Trial Outcomes & Findings for Paclitaxel Albumin-Stabilized Nanoparticle Formulation in Treating Patients With Recurrent or Persistent Ovarian Epithelial Cancer, Fallopian Tube Cancer, or Primary Peritoneal Cancer (NCT NCT00499252)

Last Updated: 2018-01-11

Results Overview

Complete and Partial Tumor Response by Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0). Per RECIST v1.0 for target lesions and assessed by MRIor CT scan: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), \>=30% decrease in the sum of the longest dimensions (LD) of all target measurable lesions taking as reference the baseline sum of LD. CT scan or MRI if used to follow lesion for measurable disease every other cycle for the first 6 months; every three months thereafter; and at any time if clinically indicated based on symptoms or physical signs suggestive of progressive disease or rising serum tumor marker levels. Responses must be confirmed by repeat imaging 4 weeks following documentation of response.

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

51 participants

Primary outcome timeframe

every other cycle for the first 6 months; every three months thereafter; and at any time if clinically indicated based on symptoms or physical signs suggestive of progressive disease or rising serum tumor marker levels

Results posted on

2018-01-11

Participant Flow

The study was activated on 6/4/2007 and closed to accrual on 1/29/2009.

Participant milestones

Participant milestones
Measure	Abraxane® Abraxane® 100 mg/m2 infused I.V. over 30 minutes weekly on days 1, 8, and 15 every 28 days until disease progression or adverse effects prohibit further therapy.
Overall Study STARTED	51
Overall Study COMPLETED	39
Overall Study NOT COMPLETED	12

Reasons for withdrawal

Reasons for withdrawal
Measure	Abraxane® Abraxane® 100 mg/m2 infused I.V. over 30 minutes weekly on days 1, 8, and 15 every 28 days until disease progression or adverse effects prohibit further therapy.
Overall Study Adverse Event	3
Overall Study Refused further treatment	2
Overall Study Ineligible	4
Overall Study <no further label>	3

Baseline Characteristics

Paclitaxel Albumin-Stabilized Nanoparticle Formulation in Treating Patients With Recurrent or Persistent Ovarian Epithelial Cancer, Fallopian Tube Cancer, or Primary Peritoneal Cancer

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Abraxane® n=47 Participants Abraxane® 100 mg/m2 infused I.V. over 30 minutes weekly on days 1, 8, and 15 every 28 days until disease progression or adverse effects prohibit further therapy.
Age, Customized 20-29 years	0 participants n=5 Participants
Age, Customized 30-39 years	1 participants n=5 Participants
Age, Customized 40-49 years	8 participants n=5 Participants
Age, Customized 50-59 years	16 participants n=5 Participants
Age, Customized 60-69 years	15 participants n=5 Participants
Age, Customized 70-79 years	7 participants n=5 Participants
Sex: Female, Male Female	47 Participants n=5 Participants
Sex: Female, Male Male	0 Participants n=5 Participants

PRIMARY outcome

Timeframe: every other cycle for the first 6 months; every three months thereafter; and at any time if clinically indicated based on symptoms or physical signs suggestive of progressive disease or rising serum tumor marker levels

Population: Eligible and Treated Patients

Outcome measures

Outcome measures
Measure	Abraxane® n=47 Participants Abraxane® 100 mg/m2 infused I.V. over 30 minutes weekly on days 1, 8, and 15 every 28 days until disease progression or adverse effects prohibit further therapy.	Grade 1 (CTCAE v 3.0) Number of patients who experienced a grade 1 event using Common Terminology Criteria version 3.0	Grade 2 (CTCAE v 3.0) Number of patients who experienced a grade 2 event using Common Terminology Criteria version 3.0	Grade 3 (CTCAE v 3.0) Number of patients who experienced a grade 3 event using Common Terminology Criteria version 3.0
Tumor Response	23.4 Percentage of participants Interval 12.3 to 38.0	—	—	—

PRIMARY outcome

Timeframe: Every cycle during treatment and up to 5 years after completion of treatment

