Trial Outcomes & Findings for A Basket Trial of an ERK1/2 Inhibitor (LY3214996) in Combination With Abemaciclib. (NCT NCT04534283)
NCT ID: NCT04534283
Last Updated: 2024-08-07
Results Overview
The number of patients who achieve a best overall response of complete response (CR) or partial response (PR) divided by the total number of patients treated (efficacy population) as determined by RECIST v1.1.
Recruitment status
TERMINATED
Study phase
PHASE2
Target enrollment
16 participants
Primary outcome timeframe
from cycle 1 day 1 until safety follow up visit (up to 1 year)
Results posted on
2024-08-07
Participant Flow
Participant milestones
| Measure |
Abemaciclib + LY3214996
Subjects will receive Abemaciclib 150 mg orally twice daily with LY3214996 200 mg orally daily until disease progression, unacceptable toxicity, or patient preference to withdraw from study.
Abemaciclib: Subjects will receive Abemaciclib 150 mg orally twice daily until disease progression, unacceptable toxicity, or patient preference to withdraw from study.
LY3214996: Subjects will recieve LY3214996 200 mg orally daily until disease progression, unacceptable toxicity, or patient preference to withdraw from study.
|
|---|---|
|
Overall Study
STARTED
|
16
|
|
Overall Study
COMPLETED
|
0
|
|
Overall Study
NOT COMPLETED
|
16
|
Reasons for withdrawal
| Measure |
Abemaciclib + LY3214996
Subjects will receive Abemaciclib 150 mg orally twice daily with LY3214996 200 mg orally daily until disease progression, unacceptable toxicity, or patient preference to withdraw from study.
Abemaciclib: Subjects will receive Abemaciclib 150 mg orally twice daily until disease progression, unacceptable toxicity, or patient preference to withdraw from study.
LY3214996: Subjects will recieve LY3214996 200 mg orally daily until disease progression, unacceptable toxicity, or patient preference to withdraw from study.
|
|---|---|
|
Overall Study
Physician Decision
|
2
|
|
Overall Study
Withdrawal by Subject
|
1
|
|
Overall Study
Disease Progression
|
12
|
|
Overall Study
Adverse Event
|
1
|
Baseline Characteristics
A Basket Trial of an ERK1/2 Inhibitor (LY3214996) in Combination With Abemaciclib.
Baseline characteristics by cohort
| Measure |
Abemaciclib + LY3214996
n=13 Participants
Subjects will receive Abemaciclib 150 mg orally twice daily with LY3214996 200 mg orally daily until disease progression, unacceptable toxicity, or patient preference to withdraw from study.
Abemaciclib: Subjects will receive Abemaciclib 150 mg orally twice daily until disease progression, unacceptable toxicity, or patient preference to withdraw from study.
LY3214996: Subjects will recieve LY3214996 200 mg orally daily until disease progression, unacceptable toxicity, or patient preference to withdraw from study.
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
7 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
6 Participants
n=5 Participants
|
|
Age, Continuous
|
62.4 years
STANDARD_DEVIATION 11.6 • n=5 Participants
|
|
Sex: Female, Male
Female
|
7 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
6 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
12 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
|
Performance Status (ECOG) at screening
0
|
3 Participants
n=5 Participants
|
|
Performance Status (ECOG) at screening
1
|
10 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: from cycle 1 day 1 until safety follow up visit (up to 1 year)Population: All enrolled patients who received at least one dose of study treatment and had a post-baseline imagining.
The number of patients who achieve a best overall response of complete response (CR) or partial response (PR) divided by the total number of patients treated (efficacy population) as determined by RECIST v1.1.
Outcome measures
| Measure |
Abemaciclib + LY3214996
n=12 Participants
Subjects will receive Abemaciclib 150 mg orally twice daily with LY3214996 200 mg orally daily until disease progression, unacceptable toxicity, or patient preference to withdraw from study.
Abemaciclib: Subjects will receive Abemaciclib 150 mg orally twice daily until disease progression, unacceptable toxicity, or patient preference to withdraw from study.
LY3214996: Subjects will recieve LY3214996 200 mg orally daily until disease progression, unacceptable toxicity, or patient preference to withdraw from study.
|
|---|---|
|
Overall Response Rate
|
0 percentage of patients
|
SECONDARY outcome
Timeframe: baseline until safety follow up visit (up to 1 year)Population: All enrolled patients who received at least one dose of study treatment.
