Trial Outcomes & Findings for Elesclomol Sodium and Paclitaxel in Treating Patients With Recurrent or Persistent Ovarian Epithelial Cancer, Fallopian Tube Cancer, or Primary Peritoneal Cancer (NCT NCT00888615)
NCT ID: NCT00888615
Last Updated: 2021-10-20
Results Overview
Proportion of Participants with Object Response (per response evaluation criteria in solid tumors criteria (RECIST V1.1) for target lesions as 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 (OR) = CR + PR.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
58 participants
Primary outcome timeframe
Up to 5 years
Results posted on
2021-10-20
Participant Flow
Participant milestones
| Measure |
Treatment (Paclitaxel, Elesclomol Sodium)
Patients receive paclitaxel IV over 1 hour and elesclomol sodium IV over 1 hour on days 1, 8, and 15. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. NOTE: Patients who are currently on treatment must not be dosed with elesclomol sodium after 12/31/2015. All other study procedures, with the exception of elesclomol sodium administration and paclitaxel administration, should continue in accordance with protocol requirements. Any treatment given after 12/31/2015, including continuation of paclitaxel, will be considered off study.
Elesclomol Sodium: Given IV
Paclitaxel: Given IV
|
|---|---|
|
Overall Study
STARTED
|
58
|
|
Overall Study
COMPLETED
|
56
|
|
Overall Study
NOT COMPLETED
|
2
|
Reasons for withdrawal
| Measure |
Treatment (Paclitaxel, Elesclomol Sodium)
Patients receive paclitaxel IV over 1 hour and elesclomol sodium IV over 1 hour on days 1, 8, and 15. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. NOTE: Patients who are currently on treatment must not be dosed with elesclomol sodium after 12/31/2015. All other study procedures, with the exception of elesclomol sodium administration and paclitaxel administration, should continue in accordance with protocol requirements. Any treatment given after 12/31/2015, including continuation of paclitaxel, will be considered off study.
Elesclomol Sodium: Given IV
Paclitaxel: Given IV
|
|---|---|
|
Overall Study
No treatment
|
2
|
Baseline Characteristics
Elesclomol Sodium and Paclitaxel in Treating Patients With Recurrent or Persistent Ovarian Epithelial Cancer, Fallopian Tube Cancer, or Primary Peritoneal Cancer
Baseline characteristics by cohort
| Measure |
Treatment (Paclitaxel, Elesclomol Sodium)
n=56 Participants
Patients receive paclitaxel IV over 1 hour and elesclomol sodium IV over 1 hour on days 1, 8, and 15. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. NOTE: Patients who are currently on treatment must not be dosed with elesclomol sodium after 12/31/2015. All other study procedures, with the exception of elesclomol sodium administration and paclitaxel administration, should continue in accordance with protocol requirements. Any treatment given after 12/31/2015, including continuation of paclitaxel, will be considered off study.
Elesclomol Sodium: Given IV
Paclitaxel: Given IV
|
|---|---|
|
Age, Customized
20-29 years
|
0 Participants
n=5 Participants
|
|
Age, Customized
30-39 years
|
0 Participants
n=5 Participants
|
|
Age, Customized
40-49 years
|
6 Participants
n=5 Participants
|
|
Age, Customized
50-59 years
|
12 Participants
n=5 Participants
|
|
Age, Customized
60-69 years
|
22 Participants
n=5 Participants
|
|
Age, Customized
70-79 years
|
14 Participants
n=5 Participants
|
|
Age, Customized
>= 80 years
|
2 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
56 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=5 Participants
|
|
Cell Type
Adenocarcinoma, nos
|
8 Participants
n=5 Participants
|
|
Cell Type
Clear cell
|
2 Participants
n=5 Participants
|
|
Cell Type
Endometrioid
|
2 Participants
n=5 Participants
|
|
Cell Type
Serous
|
44 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Up to 5 yearsProportion of Participants with Object Response (per response evaluation criteria in solid tumors criteria (RECIST V1.1) for target lesions as 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 (OR) = CR + PR.
