Trial Outcomes & Findings for Veliparib in Treating Patients With Persistent or Recurrent Epithelial Ovarian, Fallopian Tube, or Primary Peritoneal Cancer (NCT NCT01540565)

NCT ID: NCT01540565

Last Updated: 2019-07-23

Results Overview

Patients with complete and partial tumor response by RECIST V1.1 (per response evaluation criteria in Solid Tumors Criteria (RECIST V1.1) for target lesions and assessed by MRI (CT scan): Complete Response (CR), disappearance of all target lesions (confirmed at \>= 4 weeks); Partial Response (PR) \>= 30% decrease in the sum of the longest diameter of target lesions (confirmed at \>= 4 weeks); Overall Response = CR + PR.

• Recruitment status: COMPLETED
• Study phase: PHASE2
• Target enrollment: 52 participants
• Primary outcome timeframe: CT scan/MRI if used to follow lesion for measurable disease every other cycle for the first 6 months, then every 3 months until progression. Repeat at other times if clinically indicated.Responses require confirmation at >= 4 wks from first documentation.
• Results posted on: 2019-07-23

Participant Flow

Study opened to patient entry April 2012 and closed to accrual November 2012.

Participant milestones

Measure	Treatment (Veliparib) Patients receive veliparib PO BID on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. Laboratory Biomarker Analysis: Correlative studies Veliparib: Given PO
Overall Study STARTED	52
Overall Study COMPLETED	50
Overall Study NOT COMPLETED	2

Reasons for withdrawal

Measure	Treatment (Veliparib) Patients receive veliparib PO BID on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. Laboratory Biomarker Analysis: Correlative studies Veliparib: Given PO
Overall Study Ineligible	2

Baseline Characteristics

Veliparib in Treating Patients With Persistent or Recurrent Epithelial Ovarian, Fallopian Tube, or Primary Peritoneal Cancer

Baseline characteristics by cohort

Measure	Treatment (Veliparib) n=50 Participants Patients receive veliparib PO BID on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. Laboratory Biomarker Analysis: Correlative studies Veliparib: Given PO
Age, Customized 20-29 years	0 Participants n=5 Participants
Age, Customized 30-39 years	2 Participants n=5 Participants
Age, Customized 40-49 years	15 Participants n=5 Participants
Age, Customized 50-59 years	14 Participants n=5 Participants
Age, Customized 60-69 years	15 Participants n=5 Participants
Age, Customized 70-79 years	2 Participants n=5 Participants
Age, Customized >=80 years	2 Participants n=5 Participants
Sex: Female, Male Female	50 Participants n=5 Participants
Sex: Female, Male Male	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants
Race (NIH/OMB) Asian	1 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	2 Participants n=5 Participants
Race (NIH/OMB) White	44 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	3 Participants n=5 Participants
Cell Type Serous	41 Participants n=5 Participants
Cell Type Other	9 Participants n=5 Participants

PRIMARY outcome

Timeframe: CT scan/MRI if used to follow lesion for measurable disease every other cycle for the first 6 months, then every 3 months until progression. Repeat at other times if clinically indicated.Responses require confirmation at >= 4 wks from first documentation.

Population: Eligible and evaluable

Patients with complete and partial tumor response by RECIST V1.1 (per response evaluation criteria in Solid Tumors Criteria (RECIST V1.1) for target lesions and assessed by MRI (CT scan): Complete Response (CR), disappearance of all target lesions (confirmed at >= 4 weeks); Partial Response (PR) >= 30% decrease in the sum of the longest diameter of target lesions (confirmed at >= 4 weeks); Overall Response = CR + PR.

Outcome measures

Measure	Treatment (Veliparib) n=50 Participants Patients receive veliparib PO BID on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. Laboratory Biomarker Analysis: Correlative studies Veliparib: Given PO
Proportion of Patients With Complete and Partial Tumor Response	0.26 Proportion of patients Interval 0.146 to 0.403

PRIMARY outcome

Timeframe: After every cycle while on study therapy. Followed for late adverse events up to 30 days after completing therapy.

Population: Eligible and evaluable

Patients with grade 3 or greater Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported.