Number of unique patients with any Abemaciclib or LY3214996 treatment related (possible, probable, or definite) adverse events with grade \>=3. CTCAE Version 5.0 will be used.
Outcome measures
| Measure |
Abemaciclib + LY3214996
n=13 Participants
Subjects will receive Abemaciclib 150 mg orally twice daily with LY3214996 200 mg orally daily until disease progression, unacceptable toxicity, or patient preference to withdraw from study.
Abemaciclib: Subjects will receive Abemaciclib 150 mg orally twice daily until disease progression, unacceptable toxicity, or patient preference to withdraw from study.
LY3214996: Subjects will recieve LY3214996 200 mg orally daily until disease progression, unacceptable toxicity, or patient preference to withdraw from study.
|
|---|---|
|
Number of Patients With Treatment Related Adverse Events Grade 3 or Above
|
6 Participants
|
SECONDARY outcome
Timeframe: up to 1 yearPopulation: All enrolled patients who received at least one dose of study treatment and had post-baseline imaging.
Measured from the time measurement criteria are met for CR or PR (whichever is first recorded) until the first date that recurrent or progressive disease is objectively documented through RECIST v1.1. Please note that there were no patients who achieved Complete Response (CR) or Partial Response (PR) within this study.
Outcome measures
| Measure |
Abemaciclib + LY3214996
n=12 Participants
Subjects will receive Abemaciclib 150 mg orally twice daily with LY3214996 200 mg orally daily until disease progression, unacceptable toxicity, or patient preference to withdraw from study.
Abemaciclib: Subjects will receive Abemaciclib 150 mg orally twice daily until disease progression, unacceptable toxicity, or patient preference to withdraw from study.
LY3214996: Subjects will recieve LY3214996 200 mg orally daily until disease progression, unacceptable toxicity, or patient preference to withdraw from study.
|
|---|---|
|
Duration of Overall Response Rate
|
0 days
Interval 0.0 to 0.0
|
SECONDARY outcome
Timeframe: up to 1 year, 1 monthPopulation: All enrolled patients who received at least one dose of study treatment and had a post-baseline imagining.
The time from the date of start of treatment to the first date of the observed clinical or radiologically documented PD or death due to any cause, whichever occurs first. For patients who are not known to have died or progressed as of the data-inclusion cut-off date, PFS time will be censored at the date of the last objective progression-free disease assessment prior to the date of any subsequent systematic anticancer therapy. Assessment are completed using RECIST v1.1. Kaplan-Meier methods will be used and the median and 95% confidence intervals will be calculated.
Outcome measures
| Measure |
Abemaciclib + LY3214996
n=12 Participants
Subjects will receive Abemaciclib 150 mg orally twice daily with LY3214996 200 mg orally daily until disease progression, unacceptable toxicity, or patient preference to withdraw from study.
Abemaciclib: Subjects will receive Abemaciclib 150 mg orally twice daily until disease progression, unacceptable toxicity, or patient preference to withdraw from study.
LY3214996: Subjects will recieve LY3214996 200 mg orally daily until disease progression, unacceptable toxicity, or patient preference to withdraw from study.
|
|---|---|
|
Progression Free Survival
|
2.1 months
Interval 1.6 to 7.6
|
Adverse Events
Abemaciclib + LY3214996
Serious events: 7 serious events
Other events: 13 other events
Deaths: 10 deaths
Serious adverse events
| Measure |
Abemaciclib + LY3214996
n=13 participants at risk
Subjects will receive Abemaciclib 150 mg orally twice daily with LY3214996 200 mg orally daily until disease progression, unacceptable toxicity, or patient preference to withdraw from study.
Abemaciclib: Subjects will receive Abemaciclib 150 mg orally twice daily until disease progression, unacceptable toxicity, or patient preference to withdraw from study.
