Trial Outcomes & Findings for Cetuximab and Capecitabine in Treating Patients With Metastatic Colorectal Cancer That Failed Irinotecan Treatment (NCT NCT00538291)

Last Updated: 2014-08-28

Results Overview

Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by spiral CT scan: 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 (OR) = CR + PR.

Recruitment status

TERMINATED

Study phase

PHASE2

Target enrollment

13 participants

Primary outcome timeframe

Assessment after every 2 cycles of treatment, up to 1 year.

Results posted on

2014-08-28

Participant Flow

Participant milestones

Participant milestones
Measure	Arm 1 Cetuximab 400mg/m2 IV on day 1 over 2 hours then 250 mg/m2 over 1 hour weekly + Xeloda(Capecitabine) 1000mg/m2 BID on days 1-14 repeated every 21 days.
Overall Study STARTED	13
Overall Study COMPLETED	10
Overall Study NOT COMPLETED	3

Reasons for withdrawal

Reasons for withdrawal
Measure	Arm 1 Cetuximab 400mg/m2 IV on day 1 over 2 hours then 250 mg/m2 over 1 hour weekly + Xeloda(Capecitabine) 1000mg/m2 BID on days 1-14 repeated every 21 days.
Overall Study Adverse Event	2
Overall Study Withdrawal by Subject	1

Baseline Characteristics

Cetuximab and Capecitabine in Treating Patients With Metastatic Colorectal Cancer That Failed Irinotecan Treatment

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Arm 1 n=13 Participants Cetuximab 400mg/m2 IV on day 1 over 2 hours then 250 mg/m2 over 1 hour weekly + Xeloda(Capecitabine) 1000mg/m2 BID on days 1-14 repeated every 21 days.
Age, Continuous	61 years n=5 Participants
Sex: Female, Male Female	6 Participants n=5 Participants
Sex: Female, Male Male	7 Participants n=5 Participants
Region of Enrollment United States	13 participants n=5 Participants

PRIMARY outcome

Timeframe: Assessment after every 2 cycles of treatment, up to 1 year.

Population: The three patients not completing at least two courses of treatment were considered treatment failures and were included in efficacy analysis.

Outcome measures

Outcome measures
Measure	Arm 1 n=13 Participants Cetuximab 400mg/m2 IV on day 1 over 2 hours then 250 mg/m2 over 1 hour weekly + Xeloda(Capecitabine) 1000mg/m2 BID on days 1-14 repeated every 21 days.
Response Rate	1 number of responding participants

Adverse Events

Arm 1

Serious events: 4 serious events

Other events: 13 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Arm 1 n=13 participants at risk Cetuximab 400mg/m2 IV on day 1 over 2 hours then 250 mg/m2 over 1 hour weekly + Xeloda(Capecitabine) 1000mg/m2 BID on days 1-14 repeated every 21 days.
Gastrointestinal disorders Diarrhea	15.4% 2/13 • Number of events 2 • Adverse events occurred over a period of of 17 months. "Other" adverse events include all grades and attribution to treatment that are not included in "Serious" adverse events
Gastrointestinal disorders Mucositis oral	7.7% 1/13 • Number of events 1 • Adverse events occurred over a period of of 17 months. "Other" adverse events include all grades and attribution to treatment that are not included in "Serious" adverse events
Gastrointestinal disorders Nausea	7.7% 1/13 • Number of events 1 • Adverse events occurred over a period of of 17 months. "Other" adverse events include all grades and attribution to treatment that are not included in "Serious" adverse events
Gastrointestinal disorders Vomiting	7.7% 1/13 • Number of events 1 • Adverse events occurred over a period of of 17 months. "Other" adverse events include all grades and attribution to treatment that are not included in "Serious" adverse events
General disorders Death	7.7% 1/13 • Number of events 1 • Adverse events occurred over a period of of 17 months. "Other" adverse events include all grades and attribution to treatment that are not included in "Serious" adverse events
Infections and infestations Penile infection	7.7% 1/13 • Number of events 1 • Adverse events occurred over a period of of 17 months. "Other" adverse events include all grades and attribution to treatment that are not included in "Serious" adverse events
Investigations Leukocyte count decreased	7.7% 1/13 • Number of events 1 • Adverse events occurred over a period of of 17 months. "Other" adverse events include all grades and attribution to treatment that are not included in "Serious" adverse events
Metabolism and nutrition disorders Anorexia	7.7% 1/13 • Number of events 1 • Adverse events occurred over a period of of 17 months. "Other" adverse events include all grades and attribution to treatment that are not included in "Serious" adverse events
Metabolism and nutrition disorders Dehydration	15.4% 2/13 • Number of events 2 • Adverse events occurred over a period of of 17 months. "Other" adverse events include all grades and attribution to treatment that are not included in "Serious" adverse events
Metabolism and nutrition disorders Serum phosphate decreased	7.7% 1/13 • Number of events 1 • Adverse events occurred over a period of of 17 months. "Other" adverse events include all grades and attribution to treatment that are not included in "Serious" adverse events

