaciclib + Atezolizumab (Non-Randomized) arm.
|
—
0/0 • From treatment initiation through 100 days after last dose for treatment-emergent adverse events, and up to 2 years after last dose. Maximum treatment duration was 18 months.
A serious adverse event is classified using physician's discretion. All adverse events resulting in death, life threatening events, significant disability, prolonged hospitalization, congenital abnormality/birth defect, or new cancer will be considered a serious adverse event. No patients were accrued in the CDK12 Mutation Abemaciclib + Atezolizumab (Non-Randomized) arm.
|
|
Nervous system disorders
Stroke
|
14.3%
1/7 • From treatment initiation through 100 days after last dose for treatment-emergent adverse events, and up to 2 years after last dose. Maximum treatment duration was 18 months.
A serious adverse event is classified using physician's discretion. All adverse events resulting in death, life threatening events, significant disability, prolonged hospitalization, congenital abnormality/birth defect, or new cancer will be considered a serious adverse event. No patients were accrued in the CDK12 Mutation Abemaciclib + Atezolizumab (Non-Randomized) arm.
|
0.00%
0/8 • From treatment initiation through 100 days after last dose for treatment-emergent adverse events, and up to 2 years after last dose. Maximum treatment duration was 18 months.
A serious adverse event is classified using physician's discretion. All adverse events resulting in death, life threatening events, significant disability, prolonged hospitalization, congenital abnormality/birth defect, or new cancer will be considered a serious adverse event. No patients were accrued in the CDK12 Mutation Abemaciclib + Atezolizumab (Non-Randomized) arm.
|
—
0/0 • From treatment initiation through 100 days after last dose for treatment-emergent adverse events, and up to 2 years after last dose. Maximum treatment duration was 18 months.
A serious adverse event is classified using physician's discretion. All adverse events resulting in death, life threatening events, significant disability, prolonged hospitalization, congenital abnormality/birth defect, or new cancer will be considered a serious adverse event. No patients were accrued in the CDK12 Mutation Abemaciclib + Atezolizumab (Non-Randomized) arm.
|
—
0/0 • From treatment initiation through 100 days after last dose for treatment-emergent adverse events, and up to 2 years after last dose. Maximum treatment duration was 18 months.
A serious adverse event is classified using physician's discretion. All adverse events resulting in death, life threatening events, significant disability, prolonged hospitalization, congenital abnormality/birth defect, or new cancer will be considered a serious adverse event. No patients were accrued in the CDK12 Mutation Abemaciclib + Atezolizumab (Non-Randomized) arm.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonitis
|
0.00%
0/7 • From treatment initiation through 100 days after last dose for treatment-emergent adverse events, and up to 2 years after last dose. Maximum treatment duration was 18 months.
A serious adverse event is classified using physician's discretion. All adverse events resulting in death, life threatening events, significant disability, prolonged hospitalization, congenital abnormality/birth defect, or new cancer will be considered a serious adverse event. No patients were accrued in the CDK12 Mutation Abemaciclib + Atezolizumab (Non-Randomized) arm.
|
12.5%
1/8 • From treatment initiation through 100 days after last dose for treatment-emergent adverse events, and up to 2 years after last dose. Maximum treatment duration was 18 months.
A serious adverse event is classified using physician's discretion. All adverse events resulting in death, life threatening events, significant disability, prolonged hospitalization, congenital abnormality/birth defect, or new cancer will be considered a serious adverse event. No patients were accrued in the CDK12 Mutation Abemaciclib + Atezolizumab (Non-Randomized) arm.
|
—
0/0 • From treatment initiation through 100 days after last dose for treatment-emergent adverse events, and up to 2 years after last dose. Maximum treatment duration was 18 months.
A serious adverse event is classified using physician's discretion. All adverse events resulting in death, life threatening events, significant disability, prolonged hospitalization, congenital abnormality/birth defect, or new cancer will be considered a serious adverse event. No patients were accrued in the CDK12 Mutation Abemaciclib + Atezolizumab (Non-Randomized) arm.
|
—
0/0 • From treatment initiation through 100 days after last dose for treatment-emergent adverse events, and up to 2 years after last dose. Maximum treatment duration was 18 months.
A serious adverse event is classified using physician's discretion. All adverse events resulting in death, life threatening events, significant disability, prolonged hospitalization, congenital abnormality/birth defect, or new cancer will be considered a serious adverse event. No patients were accrued in the CDK12 Mutation Abemaciclib + Atezolizumab (Non-Randomized) arm.
|
Other adverse events
| Measure |
Biomarker-Unselected Abemaciclib Monotherapy (Randomized)
n=7 participants at risk
Participants in the Biomarker-Unselected Cohort, defined as those whose tumors are not known to have mutations in the CDK12 gene will be randomized to either receive Abemaciclib as monotherapy or in combination with Atezolizumab
* Monotherapy : Participants will receive Abemaciclib orally 2x daily
Abemaciclib: Taken orally 2x daily
|
Biomarker-Unselected Abemaciclib + Atezolizumab (Randomized)
n=8 participants at risk
Participants in the Biomarker-Unselected Cohort, defined as those whose tumors are not known to have mutations in the CDK12 gene will be randomized to either receive Abemaciclib as monotherapy or in combination with Atezolizumab
* Combination Therapy: Participants will receive Abemaciclib orally 2x daily and Atezolizumab intravenously Day 1 of each 21-Day cycle
Abemaciclib: Taken orally 2x daily
Atezolizumab: Intravenously Day 1 of 21 day cycle
|
CDK12 Mutation Atezolizumab Monotherapy (Non-Randomized)
n=4 participants at risk
Participants in the CDK12 Mutation Cohort defined as those whose tumors are known to have mutations in the CDK12 gene are not randomized but are assigned to receive either Atezolizumab monotherapy or in combination with Abemaciclib based on how many participants in this cohort previously received study treatment.
Atezolizumab monotherapy will be given to participants 1-5, these participants will receive Atezolizumab intravenously Day 1 of each 21-Day cycle
Atezolizumab: Intravenously Day 1 of 21 day cycle
|
CDK12 Mutation Abemaciclib + Atezolizumab (Non-Randomized)
Participants in the CDK12 Mutation Cohort defined as those whose tumors are known to have mutations in the CDK12 gene are not randomized but are assigned to receive either Atezolizumab monotherapy or in combination with Abemaciclib based on how many participants in this cohort previously received study treatment.
Combination Therapy will be given to participants 6-21, these participants will receive Abemaciclib orally 2x daily and Atezolizumab intravenously Day 1 of each 21-Day cycle
Abemaciclib: Taken orally 2x daily
Atezolizumab: Intravenously Day 1 of 21 day cycle
|
|---|---|---|---|---|
|
Blood and lymphatic system disorders
Anemia
|
71.4%
5/7 • From treatment initiation through 100 days after last dose for treatment-emergent adverse events, and up to 2 years after last dose. Maximum treatment duration was 18 months.
A serious adverse event is classified using physician's discretion. All adverse events resulting in death, life threatening events, significant disability, prolonged hospitalization, congenital abnormality/birth defect, or new cancer will be considered a serious adverse event. No patients were accrued in the CDK12 Mutation Abemaciclib + Atezolizumab (Non-Randomized) arm.
|
87.5%
7/8 • From treatment initiation through 100 days after last dose for treatment-emergent adverse events, and up to 2 years after last dose. Maximum treatment duration was 18 months.
A serious adverse event is classified using physician's discretion. All adverse events resulting in death, life threatening events, significant disability, prolonged hospitalization, congenital abnormality/birth defect, or new cancer will be considered a serious adverse event. No patients were accrued in the CDK12 Mutation Abemaciclib + Atezolizumab (Non-Randomized) arm.
|
100.0%
4/4 • From treatment initiation through 100 days after last dose for treatment-emergent adverse events, and up to 2 years after last dose. Maximum treatment duration was 18 months.
A serious adverse event is classified using physician's discretion. All adverse events resulting in death, life threatening events, significant disability, prolonged hospitalization, congenital abnormality/birth defect, or new cancer will be considered a serious adverse event. No patients were accrued in the CDK12 Mutation Abemaciclib + Atezolizumab (Non-Randomized) arm.
|
—
0/0 • From treatment initiation through 100 days after last dose for treatment-emergent adverse events, and up to 2 years after last dose. Maximum treatment duration was 18 months.
A serious adverse event is classified using physician's discretion. All adverse events resulting in death, life threatening events, significant disability, prolonged hospitalization, congenital abnormality/birth defect, or new cancer will be considered a serious adverse event. No patients were accrued in the CDK12 Mutation Abemaciclib + Atezolizumab (Non-Randomized) arm.
|
|
Cardiac disorders
Atrial fibrillation
|
0.00%
0/7 • From treatment initiation through 100 days after last dose for treatment-emergent adverse events, and up to 2 years after last dose. Maximum treatment duration was 18 months.
A serious adverse event is classified using physician's discretion. All adverse events resulting in death, life threatening events, significant disability, prolonged hospitalization, congenital abnormality/birth defect, or new cancer will be considered a serious adverse event. No patients were accrued in the CDK12 Mutation Abemaciclib + Atezolizumab (Non-Randomized) arm.
|
12.5%
1/8 • From treatment initiation through 100 days after last dose for treatment-emergent adverse events, and up to 2 years after last dose. Maximum treatment duration was 18 months.
A serious adverse event is classified using physician's discretion. All adverse events resulting in death, life threatening events, significant disability, prolonged hospitalization, congenital abnormality/birth defect, or new cancer will be considered a serious adverse event. No patients were accrued in the CDK12 Mutation Abemaciclib + Atezolizumab (Non-Randomized) arm.
|
0.00%
0/4 • From treatment initiation through 100 days after last dose for treatment-emergent adverse events, and up to 2 years after last dose. Maximum treatment duration was 18 months.
A serious adverse event is classified using physician's discretion. All adverse events resulting in death, life threatening events, significant disability, prolonged hospitalization, congenital abnormality/birth defect, or new cancer will be considered a serious adverse event. No patients were accrued in the CDK12 Mutation Abemaciclib + Atezolizumab (Non-Randomized) arm.
|
—
0/0 • From treatment initiation through 100 days after last dose for treatment-emergent adverse events, and up to 2 years after last dose. Maximum treatment duration was 18 months.
A serious adverse event is classified using physician's discretion. All adverse events resulting in death, life threatening events, significant disability, prolonged hospitalization, congenital abnormality/birth defect, or new cancer will be considered a serious adverse event. No patients were accrued in the CDK12 Mutation Abemaciclib + Atezolizumab (Non-Randomized) arm.
|
|
Cardiac disorders
Cardiac disorders - Other, specify
|
14.3%
1/7 • From treatment initiation through 100 days after last dose for treatment-emergent adverse events, and up to 2 years after last dose. Maximum treatment duration was 18 months.
A serious adverse event is classified using physician's discretion. All adverse events resulting in death, life threatening events, significant disability, prolonged hospitalization, congenital abnormality/birth defect, or new cancer will be considered a serious adverse event. No patients were accrued in the CDK12 Mutation Abemaciclib + Atezolizumab (Non-Randomized) arm.
|
0.00%
0/8 • From treatment initiation through 100 days after last dose for treatment-emergent adverse events, and up to 2 years after last dose. Maximum treatment duration was 18 months.
A serious adverse event is classified using physician's discretion. All adverse events resulting in death, life threatening events, significant disability, prolonged hospitalization, congenital abnormality/birth defect, or new cancer will be considered a serious adverse event. No patients were accrued in the CDK12 Mutation Abemaciclib + Atezolizumab (Non-Randomized) arm.
|
0.00%
0/4 • From treatment initiation through 100 days after last dose for treatment-emergent adverse events, and up to 2 years after last dose. Maximum treatment duration was 18 months.
A serious adverse event is classified using physician's discretion. All adverse events resulting in death, life threatening events, significant disability, prolonged hospitalization, congenital abnormality/birth defect, or new cancer will be considered a serious adverse event. No patients were accrued in the CDK12 Mutation Abemaciclib + Atezolizumab (Non-Randomized) arm.
|
—
0/0 • From treatment initiation through 100 days after last dose for treatment-emergent adverse events, and up to 2 years after last dose. Maximum treatment duration was 18 months.
A serious adverse event is classified using physician's discretion. All adverse events resulting in death, life threatening events, significant disability, prolonged hospitalization, congenital abnormality/birth defect, or new cancer will be considered a serious adverse event. No patients were accrued in the CDK12 Mutation Abemaciclib + Atezolizumab (Non-Randomized) arm.
|
|
Cardiac disorders
Palpitations
|
14.3%
1/7 • From treatment initiation through 100 days after last dose for treatment-emergent adverse events, and up to 2 years after last dose. Maximum treatment duration was 18 months.
A serious adverse event is classified using physician's discretion. All adverse events resulting in death, life threatening events, significant disability, prolonged hospitalization, congenital abnormality/birth defect, or new cancer will be considered a serious adverse event. No patients were accrued in the CDK12 Mutation Abemaciclib + Atezolizumab (Non-Randomized) arm.
|
0.00%
0/8 • From treatment initiation through 100 days after last dose for treatment-emergent adverse events, and up to 2 years after last dose. Maximum treatment duration was 18 months.
A serious adverse event is classified using physician's discretion. All adverse events resulting in death, life threatening events, significant disability, prolonged hospitalization, congenital abnormality/birth defect, or new cancer will be considered a serious adverse event. No patients were accrued in the CDK12 Mutation Abemaciclib + Atezolizumab (Non-Randomized) arm.
|
0.00%
0/4 • From treatment initiation through 100 days after last dose for treatment-emergent adverse events, and up to 2 years after last dose. Maximum treatment duration was 18 months.
A serious adverse event is classified using physician's discretion. All adverse events resulting in death, life threatening events, significant disability, prolonged hospitalization, congenital abnormality/birth defect, or new cancer will be considered a serious adverse event. No patients were accrued in the CDK12 Mutation Abemaciclib + Atezolizumab (Non-Randomized) arm.
|
—
0/0 • From treatment initiation through 100 days after last dose for treatment-emergent adverse events, and up to 2 years after last dose. Maximum treatment duration was 18 months.
A serious adverse event is classified using physician's discretion. All adverse events resulting in death, life threatening events, significant disability, prolonged hospitalization, congenital abnormality/birth defect, or new cancer will be considered a serious adverse event. No patients were accrued in the CDK12 Mutation Abemaciclib + Atezolizumab (Non-Randomized) arm.
|
|
Cardiac disorders
Sinus tachycardia
|
14.3%
1/7 • From treatment initiation through 100 days after last dose for treatment-emergent adverse events, and up to 2 years after last dose. Maximum treatment duration was 18 months.
A serious adverse event is classified using physician's discretion. All adverse events resulting in death, life threatening events, significant disability, prolonged hospitalization, congenital abnormality/birth defect, or new cancer will be considered a serious adverse event. No patients were accrued in the CDK12 Mutation Abemaciclib + Atezolizumab (Non-Randomized) arm.
|
12.5%
1/8 • From treatment initiation through 100 days after last dose for treatment-emergent adverse events, and up to 2 years after last dose. Maximum treatment duration was 18 months.
A serious adverse event is classified using physician's discretion. All adverse events resulting in death, life threatening events, significant disability, prolonged hospitalization, congenital abnormality/birth defect, or new cancer will be considered a serious adverse event. No patients were accrued in the CDK12 Mutation Abemaciclib + Atezolizumab (Non-Randomized) arm.
|
0.00%
0/4 • From treatment initiation through 100 days after last dose for treatment-emergent adverse events, and up to 2 years after last dose. Maximum treatment duration was 18 months.
A serious adverse event is classified using physician's discretion. All adverse events resulting in death, life threatening events, significant disability, prolonged hospitalization, congenital abnormality/birth defect, or new cancer will be considered a serious adverse event. No patients were accrued in the CDK12 Mutation Abemaciclib + Atezolizumab (Non-Randomized) arm.
|
—
0/0 • From treatment initiation through 100 days after last dose for treatment-emergent adverse events, and up to 2 years after last dose. Maximum treatment duration was 18 months.
A serious adverse event is classified using physician's discretion. All adverse events resulting in death, life threatening events, significant disability, prolonged hospitalization, congenital abnormality/birth defect, or new cancer will be considered a serious adverse event. No patients were accrued in the CDK12 Mutation Abemaciclib + Atezolizumab (Non-Randomized) arm.
|
|
Ear and labyrinth disorders
Vertigo
|
0.00%
0/7 • From treatment initiation through 100 days after last dose for treatment-emergent adverse events, and up to 2 years after last dose. Maximum treatment duration was 18 months.
A serious adverse event is classified using physician's discretion. All adverse events resulting in death, life threatening events, significant disability, prolonged hospitalization, congenital abnormality/birth defect, or new cancer will be considered a serious adverse event. No patients were accrued in the CDK12 Mutation Abemaciclib + Atezolizumab (Non-Randomized) arm.
|
12.5%
1/8 • From treatment initiation through 100 days after last dose for treatment-emergent adverse events, and up to 2 years after last dose. Maximum treatment duration was 18 months.
A serious adverse event is classified using physician's discretion. All adverse events resulting in death, life threatening events, significant disability, prolonged hospitalization, congenital abnormality/birth defect, or new cancer will be considered a serious adverse event. No patients were accrued in the CDK12 Mutation Abemaciclib + Atezolizumab (Non-Randomized) arm.
|
0.00%
0/4 • From treatment initiation through 100 days after last dose for treatment-emergent adverse events, and up to 2 years after last dose. Maximum treatment duration was 18 months.
A serious adverse event is classified using physician's discretion. All adverse events resulting in death, life threatening events, significant disability, prolonged hospitalization, congenital abnormality/birth defect, or new cancer will be considered a serious adverse event. No patients were accrued in the CDK12 Mutation Abemaciclib + Atezolizumab (Non-Randomized) arm.
|
—
0/0 • From treatment initiation through 100 days after last dose for treatment-emergent adverse events, and up to 2 years after last dose. Maximum treatment duration was 18 months.
A serious adverse event is classified using physician's discretion. All adverse events resulting in death, life threatening events, significant disability, prolonged hospitalization, congenital abnormality/birth defect, or new cancer will be considered a serious adverse event. No patients were accrued in the CDK12 Mutation Abemaciclib + Atezolizumab (Non-Randomized) arm.
|
|
Endocrine disorders
Hyperthyroidism
|
0.00%
0/7 • From treatment initiation through 100 days after last dose for treatment-emergent adverse events, and up to 2 years after last dose. Maximum treatment duration was 18 months.
A serious adverse event is classified using physician's discretion. All adverse events resulting in death, life threatening events, significant disability, prolonged hospitalization, congenital abnormality/birth defect, or new cancer will be considered a serious adverse event. No patients were accrued in the CDK12 Mutation Abemaciclib + Atezolizumab (Non-Randomized) arm.
|
0.00%
0/8 • From treatment initiation through 100 days after last dose for treatment-emergent adverse events, and up to 2 years after last dose. Maximum treatment duration was 18 months.
A serious adverse event is classified using physician's discretion. All adverse events resulting in death, life threatening events, significant disability, prolonged hospitalization, congenital abnormality/birth defect, or new cancer will be considered a serious adverse event. No patients were accrued in the CDK12 Mutation Abemaciclib + Atezolizumab (Non-Randomized) arm.
|
25.0%
1/4 • From treatment initiation through 100 days after last dose for treatment-emergent adverse events, and up to 2 years after last dose. Maximum treatment duration was 18 months.
A serious adverse event is classified using physician's discretion. All adverse events resulting in death, life threatening events, significant disability, prolonged hospitalization, congenital abnormality/birth defect, or new cancer will be considered a serious adverse event. No patients were accrued in the CDK12 Mutation Abemaciclib + Atezolizumab (Non-Randomized) arm.
|
—
0/0 • From treatment initiation through 100 days after last dose for treatment-emergent adverse events, and up to 2 years after last dose. Maximum treatment duration was 18 months.
A serious adverse event is classified using physician's discretion. All adverse events resulting in death, life threatening events, significant disability, prolonged hospitalization, congenital abnormality/birth defect, or new cancer will be considered a serious adverse event. No patients were accrued in the CDK12 Mutation Abemaciclib + Atezolizumab (Non-Randomized) arm.
|
|
Endocrine disorders
Hypothyroidism
|
14.3%
1/7 • From treatment initiation through 100 days after last dose for treatment-emergent adverse events, and up to 2 years after last dose. Maximum treatment duration was 18 months.
A serious adverse event is classified using physician's discretion. All adverse events resulting in death, life threatening events, significant disability, prolonged hospitalization, congenital abnormality/birth defect, or new cancer will be considered a serious adverse event. No patients were accrued in the CDK12 Mutation Abemaciclib + Atezolizumab (Non-Randomized) arm.
|
12.5%
1/8 • From treatment initiation through 100 days after last dose for treatment-emergent adverse events, and up to 2 years after last dose. Maximum treatment duration was 18 months.
A serious adverse event is classified using physician's discretion. All adverse events resulting in death, life threatening events, significant disability, prolonged hospitalization, congenital abnormality/birth defect, or new cancer will be considered a serious adverse event. No patients were accrued in the CDK12 Mutation Abemaciclib + Atezolizumab (Non-Randomized) arm.
|
0.00%
0/4 • From treatment initiation through 100 days after last dose for treatment-emergent adverse events, and up to 2 years after last dose. Maximum treatment duration was 18 months.
A serious adverse event is classified using physician's discretion. All adverse events resulting in death, life threatening events, significant disability, prolonged hospitalization, congenital abnormality/birth defect, or new cancer will be considered a serious adverse event. No patients were accrued in the CDK12 Mutation Abemaciclib + Atezolizumab (Non-Randomized) arm.
|
—
0/0 • From treatment initiation through 100 days after last dose for treatment-emergent adverse events, and up to 2 years after last dose. Maximum treatment duration was 18 months.
A serious adverse event is classified using physician's discretion. All adverse events resulting in death, life threatening events, significant disability, prolonged hospitalization, congenital abnormality/birth defect, or new cancer will be considered a serious adverse event. No patients were accrued in the CDK12 Mutation Abemaciclib + Atezolizumab (Non-Randomized) arm.
|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/7 • From treatment initiation through 100 days after last dose for treatment-emergent adverse events, and up to 2 years after last dose. Maximum treatment duration was 18 months.
A serious adverse event is classified using physician's discretion. All adverse events resulting in death, life threatening events, significant disability, prolonged hospitalization, congenital abnormality/birth defect, or new cancer will be considered a serious adverse event. No patients were accrued in the CDK12 Mutation Abemaciclib + Atezolizumab (Non-Randomized) arm.
|
12.5%
1/8 • From treatment initiation through 100 days after last dose for treatment-emergent adverse events, and up to 2 years after last dose. Maximum treatment duration was 18 months.
A serious adverse event is classified using physician's discretion. All adverse events resulting in death, life threatening events, significant disability, prolonged hospitalization, congenital abnormality/birth defect, or new cancer will be considered a serious adverse event. No patients were accrued in the CDK12 Mutation Abemaciclib + Atezolizumab (Non-Randomized) arm.
|
0.00%
0/4 • From treatment initiation through 100 days after last dose for treatment-emergent adverse events, and up to 2 years after last dose. Maximum treatment duration was 18 months.
A serious adverse event is classified using physician's discretion. All adverse events resulting in death, life threatening events, significant disability, prolonged hospitalization, congenital abnormality/birth defect, or new cancer will be considered a serious adverse event. No patients were accrued in the CDK12 Mutation Abemaciclib + Atezolizumab (Non-Randomized) arm.
|
—
0/0 • From treatment initiation through 100 days after last dose for treatment-emergent adverse events, and up to 2 years after last dose. Maximum treatment duration was 18 months.
A serious adverse event is classified using physician's discretion. All adverse events resulting in death, life threatening events, significant disability, prolonged hospitalization, congenital abnormality/birth defect, or new cancer will be considered a serious adverse event. No patients were accrued in the CDK12 Mutation Abemaciclib + Atezolizumab (Non-Randomized) arm.
|
|
Gastrointestinal disorders
Constipation
|
0.00%
0/7 • From treatment initiation through 100 days after last dose for treatment-emergent adverse events, and up to 2 years after last dose. Maximum treatment duration was 18 months.
A serious adverse event is classified using physician's discretion. All adverse events resulting in death, life threatening events, significant disability, prolonged hospitalization, congenital abnormality/birth defect, or new cancer will be considered a serious adverse event. No patients were accrued in the CDK12 Mutation Abemaciclib + Atezolizumab (Non-Randomized) arm.
|
12.5%
1/8 • From treatment initiation through 100 days after last dose for treatment-emergent adverse events, and up to 2 years after last dose. Maximum treatment duration was 18 months.