LY3214996: Subjects will recieve LY3214996 200 mg orally daily until disease progression, unacceptable toxicity, or patient preference to withdraw from study.
|
|---|---|
|
Musculoskeletal and connective tissue disorders
Back pain
|
7.7%
1/13 • Up to 2 years
All enrolled patients who received at least one dose of study treatment were included in the Adverse Events summaries (this includes the Serious Adverse Events). Patients who did not receive any study drug were not included.
|
|
Musculoskeletal and connective tissue disorders
Generalized muscle weakness
|
7.7%
1/13 • Up to 2 years
All enrolled patients who received at least one dose of study treatment were included in the Adverse Events summaries (this includes the Serious Adverse Events). Patients who did not receive any study drug were not included.
|
|
Renal and urinary disorders
Urinary retention
|
7.7%
1/13 • Up to 2 years
All enrolled patients who received at least one dose of study treatment were included in the Adverse Events summaries (this includes the Serious Adverse Events). Patients who did not receive any study drug were not included.
|
|
Renal and urinary disorders
Urinary tract obstruction
|
7.7%
1/13 • Up to 2 years
All enrolled patients who received at least one dose of study treatment were included in the Adverse Events summaries (this includes the Serious Adverse Events). Patients who did not receive any study drug were not included.
|
|
Vascular disorders
Hypertension
|
7.7%
1/13 • Up to 2 years
All enrolled patients who received at least one dose of study treatment were included in the Adverse Events summaries (this includes the Serious Adverse Events). Patients who did not receive any study drug were not included.
|
|
Blood and lymphatic system disorders
Anemia
|
7.7%
1/13 • Up to 2 years
All enrolled patients who received at least one dose of study treatment were included in the Adverse Events summaries (this includes the Serious Adverse Events). Patients who did not receive any study drug were not included.
|
|
Blood and lymphatic system disorders
Leukocytosis
|
7.7%
1/13 • Up to 2 years
All enrolled patients who received at least one dose of study treatment were included in the Adverse Events summaries (this includes the Serious Adverse Events). Patients who did not receive any study drug were not included.
|
|
Cardiac disorders
Sinus tachycardia
|
7.7%
1/13 • Up to 2 years
All enrolled patients who received at least one dose of study treatment were included in the Adverse Events summaries (this includes the Serious Adverse Events). Patients who did not receive any study drug were not included.
|
|
Gastrointestinal disorders
Colonic obstruction
|
7.7%
1/13 • Up to 2 years
All enrolled patients who received at least one dose of study treatment were included in the Adverse Events summaries (this includes the Serious Adverse Events). Patients who did not receive any study drug were not included.
|
|
Gastrointestinal disorders
Constipation
|
7.7%
1/13 • Up to 2 years
All enrolled patients who received at least one dose of study treatment were included in the Adverse Events summaries (this includes the Serious Adverse Events). Patients who did not receive any study drug were not included.
|
|
Gastrointestinal disorders
Ileus
|
7.7%
1/13 • Up to 2 years
All enrolled patients who received at least one dose of study treatment were included in the Adverse Events summaries (this includes the Serious Adverse Events). Patients who did not receive any study drug were not included.
|
|
Gastrointestinal disorders
Lower gastrointestinal hemorrhage
|
7.7%
1/13 • Up to 2 years
All enrolled patients who received at least one dose of study treatment were included in the Adverse Events summaries (this includes the Serious Adverse Events). Patients who did not receive any study drug were not included.
|
|
Gastrointestinal disorders
Small intestinal obstruction
|
7.7%
1/13 • Up to 2 years
All enrolled patients who received at least one dose of study treatment were included in the Adverse Events summaries (this includes the Serious Adverse Events). Patients who did not receive any study drug were not included.
|
|
Gastrointestinal disorders
Vomiting
|
7.7%
1/13 • Up to 2 years
All enrolled patients who received at least one dose of study treatment were included in the Adverse Events summaries (this includes the Serious Adverse Events). Patients who did not receive any study drug were not included.
|
|
Infections and infestations
Lung infection
|
15.4%
2/13 • Up to 2 years
All enrolled patients who received at least one dose of study treatment were included in the Adverse Events summaries (this includes the Serious Adverse Events). Patients who did not receive any study drug were not included.
|
|
Infections and infestations
Urinary tract infection
|
7.7%
1/13 • Up to 2 years
All enrolled patients who received at least one dose of study treatment were included in the Adverse Events summaries (this includes the Serious Adverse Events). Patients who did not receive any study drug were not included.
|
|
Injury, poisoning and procedural complications
Fall
|
7.7%
1/13 • Up to 2 years
All enrolled patients who received at least one dose of study treatment were included in the Adverse Events summaries (this includes the Serious Adverse Events). Patients who did not receive any study drug were not included.
|
Other adverse events
| Measure |
Abemaciclib + LY3214996
n=13 participants at risk
Subjects will receive Abemaciclib 150 mg orally twice daily with LY3214996 200 mg orally daily until disease progression, unacceptable toxicity, or patient preference to withdraw from study.
