Trial Outcomes & Findings for Gefitinib and PEG-Interferon Alfa-2b in Treating Patients With Unresectable or Metastatic Kidney Cancer (NCT NCT00467077)

NCT ID: NCT00467077

Last Updated: 2017-03-17

Results Overview

Estimated using the product-limit method of Kaplan and Meier. Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of LD of target lesions taking as references the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions or unequivocal progression of existing non-target lesions

• Recruitment status: TERMINATED
• Study phase: PHASE2
• Target enrollment: 21 participants
• Primary outcome timeframe: From the date treatment started until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 6 months
• Results posted on: 2017-03-17

Participant Flow

Participant milestones

Measure	Gefitinib and PEG-IFNa Treatment Gefitinib administered at a dose of 250 mg orally once daily for 12 weeks. PEG-IFNa at 4.0 µg/kg/wk administered subcutaneously once weekly for 6 weeks (cycle repeated once for a total of 2 cycles).
Overall Study STARTED	21
Overall Study COMPLETED	21
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Gefitinib and PEG-Interferon Alfa-2b in Treating Patients With Unresectable or Metastatic Kidney Cancer

Baseline characteristics by cohort

Measure	Gefitinib and PEG-IFNa Treatment n=21 Participants Gefitinib administered at a dose of 250 mg orally once daily for 12 weeks. PEG-IFNa at 4.0 µg/kg/wk administered subcutaneously once weekly for 6 weeks (cycle repeated once for a total of 2 cycles).
Age, Continuous	60 years n=5 Participants
Sex: Female, Male Female	6 Participants n=5 Participants
Sex: Female, Male Male	15 Participants n=5 Participants
Region of Enrollment United States	21 participants n=5 Participants

PRIMARY outcome

Timeframe: From the date treatment started until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 6 months

Estimated using the product-limit method of Kaplan and Meier. Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of LD of target lesions taking as references the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions or unequivocal progression of existing non-target lesions

Outcome measures

Measure	Gefitinib and PEG-IFNa Treatment n=21 Participants Gefitinib administered at a dose of 250 mg orally once daily for 12 weeks. PEG-IFNa at 4.0 µg/kg/wk administered subcutaneously once weekly for 6 weeks (cycle repeated once for a total of 2 cycles).
Six-month Progression-free Survival	29 percentage of participants Interval 15.0 to 56.0

SECONDARY outcome

Timeframe: After 2 cycles of treatment, up to 2 years.

Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Overall Response = CR + PR

Outcome measures

Measure	Gefitinib and PEG-IFNa Treatment n=21 Participants Gefitinib administered at a dose of 250 mg orally once daily for 12 weeks. PEG-IFNa at 4.0 µg/kg/wk administered subcutaneously once weekly for 6 weeks (cycle repeated once for a total of 2 cycles).
Number of Participants With Overall Response as Measured by RECIST Criteria	2 participants

SECONDARY outcome

Timeframe: Until disease progression, up to 5 years.

Estimated using the product-limit method of Kaplan and Meier. Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions.

Outcome measures

Measure	Gefitinib and PEG-IFNa Treatment n=21 Participants Gefitinib administered at a dose of 250 mg orally once daily for 12 weeks. PEG-IFNa at 4.0 µg/kg/wk administered subcutaneously once weekly for 6 weeks (cycle repeated once for a total of 2 cycles).
Progression-Free Survival	5.2 Months Interval 3.0 to 10.1

SECONDARY outcome

Timeframe: Up to 5 years.

Estimated using the product-limit method of Kaplan and Meier.

Outcome measures

Measure	Gefitinib and PEG-IFNa Treatment n=21 Participants Gefitinib administered at a dose of 250 mg orally once daily for 12 weeks. PEG-IFNa at 4.0 µg/kg/wk administered subcutaneously once weekly for 6 weeks (cycle repeated once for a total of 2 cycles).
Overall Survival	13.6 Months Interval 10.3 to NA - The upper limit of the 95% confidence interval was not calculable because an insufficient number of participants reached the event at the final time point for assessment.