Outcome measures

Measure	Treatment (Veliparib) n=50 Participants Patients receive veliparib PO BID on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. Laboratory Biomarker Analysis: Correlative studies Veliparib: Given PO
Proportion of Patients With Adverse Events as Assessed by CTCAE v4.0	0.32 Proportion of patients Interval 0.195 to 0.467

SECONDARY outcome

Timeframe: CT scan/MRI if used to follow lesion for measurable disease every other cycle for the first 6 months, then every 3 months until progression. Patients who begin subsequent therapy without progression will be monitored for PFS for 5 years.

Population: Eligible and evaluable

The time from randomization until disease progression, death, or date of last contact. Endpoints are progression or death. Patients who are not observed with an endpoint are censored. Progression is defined using Response Evaluation Criteria in Solid Tumors Criteria (RECIST v1.1), as a 20% increase in the sum of the longest diameter of target lesions (and >= 5 mm increase of target lesions), or a measurable increase in a non-target lesion, or the appearance of new lesions.

Outcome measures

Measure	Treatment (Veliparib) n=50 Participants Patients receive veliparib PO BID on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. Laboratory Biomarker Analysis: Correlative studies Veliparib: Given PO
Duration of PFS	8.18 months Interval 5.45 to 9.63

SECONDARY outcome

Timeframe: Every cycle while patient is receiving protocol therapy. Patients will be monitored for survival after going off therapy for a 5 year period, every 3 months for the first 2 years, then every 6 months for the last 3 years.

Population: Eligible and evaluable

Overall survival

Outcome measures

Measure	Treatment (Veliparib) n=50 Participants Patients receive veliparib PO BID on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. Laboratory Biomarker Analysis: Correlative studies Veliparib: Given PO
Duration of OS	NA Months Interval 13.4 to The sample size was not sufficient for the calculation of the median. The first quartile of 13.4 months was calculated, but the data was not adequate for the computation of the median or the third quartile.

SECONDARY outcome

Timeframe: 6 months

Population: Eligible and evaluable

This outcome captures whether or not the patient survived progression-free for at least 6 months, and is displayed as a proportion.

Outcome measures

Measure	Treatment (Veliparib) n=50 Participants Patients receive veliparib PO BID on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. Laboratory Biomarker Analysis: Correlative studies Veliparib: Given PO
The Proportion of Patients Who Survive Progression-free for at Least 6 Months	0.54 Proportion of patients Interval 0.393 to 0.682

OTHER_PRE_SPECIFIED outcome

Timeframe: Baseline

Population: Data not collected

If the clinical trial goes to the second stage and there is sufficient variability in the SNPs, then patients can be categorized by the nature of their SNPs and assessed for prognostic value through survival analysis (e.g. log-rank tests and Cox proportional hazards modeling). If the variability in SNPs is relatively low, assessment of prognostic value can be conducted with odds ratios of patients responding or surviving progression-free for at least 6 months. These techniques will use exact methods such as Fisher's exact test.

Outcome measures

Outcome data not reported

OTHER_PRE_SPECIFIED outcome

Timeframe: Baseline

Population: Data not collected

BRCA mutational status will be tabulated against the germline mutation to see what proportion of patients have a mutation reversal within the tumor and whether such reversals can explain resistance to the regimen under study.

Outcome measures

Outcome data not reported

Adverse Events

Treatment (Veliparib)