Outcome measures
| Measure |
Treatment (Paclitaxel, Elesclomol Sodium)
n=56 Participants
Patients receive paclitaxel IV over 1 hour and elesclomol sodium IV over 1 hour on days 1, 8, and 15. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. NOTE: Patients who are currently on treatment must not be dosed with elesclomol sodium after 12/31/2015. All other study procedures, with the exception of elesclomol sodium administration and paclitaxel administration, should continue in accordance with protocol requirements. Any treatment given after 12/31/2015, including continuation of paclitaxel, will be considered off study.
Elesclomol Sodium: Given IV
Paclitaxel: Given IV
|
|---|---|
|
Proportion of Participants With Objective Response
|
0.196 Proportion of participants
Interval 0.114 to 0.304
|
PRIMARY outcome
Timeframe: Up to 5 yearsDuration of objective response (months)
Outcome measures
| Measure |
Treatment (Paclitaxel, Elesclomol Sodium)
n=56 Participants
Patients receive paclitaxel IV over 1 hour and elesclomol sodium IV over 1 hour on days 1, 8, and 15. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. NOTE: Patients who are currently on treatment must not be dosed with elesclomol sodium after 12/31/2015. All other study procedures, with the exception of elesclomol sodium administration and paclitaxel administration, should continue in accordance with protocol requirements. Any treatment given after 12/31/2015, including continuation of paclitaxel, will be considered off study.
Elesclomol Sodium: Given IV
Paclitaxel: Given IV
|
|---|---|
|
Duration of Objective Response
|
9.2 months
Interval 5.5 to 14.9
|
PRIMARY outcome
Timeframe: Up to 5 yearsThe frequency of patients who experienced at least one adverse effect (with a grade of 1 or higher). Adverse effects are defined as any unfavorable and unintended sign, symptom, or disease that occurs in a patient administered a medical treatment, whether the event is considered related or unrelated to the medical treatment.
Outcome measures
| Measure |
Treatment (Paclitaxel, Elesclomol Sodium)
n=56 Participants
Patients receive paclitaxel IV over 1 hour and elesclomol sodium IV over 1 hour on days 1, 8, and 15. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. NOTE: Patients who are currently on treatment must not be dosed with elesclomol sodium after 12/31/2015. All other study procedures, with the exception of elesclomol sodium administration and paclitaxel administration, should continue in accordance with protocol requirements. Any treatment given after 12/31/2015, including continuation of paclitaxel, will be considered off study.
Elesclomol Sodium: Given IV
Paclitaxel: Given IV
|
|---|---|
|
Number of Participants Who Experienced at Least One Adverse Event
|
56 Participants
|
PRIMARY outcome
Timeframe: Up to 5 yearsThe number of participants who experienced at least one grade three (or higher) adverse effect. The severity of observed adverse effects is graded using the NCI CTCAE version 4.0.
Outcome measures
| Measure |
Treatment (Paclitaxel, Elesclomol Sodium)
n=56 Participants
Patients receive paclitaxel IV over 1 hour and elesclomol sodium IV over 1 hour on days 1, 8, and 15. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. NOTE: Patients who are currently on treatment must not be dosed with elesclomol sodium after 12/31/2015. All other study procedures, with the exception of elesclomol sodium administration and paclitaxel administration, should continue in accordance with protocol requirements. Any treatment given after 12/31/2015, including continuation of paclitaxel, will be considered off study.
Elesclomol Sodium: Given IV
Paclitaxel: Given IV
|
|---|---|
|
The Number of Participants Who Experienced at Least One Grade 3 Adverse Event
|
26 Participants
|
SECONDARY outcome
Timeframe: From start of treatment to time of progression or death, whichever occurs first, assessed up to 5 yearsProgression-free survival (median, in months) will be analyzed by Kaplan-Meier analysis (progression is defined using Response Evaluation Criteria in Solid Tumors Criteria (RECIST v1.1), as a 20% increase in the sum of the longest diameter of target lesions (also a 5 mm absolute increase is also required), or a measurable increase in a non-target lesion, or the appearance of new lesions.
Outcome measures
| Measure |
Treatment (Paclitaxel, Elesclomol Sodium)
n=56 Participants
Patients receive paclitaxel IV over 1 hour and elesclomol sodium IV over 1 hour on days 1, 8, and 15. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. NOTE: Patients who are currently on treatment must not be dosed with elesclomol sodium after 12/31/2015. All other study procedures, with the exception of elesclomol sodium administration and paclitaxel administration, should continue in accordance with protocol requirements. Any treatment given after 12/31/2015, including continuation of paclitaxel, will be considered off study.
