Trial Outcomes & Findings for A Phase I/II Study of Ribociclib,a CDK4/6 Inhibitor, Following Radiation Therapy (NCT NCT02607124)

NCT ID: NCT02607124

Last Updated: 2020-11-05

Results Overview

Primary feasibility endpoint is the number of individual toxicities and incidence of significant delays

• Recruitment status: TERMINATED
• Study phase: PHASE1/PHASE2
• Target enrollment: 11 participants
• Primary outcome timeframe: 6 months
• Results posted on: 2020-11-05

Participant Flow

Participant milestones

Measure	Non-Biopsied Diffuse Instrinsic Pontine Glioma/Diffuse Midline Glioma Ribociclib administered orally; daily on days 1-21 each 28 day cycle; dose calculation age dependent (\>21 yrs of age 600mg daily (DIPG); \<21 yrs of age 350 mg/m2/day)
Overall Study STARTED	10
Overall Study COMPLETED	10
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

One enrolled participant was ineligible for study treatment and removed from trial therefore deemed inevaluable.

Baseline characteristics by cohort

Measure	Diffuse Instrinsic Pontine Glioma and Diffuse Midline Glioma n=10 Participants Ribociclib administered orally; daily on days 1-21 each 28 day cycle; dose calculation age dependent (\>21 yrs of age 600mg daily (DIPG); \<21 yrs of age 350 mg/m2/day) Baseline characteristics data are collected irrespective of Arm/Group and cannot be reported separately.
Age, Categorical <=18 years	9 Participants n=5 Participants • One enrolled participant was ineligible for study treatment and removed from trial therefore deemed inevaluable.
Age, Categorical Between 18 and 65 years	1 Participants n=5 Participants • One enrolled participant was ineligible for study treatment and removed from trial therefore deemed inevaluable.
Age, Categorical >=65 years	0 Participants n=5 Participants • One enrolled participant was ineligible for study treatment and removed from trial therefore deemed inevaluable.
Age, Continuous	7.5 years n=5 Participants
Sex: Female, Male Female	7 Participants n=5 Participants
Sex: Female, Male Male	3 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	1 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	9 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 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	0 Participants n=5 Participants
Race (NIH/OMB) White	9 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	1 Participants n=5 Participants
Region of Enrollment United States	10 participants n=5 Participants

PRIMARY outcome

Timeframe: 6 months

Population: Number of participants receiving investigational agent.

Primary feasibility endpoint is the number of individual toxicities and incidence of significant delays

Outcome measures

Measure	RB+ High Grade Glioma n=1 Participants Ribociclib administered orally; daily on days 1-21 each 28 day cycle; dose calculation age dependent (\>21 yrs of age 600mg daily (DIPG); \<21 yrs of age 350 mg/m2/day) Ribociclib	Non-Biopsied Diffuse Instrinsic Pontine Glioma n=9 Participants Ribociclib administered orally; daily on days 1-21 each 28 day cycle; dose calculation age dependent (\>21 yrs of age 600mg daily (DIPG); \<21 yrs of age 350 mg/m2/day) Ribociclib
Number of Adverse Events	9 adverse event	144 adverse event

PRIMARY outcome

Timeframe: 1 year

Population: Number of enrolled and evaluable participants

Outcome measures

Measure	RB+ High Grade Glioma n=1 Participants Ribociclib administered orally; daily on days 1-21 each 28 day cycle; dose calculation age dependent (\>21 yrs of age 600mg daily (DIPG); \<21 yrs of age 350 mg/m2/day) Ribociclib	Non-Biopsied Diffuse Instrinsic Pontine Glioma n=9 Participants Ribociclib administered orally; daily on days 1-21 each 28 day cycle; dose calculation age dependent (\>21 yrs of age 600mg daily (DIPG); \<21 yrs of age 350 mg/m2/day) Ribociclib
Number of Patients Alive at One Year	0 Participants	8 Participants