Other adverse events

Other adverse events
Measure	Arm 1 n=13 participants at risk Cetuximab 400mg/m2 IV on day 1 over 2 hours then 250 mg/m2 over 1 hour weekly + Xeloda(Capecitabine) 1000mg/m2 BID on days 1-14 repeated every 21 days.
Blood and lymphatic system disorders Hemoglobin decreased	69.2% 9/13 • Number of events 23 • Adverse events occurred over a period of of 17 months. "Other" adverse events include all grades and attribution to treatment that are not included in "Serious" adverse events
Cardiac disorders Sinus tachycardia	15.4% 2/13 • Number of events 2 • Adverse events occurred over a period of of 17 months. "Other" adverse events include all grades and attribution to treatment that are not included in "Serious" adverse events
Gastrointestinal disorders Abdominal distension	7.7% 1/13 • Number of events 4 • Adverse events occurred over a period of of 17 months. "Other" adverse events include all grades and attribution to treatment that are not included in "Serious" adverse events
Gastrointestinal disorders Abdominal pain	15.4% 2/13 • Number of events 3 • Adverse events occurred over a period of of 17 months. "Other" adverse events include all grades and attribution to treatment that are not included in "Serious" adverse events
Gastrointestinal disorders Constipation	7.7% 1/13 • Number of events 1 • Adverse events occurred over a period of of 17 months. "Other" adverse events include all grades and attribution to treatment that are not included in "Serious" adverse events
Gastrointestinal disorders Diarrhea	23.1% 3/13 • Number of events 5 • Adverse events occurred over a period of of 17 months. "Other" adverse events include all grades and attribution to treatment that are not included in "Serious" adverse events
Gastrointestinal disorders Dyspepsia	7.7% 1/13 • Number of events 1 • Adverse events occurred over a period of of 17 months. "Other" adverse events include all grades and attribution to treatment that are not included in "Serious" adverse events
Gastrointestinal disorders Dysphagia	7.7% 1/13 • Number of events 1 • Adverse events occurred over a period of of 17 months. "Other" adverse events include all grades and attribution to treatment that are not included in "Serious" adverse events
Gastrointestinal disorders Ear, nose and throat examination abnormal	23.1% 3/13 • Number of events 3 • Adverse events occurred over a period of of 17 months. "Other" adverse events include all grades and attribution to treatment that are not included in "Serious" adverse events
Gastrointestinal disorders Enteritis	7.7% 1/13 • Number of events 1 • Adverse events occurred over a period of of 17 months. "Other" adverse events include all grades and attribution to treatment that are not included in "Serious" adverse events
Gastrointestinal disorders Nausea	15.4% 2/13 • Number of events 2 • Adverse events occurred over a period of of 17 months. "Other" adverse events include all grades and attribution to treatment that are not included in "Serious" adverse events
Gastrointestinal disorders Rectal pain	7.7% 1/13 • Number of events 1 • Adverse events occurred over a period of of 17 months. "Other" adverse events include all grades and attribution to treatment that are not included in "Serious" adverse events
Gastrointestinal disorders Vomiting	15.4% 2/13 • Number of events 2 • Adverse events occurred over a period of of 17 months. "Other" adverse events include all grades and attribution to treatment that are not included in "Serious" adverse events
General disorders Chest pain	7.7% 1/13 • Number of events 1 • Adverse events occurred over a period of of 17 months. "Other" adverse events include all grades and attribution to treatment that are not included in "Serious" adverse events
General disorders Chills	7.7% 1/13 • Number of events 1 • Adverse events occurred over a period of of 17 months. "Other" adverse events include all grades and attribution to treatment that are not included in "Serious" adverse events
General disorders Edema limbs	30.8% 4/13 • Number of events 5 • Adverse events occurred over a period of of 17 months. "Other" adverse events include all grades and attribution to treatment that are not included in "Serious" adverse events
General disorders Fatigue	92.3% 12/13 • Number of events 42 • Adverse events occurred over a period of of 17 months. "Other" adverse events include all grades and attribution to treatment that are not included in "Serious" adverse events
General disorders Fever	23.1% 3/13 • Number of events 3 • Adverse events occurred over a period of of 17 months. "Other" adverse events include all grades and attribution to treatment that are not included in "Serious" adverse events