Abemaciclib: Subjects will receive Abemaciclib 150 mg orally twice daily until disease progression, unacceptable toxicity, or patient preference to withdraw from study.
LY3214996: Subjects will recieve LY3214996 200 mg orally daily until disease progression, unacceptable toxicity, or patient preference to withdraw from study.
|
|---|---|
|
Blood and lymphatic system disorders
Anemia
|
38.5%
5/13 • Up to 2 years
All enrolled patients who received at least one dose of study treatment were included in the Adverse Events summaries (this includes the Serious Adverse Events). Patients who did not receive any study drug were not included.
|
|
Blood and lymphatic system disorders
Thrombotic thrombocytopenic purpura
|
7.7%
1/13 • Up to 2 years
All enrolled patients who received at least one dose of study treatment were included in the Adverse Events summaries (this includes the Serious Adverse Events). Patients who did not receive any study drug were not included.
|
|
Gastrointestinal disorders
Abdominal pain
|
23.1%
3/13 • Up to 2 years
All enrolled patients who received at least one dose of study treatment were included in the Adverse Events summaries (this includes the Serious Adverse Events). Patients who did not receive any study drug were not included.
|
|
Gastrointestinal disorders
Anal hemorrhage
|
7.7%
1/13 • Up to 2 years
All enrolled patients who received at least one dose of study treatment were included in the Adverse Events summaries (this includes the Serious Adverse Events). Patients who did not receive any study drug were not included.
|
|
Gastrointestinal disorders
Bloating
|
7.7%
1/13 • Up to 2 years
All enrolled patients who received at least one dose of study treatment were included in the Adverse Events summaries (this includes the Serious Adverse Events). Patients who did not receive any study drug were not included.
|
|
Gastrointestinal disorders
Constipation
|
30.8%
4/13 • Up to 2 years
All enrolled patients who received at least one dose of study treatment were included in the Adverse Events summaries (this includes the Serious Adverse Events). Patients who did not receive any study drug were not included.
|
|
Gastrointestinal disorders
Diarrhea
|
69.2%
9/13 • Up to 2 years
All enrolled patients who received at least one dose of study treatment were included in the Adverse Events summaries (this includes the Serious Adverse Events). Patients who did not receive any study drug were not included.
|
|
Gastrointestinal disorders
Dry mouth
|
7.7%
1/13 • Up to 2 years
All enrolled patients who received at least one dose of study treatment were included in the Adverse Events summaries (this includes the Serious Adverse Events). Patients who did not receive any study drug were not included.
|
|
Gastrointestinal disorders
Dyspepsia
|
15.4%
2/13 • Up to 2 years
All enrolled patients who received at least one dose of study treatment were included in the Adverse Events summaries (this includes the Serious Adverse Events). Patients who did not receive any study drug were not included.
|
|
Gastrointestinal disorders
Flatulence
|
7.7%
1/13 • Up to 2 years
All enrolled patients who received at least one dose of study treatment were included in the Adverse Events summaries (this includes the Serious Adverse Events). Patients who did not receive any study drug were not included.
|
|
Gastrointestinal disorders
Mucositis oral
|
7.7%
1/13 • Up to 2 years
All enrolled patients who received at least one dose of study treatment were included in the Adverse Events summaries (this includes the Serious Adverse Events). Patients who did not receive any study drug were not included.
|
|
Gastrointestinal disorders
Nausea
|
53.8%
7/13 • Up to 2 years
All enrolled patients who received at least one dose of study treatment were included in the Adverse Events summaries (this includes the Serious Adverse Events). Patients who did not receive any study drug were not included.
|
|
Gastrointestinal disorders
Rectal pain
|
7.7%
1/13 • Up to 2 years
All enrolled patients who received at least one dose of study treatment were included in the Adverse Events summaries (this includes the Serious Adverse Events). Patients who did not receive any study drug were not included.
|
|
Gastrointestinal disorders
Stomach pain
|
7.7%
1/13 • Up to 2 years
All enrolled patients who received at least one dose of study treatment were included in the Adverse Events summaries (this includes the Serious Adverse Events). Patients who did not receive any study drug were not included.