Population: Treated and Eligible patients

Outcome measures

Outcome measures
Measure	Abraxane® n=47 Participants Abraxane® 100 mg/m2 infused I.V. over 30 minutes weekly on days 1, 8, and 15 every 28 days until disease progression or adverse effects prohibit further therapy.	Grade 1 (CTCAE v 3.0) n=47 Participants Number of patients who experienced a grade 1 event using Common Terminology Criteria version 3.0	Grade 2 (CTCAE v 3.0) n=47 Participants Number of patients who experienced a grade 2 event using Common Terminology Criteria version 3.0	Grade 3 (CTCAE v 3.0) n=47 Participants Number of patients who experienced a grade 3 event using Common Terminology Criteria version 3.0
Frequency and Severity of Observed Adverse Effects Leukopenia	20 Participants	15 Participants	11 Participants	1 Participants
Frequency and Severity of Observed Adverse Effects Thrombocytopenia	43 Participants	4 Participants	0 Participants	0 Participants
Frequency and Severity of Observed Adverse Effects Anemia	5 Participants	19 Participants	20 Participants	3 Participants
Frequency and Severity of Observed Adverse Effects Cardiac	45 Participants	2 Participants	0 Participants	0 Participants
Frequency and Severity of Observed Adverse Effects Gastrointestinal	18 Participants	19 Participants	8 Participants	2 Participants
Frequency and Severity of Observed Adverse Effects Hemorrhage	45 Participants	1 Participants	1 Participants	0 Participants
Frequency and Severity of Observed Adverse Effects Neurosensory	27 Participants	14 Participants	5 Participants	1 Participants
Frequency and Severity of Observed Adverse Effects Other neurological	42 Participants	4 Participants	1 Participants	0 Participants
Frequency and Severity of Observed Adverse Effects Neutropenia	30 Participants	5 Participants	6 Participants	6 Participants
Frequency and Severity of Observed Adverse Effects Constitutional	12 Participants	20 Participants	15 Participants	0 Participants
Frequency and Severity of Observed Adverse Effects Dermatologic	28 Participants	10 Participants	9 Participants	0 Participants
Frequency and Severity of Observed Adverse Effects Lymphatics	41 Participants	6 Participants	0 Participants	0 Participants
Frequency and Severity of Observed Adverse Effects Metabolic	35 Participants	8 Participants	2 Participants	2 Participants
Frequency and Severity of Observed Adverse Effects Musculoskeletal	44 Participants	2 Participants	1 Participants	0 Participants
Frequency and Severity of Observed Adverse Effects Ocular/Visual	45 Participants	1 Participants	1 Participants	0 Participants
Frequency and Severity of Observed Adverse Effects Pain	32 Participants	10 Participants	3 Participants	2 Participants
Frequency and Severity of Observed Adverse Effects Pulmonary	40 Participants	3 Participants	4 Participants	0 Participants

SECONDARY outcome

Timeframe: from study entry until disease progression, death or date of last contact.

Population: Eligible and Treated Patients

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 (LD) of target lesions taking as reference the smallest sum LD recorded since study entry, or unequivocal progression of existing non-target lesions, or the appearance of one or more new lesions. CT scan or MRI if used to follow lesion for measurable disease every other cycle for the first 6 months; every three months thereafter; and at any time if clinically indicated based on symptoms or physical signs suggestive of progressive disease or rising serum tumor marker levels. Responses must be confirmed by repeat imaging 4 weeks following documentation of response.

Outcome measures

Outcome measures
Measure	Abraxane® n=47 Participants Abraxane® 100 mg/m2 infused I.V. over 30 minutes weekly on days 1, 8, and 15 every 28 days until disease progression or adverse effects prohibit further therapy.	Grade 1 (CTCAE v 3.0) Number of patients who experienced a grade 1 event using Common Terminology Criteria version 3.0	Grade 2 (CTCAE v 3.0) Number of patients who experienced a grade 2 event using Common Terminology Criteria version 3.0	Grade 3 (CTCAE v 3.0) Number of patients who experienced a grade 3 event using Common Terminology Criteria version 3.0
Progression-free Survival	4.5 months Interval 2.2 to 6.7	—	—	—

SECONDARY outcome

Timeframe: from entry into the study to death or the date of last contact.

