Trial Outcomes & Findings for Rilotumumab in Treating Patients With Persistent or Recurrent Ovarian Epithelial Cancer, Fallopian Tube Cancer, or Primary Peritoneal Cancer (NCT NCT01039207)
NCT ID: NCT01039207
Last Updated: 2017-09-07
Results Overview
Complete and Partial Tumor Response by RECIST 1.1. RECIST 1.1 defines complete response as the disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to \<10 mm and the disappearance of all non-target lesions and normalization of tumor marker level. Partial response is defined as at least a 30% decrease in the sum of the diameters of target lesions, taking as reference the baseline sum diameters. Only those patients who have measurable disease present at baseline, have received at least one cycle of therapy, and have had their disease re-evaluated will be considered evaluable for response. These patients will have their response classified according to the definitions stated above. Complete and partial responses are included in the objective tumor response rate.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
31 participants
Primary outcome timeframe
CT scan or MRI if used to follow lesion for measurable disease every other cycle during treatment then every 3 months thereafter until disease progression is confirmed; also repeat at any time if clinically indicated up to 5 years.
Results posted on
2017-09-07
Participant Flow
This trial was opened to patient entry on October 10, 2010 and was closed to accrual on May 10, 2011.
Participant milestones
| Measure |
AMG 102
AMG 102 (rilotumumab) 20 mg/kg IV q 2 weeks until disease progression or adverse effects prohibit further therapy (cycle = 28 days)
|
|---|---|
|
Overall Study
STARTED
|
31
|
|
Overall Study
COMPLETED
|
31
|
|
Overall Study
NOT COMPLETED
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Rilotumumab in Treating Patients With Persistent or Recurrent Ovarian Epithelial Cancer, Fallopian Tube Cancer, or Primary Peritoneal Cancer
Baseline characteristics by cohort
| Measure |
AMG 102
n=31 Participants
AMG 102 (rilotumumab) 20 mg/kg IV q 2 weeks until disease progression or adverse effects prohibit further therapy (cycle = 28 days)
|
|---|---|
|
Age, Customized
40-49 years
|
4 participants
n=93 Participants
|
|
Age, Customized
50-59 years
|
6 participants
n=93 Participants
|
|
Age, Customized
60-69 years
|
9 participants
n=93 Participants
|
|
Age, Customized
70-79 years
|
10 participants
n=93 Participants
|
|
Age, Customized
80-89 years
|
2 participants
n=93 Participants
|
|
Sex: Female, Male
Female
|
31 Participants
n=93 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=93 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=93 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=93 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=93 Participants
|
|
Race (NIH/OMB)
Black or African American
|
4 Participants
n=93 Participants
|
|
Race (NIH/OMB)
White
|
27 Participants
n=93 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=93 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=93 Participants
|
PRIMARY outcome
Timeframe: CT scan or MRI if used to follow lesion for measurable disease every other cycle during treatment then every 3 months thereafter until disease progression is confirmed; also repeat at any time if clinically indicated up to 5 years.Population: Eligible and treated patients.
Complete and Partial Tumor Response by RECIST 1.1. RECIST 1.1 defines complete response as the disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to \<10 mm and the disappearance of all non-target lesions and normalization of tumor marker level. Partial response is defined as at least a 30% decrease in the sum of the diameters of target lesions, taking as reference the baseline sum diameters. Only those patients who have measurable disease present at baseline, have received at least one cycle of therapy, and have had their disease re-evaluated will be considered evaluable for response. These patients will have their response classified according to the definitions stated above. Complete and partial responses are included in the objective tumor response rate.
Outcome measures
| Measure |
AMG 102
n=31 Participants
AMG 102 (rilotumumab) 20 mg/kg IV q 2 weeks until disease progression or adverse effects prohibit further therapy (cycle = 28 days)
|
|---|---|
|
Proportion of Patients With Objective Tumor Response Rate (Complete Response [CR] or Partial Response [PR]) Using RECIST Version 1.1
Complete response
|
1 participants
|
|
Proportion of Patients With Objective Tumor Response Rate (Complete Response [CR] or Partial Response [PR]) Using RECIST Version 1.1
Partial response
|
0 participants
|
PRIMARY outcome
Timeframe: CT scan or MRI if used to follow lesion for measurable disease every other cycle during treatment then every 3 months thereafter until disease progression is confirmed; up to 6 months.Population: Eligible and treated patients
Progression-free survival (PFS) was defined as the period from study entry until disease progression, death, or the last date of contact. Progression was based on RECIST 1.1. RECIST 1.1 defines progressive disease as at least a 20% increase in the sum of the diameters of target lesions, taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study). In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. The appearance of one or more new lesions or unequivocal progression of non-target lesions is also considered progression.