Adverse Events

Diffuse Intrinsic Pontine Glioma and High Grade Glioma

Serious events: 4 serious events

Other events: 10 other events

Deaths: 10 deaths

Serious adverse events

Measure	Diffuse Intrinsic Pontine Glioma and High Grade Glioma n=10 participants at risk Ribociclib administered orally; daily on days 1-21 each 28 day cycle; dose calculation age dependent (\>21 yrs of age 600mg daily (DIPG); \<21 yrs of age 350 mg/m2/day)
Gastrointestinal disorders Abdominal Pain	10.0% 1/10 • 2 years Adverse events grades 1 and 2 that are at least possibly related to ribociclib and all adverse events grades 3 and higher regardless of attribution during study treatment were recorded for the purposes of safety monitoring. There were no serious adverse events attributable to study treatment.
Nervous system disorders Accessory nerve disorder	10.0% 1/10 • 2 years Adverse events grades 1 and 2 that are at least possibly related to ribociclib and all adverse events grades 3 and higher regardless of attribution during study treatment were recorded for the purposes of safety monitoring. There were no serious adverse events attributable to study treatment.
Psychiatric disorders agitation	10.0% 1/10 • 2 years Adverse events grades 1 and 2 that are at least possibly related to ribociclib and all adverse events grades 3 and higher regardless of attribution during study treatment were recorded for the purposes of safety monitoring. There were no serious adverse events attributable to study treatment.
Respiratory, thoracic and mediastinal disorders Aspiration	10.0% 1/10 • 2 years Adverse events grades 1 and 2 that are at least possibly related to ribociclib and all adverse events grades 3 and higher regardless of attribution during study treatment were recorded for the purposes of safety monitoring. There were no serious adverse events attributable to study treatment.
Metabolism and nutrition disorders Dehydration	10.0% 1/10 • 2 years Adverse events grades 1 and 2 that are at least possibly related to ribociclib and all adverse events grades 3 and higher regardless of attribution during study treatment were recorded for the purposes of safety monitoring. There were no serious adverse events attributable to study treatment.
Gastrointestinal disorders Diarrhea	10.0% 1/10 • 2 years Adverse events grades 1 and 2 that are at least possibly related to ribociclib and all adverse events grades 3 and higher regardless of attribution during study treatment were recorded for the purposes of safety monitoring. There were no serious adverse events attributable to study treatment.
Nervous system disorders Dysarthria	10.0% 1/10 • 2 years Adverse events grades 1 and 2 that are at least possibly related to ribociclib and all adverse events grades 3 and higher regardless of attribution during study treatment were recorded for the purposes of safety monitoring. There were no serious adverse events attributable to study treatment.
General disorders Gait Disturbance	10.0% 1/10 • 2 years Adverse events grades 1 and 2 that are at least possibly related to ribociclib and all adverse events grades 3 and higher regardless of attribution during study treatment were recorded for the purposes of safety monitoring. There were no serious adverse events attributable to study treatment.
Psychiatric disorders hallucination	10.0% 1/10 • 2 years Adverse events grades 1 and 2 that are at least possibly related to ribociclib and all adverse events grades 3 and higher regardless of attribution during study treatment were recorded for the purposes of safety monitoring. There were no serious adverse events attributable to study treatment.
Nervous system disorders Headache	10.0% 1/10 • 2 years Adverse events grades 1 and 2 that are at least possibly related to ribociclib and all adverse events grades 3 and higher regardless of attribution during study treatment were recorded for the purposes of safety monitoring. There were no serious adverse events attributable to study treatment.
Respiratory, thoracic and mediastinal disorders Hypoxia	10.0% 1/10 • 2 years Adverse events grades 1 and 2 that are at least possibly related to ribociclib and all adverse events grades 3 and higher regardless of attribution during study treatment were recorded for the purposes of safety monitoring. There were no serious adverse events attributable to study treatment.
Infections and infestations Infection-Other	10.0% 1/10 • 2 years Adverse events grades 1 and 2 that are at least possibly related to ribociclib and all adverse events grades 3 and higher regardless of attribution during study treatment were recorded for the purposes of safety monitoring. There were no serious adverse events attributable to study treatment.