General disorders Injection site reaction	7.7% 1/13 • Number of events 1 • Adverse events occurred over a period of of 17 months. "Other" adverse events include all grades and attribution to treatment that are not included in "Serious" adverse events
Infections and infestations Conjunctivitis infective	7.7% 1/13 • Number of events 1 • Adverse events occurred over a period of of 17 months. "Other" adverse events include all grades and attribution to treatment that are not included in "Serious" adverse events
Infections and infestations Upper respiratory infection	7.7% 1/13 • Number of events 1 • Adverse events occurred over a period of of 17 months. "Other" adverse events include all grades and attribution to treatment that are not included in "Serious" adverse events
Infections and infestations Vaginal infection	7.7% 1/13 • Number of events 1 • Adverse events occurred over a period of of 17 months. "Other" adverse events include all grades and attribution to treatment that are not included in "Serious" adverse events
Injury, poisoning and procedural complications Vascular access complication	7.7% 1/13 • Number of events 1 • Adverse events occurred over a period of of 17 months. "Other" adverse events include all grades and attribution to treatment that are not included in "Serious" adverse events
Investigations Activated partial thromboplastin time prolonged	7.7% 1/13 • Number of events 1 • Adverse events occurred over a period of of 17 months. "Other" adverse events include all grades and attribution to treatment that are not included in "Serious" adverse events
Investigations Alanine aminotransferase increased	61.5% 8/13 • Number of events 20 • Adverse events occurred over a period of of 17 months. "Other" adverse events include all grades and attribution to treatment that are not included in "Serious" adverse events
Investigations Alkaline phosphatase increased	69.2% 9/13 • Number of events 20 • Adverse events occurred over a period of of 17 months. "Other" adverse events include all grades and attribution to treatment that are not included in "Serious" adverse events
Investigations Aspartate aminotransferase increased	84.6% 11/13 • Number of events 37 • Adverse events occurred over a period of of 17 months. "Other" adverse events include all grades and attribution to treatment that are not included in "Serious" adverse events
Investigations Bilirubin increased	23.1% 3/13 • Number of events 3 • Adverse events occurred over a period of of 17 months. "Other" adverse events include all grades and attribution to treatment that are not included in "Serious" adverse events
Investigations Creatinine increased	15.4% 2/13 • Number of events 2 • Adverse events occurred over a period of of 17 months. "Other" adverse events include all grades and attribution to treatment that are not included in "Serious" adverse events
Investigations Hyperbilirubinemia	15.4% 2/13 • Number of events 5 • Adverse events occurred over a period of of 17 months. "Other" adverse events include all grades and attribution to treatment that are not included in "Serious" adverse events
Investigations Leukocyte count decreased	38.5% 5/13 • Number of events 8 • Adverse events occurred over a period of of 17 months. "Other" adverse events include all grades and attribution to treatment that are not included in "Serious" adverse events
Investigations Leukopenia	7.7% 1/13 • Number of events 2 • Adverse events occurred over a period of of 17 months. "Other" adverse events include all grades and attribution to treatment that are not included in "Serious" adverse events
Investigations Lipase increased	7.7% 1/13 • Number of events 1 • Adverse events occurred over a period of of 17 months. "Other" adverse events include all grades and attribution to treatment that are not included in "Serious" adverse events
Investigations Lymphocyte count decreased	7.7% 1/13 • Number of events 2 • Adverse events occurred over a period of of 17 months. "Other" adverse events include all grades and attribution to treatment that are not included in "Serious" adverse events
Investigations Lymphopenia	23.1% 3/13 • Number of events 5 • Adverse events occurred over a period of of 17 months. "Other" adverse events include all grades and attribution to treatment that are not included in "Serious" adverse events
Investigations Neutrophil count decreased	15.4% 2/13 • Number of events 3 • Adverse events occurred over a period of of 17 months. "Other" adverse events include all grades and attribution to treatment that are not included in "Serious" adverse events
Investigations Platelet count decreased	23.1% 3/13 • Number of events 16 • Adverse events occurred over a period of of 17 months. "Other" adverse events include all grades and attribution to treatment that are not included in "Serious" adverse events