Outcome measures
| Measure |
AMG 102
n=31 Participants
AMG 102 (rilotumumab) 20 mg/kg IV q 2 weeks until disease progression or adverse effects prohibit further therapy (cycle = 28 days)
|
|---|---|
|
Progression-free Survival > 6 Months Using RECIST 1.0
Patients with PFS<6 months
|
29 participants
|
|
Progression-free Survival > 6 Months Using RECIST 1.0
Patient with PFS>6 Months
|
2 participants
|
SECONDARY outcome
Timeframe: Assessed every cycle while on treatment, 30 days after the last cycle of treatmentPopulation: Eligible and treated patients.
Number of participants with a maximum grade of 3 or higher during the treatment period.
Outcome measures
| Measure |
AMG 102
n=31 Participants
AMG 102 (rilotumumab) 20 mg/kg IV q 2 weeks until disease progression or adverse effects prohibit further therapy (cycle = 28 days)
|
|---|---|
|
Incidence of Adverse Effects (Grade 3 or Higher) as Assessed by Common Terminology Criteria for Adverse Events Version 4.0
Vomiting
|
4 participants
|
|
Incidence of Adverse Effects (Grade 3 or Higher) as Assessed by Common Terminology Criteria for Adverse Events Version 4.0
Other Gastrointestinal
|
7 participants
|
|
Incidence of Adverse Effects (Grade 3 or Higher) as Assessed by Common Terminology Criteria for Adverse Events Version 4.0
General and administration site
|
4 participants
|
|
Incidence of Adverse Effects (Grade 3 or Higher) as Assessed by Common Terminology Criteria for Adverse Events Version 4.0
Hepatobiliary
|
1 participants
|
|
Incidence of Adverse Effects (Grade 3 or Higher) as Assessed by Common Terminology Criteria for Adverse Events Version 4.0
Infections/infestations
|
2 participants
|
|
Incidence of Adverse Effects (Grade 3 or Higher) as Assessed by Common Terminology Criteria for Adverse Events Version 4.0
Metabolism/nutrition
|
5 participants
|
|
Incidence of Adverse Effects (Grade 3 or Higher) as Assessed by Common Terminology Criteria for Adverse Events Version 4.0
Respiratory/thoracic/mediastinal
|
1 participants
|
|
Incidence of Adverse Effects (Grade 3 or Higher) as Assessed by Common Terminology Criteria for Adverse Events Version 4.0
Skin/subcutaneous
|
1 participants
|
|
Incidence of Adverse Effects (Grade 3 or Higher) as Assessed by Common Terminology Criteria for Adverse Events Version 4.0
Vascular disorders
|
2 participants
|
|
Incidence of Adverse Effects (Grade 3 or Higher) as Assessed by Common Terminology Criteria for Adverse Events Version 4.0
Leukopenia
|
1 participants
|
|
Incidence of Adverse Effects (Grade 3 or Higher) as Assessed by Common Terminology Criteria for Adverse Events Version 4.0
Neutropenia
|
1 participants
|
|
Incidence of Adverse Effects (Grade 3 or Higher) as Assessed by Common Terminology Criteria for Adverse Events Version 4.0
Cardiac
|
1 participants
|
|
Incidence of Adverse Effects (Grade 3 or Higher) as Assessed by Common Terminology Criteria for Adverse Events Version 4.0
Nausea
|
2 participants
|
SECONDARY outcome
Timeframe: Every cycle during treatment, then every 3 months for the first 2 years, then every six months for the next three years and then annually for the next 5 years.Population: Eligible and treated patients. Measure type = The first quartile of the distribution since follow-up time is insufficient to obtain adequate median estimates.
Overall survival is defined as the duration of time from study entry to time of death or the date of last contact.