A serious adverse event is classified using physician's discretion. All adverse events resulting in death, life threatening events, significant disability, prolonged hospitalization, congenital abnormality/birth defect, or new cancer will be considered a serious adverse event. No patients were accrued in the CDK12 Mutation Abemaciclib + Atezolizumab (Non-Randomized) arm.
|
0.00%
0/4 • From treatment initiation through 100 days after last dose for treatment-emergent adverse events, and up to 2 years after last dose. Maximum treatment duration was 18 months.
A serious adverse event is classified using physician's discretion. All adverse events resulting in death, life threatening events, significant disability, prolonged hospitalization, congenital abnormality/birth defect, or new cancer will be considered a serious adverse event. No patients were accrued in the CDK12 Mutation Abemaciclib + Atezolizumab (Non-Randomized) arm.
|
—
0/0 • From treatment initiation through 100 days after last dose for treatment-emergent adverse events, and up to 2 years after last dose. Maximum treatment duration was 18 months.
A serious adverse event is classified using physician's discretion. All adverse events resulting in death, life threatening events, significant disability, prolonged hospitalization, congenital abnormality/birth defect, or new cancer will be considered a serious adverse event. No patients were accrued in the CDK12 Mutation Abemaciclib + Atezolizumab (Non-Randomized) arm.
|
|
Gastrointestinal disorders
Diarrhea
|
71.4%
5/7 • From treatment initiation through 100 days after last dose for treatment-emergent adverse events, and up to 2 years after last dose. Maximum treatment duration was 18 months.
A serious adverse event is classified using physician's discretion. All adverse events resulting in death, life threatening events, significant disability, prolonged hospitalization, congenital abnormality/birth defect, or new cancer will be considered a serious adverse event. No patients were accrued in the CDK12 Mutation Abemaciclib + Atezolizumab (Non-Randomized) arm.
|
62.5%
5/8 • From treatment initiation through 100 days after last dose for treatment-emergent adverse events, and up to 2 years after last dose. Maximum treatment duration was 18 months.
A serious adverse event is classified using physician's discretion. All adverse events resulting in death, life threatening events, significant disability, prolonged hospitalization, congenital abnormality/birth defect, or new cancer will be considered a serious adverse event. No patients were accrued in the CDK12 Mutation Abemaciclib + Atezolizumab (Non-Randomized) arm.
|
0.00%
0/4 • From treatment initiation through 100 days after last dose for treatment-emergent adverse events, and up to 2 years after last dose. Maximum treatment duration was 18 months.
A serious adverse event is classified using physician's discretion. All adverse events resulting in death, life threatening events, significant disability, prolonged hospitalization, congenital abnormality/birth defect, or new cancer will be considered a serious adverse event. No patients were accrued in the CDK12 Mutation Abemaciclib + Atezolizumab (Non-Randomized) arm.
|
—
0/0 • From treatment initiation through 100 days after last dose for treatment-emergent adverse events, and up to 2 years after last dose. Maximum treatment duration was 18 months.
A serious adverse event is classified using physician's discretion. All adverse events resulting in death, life threatening events, significant disability, prolonged hospitalization, congenital abnormality/birth defect, or new cancer will be considered a serious adverse event. No patients were accrued in the CDK12 Mutation Abemaciclib + Atezolizumab (Non-Randomized) arm.
|
|
Gastrointestinal disorders
Dry mouth
|
0.00%
0/7 • From treatment initiation through 100 days after last dose for treatment-emergent adverse events, and up to 2 years after last dose. Maximum treatment duration was 18 months.
A serious adverse event is classified using physician's discretion. All adverse events resulting in death, life threatening events, significant disability, prolonged hospitalization, congenital abnormality/birth defect, or new cancer will be considered a serious adverse event. No patients were accrued in the CDK12 Mutation Abemaciclib + Atezolizumab (Non-Randomized) arm.
|
0.00%
0/8 • From treatment initiation through 100 days after last dose for treatment-emergent adverse events, and up to 2 years after last dose. Maximum treatment duration was 18 months.
A serious adverse event is classified using physician's discretion. All adverse events resulting in death, life threatening events, significant disability, prolonged hospitalization, congenital abnormality/birth defect, or new cancer will be considered a serious adverse event. No patients were accrued in the CDK12 Mutation Abemaciclib + Atezolizumab (Non-Randomized) arm.
|
25.0%
1/4 • From treatment initiation through 100 days after last dose for treatment-emergent adverse events, and up to 2 years after last dose. Maximum treatment duration was 18 months.
A serious adverse event is classified using physician's discretion. All adverse events resulting in death, life threatening events, significant disability, prolonged hospitalization, congenital abnormality/birth defect, or new cancer will be considered a serious adverse event. No patients were accrued in the CDK12 Mutation Abemaciclib + Atezolizumab (Non-Randomized) arm.
|
—
0/0 • From treatment initiation through 100 days after last dose for treatment-emergent adverse events, and up to 2 years after last dose. Maximum treatment duration was 18 months.
A serious adverse event is classified using physician's discretion. All adverse events resulting in death, life threatening events, significant disability, prolonged hospitalization, congenital abnormality/birth defect, or new cancer will be considered a serious adverse event. No patients were accrued in the CDK12 Mutation Abemaciclib + Atezolizumab (Non-Randomized) arm.
|
|
Gastrointestinal disorders
Dysphagia
|
14.3%
1/7 • From treatment initiation through 100 days after last dose for treatment-emergent adverse events, and up to 2 years after last dose. Maximum treatment duration was 18 months.
A serious adverse event is classified using physician's discretion. All adverse events resulting in death, life threatening events, significant disability, prolonged hospitalization, congenital abnormality/birth defect, or new cancer will be considered a serious adverse event. No patients were accrued in the CDK12 Mutation Abemaciclib + Atezolizumab (Non-Randomized) arm.
|
0.00%
0/8 • From treatment initiation through 100 days after last dose for treatment-emergent adverse events, and up to 2 years after last dose. Maximum treatment duration was 18 months.
A serious adverse event is classified using physician's discretion. All adverse events resulting in death, life threatening events, significant disability, prolonged hospitalization, congenital abnormality/birth defect, or new cancer will be considered a serious adverse event. No patients were accrued in the CDK12 Mutation Abemaciclib + Atezolizumab (Non-Randomized) arm.
|
0.00%
0/4 • From treatment initiation through 100 days after last dose for treatment-emergent adverse events, and up to 2 years after last dose. Maximum treatment duration was 18 months.
A serious adverse event is classified using physician's discretion. All adverse events resulting in death, life threatening events, significant disability, prolonged hospitalization, congenital abnormality/birth defect, or new cancer will be considered a serious adverse event. No patients were accrued in the CDK12 Mutation Abemaciclib + Atezolizumab (Non-Randomized) arm.
|
—
0/0 • From treatment initiation through 100 days after last dose for treatment-emergent adverse events, and up to 2 years after last dose. Maximum treatment duration was 18 months.
A serious adverse event is classified using physician's discretion. All adverse events resulting in death, life threatening events, significant disability, prolonged hospitalization, congenital abnormality/birth defect, or new cancer will be considered a serious adverse event. No patients were accrued in the CDK12 Mutation Abemaciclib + Atezolizumab (Non-Randomized) arm.
|
|
Gastrointestinal disorders
Gastroesophageal reflux disease
|
28.6%
2/7 • From treatment initiation through 100 days after last dose for treatment-emergent adverse events, and up to 2 years after last dose. Maximum treatment duration was 18 months.
A serious adverse event is classified using physician's discretion. All adverse events resulting in death, life threatening events, significant disability, prolonged hospitalization, congenital abnormality/birth defect, or new cancer will be considered a serious adverse event. No patients were accrued in the CDK12 Mutation Abemaciclib + Atezolizumab (Non-Randomized) arm.
|
12.5%
1/8 • From treatment initiation through 100 days after last dose for treatment-emergent adverse events, and up to 2 years after last dose. Maximum treatment duration was 18 months.
A serious adverse event is classified using physician's discretion. All adverse events resulting in death, life threatening events, significant disability, prolonged hospitalization, congenital abnormality/birth defect, or new cancer will be considered a serious adverse event. No patients were accrued in the CDK12 Mutation Abemaciclib + Atezolizumab (Non-Randomized) arm.
|
50.0%
2/4 • From treatment initiation through 100 days after last dose for treatment-emergent adverse events, and up to 2 years after last dose. Maximum treatment duration was 18 months.
A serious adverse event is classified using physician's discretion. All adverse events resulting in death, life threatening events, significant disability, prolonged hospitalization, congenital abnormality/birth defect, or new cancer will be considered a serious adverse event. No patients were accrued in the CDK12 Mutation Abemaciclib + Atezolizumab (Non-Randomized) arm.
|
—
0/0 • From treatment initiation through 100 days after last dose for treatment-emergent adverse events, and up to 2 years after last dose. Maximum treatment duration was 18 months.
A serious adverse event is classified using physician's discretion. All adverse events resulting in death, life threatening events, significant disability, prolonged hospitalization, congenital abnormality/birth defect, or new cancer will be considered a serious adverse event. No patients were accrued in the CDK12 Mutation Abemaciclib + Atezolizumab (Non-Randomized) arm.
|
|
Gastrointestinal disorders
Nausea
|
28.6%
2/7 • From treatment initiation through 100 days after last dose for treatment-emergent adverse events, and up to 2 years after last dose. Maximum treatment duration was 18 months.
A serious adverse event is classified using physician's discretion. All adverse events resulting in death, life threatening events, significant disability, prolonged hospitalization, congenital abnormality/birth defect, or new cancer will be considered a serious adverse event. No patients were accrued in the CDK12 Mutation Abemaciclib + Atezolizumab (Non-Randomized) arm.
|
37.5%
3/8 • From treatment initiation through 100 days after last dose for treatment-emergent adverse events, and up to 2 years after last dose. Maximum treatment duration was 18 months.
A serious adverse event is classified using physician's discretion. All adverse events resulting in death, life threatening events, significant disability, prolonged hospitalization, congenital abnormality/birth defect, or new cancer will be considered a serious adverse event. No patients were accrued in the CDK12 Mutation Abemaciclib + Atezolizumab (Non-Randomized) arm.
|
50.0%
2/4 • From treatment initiation through 100 days after last dose for treatment-emergent adverse events, and up to 2 years after last dose. Maximum treatment duration was 18 months.
A serious adverse event is classified using physician's discretion. All adverse events resulting in death, life threatening events, significant disability, prolonged hospitalization, congenital abnormality/birth defect, or new cancer will be considered a serious adverse event. No patients were accrued in the CDK12 Mutation Abemaciclib + Atezolizumab (Non-Randomized) arm.
|
—
0/0 • From treatment initiation through 100 days after last dose for treatment-emergent adverse events, and up to 2 years after last dose. Maximum treatment duration was 18 months.
A serious adverse event is classified using physician's discretion. All adverse events resulting in death, life threatening events, significant disability, prolonged hospitalization, congenital abnormality/birth defect, or new cancer will be considered a serious adverse event. No patients were accrued in the CDK12 Mutation Abemaciclib + Atezolizumab (Non-Randomized) arm.
|
|
Gastrointestinal disorders
Stomach pain
|
14.3%
1/7 • From treatment initiation through 100 days after last dose for treatment-emergent adverse events, and up to 2 years after last dose. Maximum treatment duration was 18 months.
A serious adverse event is classified using physician's discretion. All adverse events resulting in death, life threatening events, significant disability, prolonged hospitalization, congenital abnormality/birth defect, or new cancer will be considered a serious adverse event. No patients were accrued in the CDK12 Mutation Abemaciclib + Atezolizumab (Non-Randomized) arm.
|
12.5%
1/8 • From treatment initiation through 100 days after last dose for treatment-emergent adverse events, and up to 2 years after last dose. Maximum treatment duration was 18 months.
A serious adverse event is classified using physician's discretion. All adverse events resulting in death, life threatening events, significant disability, prolonged hospitalization, congenital abnormality/birth defect, or new cancer will be considered a serious adverse event. No patients were accrued in the CDK12 Mutation Abemaciclib + Atezolizumab (Non-Randomized) arm.
|
0.00%
0/4 • From treatment initiation through 100 days after last dose for treatment-emergent adverse events, and up to 2 years after last dose. Maximum treatment duration was 18 months.
A serious adverse event is classified using physician's discretion. All adverse events resulting in death, life threatening events, significant disability, prolonged hospitalization, congenital abnormality/birth defect, or new cancer will be considered a serious adverse event. No patients were accrued in the CDK12 Mutation Abemaciclib + Atezolizumab (Non-Randomized) arm.
|
—
0/0 • From treatment initiation through 100 days after last dose for treatment-emergent adverse events, and up to 2 years after last dose. Maximum treatment duration was 18 months.
A serious adverse event is classified using physician's discretion. All adverse events resulting in death, life threatening events, significant disability, prolonged hospitalization, congenital abnormality/birth defect, or new cancer will be considered a serious adverse event. No patients were accrued in the CDK12 Mutation Abemaciclib + Atezolizumab (Non-Randomized) arm.
|
|
Gastrointestinal disorders
Vomiting
|
14.3%
1/7 • From treatment initiation through 100 days after last dose for treatment-emergent adverse events, and up to 2 years after last dose. Maximum treatment duration was 18 months.
A serious adverse event is classified using physician's discretion. All adverse events resulting in death, life threatening events, significant disability, prolonged hospitalization, congenital abnormality/birth defect, or new cancer will be considered a serious adverse event. No patients were accrued in the CDK12 Mutation Abemaciclib + Atezolizumab (Non-Randomized) arm.
|
25.0%
2/8 • From treatment initiation through 100 days after last dose for treatment-emergent adverse events, and up to 2 years after last dose. Maximum treatment duration was 18 months.
A serious adverse event is classified using physician's discretion. All adverse events resulting in death, life threatening events, significant disability, prolonged hospitalization, congenital abnormality/birth defect, or new cancer will be considered a serious adverse event. No patients were accrued in the CDK12 Mutation Abemaciclib + Atezolizumab (Non-Randomized) arm.
|
25.0%
1/4 • From treatment initiation through 100 days after last dose for treatment-emergent adverse events, and up to 2 years after last dose. Maximum treatment duration was 18 months.
A serious adverse event is classified using physician's discretion. All adverse events resulting in death, life threatening events, significant disability, prolonged hospitalization, congenital abnormality/birth defect, or new cancer will be considered a serious adverse event. No patients were accrued in the CDK12 Mutation Abemaciclib + Atezolizumab (Non-Randomized) arm.
|
—
0/0 • From treatment initiation through 100 days after last dose for treatment-emergent adverse events, and up to 2 years after last dose. Maximum treatment duration was 18 months.
A serious adverse event is classified using physician's discretion. All adverse events resulting in death, life threatening events, significant disability, prolonged hospitalization, congenital abnormality/birth defect, or new cancer will be considered a serious adverse event. No patients were accrued in the CDK12 Mutation Abemaciclib + Atezolizumab (Non-Randomized) arm.
|
|
General disorders
Edema limbs
|
0.00%
0/7 • From treatment initiation through 100 days after last dose for treatment-emergent adverse events, and up to 2 years after last dose. Maximum treatment duration was 18 months.
A serious adverse event is classified using physician's discretion. All adverse events resulting in death, life threatening events, significant disability, prolonged hospitalization, congenital abnormality/birth defect, or new cancer will be considered a serious adverse event. No patients were accrued in the CDK12 Mutation Abemaciclib + Atezolizumab (Non-Randomized) arm.
|
12.5%
1/8 • From treatment initiation through 100 days after last dose for treatment-emergent adverse events, and up to 2 years after last dose. Maximum treatment duration was 18 months.
A serious adverse event is classified using physician's discretion. All adverse events resulting in death, life threatening events, significant disability, prolonged hospitalization, congenital abnormality/birth defect, or new cancer will be considered a serious adverse event. No patients were accrued in the CDK12 Mutation Abemaciclib + Atezolizumab (Non-Randomized) arm.
|
50.0%
2/4 • From treatment initiation through 100 days after last dose for treatment-emergent adverse events, and up to 2 years after last dose. Maximum treatment duration was 18 months.
A serious adverse event is classified using physician's discretion. All adverse events resulting in death, life threatening events, significant disability, prolonged hospitalization, congenital abnormality/birth defect, or new cancer will be considered a serious adverse event. No patients were accrued in the CDK12 Mutation Abemaciclib + Atezolizumab (Non-Randomized) arm.
|
—
0/0 • From treatment initiation through 100 days after last dose for treatment-emergent adverse events, and up to 2 years after last dose. Maximum treatment duration was 18 months.
A serious adverse event is classified using physician's discretion. All adverse events resulting in death, life threatening events, significant disability, prolonged hospitalization, congenital abnormality/birth defect, or new cancer will be considered a serious adverse event. No patients were accrued in the CDK12 Mutation Abemaciclib + Atezolizumab (Non-Randomized) arm.
|
|
General disorders
Fatigue
|
28.6%
2/7 • From treatment initiation through 100 days after last dose for treatment-emergent adverse events, and up to 2 years after last dose. Maximum treatment duration was 18 months.
A serious adverse event is classified using physician's discretion. All adverse events resulting in death, life threatening events, significant disability, prolonged hospitalization, congenital abnormality/birth defect, or new cancer will be considered a serious adverse event. No patients were accrued in the CDK12 Mutation Abemaciclib + Atezolizumab (Non-Randomized) arm.
|
62.5%
5/8 • From treatment initiation through 100 days after last dose for treatment-emergent adverse events, and up to 2 years after last dose. Maximum treatment duration was 18 months.
A serious adverse event is classified using physician's discretion. All adverse events resulting in death, life threatening events, significant disability, prolonged hospitalization, congenital abnormality/birth defect, or new cancer will be considered a serious adverse event. No patients were accrued in the CDK12 Mutation Abemaciclib + Atezolizumab (Non-Randomized) arm.
|
50.0%
2/4 • From treatment initiation through 100 days after last dose for treatment-emergent adverse events, and up to 2 years after last dose. Maximum treatment duration was 18 months.
A serious adverse event is classified using physician's discretion. All adverse events resulting in death, life threatening events, significant disability, prolonged hospitalization, congenital abnormality/birth defect, or new cancer will be considered a serious adverse event. No patients were accrued in the CDK12 Mutation Abemaciclib + Atezolizumab (Non-Randomized) arm.
|
—
0/0 • From treatment initiation through 100 days after last dose for treatment-emergent adverse events, and up to 2 years after last dose. Maximum treatment duration was 18 months.
A serious adverse event is classified using physician's discretion. All adverse events resulting in death, life threatening events, significant disability, prolonged hospitalization, congenital abnormality/birth defect, or new cancer will be considered a serious adverse event. No patients were accrued in the CDK12 Mutation Abemaciclib + Atezolizumab (Non-Randomized) arm.
|
|
General disorders
Fever
|
0.00%
0/7 • From treatment initiation through 100 days after last dose for treatment-emergent adverse events, and up to 2 years after last dose. Maximum treatment duration was 18 months.
A serious adverse event is classified using physician's discretion. All adverse events resulting in death, life threatening events, significant disability, prolonged hospitalization, congenital abnormality/birth defect, or new cancer will be considered a serious adverse event. No patients were accrued in the CDK12 Mutation Abemaciclib + Atezolizumab (Non-Randomized) arm.
|
37.5%
3/8 • From treatment initiation through 100 days after last dose for treatment-emergent adverse events, and up to 2 years after last dose. Maximum treatment duration was 18 months.
A serious adverse event is classified using physician's discretion. All adverse events resulting in death, life threatening events, significant disability, prolonged hospitalization, congenital abnormality/birth defect, or new cancer will be considered a serious adverse event. No patients were accrued in the CDK12 Mutation Abemaciclib + Atezolizumab (Non-Randomized) arm.
|
0.00%
0/4 • From treatment initiation through 100 days after last dose for treatment-emergent adverse events, and up to 2 years after last dose. Maximum treatment duration was 18 months.
A serious adverse event is classified using physician's discretion. All adverse events resulting in death, life threatening events, significant disability, prolonged hospitalization, congenital abnormality/birth defect, or new cancer will be considered a serious adverse event. No patients were accrued in the CDK12 Mutation Abemaciclib + Atezolizumab (Non-Randomized) arm.
|
—
0/0 • From treatment initiation through 100 days after last dose for treatment-emergent adverse events, and up to 2 years after last dose. Maximum treatment duration was 18 months.
A serious adverse event is classified using physician's discretion. All adverse events resulting in death, life threatening events, significant disability, prolonged hospitalization, congenital abnormality/birth defect, or new cancer will be considered a serious adverse event. No patients were accrued in the CDK12 Mutation Abemaciclib + Atezolizumab (Non-Randomized) arm.
|
|
General disorders
Flu like symptoms
|
0.00%
0/7 • From treatment initiation through 100 days after last dose for treatment-emergent adverse events, and up to 2 years after last dose. Maximum treatment duration was 18 months.
A serious adverse event is classified using physician's discretion. All adverse events resulting in death, life threatening events, significant disability, prolonged hospitalization, congenital abnormality/birth defect, or new cancer will be considered a serious adverse event. No patients were accrued in the CDK12 Mutation Abemaciclib + Atezolizumab (Non-Randomized) arm.
|
0.00%
0/8 • From treatment initiation through 100 days after last dose for treatment-emergent adverse events, and up to 2 years after last dose. Maximum treatment duration was 18 months.
A serious adverse event is classified using physician's discretion. All adverse events resulting in death, life threatening events, significant disability, prolonged hospitalization, congenital abnormality/birth defect, or new cancer will be considered a serious adverse event. No patients were accrued in the CDK12 Mutation Abemaciclib + Atezolizumab (Non-Randomized) arm.
|
25.0%
1/4 • From treatment initiation through 100 days after last dose for treatment-emergent adverse events, and up to 2 years after last dose. Maximum treatment duration was 18 months.
A serious adverse event is classified using physician's discretion. All adverse events resulting in death, life threatening events, significant disability, prolonged hospitalization, congenital abnormality/birth defect, or new cancer will be considered a serious adverse event. No patients were accrued in the CDK12 Mutation Abemaciclib + Atezolizumab (Non-Randomized) arm.
|
—
0/0 • From treatment initiation through 100 days after last dose for treatment-emergent adverse events, and up to 2 years after last dose. Maximum treatment duration was 18 months.
A serious adverse event is classified using physician's discretion. All adverse events resulting in death, life threatening events, significant disability, prolonged hospitalization, congenital abnormality/birth defect, or new cancer will be considered a serious adverse event. No patients were accrued in the CDK12 Mutation Abemaciclib + Atezolizumab (Non-Randomized) arm.
|
|
General disorders
General disorders and administration site conditions - Other, specify
|
14.3%
1/7 • From treatment initiation through 100 days after last dose for treatment-emergent adverse events, and up to 2 years after last dose. Maximum treatment duration was 18 months.
A serious adverse event is classified using physician's discretion. All adverse events resulting in death, life threatening events, significant disability, prolonged hospitalization, congenital abnormality/birth defect, or new cancer will be considered a serious adverse event. No patients were accrued in the CDK12 Mutation Abemaciclib + Atezolizumab (Non-Randomized) arm.
|
12.5%
1/8 • From treatment initiation through 100 days after last dose for treatment-emergent adverse events, and up to 2 years after last dose. Maximum treatment duration was 18 months.
A serious adverse event is classified using physician's discretion. All adverse events resulting in death, life threatening events, significant disability, prolonged hospitalization, congenital abnormality/birth defect, or new cancer will be considered a serious adverse event. No patients were accrued in the CDK12 Mutation Abemaciclib + Atezolizumab (Non-Randomized) arm.
|
0.00%
0/4 • From treatment initiation through 100 days after last dose for treatment-emergent adverse events, and up to 2 years after last dose. Maximum treatment duration was 18 months.
A serious adverse event is classified using physician's discretion. All adverse events resulting in death, life threatening events, significant disability, prolonged hospitalization, congenital abnormality/birth defect, or new cancer will be considered a serious adverse event. No patients were accrued in the CDK12 Mutation Abemaciclib + Atezolizumab (Non-Randomized) arm.
|
—
0/0 • From treatment initiation through 100 days after last dose for treatment-emergent adverse events, and up to 2 years after last dose. Maximum treatment duration was 18 months.