Serious events: 10 serious events

Other events: 48 other events

Deaths: 21 deaths

Serious adverse events

Measure	Treatment (Veliparib) n=50 participants at risk Patients receive veliparib PO BID on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. Laboratory Biomarker Analysis: Correlative studies Veliparib: Given PO
Gastrointestinal disorders Small Intestinal Obstruction	6.0% 3/50 • Adverse events are collected from study enrollment until 30 days after the last treatment, up to 5 years from enrollment.
Gastrointestinal disorders Abdominal Pain	2.0% 1/50 • Adverse events are collected from study enrollment until 30 days after the last treatment, up to 5 years from enrollment.
Gastrointestinal disorders Nausea	2.0% 1/50 • Adverse events are collected from study enrollment until 30 days after the last treatment, up to 5 years from enrollment.
Gastrointestinal disorders Ascites	2.0% 1/50 • Adverse events are collected from study enrollment until 30 days after the last treatment, up to 5 years from enrollment.
Hepatobiliary disorders Hepatobiliary Disorders - Other	2.0% 1/50 • Adverse events are collected from study enrollment until 30 days after the last treatment, up to 5 years from enrollment.
Investigations Alanine Aminotransferase Increased	2.0% 1/50 • Adverse events are collected from study enrollment until 30 days after the last treatment, up to 5 years from enrollment.
Metabolism and nutrition disorders Dehydration	2.0% 1/50 • Adverse events are collected from study enrollment until 30 days after the last treatment, up to 5 years from enrollment.
Respiratory, thoracic and mediastinal disorders Pleural Effusion	2.0% 1/50 • Adverse events are collected from study enrollment until 30 days after the last treatment, up to 5 years from enrollment.
Respiratory, thoracic and mediastinal disorders Adult Respiratory Distress Syndrome	2.0% 1/50 • Adverse events are collected from study enrollment until 30 days after the last treatment, up to 5 years from enrollment.
Vascular disorders Thromboembolic Event	2.0% 1/50 • Adverse events are collected from study enrollment until 30 days after the last treatment, up to 5 years from enrollment.