Elesclomol Sodium: Given IV
Paclitaxel: Given IV
|
|---|---|
|
Progression-free Survival (Median)
|
3.6 months
Interval 2.03 to 5.65
|
SECONDARY outcome
Timeframe: From start of treatment to time of death or the date of last contact, assessed up to 5 yearsOverall survival (median, in months) will be analyzed by Kaplan-Meier analysis.
Outcome measures
| Measure |
Treatment (Paclitaxel, Elesclomol Sodium)
n=56 Participants
Patients receive paclitaxel IV over 1 hour and elesclomol sodium IV over 1 hour on days 1, 8, and 15. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. NOTE: Patients who are currently on treatment must not be dosed with elesclomol sodium after 12/31/2015. All other study procedures, with the exception of elesclomol sodium administration and paclitaxel administration, should continue in accordance with protocol requirements. Any treatment given after 12/31/2015, including continuation of paclitaxel, will be considered off study.
Elesclomol Sodium: Given IV
Paclitaxel: Given IV
|
|---|---|
|
Overall Survival (Median)
|
13.3 months
Interval 10.38 to 19.45
|
Adverse Events
Treatment (Paclitaxel, Elesclomol Sodium)
Serious events: 18 serious events
Other events: 56 other events
Deaths: 43 deaths
Serious adverse events
| Measure |
Treatment (Paclitaxel, Elesclomol Sodium)
n=56 participants at risk
Patients receive paclitaxel IV over 1 hour and elesclomol sodium IV over 1 hour on days 1, 8, and 15. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. NOTE: Patients who are currently on treatment must not be dosed with elesclomol sodium after 12/31/2015. All other study procedures, with the exception of elesclomol sodium administration and paclitaxel administration, should continue in accordance with protocol requirements. Any treatment given after 12/31/2015, including continuation of paclitaxel, will be considered off study.
Elesclomol Sodium: Given IV
Paclitaxel: Given IV
|
|---|---|
|
Cardiac disorders
Atrial Fibrillation
|
1.8%
1/56
|
|
Cardiac disorders
Pericardial Effusion
|
1.8%
1/56
|
|
Gastrointestinal disorders
Colonic Hemorrhage
|
1.8%
1/56
|
|
Gastrointestinal disorders
Bloating
|
1.8%
1/56
|
|
Gastrointestinal disorders
Small Intestinal Obstruction
|
3.6%
2/56
|
|
Gastrointestinal disorders
Ileus
|
1.8%
1/56
|
|
Gastrointestinal disorders
Nausea
|
1.8%
1/56
|
|
Infections and infestations
Skin Infection
|
1.8%
1/56
|
|
Infections and infestations
Lung Infection
|
1.8%
1/56
|
|
Metabolism and nutrition disorders
Hyperglycemia
|
5.4%
3/56
|
|
Metabolism and nutrition disorders
Dehydration
|
1.8%
1/56
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory Failure
|
3.6%
2/56
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
1.8%
1/56
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
1.8%
1/56
|
|
Surgical and medical procedures
Surgical And Medical Procedures - Other
|
1.8%
1/56
|
Other adverse events
| Measure |
Treatment (Paclitaxel, Elesclomol Sodium)
n=56 participants at risk
Patients receive paclitaxel IV over 1 hour and elesclomol sodium IV over 1 hour on days 1, 8, and 15. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. NOTE: Patients who are currently on treatment must not be dosed with elesclomol sodium after 12/31/2015. All other study procedures, with the exception of elesclomol sodium administration and paclitaxel administration, should continue in accordance with protocol requirements. Any treatment given after 12/31/2015, including continuation of paclitaxel, will be considered off study.