A serious adverse event is classified using physician's discretion. All adverse events resulting in death, life threatening events, significant disability, prolonged hospitalization, congenital abnormality/birth defect, or new cancer will be considered a serious adverse event. No patients were accrued in the CDK12 Mutation Abemaciclib + Atezolizumab (Non-Randomized) arm.
|
|
General disorders
Pain
|
14.3%
1/7 • From treatment initiation through 100 days after last dose for treatment-emergent adverse events, and up to 2 years after last dose. Maximum treatment duration was 18 months.
A serious adverse event is classified using physician's discretion. All adverse events resulting in death, life threatening events, significant disability, prolonged hospitalization, congenital abnormality/birth defect, or new cancer will be considered a serious adverse event. No patients were accrued in the CDK12 Mutation Abemaciclib + Atezolizumab (Non-Randomized) arm.
|
0.00%
0/8 • From treatment initiation through 100 days after last dose for treatment-emergent adverse events, and up to 2 years after last dose. Maximum treatment duration was 18 months.
A serious adverse event is classified using physician's discretion. All adverse events resulting in death, life threatening events, significant disability, prolonged hospitalization, congenital abnormality/birth defect, or new cancer will be considered a serious adverse event. No patients were accrued in the CDK12 Mutation Abemaciclib + Atezolizumab (Non-Randomized) arm.
|
25.0%
1/4 • From treatment initiation through 100 days after last dose for treatment-emergent adverse events, and up to 2 years after last dose. Maximum treatment duration was 18 months.
A serious adverse event is classified using physician's discretion. All adverse events resulting in death, life threatening events, significant disability, prolonged hospitalization, congenital abnormality/birth defect, or new cancer will be considered a serious adverse event. No patients were accrued in the CDK12 Mutation Abemaciclib + Atezolizumab (Non-Randomized) arm.
|
—
0/0 • From treatment initiation through 100 days after last dose for treatment-emergent adverse events, and up to 2 years after last dose. Maximum treatment duration was 18 months.
A serious adverse event is classified using physician's discretion. All adverse events resulting in death, life threatening events, significant disability, prolonged hospitalization, congenital abnormality/birth defect, or new cancer will be considered a serious adverse event. No patients were accrued in the CDK12 Mutation Abemaciclib + Atezolizumab (Non-Randomized) arm.
|
|
Hepatobiliary disorders
Hepatobiliary disorders - Other, specify
|
14.3%
1/7 • From treatment initiation through 100 days after last dose for treatment-emergent adverse events, and up to 2 years after last dose. Maximum treatment duration was 18 months.
A serious adverse event is classified using physician's discretion. All adverse events resulting in death, life threatening events, significant disability, prolonged hospitalization, congenital abnormality/birth defect, or new cancer will be considered a serious adverse event. No patients were accrued in the CDK12 Mutation Abemaciclib + Atezolizumab (Non-Randomized) arm.
|
0.00%
0/8 • From treatment initiation through 100 days after last dose for treatment-emergent adverse events, and up to 2 years after last dose. Maximum treatment duration was 18 months.
A serious adverse event is classified using physician's discretion. All adverse events resulting in death, life threatening events, significant disability, prolonged hospitalization, congenital abnormality/birth defect, or new cancer will be considered a serious adverse event. No patients were accrued in the CDK12 Mutation Abemaciclib + Atezolizumab (Non-Randomized) arm.
|
0.00%
0/4 • From treatment initiation through 100 days after last dose for treatment-emergent adverse events, and up to 2 years after last dose. Maximum treatment duration was 18 months.
A serious adverse event is classified using physician's discretion. All adverse events resulting in death, life threatening events, significant disability, prolonged hospitalization, congenital abnormality/birth defect, or new cancer will be considered a serious adverse event. No patients were accrued in the CDK12 Mutation Abemaciclib + Atezolizumab (Non-Randomized) arm.
|
—
0/0 • From treatment initiation through 100 days after last dose for treatment-emergent adverse events, and up to 2 years after last dose. Maximum treatment duration was 18 months.
A serious adverse event is classified using physician's discretion. All adverse events resulting in death, life threatening events, significant disability, prolonged hospitalization, congenital abnormality/birth defect, or new cancer will be considered a serious adverse event. No patients were accrued in the CDK12 Mutation Abemaciclib + Atezolizumab (Non-Randomized) arm.
|
|
Immune system disorders
Allergic reaction
|
0.00%
0/7 • From treatment initiation through 100 days after last dose for treatment-emergent adverse events, and up to 2 years after last dose. Maximum treatment duration was 18 months.
A serious adverse event is classified using physician's discretion. All adverse events resulting in death, life threatening events, significant disability, prolonged hospitalization, congenital abnormality/birth defect, or new cancer will be considered a serious adverse event. No patients were accrued in the CDK12 Mutation Abemaciclib + Atezolizumab (Non-Randomized) arm.
|
12.5%
1/8 • From treatment initiation through 100 days after last dose for treatment-emergent adverse events, and up to 2 years after last dose. Maximum treatment duration was 18 months.
A serious adverse event is classified using physician's discretion. All adverse events resulting in death, life threatening events, significant disability, prolonged hospitalization, congenital abnormality/birth defect, or new cancer will be considered a serious adverse event. No patients were accrued in the CDK12 Mutation Abemaciclib + Atezolizumab (Non-Randomized) arm.
|
0.00%
0/4 • From treatment initiation through 100 days after last dose for treatment-emergent adverse events, and up to 2 years after last dose. Maximum treatment duration was 18 months.
A serious adverse event is classified using physician's discretion. All adverse events resulting in death, life threatening events, significant disability, prolonged hospitalization, congenital abnormality/birth defect, or new cancer will be considered a serious adverse event. No patients were accrued in the CDK12 Mutation Abemaciclib + Atezolizumab (Non-Randomized) arm.
|
—
0/0 • From treatment initiation through 100 days after last dose for treatment-emergent adverse events, and up to 2 years after last dose. Maximum treatment duration was 18 months.
A serious adverse event is classified using physician's discretion. All adverse events resulting in death, life threatening events, significant disability, prolonged hospitalization, congenital abnormality/birth defect, or new cancer will be considered a serious adverse event. No patients were accrued in the CDK12 Mutation Abemaciclib + Atezolizumab (Non-Randomized) arm.
|
|
Infections and infestations
Infections and infestations - Other, specify
|
14.3%
1/7 • From treatment initiation through 100 days after last dose for treatment-emergent adverse events, and up to 2 years after last dose. Maximum treatment duration was 18 months.
A serious adverse event is classified using physician's discretion. All adverse events resulting in death, life threatening events, significant disability, prolonged hospitalization, congenital abnormality/birth defect, or new cancer will be considered a serious adverse event. No patients were accrued in the CDK12 Mutation Abemaciclib + Atezolizumab (Non-Randomized) arm.
|
0.00%
0/8 • From treatment initiation through 100 days after last dose for treatment-emergent adverse events, and up to 2 years after last dose. Maximum treatment duration was 18 months.
A serious adverse event is classified using physician's discretion. All adverse events resulting in death, life threatening events, significant disability, prolonged hospitalization, congenital abnormality/birth defect, or new cancer will be considered a serious adverse event. No patients were accrued in the CDK12 Mutation Abemaciclib + Atezolizumab (Non-Randomized) arm.
|
0.00%
0/4 • From treatment initiation through 100 days after last dose for treatment-emergent adverse events, and up to 2 years after last dose. Maximum treatment duration was 18 months.
A serious adverse event is classified using physician's discretion. All adverse events resulting in death, life threatening events, significant disability, prolonged hospitalization, congenital abnormality/birth defect, or new cancer will be considered a serious adverse event. No patients were accrued in the CDK12 Mutation Abemaciclib + Atezolizumab (Non-Randomized) arm.
|
—
0/0 • From treatment initiation through 100 days after last dose for treatment-emergent adverse events, and up to 2 years after last dose. Maximum treatment duration was 18 months.
A serious adverse event is classified using physician's discretion. All adverse events resulting in death, life threatening events, significant disability, prolonged hospitalization, congenital abnormality/birth defect, or new cancer will be considered a serious adverse event. No patients were accrued in the CDK12 Mutation Abemaciclib + Atezolizumab (Non-Randomized) arm.
|
|
Infections and infestations
Tooth infection
|
14.3%
1/7 • From treatment initiation through 100 days after last dose for treatment-emergent adverse events, and up to 2 years after last dose. Maximum treatment duration was 18 months.
A serious adverse event is classified using physician's discretion. All adverse events resulting in death, life threatening events, significant disability, prolonged hospitalization, congenital abnormality/birth defect, or new cancer will be considered a serious adverse event. No patients were accrued in the CDK12 Mutation Abemaciclib + Atezolizumab (Non-Randomized) arm.
|
0.00%
0/8 • From treatment initiation through 100 days after last dose for treatment-emergent adverse events, and up to 2 years after last dose. Maximum treatment duration was 18 months.
A serious adverse event is classified using physician's discretion. All adverse events resulting in death, life threatening events, significant disability, prolonged hospitalization, congenital abnormality/birth defect, or new cancer will be considered a serious adverse event. No patients were accrued in the CDK12 Mutation Abemaciclib + Atezolizumab (Non-Randomized) arm.
|
0.00%
0/4 • From treatment initiation through 100 days after last dose for treatment-emergent adverse events, and up to 2 years after last dose. Maximum treatment duration was 18 months.
A serious adverse event is classified using physician's discretion. All adverse events resulting in death, life threatening events, significant disability, prolonged hospitalization, congenital abnormality/birth defect, or new cancer will be considered a serious adverse event. No patients were accrued in the CDK12 Mutation Abemaciclib + Atezolizumab (Non-Randomized) arm.
|
—
0/0 • From treatment initiation through 100 days after last dose for treatment-emergent adverse events, and up to 2 years after last dose. Maximum treatment duration was 18 months.
A serious adverse event is classified using physician's discretion. All adverse events resulting in death, life threatening events, significant disability, prolonged hospitalization, congenital abnormality/birth defect, or new cancer will be considered a serious adverse event. No patients were accrued in the CDK12 Mutation Abemaciclib + Atezolizumab (Non-Randomized) arm.
|
|
Infections and infestations
Upper respiratory infection
|
0.00%
0/7 • From treatment initiation through 100 days after last dose for treatment-emergent adverse events, and up to 2 years after last dose. Maximum treatment duration was 18 months.
A serious adverse event is classified using physician's discretion. All adverse events resulting in death, life threatening events, significant disability, prolonged hospitalization, congenital abnormality/birth defect, or new cancer will be considered a serious adverse event. No patients were accrued in the CDK12 Mutation Abemaciclib + Atezolizumab (Non-Randomized) arm.
|
12.5%
1/8 • From treatment initiation through 100 days after last dose for treatment-emergent adverse events, and up to 2 years after last dose. Maximum treatment duration was 18 months.
A serious adverse event is classified using physician's discretion. All adverse events resulting in death, life threatening events, significant disability, prolonged hospitalization, congenital abnormality/birth defect, or new cancer will be considered a serious adverse event. No patients were accrued in the CDK12 Mutation Abemaciclib + Atezolizumab (Non-Randomized) arm.
|
0.00%
0/4 • From treatment initiation through 100 days after last dose for treatment-emergent adverse events, and up to 2 years after last dose. Maximum treatment duration was 18 months.
A serious adverse event is classified using physician's discretion. All adverse events resulting in death, life threatening events, significant disability, prolonged hospitalization, congenital abnormality/birth defect, or new cancer will be considered a serious adverse event. No patients were accrued in the CDK12 Mutation Abemaciclib + Atezolizumab (Non-Randomized) arm.
|
—
0/0 • From treatment initiation through 100 days after last dose for treatment-emergent adverse events, and up to 2 years after last dose. Maximum treatment duration was 18 months.
A serious adverse event is classified using physician's discretion. All adverse events resulting in death, life threatening events, significant disability, prolonged hospitalization, congenital abnormality/birth defect, or new cancer will be considered a serious adverse event. No patients were accrued in the CDK12 Mutation Abemaciclib + Atezolizumab (Non-Randomized) arm.
|
|
Investigations
Activated partial thromboplastin time prolonged
|
0.00%
0/7 • From treatment initiation through 100 days after last dose for treatment-emergent adverse events, and up to 2 years after last dose. Maximum treatment duration was 18 months.
A serious adverse event is classified using physician's discretion. All adverse events resulting in death, life threatening events, significant disability, prolonged hospitalization, congenital abnormality/birth defect, or new cancer will be considered a serious adverse event. No patients were accrued in the CDK12 Mutation Abemaciclib + Atezolizumab (Non-Randomized) arm.
|
12.5%
1/8 • From treatment initiation through 100 days after last dose for treatment-emergent adverse events, and up to 2 years after last dose. Maximum treatment duration was 18 months.
A serious adverse event is classified using physician's discretion. All adverse events resulting in death, life threatening events, significant disability, prolonged hospitalization, congenital abnormality/birth defect, or new cancer will be considered a serious adverse event. No patients were accrued in the CDK12 Mutation Abemaciclib + Atezolizumab (Non-Randomized) arm.
|
0.00%
0/4 • From treatment initiation through 100 days after last dose for treatment-emergent adverse events, and up to 2 years after last dose. Maximum treatment duration was 18 months.
A serious adverse event is classified using physician's discretion. All adverse events resulting in death, life threatening events, significant disability, prolonged hospitalization, congenital abnormality/birth defect, or new cancer will be considered a serious adverse event. No patients were accrued in the CDK12 Mutation Abemaciclib + Atezolizumab (Non-Randomized) arm.
|
—
0/0 • From treatment initiation through 100 days after last dose for treatment-emergent adverse events, and up to 2 years after last dose. Maximum treatment duration was 18 months.
A serious adverse event is classified using physician's discretion. All adverse events resulting in death, life threatening events, significant disability, prolonged hospitalization, congenital abnormality/birth defect, or new cancer will be considered a serious adverse event. No patients were accrued in the CDK12 Mutation Abemaciclib + Atezolizumab (Non-Randomized) arm.
|
|
Investigations
Alanine aminotransferase increased
|
14.3%
1/7 • From treatment initiation through 100 days after last dose for treatment-emergent adverse events, and up to 2 years after last dose. Maximum treatment duration was 18 months.
A serious adverse event is classified using physician's discretion. All adverse events resulting in death, life threatening events, significant disability, prolonged hospitalization, congenital abnormality/birth defect, or new cancer will be considered a serious adverse event. No patients were accrued in the CDK12 Mutation Abemaciclib + Atezolizumab (Non-Randomized) arm.
|
25.0%
2/8 • From treatment initiation through 100 days after last dose for treatment-emergent adverse events, and up to 2 years after last dose. Maximum treatment duration was 18 months.
A serious adverse event is classified using physician's discretion. All adverse events resulting in death, life threatening events, significant disability, prolonged hospitalization, congenital abnormality/birth defect, or new cancer will be considered a serious adverse event. No patients were accrued in the CDK12 Mutation Abemaciclib + Atezolizumab (Non-Randomized) arm.
|
25.0%
1/4 • From treatment initiation through 100 days after last dose for treatment-emergent adverse events, and up to 2 years after last dose. Maximum treatment duration was 18 months.
A serious adverse event is classified using physician's discretion. All adverse events resulting in death, life threatening events, significant disability, prolonged hospitalization, congenital abnormality/birth defect, or new cancer will be considered a serious adverse event. No patients were accrued in the CDK12 Mutation Abemaciclib + Atezolizumab (Non-Randomized) arm.
|
—
0/0 • From treatment initiation through 100 days after last dose for treatment-emergent adverse events, and up to 2 years after last dose. Maximum treatment duration was 18 months.
A serious adverse event is classified using physician's discretion. All adverse events resulting in death, life threatening events, significant disability, prolonged hospitalization, congenital abnormality/birth defect, or new cancer will be considered a serious adverse event. No patients were accrued in the CDK12 Mutation Abemaciclib + Atezolizumab (Non-Randomized) arm.
|
|
Investigations
Alkaline phosphatase increased
|
28.6%
2/7 • From treatment initiation through 100 days after last dose for treatment-emergent adverse events, and up to 2 years after last dose. Maximum treatment duration was 18 months.
A serious adverse event is classified using physician's discretion. All adverse events resulting in death, life threatening events, significant disability, prolonged hospitalization, congenital abnormality/birth defect, or new cancer will be considered a serious adverse event. No patients were accrued in the CDK12 Mutation Abemaciclib + Atezolizumab (Non-Randomized) arm.
|
37.5%
3/8 • From treatment initiation through 100 days after last dose for treatment-emergent adverse events, and up to 2 years after last dose. Maximum treatment duration was 18 months.
A serious adverse event is classified using physician's discretion. All adverse events resulting in death, life threatening events, significant disability, prolonged hospitalization, congenital abnormality/birth defect, or new cancer will be considered a serious adverse event. No patients were accrued in the CDK12 Mutation Abemaciclib + Atezolizumab (Non-Randomized) arm.
|
75.0%
3/4 • From treatment initiation through 100 days after last dose for treatment-emergent adverse events, and up to 2 years after last dose. Maximum treatment duration was 18 months.
A serious adverse event is classified using physician's discretion. All adverse events resulting in death, life threatening events, significant disability, prolonged hospitalization, congenital abnormality/birth defect, or new cancer will be considered a serious adverse event. No patients were accrued in the CDK12 Mutation Abemaciclib + Atezolizumab (Non-Randomized) arm.
|
—
0/0 • From treatment initiation through 100 days after last dose for treatment-emergent adverse events, and up to 2 years after last dose. Maximum treatment duration was 18 months.
A serious adverse event is classified using physician's discretion. All adverse events resulting in death, life threatening events, significant disability, prolonged hospitalization, congenital abnormality/birth defect, or new cancer will be considered a serious adverse event. No patients were accrued in the CDK12 Mutation Abemaciclib + Atezolizumab (Non-Randomized) arm.
|
|
Investigations
Aspartate aminotransferase increased
|
0.00%
0/7 • From treatment initiation through 100 days after last dose for treatment-emergent adverse events, and up to 2 years after last dose. Maximum treatment duration was 18 months.
A serious adverse event is classified using physician's discretion. All adverse events resulting in death, life threatening events, significant disability, prolonged hospitalization, congenital abnormality/birth defect, or new cancer will be considered a serious adverse event. No patients were accrued in the CDK12 Mutation Abemaciclib + Atezolizumab (Non-Randomized) arm.
|
37.5%
3/8 • From treatment initiation through 100 days after last dose for treatment-emergent adverse events, and up to 2 years after last dose. Maximum treatment duration was 18 months.
A serious adverse event is classified using physician's discretion. All adverse events resulting in death, life threatening events, significant disability, prolonged hospitalization, congenital abnormality/birth defect, or new cancer will be considered a serious adverse event. No patients were accrued in the CDK12 Mutation Abemaciclib + Atezolizumab (Non-Randomized) arm.
|
25.0%
1/4 • From treatment initiation through 100 days after last dose for treatment-emergent adverse events, and up to 2 years after last dose. Maximum treatment duration was 18 months.
A serious adverse event is classified using physician's discretion. All adverse events resulting in death, life threatening events, significant disability, prolonged hospitalization, congenital abnormality/birth defect, or new cancer will be considered a serious adverse event. No patients were accrued in the CDK12 Mutation Abemaciclib + Atezolizumab (Non-Randomized) arm.
|
—
0/0 • From treatment initiation through 100 days after last dose for treatment-emergent adverse events, and up to 2 years after last dose. Maximum treatment duration was 18 months.
A serious adverse event is classified using physician's discretion. All adverse events resulting in death, life threatening events, significant disability, prolonged hospitalization, congenital abnormality/birth defect, or new cancer will be considered a serious adverse event. No patients were accrued in the CDK12 Mutation Abemaciclib + Atezolizumab (Non-Randomized) arm.
|
|
Investigations
Blood bilirubin increased
|
0.00%
0/7 • From treatment initiation through 100 days after last dose for treatment-emergent adverse events, and up to 2 years after last dose. Maximum treatment duration was 18 months.
A serious adverse event is classified using physician's discretion. All adverse events resulting in death, life threatening events, significant disability, prolonged hospitalization, congenital abnormality/birth defect, or new cancer will be considered a serious adverse event. No patients were accrued in the CDK12 Mutation Abemaciclib + Atezolizumab (Non-Randomized) arm.
|
12.5%
1/8 • From treatment initiation through 100 days after last dose for treatment-emergent adverse events, and up to 2 years after last dose. Maximum treatment duration was 18 months.
A serious adverse event is classified using physician's discretion. All adverse events resulting in death, life threatening events, significant disability, prolonged hospitalization, congenital abnormality/birth defect, or new cancer will be considered a serious adverse event. No patients were accrued in the CDK12 Mutation Abemaciclib + Atezolizumab (Non-Randomized) arm.
|
0.00%
0/4 • From treatment initiation through 100 days after last dose for treatment-emergent adverse events, and up to 2 years after last dose. Maximum treatment duration was 18 months.
A serious adverse event is classified using physician's discretion. All adverse events resulting in death, life threatening events, significant disability, prolonged hospitalization, congenital abnormality/birth defect, or new cancer will be considered a serious adverse event. No patients were accrued in the CDK12 Mutation Abemaciclib + Atezolizumab (Non-Randomized) arm.
|
—
0/0 • From treatment initiation through 100 days after last dose for treatment-emergent adverse events, and up to 2 years after last dose. Maximum treatment duration was 18 months.
A serious adverse event is classified using physician's discretion. All adverse events resulting in death, life threatening events, significant disability, prolonged hospitalization, congenital abnormality/birth defect, or new cancer will be considered a serious adverse event. No patients were accrued in the CDK12 Mutation Abemaciclib + Atezolizumab (Non-Randomized) arm.
|
|
Investigations
Cardiac troponin T increased
|
0.00%
0/7 • From treatment initiation through 100 days after last dose for treatment-emergent adverse events, and up to 2 years after last dose. Maximum treatment duration was 18 months.
A serious adverse event is classified using physician's discretion. All adverse events resulting in death, life threatening events, significant disability, prolonged hospitalization, congenital abnormality/birth defect, or new cancer will be considered a serious adverse event. No patients were accrued in the CDK12 Mutation Abemaciclib + Atezolizumab (Non-Randomized) arm.
|
12.5%
1/8 • From treatment initiation through 100 days after last dose for treatment-emergent adverse events, and up to 2 years after last dose. Maximum treatment duration was 18 months.
A serious adverse event is classified using physician's discretion. All adverse events resulting in death, life threatening events, significant disability, prolonged hospitalization, congenital abnormality/birth defect, or new cancer will be considered a serious adverse event. No patients were accrued in the CDK12 Mutation Abemaciclib + Atezolizumab (Non-Randomized) arm.
|
0.00%
0/4 • From treatment initiation through 100 days after last dose for treatment-emergent adverse events, and up to 2 years after last dose. Maximum treatment duration was 18 months.
A serious adverse event is classified using physician's discretion. All adverse events resulting in death, life threatening events, significant disability, prolonged hospitalization, congenital abnormality/birth defect, or new cancer will be considered a serious adverse event. No patients were accrued in the CDK12 Mutation Abemaciclib + Atezolizumab (Non-Randomized) arm.
|
—
0/0 • From treatment initiation through 100 days after last dose for treatment-emergent adverse events, and up to 2 years after last dose. Maximum treatment duration was 18 months.
A serious adverse event is classified using physician's discretion. All adverse events resulting in death, life threatening events, significant disability, prolonged hospitalization, congenital abnormality/birth defect, or new cancer will be considered a serious adverse event. No patients were accrued in the CDK12 Mutation Abemaciclib + Atezolizumab (Non-Randomized) arm.
|
|
Investigations
Creatinine increased
|
57.1%
4/7 • From treatment initiation through 100 days after last dose for treatment-emergent adverse events, and up to 2 years after last dose. Maximum treatment duration was 18 months.
A serious adverse event is classified using physician's discretion. All adverse events resulting in death, life threatening events, significant disability, prolonged hospitalization, congenital abnormality/birth defect, or new cancer will be considered a serious adverse event. No patients were accrued in the CDK12 Mutation Abemaciclib + Atezolizumab (Non-Randomized) arm.
|
62.5%
5/8 • From treatment initiation through 100 days after last dose for treatment-emergent adverse events, and up to 2 years after last dose. Maximum treatment duration was 18 months.
A serious adverse event is classified using physician's discretion. All adverse events resulting in death, life threatening events, significant disability, prolonged hospitalization, congenital abnormality/birth defect, or new cancer will be considered a serious adverse event. No patients were accrued in the CDK12 Mutation Abemaciclib + Atezolizumab (Non-Randomized) arm.
|
25.0%
1/4 • From treatment initiation through 100 days after last dose for treatment-emergent adverse events, and up to 2 years after last dose. Maximum treatment duration was 18 months.