Adverse Events

Arm 1

Serious events: 11 serious events

Other events: 20 other events

Deaths: 0 deaths

Serious adverse events

Measure	Arm 1 n=21 participants at risk Gefitinib administered at a dose of 250 mg orally once daily for 12 weeks. PEG-IFNa at 4.0 µg/kg/wk administered subcutaneously once weekly for 6 weeks (cycle repeated once for a total of 2 cycles).
Cardiac disorders Atrial fibrillation	4.8% 1/21 • Number of events 1 • Adverse events were collected over a period of 38 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Gastrointestinal disorders Nausea	9.5% 2/21 • Number of events 2 • Adverse events were collected over a period of 38 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
General disorders Edema limbs	4.8% 1/21 • Number of events 1 • Adverse events were collected over a period of 38 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
General disorders Fatigue	9.5% 2/21 • Number of events 2 • Adverse events were collected over a period of 38 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Injury, poisoning and procedural complications Fracture	4.8% 1/21 • Number of events 1 • Adverse events were collected over a period of 38 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Investigations Aspartate aminotransferase increased	4.8% 1/21 • Number of events 1 • Adverse events were collected over a period of 38 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Investigations Creatinine increased	4.8% 1/21 • Number of events 1 • Adverse events were collected over a period of 38 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Investigations INR increased	4.8% 1/21 • Number of events 1 • Adverse events were collected over a period of 38 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Investigations Leukopenia	4.8% 1/21 • Number of events 1 • Adverse events were collected over a period of 38 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Investigations Lymphopenia	4.8% 1/21 • Number of events 1 • Adverse events were collected over a period of 38 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Investigations Neutrophil count decreased	4.8% 1/21 • Number of events 1 • Adverse events were collected over a period of 38 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Metabolism and nutrition disorders Anorexia	4.8% 1/21 • Number of events 1 • Adverse events were collected over a period of 38 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Metabolism and nutrition disorders Dehydration	9.5% 2/21 • Number of events 2 • Adverse events were collected over a period of 38 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Metabolism and nutrition disorders Hypokalemia	4.8% 1/21 • Number of events 1 • Adverse events were collected over a period of 38 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Metabolism and nutrition disorders Hyponatremia	9.5% 2/21 • Number of events 2 • Adverse events were collected over a period of 38 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Musculoskeletal and connective tissue disorders Muscle weakness	4.8% 1/21 • Number of events 1 • Adverse events were collected over a period of 38 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Nervous system disorders Syncope	4.8% 1/21 • Number of events 1 • Adverse events were collected over a period of 38 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Renal and urinary disorders Renal failure	4.8% 1/21 • Number of events 2 • Adverse events were collected over a period of 38 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Respiratory, thoracic and mediastinal disorders Dyspnea	14.3% 3/21 • Number of events 3 • Adverse events were collected over a period of 38 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Respiratory, thoracic and mediastinal disorders Hypoxia	4.8% 1/21 • Number of events 1 • Adverse events were collected over a period of 38 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Skin and subcutaneous tissue disorders Acne	4.8% 1/21 • Number of events 1 • Adverse events were collected over a period of 38 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Vascular disorders Hypotension	14.3% 3/21 • Number of events 3 • Adverse events were collected over a period of 38 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Vascular disorders Thrombosis	4.8% 1/21 • Number of events 1 • Adverse events were collected over a period of 38 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.