Other adverse events

Measure	Treatment (Veliparib) n=50 participants at risk Patients receive veliparib PO BID on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. Laboratory Biomarker Analysis: Correlative studies Veliparib: Given PO
Renal and urinary disorders Proteinuria	4.0% 2/50 • Adverse events are collected from study enrollment until 30 days after the last treatment, up to 5 years from enrollment.
Renal and urinary disorders Chronic Kidney Disease	2.0% 1/50 • Adverse events are collected from study enrollment until 30 days after the last treatment, up to 5 years from enrollment.
Reproductive system and breast disorders Pelvic Pain	4.0% 2/50 • Adverse events are collected from study enrollment until 30 days after the last treatment, up to 5 years from enrollment.
Reproductive system and breast disorders Vaginal Discharge	2.0% 1/50 • Adverse events are collected from study enrollment until 30 days after the last treatment, up to 5 years from enrollment.
Respiratory, thoracic and mediastinal disorders Sore Throat	4.0% 2/50 • Adverse events are collected from study enrollment until 30 days after the last treatment, up to 5 years from enrollment.
Respiratory, thoracic and mediastinal disorders Pulmonary Edema	2.0% 1/50 • Adverse events are collected from study enrollment until 30 days after the last treatment, up to 5 years from enrollment.
Respiratory, thoracic and mediastinal disorders Postnasal Drip	4.0% 2/50 • Adverse events are collected from study enrollment until 30 days after the last treatment, up to 5 years from enrollment.
Blood and lymphatic system disorders Anemia	58.0% 29/50 • Adverse events are collected from study enrollment until 30 days after the last treatment, up to 5 years from enrollment.
Cardiac disorders Palpitations	2.0% 1/50 • Adverse events are collected from study enrollment until 30 days after the last treatment, up to 5 years from enrollment.
Cardiac disorders Heart Failure	2.0% 1/50 • Adverse events are collected from study enrollment until 30 days after the last treatment, up to 5 years from enrollment.
Cardiac disorders Paroxysmal Atrial Tachycardia	2.0% 1/50 • Adverse events are collected from study enrollment until 30 days after the last treatment, up to 5 years from enrollment.
Cardiac disorders Sinus Tachycardia	2.0% 1/50 • Adverse events are collected from study enrollment until 30 days after the last treatment, up to 5 years from enrollment.
Ear and labyrinth disorders Vertigo	6.0% 3/50 • Adverse events are collected from study enrollment until 30 days after the last treatment, up to 5 years from enrollment.
Ear and labyrinth disorders Tinnitus	8.0% 4/50 • Adverse events are collected from study enrollment until 30 days after the last treatment, up to 5 years from enrollment.
Ear and labyrinth disorders Hearing Impaired	2.0% 1/50 • Adverse events are collected from study enrollment until 30 days after the last treatment, up to 5 years from enrollment.
Eye disorders Watering Eyes	4.0% 2/50 • Adverse events are collected from study enrollment until 30 days after the last treatment, up to 5 years from enrollment.
Eye disorders Conjunctivitis	2.0% 1/50 • Adverse events are collected from study enrollment until 30 days after the last treatment, up to 5 years from enrollment.
Eye disorders Blurred Vision	6.0% 3/50 • Adverse events are collected from study enrollment until 30 days after the last treatment, up to 5 years from enrollment.
Gastrointestinal disorders Dyspepsia	8.0% 4/50 • Adverse events are collected from study enrollment until 30 days after the last treatment, up to 5 years from enrollment.
Gastrointestinal disorders Dry Mouth	8.0% 4/50 • Adverse events are collected from study enrollment until 30 days after the last treatment, up to 5 years from enrollment.
Gastrointestinal disorders Colonic Perforation	2.0% 1/50 • Adverse events are collected from study enrollment until 30 days after the last treatment, up to 5 years from enrollment.
Gastrointestinal disorders Colonic Fistula	2.0% 1/50 • Adverse events are collected from study enrollment until 30 days after the last treatment, up to 5 years from enrollment.
Gastrointestinal disorders Constipation	40.0% 20/50 • Adverse events are collected from study enrollment until 30 days after the last treatment, up to 5 years from enrollment.
Gastrointestinal disorders Diarrhea	32.0% 16/50 • Adverse events are collected from study enrollment until 30 days after the last treatment, up to 5 years from enrollment.
Gastrointestinal disorders Vomiting	66.0% 33/50 • Adverse events are collected from study enrollment until 30 days after the last treatment, up to 5 years from enrollment.
Gastrointestinal disorders Bloating	16.0% 8/50 • Adverse events are collected from study enrollment until 30 days after the last treatment, up to 5 years from enrollment.