A serious adverse event is classified using physician's discretion. All adverse events resulting in death, life threatening events, significant disability, prolonged hospitalization, congenital abnormality/birth defect, or new cancer will be considered a serious adverse event. No patients were accrued in the CDK12 Mutation Abemaciclib + Atezolizumab (Non-Randomized) arm.
|
—
0/0 • From treatment initiation through 100 days after last dose for treatment-emergent adverse events, and up to 2 years after last dose. Maximum treatment duration was 18 months.
A serious adverse event is classified using physician's discretion. All adverse events resulting in death, life threatening events, significant disability, prolonged hospitalization, congenital abnormality/birth defect, or new cancer will be considered a serious adverse event. No patients were accrued in the CDK12 Mutation Abemaciclib + Atezolizumab (Non-Randomized) arm.
|
|
Investigations
Investigations - Other, specify
|
0.00%
0/7 • From treatment initiation through 100 days after last dose for treatment-emergent adverse events, and up to 2 years after last dose. Maximum treatment duration was 18 months.
A serious adverse event is classified using physician's discretion. All adverse events resulting in death, life threatening events, significant disability, prolonged hospitalization, congenital abnormality/birth defect, or new cancer will be considered a serious adverse event. No patients were accrued in the CDK12 Mutation Abemaciclib + Atezolizumab (Non-Randomized) arm.
|
12.5%
1/8 • From treatment initiation through 100 days after last dose for treatment-emergent adverse events, and up to 2 years after last dose. Maximum treatment duration was 18 months.
A serious adverse event is classified using physician's discretion. All adverse events resulting in death, life threatening events, significant disability, prolonged hospitalization, congenital abnormality/birth defect, or new cancer will be considered a serious adverse event. No patients were accrued in the CDK12 Mutation Abemaciclib + Atezolizumab (Non-Randomized) arm.
|
0.00%
0/4 • From treatment initiation through 100 days after last dose for treatment-emergent adverse events, and up to 2 years after last dose. Maximum treatment duration was 18 months.
A serious adverse event is classified using physician's discretion. All adverse events resulting in death, life threatening events, significant disability, prolonged hospitalization, congenital abnormality/birth defect, or new cancer will be considered a serious adverse event. No patients were accrued in the CDK12 Mutation Abemaciclib + Atezolizumab (Non-Randomized) arm.
|
—
0/0 • From treatment initiation through 100 days after last dose for treatment-emergent adverse events, and up to 2 years after last dose. Maximum treatment duration was 18 months.
A serious adverse event is classified using physician's discretion. All adverse events resulting in death, life threatening events, significant disability, prolonged hospitalization, congenital abnormality/birth defect, or new cancer will be considered a serious adverse event. No patients were accrued in the CDK12 Mutation Abemaciclib + Atezolizumab (Non-Randomized) arm.
|
|
Investigations
Neutrophil count decreased
|
57.1%
4/7 • From treatment initiation through 100 days after last dose for treatment-emergent adverse events, and up to 2 years after last dose. Maximum treatment duration was 18 months.
A serious adverse event is classified using physician's discretion. All adverse events resulting in death, life threatening events, significant disability, prolonged hospitalization, congenital abnormality/birth defect, or new cancer will be considered a serious adverse event. No patients were accrued in the CDK12 Mutation Abemaciclib + Atezolizumab (Non-Randomized) arm.
|
50.0%
4/8 • From treatment initiation through 100 days after last dose for treatment-emergent adverse events, and up to 2 years after last dose. Maximum treatment duration was 18 months.
A serious adverse event is classified using physician's discretion. All adverse events resulting in death, life threatening events, significant disability, prolonged hospitalization, congenital abnormality/birth defect, or new cancer will be considered a serious adverse event. No patients were accrued in the CDK12 Mutation Abemaciclib + Atezolizumab (Non-Randomized) arm.
|
0.00%
0/4 • From treatment initiation through 100 days after last dose for treatment-emergent adverse events, and up to 2 years after last dose. Maximum treatment duration was 18 months.
A serious adverse event is classified using physician's discretion. All adverse events resulting in death, life threatening events, significant disability, prolonged hospitalization, congenital abnormality/birth defect, or new cancer will be considered a serious adverse event. No patients were accrued in the CDK12 Mutation Abemaciclib + Atezolizumab (Non-Randomized) arm.
|
—
0/0 • From treatment initiation through 100 days after last dose for treatment-emergent adverse events, and up to 2 years after last dose. Maximum treatment duration was 18 months.
A serious adverse event is classified using physician's discretion. All adverse events resulting in death, life threatening events, significant disability, prolonged hospitalization, congenital abnormality/birth defect, or new cancer will be considered a serious adverse event. No patients were accrued in the CDK12 Mutation Abemaciclib + Atezolizumab (Non-Randomized) arm.
|
|
Investigations
Platelet count decreased
|
57.1%
4/7 • From treatment initiation through 100 days after last dose for treatment-emergent adverse events, and up to 2 years after last dose. Maximum treatment duration was 18 months.
A serious adverse event is classified using physician's discretion. All adverse events resulting in death, life threatening events, significant disability, prolonged hospitalization, congenital abnormality/birth defect, or new cancer will be considered a serious adverse event. No patients were accrued in the CDK12 Mutation Abemaciclib + Atezolizumab (Non-Randomized) arm.
|
37.5%
3/8 • From treatment initiation through 100 days after last dose for treatment-emergent adverse events, and up to 2 years after last dose. Maximum treatment duration was 18 months.
A serious adverse event is classified using physician's discretion. All adverse events resulting in death, life threatening events, significant disability, prolonged hospitalization, congenital abnormality/birth defect, or new cancer will be considered a serious adverse event. No patients were accrued in the CDK12 Mutation Abemaciclib + Atezolizumab (Non-Randomized) arm.
|
25.0%
1/4 • From treatment initiation through 100 days after last dose for treatment-emergent adverse events, and up to 2 years after last dose. Maximum treatment duration was 18 months.
A serious adverse event is classified using physician's discretion. All adverse events resulting in death, life threatening events, significant disability, prolonged hospitalization, congenital abnormality/birth defect, or new cancer will be considered a serious adverse event. No patients were accrued in the CDK12 Mutation Abemaciclib + Atezolizumab (Non-Randomized) arm.
|
—
0/0 • From treatment initiation through 100 days after last dose for treatment-emergent adverse events, and up to 2 years after last dose. Maximum treatment duration was 18 months.
A serious adverse event is classified using physician's discretion. All adverse events resulting in death, life threatening events, significant disability, prolonged hospitalization, congenital abnormality/birth defect, or new cancer will be considered a serious adverse event. No patients were accrued in the CDK12 Mutation Abemaciclib + Atezolizumab (Non-Randomized) arm.
|
|
Investigations
Weight loss
|
14.3%
1/7 • From treatment initiation through 100 days after last dose for treatment-emergent adverse events, and up to 2 years after last dose. Maximum treatment duration was 18 months.
A serious adverse event is classified using physician's discretion. All adverse events resulting in death, life threatening events, significant disability, prolonged hospitalization, congenital abnormality/birth defect, or new cancer will be considered a serious adverse event. No patients were accrued in the CDK12 Mutation Abemaciclib + Atezolizumab (Non-Randomized) arm.
|
25.0%
2/8 • From treatment initiation through 100 days after last dose for treatment-emergent adverse events, and up to 2 years after last dose. Maximum treatment duration was 18 months.
A serious adverse event is classified using physician's discretion. All adverse events resulting in death, life threatening events, significant disability, prolonged hospitalization, congenital abnormality/birth defect, or new cancer will be considered a serious adverse event. No patients were accrued in the CDK12 Mutation Abemaciclib + Atezolizumab (Non-Randomized) arm.
|
0.00%
0/4 • From treatment initiation through 100 days after last dose for treatment-emergent adverse events, and up to 2 years after last dose. Maximum treatment duration was 18 months.
A serious adverse event is classified using physician's discretion. All adverse events resulting in death, life threatening events, significant disability, prolonged hospitalization, congenital abnormality/birth defect, or new cancer will be considered a serious adverse event. No patients were accrued in the CDK12 Mutation Abemaciclib + Atezolizumab (Non-Randomized) arm.
|
—
0/0 • From treatment initiation through 100 days after last dose for treatment-emergent adverse events, and up to 2 years after last dose. Maximum treatment duration was 18 months.
A serious adverse event is classified using physician's discretion. All adverse events resulting in death, life threatening events, significant disability, prolonged hospitalization, congenital abnormality/birth defect, or new cancer will be considered a serious adverse event. No patients were accrued in the CDK12 Mutation Abemaciclib + Atezolizumab (Non-Randomized) arm.
|
|
Investigations
White blood cell decreased
|
42.9%
3/7 • From treatment initiation through 100 days after last dose for treatment-emergent adverse events, and up to 2 years after last dose. Maximum treatment duration was 18 months.
A serious adverse event is classified using physician's discretion. All adverse events resulting in death, life threatening events, significant disability, prolonged hospitalization, congenital abnormality/birth defect, or new cancer will be considered a serious adverse event. No patients were accrued in the CDK12 Mutation Abemaciclib + Atezolizumab (Non-Randomized) arm.
|
37.5%
3/8 • From treatment initiation through 100 days after last dose for treatment-emergent adverse events, and up to 2 years after last dose. Maximum treatment duration was 18 months.
A serious adverse event is classified using physician's discretion. All adverse events resulting in death, life threatening events, significant disability, prolonged hospitalization, congenital abnormality/birth defect, or new cancer will be considered a serious adverse event. No patients were accrued in the CDK12 Mutation Abemaciclib + Atezolizumab (Non-Randomized) arm.
|
0.00%
0/4 • From treatment initiation through 100 days after last dose for treatment-emergent adverse events, and up to 2 years after last dose. Maximum treatment duration was 18 months.
A serious adverse event is classified using physician's discretion. All adverse events resulting in death, life threatening events, significant disability, prolonged hospitalization, congenital abnormality/birth defect, or new cancer will be considered a serious adverse event. No patients were accrued in the CDK12 Mutation Abemaciclib + Atezolizumab (Non-Randomized) arm.
|
—
0/0 • From treatment initiation through 100 days after last dose for treatment-emergent adverse events, and up to 2 years after last dose. Maximum treatment duration was 18 months.
A serious adverse event is classified using physician's discretion. All adverse events resulting in death, life threatening events, significant disability, prolonged hospitalization, congenital abnormality/birth defect, or new cancer will be considered a serious adverse event. No patients were accrued in the CDK12 Mutation Abemaciclib + Atezolizumab (Non-Randomized) arm.
|
|
Metabolism and nutrition disorders
Anorexia
|
14.3%
1/7 • From treatment initiation through 100 days after last dose for treatment-emergent adverse events, and up to 2 years after last dose. Maximum treatment duration was 18 months.
A serious adverse event is classified using physician's discretion. All adverse events resulting in death, life threatening events, significant disability, prolonged hospitalization, congenital abnormality/birth defect, or new cancer will be considered a serious adverse event. No patients were accrued in the CDK12 Mutation Abemaciclib + Atezolizumab (Non-Randomized) arm.
|
25.0%
2/8 • From treatment initiation through 100 days after last dose for treatment-emergent adverse events, and up to 2 years after last dose. Maximum treatment duration was 18 months.
A serious adverse event is classified using physician's discretion. All adverse events resulting in death, life threatening events, significant disability, prolonged hospitalization, congenital abnormality/birth defect, or new cancer will be considered a serious adverse event. No patients were accrued in the CDK12 Mutation Abemaciclib + Atezolizumab (Non-Randomized) arm.
|
25.0%
1/4 • From treatment initiation through 100 days after last dose for treatment-emergent adverse events, and up to 2 years after last dose. Maximum treatment duration was 18 months.
A serious adverse event is classified using physician's discretion. All adverse events resulting in death, life threatening events, significant disability, prolonged hospitalization, congenital abnormality/birth defect, or new cancer will be considered a serious adverse event. No patients were accrued in the CDK12 Mutation Abemaciclib + Atezolizumab (Non-Randomized) arm.
|
—
0/0 • From treatment initiation through 100 days after last dose for treatment-emergent adverse events, and up to 2 years after last dose. Maximum treatment duration was 18 months.
A serious adverse event is classified using physician's discretion. All adverse events resulting in death, life threatening events, significant disability, prolonged hospitalization, congenital abnormality/birth defect, or new cancer will be considered a serious adverse event. No patients were accrued in the CDK12 Mutation Abemaciclib + Atezolizumab (Non-Randomized) arm.
|
|
Metabolism and nutrition disorders
Dehydration
|
14.3%
1/7 • From treatment initiation through 100 days after last dose for treatment-emergent adverse events, and up to 2 years after last dose. Maximum treatment duration was 18 months.
A serious adverse event is classified using physician's discretion. All adverse events resulting in death, life threatening events, significant disability, prolonged hospitalization, congenital abnormality/birth defect, or new cancer will be considered a serious adverse event. No patients were accrued in the CDK12 Mutation Abemaciclib + Atezolizumab (Non-Randomized) arm.
|
0.00%
0/8 • From treatment initiation through 100 days after last dose for treatment-emergent adverse events, and up to 2 years after last dose. Maximum treatment duration was 18 months.
A serious adverse event is classified using physician's discretion. All adverse events resulting in death, life threatening events, significant disability, prolonged hospitalization, congenital abnormality/birth defect, or new cancer will be considered a serious adverse event. No patients were accrued in the CDK12 Mutation Abemaciclib + Atezolizumab (Non-Randomized) arm.
|
0.00%
0/4 • From treatment initiation through 100 days after last dose for treatment-emergent adverse events, and up to 2 years after last dose. Maximum treatment duration was 18 months.
A serious adverse event is classified using physician's discretion. All adverse events resulting in death, life threatening events, significant disability, prolonged hospitalization, congenital abnormality/birth defect, or new cancer will be considered a serious adverse event. No patients were accrued in the CDK12 Mutation Abemaciclib + Atezolizumab (Non-Randomized) arm.
|
—
0/0 • From treatment initiation through 100 days after last dose for treatment-emergent adverse events, and up to 2 years after last dose. Maximum treatment duration was 18 months.
A serious adverse event is classified using physician's discretion. All adverse events resulting in death, life threatening events, significant disability, prolonged hospitalization, congenital abnormality/birth defect, or new cancer will be considered a serious adverse event. No patients were accrued in the CDK12 Mutation Abemaciclib + Atezolizumab (Non-Randomized) arm.
|
|
Metabolism and nutrition disorders
Hyperglycemia
|
28.6%
2/7 • From treatment initiation through 100 days after last dose for treatment-emergent adverse events, and up to 2 years after last dose. Maximum treatment duration was 18 months.
A serious adverse event is classified using physician's discretion. All adverse events resulting in death, life threatening events, significant disability, prolonged hospitalization, congenital abnormality/birth defect, or new cancer will be considered a serious adverse event. No patients were accrued in the CDK12 Mutation Abemaciclib + Atezolizumab (Non-Randomized) arm.
|
0.00%
0/8 • From treatment initiation through 100 days after last dose for treatment-emergent adverse events, and up to 2 years after last dose. Maximum treatment duration was 18 months.
A serious adverse event is classified using physician's discretion. All adverse events resulting in death, life threatening events, significant disability, prolonged hospitalization, congenital abnormality/birth defect, or new cancer will be considered a serious adverse event. No patients were accrued in the CDK12 Mutation Abemaciclib + Atezolizumab (Non-Randomized) arm.
|
25.0%
1/4 • From treatment initiation through 100 days after last dose for treatment-emergent adverse events, and up to 2 years after last dose. Maximum treatment duration was 18 months.
A serious adverse event is classified using physician's discretion. All adverse events resulting in death, life threatening events, significant disability, prolonged hospitalization, congenital abnormality/birth defect, or new cancer will be considered a serious adverse event. No patients were accrued in the CDK12 Mutation Abemaciclib + Atezolizumab (Non-Randomized) arm.
|
—
0/0 • From treatment initiation through 100 days after last dose for treatment-emergent adverse events, and up to 2 years after last dose. Maximum treatment duration was 18 months.
A serious adverse event is classified using physician's discretion. All adverse events resulting in death, life threatening events, significant disability, prolonged hospitalization, congenital abnormality/birth defect, or new cancer will be considered a serious adverse event. No patients were accrued in the CDK12 Mutation Abemaciclib + Atezolizumab (Non-Randomized) arm.
|
|
Metabolism and nutrition disorders
Hyperlipidemia
|
14.3%
1/7 • From treatment initiation through 100 days after last dose for treatment-emergent adverse events, and up to 2 years after last dose. Maximum treatment duration was 18 months.
A serious adverse event is classified using physician's discretion. All adverse events resulting in death, life threatening events, significant disability, prolonged hospitalization, congenital abnormality/birth defect, or new cancer will be considered a serious adverse event. No patients were accrued in the CDK12 Mutation Abemaciclib + Atezolizumab (Non-Randomized) arm.
|
0.00%
0/8 • From treatment initiation through 100 days after last dose for treatment-emergent adverse events, and up to 2 years after last dose. Maximum treatment duration was 18 months.
A serious adverse event is classified using physician's discretion. All adverse events resulting in death, life threatening events, significant disability, prolonged hospitalization, congenital abnormality/birth defect, or new cancer will be considered a serious adverse event. No patients were accrued in the CDK12 Mutation Abemaciclib + Atezolizumab (Non-Randomized) arm.
|
25.0%
1/4 • From treatment initiation through 100 days after last dose for treatment-emergent adverse events, and up to 2 years after last dose. Maximum treatment duration was 18 months.
A serious adverse event is classified using physician's discretion. All adverse events resulting in death, life threatening events, significant disability, prolonged hospitalization, congenital abnormality/birth defect, or new cancer will be considered a serious adverse event. No patients were accrued in the CDK12 Mutation Abemaciclib + Atezolizumab (Non-Randomized) arm.
|
—
0/0 • From treatment initiation through 100 days after last dose for treatment-emergent adverse events, and up to 2 years after last dose. Maximum treatment duration was 18 months.
A serious adverse event is classified using physician's discretion. All adverse events resulting in death, life threatening events, significant disability, prolonged hospitalization, congenital abnormality/birth defect, or new cancer will be considered a serious adverse event. No patients were accrued in the CDK12 Mutation Abemaciclib + Atezolizumab (Non-Randomized) arm.
|
|
Metabolism and nutrition disorders
Hypoalbuminemia
|
14.3%
1/7 • From treatment initiation through 100 days after last dose for treatment-emergent adverse events, and up to 2 years after last dose. Maximum treatment duration was 18 months.
A serious adverse event is classified using physician's discretion. All adverse events resulting in death, life threatening events, significant disability, prolonged hospitalization, congenital abnormality/birth defect, or new cancer will be considered a serious adverse event. No patients were accrued in the CDK12 Mutation Abemaciclib + Atezolizumab (Non-Randomized) arm.
|
12.5%
1/8 • From treatment initiation through 100 days after last dose for treatment-emergent adverse events, and up to 2 years after last dose. Maximum treatment duration was 18 months.
A serious adverse event is classified using physician's discretion. All adverse events resulting in death, life threatening events, significant disability, prolonged hospitalization, congenital abnormality/birth defect, or new cancer will be considered a serious adverse event. No patients were accrued in the CDK12 Mutation Abemaciclib + Atezolizumab (Non-Randomized) arm.
|
0.00%
0/4 • From treatment initiation through 100 days after last dose for treatment-emergent adverse events, and up to 2 years after last dose. Maximum treatment duration was 18 months.
A serious adverse event is classified using physician's discretion. All adverse events resulting in death, life threatening events, significant disability, prolonged hospitalization, congenital abnormality/birth defect, or new cancer will be considered a serious adverse event. No patients were accrued in the CDK12 Mutation Abemaciclib + Atezolizumab (Non-Randomized) arm.
|
—
0/0 • From treatment initiation through 100 days after last dose for treatment-emergent adverse events, and up to 2 years after last dose. Maximum treatment duration was 18 months.
A serious adverse event is classified using physician's discretion. All adverse events resulting in death, life threatening events, significant disability, prolonged hospitalization, congenital abnormality/birth defect, or new cancer will be considered a serious adverse event. No patients were accrued in the CDK12 Mutation Abemaciclib + Atezolizumab (Non-Randomized) arm.
|
|
Metabolism and nutrition disorders
Hypocalcemia
|
0.00%
0/7 • From treatment initiation through 100 days after last dose for treatment-emergent adverse events, and up to 2 years after last dose. Maximum treatment duration was 18 months.
A serious adverse event is classified using physician's discretion. All adverse events resulting in death, life threatening events, significant disability, prolonged hospitalization, congenital abnormality/birth defect, or new cancer will be considered a serious adverse event. No patients were accrued in the CDK12 Mutation Abemaciclib + Atezolizumab (Non-Randomized) arm.
|
0.00%
0/8 • From treatment initiation through 100 days after last dose for treatment-emergent adverse events, and up to 2 years after last dose. Maximum treatment duration was 18 months.
A serious adverse event is classified using physician's discretion. All adverse events resulting in death, life threatening events, significant disability, prolonged hospitalization, congenital abnormality/birth defect, or new cancer will be considered a serious adverse event. No patients were accrued in the CDK12 Mutation Abemaciclib + Atezolizumab (Non-Randomized) arm.
|
25.0%
1/4 • From treatment initiation through 100 days after last dose for treatment-emergent adverse events, and up to 2 years after last dose. Maximum treatment duration was 18 months.
A serious adverse event is classified using physician's discretion. All adverse events resulting in death, life threatening events, significant disability, prolonged hospitalization, congenital abnormality/birth defect, or new cancer will be considered a serious adverse event. No patients were accrued in the CDK12 Mutation Abemaciclib + Atezolizumab (Non-Randomized) arm.
|
—
0/0 • From treatment initiation through 100 days after last dose for treatment-emergent adverse events, and up to 2 years after last dose. Maximum treatment duration was 18 months.
A serious adverse event is classified using physician's discretion. All adverse events resulting in death, life threatening events, significant disability, prolonged hospitalization, congenital abnormality/birth defect, or new cancer will be considered a serious adverse event. No patients were accrued in the CDK12 Mutation Abemaciclib + Atezolizumab (Non-Randomized) arm.
|
|
Metabolism and nutrition disorders
Hypokalemia
|
0.00%
0/7 • From treatment initiation through 100 days after last dose for treatment-emergent adverse events, and up to 2 years after last dose. Maximum treatment duration was 18 months.
A serious adverse event is classified using physician's discretion. All adverse events resulting in death, life threatening events, significant disability, prolonged hospitalization, congenital abnormality/birth defect, or new cancer will be considered a serious adverse event. No patients were accrued in the CDK12 Mutation Abemaciclib + Atezolizumab (Non-Randomized) arm.
|
25.0%
2/8 • From treatment initiation through 100 days after last dose for treatment-emergent adverse events, and up to 2 years after last dose. Maximum treatment duration was 18 months.
A serious adverse event is classified using physician's discretion. All adverse events resulting in death, life threatening events, significant disability, prolonged hospitalization, congenital abnormality/birth defect, or new cancer will be considered a serious adverse event. No patients were accrued in the CDK12 Mutation Abemaciclib + Atezolizumab (Non-Randomized) arm.
|
0.00%
0/4 • From treatment initiation through 100 days after last dose for treatment-emergent adverse events, and up to 2 years after last dose. Maximum treatment duration was 18 months.
A serious adverse event is classified using physician's discretion. All adverse events resulting in death, life threatening events, significant disability, prolonged hospitalization, congenital abnormality/birth defect, or new cancer will be considered a serious adverse event. No patients were accrued in the CDK12 Mutation Abemaciclib + Atezolizumab (Non-Randomized) arm.
|
—
0/0 • From treatment initiation through 100 days after last dose for treatment-emergent adverse events, and up to 2 years after last dose. Maximum treatment duration was 18 months.
A serious adverse event is classified using physician's discretion. All adverse events resulting in death, life threatening events, significant disability, prolonged hospitalization, congenital abnormality/birth defect, or new cancer will be considered a serious adverse event. No patients were accrued in the CDK12 Mutation Abemaciclib + Atezolizumab (Non-Randomized) arm.
|
|
Metabolism and nutrition disorders
Hyponatremia
|
14.3%
1/7 • From treatment initiation through 100 days after last dose for treatment-emergent adverse events, and up to 2 years after last dose. Maximum treatment duration was 18 months.