Outcome measures
| Measure |
AMG 102
n=31 Participants
AMG 102 (rilotumumab) 20 mg/kg IV q 2 weeks until disease progression or adverse effects prohibit further therapy (cycle = 28 days)
|
|---|---|
|
Duration of Overall Survival (OS)
|
4.3 months
Interval 1.9 to 5.8
|
SECONDARY outcome
Timeframe: CT scan or MRI if used to follow lesion for measurable disease every other cycle during treatment then every 3 months thereafter until disease progression is confirmed; also repeat at any time if clinically indicated up to 5 years.Population: Eligible and treated patients
Progression-free survival (PFS) was defined as the period from study entry until disease progression, death, or the last date of contact. Progression was based on RECIST 1.1. RECIST 1.1 defines progressive disease as at least a 20% increase in the sum of the diameters of target lesions, taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study). In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. The appearance of one or more new lesions or unequivocal progression of non-target lesions is also considered progression.
Outcome measures
| Measure |
AMG 102
n=31 Participants
AMG 102 (rilotumumab) 20 mg/kg IV q 2 weeks until disease progression or adverse effects prohibit further therapy (cycle = 28 days)
|
|---|---|
|
Duration of Progression-free Survival (PFS)
|
1.8 months
Interval 1.7 to 1.9
|
OTHER_PRE_SPECIFIED outcome
Timeframe: BaselineA panel of biomarkers from fixed and embedded tumor tissue will be tested for association with measures of response to treatment including PFS and OS.
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: Up to 1 day prior to course 2Exploratory analyses will be conducted to assess the possible effects of the study regimen on the biomarkers of interest as well as associations between the biomarkers and clinical outcome (such as PFS and OS).
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: Up to 1 day prior to course 2Exploratory analyses will be conducted to assess the possible effects of the study regimen on the biomarkers of interest as well as associations between the biomarkers and clinical outcome (such as PFS and OS).
Outcome measures
Outcome data not reported
Adverse Events
AMG 102
Serious events: 14 serious events
Other events: 31 other events
Deaths: 14 deaths
Serious adverse events
| Measure |
AMG 102
n=31 participants at risk
AMG 102 (rilotumumab) 20 mg/kg IV q 2 weeks until disease progression or adverse effects prohibit further therapy (cycle = 28 days)
|
|---|---|
|
Gastrointestinal disorders
Diarrhea
|
3.2%
1/31 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment, and up to 5 years in follow-up
|
|
Gastrointestinal disorders
Vomiting
|
9.7%
3/31 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment, and up to 5 years in follow-up
|
|
Gastrointestinal disorders
Small Intestinal Obstruction
|
3.2%
1/31 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment, and up to 5 years in follow-up
|
|
Gastrointestinal disorders
Abdominal Pain
|
9.7%
3/31 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment, and up to 5 years in follow-up
|
|
Gastrointestinal disorders
Gastrointestinal Disorders - Other
|
3.2%
1/31 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment, and up to 5 years in follow-up
|
|
Gastrointestinal disorders
Ascites
|
3.2%
1/31 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment, and up to 5 years in follow-up
|
|
General disorders
Death Nos
|
9.7%
3/31 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment, and up to 5 years in follow-up
|
|
Injury, poisoning and procedural complications
Fall
|
3.2%
1/31 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment, and up to 5 years in follow-up
|
|
Metabolism and nutrition disorders
Hyperglycemia
|
3.2%
1/31 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment, and up to 5 years in follow-up
|
|
Respiratory, thoracic and mediastinal disorders
Pleural Effusion
|
6.5%
2/31 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment, and up to 5 years in follow-up
|
|
Vascular disorders
Thromboembolic Event
|
3.2%
1/31 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment, and up to 5 years in follow-up
|
Other adverse events
| Measure |
AMG 102
n=31 participants at risk
AMG 102 (rilotumumab) 20 mg/kg IV q 2 weeks until disease progression or adverse effects prohibit further therapy (cycle = 28 days)
|
|---|---|
|
Blood and lymphatic system disorders
Anemia
|
64.5%
20/31 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment, and up to 5 years in follow-up
|
|
Cardiac disorders
Atrial Fibrillation
|
3.2%
1/31 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment, and up to 5 years in follow-up
|
|
Cardiac disorders
Ventricular Tachycardia
|
3.2%
1/31 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment, and up to 5 years in follow-up
|
|
Ear and labyrinth disorders
Tinnitus
|
3.2%
1/31 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment, and up to 5 years in follow-up
|
|
Eye disorders
Eye Disorders - Other
|
3.2%
1/31 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment, and up to 5 years in follow-up
|
|
Eye disorders
Blurred Vision
|
6.5%
2/31 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment, and up to 5 years in follow-up
|
|
Gastrointestinal disorders
Duodenal Obstruction
|
3.2%