Gastrointestinal disorders Nausea	10.0% 1/10 • 2 years Adverse events grades 1 and 2 that are at least possibly related to ribociclib and all adverse events grades 3 and higher regardless of attribution during study treatment were recorded for the purposes of safety monitoring. There were no serious adverse events attributable to study treatment.
Nervous system disorders Nervous system disorders - Other, specify (hemiparesis)	10.0% 1/10 • 2 years Adverse events grades 1 and 2 that are at least possibly related to ribociclib and all adverse events grades 3 and higher regardless of attribution during study treatment were recorded for the purposes of safety monitoring. There were no serious adverse events attributable to study treatment.
General disorders Non Cardiac chest pain	10.0% 1/10 • 2 years Adverse events grades 1 and 2 that are at least possibly related to ribociclib and all adverse events grades 3 and higher regardless of attribution during study treatment were recorded for the purposes of safety monitoring. There were no serious adverse events attributable to study treatment.
General disorders Pain	10.0% 1/10 • 2 years Adverse events grades 1 and 2 that are at least possibly related to ribociclib and all adverse events grades 3 and higher regardless of attribution during study treatment were recorded for the purposes of safety monitoring. There were no serious adverse events attributable to study treatment.
Respiratory, thoracic and mediastinal disorders Pleural effusion	10.0% 1/10 • 2 years Adverse events grades 1 and 2 that are at least possibly related to ribociclib and all adverse events grades 3 and higher regardless of attribution during study treatment were recorded for the purposes of safety monitoring. There were no serious adverse events attributable to study treatment.
Respiratory, thoracic and mediastinal disorders Pneumothorax	10.0% 1/10 • 2 years Adverse events grades 1 and 2 that are at least possibly related to ribociclib and all adverse events grades 3 and higher regardless of attribution during study treatment were recorded for the purposes of safety monitoring. There were no serious adverse events attributable to study treatment.
Nervous system disorders Pyramidal tract syndrome	10.0% 1/10 • 2 years Adverse events grades 1 and 2 that are at least possibly related to ribociclib and all adverse events grades 3 and higher regardless of attribution during study treatment were recorded for the purposes of safety monitoring. There were no serious adverse events attributable to study treatment.
Skin and subcutaneous tissue disorders Rash maculo-papular	10.0% 1/10 • 2 years Adverse events grades 1 and 2 that are at least possibly related to ribociclib and all adverse events grades 3 and higher regardless of attribution during study treatment were recorded for the purposes of safety monitoring. There were no serious adverse events attributable to study treatment.
Respiratory, thoracic and mediastinal disorders Respiratory failure	10.0% 1/10 • 2 years Adverse events grades 1 and 2 that are at least possibly related to ribociclib and all adverse events grades 3 and higher regardless of attribution during study treatment were recorded for the purposes of safety monitoring. There were no serious adverse events attributable to study treatment.
Respiratory, thoracic and mediastinal disorders Respiratory, thoracic and mediastinal disorders - Other, specify (tachypnea)	10.0% 1/10 • 2 years Adverse events grades 1 and 2 that are at least possibly related to ribociclib and all adverse events grades 3 and higher regardless of attribution during study treatment were recorded for the purposes of safety monitoring. There were no serious adverse events attributable to study treatment.
Nervous system disorders Reversible posterior leukoencephalopathy syndrome	10.0% 1/10 • 2 years Adverse events grades 1 and 2 that are at least possibly related to ribociclib and all adverse events grades 3 and higher regardless of attribution during study treatment were recorded for the purposes of safety monitoring. There were no serious adverse events attributable to study treatment.
Gastrointestinal disorders Vomiting	10.0% 1/10 • 2 years Adverse events grades 1 and 2 that are at least possibly related to ribociclib and all adverse events grades 3 and higher regardless of attribution during study treatment were recorded for the purposes of safety monitoring. There were no serious adverse events attributable to study treatment.