|
|
Gastrointestinal disorders
Toothache
|
7.7%
1/13 • Up to 2 years
All enrolled patients who received at least one dose of study treatment were included in the Adverse Events summaries (this includes the Serious Adverse Events). Patients who did not receive any study drug were not included.
|
|
Gastrointestinal disorders
Vomiting
|
46.2%
6/13 • Up to 2 years
All enrolled patients who received at least one dose of study treatment were included in the Adverse Events summaries (this includes the Serious Adverse Events). Patients who did not receive any study drug were not included.
|
|
General disorders
Chills
|
7.7%
1/13 • Up to 2 years
All enrolled patients who received at least one dose of study treatment were included in the Adverse Events summaries (this includes the Serious Adverse Events). Patients who did not receive any study drug were not included.
|
|
General disorders
Edema limbs
|
23.1%
3/13 • Up to 2 years
All enrolled patients who received at least one dose of study treatment were included in the Adverse Events summaries (this includes the Serious Adverse Events). Patients who did not receive any study drug were not included.
|
|
General disorders
Fatigue
|
76.9%
10/13 • Up to 2 years
All enrolled patients who received at least one dose of study treatment were included in the Adverse Events summaries (this includes the Serious Adverse Events). Patients who did not receive any study drug were not included.
|
|
General disorders
Fever
|
30.8%
4/13 • Up to 2 years
All enrolled patients who received at least one dose of study treatment were included in the Adverse Events summaries (this includes the Serious Adverse Events). Patients who did not receive any study drug were not included.
|
|
General disorders
Pain
|
15.4%
2/13 • Up to 2 years
All enrolled patients who received at least one dose of study treatment were included in the Adverse Events summaries (this includes the Serious Adverse Events). Patients who did not receive any study drug were not included.
|
|
Infections and infestations
Infections and infestations - Other, specify
|
7.7%
1/13 • Up to 2 years
All enrolled patients who received at least one dose of study treatment were included in the Adverse Events summaries (this includes the Serious Adverse Events). Patients who did not receive any study drug were not included.
|
|
Infections and infestations
Lung infection
|
7.7%
1/13 • Up to 2 years
All enrolled patients who received at least one dose of study treatment were included in the Adverse Events summaries (this includes the Serious Adverse Events). Patients who did not receive any study drug were not included.
|
|
Infections and infestations
Sinusitis
|
7.7%
1/13 • Up to 2 years
All enrolled patients who received at least one dose of study treatment were included in the Adverse Events summaries (this includes the Serious Adverse Events). Patients who did not receive any study drug were not included.
|
|
Infections and infestations
Urinary tract infection
|
15.4%
2/13 • Up to 2 years
All enrolled patients who received at least one dose of study treatment were included in the Adverse Events summaries (this includes the Serious Adverse Events). Patients who did not receive any study drug were not included.
|
|
Investigations
Alanine aminotransferase increased
|
7.7%
1/13 • Up to 2 years
All enrolled patients who received at least one dose of study treatment were included in the Adverse Events summaries (this includes the Serious Adverse Events). Patients who did not receive any study drug were not included.
|
|
Investigations
Alkaline phosphatase increased
|
7.7%
1/13 • Up to 2 years
All enrolled patients who received at least one dose of study treatment were included in the Adverse Events summaries (this includes the Serious Adverse Events). Patients who did not receive any study drug were not included.
|
|
Investigations
Aspartate aminotransferase increased
|
7.7%
1/13 • Up to 2 years
All enrolled patients who received at least one dose of study treatment were included in the Adverse Events summaries (this includes the Serious Adverse Events). Patients who did not receive any study drug were not included.
|
|
Investigations
Blood lactate dehydrogenase increased
|
7.7%
1/13 • Up to 2 years
All enrolled patients who received at least one dose of study treatment were included in the Adverse Events summaries (this includes the Serious Adverse Events). Patients who did not receive any study drug were not included.
|
|
Investigations
Creatinine increased
|
30.8%
4/13 • Up to 2 years
All enrolled patients who received at least one dose of study treatment were included in the Adverse Events summaries (this includes the Serious Adverse Events). Patients who did not receive any study drug were not included.
|
|
Investigations
Neutrophil count decreased
|
7.7%
1/13 • Up to 2 years
All enrolled patients who received at least one dose of study treatment were included in the Adverse Events summaries (this includes the Serious Adverse Events). Patients who did not receive any study drug were not included.