Other adverse events

Measure	Arm 1 n=21 participants at risk Gefitinib administered at a dose of 250 mg orally once daily for 12 weeks. PEG-IFNa at 4.0 µg/kg/wk administered subcutaneously once weekly for 6 weeks (cycle repeated once for a total of 2 cycles).
Blood and lymphatic system disorders Hemoglobin decreased	81.0% 17/21 • Number of events 63 • Adverse events were collected over a period of 38 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Cardiac disorders Cardiac disorder	4.8% 1/21 • Number of events 3 • Adverse events were collected over a period of 38 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Cardiac disorders Palpitations	4.8% 1/21 • Number of events 1 • Adverse events were collected over a period of 38 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Eye disorders Conjunctival disorder	4.8% 1/21 • Number of events 6 • Adverse events were collected over a period of 38 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Eye disorders Dry eye syndrome	4.8% 1/21 • Number of events 3 • Adverse events were collected over a period of 38 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Eye disorders Eye disorder	4.8% 1/21 • Number of events 1 • Adverse events were collected over a period of 38 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Eye disorders Eyelid function disorder	9.5% 2/21 • Number of events 11 • Adverse events were collected over a period of 38 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Eye disorders Retinopathy	4.8% 1/21 • Number of events 3 • Adverse events were collected over a period of 38 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Eye disorders Vision blurred	9.5% 2/21 • Number of events 3 • Adverse events were collected over a period of 38 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Eye disorders Watering eyes	4.8% 1/21 • Number of events 2 • Adverse events were collected over a period of 38 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Gastrointestinal disorders Abdominal pain	14.3% 3/21 • Number of events 9 • Adverse events were collected over a period of 38 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Gastrointestinal disorders Constipation	4.8% 1/21 • Number of events 1 • Adverse events were collected over a period of 38 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Gastrointestinal disorders Diarrhea	61.9% 13/21 • Number of events 28 • Adverse events were collected over a period of 38 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Gastrointestinal disorders Dry mouth	14.3% 3/21 • Number of events 4 • Adverse events were collected over a period of 38 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Gastrointestinal disorders Dyspepsia	4.8% 1/21 • Number of events 1 • Adverse events were collected over a period of 38 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Gastrointestinal disorders Dysphagia	9.5% 2/21 • Number of events 2 • Adverse events were collected over a period of 38 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Gastrointestinal disorders Ear, nose and throat examination abnormal	9.5% 2/21 • Number of events 3 • Adverse events were collected over a period of 38 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Gastrointestinal disorders Hemorrhoids	4.8% 1/21 • Number of events 1 • Adverse events were collected over a period of 38 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Gastrointestinal disorders Mucositis oral	4.8% 1/21 • Number of events 1 • Adverse events were collected over a period of 38 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Gastrointestinal disorders Nausea	61.9% 13/21 • Number of events 21 • Adverse events were collected over a period of 38 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Gastrointestinal disorders Vomiting	38.1% 8/21 • Number of events 10 • Adverse events were collected over a period of 38 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
General disorders Chills	4.8% 1/21 • Number of events 1 • Adverse events were collected over a period of 38 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
General disorders Disease progression	33.3% 7/21 • Number of events 7 • Adverse events were collected over a period of 38 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
General disorders Edema limbs	9.5% 2/21 • Number of events 12 • Adverse events were collected over a period of 38 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
General disorders Fatigue	81.0% 17/21 • Number of events 48 • Adverse events were collected over a period of 38 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
General disorders Fever	9.5% 2/21 • Number of events 2 • Adverse events were collected over a period of 38 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
General disorders Flu-like symptoms	4.8% 1/21 • Number of events 1 • Adverse events were collected over a period of 38 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
General disorders Gait abnormal	4.8% 1/21 • Number of events 2 • Adverse events were collected over a period of 38 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
General disorders General symptom	4.8% 1/21 • Number of events 2 • Adverse events were collected over a period of 38 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
General disorders Injection site reaction	4.8% 1/21 • Number of events 1 • Adverse events were collected over a period of 38 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