A serious adverse event is classified using physician's discretion. All adverse events resulting in death, life threatening events, significant disability, prolonged hospitalization, congenital abnormality/birth defect, or new cancer will be considered a serious adverse event. No patients were accrued in the CDK12 Mutation Abemaciclib + Atezolizumab (Non-Randomized) arm.
|
12.5%
1/8 • From treatment initiation through 100 days after last dose for treatment-emergent adverse events, and up to 2 years after last dose. Maximum treatment duration was 18 months.
A serious adverse event is classified using physician's discretion. All adverse events resulting in death, life threatening events, significant disability, prolonged hospitalization, congenital abnormality/birth defect, or new cancer will be considered a serious adverse event. No patients were accrued in the CDK12 Mutation Abemaciclib + Atezolizumab (Non-Randomized) arm.
|
0.00%
0/4 • From treatment initiation through 100 days after last dose for treatment-emergent adverse events, and up to 2 years after last dose. Maximum treatment duration was 18 months.
A serious adverse event is classified using physician's discretion. All adverse events resulting in death, life threatening events, significant disability, prolonged hospitalization, congenital abnormality/birth defect, or new cancer will be considered a serious adverse event. No patients were accrued in the CDK12 Mutation Abemaciclib + Atezolizumab (Non-Randomized) arm.
|
—
0/0 • From treatment initiation through 100 days after last dose for treatment-emergent adverse events, and up to 2 years after last dose. Maximum treatment duration was 18 months.
A serious adverse event is classified using physician's discretion. All adverse events resulting in death, life threatening events, significant disability, prolonged hospitalization, congenital abnormality/birth defect, or new cancer will be considered a serious adverse event. No patients were accrued in the CDK12 Mutation Abemaciclib + Atezolizumab (Non-Randomized) arm.
|
|
Metabolism and nutrition disorders
Obesity
|
28.6%
2/7 • From treatment initiation through 100 days after last dose for treatment-emergent adverse events, and up to 2 years after last dose. Maximum treatment duration was 18 months.
A serious adverse event is classified using physician's discretion. All adverse events resulting in death, life threatening events, significant disability, prolonged hospitalization, congenital abnormality/birth defect, or new cancer will be considered a serious adverse event. No patients were accrued in the CDK12 Mutation Abemaciclib + Atezolizumab (Non-Randomized) arm.
|
0.00%
0/8 • From treatment initiation through 100 days after last dose for treatment-emergent adverse events, and up to 2 years after last dose. Maximum treatment duration was 18 months.
A serious adverse event is classified using physician's discretion. All adverse events resulting in death, life threatening events, significant disability, prolonged hospitalization, congenital abnormality/birth defect, or new cancer will be considered a serious adverse event. No patients were accrued in the CDK12 Mutation Abemaciclib + Atezolizumab (Non-Randomized) arm.
|
0.00%
0/4 • From treatment initiation through 100 days after last dose for treatment-emergent adverse events, and up to 2 years after last dose. Maximum treatment duration was 18 months.
A serious adverse event is classified using physician's discretion. All adverse events resulting in death, life threatening events, significant disability, prolonged hospitalization, congenital abnormality/birth defect, or new cancer will be considered a serious adverse event. No patients were accrued in the CDK12 Mutation Abemaciclib + Atezolizumab (Non-Randomized) arm.
|
—
0/0 • From treatment initiation through 100 days after last dose for treatment-emergent adverse events, and up to 2 years after last dose. Maximum treatment duration was 18 months.
A serious adverse event is classified using physician's discretion. All adverse events resulting in death, life threatening events, significant disability, prolonged hospitalization, congenital abnormality/birth defect, or new cancer will be considered a serious adverse event. No patients were accrued in the CDK12 Mutation Abemaciclib + Atezolizumab (Non-Randomized) arm.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.00%
0/7 • From treatment initiation through 100 days after last dose for treatment-emergent adverse events, and up to 2 years after last dose. Maximum treatment duration was 18 months.
A serious adverse event is classified using physician's discretion. All adverse events resulting in death, life threatening events, significant disability, prolonged hospitalization, congenital abnormality/birth defect, or new cancer will be considered a serious adverse event. No patients were accrued in the CDK12 Mutation Abemaciclib + Atezolizumab (Non-Randomized) arm.
|
12.5%
1/8 • From treatment initiation through 100 days after last dose for treatment-emergent adverse events, and up to 2 years after last dose. Maximum treatment duration was 18 months.
A serious adverse event is classified using physician's discretion. All adverse events resulting in death, life threatening events, significant disability, prolonged hospitalization, congenital abnormality/birth defect, or new cancer will be considered a serious adverse event. No patients were accrued in the CDK12 Mutation Abemaciclib + Atezolizumab (Non-Randomized) arm.
|
0.00%
0/4 • From treatment initiation through 100 days after last dose for treatment-emergent adverse events, and up to 2 years after last dose. Maximum treatment duration was 18 months.
A serious adverse event is classified using physician's discretion. All adverse events resulting in death, life threatening events, significant disability, prolonged hospitalization, congenital abnormality/birth defect, or new cancer will be considered a serious adverse event. No patients were accrued in the CDK12 Mutation Abemaciclib + Atezolizumab (Non-Randomized) arm.
|
—
0/0 • From treatment initiation through 100 days after last dose for treatment-emergent adverse events, and up to 2 years after last dose. Maximum treatment duration was 18 months.
A serious adverse event is classified using physician's discretion. All adverse events resulting in death, life threatening events, significant disability, prolonged hospitalization, congenital abnormality/birth defect, or new cancer will be considered a serious adverse event. No patients were accrued in the CDK12 Mutation Abemaciclib + Atezolizumab (Non-Randomized) arm.
|
|
Musculoskeletal and connective tissue disorders
Arthritis
|
14.3%
1/7 • From treatment initiation through 100 days after last dose for treatment-emergent adverse events, and up to 2 years after last dose. Maximum treatment duration was 18 months.
A serious adverse event is classified using physician's discretion. All adverse events resulting in death, life threatening events, significant disability, prolonged hospitalization, congenital abnormality/birth defect, or new cancer will be considered a serious adverse event. No patients were accrued in the CDK12 Mutation Abemaciclib + Atezolizumab (Non-Randomized) arm.
|
0.00%
0/8 • From treatment initiation through 100 days after last dose for treatment-emergent adverse events, and up to 2 years after last dose. Maximum treatment duration was 18 months.
A serious adverse event is classified using physician's discretion. All adverse events resulting in death, life threatening events, significant disability, prolonged hospitalization, congenital abnormality/birth defect, or new cancer will be considered a serious adverse event. No patients were accrued in the CDK12 Mutation Abemaciclib + Atezolizumab (Non-Randomized) arm.
|
0.00%
0/4 • From treatment initiation through 100 days after last dose for treatment-emergent adverse events, and up to 2 years after last dose. Maximum treatment duration was 18 months.
A serious adverse event is classified using physician's discretion. All adverse events resulting in death, life threatening events, significant disability, prolonged hospitalization, congenital abnormality/birth defect, or new cancer will be considered a serious adverse event. No patients were accrued in the CDK12 Mutation Abemaciclib + Atezolizumab (Non-Randomized) arm.
|
—
0/0 • From treatment initiation through 100 days after last dose for treatment-emergent adverse events, and up to 2 years after last dose. Maximum treatment duration was 18 months.
A serious adverse event is classified using physician's discretion. All adverse events resulting in death, life threatening events, significant disability, prolonged hospitalization, congenital abnormality/birth defect, or new cancer will be considered a serious adverse event. No patients were accrued in the CDK12 Mutation Abemaciclib + Atezolizumab (Non-Randomized) arm.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
28.6%
2/7 • From treatment initiation through 100 days after last dose for treatment-emergent adverse events, and up to 2 years after last dose. Maximum treatment duration was 18 months.
A serious adverse event is classified using physician's discretion. All adverse events resulting in death, life threatening events, significant disability, prolonged hospitalization, congenital abnormality/birth defect, or new cancer will be considered a serious adverse event. No patients were accrued in the CDK12 Mutation Abemaciclib + Atezolizumab (Non-Randomized) arm.
|
0.00%
0/8 • From treatment initiation through 100 days after last dose for treatment-emergent adverse events, and up to 2 years after last dose. Maximum treatment duration was 18 months.
A serious adverse event is classified using physician's discretion. All adverse events resulting in death, life threatening events, significant disability, prolonged hospitalization, congenital abnormality/birth defect, or new cancer will be considered a serious adverse event. No patients were accrued in the CDK12 Mutation Abemaciclib + Atezolizumab (Non-Randomized) arm.
|
75.0%
3/4 • From treatment initiation through 100 days after last dose for treatment-emergent adverse events, and up to 2 years after last dose. Maximum treatment duration was 18 months.
A serious adverse event is classified using physician's discretion. All adverse events resulting in death, life threatening events, significant disability, prolonged hospitalization, congenital abnormality/birth defect, or new cancer will be considered a serious adverse event. No patients were accrued in the CDK12 Mutation Abemaciclib + Atezolizumab (Non-Randomized) arm.
|
—
0/0 • From treatment initiation through 100 days after last dose for treatment-emergent adverse events, and up to 2 years after last dose. Maximum treatment duration was 18 months.
A serious adverse event is classified using physician's discretion. All adverse events resulting in death, life threatening events, significant disability, prolonged hospitalization, congenital abnormality/birth defect, or new cancer will be considered a serious adverse event. No patients were accrued in the CDK12 Mutation Abemaciclib + Atezolizumab (Non-Randomized) arm.
|
|
Musculoskeletal and connective tissue disorders
Bone pain
|
14.3%
1/7 • From treatment initiation through 100 days after last dose for treatment-emergent adverse events, and up to 2 years after last dose. Maximum treatment duration was 18 months.
A serious adverse event is classified using physician's discretion. All adverse events resulting in death, life threatening events, significant disability, prolonged hospitalization, congenital abnormality/birth defect, or new cancer will be considered a serious adverse event. No patients were accrued in the CDK12 Mutation Abemaciclib + Atezolizumab (Non-Randomized) arm.
|
12.5%
1/8 • From treatment initiation through 100 days after last dose for treatment-emergent adverse events, and up to 2 years after last dose. Maximum treatment duration was 18 months.
A serious adverse event is classified using physician's discretion. All adverse events resulting in death, life threatening events, significant disability, prolonged hospitalization, congenital abnormality/birth defect, or new cancer will be considered a serious adverse event. No patients were accrued in the CDK12 Mutation Abemaciclib + Atezolizumab (Non-Randomized) arm.
|
0.00%
0/4 • From treatment initiation through 100 days after last dose for treatment-emergent adverse events, and up to 2 years after last dose. Maximum treatment duration was 18 months.
A serious adverse event is classified using physician's discretion. All adverse events resulting in death, life threatening events, significant disability, prolonged hospitalization, congenital abnormality/birth defect, or new cancer will be considered a serious adverse event. No patients were accrued in the CDK12 Mutation Abemaciclib + Atezolizumab (Non-Randomized) arm.
|
—
0/0 • From treatment initiation through 100 days after last dose for treatment-emergent adverse events, and up to 2 years after last dose. Maximum treatment duration was 18 months.
A serious adverse event is classified using physician's discretion. All adverse events resulting in death, life threatening events, significant disability, prolonged hospitalization, congenital abnormality/birth defect, or new cancer will be considered a serious adverse event. No patients were accrued in the CDK12 Mutation Abemaciclib + Atezolizumab (Non-Randomized) arm.
|
|
Musculoskeletal and connective tissue disorders
Flank pain
|
14.3%
1/7 • From treatment initiation through 100 days after last dose for treatment-emergent adverse events, and up to 2 years after last dose. Maximum treatment duration was 18 months.
A serious adverse event is classified using physician's discretion. All adverse events resulting in death, life threatening events, significant disability, prolonged hospitalization, congenital abnormality/birth defect, or new cancer will be considered a serious adverse event. No patients were accrued in the CDK12 Mutation Abemaciclib + Atezolizumab (Non-Randomized) arm.
|
0.00%
0/8 • From treatment initiation through 100 days after last dose for treatment-emergent adverse events, and up to 2 years after last dose. Maximum treatment duration was 18 months.
A serious adverse event is classified using physician's discretion. All adverse events resulting in death, life threatening events, significant disability, prolonged hospitalization, congenital abnormality/birth defect, or new cancer will be considered a serious adverse event. No patients were accrued in the CDK12 Mutation Abemaciclib + Atezolizumab (Non-Randomized) arm.
|
0.00%
0/4 • From treatment initiation through 100 days after last dose for treatment-emergent adverse events, and up to 2 years after last dose. Maximum treatment duration was 18 months.
A serious adverse event is classified using physician's discretion. All adverse events resulting in death, life threatening events, significant disability, prolonged hospitalization, congenital abnormality/birth defect, or new cancer will be considered a serious adverse event. No patients were accrued in the CDK12 Mutation Abemaciclib + Atezolizumab (Non-Randomized) arm.
|
—
0/0 • From treatment initiation through 100 days after last dose for treatment-emergent adverse events, and up to 2 years after last dose. Maximum treatment duration was 18 months.
A serious adverse event is classified using physician's discretion. All adverse events resulting in death, life threatening events, significant disability, prolonged hospitalization, congenital abnormality/birth defect, or new cancer will be considered a serious adverse event. No patients were accrued in the CDK12 Mutation Abemaciclib + Atezolizumab (Non-Randomized) arm.
|
|
Musculoskeletal and connective tissue disorders
Generalized muscle weakness
|
14.3%
1/7 • From treatment initiation through 100 days after last dose for treatment-emergent adverse events, and up to 2 years after last dose. Maximum treatment duration was 18 months.
A serious adverse event is classified using physician's discretion. All adverse events resulting in death, life threatening events, significant disability, prolonged hospitalization, congenital abnormality/birth defect, or new cancer will be considered a serious adverse event. No patients were accrued in the CDK12 Mutation Abemaciclib + Atezolizumab (Non-Randomized) arm.
|
12.5%
1/8 • From treatment initiation through 100 days after last dose for treatment-emergent adverse events, and up to 2 years after last dose. Maximum treatment duration was 18 months.
A serious adverse event is classified using physician's discretion. All adverse events resulting in death, life threatening events, significant disability, prolonged hospitalization, congenital abnormality/birth defect, or new cancer will be considered a serious adverse event. No patients were accrued in the CDK12 Mutation Abemaciclib + Atezolizumab (Non-Randomized) arm.
|
0.00%
0/4 • From treatment initiation through 100 days after last dose for treatment-emergent adverse events, and up to 2 years after last dose. Maximum treatment duration was 18 months.
A serious adverse event is classified using physician's discretion. All adverse events resulting in death, life threatening events, significant disability, prolonged hospitalization, congenital abnormality/birth defect, or new cancer will be considered a serious adverse event. No patients were accrued in the CDK12 Mutation Abemaciclib + Atezolizumab (Non-Randomized) arm.
|
—
0/0 • From treatment initiation through 100 days after last dose for treatment-emergent adverse events, and up to 2 years after last dose. Maximum treatment duration was 18 months.
A serious adverse event is classified using physician's discretion. All adverse events resulting in death, life threatening events, significant disability, prolonged hospitalization, congenital abnormality/birth defect, or new cancer will be considered a serious adverse event. No patients were accrued in the CDK12 Mutation Abemaciclib + Atezolizumab (Non-Randomized) arm.
|
|
Musculoskeletal and connective tissue disorders
Joint range of motion decreased
|
0.00%
0/7 • From treatment initiation through 100 days after last dose for treatment-emergent adverse events, and up to 2 years after last dose. Maximum treatment duration was 18 months.
A serious adverse event is classified using physician's discretion. All adverse events resulting in death, life threatening events, significant disability, prolonged hospitalization, congenital abnormality/birth defect, or new cancer will be considered a serious adverse event. No patients were accrued in the CDK12 Mutation Abemaciclib + Atezolizumab (Non-Randomized) arm.
|
12.5%
1/8 • From treatment initiation through 100 days after last dose for treatment-emergent adverse events, and up to 2 years after last dose. Maximum treatment duration was 18 months.
A serious adverse event is classified using physician's discretion. All adverse events resulting in death, life threatening events, significant disability, prolonged hospitalization, congenital abnormality/birth defect, or new cancer will be considered a serious adverse event. No patients were accrued in the CDK12 Mutation Abemaciclib + Atezolizumab (Non-Randomized) arm.
|
0.00%
0/4 • From treatment initiation through 100 days after last dose for treatment-emergent adverse events, and up to 2 years after last dose. Maximum treatment duration was 18 months.
A serious adverse event is classified using physician's discretion. All adverse events resulting in death, life threatening events, significant disability, prolonged hospitalization, congenital abnormality/birth defect, or new cancer will be considered a serious adverse event. No patients were accrued in the CDK12 Mutation Abemaciclib + Atezolizumab (Non-Randomized) arm.
|
—
0/0 • From treatment initiation through 100 days after last dose for treatment-emergent adverse events, and up to 2 years after last dose. Maximum treatment duration was 18 months.
A serious adverse event is classified using physician's discretion. All adverse events resulting in death, life threatening events, significant disability, prolonged hospitalization, congenital abnormality/birth defect, or new cancer will be considered a serious adverse event. No patients were accrued in the CDK12 Mutation Abemaciclib + Atezolizumab (Non-Randomized) arm.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal and connective tissue disorder - Other, specify
|
0.00%
0/7 • From treatment initiation through 100 days after last dose for treatment-emergent adverse events, and up to 2 years after last dose. Maximum treatment duration was 18 months.
A serious adverse event is classified using physician's discretion. All adverse events resulting in death, life threatening events, significant disability, prolonged hospitalization, congenital abnormality/birth defect, or new cancer will be considered a serious adverse event. No patients were accrued in the CDK12 Mutation Abemaciclib + Atezolizumab (Non-Randomized) arm.
|
12.5%
1/8 • From treatment initiation through 100 days after last dose for treatment-emergent adverse events, and up to 2 years after last dose. Maximum treatment duration was 18 months.
A serious adverse event is classified using physician's discretion. All adverse events resulting in death, life threatening events, significant disability, prolonged hospitalization, congenital abnormality/birth defect, or new cancer will be considered a serious adverse event. No patients were accrued in the CDK12 Mutation Abemaciclib + Atezolizumab (Non-Randomized) arm.
|
0.00%
0/4 • From treatment initiation through 100 days after last dose for treatment-emergent adverse events, and up to 2 years after last dose. Maximum treatment duration was 18 months.
A serious adverse event is classified using physician's discretion. All adverse events resulting in death, life threatening events, significant disability, prolonged hospitalization, congenital abnormality/birth defect, or new cancer will be considered a serious adverse event. No patients were accrued in the CDK12 Mutation Abemaciclib + Atezolizumab (Non-Randomized) arm.
|
—
0/0 • From treatment initiation through 100 days after last dose for treatment-emergent adverse events, and up to 2 years after last dose. Maximum treatment duration was 18 months.
A serious adverse event is classified using physician's discretion. All adverse events resulting in death, life threatening events, significant disability, prolonged hospitalization, congenital abnormality/birth defect, or new cancer will be considered a serious adverse event. No patients were accrued in the CDK12 Mutation Abemaciclib + Atezolizumab (Non-Randomized) arm.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
0.00%
0/7 • From treatment initiation through 100 days after last dose for treatment-emergent adverse events, and up to 2 years after last dose. Maximum treatment duration was 18 months.
A serious adverse event is classified using physician's discretion. All adverse events resulting in death, life threatening events, significant disability, prolonged hospitalization, congenital abnormality/birth defect, or new cancer will be considered a serious adverse event. No patients were accrued in the CDK12 Mutation Abemaciclib + Atezolizumab (Non-Randomized) arm.
|
0.00%
0/8 • From treatment initiation through 100 days after last dose for treatment-emergent adverse events, and up to 2 years after last dose. Maximum treatment duration was 18 months.
A serious adverse event is classified using physician's discretion. All adverse events resulting in death, life threatening events, significant disability, prolonged hospitalization, congenital abnormality/birth defect, or new cancer will be considered a serious adverse event. No patients were accrued in the CDK12 Mutation Abemaciclib + Atezolizumab (Non-Randomized) arm.
|
25.0%
1/4 • From treatment initiation through 100 days after last dose for treatment-emergent adverse events, and up to 2 years after last dose. Maximum treatment duration was 18 months.
A serious adverse event is classified using physician's discretion. All adverse events resulting in death, life threatening events, significant disability, prolonged hospitalization, congenital abnormality/birth defect, or new cancer will be considered a serious adverse event. No patients were accrued in the CDK12 Mutation Abemaciclib + Atezolizumab (Non-Randomized) arm.
|
—
0/0 • From treatment initiation through 100 days after last dose for treatment-emergent adverse events, and up to 2 years after last dose. Maximum treatment duration was 18 months.
A serious adverse event is classified using physician's discretion. All adverse events resulting in death, life threatening events, significant disability, prolonged hospitalization, congenital abnormality/birth defect, or new cancer will be considered a serious adverse event. No patients were accrued in the CDK12 Mutation Abemaciclib + Atezolizumab (Non-Randomized) arm.
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
0.00%
0/7 • From treatment initiation through 100 days after last dose for treatment-emergent adverse events, and up to 2 years after last dose. Maximum treatment duration was 18 months.
A serious adverse event is classified using physician's discretion. All adverse events resulting in death, life threatening events, significant disability, prolonged hospitalization, congenital abnormality/birth defect, or new cancer will be considered a serious adverse event. No patients were accrued in the CDK12 Mutation Abemaciclib + Atezolizumab (Non-Randomized) arm.
|
0.00%
0/8 • From treatment initiation through 100 days after last dose for treatment-emergent adverse events, and up to 2 years after last dose. Maximum treatment duration was 18 months.
A serious adverse event is classified using physician's discretion. All adverse events resulting in death, life threatening events, significant disability, prolonged hospitalization, congenital abnormality/birth defect, or new cancer will be considered a serious adverse event. No patients were accrued in the CDK12 Mutation Abemaciclib + Atezolizumab (Non-Randomized) arm.
|
25.0%
1/4 • From treatment initiation through 100 days after last dose for treatment-emergent adverse events, and up to 2 years after last dose. Maximum treatment duration was 18 months.
A serious adverse event is classified using physician's discretion. All adverse events resulting in death, life threatening events, significant disability, prolonged hospitalization, congenital abnormality/birth defect, or new cancer will be considered a serious adverse event. No patients were accrued in the CDK12 Mutation Abemaciclib + Atezolizumab (Non-Randomized) arm.
|
—
0/0 • From treatment initiation through 100 days after last dose for treatment-emergent adverse events, and up to 2 years after last dose. Maximum treatment duration was 18 months.
A serious adverse event is classified using physician's discretion. All adverse events resulting in death, life threatening events, significant disability, prolonged hospitalization, congenital abnormality/birth defect, or new cancer will be considered a serious adverse event. No patients were accrued in the CDK12 Mutation Abemaciclib + Atezolizumab (Non-Randomized) arm.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
14.3%
1/7 • From treatment initiation through 100 days after last dose for treatment-emergent adverse events, and up to 2 years after last dose. Maximum treatment duration was 18 months.
A serious adverse event is classified using physician's discretion. All adverse events resulting in death, life threatening events, significant disability, prolonged hospitalization, congenital abnormality/birth defect, or new cancer will be considered a serious adverse event. No patients were accrued in the CDK12 Mutation Abemaciclib + Atezolizumab (Non-Randomized) arm.
|
12.5%
1/8 • From treatment initiation through 100 days after last dose for treatment-emergent adverse events, and up to 2 years after last dose. Maximum treatment duration was 18 months.
A serious adverse event is classified using physician's discretion. All adverse events resulting in death, life threatening events, significant disability, prolonged hospitalization, congenital abnormality/birth defect, or new cancer will be considered a serious adverse event. No patients were accrued in the CDK12 Mutation Abemaciclib + Atezolizumab (Non-Randomized) arm.
|
25.0%
1/4 • From treatment initiation through 100 days after last dose for treatment-emergent adverse events, and up to 2 years after last dose. Maximum treatment duration was 18 months.
A serious adverse event is classified using physician's discretion. All adverse events resulting in death, life threatening events, significant disability, prolonged hospitalization, congenital abnormality/birth defect, or new cancer will be considered a serious adverse event. No patients were accrued in the CDK12 Mutation Abemaciclib + Atezolizumab (Non-Randomized) arm.
|
—
0/0 • From treatment initiation through 100 days after last dose for treatment-emergent adverse events, and up to 2 years after last dose. Maximum treatment duration was 18 months.