Other adverse events

Measure	Diffuse Intrinsic Pontine Glioma and High Grade Glioma n=10 participants at risk Ribociclib administered orally; daily on days 1-21 each 28 day cycle; dose calculation age dependent (\>21 yrs of age 600mg daily (DIPG); \<21 yrs of age 350 mg/m2/day)
Blood and lymphatic system disorders Anemia	60.0% 6/10 • 2 years Adverse events grades 1 and 2 that are at least possibly related to ribociclib and all adverse events grades 3 and higher regardless of attribution during study treatment were recorded for the purposes of safety monitoring. There were no serious adverse events attributable to study treatment.
Gastrointestinal disorders Vomiting	80.0% 8/10 • 2 years Adverse events grades 1 and 2 that are at least possibly related to ribociclib and all adverse events grades 3 and higher regardless of attribution during study treatment were recorded for the purposes of safety monitoring. There were no serious adverse events attributable to study treatment.
Gastrointestinal disorders Nausea	80.0% 8/10 • 2 years Adverse events grades 1 and 2 that are at least possibly related to ribociclib and all adverse events grades 3 and higher regardless of attribution during study treatment were recorded for the purposes of safety monitoring. There were no serious adverse events attributable to study treatment.
Gastrointestinal disorders Constipation	20.0% 2/10 • 2 years Adverse events grades 1 and 2 that are at least possibly related to ribociclib and all adverse events grades 3 and higher regardless of attribution during study treatment were recorded for the purposes of safety monitoring. There were no serious adverse events attributable to study treatment.
Gastrointestinal disorders Abdominal Pain	10.0% 1/10 • 2 years Adverse events grades 1 and 2 that are at least possibly related to ribociclib and all adverse events grades 3 and higher regardless of attribution during study treatment were recorded for the purposes of safety monitoring. There were no serious adverse events attributable to study treatment.
Gastrointestinal disorders Dysphagia	10.0% 1/10 • 2 years Adverse events grades 1 and 2 that are at least possibly related to ribociclib and all adverse events grades 3 and higher regardless of attribution during study treatment were recorded for the purposes of safety monitoring. There were no serious adverse events attributable to study treatment.
Gastrointestinal disorders Gastroesophageal reflux diease	10.0% 1/10 • 2 years Adverse events grades 1 and 2 that are at least possibly related to ribociclib and all adverse events grades 3 and higher regardless of attribution during study treatment were recorded for the purposes of safety monitoring. There were no serious adverse events attributable to study treatment.
Gastrointestinal disorders Diarrhea	10.0% 1/10 • 2 years Adverse events grades 1 and 2 that are at least possibly related to ribociclib and all adverse events grades 3 and higher regardless of attribution during study treatment were recorded for the purposes of safety monitoring. There were no serious adverse events attributable to study treatment.
General disorders Fatigue	80.0% 8/10 • 2 years Adverse events grades 1 and 2 that are at least possibly related to ribociclib and all adverse events grades 3 and higher regardless of attribution during study treatment were recorded for the purposes of safety monitoring. There were no serious adverse events attributable to study treatment.
General disorders Gait Disturbance	10.0% 1/10 • 2 years Adverse events grades 1 and 2 that are at least possibly related to ribociclib and all adverse events grades 3 and higher regardless of attribution during study treatment were recorded for the purposes of safety monitoring. There were no serious adverse events attributable to study treatment.
General disorders Pain	10.0% 1/10 • 2 years Adverse events grades 1 and 2 that are at least possibly related to ribociclib and all adverse events grades 3 and higher regardless of attribution during study treatment were recorded for the purposes of safety monitoring. There were no serious adverse events attributable to study treatment.
General disorders Edema limbs	10.0% 1/10 • 2 years Adverse events grades 1 and 2 that are at least possibly related to ribociclib and all adverse events grades 3 and higher regardless of attribution during study treatment were recorded for the purposes of safety monitoring. There were no serious adverse events attributable to study treatment.
Investigations Alanine aminotransferase increased	40.0% 4/10 • 2 years Adverse events grades 1 and 2 that are at least possibly related to ribociclib and all adverse events grades 3 and higher regardless of attribution during study treatment were recorded for the purposes of safety monitoring. There were no serious adverse events attributable to study treatment.
Investigations Aspartate aminotransferase increased	30.0% 3/10 • 2 years Adverse events grades 1 and 2 that are at least possibly related to ribociclib and all adverse events grades 3 and higher regardless of attribution during study treatment were recorded for the purposes of safety monitoring. There were no serious adverse events attributable to study treatment.
Investigations Creatinine Increased	100.0% 10/10 • 2 years Adverse events grades 1 and 2 that are at least possibly related to ribociclib and all adverse events grades 3 and higher regardless of attribution during study treatment were recorded for the purposes of safety monitoring. There were no serious adverse events attributable to study treatment.