General disorders Pain	9.5% 2/21 • Number of events 3 • Adverse events were collected over a period of 38 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Infections and infestations Eye infection	4.8% 1/21 • Number of events 2 • Adverse events were collected over a period of 38 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Infections and infestations Infection	9.5% 2/21 • Number of events 2 • Adverse events were collected over a period of 38 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Infections and infestations Nail infection	4.8% 1/21 • Number of events 3 • Adverse events were collected over a period of 38 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Infections and infestations Pneumonia	4.8% 1/21 • Number of events 1 • Adverse events were collected over a period of 38 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Infections and infestations Rhinitis infective	4.8% 1/21 • Number of events 3 • Adverse events were collected over a period of 38 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Infections and infestations Scrotal infection	4.8% 1/21 • Number of events 1 • Adverse events were collected over a period of 38 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Infections and infestations Upper respiratory infection	9.5% 2/21 • Number of events 3 • Adverse events were collected over a period of 38 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Infections and infestations Urinary tract infection	4.8% 1/21 • Number of events 1 • Adverse events were collected over a period of 38 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Injury, poisoning and procedural complications Bruising	4.8% 1/21 • Number of events 2 • Adverse events were collected over a period of 38 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Injury, poisoning and procedural complications Fracture	4.8% 1/21 • Number of events 1 • Adverse events were collected over a period of 38 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Investigations Alanine aminotransferase increased	38.1% 8/21 • Number of events 15 • Adverse events were collected over a period of 38 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Investigations Alkaline phosphatase increased	28.6% 6/21 • Number of events 8 • Adverse events were collected over a period of 38 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Investigations Aspartate aminotransferase increased	47.6% 10/21 • Number of events 22 • Adverse events were collected over a period of 38 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Investigations Bilirubin increased	9.5% 2/21 • Number of events 9 • Adverse events were collected over a period of 38 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Investigations Creatinine increased	38.1% 8/21 • Number of events 34 • Adverse events were collected over a period of 38 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Investigations Hyperbilirubinemia	14.3% 3/21 • Number of events 4 • Adverse events were collected over a period of 38 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Investigations INR increased	4.8% 1/21 • Number of events 2 • Adverse events were collected over a period of 38 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Investigations Leukocyte count decreased	23.8% 5/21 • Number of events 10 • Adverse events were collected over a period of 38 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Investigations Leukopenia	52.4% 11/21 • Number of events 18 • Adverse events were collected over a period of 38 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Investigations Lymphocyte count decreased	19.0% 4/21 • Number of events 10 • Adverse events were collected over a period of 38 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Investigations Lymphopenia	14.3% 3/21 • Number of events 5 • Adverse events were collected over a period of 38 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Investigations Neutrophil count decreased	47.6% 10/21 • Number of events 16 • Adverse events were collected over a period of 38 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Investigations Platelet count decreased	28.6% 6/21 • Number of events 9 • Adverse events were collected over a period of 38 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Investigations Weight loss	28.6% 6/21 • Number of events 18 • Adverse events were collected over a period of 38 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Metabolism and nutrition disorders Anorexia	61.9% 13/21 • Number of events 29 • Adverse events were collected over a period of 38 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Metabolism and nutrition disorders Blood glucose increased	9.5% 2/21 • Number of events 11 • Adverse events were collected over a period of 38 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Metabolism and nutrition disorders Dehydration	23.8% 5/21 • Number of events 5 • Adverse events were collected over a period of 38 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Metabolism and nutrition disorders Hypercalcemia	14.3% 3/21 • Number of events 5 • Adverse events were collected over a period of 38 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Metabolism and nutrition disorders Hyperglycemia	52.4% 11/21 • Number of events 36 • Adverse events were collected over a period of 38 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Metabolism and nutrition disorders Hyperkalemia	9.5% 2/21 • Number of events 3 • Adverse events were collected over a period of 38 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Metabolism and nutrition disorders Hypernatremia	4.8% 1/21 • Number of events 1 • Adverse events were collected over a period of 38 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Metabolism and nutrition disorders Hypoalbuminemia	57.1% 12/21 • Number of events 28 • Adverse events were collected over a period of 38 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Metabolism and nutrition disorders Hypocalcemia	