A serious adverse event is classified using physician's discretion. All adverse events resulting in death, life threatening events, significant disability, prolonged hospitalization, congenital abnormality/birth defect, or new cancer will be considered a serious adverse event. No patients were accrued in the CDK12 Mutation Abemaciclib + Atezolizumab (Non-Randomized) arm.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Tumor pain
|
14.3%
1/7 • From treatment initiation through 100 days after last dose for treatment-emergent adverse events, and up to 2 years after last dose. Maximum treatment duration was 18 months.
A serious adverse event is classified using physician's discretion. All adverse events resulting in death, life threatening events, significant disability, prolonged hospitalization, congenital abnormality/birth defect, or new cancer will be considered a serious adverse event. No patients were accrued in the CDK12 Mutation Abemaciclib + Atezolizumab (Non-Randomized) arm.
|
0.00%
0/8 • From treatment initiation through 100 days after last dose for treatment-emergent adverse events, and up to 2 years after last dose. Maximum treatment duration was 18 months.
A serious adverse event is classified using physician's discretion. All adverse events resulting in death, life threatening events, significant disability, prolonged hospitalization, congenital abnormality/birth defect, or new cancer will be considered a serious adverse event. No patients were accrued in the CDK12 Mutation Abemaciclib + Atezolizumab (Non-Randomized) arm.
|
0.00%
0/4 • From treatment initiation through 100 days after last dose for treatment-emergent adverse events, and up to 2 years after last dose. Maximum treatment duration was 18 months.
A serious adverse event is classified using physician's discretion. All adverse events resulting in death, life threatening events, significant disability, prolonged hospitalization, congenital abnormality/birth defect, or new cancer will be considered a serious adverse event. No patients were accrued in the CDK12 Mutation Abemaciclib + Atezolizumab (Non-Randomized) arm.
|
—
0/0 • From treatment initiation through 100 days after last dose for treatment-emergent adverse events, and up to 2 years after last dose. Maximum treatment duration was 18 months.
A serious adverse event is classified using physician's discretion. All adverse events resulting in death, life threatening events, significant disability, prolonged hospitalization, congenital abnormality/birth defect, or new cancer will be considered a serious adverse event. No patients were accrued in the CDK12 Mutation Abemaciclib + Atezolizumab (Non-Randomized) arm.
|
|
Nervous system disorders
Dizziness
|
28.6%
2/7 • From treatment initiation through 100 days after last dose for treatment-emergent adverse events, and up to 2 years after last dose. Maximum treatment duration was 18 months.
A serious adverse event is classified using physician's discretion. All adverse events resulting in death, life threatening events, significant disability, prolonged hospitalization, congenital abnormality/birth defect, or new cancer will be considered a serious adverse event. No patients were accrued in the CDK12 Mutation Abemaciclib + Atezolizumab (Non-Randomized) arm.
|
0.00%
0/8 • From treatment initiation through 100 days after last dose for treatment-emergent adverse events, and up to 2 years after last dose. Maximum treatment duration was 18 months.
A serious adverse event is classified using physician's discretion. All adverse events resulting in death, life threatening events, significant disability, prolonged hospitalization, congenital abnormality/birth defect, or new cancer will be considered a serious adverse event. No patients were accrued in the CDK12 Mutation Abemaciclib + Atezolizumab (Non-Randomized) arm.
|
0.00%
0/4 • From treatment initiation through 100 days after last dose for treatment-emergent adverse events, and up to 2 years after last dose. Maximum treatment duration was 18 months.
A serious adverse event is classified using physician's discretion. All adverse events resulting in death, life threatening events, significant disability, prolonged hospitalization, congenital abnormality/birth defect, or new cancer will be considered a serious adverse event. No patients were accrued in the CDK12 Mutation Abemaciclib + Atezolizumab (Non-Randomized) arm.
|
—
0/0 • From treatment initiation through 100 days after last dose for treatment-emergent adverse events, and up to 2 years after last dose. Maximum treatment duration was 18 months.
A serious adverse event is classified using physician's discretion. All adverse events resulting in death, life threatening events, significant disability, prolonged hospitalization, congenital abnormality/birth defect, or new cancer will be considered a serious adverse event. No patients were accrued in the CDK12 Mutation Abemaciclib + Atezolizumab (Non-Randomized) arm.
|
|
Nervous system disorders
Dysgeusia
|
0.00%
0/7 • From treatment initiation through 100 days after last dose for treatment-emergent adverse events, and up to 2 years after last dose. Maximum treatment duration was 18 months.
A serious adverse event is classified using physician's discretion. All adverse events resulting in death, life threatening events, significant disability, prolonged hospitalization, congenital abnormality/birth defect, or new cancer will be considered a serious adverse event. No patients were accrued in the CDK12 Mutation Abemaciclib + Atezolizumab (Non-Randomized) arm.
|
12.5%
1/8 • From treatment initiation through 100 days after last dose for treatment-emergent adverse events, and up to 2 years after last dose. Maximum treatment duration was 18 months.
A serious adverse event is classified using physician's discretion. All adverse events resulting in death, life threatening events, significant disability, prolonged hospitalization, congenital abnormality/birth defect, or new cancer will be considered a serious adverse event. No patients were accrued in the CDK12 Mutation Abemaciclib + Atezolizumab (Non-Randomized) arm.
|
0.00%
0/4 • From treatment initiation through 100 days after last dose for treatment-emergent adverse events, and up to 2 years after last dose. Maximum treatment duration was 18 months.
A serious adverse event is classified using physician's discretion. All adverse events resulting in death, life threatening events, significant disability, prolonged hospitalization, congenital abnormality/birth defect, or new cancer will be considered a serious adverse event. No patients were accrued in the CDK12 Mutation Abemaciclib + Atezolizumab (Non-Randomized) arm.
|
—
0/0 • From treatment initiation through 100 days after last dose for treatment-emergent adverse events, and up to 2 years after last dose. Maximum treatment duration was 18 months.
A serious adverse event is classified using physician's discretion. All adverse events resulting in death, life threatening events, significant disability, prolonged hospitalization, congenital abnormality/birth defect, or new cancer will be considered a serious adverse event. No patients were accrued in the CDK12 Mutation Abemaciclib + Atezolizumab (Non-Randomized) arm.
|
|
Nervous system disorders
Headache
|
14.3%
1/7 • From treatment initiation through 100 days after last dose for treatment-emergent adverse events, and up to 2 years after last dose. Maximum treatment duration was 18 months.
A serious adverse event is classified using physician's discretion. All adverse events resulting in death, life threatening events, significant disability, prolonged hospitalization, congenital abnormality/birth defect, or new cancer will be considered a serious adverse event. No patients were accrued in the CDK12 Mutation Abemaciclib + Atezolizumab (Non-Randomized) arm.
|
0.00%
0/8 • From treatment initiation through 100 days after last dose for treatment-emergent adverse events, and up to 2 years after last dose. Maximum treatment duration was 18 months.
A serious adverse event is classified using physician's discretion. All adverse events resulting in death, life threatening events, significant disability, prolonged hospitalization, congenital abnormality/birth defect, or new cancer will be considered a serious adverse event. No patients were accrued in the CDK12 Mutation Abemaciclib + Atezolizumab (Non-Randomized) arm.
|
0.00%
0/4 • From treatment initiation through 100 days after last dose for treatment-emergent adverse events, and up to 2 years after last dose. Maximum treatment duration was 18 months.
A serious adverse event is classified using physician's discretion. All adverse events resulting in death, life threatening events, significant disability, prolonged hospitalization, congenital abnormality/birth defect, or new cancer will be considered a serious adverse event. No patients were accrued in the CDK12 Mutation Abemaciclib + Atezolizumab (Non-Randomized) arm.
|
—
0/0 • From treatment initiation through 100 days after last dose for treatment-emergent adverse events, and up to 2 years after last dose. Maximum treatment duration was 18 months.
A serious adverse event is classified using physician's discretion. All adverse events resulting in death, life threatening events, significant disability, prolonged hospitalization, congenital abnormality/birth defect, or new cancer will be considered a serious adverse event. No patients were accrued in the CDK12 Mutation Abemaciclib + Atezolizumab (Non-Randomized) arm.
|
|
Nervous system disorders
Nervous system disorders - Other, specify
|
0.00%
0/7 • From treatment initiation through 100 days after last dose for treatment-emergent adverse events, and up to 2 years after last dose. Maximum treatment duration was 18 months.
A serious adverse event is classified using physician's discretion. All adverse events resulting in death, life threatening events, significant disability, prolonged hospitalization, congenital abnormality/birth defect, or new cancer will be considered a serious adverse event. No patients were accrued in the CDK12 Mutation Abemaciclib + Atezolizumab (Non-Randomized) arm.
|
0.00%
0/8 • From treatment initiation through 100 days after last dose for treatment-emergent adverse events, and up to 2 years after last dose. Maximum treatment duration was 18 months.
A serious adverse event is classified using physician's discretion. All adverse events resulting in death, life threatening events, significant disability, prolonged hospitalization, congenital abnormality/birth defect, or new cancer will be considered a serious adverse event. No patients were accrued in the CDK12 Mutation Abemaciclib + Atezolizumab (Non-Randomized) arm.
|
25.0%
1/4 • From treatment initiation through 100 days after last dose for treatment-emergent adverse events, and up to 2 years after last dose. Maximum treatment duration was 18 months.
A serious adverse event is classified using physician's discretion. All adverse events resulting in death, life threatening events, significant disability, prolonged hospitalization, congenital abnormality/birth defect, or new cancer will be considered a serious adverse event. No patients were accrued in the CDK12 Mutation Abemaciclib + Atezolizumab (Non-Randomized) arm.
|
—
0/0 • From treatment initiation through 100 days after last dose for treatment-emergent adverse events, and up to 2 years after last dose. Maximum treatment duration was 18 months.
A serious adverse event is classified using physician's discretion. All adverse events resulting in death, life threatening events, significant disability, prolonged hospitalization, congenital abnormality/birth defect, or new cancer will be considered a serious adverse event. No patients were accrued in the CDK12 Mutation Abemaciclib + Atezolizumab (Non-Randomized) arm.
|
|
Nervous system disorders
Peripheral sensory neuropathy
|
14.3%
1/7 • From treatment initiation through 100 days after last dose for treatment-emergent adverse events, and up to 2 years after last dose. Maximum treatment duration was 18 months.
A serious adverse event is classified using physician's discretion. All adverse events resulting in death, life threatening events, significant disability, prolonged hospitalization, congenital abnormality/birth defect, or new cancer will be considered a serious adverse event. No patients were accrued in the CDK12 Mutation Abemaciclib + Atezolizumab (Non-Randomized) arm.
|
12.5%
1/8 • From treatment initiation through 100 days after last dose for treatment-emergent adverse events, and up to 2 years after last dose. Maximum treatment duration was 18 months.
A serious adverse event is classified using physician's discretion. All adverse events resulting in death, life threatening events, significant disability, prolonged hospitalization, congenital abnormality/birth defect, or new cancer will be considered a serious adverse event. No patients were accrued in the CDK12 Mutation Abemaciclib + Atezolizumab (Non-Randomized) arm.
|
0.00%
0/4 • From treatment initiation through 100 days after last dose for treatment-emergent adverse events, and up to 2 years after last dose. Maximum treatment duration was 18 months.
A serious adverse event is classified using physician's discretion. All adverse events resulting in death, life threatening events, significant disability, prolonged hospitalization, congenital abnormality/birth defect, or new cancer will be considered a serious adverse event. No patients were accrued in the CDK12 Mutation Abemaciclib + Atezolizumab (Non-Randomized) arm.
|
—
0/0 • From treatment initiation through 100 days after last dose for treatment-emergent adverse events, and up to 2 years after last dose. Maximum treatment duration was 18 months.
A serious adverse event is classified using physician's discretion. All adverse events resulting in death, life threatening events, significant disability, prolonged hospitalization, congenital abnormality/birth defect, or new cancer will be considered a serious adverse event. No patients were accrued in the CDK12 Mutation Abemaciclib + Atezolizumab (Non-Randomized) arm.
|
|
Nervous system disorders
Presyncope
|
0.00%
0/7 • From treatment initiation through 100 days after last dose for treatment-emergent adverse events, and up to 2 years after last dose. Maximum treatment duration was 18 months.
A serious adverse event is classified using physician's discretion. All adverse events resulting in death, life threatening events, significant disability, prolonged hospitalization, congenital abnormality/birth defect, or new cancer will be considered a serious adverse event. No patients were accrued in the CDK12 Mutation Abemaciclib + Atezolizumab (Non-Randomized) arm.
|
12.5%
1/8 • From treatment initiation through 100 days after last dose for treatment-emergent adverse events, and up to 2 years after last dose. Maximum treatment duration was 18 months.
A serious adverse event is classified using physician's discretion. All adverse events resulting in death, life threatening events, significant disability, prolonged hospitalization, congenital abnormality/birth defect, or new cancer will be considered a serious adverse event. No patients were accrued in the CDK12 Mutation Abemaciclib + Atezolizumab (Non-Randomized) arm.
|
0.00%
0/4 • From treatment initiation through 100 days after last dose for treatment-emergent adverse events, and up to 2 years after last dose. Maximum treatment duration was 18 months.
A serious adverse event is classified using physician's discretion. All adverse events resulting in death, life threatening events, significant disability, prolonged hospitalization, congenital abnormality/birth defect, or new cancer will be considered a serious adverse event. No patients were accrued in the CDK12 Mutation Abemaciclib + Atezolizumab (Non-Randomized) arm.
|
—
0/0 • From treatment initiation through 100 days after last dose for treatment-emergent adverse events, and up to 2 years after last dose. Maximum treatment duration was 18 months.
A serious adverse event is classified using physician's discretion. All adverse events resulting in death, life threatening events, significant disability, prolonged hospitalization, congenital abnormality/birth defect, or new cancer will be considered a serious adverse event. No patients were accrued in the CDK12 Mutation Abemaciclib + Atezolizumab (Non-Randomized) arm.
|
|
Nervous system disorders
Syncope
|
0.00%
0/7 • From treatment initiation through 100 days after last dose for treatment-emergent adverse events, and up to 2 years after last dose. Maximum treatment duration was 18 months.
A serious adverse event is classified using physician's discretion. All adverse events resulting in death, life threatening events, significant disability, prolonged hospitalization, congenital abnormality/birth defect, or new cancer will be considered a serious adverse event. No patients were accrued in the CDK12 Mutation Abemaciclib + Atezolizumab (Non-Randomized) arm.
|
12.5%
1/8 • From treatment initiation through 100 days after last dose for treatment-emergent adverse events, and up to 2 years after last dose. Maximum treatment duration was 18 months.
A serious adverse event is classified using physician's discretion. All adverse events resulting in death, life threatening events, significant disability, prolonged hospitalization, congenital abnormality/birth defect, or new cancer will be considered a serious adverse event. No patients were accrued in the CDK12 Mutation Abemaciclib + Atezolizumab (Non-Randomized) arm.
|
0.00%
0/4 • From treatment initiation through 100 days after last dose for treatment-emergent adverse events, and up to 2 years after last dose. Maximum treatment duration was 18 months.
A serious adverse event is classified using physician's discretion. All adverse events resulting in death, life threatening events, significant disability, prolonged hospitalization, congenital abnormality/birth defect, or new cancer will be considered a serious adverse event. No patients were accrued in the CDK12 Mutation Abemaciclib + Atezolizumab (Non-Randomized) arm.
|
—
0/0 • From treatment initiation through 100 days after last dose for treatment-emergent adverse events, and up to 2 years after last dose. Maximum treatment duration was 18 months.
A serious adverse event is classified using physician's discretion. All adverse events resulting in death, life threatening events, significant disability, prolonged hospitalization, congenital abnormality/birth defect, or new cancer will be considered a serious adverse event. No patients were accrued in the CDK12 Mutation Abemaciclib + Atezolizumab (Non-Randomized) arm.
|
|
Psychiatric disorders
Anxiety
|
0.00%
0/7 • From treatment initiation through 100 days after last dose for treatment-emergent adverse events, and up to 2 years after last dose. Maximum treatment duration was 18 months.
A serious adverse event is classified using physician's discretion. All adverse events resulting in death, life threatening events, significant disability, prolonged hospitalization, congenital abnormality/birth defect, or new cancer will be considered a serious adverse event. No patients were accrued in the CDK12 Mutation Abemaciclib + Atezolizumab (Non-Randomized) arm.
|
12.5%
1/8 • From treatment initiation through 100 days after last dose for treatment-emergent adverse events, and up to 2 years after last dose. Maximum treatment duration was 18 months.
A serious adverse event is classified using physician's discretion. All adverse events resulting in death, life threatening events, significant disability, prolonged hospitalization, congenital abnormality/birth defect, or new cancer will be considered a serious adverse event. No patients were accrued in the CDK12 Mutation Abemaciclib + Atezolizumab (Non-Randomized) arm.
|
0.00%
0/4 • From treatment initiation through 100 days after last dose for treatment-emergent adverse events, and up to 2 years after last dose. Maximum treatment duration was 18 months.
A serious adverse event is classified using physician's discretion. All adverse events resulting in death, life threatening events, significant disability, prolonged hospitalization, congenital abnormality/birth defect, or new cancer will be considered a serious adverse event. No patients were accrued in the CDK12 Mutation Abemaciclib + Atezolizumab (Non-Randomized) arm.
|
—
0/0 • From treatment initiation through 100 days after last dose for treatment-emergent adverse events, and up to 2 years after last dose. Maximum treatment duration was 18 months.
A serious adverse event is classified using physician's discretion. All adverse events resulting in death, life threatening events, significant disability, prolonged hospitalization, congenital abnormality/birth defect, or new cancer will be considered a serious adverse event. No patients were accrued in the CDK12 Mutation Abemaciclib + Atezolizumab (Non-Randomized) arm.
|
|
Psychiatric disorders
Depression
|
28.6%
2/7 • From treatment initiation through 100 days after last dose for treatment-emergent adverse events, and up to 2 years after last dose. Maximum treatment duration was 18 months.
A serious adverse event is classified using physician's discretion. All adverse events resulting in death, life threatening events, significant disability, prolonged hospitalization, congenital abnormality/birth defect, or new cancer will be considered a serious adverse event. No patients were accrued in the CDK12 Mutation Abemaciclib + Atezolizumab (Non-Randomized) arm.
|
25.0%
2/8 • From treatment initiation through 100 days after last dose for treatment-emergent adverse events, and up to 2 years after last dose. Maximum treatment duration was 18 months.
A serious adverse event is classified using physician's discretion. All adverse events resulting in death, life threatening events, significant disability, prolonged hospitalization, congenital abnormality/birth defect, or new cancer will be considered a serious adverse event. No patients were accrued in the CDK12 Mutation Abemaciclib + Atezolizumab (Non-Randomized) arm.
|
0.00%
0/4 • From treatment initiation through 100 days after last dose for treatment-emergent adverse events, and up to 2 years after last dose. Maximum treatment duration was 18 months.
A serious adverse event is classified using physician's discretion. All adverse events resulting in death, life threatening events, significant disability, prolonged hospitalization, congenital abnormality/birth defect, or new cancer will be considered a serious adverse event. No patients were accrued in the CDK12 Mutation Abemaciclib + Atezolizumab (Non-Randomized) arm.
|
—
0/0 • From treatment initiation through 100 days after last dose for treatment-emergent adverse events, and up to 2 years after last dose. Maximum treatment duration was 18 months.
A serious adverse event is classified using physician's discretion. All adverse events resulting in death, life threatening events, significant disability, prolonged hospitalization, congenital abnormality/birth defect, or new cancer will be considered a serious adverse event. No patients were accrued in the CDK12 Mutation Abemaciclib + Atezolizumab (Non-Randomized) arm.
|
|
Psychiatric disorders
Insomnia
|
0.00%
0/7 • From treatment initiation through 100 days after last dose for treatment-emergent adverse events, and up to 2 years after last dose. Maximum treatment duration was 18 months.
A serious adverse event is classified using physician's discretion. All adverse events resulting in death, life threatening events, significant disability, prolonged hospitalization, congenital abnormality/birth defect, or new cancer will be considered a serious adverse event. No patients were accrued in the CDK12 Mutation Abemaciclib + Atezolizumab (Non-Randomized) arm.
|
25.0%
2/8 • From treatment initiation through 100 days after last dose for treatment-emergent adverse events, and up to 2 years after last dose. Maximum treatment duration was 18 months.
A serious adverse event is classified using physician's discretion. All adverse events resulting in death, life threatening events, significant disability, prolonged hospitalization, congenital abnormality/birth defect, or new cancer will be considered a serious adverse event. No patients were accrued in the CDK12 Mutation Abemaciclib + Atezolizumab (Non-Randomized) arm.
|
0.00%
0/4 • From treatment initiation through 100 days after last dose for treatment-emergent adverse events, and up to 2 years after last dose. Maximum treatment duration was 18 months.
A serious adverse event is classified using physician's discretion. All adverse events resulting in death, life threatening events, significant disability, prolonged hospitalization, congenital abnormality/birth defect, or new cancer will be considered a serious adverse event. No patients were accrued in the CDK12 Mutation Abemaciclib + Atezolizumab (Non-Randomized) arm.
|
—
0/0 • From treatment initiation through 100 days after last dose for treatment-emergent adverse events, and up to 2 years after last dose. Maximum treatment duration was 18 months.
A serious adverse event is classified using physician's discretion. All adverse events resulting in death, life threatening events, significant disability, prolonged hospitalization, congenital abnormality/birth defect, or new cancer will be considered a serious adverse event. No patients were accrued in the CDK12 Mutation Abemaciclib + Atezolizumab (Non-Randomized) arm.
|
|
Renal and urinary disorders
Acute kidney injury
|
14.3%
1/7 • From treatment initiation through 100 days after last dose for treatment-emergent adverse events, and up to 2 years after last dose. Maximum treatment duration was 18 months.
A serious adverse event is classified using physician's discretion. All adverse events resulting in death, life threatening events, significant disability, prolonged hospitalization, congenital abnormality/birth defect, or new cancer will be considered a serious adverse event. No patients were accrued in the CDK12 Mutation Abemaciclib + Atezolizumab (Non-Randomized) arm.
|
0.00%
0/8 • From treatment initiation through 100 days after last dose for treatment-emergent adverse events, and up to 2 years after last dose. Maximum treatment duration was 18 months.
A serious adverse event is classified using physician's discretion. All adverse events resulting in death, life threatening events, significant disability, prolonged hospitalization, congenital abnormality/birth defect, or new cancer will be considered a serious adverse event. No patients were accrued in the CDK12 Mutation Abemaciclib + Atezolizumab (Non-Randomized) arm.
|
0.00%
0/4 • From treatment initiation through 100 days after last dose for treatment-emergent adverse events, and up to 2 years after last dose. Maximum treatment duration was 18 months.
A serious adverse event is classified using physician's discretion. All adverse events resulting in death, life threatening events, significant disability, prolonged hospitalization, congenital abnormality/birth defect, or new cancer will be considered a serious adverse event. No patients were accrued in the CDK12 Mutation Abemaciclib + Atezolizumab (Non-Randomized) arm.
|
—
0/0 • From treatment initiation through 100 days after last dose for treatment-emergent adverse events, and up to 2 years after last dose. Maximum treatment duration was 18 months.
A serious adverse event is classified using physician's discretion. All adverse events resulting in death, life threatening events, significant disability, prolonged hospitalization, congenital abnormality/birth defect, or new cancer will be considered a serious adverse event. No patients were accrued in the CDK12 Mutation Abemaciclib + Atezolizumab (Non-Randomized) arm.
|
|
Renal and urinary disorders
Dysuria
|
0.00%
0/7 • From treatment initiation through 100 days after last dose for treatment-emergent adverse events, and up to 2 years after last dose. Maximum treatment duration was 18 months.
A serious adverse event is classified using physician's discretion. All adverse events resulting in death, life threatening events, significant disability, prolonged hospitalization, congenital abnormality/birth defect, or new cancer will be considered a serious adverse event. No patients were accrued in the CDK12 Mutation Abemaciclib + Atezolizumab (Non-Randomized) arm.
|
12.5%
1/8 • From treatment initiation through 100 days after last dose for treatment-emergent adverse events, and up to 2 years after last dose. Maximum treatment duration was 18 months.
A serious adverse event is classified using physician's discretion. All adverse events resulting in death, life threatening events, significant disability, prolonged hospitalization, congenital abnormality/birth defect, or new cancer will be considered a serious adverse event. No patients were accrued in the CDK12 Mutation Abemaciclib + Atezolizumab (Non-Randomized) arm.
|
0.00%
0/4 • From treatment initiation through 100 days after last dose for treatment-emergent adverse events, and up to 2 years after last dose. Maximum treatment duration was 18 months.