Elesclomol Sodium: Given IV
Paclitaxel: Given IV
|
|---|---|
|
Blood and lymphatic system disorders
Blood And Lymphatic System Disorders - Other
|
1.8%
1/56
|
|
Blood and lymphatic system disorders
Anemia
|
94.6%
53/56
|
|
Cardiac disorders
Supraventricular Tachycardia
|
1.8%
1/56
|
|
Cardiac disorders
Palpitations
|
1.8%
1/56
|
|
Cardiac disorders
Cardiac Disorders - Other
|
1.8%
1/56
|
|
Cardiac disorders
Ventricular Arrhythmia
|
1.8%
1/56
|
|
Cardiac disorders
Sinus Tachycardia
|
3.6%
2/56
|
|
Cardiac disorders
Chest Pain - Cardiac
|
1.8%
1/56
|
|
Ear and labyrinth disorders
Tinnitus
|
5.4%
3/56
|
|
Ear and labyrinth disorders
Hearing Impaired
|
3.6%
2/56
|
|
Eye disorders
Watering Eyes
|
1.8%
1/56
|
|
Eye disorders
Flashing Lights
|
1.8%
1/56
|
|
Eye disorders
Blurred Vision
|
5.4%
3/56
|
|
Eye disorders
Floaters
|
1.8%
1/56
|
|
Gastrointestinal disorders
Dyspepsia
|
5.4%
3/56
|
|
Gastrointestinal disorders
Dry Mouth
|
3.6%
2/56
|
|
Gastrointestinal disorders
Colonic Obstruction
|
3.6%
2/56
|
|
Gastrointestinal disorders
Constipation
|
44.6%
25/56
|
|
Gastrointestinal disorders
Diarrhea
|
26.8%
15/56
|
|
Gastrointestinal disorders
Vomiting
|
26.8%
15/56
|
|
Gastrointestinal disorders
Upper Gastrointestinal Hemorrhage
|
1.8%
1/56
|
|
Gastrointestinal disorders
Bloating
|
12.5%
7/56
|
|
Gastrointestinal disorders
Stomach Pain
|
3.6%
2/56
|
|
Gastrointestinal disorders
Small Intestinal Obstruction
|
1.8%
1/56
|
|
Gastrointestinal disorders
Abdominal Pain
|
39.3%
22/56
|
|
Gastrointestinal disorders
Rectal Hemorrhage
|
1.8%
1/56
|
|
Gastrointestinal disorders
Oral Dysesthesia
|
3.6%
2/56
|
|
Gastrointestinal disorders
Mucositis Oral
|
10.7%
6/56
|
|
Gastrointestinal disorders
Lower Gastrointestinal Hemorrhage
|
1.8%
1/56
|
|
Gastrointestinal disorders
Abdominal Distension
|
12.5%
7/56
|
|
Gastrointestinal disorders
Nausea
|
53.6%
30/56
|
|
Gastrointestinal disorders
Gastroesophageal Reflux Disease
|
3.6%
2/56
|
|
Gastrointestinal disorders
Ascites
|
8.9%
5/56
|
|
Gastrointestinal disorders
Flatulence
|
3.6%
2/56
|
|
General disorders
Pain
|
8.9%
5/56
|
|
General disorders
Flu Like Symptoms
|
1.8%
1/56
|
|
General disorders
Edema Limbs
|
16.1%
9/56
|
|
General disorders
Facial Pain
|
1.8%
1/56
|
|
General disorders
Edema Face
|
1.8%
1/56
|
|
General disorders
Fatigue
|
73.2%
41/56
|
|
General disorders
Fever
|
14.3%
8/56
|
|
General disorders
Gait Disturbance
|
1.8%
1/56
|
|
General disorders
Chills
|
1.8%
1/56
|
|
Infections and infestations
Upper Respiratory Infection
|
7.1%
4/56
|
|
Infections and infestations
Tooth Infection
|
1.8%
1/56
|
|
Infections and infestations
Skin Infection
|
3.6%
2/56
|
|
Infections and infestations
Nail Infection
|
1.8%
1/56
|
|
Infections and infestations
Lung Infection
|
1.8%
1/56
|
|
Infections and infestations
Esophageal Infection
|
1.8%
1/56
|
|
Infections and infestations
Device Related Infection
|
1.8%
1/56
|
|
Infections and infestations
Urinary Tract Infection
|
14.3%
8/56
|
|
Infections and infestations
Bronchial Infection
|
5.4%
3/56
|
|
Infections and infestations
Enterocolitis Infectious
|
1.8%
1/56
|
|
Injury, poisoning and procedural complications
Spinal Fracture
|
1.8%
1/56
|
|