Population: Eligible and Treated Patients

Outcome measures

Outcome measures
Measure	Abraxane® n=47 Participants Abraxane® 100 mg/m2 infused I.V. over 30 minutes weekly on days 1, 8, and 15 every 28 days until disease progression or adverse effects prohibit further therapy.	Grade 1 (CTCAE v 3.0) Number of patients who experienced a grade 1 event using Common Terminology Criteria version 3.0	Grade 2 (CTCAE v 3.0) Number of patients who experienced a grade 2 event using Common Terminology Criteria version 3.0	Grade 3 (CTCAE v 3.0) Number of patients who experienced a grade 3 event using Common Terminology Criteria version 3.0
Overall Survival	17.4 months Interval 13.2 to 20.8	—	—	—

Adverse Events

Abraxane®

Serious events: 11 serious events

Other events: 47 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Abraxane® n=47 participants at risk Abraxane® 100 mg/m2 infused I.V. over 30 minutes weekly on days 1, 8, and 15 every 28 days until disease progression or adverse effects prohibit further therapy.
Gastrointestinal disorders Ileus	4.3% 2/47 • every cycle "Number of participants at risk" total includes eligible and treated patients.
Gastrointestinal disorders Obstruction, Gi - Small Bowel Nos	8.5% 4/47 • every cycle "Number of participants at risk" total includes eligible and treated patients.
Gastrointestinal disorders Vomiting	2.1% 1/47 • every cycle "Number of participants at risk" total includes eligible and treated patients.
Gastrointestinal disorders Dehydration	2.1% 1/47 • every cycle "Number of participants at risk" total includes eligible and treated patients.
Infections and infestations Inf W/Nml Or Gr 1 Or 2 Anc: Skin(Cellulitis)	2.1% 1/47 • every cycle "Number of participants at risk" total includes eligible and treated patients.
Metabolism and nutrition disorders Hypercalcemia	2.1% 1/47 • every cycle "Number of participants at risk" total includes eligible and treated patients.
General disorders Pain: Extremity-Limb	2.1% 1/47 • every cycle "Number of participants at risk" total includes eligible and treated patients.
Respiratory, thoracic and mediastinal disorders Pleural Effusion	2.1% 1/47 • every cycle "Number of participants at risk" total includes eligible and treated patients.
Renal and urinary disorders Obstruction, Gu - Ureter	2.1% 1/47 • every cycle "Number of participants at risk" total includes eligible and treated patients.