Gastrointestinal disorders Stomach Pain	8.0% 4/50 • Adverse events are collected from study enrollment until 30 days after the last treatment, up to 5 years from enrollment.
Gastrointestinal disorders Small Intestinal Obstruction	4.0% 2/50 • Adverse events are collected from study enrollment until 30 days after the last treatment, up to 5 years from enrollment.
Gastrointestinal disorders Abdominal Pain	30.0% 15/50 • Adverse events are collected from study enrollment until 30 days after the last treatment, up to 5 years from enrollment.
Gastrointestinal disorders Periodontal Disease	2.0% 1/50 • Adverse events are collected from study enrollment until 30 days after the last treatment, up to 5 years from enrollment.
Gastrointestinal disorders Rectal Hemorrhage	2.0% 1/50 • Adverse events are collected from study enrollment until 30 days after the last treatment, up to 5 years from enrollment.
Gastrointestinal disorders Mucositis Oral	6.0% 3/50 • Adverse events are collected from study enrollment until 30 days after the last treatment, up to 5 years from enrollment.
Gastrointestinal disorders Abdominal Distension	4.0% 2/50 • Adverse events are collected from study enrollment until 30 days after the last treatment, up to 5 years from enrollment.
Gastrointestinal disorders Nausea	90.0% 45/50 • Adverse events are collected from study enrollment until 30 days after the last treatment, up to 5 years from enrollment.
Gastrointestinal disorders Gastroesophageal Reflux Disease	8.0% 4/50 • Adverse events are collected from study enrollment until 30 days after the last treatment, up to 5 years from enrollment.
Gastrointestinal disorders Hemorrhoids	4.0% 2/50 • Adverse events are collected from study enrollment until 30 days after the last treatment, up to 5 years from enrollment.
Gastrointestinal disorders Flatulence	8.0% 4/50 • Adverse events are collected from study enrollment until 30 days after the last treatment, up to 5 years from enrollment.
Gastrointestinal disorders Gastritis	4.0% 2/50 • Adverse events are collected from study enrollment until 30 days after the last treatment, up to 5 years from enrollment.
General disorders Pain	10.0% 5/50 • Adverse events are collected from study enrollment until 30 days after the last treatment, up to 5 years from enrollment.
General disorders Malaise	8.0% 4/50 • Adverse events are collected from study enrollment until 30 days after the last treatment, up to 5 years from enrollment.
General disorders Flu Like Symptoms	12.0% 6/50 • Adverse events are collected from study enrollment until 30 days after the last treatment, up to 5 years from enrollment.
General disorders Edema Trunk	4.0% 2/50 • Adverse events are collected from study enrollment until 30 days after the last treatment, up to 5 years from enrollment.
General disorders Non-Cardiac Chest Pain	8.0% 4/50 • Adverse events are collected from study enrollment until 30 days after the last treatment, up to 5 years from enrollment.
General disorders Edema Limbs	4.0% 2/50 • Adverse events are collected from study enrollment until 30 days after the last treatment, up to 5 years from enrollment.
General disorders Fatigue	70.0% 35/50 • Adverse events are collected from study enrollment until 30 days after the last treatment, up to 5 years from enrollment.
General disorders Fever	4.0% 2/50 • Adverse events are collected from study enrollment until 30 days after the last treatment, up to 5 years from enrollment.
General disorders Chills	4.0% 2/50 • Adverse events are collected from study enrollment until 30 days after the last treatment, up to 5 years from enrollment.
Infections and infestations Sepsis	2.0% 1/50 • Adverse events are collected from study enrollment until 30 days after the last treatment, up to 5 years from enrollment.
Infections and infestations Urinary Tract Infection	10.0% 5/50 • Adverse events are collected from study enrollment until 30 days after the last treatment, up to 5 years from enrollment.
Infections and infestations Enterocolitis Infectious	2.0% 1/50 • Adverse events are collected from study enrollment until 30 days after the last treatment, up to 5 years from enrollment.
Injury, poisoning and procedural complications Gastrointestinal Anastomotic Leak	2.0% 1/50 • Adverse events are collected from study enrollment until 30 days after the last treatment, up to 5 years from enrollment.
Injury, poisoning and procedural complications Fracture	2.0% 1/50 • Adverse events are collected from study enrollment until 30 days after the last treatment, up to 5 years from enrollment.
Injury, poisoning and procedural complications Fall	4.0% 2/50 • Adverse events are collected from study enrollment until 30 days after the last treatment, up to 5 years from enrollment.
Injury, poisoning and procedural complications Ankle Fracture	2.0% 1/50 • Adverse events are collected from study enrollment until 30 days after the last treatment, up to 5 years from enrollment.