Injury, poisoning and procedural complications
Fracture
|
1.8%
1/56
|
|
Injury, poisoning and procedural complications
Fall
|
1.8%
1/56
|
|
Injury, poisoning and procedural complications
Bruising
|
1.8%
1/56
|
|
Investigations
Investigations - Other
|
3.6%
2/56
|
|
Investigations
Weight Loss
|
5.4%
3/56
|
|
Investigations
Weight Gain
|
7.1%
4/56
|
|
Investigations
Platelet Count Decreased
|
17.9%
10/56
|
|
Investigations
Lymphocyte Count Decreased
|
8.9%
5/56
|
|
Investigations
Ejection Fraction Decreased
|
1.8%
1/56
|
|
Investigations
Creatinine Increased
|
12.5%
7/56
|
|
Investigations
Cholesterol High
|
5.4%
3/56
|
|
Investigations
Neutrophil Count Decreased
|
48.2%
27/56
|
|
Investigations
Blood Bilirubin Increased
|
3.6%
2/56
|
|
Investigations
White Blood Cell Decreased
|
66.1%
37/56
|
|
Investigations
Aspartate Aminotransferase Increased
|
8.9%
5/56
|
|
Investigations
Alkaline Phosphatase Increased
|
16.1%
9/56
|
|
Investigations
Alanine Aminotransferase Increased
|
14.3%
8/56
|
|
Metabolism and nutrition disorders
Metabolism And Nutrition Disorders - Other
|
3.6%
2/56
|
|
Metabolism and nutrition disorders
Hypophosphatemia
|
1.8%
1/56
|
|
Metabolism and nutrition disorders
Hyponatremia
|
12.5%
7/56
|
|
Metabolism and nutrition disorders
Hypomagnesemia
|
25.0%
14/56
|
|
Metabolism and nutrition disorders
Hypokalemia
|
19.6%
11/56
|
|
Metabolism and nutrition disorders
Hypoglycemia
|
5.4%
3/56
|
|
Metabolism and nutrition disorders
Hypocalcemia
|
16.1%
9/56
|
|
Metabolism and nutrition disorders
Hypoalbuminemia
|
23.2%
13/56
|
|
Metabolism and nutrition disorders
Hypertriglyceridemia
|
5.4%
3/56
|
|
Metabolism and nutrition disorders
Hypermagnesemia
|
5.4%
3/56
|
|
Metabolism and nutrition disorders
Hyperkalemia
|
1.8%
1/56
|
|
Metabolism and nutrition disorders
Hyperglycemia
|
32.1%
18/56
|
|
Metabolism and nutrition disorders
Hypercalcemia
|
1.8%
1/56
|
|
Metabolism and nutrition disorders
Glucose Intolerance
|
1.8%
1/56
|
|
Metabolism and nutrition disorders
Dehydration
|
5.4%
3/56
|
|
Metabolism and nutrition disorders
Anorexia
|
39.3%
22/56
|
|
Musculoskeletal and connective tissue disorders
Pain In Extremity
|
12.5%
7/56
|
|
Musculoskeletal and connective tissue disorders
Neck Pain
|
3.6%
2/56
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
8.9%
5/56
|
|
Musculoskeletal and connective tissue disorders
Generalized Muscle Weakness
|
14.3%
8/56
|
|
Musculoskeletal and connective tissue disorders
Back Pain
|
10.7%
6/56
|
|
Musculoskeletal and connective tissue disorders
Arthritis
|
1.8%
1/56
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
8.9%
5/56
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Neoplasms Benign, Malignant And Unspecified (Incl
|
1.8%
1/56
|
|
Nervous system disorders
Tremor
|
1.8%
1/56
|
|
Nervous system disorders
Somnolence
|
1.8%
1/56
|
|
Nervous system disorders
Peripheral Sensory Neuropathy
|
53.6%
30/56
|
|
Nervous system disorders
Peripheral Motor Neuropathy
|
7.1%
4/56
|
|
Nervous system disorders
Paresthesia
|
7.1%
4/56
|
|
Nervous system disorders
Neuralgia
|
1.8%
1/56
|
|
Nervous system disorders
Headache
|
12.5%
7/56
|
|
Nervous system disorders
Extrapyramidal Disorder
|
1.8%
1/56
|
|