A serious adverse event is classified using physician's discretion. All adverse events resulting in death, life threatening events, significant disability, prolonged hospitalization, congenital abnormality/birth defect, or new cancer will be considered a serious adverse event. No patients were accrued in the CDK12 Mutation Abemaciclib + Atezolizumab (Non-Randomized) arm.
|
—
0/0 • From treatment initiation through 100 days after last dose for treatment-emergent adverse events, and up to 2 years after last dose. Maximum treatment duration was 18 months.
A serious adverse event is classified using physician's discretion. All adverse events resulting in death, life threatening events, significant disability, prolonged hospitalization, congenital abnormality/birth defect, or new cancer will be considered a serious adverse event. No patients were accrued in the CDK12 Mutation Abemaciclib + Atezolizumab (Non-Randomized) arm.
|
|
Renal and urinary disorders
Hematuria
|
14.3%
1/7 • From treatment initiation through 100 days after last dose for treatment-emergent adverse events, and up to 2 years after last dose. Maximum treatment duration was 18 months.
A serious adverse event is classified using physician's discretion. All adverse events resulting in death, life threatening events, significant disability, prolonged hospitalization, congenital abnormality/birth defect, or new cancer will be considered a serious adverse event. No patients were accrued in the CDK12 Mutation Abemaciclib + Atezolizumab (Non-Randomized) arm.
|
12.5%
1/8 • From treatment initiation through 100 days after last dose for treatment-emergent adverse events, and up to 2 years after last dose. Maximum treatment duration was 18 months.
A serious adverse event is classified using physician's discretion. All adverse events resulting in death, life threatening events, significant disability, prolonged hospitalization, congenital abnormality/birth defect, or new cancer will be considered a serious adverse event. No patients were accrued in the CDK12 Mutation Abemaciclib + Atezolizumab (Non-Randomized) arm.
|
0.00%
0/4 • From treatment initiation through 100 days after last dose for treatment-emergent adverse events, and up to 2 years after last dose. Maximum treatment duration was 18 months.
A serious adverse event is classified using physician's discretion. All adverse events resulting in death, life threatening events, significant disability, prolonged hospitalization, congenital abnormality/birth defect, or new cancer will be considered a serious adverse event. No patients were accrued in the CDK12 Mutation Abemaciclib + Atezolizumab (Non-Randomized) arm.
|
—
0/0 • From treatment initiation through 100 days after last dose for treatment-emergent adverse events, and up to 2 years after last dose. Maximum treatment duration was 18 months.
A serious adverse event is classified using physician's discretion. All adverse events resulting in death, life threatening events, significant disability, prolonged hospitalization, congenital abnormality/birth defect, or new cancer will be considered a serious adverse event. No patients were accrued in the CDK12 Mutation Abemaciclib + Atezolizumab (Non-Randomized) arm.
|
|
Renal and urinary disorders
Urinary frequency
|
0.00%
0/7 • From treatment initiation through 100 days after last dose for treatment-emergent adverse events, and up to 2 years after last dose. Maximum treatment duration was 18 months.
A serious adverse event is classified using physician's discretion. All adverse events resulting in death, life threatening events, significant disability, prolonged hospitalization, congenital abnormality/birth defect, or new cancer will be considered a serious adverse event. No patients were accrued in the CDK12 Mutation Abemaciclib + Atezolizumab (Non-Randomized) arm.
|
25.0%
2/8 • From treatment initiation through 100 days after last dose for treatment-emergent adverse events, and up to 2 years after last dose. Maximum treatment duration was 18 months.
A serious adverse event is classified using physician's discretion. All adverse events resulting in death, life threatening events, significant disability, prolonged hospitalization, congenital abnormality/birth defect, or new cancer will be considered a serious adverse event. No patients were accrued in the CDK12 Mutation Abemaciclib + Atezolizumab (Non-Randomized) arm.
|
25.0%
1/4 • From treatment initiation through 100 days after last dose for treatment-emergent adverse events, and up to 2 years after last dose. Maximum treatment duration was 18 months.
A serious adverse event is classified using physician's discretion. All adverse events resulting in death, life threatening events, significant disability, prolonged hospitalization, congenital abnormality/birth defect, or new cancer will be considered a serious adverse event. No patients were accrued in the CDK12 Mutation Abemaciclib + Atezolizumab (Non-Randomized) arm.
|
—
0/0 • From treatment initiation through 100 days after last dose for treatment-emergent adverse events, and up to 2 years after last dose. Maximum treatment duration was 18 months.
A serious adverse event is classified using physician's discretion. All adverse events resulting in death, life threatening events, significant disability, prolonged hospitalization, congenital abnormality/birth defect, or new cancer will be considered a serious adverse event. No patients were accrued in the CDK12 Mutation Abemaciclib + Atezolizumab (Non-Randomized) arm.
|
|
Renal and urinary disorders
Urinary tract obstruction
|
0.00%
0/7 • From treatment initiation through 100 days after last dose for treatment-emergent adverse events, and up to 2 years after last dose. Maximum treatment duration was 18 months.
A serious adverse event is classified using physician's discretion. All adverse events resulting in death, life threatening events, significant disability, prolonged hospitalization, congenital abnormality/birth defect, or new cancer will be considered a serious adverse event. No patients were accrued in the CDK12 Mutation Abemaciclib + Atezolizumab (Non-Randomized) arm.
|
12.5%
1/8 • From treatment initiation through 100 days after last dose for treatment-emergent adverse events, and up to 2 years after last dose. Maximum treatment duration was 18 months.
A serious adverse event is classified using physician's discretion. All adverse events resulting in death, life threatening events, significant disability, prolonged hospitalization, congenital abnormality/birth defect, or new cancer will be considered a serious adverse event. No patients were accrued in the CDK12 Mutation Abemaciclib + Atezolizumab (Non-Randomized) arm.
|
0.00%
0/4 • From treatment initiation through 100 days after last dose for treatment-emergent adverse events, and up to 2 years after last dose. Maximum treatment duration was 18 months.
A serious adverse event is classified using physician's discretion. All adverse events resulting in death, life threatening events, significant disability, prolonged hospitalization, congenital abnormality/birth defect, or new cancer will be considered a serious adverse event. No patients were accrued in the CDK12 Mutation Abemaciclib + Atezolizumab (Non-Randomized) arm.
|
—
0/0 • From treatment initiation through 100 days after last dose for treatment-emergent adverse events, and up to 2 years after last dose. Maximum treatment duration was 18 months.
A serious adverse event is classified using physician's discretion. All adverse events resulting in death, life threatening events, significant disability, prolonged hospitalization, congenital abnormality/birth defect, or new cancer will be considered a serious adverse event. No patients were accrued in the CDK12 Mutation Abemaciclib + Atezolizumab (Non-Randomized) arm.
|
|
Renal and urinary disorders
Urinary tract pain
|
0.00%
0/7 • From treatment initiation through 100 days after last dose for treatment-emergent adverse events, and up to 2 years after last dose. Maximum treatment duration was 18 months.
A serious adverse event is classified using physician's discretion. All adverse events resulting in death, life threatening events, significant disability, prolonged hospitalization, congenital abnormality/birth defect, or new cancer will be considered a serious adverse event. No patients were accrued in the CDK12 Mutation Abemaciclib + Atezolizumab (Non-Randomized) arm.
|
12.5%
1/8 • From treatment initiation through 100 days after last dose for treatment-emergent adverse events, and up to 2 years after last dose. Maximum treatment duration was 18 months.
A serious adverse event is classified using physician's discretion. All adverse events resulting in death, life threatening events, significant disability, prolonged hospitalization, congenital abnormality/birth defect, or new cancer will be considered a serious adverse event. No patients were accrued in the CDK12 Mutation Abemaciclib + Atezolizumab (Non-Randomized) arm.
|
0.00%
0/4 • From treatment initiation through 100 days after last dose for treatment-emergent adverse events, and up to 2 years after last dose. Maximum treatment duration was 18 months.
A serious adverse event is classified using physician's discretion. All adverse events resulting in death, life threatening events, significant disability, prolonged hospitalization, congenital abnormality/birth defect, or new cancer will be considered a serious adverse event. No patients were accrued in the CDK12 Mutation Abemaciclib + Atezolizumab (Non-Randomized) arm.
|
—
0/0 • From treatment initiation through 100 days after last dose for treatment-emergent adverse events, and up to 2 years after last dose. Maximum treatment duration was 18 months.
A serious adverse event is classified using physician's discretion. All adverse events resulting in death, life threatening events, significant disability, prolonged hospitalization, congenital abnormality/birth defect, or new cancer will be considered a serious adverse event. No patients were accrued in the CDK12 Mutation Abemaciclib + Atezolizumab (Non-Randomized) arm.
|
|
Renal and urinary disorders
Urinary urgency
|
14.3%
1/7 • From treatment initiation through 100 days after last dose for treatment-emergent adverse events, and up to 2 years after last dose. Maximum treatment duration was 18 months.
A serious adverse event is classified using physician's discretion. All adverse events resulting in death, life threatening events, significant disability, prolonged hospitalization, congenital abnormality/birth defect, or new cancer will be considered a serious adverse event. No patients were accrued in the CDK12 Mutation Abemaciclib + Atezolizumab (Non-Randomized) arm.
|
0.00%
0/8 • From treatment initiation through 100 days after last dose for treatment-emergent adverse events, and up to 2 years after last dose. Maximum treatment duration was 18 months.
A serious adverse event is classified using physician's discretion. All adverse events resulting in death, life threatening events, significant disability, prolonged hospitalization, congenital abnormality/birth defect, or new cancer will be considered a serious adverse event. No patients were accrued in the CDK12 Mutation Abemaciclib + Atezolizumab (Non-Randomized) arm.
|
0.00%
0/4 • From treatment initiation through 100 days after last dose for treatment-emergent adverse events, and up to 2 years after last dose. Maximum treatment duration was 18 months.
A serious adverse event is classified using physician's discretion. All adverse events resulting in death, life threatening events, significant disability, prolonged hospitalization, congenital abnormality/birth defect, or new cancer will be considered a serious adverse event. No patients were accrued in the CDK12 Mutation Abemaciclib + Atezolizumab (Non-Randomized) arm.
|
—
0/0 • From treatment initiation through 100 days after last dose for treatment-emergent adverse events, and up to 2 years after last dose. Maximum treatment duration was 18 months.
A serious adverse event is classified using physician's discretion. All adverse events resulting in death, life threatening events, significant disability, prolonged hospitalization, congenital abnormality/birth defect, or new cancer will be considered a serious adverse event. No patients were accrued in the CDK12 Mutation Abemaciclib + Atezolizumab (Non-Randomized) arm.
|
|
Reproductive system and breast disorders
Testicular pain
|
14.3%
1/7 • From treatment initiation through 100 days after last dose for treatment-emergent adverse events, and up to 2 years after last dose. Maximum treatment duration was 18 months.
A serious adverse event is classified using physician's discretion. All adverse events resulting in death, life threatening events, significant disability, prolonged hospitalization, congenital abnormality/birth defect, or new cancer will be considered a serious adverse event. No patients were accrued in the CDK12 Mutation Abemaciclib + Atezolizumab (Non-Randomized) arm.
|
0.00%
0/8 • From treatment initiation through 100 days after last dose for treatment-emergent adverse events, and up to 2 years after last dose. Maximum treatment duration was 18 months.
A serious adverse event is classified using physician's discretion. All adverse events resulting in death, life threatening events, significant disability, prolonged hospitalization, congenital abnormality/birth defect, or new cancer will be considered a serious adverse event. No patients were accrued in the CDK12 Mutation Abemaciclib + Atezolizumab (Non-Randomized) arm.
|
0.00%
0/4 • From treatment initiation through 100 days after last dose for treatment-emergent adverse events, and up to 2 years after last dose. Maximum treatment duration was 18 months.
A serious adverse event is classified using physician's discretion. All adverse events resulting in death, life threatening events, significant disability, prolonged hospitalization, congenital abnormality/birth defect, or new cancer will be considered a serious adverse event. No patients were accrued in the CDK12 Mutation Abemaciclib + Atezolizumab (Non-Randomized) arm.
|
—
0/0 • From treatment initiation through 100 days after last dose for treatment-emergent adverse events, and up to 2 years after last dose. Maximum treatment duration was 18 months.
A serious adverse event is classified using physician's discretion. All adverse events resulting in death, life threatening events, significant disability, prolonged hospitalization, congenital abnormality/birth defect, or new cancer will be considered a serious adverse event. No patients were accrued in the CDK12 Mutation Abemaciclib + Atezolizumab (Non-Randomized) arm.
|
|
Respiratory, thoracic and mediastinal disorders
Allergic rhinitis
|
0.00%
0/7 • From treatment initiation through 100 days after last dose for treatment-emergent adverse events, and up to 2 years after last dose. Maximum treatment duration was 18 months.
A serious adverse event is classified using physician's discretion. All adverse events resulting in death, life threatening events, significant disability, prolonged hospitalization, congenital abnormality/birth defect, or new cancer will be considered a serious adverse event. No patients were accrued in the CDK12 Mutation Abemaciclib + Atezolizumab (Non-Randomized) arm.
|
12.5%
1/8 • From treatment initiation through 100 days after last dose for treatment-emergent adverse events, and up to 2 years after last dose. Maximum treatment duration was 18 months.
A serious adverse event is classified using physician's discretion. All adverse events resulting in death, life threatening events, significant disability, prolonged hospitalization, congenital abnormality/birth defect, or new cancer will be considered a serious adverse event. No patients were accrued in the CDK12 Mutation Abemaciclib + Atezolizumab (Non-Randomized) arm.
|
0.00%
0/4 • From treatment initiation through 100 days after last dose for treatment-emergent adverse events, and up to 2 years after last dose. Maximum treatment duration was 18 months.
A serious adverse event is classified using physician's discretion. All adverse events resulting in death, life threatening events, significant disability, prolonged hospitalization, congenital abnormality/birth defect, or new cancer will be considered a serious adverse event. No patients were accrued in the CDK12 Mutation Abemaciclib + Atezolizumab (Non-Randomized) arm.
|
—
0/0 • From treatment initiation through 100 days after last dose for treatment-emergent adverse events, and up to 2 years after last dose. Maximum treatment duration was 18 months.
A serious adverse event is classified using physician's discretion. All adverse events resulting in death, life threatening events, significant disability, prolonged hospitalization, congenital abnormality/birth defect, or new cancer will be considered a serious adverse event. No patients were accrued in the CDK12 Mutation Abemaciclib + Atezolizumab (Non-Randomized) arm.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
14.3%
1/7 • From treatment initiation through 100 days after last dose for treatment-emergent adverse events, and up to 2 years after last dose. Maximum treatment duration was 18 months.
A serious adverse event is classified using physician's discretion. All adverse events resulting in death, life threatening events, significant disability, prolonged hospitalization, congenital abnormality/birth defect, or new cancer will be considered a serious adverse event. No patients were accrued in the CDK12 Mutation Abemaciclib + Atezolizumab (Non-Randomized) arm.
|
12.5%
1/8 • From treatment initiation through 100 days after last dose for treatment-emergent adverse events, and up to 2 years after last dose. Maximum treatment duration was 18 months.
A serious adverse event is classified using physician's discretion. All adverse events resulting in death, life threatening events, significant disability, prolonged hospitalization, congenital abnormality/birth defect, or new cancer will be considered a serious adverse event. No patients were accrued in the CDK12 Mutation Abemaciclib + Atezolizumab (Non-Randomized) arm.
|
0.00%
0/4 • From treatment initiation through 100 days after last dose for treatment-emergent adverse events, and up to 2 years after last dose. Maximum treatment duration was 18 months.
A serious adverse event is classified using physician's discretion. All adverse events resulting in death, life threatening events, significant disability, prolonged hospitalization, congenital abnormality/birth defect, or new cancer will be considered a serious adverse event. No patients were accrued in the CDK12 Mutation Abemaciclib + Atezolizumab (Non-Randomized) arm.
|
—
0/0 • From treatment initiation through 100 days after last dose for treatment-emergent adverse events, and up to 2 years after last dose. Maximum treatment duration was 18 months.
A serious adverse event is classified using physician's discretion. All adverse events resulting in death, life threatening events, significant disability, prolonged hospitalization, congenital abnormality/birth defect, or new cancer will be considered a serious adverse event. No patients were accrued in the CDK12 Mutation Abemaciclib + Atezolizumab (Non-Randomized) arm.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
57.1%
4/7 • From treatment initiation through 100 days after last dose for treatment-emergent adverse events, and up to 2 years after last dose. Maximum treatment duration was 18 months.
A serious adverse event is classified using physician's discretion. All adverse events resulting in death, life threatening events, significant disability, prolonged hospitalization, congenital abnormality/birth defect, or new cancer will be considered a serious adverse event. No patients were accrued in the CDK12 Mutation Abemaciclib + Atezolizumab (Non-Randomized) arm.
|
25.0%
2/8 • From treatment initiation through 100 days after last dose for treatment-emergent adverse events, and up to 2 years after last dose. Maximum treatment duration was 18 months.
A serious adverse event is classified using physician's discretion. All adverse events resulting in death, life threatening events, significant disability, prolonged hospitalization, congenital abnormality/birth defect, or new cancer will be considered a serious adverse event. No patients were accrued in the CDK12 Mutation Abemaciclib + Atezolizumab (Non-Randomized) arm.
|
0.00%
0/4 • From treatment initiation through 100 days after last dose for treatment-emergent adverse events, and up to 2 years after last dose. Maximum treatment duration was 18 months.
A serious adverse event is classified using physician's discretion. All adverse events resulting in death, life threatening events, significant disability, prolonged hospitalization, congenital abnormality/birth defect, or new cancer will be considered a serious adverse event. No patients were accrued in the CDK12 Mutation Abemaciclib + Atezolizumab (Non-Randomized) arm.
|
—
0/0 • From treatment initiation through 100 days after last dose for treatment-emergent adverse events, and up to 2 years after last dose. Maximum treatment duration was 18 months.
A serious adverse event is classified using physician's discretion. All adverse events resulting in death, life threatening events, significant disability, prolonged hospitalization, congenital abnormality/birth defect, or new cancer will be considered a serious adverse event. No patients were accrued in the CDK12 Mutation Abemaciclib + Atezolizumab (Non-Randomized) arm.
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
14.3%
1/7 • From treatment initiation through 100 days after last dose for treatment-emergent adverse events, and up to 2 years after last dose. Maximum treatment duration was 18 months.
A serious adverse event is classified using physician's discretion. All adverse events resulting in death, life threatening events, significant disability, prolonged hospitalization, congenital abnormality/birth defect, or new cancer will be considered a serious adverse event. No patients were accrued in the CDK12 Mutation Abemaciclib + Atezolizumab (Non-Randomized) arm.
|
0.00%
0/8 • From treatment initiation through 100 days after last dose for treatment-emergent adverse events, and up to 2 years after last dose. Maximum treatment duration was 18 months.
A serious adverse event is classified using physician's discretion. All adverse events resulting in death, life threatening events, significant disability, prolonged hospitalization, congenital abnormality/birth defect, or new cancer will be considered a serious adverse event. No patients were accrued in the CDK12 Mutation Abemaciclib + Atezolizumab (Non-Randomized) arm.
|
0.00%
0/4 • From treatment initiation through 100 days after last dose for treatment-emergent adverse events, and up to 2 years after last dose. Maximum treatment duration was 18 months.
A serious adverse event is classified using physician's discretion. All adverse events resulting in death, life threatening events, significant disability, prolonged hospitalization, congenital abnormality/birth defect, or new cancer will be considered a serious adverse event. No patients were accrued in the CDK12 Mutation Abemaciclib + Atezolizumab (Non-Randomized) arm.
|
—
0/0 • From treatment initiation through 100 days after last dose for treatment-emergent adverse events, and up to 2 years after last dose. Maximum treatment duration was 18 months.
A serious adverse event is classified using physician's discretion. All adverse events resulting in death, life threatening events, significant disability, prolonged hospitalization, congenital abnormality/birth defect, or new cancer will be considered a serious adverse event. No patients were accrued in the CDK12 Mutation Abemaciclib + Atezolizumab (Non-Randomized) arm.
|
|
Respiratory, thoracic and mediastinal disorders
Hiccups
|
0.00%
0/7 • From treatment initiation through 100 days after last dose for treatment-emergent adverse events, and up to 2 years after last dose. Maximum treatment duration was 18 months.
A serious adverse event is classified using physician's discretion. All adverse events resulting in death, life threatening events, significant disability, prolonged hospitalization, congenital abnormality/birth defect, or new cancer will be considered a serious adverse event. No patients were accrued in the CDK12 Mutation Abemaciclib + Atezolizumab (Non-Randomized) arm.
|
12.5%
1/8 • From treatment initiation through 100 days after last dose for treatment-emergent adverse events, and up to 2 years after last dose. Maximum treatment duration was 18 months.
A serious adverse event is classified using physician's discretion. All adverse events resulting in death, life threatening events, significant disability, prolonged hospitalization, congenital abnormality/birth defect, or new cancer will be considered a serious adverse event. No patients were accrued in the CDK12 Mutation Abemaciclib + Atezolizumab (Non-Randomized) arm.
|
0.00%
0/4 • From treatment initiation through 100 days after last dose for treatment-emergent adverse events, and up to 2 years after last dose. Maximum treatment duration was 18 months.
A serious adverse event is classified using physician's discretion. All adverse events resulting in death, life threatening events, significant disability, prolonged hospitalization, congenital abnormality/birth defect, or new cancer will be considered a serious adverse event. No patients were accrued in the CDK12 Mutation Abemaciclib + Atezolizumab (Non-Randomized) arm.
|
—
0/0 • From treatment initiation through 100 days after last dose for treatment-emergent adverse events, and up to 2 years after last dose. Maximum treatment duration was 18 months.
A serious adverse event is classified using physician's discretion. All adverse events resulting in death, life threatening events, significant disability, prolonged hospitalization, congenital abnormality/birth defect, or new cancer will be considered a serious adverse event. No patients were accrued in the CDK12 Mutation Abemaciclib + Atezolizumab (Non-Randomized) arm.
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
0.00%
0/7 • From treatment initiation through 100 days after last dose for treatment-emergent adverse events, and up to 2 years after last dose. Maximum treatment duration was 18 months.
A serious adverse event is classified using physician's discretion. All adverse events resulting in death, life threatening events, significant disability, prolonged hospitalization, congenital abnormality/birth defect, or new cancer will be considered a serious adverse event. No patients were accrued in the CDK12 Mutation Abemaciclib + Atezolizumab (Non-Randomized) arm.
|
0.00%
0/8 • From treatment initiation through 100 days after last dose for treatment-emergent adverse events, and up to 2 years after last dose. Maximum treatment duration was 18 months.
A serious adverse event is classified using physician's discretion. All adverse events resulting in death, life threatening events, significant disability, prolonged hospitalization, congenital abnormality/birth defect, or new cancer will be considered a serious adverse event. No patients were accrued in the CDK12 Mutation Abemaciclib + Atezolizumab (Non-Randomized) arm.
|
25.0%
1/4 • From treatment initiation through 100 days after last dose for treatment-emergent adverse events, and up to 2 years after last dose. Maximum treatment duration was 18 months.
A serious adverse event is classified using physician's discretion. All adverse events resulting in death, life threatening events, significant disability, prolonged hospitalization, congenital abnormality/birth defect, or new cancer will be considered a serious adverse event. No patients were accrued in the CDK12 Mutation Abemaciclib + Atezolizumab (Non-Randomized) arm.
|
—
0/0 • From treatment initiation through 100 days after last dose for treatment-emergent adverse events, and up to 2 years after last dose. Maximum treatment duration was 18 months.
A serious adverse event is classified using physician's discretion. All adverse events resulting in death, life threatening events, significant disability, prolonged hospitalization, congenital abnormality/birth defect, or new cancer will be considered a serious adverse event. No patients were accrued in the CDK12 Mutation Abemaciclib + Atezolizumab (Non-Randomized) arm.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonitis
|
0.00%
0/7 • From treatment initiation through 100 days after last dose for treatment-emergent adverse events, and up to 2 years after last dose. Maximum treatment duration was 18 months.
A serious adverse event is classified using physician's discretion. All adverse events resulting in death, life threatening events, significant disability, prolonged hospitalization, congenital abnormality/birth defect, or new cancer will be considered a serious adverse event. No patients were accrued in the CDK12 Mutation Abemaciclib + Atezolizumab (Non-Randomized) arm.
|
12.5%
1/8 • From treatment initiation through 100 days after last dose for treatment-emergent adverse events, and up to 2 years after last dose. Maximum treatment duration was 18 months.