Investigations Weight Loss	4.0% 2/50 • Adverse events are collected from study enrollment until 30 days after the last treatment, up to 5 years from enrollment.
Investigations Weight Gain	8.0% 4/50 • Adverse events are collected from study enrollment until 30 days after the last treatment, up to 5 years from enrollment.
Investigations Platelet Count Decreased	20.0% 10/50 • Adverse events are collected from study enrollment until 30 days after the last treatment, up to 5 years from enrollment.
Investigations Lymphocyte Count Decreased	16.0% 8/50 • Adverse events are collected from study enrollment until 30 days after the last treatment, up to 5 years from enrollment.
Investigations Creatinine Increased	6.0% 3/50 • Adverse events are collected from study enrollment until 30 days after the last treatment, up to 5 years from enrollment.
Investigations Neutrophil Count Decreased	36.0% 18/50 • Adverse events are collected from study enrollment until 30 days after the last treatment, up to 5 years from enrollment.
Investigations Blood Bilirubin Increased	6.0% 3/50 • Adverse events are collected from study enrollment until 30 days after the last treatment, up to 5 years from enrollment.
Investigations White Blood Cell Decreased	50.0% 25/50 • Adverse events are collected from study enrollment until 30 days after the last treatment, up to 5 years from enrollment.
Investigations Aspartate Aminotransferase Increased	16.0% 8/50 • Adverse events are collected from study enrollment until 30 days after the last treatment, up to 5 years from enrollment.
Investigations Alkaline Phosphatase Increased	18.0% 9/50 • Adverse events are collected from study enrollment until 30 days after the last treatment, up to 5 years from enrollment.
Investigations Alanine Aminotransferase Increased	18.0% 9/50 • Adverse events are collected from study enrollment until 30 days after the last treatment, up to 5 years from enrollment.
Investigations Activated Partial Thromboplastin Time Prolonged	2.0% 1/50 • Adverse events are collected from study enrollment until 30 days after the last treatment, up to 5 years from enrollment.
Metabolism and nutrition disorders Hypophosphatemia	10.0% 5/50 • Adverse events are collected from study enrollment until 30 days after the last treatment, up to 5 years from enrollment.
Metabolism and nutrition disorders Hyponatremia	22.0% 11/50 • Adverse events are collected from study enrollment until 30 days after the last treatment, up to 5 years from enrollment.
Metabolism and nutrition disorders Hypomagnesemia	30.0% 15/50 • Adverse events are collected from study enrollment until 30 days after the last treatment, up to 5 years from enrollment.
Metabolism and nutrition disorders Hypokalemia	20.0% 10/50 • Adverse events are collected from study enrollment until 30 days after the last treatment, up to 5 years from enrollment.
Metabolism and nutrition disorders Hypoglycemia	2.0% 1/50 • Adverse events are collected from study enrollment until 30 days after the last treatment, up to 5 years from enrollment.
Metabolism and nutrition disorders Hypocalcemia	20.0% 10/50 • Adverse events are collected from study enrollment until 30 days after the last treatment, up to 5 years from enrollment.
Metabolism and nutrition disorders Hypoalbuminemia	14.0% 7/50 • Adverse events are collected from study enrollment until 30 days after the last treatment, up to 5 years from enrollment.
Metabolism and nutrition disorders Hyperuricemia	2.0% 1/50 • Adverse events are collected from study enrollment until 30 days after the last treatment, up to 5 years from enrollment.
Metabolism and nutrition disorders Hypermagnesemia	2.0% 1/50 • Adverse events are collected from study enrollment until 30 days after the last treatment, up to 5 years from enrollment.
Metabolism and nutrition disorders Hyperkalemia	4.0% 2/50 • Adverse events are collected from study enrollment until 30 days after the last treatment, up to 5 years from enrollment.
Metabolism and nutrition disorders Hyperglycemia	20.0% 10/50 • Adverse events are collected from study enrollment until 30 days after the last treatment, up to 5 years from enrollment.
Metabolism and nutrition disorders Hypercalcemia	2.0% 1/50 • Adverse events are collected from study enrollment until 30 days after the last treatment, up to 5 years from enrollment.
Metabolism and nutrition disorders Glucose Intolerance	2.0% 1/50 • Adverse events are collected from study enrollment until 30 days after the last treatment, up to 5 years from enrollment.
Metabolism and nutrition disorders Dehydration	2.0% 1/50 • Adverse events are collected from study enrollment until 30 days after the last treatment, up to 5 years from enrollment.
Metabolism and nutrition disorders Anorexia	24.0% 12/50 • Adverse events are collected from study enrollment until 30 days after the last treatment, up to 5 years from enrollment.