Other adverse events

Other adverse events
Measure	Abraxane® n=47 participants at risk Abraxane® 100 mg/m2 infused I.V. over 30 minutes weekly on days 1, 8, and 15 every 28 days until disease progression or adverse effects prohibit further therapy.
Immune system disorders Rhinitis	2.1% 1/47 • every cycle "Number of participants at risk" total includes eligible and treated patients.
Ear and labyrinth disorders Tinnitus	2.1% 1/47 • every cycle "Number of participants at risk" total includes eligible and treated patients.
Blood and lymphatic system disorders Neutrophils	36.2% 17/47 • every cycle "Number of participants at risk" total includes eligible and treated patients.
Blood and lymphatic system disorders Platelets	8.5% 4/47 • every cycle "Number of participants at risk" total includes eligible and treated patients.
Blood and lymphatic system disorders Leukocytes	59.6% 28/47 • every cycle "Number of participants at risk" total includes eligible and treated patients.
Blood and lymphatic system disorders Hemoglobin	89.4% 42/47 • every cycle "Number of participants at risk" total includes eligible and treated patients.
Cardiac disorders Palpitations	2.1% 1/47 • every cycle "Number of participants at risk" total includes eligible and treated patients.
Cardiac disorders Ventricular Arrhythmia - Tachycardia	2.1% 1/47 • every cycle "Number of participants at risk" total includes eligible and treated patients.
Cardiac disorders Hypertension	2.1% 1/47 • every cycle "Number of participants at risk" total includes eligible and treated patients.
Cardiac disorders Cardiac General - Other	2.1% 1/47 • every cycle "Number of participants at risk" total includes eligible and treated patients.
Cardiac disorders Hypotension	2.1% 1/47 • every cycle "Number of participants at risk" total includes eligible and treated patients.
General disorders Sweating	2.1% 1/47 • every cycle "Number of participants at risk" total includes eligible and treated patients.
General disorders Weight Gain	10.6% 5/47 • every cycle "Number of participants at risk" total includes eligible and treated patients.
General disorders Fever	4.3% 2/47 • every cycle "Number of participants at risk" total includes eligible and treated patients.
General disorders Weight Loss	4.3% 2/47 • every cycle "Number of participants at risk" total includes eligible and treated patients.
General disorders Rigors/Chills	2.1% 1/47 • every cycle "Number of participants at risk" total includes eligible and treated patients.
General disorders Fatigue	70.2% 33/47 • every cycle "Number of participants at risk" total includes eligible and treated patients.
General disorders Insomnia	4.3% 2/47 • every cycle "Number of participants at risk" total includes eligible and treated patients.
Skin and subcutaneous tissue disorders Nail Changes	6.4% 3/47 • every cycle "Number of participants at risk" total includes eligible and treated patients.
Skin and subcutaneous tissue disorders Photosensitivity	2.1% 1/47 • every cycle "Number of participants at risk" total includes eligible and treated patients.
Skin and subcutaneous tissue disorders Hair Loss/Alopecia (Scalp Or Body)	40.4% 19/47 • every cycle "Number of participants at risk" total includes eligible and treated patients.
Skin and subcutaneous tissue disorders Bruising	2.1% 1/47 • every cycle "Number of participants at risk" total includes eligible and treated patients.
Skin and subcutaneous tissue disorders Rash	14.9% 7/47 • every cycle "Number of participants at risk" total includes eligible and treated patients.
Skin and subcutaneous tissue disorders Dry Skin	2.1% 1/47 • every cycle "Number of participants at risk" total includes eligible and treated patients.
Skin and subcutaneous tissue disorders Pruritus	2.1% 1/47 • every cycle "Number of participants at risk" total includes eligible and treated patients.
Endocrine disorders Hot Flashes	6.4% 3/47 • every cycle "Number of participants at risk" total includes eligible and treated patients.
Gastrointestinal disorders Fistula, Gi - Small Bowel Nos	2.1% 1/47 • every cycle "Number of participants at risk" total includes eligible and treated patients.
Gastrointestinal disorders Esophagitis	2.1% 1/47 • every cycle "Number of participants at risk" total includes eligible and treated patients.
Gastrointestinal disorders Heartburn	6.4% 3/47 • every cycle "Number of participants at risk" total includes eligible and treated patients.
