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.

Recruitment status

ACTIVE_NOT_RECRUITING

Study phase

PHASE2

Target enrollment

19 participants

Primary outcome timeframe

6 months

Results posted on

2025-10-02

Participant Flow

Participant milestones

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

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

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 months

Population: 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

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 months

Population: 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

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

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 discontinuation

Proportion 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 years

The 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 reason

The 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 years

The 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 months

Population: 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

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 dose

Number 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)

Serious events: 3 serious events
Other events: 6 other events
Deaths: 5 deaths

Biomarker-Unselected Abemaciclib + Atezolizumab (Randomized)

Serious events: 4 serious events
Other events: 8 other events
Deaths: 7 deaths

CDK12 Mutation Atezolizumab Monotherapy (Non-Randomized)

Serious events: 0 serious events
Other events: 4 other events
Deaths: 4 deaths

CDK12 Mutation Abemaciclib + Atezolizumab (Non-Randomized)

Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths

Serious adverse events

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

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

Atish Choudhury, MD PhD

Dana-Farber Cancer Institute

Phone: 6176326328

Results disclosure agreements

  • Principal investigator is a sponsor employee
  • Publication restrictions are in place