Musculoskeletal and connective tissue disorders Pain In Extremity	6.0% 3/50 • Adverse events are collected from study enrollment until 30 days after the last treatment, up to 5 years from enrollment.
Musculoskeletal and connective tissue disorders Myalgia	12.0% 6/50 • Adverse events are collected from study enrollment until 30 days after the last treatment, up to 5 years from enrollment.
Musculoskeletal and connective tissue disorders Muscle Weakness Upper Limb	2.0% 1/50 • Adverse events are collected from study enrollment until 30 days after the last treatment, up to 5 years from enrollment.
Musculoskeletal and connective tissue disorders Muscle Weakness Lower Limb	2.0% 1/50 • Adverse events are collected from study enrollment until 30 days after the last treatment, up to 5 years from enrollment.
Musculoskeletal and connective tissue disorders Generalized Muscle Weakness	8.0% 4/50 • Adverse events are collected from study enrollment until 30 days after the last treatment, up to 5 years from enrollment.
Musculoskeletal and connective tissue disorders Chest Wall Pain	2.0% 1/50 • Adverse events are collected from study enrollment until 30 days after the last treatment, up to 5 years from enrollment.
Musculoskeletal and connective tissue disorders Bone Pain	8.0% 4/50 • Adverse events are collected from study enrollment until 30 days after the last treatment, up to 5 years from enrollment.
Musculoskeletal and connective tissue disorders Back Pain	10.0% 5/50 • Adverse events are collected from study enrollment until 30 days after the last treatment, up to 5 years from enrollment.
Musculoskeletal and connective tissue disorders Arthralgia	10.0% 5/50 • Adverse events are collected from study enrollment until 30 days after the last treatment, up to 5 years from enrollment.
Nervous system disorders Tremor	2.0% 1/50 • Adverse events are collected from study enrollment until 30 days after the last treatment, up to 5 years from enrollment.
Nervous system disorders Somnolence	2.0% 1/50 • Adverse events are collected from study enrollment until 30 days after the last treatment, up to 5 years from enrollment.
Nervous system disorders Peripheral Sensory Neuropathy	28.0% 14/50 • Adverse events are collected from study enrollment until 30 days after the last treatment, up to 5 years from enrollment.
Nervous system disorders Paresthesia	2.0% 1/50 • Adverse events are collected from study enrollment until 30 days after the last treatment, up to 5 years from enrollment.
Nervous system disorders Memory Impairment	6.0% 3/50 • Adverse events are collected from study enrollment until 30 days after the last treatment, up to 5 years from enrollment.
Nervous system disorders Movements Involuntary	4.0% 2/50 • Adverse events are collected from study enrollment until 30 days after the last treatment, up to 5 years from enrollment.
Nervous system disorders Headache	28.0% 14/50 • Adverse events are collected from study enrollment until 30 days after the last treatment, up to 5 years from enrollment.
Nervous system disorders Dysgeusia	10.0% 5/50 • Adverse events are collected from study enrollment until 30 days after the last treatment, up to 5 years from enrollment.
Nervous system disorders Syncope	2.0% 1/50 • Adverse events are collected from study enrollment until 30 days after the last treatment, up to 5 years from enrollment.
Nervous system disorders Dizziness	26.0% 13/50 • Adverse events are collected from study enrollment until 30 days after the last treatment, up to 5 years from enrollment.
Nervous system disorders Depressed Level Of Consciousness	2.0% 1/50 • Adverse events are collected from study enrollment until 30 days after the last treatment, up to 5 years from enrollment.
Nervous system disorders Concentration Impairment	2.0% 1/50 • Adverse events are collected from study enrollment until 30 days after the last treatment, up to 5 years from enrollment.
Nervous system disorders Cognitive Disturbance	2.0% 1/50 • Adverse events are collected from study enrollment until 30 days after the last treatment, up to 5 years from enrollment.
Psychiatric disorders Restlessness	2.0% 1/50 • Adverse events are collected from study enrollment until 30 days after the last treatment, up to 5 years from enrollment.
Psychiatric disorders Insomnia	26.0% 13/50 • Adverse events are collected from study enrollment until 30 days after the last treatment, up to 5 years from enrollment.
Psychiatric disorders Depression	14.0% 7/50 • Adverse events are collected from study enrollment until 30 days after the last treatment, up to 5 years from enrollment.
Psychiatric disorders Confusion	2.0% 1/50 • Adverse events are collected from study enrollment until 30 days after the last treatment, up to 5 years from enrollment.
Psychiatric disorders Anxiety	24.0% 12/50 • Adverse events are collected from study enrollment until 30 days after the last treatment, up to 5 years from enrollment.