Gastrointestinal disorders Dental: Teeth	2.1% 1/47 • every cycle "Number of participants at risk" total includes eligible and treated patients.
Gastrointestinal disorders Ascites	2.1% 1/47 • every cycle "Number of participants at risk" total includes eligible and treated patients.
Gastrointestinal disorders Ileus	2.1% 1/47 • every cycle "Number of participants at risk" total includes eligible and treated patients.
Gastrointestinal disorders Dysphagia	2.1% 1/47 • every cycle "Number of participants at risk" total includes eligible and treated patients.
Gastrointestinal disorders Distention	6.4% 3/47 • every cycle "Number of participants at risk" total includes eligible and treated patients.
Gastrointestinal disorders Taste Alteration	4.3% 2/47 • every cycle "Number of participants at risk" total includes eligible and treated patients.
Gastrointestinal disorders Mucositis (Functional/Sympt) - Oral Cavity	4.3% 2/47 • every cycle "Number of participants at risk" total includes eligible and treated patients.
Gastrointestinal disorders Obstruction, Gi - Small Bowel Nos	6.4% 3/47 • every cycle "Number of participants at risk" total includes eligible and treated patients.
Gastrointestinal disorders Mucositis (Clinical Exam) - Oral Cavity	2.1% 1/47 • every cycle "Number of participants at risk" total includes eligible and treated patients.
Gastrointestinal disorders Vomiting	29.8% 14/47 • every cycle "Number of participants at risk" total includes eligible and treated patients.
Gastrointestinal disorders Anorexia	14.9% 7/47 • every cycle "Number of participants at risk" total includes eligible and treated patients.
Gastrointestinal disorders Dehydration	4.3% 2/47 • every cycle "Number of participants at risk" total includes eligible and treated patients.
Gastrointestinal disorders Constipation	25.5% 12/47 • every cycle "Number of participants at risk" total includes eligible and treated patients.
Gastrointestinal disorders Nausea	44.7% 21/47 • every cycle "Number of participants at risk" total includes eligible and treated patients.
Gastrointestinal disorders Diarrhea	25.5% 12/47 • every cycle "Number of participants at risk" total includes eligible and treated patients.
Vascular disorders Hemorrhage, Gi - Rectum	2.1% 1/47 • every cycle "Number of participants at risk" total includes eligible and treated patients.
Vascular disorders Hemorrhage/Pulmonary - Nose	6.4% 3/47 • every cycle "Number of participants at risk" total includes eligible and treated patients.
Vascular disorders Hematoma	2.1% 1/47 • every cycle "Number of participants at risk" total includes eligible and treated patients.
Vascular disorders Petechiae	2.1% 1/47 • every cycle "Number of participants at risk" total includes eligible and treated patients.
Infections and infestations Inf W/Nml Or Gr 1 Or 2 Anc: Upper Airway Nos	2.1% 1/47 • every cycle "Number of participants at risk" total includes eligible and treated patients.
Infections and infestations Inf W/Nml Or Gr 1 Or 2 Anc: Oral Cavity-Gums	2.1% 1/47 • every cycle "Number of participants at risk" total includes eligible and treated patients.
Infections and infestations Inf Unknown Anc: Sinus	2.1% 1/47 • every cycle "Number of participants at risk" total includes eligible and treated patients.
Infections and infestations Inf W/Nml Or Gr 1 Or 2 Anc: Urinary Tract Nos	8.5% 4/47 • every cycle "Number of participants at risk" total includes eligible and treated patients.
Infections and infestations Inf W/Nml Or Gr 1 Or 2 Anc: Bronchus	2.1% 1/47 • every cycle "Number of participants at risk" total includes eligible and treated patients.
Infections and infestations Inf Unknown Anc: Upper Airway Nos	2.1% 1/47 • every cycle "Number of participants at risk" total includes eligible and treated patients.
Infections and infestations Inf W/Nml Or Gr 1 Or 2 Anc: Sinus	4.3% 2/47 • every cycle "Number of participants at risk" total includes eligible and treated patients.
Infections and infestations Inf W/Nml Or Gr 1 Or 2 Anc: Bladder	4.3% 2/47 • every cycle "Number of participants at risk" total includes eligible and treated patients.
Blood and lymphatic system disorders Lymphedema-Related Fibrosis	2.1% 1/47 • every cycle "Number of participants at risk" total includes eligible and treated patients.
Blood and lymphatic system disorders Edema: Trunk/Genital	4.3% 2/47 • every cycle "Number of participants at risk" total includes eligible and treated patients.