Nervous system disorders
Dysphasia
|
1.8%
1/56
|
|
Nervous system disorders
Dysgeusia
|
8.9%
5/56
|
|
Nervous system disorders
Dizziness
|
3.6%
2/56
|
|
Nervous system disorders
Concentration Impairment
|
1.8%
1/56
|
|
Nervous system disorders
Akathisia
|
1.8%
1/56
|
|
Psychiatric disorders
Insomnia
|
25.0%
14/56
|
|
Psychiatric disorders
Depression
|
16.1%
9/56
|
|
Psychiatric disorders
Delirium
|
1.8%
1/56
|
|
Psychiatric disorders
Confusion
|
3.6%
2/56
|
|
Psychiatric disorders
Anxiety
|
8.9%
5/56
|
|
Renal and urinary disorders
Renal And Urinary Disorders - Other
|
1.8%
1/56
|
|
Renal and urinary disorders
Urinary Urgency
|
1.8%
1/56
|
|
Renal and urinary disorders
Urinary Incontinence
|
1.8%
1/56
|
|
Renal and urinary disorders
Urinary Tract Pain
|
5.4%
3/56
|
|
Renal and urinary disorders
Urinary Frequency
|
10.7%
6/56
|
|
Renal and urinary disorders
Proteinuria
|
3.6%
2/56
|
|
Renal and urinary disorders
Hematuria
|
3.6%
2/56
|
|
Renal and urinary disorders
Chronic Kidney Disease
|
1.8%
1/56
|
|
Reproductive system and breast disorders
Pelvic Pain
|
1.8%
1/56
|
|
Reproductive system and breast disorders
Breast Pain
|
1.8%
1/56
|
|
Respiratory, thoracic and mediastinal disorders
Sore Throat
|
1.8%
1/56
|
|
Respiratory, thoracic and mediastinal disorders
Sinus Disorder
|
1.8%
1/56
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonitis
|
1.8%
1/56
|
|
Respiratory, thoracic and mediastinal disorders
Pleural Effusion
|
1.8%
1/56
|
|
Respiratory, thoracic and mediastinal disorders
Nasal Congestion
|
7.1%
4/56
|
|
Respiratory, thoracic and mediastinal disorders
Pleuritic Pain
|
1.8%
1/56
|
|
Respiratory, thoracic and mediastinal disorders
Laryngopharyngeal Dysesthesia
|
1.8%
1/56
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
1.8%
1/56
|
|
Respiratory, thoracic and mediastinal disorders
Hoarseness
|
1.8%
1/56
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
7.1%
4/56
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
30.4%
17/56
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
17.9%
10/56
|
|
Skin and subcutaneous tissue disorders
Scalp Pain
|
1.8%
1/56
|
|
Skin and subcutaneous tissue disorders
Rash Acneiform
|
7.1%
4/56
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
3.6%
2/56
|
|
Skin and subcutaneous tissue disorders
Rash Maculo-Papular
|
5.4%
3/56
|
|
Skin and subcutaneous tissue disorders
Nail Ridging
|
1.8%
1/56
|
|
Skin and subcutaneous tissue disorders
Nail Loss
|
1.8%
1/56
|
|
Skin and subcutaneous tissue disorders
Nail Discoloration
|
5.4%
3/56
|
|
Skin and subcutaneous tissue disorders
Erythema Multiforme
|
1.8%
1/56
|
|
Skin and subcutaneous tissue disorders
Dry Skin
|
3.6%
2/56
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
44.6%
25/56
|
|
Vascular disorders
Thromboembolic Event
|
5.4%
3/56
|
|
Vascular disorders
Lymphedema
|
3.6%
2/56
|
|
Vascular disorders
Hypotension
|
1.8%
1/56
|
|
Vascular disorders
Hypertension
|
7.1%
4/56
|
|
Vascular disorders
Hot Flashes
|
8.9%
5/56
|
|
Vascular disorders
Flushing
|
1.8%
1/56
|
Additional Information
Christopher Purdy on behalf of James Kauderer
NRG Oncology
Phone: (716)845-1300
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: LTE60