Psychiatric disorders Agitation	4.0% 2/50 • Adverse events are collected from study enrollment until 30 days after the last treatment, up to 5 years from enrollment.
Renal and urinary disorders Urinary Incontinence	2.0% 1/50 • Adverse events are collected from study enrollment until 30 days after the last treatment, up to 5 years from enrollment.
Renal and urinary disorders Urinary Frequency	2.0% 1/50 • Adverse events are collected from study enrollment until 30 days after the last treatment, up to 5 years from enrollment.
Respiratory, thoracic and mediastinal disorders Pleural Effusion	6.0% 3/50 • Adverse events are collected from study enrollment until 30 days after the last treatment, up to 5 years from enrollment.
Respiratory, thoracic and mediastinal disorders Nasal Congestion	6.0% 3/50 • Adverse events are collected from study enrollment until 30 days after the last treatment, up to 5 years from enrollment.
Respiratory, thoracic and mediastinal disorders Pharyngeal Stenosis	2.0% 1/50 • Adverse events are collected from study enrollment until 30 days after the last treatment, up to 5 years from enrollment.
Respiratory, thoracic and mediastinal disorders Hypoxia	2.0% 1/50 • Adverse events are collected from study enrollment until 30 days after the last treatment, up to 5 years from enrollment.
Respiratory, thoracic and mediastinal disorders Hoarseness	2.0% 1/50 • Adverse events are collected from study enrollment until 30 days after the last treatment, up to 5 years from enrollment.
Respiratory, thoracic and mediastinal disorders Epistaxis	4.0% 2/50 • Adverse events are collected from study enrollment until 30 days after the last treatment, up to 5 years from enrollment.
Respiratory, thoracic and mediastinal disorders Dyspnea	2.0% 1/50 • Adverse events are collected from study enrollment until 30 days after the last treatment, up to 5 years from enrollment.
Respiratory, thoracic and mediastinal disorders Cough	10.0% 5/50 • Adverse events are collected from study enrollment until 30 days after the last treatment, up to 5 years from enrollment.
Respiratory, thoracic and mediastinal disorders Atelectasis	2.0% 1/50 • Adverse events are collected from study enrollment until 30 days after the last treatment, up to 5 years from enrollment.
Respiratory, thoracic and mediastinal disorders Allergic Rhinitis	4.0% 2/50 • Adverse events are collected from study enrollment until 30 days after the last treatment, up to 5 years from enrollment.
Skin and subcutaneous tissue disorders Skin Hyperpigmentation	2.0% 1/50 • Adverse events are collected from study enrollment until 30 days after the last treatment, up to 5 years from enrollment.
Skin and subcutaneous tissue disorders Rash Acneiform	2.0% 1/50 • Adverse events are collected from study enrollment until 30 days after the last treatment, up to 5 years from enrollment.
Skin and subcutaneous tissue disorders Pruritus	2.0% 1/50 • Adverse events are collected from study enrollment until 30 days after the last treatment, up to 5 years from enrollment.
Skin and subcutaneous tissue disorders Rash Maculo-Papular	12.0% 6/50 • Adverse events are collected from study enrollment until 30 days after the last treatment, up to 5 years from enrollment.
Skin and subcutaneous tissue disorders Nail Discoloration	2.0% 1/50 • Adverse events are collected from study enrollment until 30 days after the last treatment, up to 5 years from enrollment.
Skin and subcutaneous tissue disorders Dry Skin	2.0% 1/50 • Adverse events are collected from study enrollment until 30 days after the last treatment, up to 5 years from enrollment.
Skin and subcutaneous tissue disorders Alopecia	10.0% 5/50 • Adverse events are collected from study enrollment until 30 days after the last treatment, up to 5 years from enrollment.
Vascular disorders Lymphedema	2.0% 1/50 • Adverse events are collected from study enrollment until 30 days after the last treatment, up to 5 years from enrollment.
Vascular disorders Hypotension	2.0% 1/50 • Adverse events are collected from study enrollment until 30 days after the last treatment, up to 5 years from enrollment.
Vascular disorders Hypertension	12.0% 6/50 • Adverse events are collected from study enrollment until 30 days after the last treatment, up to 5 years from enrollment.
Vascular disorders Hot Flashes	12.0% 6/50 • Adverse events are collected from study enrollment until 30 days after the last treatment, up to 5 years from enrollment.
Vascular disorders Flushing	2.0% 1/50 • Adverse events are collected from study enrollment until 30 days after the last treatment, up to 5 years from enrollment.

Additional Information

Christopher Purdy on behalf of Mike Sill

NRG Oncology

Phone: (716)845-1300

Email: purdyc@nrgoncology.org

Results disclosure agreements

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

Restriction type: LTE60