|
|
Investigations
Platelet count decreased
|
15.4%
2/13 • Up to 2 years
All enrolled patients who received at least one dose of study treatment were included in the Adverse Events summaries (this includes the Serious Adverse Events). Patients who did not receive any study drug were not included.
|
|
Metabolism and nutrition disorders
Anorexia
|
53.8%
7/13 • Up to 2 years
All enrolled patients who received at least one dose of study treatment were included in the Adverse Events summaries (this includes the Serious Adverse Events). Patients who did not receive any study drug were not included.
|
|
Metabolism and nutrition disorders
Dehydration
|
7.7%
1/13 • Up to 2 years
All enrolled patients who received at least one dose of study treatment were included in the Adverse Events summaries (this includes the Serious Adverse Events). Patients who did not receive any study drug were not included.
|
|
Metabolism and nutrition disorders
Hypokalemia
|
23.1%
3/13 • Up to 2 years
All enrolled patients who received at least one dose of study treatment were included in the Adverse Events summaries (this includes the Serious Adverse Events). Patients who did not receive any study drug were not included.
|
|
Metabolism and nutrition disorders
Hypomagnesemia
|
7.7%
1/13 • Up to 2 years
All enrolled patients who received at least one dose of study treatment were included in the Adverse Events summaries (this includes the Serious Adverse Events). Patients who did not receive any study drug were not included.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
15.4%
2/13 • Up to 2 years
All enrolled patients who received at least one dose of study treatment were included in the Adverse Events summaries (this includes the Serious Adverse Events). Patients who did not receive any study drug were not included.
|
|
Musculoskeletal and connective tissue disorders
Bone pain
|
7.7%
1/13 • Up to 2 years
All enrolled patients who received at least one dose of study treatment were included in the Adverse Events summaries (this includes the Serious Adverse Events). Patients who did not receive any study drug were not included.
|
|
Musculoskeletal and connective tissue disorders
Chest wall pain
|
15.4%
2/13 • Up to 2 years
All enrolled patients who received at least one dose of study treatment were included in the Adverse Events summaries (this includes the Serious Adverse Events). Patients who did not receive any study drug were not included.
|
|
Musculoskeletal and connective tissue disorders
Flank pain
|
7.7%
1/13 • Up to 2 years
All enrolled patients who received at least one dose of study treatment were included in the Adverse Events summaries (this includes the Serious Adverse Events). Patients who did not receive any study drug were not included.
|
|
Musculoskeletal and connective tissue disorders
Generalized muscle weakness
|
7.7%
1/13 • Up to 2 years
All enrolled patients who received at least one dose of study treatment were included in the Adverse Events summaries (this includes the Serious Adverse Events). Patients who did not receive any study drug were not included.
|
|
Musculoskeletal and connective tissue disorders
Muscle cramp
|
15.4%
2/13 • Up to 2 years
All enrolled patients who received at least one dose of study treatment were included in the Adverse Events summaries (this includes the Serious Adverse Events). Patients who did not receive any study drug were not included.
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
7.7%
1/13 • Up to 2 years
All enrolled patients who received at least one dose of study treatment were included in the Adverse Events summaries (this includes the Serious Adverse Events). Patients who did not receive any study drug were not included.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
7.7%
1/13 • Up to 2 years
All enrolled patients who received at least one dose of study treatment were included in the Adverse Events summaries (this includes the Serious Adverse Events). Patients who did not receive any study drug were not included.
|
|
Nervous system disorders
Dizziness
|
15.4%
2/13 • Up to 2 years
All enrolled patients who received at least one dose of study treatment were included in the Adverse Events summaries (this includes the Serious Adverse Events). Patients who did not receive any study drug were not included.
|
|
Nervous system disorders
Headache
|
7.7%
1/13 • Up to 2 years
All enrolled patients who received at least one dose of study treatment were included in the Adverse Events summaries (this includes the Serious Adverse Events). Patients who did not receive any study drug were not included.
|
|
Nervous system disorders
Peripheral sensory neuropathy
|
23.1%
3/13 • Up to 2 years
All enrolled patients who received at least one dose of study treatment were included in the Adverse Events summaries (this includes the Serious Adverse Events). Patients who did not receive any study drug were not included.