Blood and lymphatic system disorders Edema: Limb	17.0% 8/47 • every cycle "Number of participants at risk" total includes eligible and treated patients.
Metabolism and nutrition disorders Ast	4.3% 2/47 • every cycle "Number of participants at risk" total includes eligible and treated patients.
Metabolism and nutrition disorders Creatinine	4.3% 2/47 • every cycle "Number of participants at risk" total includes eligible and treated patients.
Metabolism and nutrition disorders Hypoalbuminemia	4.3% 2/47 • every cycle "Number of participants at risk" total includes eligible and treated patients.
Metabolism and nutrition disorders Alt	4.3% 2/47 • every cycle "Number of participants at risk" total includes eligible and treated patients.
Metabolism and nutrition disorders Alkaline Phosphatase	4.3% 2/47 • every cycle "Number of participants at risk" total includes eligible and treated patients.
Metabolism and nutrition disorders Bilirubin	4.3% 2/47 • every cycle "Number of participants at risk" total includes eligible and treated patients.
Metabolism and nutrition disorders Hypophosphatemia	4.3% 2/47 • every cycle "Number of participants at risk" total includes eligible and treated patients.
Metabolism and nutrition disorders Hyponatremia	8.5% 4/47 • every cycle "Number of participants at risk" total includes eligible and treated patients.
Metabolism and nutrition disorders Hypertriglyceridemia	2.1% 1/47 • every cycle "Number of participants at risk" total includes eligible and treated patients.
Metabolism and nutrition disorders Hypocalcemia	8.5% 4/47 • every cycle "Number of participants at risk" total includes eligible and treated patients.
Metabolism and nutrition disorders Hyperkalemia	6.4% 3/47 • every cycle "Number of participants at risk" total includes eligible and treated patients.
Metabolism and nutrition disorders Hyperglycemia	12.8% 6/47 • every cycle "Number of participants at risk" total includes eligible and treated patients.
Metabolism and nutrition disorders Hypokalemia	8.5% 4/47 • every cycle "Number of participants at risk" total includes eligible and treated patients.
Metabolism and nutrition disorders Hypercalcemia	4.3% 2/47 • every cycle "Number of participants at risk" total includes eligible and treated patients.
Metabolism and nutrition disorders Hypomagnesemia	14.9% 7/47 • every cycle "Number of participants at risk" total includes eligible and treated patients.
Musculoskeletal and connective tissue disorders Joint-Function	2.1% 1/47 • every cycle "Number of participants at risk" total includes eligible and treated patients.
Musculoskeletal and connective tissue disorders Joint Effusion	2.1% 1/47 • every cycle "Number of participants at risk" total includes eligible and treated patients.
Musculoskeletal and connective tissue disorders Arthritis	4.3% 2/47 • every cycle "Number of participants at risk" total includes eligible and treated patients.
Musculoskeletal and connective tissue disorders Muscle Weakness - Whole Body/Generalized	2.1% 1/47 • every cycle "Number of participants at risk" total includes eligible and treated patients.
Musculoskeletal and connective tissue disorders Muscle Weakness - Extremity-Lower	2.1% 1/47 • every cycle "Number of participants at risk" total includes eligible and treated patients.
Nervous system disorders Syncope	2.1% 1/47 • every cycle "Number of participants at risk" total includes eligible and treated patients.
Nervous system disorders Mood Alteration - Depression	10.6% 5/47 • every cycle "Number of participants at risk" total includes eligible and treated patients.
Nervous system disorders Mood Alteration - Anxiety	10.6% 5/47 • every cycle "Number of participants at risk" total includes eligible and treated patients.
Nervous system disorders Ataxia	2.1% 1/47 • every cycle "Number of participants at risk" total includes eligible and treated patients.
Nervous system disorders Memory Impairment	2.1% 1/47 • every cycle "Number of participants at risk" total includes eligible and treated patients.
Nervous system disorders Dizziness	6.4% 3/47 • every cycle "Number of participants at risk" total includes eligible and treated patients.
Nervous system disorders Neuropathy-Sensory	51.1% 24/47 • every cycle "Number of participants at risk" total includes eligible and treated patients.