Investigations Weight loss	23.1% 3/13 • Number of events 3 • Adverse events occurred over a period of of 17 months. "Other" adverse events include all grades and attribution to treatment that are not included in "Serious" adverse events
Metabolism and nutrition disorders Anorexia	23.1% 3/13 • Number of events 3 • Adverse events occurred over a period of of 17 months. "Other" adverse events include all grades and attribution to treatment that are not included in "Serious" adverse events
Metabolism and nutrition disorders Blood bicarbonate decreased	7.7% 1/13 • Number of events 1 • Adverse events occurred over a period of of 17 months. "Other" adverse events include all grades and attribution to treatment that are not included in "Serious" adverse events
Metabolism and nutrition disorders Blood glucose increased	15.4% 2/13 • Number of events 3 • Adverse events occurred over a period of of 17 months. "Other" adverse events include all grades and attribution to treatment that are not included in "Serious" adverse events
Metabolism and nutrition disorders Hypercalcemia	7.7% 1/13 • Number of events 1 • Adverse events occurred over a period of of 17 months. "Other" adverse events include all grades and attribution to treatment that are not included in "Serious" adverse events
Metabolism and nutrition disorders Hyperglycemia	23.1% 3/13 • Number of events 7 • Adverse events occurred over a period of of 17 months. "Other" adverse events include all grades and attribution to treatment that are not included in "Serious" adverse events
Metabolism and nutrition disorders Hypoalbuminemia	30.8% 4/13 • Number of events 13 • Adverse events occurred over a period of of 17 months. "Other" adverse events include all grades and attribution to treatment that are not included in "Serious" adverse events
Metabolism and nutrition disorders Hypocalcemia	30.8% 4/13 • Number of events 11 • Adverse events occurred over a period of of 17 months. "Other" adverse events include all grades and attribution to treatment that are not included in "Serious" adverse events
Metabolism and nutrition disorders Hypokalemia	7.7% 1/13 • Number of events 6 • Adverse events occurred over a period of of 17 months. "Other" adverse events include all grades and attribution to treatment that are not included in "Serious" adverse events
Metabolism and nutrition disorders Hypomagnesemia	7.7% 1/13 • Number of events 2 • Adverse events occurred over a period of of 17 months. "Other" adverse events include all grades and attribution to treatment that are not included in "Serious" adverse events
Metabolism and nutrition disorders Hyponatremia	15.4% 2/13 • Number of events 4 • Adverse events occurred over a period of of 17 months. "Other" adverse events include all grades and attribution to treatment that are not included in "Serious" adverse events
Metabolism and nutrition disorders Hypophosphatemia	23.1% 3/13 • Number of events 6 • Adverse events occurred over a period of of 17 months. "Other" adverse events include all grades and attribution to treatment that are not included in "Serious" adverse events
Metabolism and nutrition disorders Serum albumin decreased	30.8% 4/13 • Number of events 7 • Adverse events occurred over a period of of 17 months. "Other" adverse events include all grades and attribution to treatment that are not included in "Serious" adverse events
Metabolism and nutrition disorders Serum calcium decreased	23.1% 3/13 • Number of events 6 • Adverse events occurred over a period of of 17 months. "Other" adverse events include all grades and attribution to treatment that are not included in "Serious" adverse events
Metabolism and nutrition disorders Serum calcium increased	7.7% 1/13 • Number of events 1 • Adverse events occurred over a period of of 17 months. "Other" adverse events include all grades and attribution to treatment that are not included in "Serious" adverse events
Metabolism and nutrition disorders Serum glucose decreased	7.7% 1/13 • Number of events 1 • Adverse events occurred over a period of of 17 months. "Other" adverse events include all grades and attribution to treatment that are not included in "Serious" adverse events
Metabolism and nutrition disorders Serum magnesium decreased	30.8% 4/13 • Number of events 11 • Adverse events occurred over a period of of 17 months. "Other" adverse events include all grades and attribution to treatment that are not included in "Serious" adverse events
Metabolism and nutrition disorders Serum magnesium increased	15.4% 2/13 • Number of events 2 • Adverse events occurred over a period of of 17 months. "Other" adverse events include all grades and attribution to treatment that are not included in "Serious" adverse events