Investigations Ejection fraction decreased	20.0% 2/10 • 2 years Adverse events grades 1 and 2 that are at least possibly related to ribociclib and all adverse events grades 3 and higher regardless of attribution during study treatment were recorded for the purposes of safety monitoring. There were no serious adverse events attributable to study treatment.
Investigations Electrocardiogram QT corrected interval prolonged	20.0% 2/10 • 2 years Adverse events grades 1 and 2 that are at least possibly related to ribociclib and all adverse events grades 3 and higher regardless of attribution during study treatment were recorded for the purposes of safety monitoring. There were no serious adverse events attributable to study treatment.
Investigations Lymphocyte Count Decreased	100.0% 10/10 • 2 years Adverse events grades 1 and 2 that are at least possibly related to ribociclib and all adverse events grades 3 and higher regardless of attribution during study treatment were recorded for the purposes of safety monitoring. There were no serious adverse events attributable to study treatment.
Investigations Neutrophil Count Decreased	100.0% 10/10 • 2 years Adverse events grades 1 and 2 that are at least possibly related to ribociclib and all adverse events grades 3 and higher regardless of attribution during study treatment were recorded for the purposes of safety monitoring. There were no serious adverse events attributable to study treatment.
Investigations Platelet Count Decreased	50.0% 5/10 • 2 years Adverse events grades 1 and 2 that are at least possibly related to ribociclib and all adverse events grades 3 and higher regardless of attribution during study treatment were recorded for the purposes of safety monitoring. There were no serious adverse events attributable to study treatment.
Investigations Weight Gain	20.0% 2/10 • 2 years Adverse events grades 1 and 2 that are at least possibly related to ribociclib and all adverse events grades 3 and higher regardless of attribution during study treatment were recorded for the purposes of safety monitoring. There were no serious adverse events attributable to study treatment.
Investigations Weight Loss	20.0% 2/10 • 2 years Adverse events grades 1 and 2 that are at least possibly related to ribociclib and all adverse events grades 3 and higher regardless of attribution during study treatment were recorded for the purposes of safety monitoring. There were no serious adverse events attributable to study treatment.
Investigations White Blood Cell Decreased	100.0% 10/10 • 2 years Adverse events grades 1 and 2 that are at least possibly related to ribociclib and all adverse events grades 3 and higher regardless of attribution during study treatment were recorded for the purposes of safety monitoring. There were no serious adverse events attributable to study treatment.
Metabolism and nutrition disorders Anorexia	50.0% 5/10 • 2 years Adverse events grades 1 and 2 that are at least possibly related to ribociclib and all adverse events grades 3 and higher regardless of attribution during study treatment were recorded for the purposes of safety monitoring. There were no serious adverse events attributable to study treatment.
Metabolism and nutrition disorders Dehydration	10.0% 1/10 • 2 years Adverse events grades 1 and 2 that are at least possibly related to ribociclib and all adverse events grades 3 and higher regardless of attribution during study treatment were recorded for the purposes of safety monitoring. There were no serious adverse events attributable to study treatment.
Metabolism and nutrition disorders Hyperglycemia	10.0% 1/10 • 2 years Adverse events grades 1 and 2 that are at least possibly related to ribociclib and all adverse events grades 3 and higher regardless of attribution during study treatment were recorded for the purposes of safety monitoring. There were no serious adverse events attributable to study treatment.
Metabolism and nutrition disorders Hypoalbuminemia	20.0% 2/10 • 2 years Adverse events grades 1 and 2 that are at least possibly related to ribociclib and all adverse events grades 3 and higher regardless of attribution during study treatment were recorded for the purposes of safety monitoring. There were no serious adverse events attributable to study treatment.
Metabolism and nutrition disorders Hypocalcemia	10.0% 1/10 • 2 years Adverse events grades 1 and 2 that are at least possibly related to ribociclib and all adverse events grades 3 and higher regardless of attribution during study treatment were recorded for the purposes of safety monitoring. There were no serious adverse events attributable to study treatment.
Metabolism and nutrition disorders Hypoglycemia	10.0% 1/10 • 2 years Adverse events grades 1 and 2 that are at least possibly related to ribociclib and all adverse events grades 3 and higher regardless of attribution during study treatment were recorded for the purposes of safety monitoring. There were no serious adverse events attributable to study treatment.
Metabolism and nutrition disorders Hypokalemia	30.0% 3/10 • 2 years Adverse events grades 1 and 2 that are at least possibly related to ribociclib and all adverse events grades 3 and higher regardless of attribution during study treatment were recorded for the purposes of safety monitoring. There were no serious adverse events attributable to study treatment.
Metabolism and nutrition disorders Hyponatremia	20.0% 2/10 • 2 years Adverse events grades 1 and 2 that are at least possibly related to ribociclib and all adverse events grades 3 and higher regardless of attribution during study treatment were recorded for the purposes of safety monitoring. There were no serious adverse events attributable to study treatment.