Nervous system disorders Neuropathy-Motor	6.4% 3/47 • every cycle "Number of participants at risk" total includes eligible and treated patients.
Eye disorders Blurred Vision	6.4% 3/47 • every cycle "Number of participants at risk" total includes eligible and treated patients.
General disorders Pain - Other	2.1% 1/47 • every cycle "Number of participants at risk" total includes eligible and treated patients.
General disorders Pain: Pelvis	2.1% 1/47 • every cycle "Number of participants at risk" total includes eligible and treated patients.
General disorders Pain: Chest /Thorax Nos	4.3% 2/47 • every cycle "Number of participants at risk" total includes eligible and treated patients.
General disorders Pain: Head/Headache	12.8% 6/47 • every cycle "Number of participants at risk" total includes eligible and treated patients.
General disorders Pain: Extremity-Limb	8.5% 4/47 • every cycle "Number of participants at risk" total includes eligible and treated patients.
General disorders Pain: Buttock	2.1% 1/47 • every cycle "Number of participants at risk" total includes eligible and treated patients.
General disorders Pain: Back	10.6% 5/47 • every cycle "Number of participants at risk" total includes eligible and treated patients.
General disorders Pain: Joint	14.9% 7/47 • every cycle "Number of participants at risk" total includes eligible and treated patients.
General disorders Pain: Bone	2.1% 1/47 • every cycle "Number of participants at risk" total includes eligible and treated patients.
General disorders Pain: Pain Nos	2.1% 1/47 • every cycle "Number of participants at risk" total includes eligible and treated patients.
General disorders Pain: Stomach	2.1% 1/47 • every cycle "Number of participants at risk" total includes eligible and treated patients.
General disorders Pain: Rectum	2.1% 1/47 • every cycle "Number of participants at risk" total includes eligible and treated patients.
General disorders Pain: Abdominal Pain Nos	29.8% 14/47 • every cycle "Number of participants at risk" total includes eligible and treated patients.
General disorders Pain: Tumor	2.1% 1/47 • every cycle "Number of participants at risk" total includes eligible and treated patients.
General disorders Pain: Muscle	2.1% 1/47 • every cycle "Number of participants at risk" total includes eligible and treated patients.
General disorders Pain: Neuralgia	2.1% 1/47 • every cycle "Number of participants at risk" total includes eligible and treated patients.
Respiratory, thoracic and mediastinal disorders Pulmonary: Other	6.4% 3/47 • every cycle "Number of participants at risk" total includes eligible and treated patients.
Respiratory, thoracic and mediastinal disorders Nasal/Paranasal Reactions	6.4% 3/47 • every cycle "Number of participants at risk" total includes eligible and treated patients.
Respiratory, thoracic and mediastinal disorders Pneumothorax	2.1% 1/47 • every cycle "Number of participants at risk" total includes eligible and treated patients.
Respiratory, thoracic and mediastinal disorders Cough	17.0% 8/47 • every cycle "Number of participants at risk" total includes eligible and treated patients.
Respiratory, thoracic and mediastinal disorders Pleural Effusion	4.3% 2/47 • every cycle "Number of participants at risk" total includes eligible and treated patients.
Respiratory, thoracic and mediastinal disorders Dyspnea	23.4% 11/47 • every cycle "Number of participants at risk" total includes eligible and treated patients.
Renal and urinary disorders Cystitis	2.1% 1/47 • every cycle "Number of participants at risk" total includes eligible and treated patients.
Renal and urinary disorders Incontinence, Urinary	2.1% 1/47 • every cycle "Number of participants at risk" total includes eligible and treated patients.
Renal and urinary disorders Urinary Frequency	2.1% 1/47 • every cycle "Number of participants at risk" total includes eligible and treated patients.
Reproductive system and breast disorders Vaginitis	2.1% 1/47 • every cycle "Number of participants at risk" total includes eligible and treated patients.
Reproductive system and breast disorders Vaginal Discharge	2.1% 1/47 • every cycle "Number of participants at risk" total includes eligible and treated patients.

Additional Information

Angela M. Kuras, Associate Director of Data Management

NRG Oncology Statistics and Data Management Center - Buffalo

Phone: 716-845-7733

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place