|
|
Nervous system disorders
Somnolence
|
7.7%
1/13 • Up to 2 years
All enrolled patients who received at least one dose of study treatment were included in the Adverse Events summaries (this includes the Serious Adverse Events). Patients who did not receive any study drug were not included.
|
|
Nervous system disorders
Syncope
|
7.7%
1/13 • Up to 2 years
All enrolled patients who received at least one dose of study treatment were included in the Adverse Events summaries (this includes the Serious Adverse Events). Patients who did not receive any study drug were not included.
|
|
Psychiatric disorders
Confusion
|
7.7%
1/13 • Up to 2 years
All enrolled patients who received at least one dose of study treatment were included in the Adverse Events summaries (this includes the Serious Adverse Events). Patients who did not receive any study drug were not included.
|
|
Psychiatric disorders
Hallucinations
|
7.7%
1/13 • Up to 2 years
All enrolled patients who received at least one dose of study treatment were included in the Adverse Events summaries (this includes the Serious Adverse Events). Patients who did not receive any study drug were not included.
|
|
Psychiatric disorders
Insomnia
|
7.7%
1/13 • Up to 2 years
All enrolled patients who received at least one dose of study treatment were included in the Adverse Events summaries (this includes the Serious Adverse Events). Patients who did not receive any study drug were not included.
|
|
Renal and urinary disorders
Urinary incontinence
|
7.7%
1/13 • Up to 2 years
All enrolled patients who received at least one dose of study treatment were included in the Adverse Events summaries (this includes the Serious Adverse Events). Patients who did not receive any study drug were not included.
|
|
Reproductive system and breast disorders
Vaginal dryness
|
7.7%
1/13 • Up to 2 years
All enrolled patients who received at least one dose of study treatment were included in the Adverse Events summaries (this includes the Serious Adverse Events). Patients who did not receive any study drug were not included.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
53.8%
7/13 • Up to 2 years
All enrolled patients who received at least one dose of study treatment were included in the Adverse Events summaries (this includes the Serious Adverse Events). Patients who did not receive any study drug were not included.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
30.8%
4/13 • Up to 2 years
All enrolled patients who received at least one dose of study treatment were included in the Adverse Events summaries (this includes the Serious Adverse Events). Patients who did not receive any study drug were not included.
|
|
Respiratory, thoracic and mediastinal disorders
Hoarseness
|
7.7%
1/13 • Up to 2 years
All enrolled patients who received at least one dose of study treatment were included in the Adverse Events summaries (this includes the Serious Adverse Events). Patients who did not receive any study drug were not included.
|
|
Respiratory, thoracic and mediastinal disorders
Laryngeal hemorrhage
|
7.7%
1/13 • Up to 2 years
All enrolled patients who received at least one dose of study treatment were included in the Adverse Events summaries (this includes the Serious Adverse Events). Patients who did not receive any study drug were not included.
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
7.7%
1/13 • Up to 2 years
All enrolled patients who received at least one dose of study treatment were included in the Adverse Events summaries (this includes the Serious Adverse Events). Patients who did not receive any study drug were not included.
|
|
Respiratory, thoracic and mediastinal disorders
Pleuritic pain
|
7.7%
1/13 • Up to 2 years
All enrolled patients who received at least one dose of study treatment were included in the Adverse Events summaries (this includes the Serious Adverse Events). Patients who did not receive any study drug were not included.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonitis
|
15.4%
2/13 • Up to 2 years
All enrolled patients who received at least one dose of study treatment were included in the Adverse Events summaries (this includes the Serious Adverse Events). Patients who did not receive any study drug were not included.
|
|
Skin and subcutaneous tissue disorders
Rash acneiform
|
53.8%
7/13 • Up to 2 years
All enrolled patients who received at least one dose of study treatment were included in the Adverse Events summaries (this includes the Serious Adverse Events). Patients who did not receive any study drug were not included.
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
7.7%
1/13 • Up to 2 years
All enrolled patients who received at least one dose of study treatment were included in the Adverse Events summaries (this includes the Serious Adverse Events). Patients who did not receive any study drug were not included.
|
|
Vascular disorders
Hypotension
|
7.7%
1/13 • Up to 2 years
All enrolled patients who received at least one dose of study treatment were included in the Adverse Events summaries (this includes the Serious Adverse Events). Patients who did not receive any study drug were not included.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place