23.8% 5/21 • Number of events 6 • Adverse events were collected over a period of 38 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Metabolism and nutrition disorders Hypoglycemia	9.5% 2/21 • Number of events 3 • Adverse events were collected over a period of 38 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Metabolism and nutrition disorders Hypokalemia	14.3% 3/21 • Number of events 3 • Adverse events were collected over a period of 38 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Metabolism and nutrition disorders Hyponatremia	28.6% 6/21 • Number of events 7 • Adverse events were collected over a period of 38 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Metabolism and nutrition disorders Serum albumin decreased	19.0% 4/21 • Number of events 7 • Adverse events were collected over a period of 38 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Metabolism and nutrition disorders Serum calcium decreased	9.5% 2/21 • Number of events 3 • Adverse events were collected over a period of 38 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Metabolism and nutrition disorders Serum glucose decreased	4.8% 1/21 • Number of events 1 • Adverse events were collected over a period of 38 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Metabolism and nutrition disorders Serum potassium decreased	4.8% 1/21 • Number of events 1 • Adverse events were collected over a period of 38 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Metabolism and nutrition disorders Serum potassium increased	4.8% 1/21 • Number of events 1 • Adverse events were collected over a period of 38 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Musculoskeletal and connective tissue disorders Back pain	23.8% 5/21 • Number of events 9 • Adverse events were collected over a period of 38 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Musculoskeletal and connective tissue disorders Bone pain	4.8% 1/21 • Number of events 1 • Adverse events were collected over a period of 38 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Musculoskeletal and connective tissue disorders Joint pain	14.3% 3/21 • Number of events 16 • Adverse events were collected over a period of 38 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Musculoskeletal and connective tissue disorders Muscle weakness	14.3% 3/21 • Number of events 10 • Adverse events were collected over a period of 38 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Musculoskeletal and connective tissue disorders Muscle weakness lower limb	4.8% 1/21 • Number of events 2 • Adverse events were collected over a period of 38 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Musculoskeletal and connective tissue disorders Muscle weakness trunk	4.8% 1/21 • Number of events 1 • Adverse events were collected over a period of 38 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Musculoskeletal and connective tissue disorders Myalgia	23.8% 5/21 • Number of events 8 • Adverse events were collected over a period of 38 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Musculoskeletal and connective tissue disorders Pain in extremity	19.0% 4/21 • Number of events 9 • Adverse events were collected over a period of 38 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Nervous system disorders Dizziness	23.8% 5/21 • Number of events 9 • Adverse events were collected over a period of 38 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Nervous system disorders Headache	9.5% 2/21 • Number of events 8 • Adverse events were collected over a period of 38 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Nervous system disorders Memory impairment	9.5% 2/21 • Number of events 14 • Adverse events were collected over a period of 38 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Nervous system disorders Peripheral motor neuropathy	4.8% 1/21 • Number of events 3 • Adverse events were collected over a period of 38 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Nervous system disorders Sinus pain	4.8% 1/21 • Number of events 1 • Adverse events were collected over a period of 38 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Nervous system disorders Syncope	4.8% 1/21 • Number of events 1 • Adverse events were collected over a period of 38 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Nervous system disorders Taste alteration	4.8% 1/21 • Number of events 1 • Adverse events were collected over a period of 38 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Nervous system disorders Tremor	4.8% 1/21 • Number of events 19 • Adverse events were collected over a period of 38 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Psychiatric disorders Agitation	9.5% 2/21 • Number of events 3 • Adverse events were collected over a period of 38 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Psychiatric disorders Anxiety	19.0% 4/21 • Number of events 7 • Adverse events were collected over a period of 38 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Psychiatric disorders Depression	23.8% 5/21 • Number of events 26 • Adverse events were collected over a period of 38 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Psychiatric disorders Euphoria	4.8% 1/21 • Number of events 3 • Adverse events were collected over a period of 38 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Psychiatric disorders Insomnia	14.3% 3/21 • Number of events 4 • Adverse events were collected over a period of 38 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Renal and urinary disorders Bladder hemorrhage	4.8% 1/21 • Number of events 1 • Adverse events were collected over a period of 38 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Renal and urinary