Metabolism and nutrition disorders Serum phosphate decreased	23.1% 3/13 • Number of events 4 • Adverse events occurred over a period of of 17 months. "Other" adverse events include all grades and attribution to treatment that are not included in "Serious" adverse events
Metabolism and nutrition disorders Serum potassium decreased	30.8% 4/13 • Number of events 9 • Adverse events occurred over a period of of 17 months. "Other" adverse events include all grades and attribution to treatment that are not included in "Serious" adverse events
Metabolism and nutrition disorders Serum potassium increased	7.7% 1/13 • Number of events 1 • Adverse events occurred over a period of of 17 months. "Other" adverse events include all grades and attribution to treatment that are not included in "Serious" adverse events
Metabolism and nutrition disorders Serum sodium decreased	15.4% 2/13 • Number of events 2 • Adverse events occurred over a period of of 17 months. "Other" adverse events include all grades and attribution to treatment that are not included in "Serious" adverse events
Musculoskeletal and connective tissue disorders Back pain	23.1% 3/13 • Number of events 7 • Adverse events occurred over a period of of 17 months. "Other" adverse events include all grades and attribution to treatment that are not included in "Serious" adverse events
Musculoskeletal and connective tissue disorders Chest wall pain	15.4% 2/13 • Number of events 7 • Adverse events occurred over a period of of 17 months. "Other" adverse events include all grades and attribution to treatment that are not included in "Serious" adverse events
Musculoskeletal and connective tissue disorders Muscle weakness	7.7% 1/13 • Number of events 1 • Adverse events occurred over a period of of 17 months. "Other" adverse events include all grades and attribution to treatment that are not included in "Serious" adverse events
Musculoskeletal and connective tissue disorders Myalgia	7.7% 1/13 • Number of events 1 • Adverse events occurred over a period of of 17 months. "Other" adverse events include all grades and attribution to treatment that are not included in "Serious" adverse events
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Tumor pain	7.7% 1/13 • Number of events 1 • Adverse events occurred over a period of of 17 months. "Other" adverse events include all grades and attribution to treatment that are not included in "Serious" adverse events
Nervous system disorders Dizziness	7.7% 1/13 • Number of events 1 • Adverse events occurred over a period of of 17 months. "Other" adverse events include all grades and attribution to treatment that are not included in "Serious" adverse events
Nervous system disorders Peripheral sensory neuropathy	23.1% 3/13 • Number of events 7 • Adverse events occurred over a period of of 17 months. "Other" adverse events include all grades and attribution to treatment that are not included in "Serious" adverse events
Psychiatric disorders Confusion	15.4% 2/13 • Number of events 2 • Adverse events occurred over a period of of 17 months. "Other" adverse events include all grades and attribution to treatment that are not included in "Serious" adverse events
Psychiatric disorders Depression	7.7% 1/13 • Number of events 1 • Adverse events occurred over a period of of 17 months. "Other" adverse events include all grades and attribution to treatment that are not included in "Serious" adverse events
Psychiatric disorders Insomnia	7.7% 1/13 • Number of events 2 • Adverse events occurred over a period of of 17 months. "Other" adverse events include all grades and attribution to treatment that are not included in "Serious" adverse events
Renal and urinary disorders Bladder pain	7.7% 1/13 • Number of events 1 • Adverse events occurred over a period of of 17 months. "Other" adverse events include all grades and attribution to treatment that are not included in "Serious" adverse events
Renal and urinary disorders Protein urine positive	7.7% 1/13 • Number of events 1 • Adverse events occurred over a period of of 17 months. "Other" adverse events include all grades and attribution to treatment that are not included in "Serious" adverse events
Renal and urinary disorders Ureteric hemorrhage	15.4% 2/13 • Number of events 3 • Adverse events occurred over a period of of 17 months. "Other" adverse events include all grades and attribution to treatment that are not included in "Serious" adverse events
Renal and urinary disorders Urethral pain	7.7% 1/13 • Number of events 1 • Adverse events occurred over a period of of 17 months. "Other" adverse events include all grades and attribution to treatment that are not included in "Serious" adverse events