Metabolism and nutrition disorders Hypophosphatemia	20.0% 2/10 • 2 years Adverse events grades 1 and 2 that are at least possibly related to ribociclib and all adverse events grades 3 and higher regardless of attribution during study treatment were recorded for the purposes of safety monitoring. There were no serious adverse events attributable to study treatment.
Musculoskeletal and connective tissue disorders Musculoskeletal and connective tissue disorder - Other, specify (Osteonecrosis - hip)	10.0% 1/10 • 2 years Adverse events grades 1 and 2 that are at least possibly related to ribociclib and all adverse events grades 3 and higher regardless of attribution during study treatment were recorded for the purposes of safety monitoring. There were no serious adverse events attributable to study treatment.
Nervous system disorders Headache	10.0% 1/10 • 2 years Adverse events grades 1 and 2 that are at least possibly related to ribociclib and all adverse events grades 3 and higher regardless of attribution during study treatment were recorded for the purposes of safety monitoring. There were no serious adverse events attributable to study treatment.
Psychiatric disorders Anxiety	10.0% 1/10 • 2 years Adverse events grades 1 and 2 that are at least possibly related to ribociclib and all adverse events grades 3 and higher regardless of attribution during study treatment were recorded for the purposes of safety monitoring. There were no serious adverse events attributable to study treatment.
Psychiatric disorders Insomnia	10.0% 1/10 • 2 years Adverse events grades 1 and 2 that are at least possibly related to ribociclib and all adverse events grades 3 and higher regardless of attribution during study treatment were recorded for the purposes of safety monitoring. There were no serious adverse events attributable to study treatment.
Reproductive system and breast disorders Irregular menstruation	10.0% 1/10 • 2 years Adverse events grades 1 and 2 that are at least possibly related to ribociclib and all adverse events grades 3 and higher regardless of attribution during study treatment were recorded for the purposes of safety monitoring. There were no serious adverse events attributable to study treatment.
Respiratory, thoracic and mediastinal disorders Aspiration	10.0% 1/10 • 2 years Adverse events grades 1 and 2 that are at least possibly related to ribociclib and all adverse events grades 3 and higher regardless of attribution during study treatment were recorded for the purposes of safety monitoring. There were no serious adverse events attributable to study treatment.
Respiratory, thoracic and mediastinal disorders Sore throat	10.0% 1/10 • 2 years Adverse events grades 1 and 2 that are at least possibly related to ribociclib and all adverse events grades 3 and higher regardless of attribution during study treatment were recorded for the purposes of safety monitoring. There were no serious adverse events attributable to study treatment.
Respiratory, thoracic and mediastinal disorders Hypoxia	10.0% 1/10 • 2 years Adverse events grades 1 and 2 that are at least possibly related to ribociclib and all adverse events grades 3 and higher regardless of attribution during study treatment were recorded for the purposes of safety monitoring. There were no serious adverse events attributable to study treatment.
Skin and subcutaneous tissue disorders Alopecia	10.0% 1/10 • 2 years Adverse events grades 1 and 2 that are at least possibly related to ribociclib and all adverse events grades 3 and higher regardless of attribution during study treatment were recorded for the purposes of safety monitoring. There were no serious adverse events attributable to study treatment.
Skin and subcutaneous tissue disorders Rash maculo-papular	10.0% 1/10 • 2 years Adverse events grades 1 and 2 that are at least possibly related to ribociclib and all adverse events grades 3 and higher regardless of attribution during study treatment were recorded for the purposes of safety monitoring. There were no serious adverse events attributable to study treatment.
Skin and subcutaneous tissue disorders Other - Rash	10.0% 1/10 • 2 years Adverse events grades 1 and 2 that are at least possibly related to ribociclib and all adverse events grades 3 and higher regardless of attribution during study treatment were recorded for the purposes of safety monitoring. There were no serious adverse events attributable to study treatment.
Skin and subcutaneous tissue disorders Other - petechial rash	10.0% 1/10 • 2 years Adverse events grades 1 and 2 that are at least possibly related to ribociclib and all adverse events grades 3 and higher regardless of attribution during study treatment were recorded for the purposes of safety monitoring. There were no serious adverse events attributable to study treatment.
Vascular disorders Hypertension	10.0% 1/10 • 2 years Adverse events grades 1 and 2 that are at least possibly related to ribociclib and all adverse events grades 3 and higher regardless of attribution during study treatment were recorded for the purposes of safety monitoring. There were no serious adverse events attributable to study treatment.

Additional Information

Renee Doughman

Cincinnati Childrens Hosptial Medical Center

Phone: 513-636-1699

Email: renee.doughman@cchmc.org

Results disclosure agreements

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