A serious adverse event is classified using physician's discretion. All adverse events resulting in death, life threatening events, significant disability, prolonged hospitalization, congenital abnormality/birth defect, or new cancer will be considered a serious adverse event. No patients were accrued in the CDK12 Mutation Abemaciclib + Atezolizumab (Non-Randomized) arm.
|
0.00%
0/4 • From treatment initiation through 100 days after last dose for treatment-emergent adverse events, and up to 2 years after last dose. Maximum treatment duration was 18 months.
A serious adverse event is classified using physician's discretion. All adverse events resulting in death, life threatening events, significant disability, prolonged hospitalization, congenital abnormality/birth defect, or new cancer will be considered a serious adverse event. No patients were accrued in the CDK12 Mutation Abemaciclib + Atezolizumab (Non-Randomized) arm.
|
—
0/0 • From treatment initiation through 100 days after last dose for treatment-emergent adverse events, and up to 2 years after last dose. Maximum treatment duration was 18 months.
A serious adverse event is classified using physician's discretion. All adverse events resulting in death, life threatening events, significant disability, prolonged hospitalization, congenital abnormality/birth defect, or new cancer will be considered a serious adverse event. No patients were accrued in the CDK12 Mutation Abemaciclib + Atezolizumab (Non-Randomized) arm.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory, thoracic and mediastinal disorders - Other, specify
|
28.6%
2/7 • From treatment initiation through 100 days after last dose for treatment-emergent adverse events, and up to 2 years after last dose. Maximum treatment duration was 18 months.
A serious adverse event is classified using physician's discretion. All adverse events resulting in death, life threatening events, significant disability, prolonged hospitalization, congenital abnormality/birth defect, or new cancer will be considered a serious adverse event. No patients were accrued in the CDK12 Mutation Abemaciclib + Atezolizumab (Non-Randomized) arm.
|
12.5%
1/8 • From treatment initiation through 100 days after last dose for treatment-emergent adverse events, and up to 2 years after last dose. Maximum treatment duration was 18 months.
A serious adverse event is classified using physician's discretion. All adverse events resulting in death, life threatening events, significant disability, prolonged hospitalization, congenital abnormality/birth defect, or new cancer will be considered a serious adverse event. No patients were accrued in the CDK12 Mutation Abemaciclib + Atezolizumab (Non-Randomized) arm.
|
0.00%
0/4 • From treatment initiation through 100 days after last dose for treatment-emergent adverse events, and up to 2 years after last dose. Maximum treatment duration was 18 months.
A serious adverse event is classified using physician's discretion. All adverse events resulting in death, life threatening events, significant disability, prolonged hospitalization, congenital abnormality/birth defect, or new cancer will be considered a serious adverse event. No patients were accrued in the CDK12 Mutation Abemaciclib + Atezolizumab (Non-Randomized) arm.
|
—
0/0 • From treatment initiation through 100 days after last dose for treatment-emergent adverse events, and up to 2 years after last dose. Maximum treatment duration was 18 months.
A serious adverse event is classified using physician's discretion. All adverse events resulting in death, life threatening events, significant disability, prolonged hospitalization, congenital abnormality/birth defect, or new cancer will be considered a serious adverse event. No patients were accrued in the CDK12 Mutation Abemaciclib + Atezolizumab (Non-Randomized) arm.
|
|
Respiratory, thoracic and mediastinal disorders
Sleep apnea
|
14.3%
1/7 • From treatment initiation through 100 days after last dose for treatment-emergent adverse events, and up to 2 years after last dose. Maximum treatment duration was 18 months.
A serious adverse event is classified using physician's discretion. All adverse events resulting in death, life threatening events, significant disability, prolonged hospitalization, congenital abnormality/birth defect, or new cancer will be considered a serious adverse event. No patients were accrued in the CDK12 Mutation Abemaciclib + Atezolizumab (Non-Randomized) arm.
|
0.00%
0/8 • From treatment initiation through 100 days after last dose for treatment-emergent adverse events, and up to 2 years after last dose. Maximum treatment duration was 18 months.
A serious adverse event is classified using physician's discretion. All adverse events resulting in death, life threatening events, significant disability, prolonged hospitalization, congenital abnormality/birth defect, or new cancer will be considered a serious adverse event. No patients were accrued in the CDK12 Mutation Abemaciclib + Atezolizumab (Non-Randomized) arm.
|
0.00%
0/4 • From treatment initiation through 100 days after last dose for treatment-emergent adverse events, and up to 2 years after last dose. Maximum treatment duration was 18 months.
A serious adverse event is classified using physician's discretion. All adverse events resulting in death, life threatening events, significant disability, prolonged hospitalization, congenital abnormality/birth defect, or new cancer will be considered a serious adverse event. No patients were accrued in the CDK12 Mutation Abemaciclib + Atezolizumab (Non-Randomized) arm.
|
—
0/0 • From treatment initiation through 100 days after last dose for treatment-emergent adverse events, and up to 2 years after last dose. Maximum treatment duration was 18 months.
A serious adverse event is classified using physician's discretion. All adverse events resulting in death, life threatening events, significant disability, prolonged hospitalization, congenital abnormality/birth defect, or new cancer will be considered a serious adverse event. No patients were accrued in the CDK12 Mutation Abemaciclib + Atezolizumab (Non-Randomized) arm.
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
14.3%
1/7 • From treatment initiation through 100 days after last dose for treatment-emergent adverse events, and up to 2 years after last dose. Maximum treatment duration was 18 months.
A serious adverse event is classified using physician's discretion. All adverse events resulting in death, life threatening events, significant disability, prolonged hospitalization, congenital abnormality/birth defect, or new cancer will be considered a serious adverse event. No patients were accrued in the CDK12 Mutation Abemaciclib + Atezolizumab (Non-Randomized) arm.
|
0.00%
0/8 • From treatment initiation through 100 days after last dose for treatment-emergent adverse events, and up to 2 years after last dose. Maximum treatment duration was 18 months.
A serious adverse event is classified using physician's discretion. All adverse events resulting in death, life threatening events, significant disability, prolonged hospitalization, congenital abnormality/birth defect, or new cancer will be considered a serious adverse event. No patients were accrued in the CDK12 Mutation Abemaciclib + Atezolizumab (Non-Randomized) arm.
|
0.00%
0/4 • From treatment initiation through 100 days after last dose for treatment-emergent adverse events, and up to 2 years after last dose. Maximum treatment duration was 18 months.
A serious adverse event is classified using physician's discretion. All adverse events resulting in death, life threatening events, significant disability, prolonged hospitalization, congenital abnormality/birth defect, or new cancer will be considered a serious adverse event. No patients were accrued in the CDK12 Mutation Abemaciclib + Atezolizumab (Non-Randomized) arm.
|
—
0/0 • From treatment initiation through 100 days after last dose for treatment-emergent adverse events, and up to 2 years after last dose. Maximum treatment duration was 18 months.
A serious adverse event is classified using physician's discretion. All adverse events resulting in death, life threatening events, significant disability, prolonged hospitalization, congenital abnormality/birth defect, or new cancer will be considered a serious adverse event. No patients were accrued in the CDK12 Mutation Abemaciclib + Atezolizumab (Non-Randomized) arm.
|
|
Skin and subcutaneous tissue disorders
Nail changes
|
14.3%
1/7 • From treatment initiation through 100 days after last dose for treatment-emergent adverse events, and up to 2 years after last dose. Maximum treatment duration was 18 months.
A serious adverse event is classified using physician's discretion. All adverse events resulting in death, life threatening events, significant disability, prolonged hospitalization, congenital abnormality/birth defect, or new cancer will be considered a serious adverse event. No patients were accrued in the CDK12 Mutation Abemaciclib + Atezolizumab (Non-Randomized) arm.
|
0.00%
0/8 • From treatment initiation through 100 days after last dose for treatment-emergent adverse events, and up to 2 years after last dose. Maximum treatment duration was 18 months.
A serious adverse event is classified using physician's discretion. All adverse events resulting in death, life threatening events, significant disability, prolonged hospitalization, congenital abnormality/birth defect, or new cancer will be considered a serious adverse event. No patients were accrued in the CDK12 Mutation Abemaciclib + Atezolizumab (Non-Randomized) arm.
|
0.00%
0/4 • From treatment initiation through 100 days after last dose for treatment-emergent adverse events, and up to 2 years after last dose. Maximum treatment duration was 18 months.
A serious adverse event is classified using physician's discretion. All adverse events resulting in death, life threatening events, significant disability, prolonged hospitalization, congenital abnormality/birth defect, or new cancer will be considered a serious adverse event. No patients were accrued in the CDK12 Mutation Abemaciclib + Atezolizumab (Non-Randomized) arm.
|
—
0/0 • From treatment initiation through 100 days after last dose for treatment-emergent adverse events, and up to 2 years after last dose. Maximum treatment duration was 18 months.
A serious adverse event is classified using physician's discretion. All adverse events resulting in death, life threatening events, significant disability, prolonged hospitalization, congenital abnormality/birth defect, or new cancer will be considered a serious adverse event. No patients were accrued in the CDK12 Mutation Abemaciclib + Atezolizumab (Non-Randomized) arm.
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
14.3%
1/7 • From treatment initiation through 100 days after last dose for treatment-emergent adverse events, and up to 2 years after last dose. Maximum treatment duration was 18 months.
A serious adverse event is classified using physician's discretion. All adverse events resulting in death, life threatening events, significant disability, prolonged hospitalization, congenital abnormality/birth defect, or new cancer will be considered a serious adverse event. No patients were accrued in the CDK12 Mutation Abemaciclib + Atezolizumab (Non-Randomized) arm.
|
12.5%
1/8 • From treatment initiation through 100 days after last dose for treatment-emergent adverse events, and up to 2 years after last dose. Maximum treatment duration was 18 months.
A serious adverse event is classified using physician's discretion. All adverse events resulting in death, life threatening events, significant disability, prolonged hospitalization, congenital abnormality/birth defect, or new cancer will be considered a serious adverse event. No patients were accrued in the CDK12 Mutation Abemaciclib + Atezolizumab (Non-Randomized) arm.
|
0.00%
0/4 • From treatment initiation through 100 days after last dose for treatment-emergent adverse events, and up to 2 years after last dose. Maximum treatment duration was 18 months.
A serious adverse event is classified using physician's discretion. All adverse events resulting in death, life threatening events, significant disability, prolonged hospitalization, congenital abnormality/birth defect, or new cancer will be considered a serious adverse event. No patients were accrued in the CDK12 Mutation Abemaciclib + Atezolizumab (Non-Randomized) arm.
|
—
0/0 • From treatment initiation through 100 days after last dose for treatment-emergent adverse events, and up to 2 years after last dose. Maximum treatment duration was 18 months.
A serious adverse event is classified using physician's discretion. All adverse events resulting in death, life threatening events, significant disability, prolonged hospitalization, congenital abnormality/birth defect, or new cancer will be considered a serious adverse event. No patients were accrued in the CDK12 Mutation Abemaciclib + Atezolizumab (Non-Randomized) arm.
|
|
Skin and subcutaneous tissue disorders
Skin and subcutaneous tissue disorders - Other, specify
|
0.00%
0/7 • From treatment initiation through 100 days after last dose for treatment-emergent adverse events, and up to 2 years after last dose. Maximum treatment duration was 18 months.
A serious adverse event is classified using physician's discretion. All adverse events resulting in death, life threatening events, significant disability, prolonged hospitalization, congenital abnormality/birth defect, or new cancer will be considered a serious adverse event. No patients were accrued in the CDK12 Mutation Abemaciclib + Atezolizumab (Non-Randomized) arm.
|
12.5%
1/8 • From treatment initiation through 100 days after last dose for treatment-emergent adverse events, and up to 2 years after last dose. Maximum treatment duration was 18 months.
A serious adverse event is classified using physician's discretion. All adverse events resulting in death, life threatening events, significant disability, prolonged hospitalization, congenital abnormality/birth defect, or new cancer will be considered a serious adverse event. No patients were accrued in the CDK12 Mutation Abemaciclib + Atezolizumab (Non-Randomized) arm.
|
0.00%
0/4 • From treatment initiation through 100 days after last dose for treatment-emergent adverse events, and up to 2 years after last dose. Maximum treatment duration was 18 months.
A serious adverse event is classified using physician's discretion. All adverse events resulting in death, life threatening events, significant disability, prolonged hospitalization, congenital abnormality/birth defect, or new cancer will be considered a serious adverse event. No patients were accrued in the CDK12 Mutation Abemaciclib + Atezolizumab (Non-Randomized) arm.
|
—
0/0 • From treatment initiation through 100 days after last dose for treatment-emergent adverse events, and up to 2 years after last dose. Maximum treatment duration was 18 months.
A serious adverse event is classified using physician's discretion. All adverse events resulting in death, life threatening events, significant disability, prolonged hospitalization, congenital abnormality/birth defect, or new cancer will be considered a serious adverse event. No patients were accrued in the CDK12 Mutation Abemaciclib + Atezolizumab (Non-Randomized) arm.
|
|
Skin and subcutaneous tissue disorders
Skin ulceration
|
14.3%
1/7 • From treatment initiation through 100 days after last dose for treatment-emergent adverse events, and up to 2 years after last dose. Maximum treatment duration was 18 months.
A serious adverse event is classified using physician's discretion. All adverse events resulting in death, life threatening events, significant disability, prolonged hospitalization, congenital abnormality/birth defect, or new cancer will be considered a serious adverse event. No patients were accrued in the CDK12 Mutation Abemaciclib + Atezolizumab (Non-Randomized) arm.
|
0.00%
0/8 • From treatment initiation through 100 days after last dose for treatment-emergent adverse events, and up to 2 years after last dose. Maximum treatment duration was 18 months.
A serious adverse event is classified using physician's discretion. All adverse events resulting in death, life threatening events, significant disability, prolonged hospitalization, congenital abnormality/birth defect, or new cancer will be considered a serious adverse event. No patients were accrued in the CDK12 Mutation Abemaciclib + Atezolizumab (Non-Randomized) arm.
|
0.00%
0/4 • From treatment initiation through 100 days after last dose for treatment-emergent adverse events, and up to 2 years after last dose. Maximum treatment duration was 18 months.
A serious adverse event is classified using physician's discretion. All adverse events resulting in death, life threatening events, significant disability, prolonged hospitalization, congenital abnormality/birth defect, or new cancer will be considered a serious adverse event. No patients were accrued in the CDK12 Mutation Abemaciclib + Atezolizumab (Non-Randomized) arm.
|
—
0/0 • From treatment initiation through 100 days after last dose for treatment-emergent adverse events, and up to 2 years after last dose. Maximum treatment duration was 18 months.
A serious adverse event is classified using physician's discretion. All adverse events resulting in death, life threatening events, significant disability, prolonged hospitalization, congenital abnormality/birth defect, or new cancer will be considered a serious adverse event. No patients were accrued in the CDK12 Mutation Abemaciclib + Atezolizumab (Non-Randomized) arm.
|
|
Vascular disorders
Hot flashes
|
14.3%
1/7 • From treatment initiation through 100 days after last dose for treatment-emergent adverse events, and up to 2 years after last dose. Maximum treatment duration was 18 months.
A serious adverse event is classified using physician's discretion. All adverse events resulting in death, life threatening events, significant disability, prolonged hospitalization, congenital abnormality/birth defect, or new cancer will be considered a serious adverse event. No patients were accrued in the CDK12 Mutation Abemaciclib + Atezolizumab (Non-Randomized) arm.
|
25.0%
2/8 • From treatment initiation through 100 days after last dose for treatment-emergent adverse events, and up to 2 years after last dose. Maximum treatment duration was 18 months.
A serious adverse event is classified using physician's discretion. All adverse events resulting in death, life threatening events, significant disability, prolonged hospitalization, congenital abnormality/birth defect, or new cancer will be considered a serious adverse event. No patients were accrued in the CDK12 Mutation Abemaciclib + Atezolizumab (Non-Randomized) arm.
|
0.00%
0/4 • From treatment initiation through 100 days after last dose for treatment-emergent adverse events, and up to 2 years after last dose. Maximum treatment duration was 18 months.
A serious adverse event is classified using physician's discretion. All adverse events resulting in death, life threatening events, significant disability, prolonged hospitalization, congenital abnormality/birth defect, or new cancer will be considered a serious adverse event. No patients were accrued in the CDK12 Mutation Abemaciclib + Atezolizumab (Non-Randomized) arm.
|
—
0/0 • From treatment initiation through 100 days after last dose for treatment-emergent adverse events, and up to 2 years after last dose. Maximum treatment duration was 18 months.
A serious adverse event is classified using physician's discretion. All adverse events resulting in death, life threatening events, significant disability, prolonged hospitalization, congenital abnormality/birth defect, or new cancer will be considered a serious adverse event. No patients were accrued in the CDK12 Mutation Abemaciclib + Atezolizumab (Non-Randomized) arm.
|
|
Vascular disorders
Hypertension
|
14.3%
1/7 • From treatment initiation through 100 days after last dose for treatment-emergent adverse events, and up to 2 years after last dose. Maximum treatment duration was 18 months.
A serious adverse event is classified using physician's discretion. All adverse events resulting in death, life threatening events, significant disability, prolonged hospitalization, congenital abnormality/birth defect, or new cancer will be considered a serious adverse event. No patients were accrued in the CDK12 Mutation Abemaciclib + Atezolizumab (Non-Randomized) arm.
|
25.0%
2/8 • From treatment initiation through 100 days after last dose for treatment-emergent adverse events, and up to 2 years after last dose. Maximum treatment duration was 18 months.
A serious adverse event is classified using physician's discretion. All adverse events resulting in death, life threatening events, significant disability, prolonged hospitalization, congenital abnormality/birth defect, or new cancer will be considered a serious adverse event. No patients were accrued in the CDK12 Mutation Abemaciclib + Atezolizumab (Non-Randomized) arm.
|
25.0%
1/4 • From treatment initiation through 100 days after last dose for treatment-emergent adverse events, and up to 2 years after last dose. Maximum treatment duration was 18 months.
A serious adverse event is classified using physician's discretion. All adverse events resulting in death, life threatening events, significant disability, prolonged hospitalization, congenital abnormality/birth defect, or new cancer will be considered a serious adverse event. No patients were accrued in the CDK12 Mutation Abemaciclib + Atezolizumab (Non-Randomized) arm.
|
—
0/0 • From treatment initiation through 100 days after last dose for treatment-emergent adverse events, and up to 2 years after last dose. Maximum treatment duration was 18 months.
A serious adverse event is classified using physician's discretion. All adverse events resulting in death, life threatening events, significant disability, prolonged hospitalization, congenital abnormality/birth defect, or new cancer will be considered a serious adverse event. No patients were accrued in the CDK12 Mutation Abemaciclib + Atezolizumab (Non-Randomized) arm.
|
|
Vascular disorders
Hypotension
|
0.00%
0/7 • From treatment initiation through 100 days after last dose for treatment-emergent adverse events, and up to 2 years after last dose. Maximum treatment duration was 18 months.
A serious adverse event is classified using physician's discretion. All adverse events resulting in death, life threatening events, significant disability, prolonged hospitalization, congenital abnormality/birth defect, or new cancer will be considered a serious adverse event. No patients were accrued in the CDK12 Mutation Abemaciclib + Atezolizumab (Non-Randomized) arm.
|
12.5%
1/8 • From treatment initiation through 100 days after last dose for treatment-emergent adverse events, and up to 2 years after last dose. Maximum treatment duration was 18 months.
A serious adverse event is classified using physician's discretion. All adverse events resulting in death, life threatening events, significant disability, prolonged hospitalization, congenital abnormality/birth defect, or new cancer will be considered a serious adverse event. No patients were accrued in the CDK12 Mutation Abemaciclib + Atezolizumab (Non-Randomized) arm.
|
0.00%
0/4 • From treatment initiation through 100 days after last dose for treatment-emergent adverse events, and up to 2 years after last dose. Maximum treatment duration was 18 months.
A serious adverse event is classified using physician's discretion. All adverse events resulting in death, life threatening events, significant disability, prolonged hospitalization, congenital abnormality/birth defect, or new cancer will be considered a serious adverse event. No patients were accrued in the CDK12 Mutation Abemaciclib + Atezolizumab (Non-Randomized) arm.
|
—
0/0 • From treatment initiation through 100 days after last dose for treatment-emergent adverse events, and up to 2 years after last dose. Maximum treatment duration was 18 months.
A serious adverse event is classified using physician's discretion. All adverse events resulting in death, life threatening events, significant disability, prolonged hospitalization, congenital abnormality/birth defect, or new cancer will be considered a serious adverse event. No patients were accrued in the CDK12 Mutation Abemaciclib + Atezolizumab (Non-Randomized) arm.
|
|
Vascular disorders
Thromboembolic event
|
14.3%
1/7 • From treatment initiation through 100 days after last dose for treatment-emergent adverse events, and up to 2 years after last dose. Maximum treatment duration was 18 months.
A serious adverse event is classified using physician's discretion. All adverse events resulting in death, life threatening events, significant disability, prolonged hospitalization, congenital abnormality/birth defect, or new cancer will be considered a serious adverse event. No patients were accrued in the CDK12 Mutation Abemaciclib + Atezolizumab (Non-Randomized) arm.
|
0.00%
0/8 • From treatment initiation through 100 days after last dose for treatment-emergent adverse events, and up to 2 years after last dose. Maximum treatment duration was 18 months.
A serious adverse event is classified using physician's discretion. All adverse events resulting in death, life threatening events, significant disability, prolonged hospitalization, congenital abnormality/birth defect, or new cancer will be considered a serious adverse event. No patients were accrued in the CDK12 Mutation Abemaciclib + Atezolizumab (Non-Randomized) arm.
|
0.00%
0/4 • From treatment initiation through 100 days after last dose for treatment-emergent adverse events, and up to 2 years after last dose. Maximum treatment duration was 18 months.
A serious adverse event is classified using physician's discretion. All adverse events resulting in death, life threatening events, significant disability, prolonged hospitalization, congenital abnormality/birth defect, or new cancer will be considered a serious adverse event. No patients were accrued in the CDK12 Mutation Abemaciclib + Atezolizumab (Non-Randomized) arm.
|
—
0/0 • From treatment initiation through 100 days after last dose for treatment-emergent adverse events, and up to 2 years after last dose. Maximum treatment duration was 18 months.
A serious adverse event is classified using physician's discretion. All adverse events resulting in death, life threatening events, significant disability, prolonged hospitalization, congenital abnormality/birth defect, or new cancer will be considered a serious adverse event. No patients were accrued in the CDK12 Mutation Abemaciclib + Atezolizumab (Non-Randomized) arm.
|
|
Vascular disorders
Vascular disorders - Other, specify
|
0.00%
0/7 • From treatment initiation through 100 days after last dose for treatment-emergent adverse events, and up to 2 years after last dose. Maximum treatment duration was 18 months.
A serious adverse event is classified using physician's discretion. All adverse events resulting in death, life threatening events, significant disability, prolonged hospitalization, congenital abnormality/birth defect, or new cancer will be considered a serious adverse event. No patients were accrued in the CDK12 Mutation Abemaciclib + Atezolizumab (Non-Randomized) arm.
|
0.00%
0/8 • From treatment initiation through 100 days after last dose for treatment-emergent adverse events, and up to 2 years after last dose. Maximum treatment duration was 18 months.
A serious adverse event is classified using physician's discretion. All adverse events resulting in death, life threatening events, significant disability, prolonged hospitalization, congenital abnormality/birth defect, or new cancer will be considered a serious adverse event. No patients were accrued in the CDK12 Mutation Abemaciclib + Atezolizumab (Non-Randomized) arm.
|
25.0%
1/4 • From treatment initiation through 100 days after last dose for treatment-emergent adverse events, and up to 2 years after last dose. Maximum treatment duration was 18 months.
A serious adverse event is classified using physician's discretion. All adverse events resulting in death, life threatening events, significant disability, prolonged hospitalization, congenital abnormality/birth defect, or new cancer will be considered a serious adverse event. No patients were accrued in the CDK12 Mutation Abemaciclib + Atezolizumab (Non-Randomized) arm.
|
—
0/0 • From treatment initiation through 100 days after last dose for treatment-emergent adverse events, and up to 2 years after last dose. Maximum treatment duration was 18 months.
A serious adverse event is classified using physician's discretion. All adverse events resulting in death, life threatening events, significant disability, prolonged hospitalization, congenital abnormality/birth defect, or new cancer will be considered a serious adverse event. No patients were accrued in the CDK12 Mutation Abemaciclib + Atezolizumab (Non-Randomized) arm.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place