Renal and urinary disorders Urinary frequency	7.7% 1/13 • Number of events 2 • Adverse events occurred over a period of of 17 months. "Other" adverse events include all grades and attribution to treatment that are not included in "Serious" adverse events
Renal and urinary disorders Urine discoloration	7.7% 1/13 • Number of events 1 • Adverse events occurred over a period of of 17 months. "Other" adverse events include all grades and attribution to treatment that are not included in "Serious" adverse events
Respiratory, thoracic and mediastinal disorders Dyspnea	30.8% 4/13 • Number of events 7 • Adverse events occurred over a period of of 17 months. "Other" adverse events include all grades and attribution to treatment that are not included in "Serious" adverse events
Respiratory, thoracic and mediastinal disorders Pharyngolaryngeal pain	7.7% 1/13 • Number of events 1 • Adverse events occurred over a period of of 17 months. "Other" adverse events include all grades and attribution to treatment that are not included in "Serious" adverse events
Respiratory, thoracic and mediastinal disorders Voice alteration	7.7% 1/13 • Number of events 1 • Adverse events occurred over a period of of 17 months. "Other" adverse events include all grades and attribution to treatment that are not included in "Serious" adverse events
Skin and subcutaneous tissue disorders Acne	30.8% 4/13 • Number of events 13 • Adverse events occurred over a period of of 17 months. "Other" adverse events include all grades and attribution to treatment that are not included in "Serious" adverse events
Skin and subcutaneous tissue disorders Dry skin	7.7% 1/13 • Number of events 2 • Adverse events occurred over a period of of 17 months. "Other" adverse events include all grades and attribution to treatment that are not included in "Serious" adverse events
Skin and subcutaneous tissue disorders Hand-and-foot syndrome	61.5% 8/13 • Number of events 15 • Adverse events occurred over a period of of 17 months. "Other" adverse events include all grades and attribution to treatment that are not included in "Serious" adverse events
Skin and subcutaneous tissue disorders Nail disorder	7.7% 1/13 • Number of events 2 • Adverse events occurred over a period of of 17 months. "Other" adverse events include all grades and attribution to treatment that are not included in "Serious" adverse events
Skin and subcutaneous tissue disorders Pruritus	7.7% 1/13 • Number of events 1 • Adverse events occurred over a period of of 17 months. "Other" adverse events include all grades and attribution to treatment that are not included in "Serious" adverse events
Skin and subcutaneous tissue disorders Rash acneiform	53.8% 7/13 • Number of events 16 • Adverse events occurred over a period of of 17 months. "Other" adverse events include all grades and attribution to treatment that are not included in "Serious" adverse events
Skin and subcutaneous tissue disorders Rash desquamating	30.8% 4/13 • Number of events 6 • Adverse events occurred over a period of of 17 months. "Other" adverse events include all grades and attribution to treatment that are not included in "Serious" adverse events
Skin and subcutaneous tissue disorders Skin disorder	7.7% 1/13 • Number of events 1 • Adverse events occurred over a period of of 17 months. "Other" adverse events include all grades and attribution to treatment that are not included in "Serious" adverse events
Skin and subcutaneous tissue disorders Skin hyperpigmentation	7.7% 1/13 • Number of events 2 • Adverse events occurred over a period of of 17 months. "Other" adverse events include all grades and attribution to treatment that are not included in "Serious" adverse events
Skin and subcutaneous tissue disorders Skin ulceration	7.7% 1/13 • Number of events 1 • Adverse events occurred over a period of of 17 months. "Other" adverse events include all grades and attribution to treatment that are not included in "Serious" adverse events
Vascular disorders Flushing	7.7% 1/13 • Number of events 2 • Adverse events occurred over a period of of 17 months. "Other" adverse events include all grades and attribution to treatment that are not included in "Serious" adverse events
Vascular disorders Hypotension	7.7% 1/13 • Number of events 1 • Adverse events occurred over a period of of 17 months. "Other" adverse events include all grades and attribution to treatment that are not included in "Serious" adverse events

Additional Information

Paul Frankel, Ph.D.

City of Hope National Medical Center

Phone: (626)359-8111

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place