disorders Bladder pain	4.8% 1/21 • Number of events 2 • Adverse events were collected over a period of 38 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Renal and urinary disorders Hemorrhage urinary tract	9.5% 2/21 • Number of events 3 • Adverse events were collected over a period of 38 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Renal and urinary disorders Proteinuria	9.5% 2/21 • Number of events 2 • Adverse events were collected over a period of 38 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Renal and urinary disorders Urethral pain	4.8% 1/21 • Number of events 1 • Adverse events were collected over a period of 38 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Renal and urinary disorders Urinary frequency	9.5% 2/21 • Number of events 4 • Adverse events were collected over a period of 38 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Renal and urinary disorders Urinary retention	4.8% 1/21 • Number of events 3 • Adverse events were collected over a period of 38 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Renal and urinary disorders Urine discoloration	4.8% 1/21 • Number of events 1 • Adverse events were collected over a period of 38 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Respiratory, thoracic and mediastinal disorders Allergic rhinitis	14.3% 3/21 • Number of events 16 • Adverse events were collected over a period of 38 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Respiratory, thoracic and mediastinal disorders Cough	9.5% 2/21 • Number of events 16 • Adverse events were collected over a period of 38 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Respiratory, thoracic and mediastinal disorders Dyspnea	28.6% 6/21 • Number of events 8 • Adverse events were collected over a period of 38 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Respiratory, thoracic and mediastinal disorders Hemorrhage nasal	4.8% 1/21 • Number of events 5 • Adverse events were collected over a period of 38 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Respiratory, thoracic and mediastinal disorders Laryngeal mucositis	4.8% 1/21 • Number of events 1 • Adverse events were collected over a period of 38 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Respiratory, thoracic and mediastinal disorders Nasal congestion	4.8% 1/21 • Number of events 1 • Adverse events were collected over a period of 38 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Respiratory, thoracic and mediastinal disorders Pharyngolaryngeal pain	4.8% 1/21 • Number of events 1 • Adverse events were collected over a period of 38 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Respiratory, thoracic and mediastinal disorders Pleuritic pain	4.8% 1/21 • Number of events 1 • Adverse events were collected over a period of 38 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Respiratory, thoracic and mediastinal disorders Respiratory disorder	4.8% 1/21 • Number of events 4 • Adverse events were collected over a period of 38 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Respiratory, thoracic and mediastinal disorders Voice alteration	9.5% 2/21 • Number of events 16 • Adverse events were collected over a period of 38 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Skin and subcutaneous tissue disorders Acne	23.8% 5/21 • Number of events 23 • Adverse events were collected over a period of 38 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Skin and subcutaneous tissue disorders Alopecia	9.5% 2/21 • Number of events 4 • Adverse events were collected over a period of 38 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Skin and subcutaneous tissue disorders Dry skin	33.3% 7/21 • Number of events 19 • Adverse events were collected over a period of 38 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Skin and subcutaneous tissue disorders Nail disorder	14.3% 3/21 • Number of events 5 • Adverse events were collected over a period of 38 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Skin and subcutaneous tissue disorders Petechiae	4.8% 1/21 • Number of events 1 • Adverse events were collected over a period of 38 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Skin and subcutaneous tissue disorders Pruritus	9.5% 2/21 • Number of events 3 • Adverse events were collected over a period of 38 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Skin and subcutaneous tissue disorders Rash acneiform	19.0% 4/21 • Number of events 19 • Adverse events were collected over a period of 38 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Skin and subcutaneous tissue disorders Rash desquamating	33.3% 7/21 • Number of events 28 • Adverse events were collected over a period of 38 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Skin and subcutaneous tissue disorders Skin disorder	4.8% 1/21 • Number of events 2 • Adverse events were collected over a period of 38 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Skin and subcutaneous tissue disorders Skin ulceration	4.8% 1/21 • Number of events 1 • Adverse events were collected over a period of 38 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Skin and subcutaneous tissue disorders Sweating	4.8% 1/21 • Number of events 2 • Adverse events were collected over a period of 38 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Vascular disorders Hypertension	9.5% 2/21 • Number of events 2 • Adverse events were collected over a period of 38 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.

Additional Information

DCC Project Administrator

California Cancer Consortium

Phone: 626-256-4673

Email: CCCP@coh.org

Results disclosure agreements

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

Restriction type: LTE60