1/31 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment, and up to 5 years in follow-up
|
|
Gastrointestinal disorders
Constipation
|
25.8%
8/31 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment, and up to 5 years in follow-up
|
|
Gastrointestinal disorders
Diarrhea
|
19.4%
6/31 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment, and up to 5 years in follow-up
|
|
Gastrointestinal disorders
Vomiting
|
35.5%
11/31 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment, and up to 5 years in follow-up
|
|
Gastrointestinal disorders
Bloating
|
3.2%
1/31 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment, and up to 5 years in follow-up
|
|
Gastrointestinal disorders
Small Intestinal Obstruction
|
3.2%
1/31 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment, and up to 5 years in follow-up
|
|
Gastrointestinal disorders
Abdominal Pain
|
19.4%
6/31 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment, and up to 5 years in follow-up
|
|
Gastrointestinal disorders
Obstruction Gastric
|
3.2%
1/31 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment, and up to 5 years in follow-up
|
|
Gastrointestinal disorders
Mucositis Oral
|
3.2%
1/31 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment, and up to 5 years in follow-up
|
|
Gastrointestinal disorders
Abdominal Distension
|
9.7%
3/31 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment, and up to 5 years in follow-up
|
|
Gastrointestinal disorders
Nausea
|
45.2%
14/31 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment, and up to 5 years in follow-up
|
|
Gastrointestinal disorders
Ascites
|
6.5%
2/31 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment, and up to 5 years in follow-up
|
|
General disorders
Pain
|
16.1%
5/31 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment, and up to 5 years in follow-up
|
|
General disorders
Localized Edema
|
3.2%
1/31 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment, and up to 5 years in follow-up
|
|
General disorders
Edema Trunk
|
3.2%
1/31 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment, and up to 5 years in follow-up
|
|
General disorders
Edema Limbs
|
22.6%
7/31 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment, and up to 5 years in follow-up
|
|
General disorders
Fatigue
|
61.3%
19/31 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment, and up to 5 years in follow-up
|
|
General disorders
Fever
|
16.1%
5/31 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment, and up to 5 years in follow-up
|
|
Hepatobiliary disorders
Hepatobiliary Disorders - Other
|
3.2%
1/31 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment, and up to 5 years in follow-up
|
|
Infections and infestations
Infections And Infestations - Other
|
3.2%
1/31 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment, and up to 5 years in follow-up
|
|
Infections and infestations
Skin Infection
|
3.2%
1/31 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment, and up to 5 years in follow-up
|
|
Infections and infestations
Sinusitis
|
3.2%
1/31 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment, and up to 5 years in follow-up
|
|
Infections and infestations
Peritoneal Infection
|
3.2%
1/31 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment, and up to 5 years in follow-up
|
|
Infections and infestations
Lung Infection
|
3.2%
1/31 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment, and up to 5 years in follow-up
|
|
Infections and infestations
Catheter Related Infection
|
3.2%
1/31 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment, and up to 5 years in follow-up
|
|
Injury, poisoning and procedural complications
Wound Complication
|
3.2%
1/31 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment, and up to 5 years in follow-up
|
|
Investigations
Weight Loss
|
3.2%
1/31 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment, and up to 5 years in follow-up
|
|
Investigations
Platelet Count Decreased
|
12.9%
4/31 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment, and up to 5 years in follow-up
|
|
Investigations
Inr Increased
|
6.5%
2/31 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment, and up to 5 years in follow-up
|
|
Investigations
Creatinine Increased
|
6.5%
2/31 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment, and up to 5 years in follow-up
|
|
Investigations
Neutrophil Count Decreased
|
3.2%
1/31 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment, and up to 5 years in follow-up
|
|
Investigations
Blood Bilirubin Increased
|
6.5%
2/31 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment, and up to 5 years in follow-up
|
|
Investigations
White Blood Cell Decreased
|
16.1%
5/31 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment, and up to 5 years in follow-up
|
|
Investigations
Aspartate Aminotransferase Increased
|
3.2%
1/31 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment, and up to 5 years in follow-up
|
|
Investigations
Alkaline Phosphatase Increased
|
9.7%
3/31 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment, and up to 5 years in follow-up
|
|
Investigations
Alanine Aminotransferase Increased
|
12.9%
4/31 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment, and up to 5 years in follow-up
|
|
Investigations
Activated Partial Thromboplastin Time Prolonged
|
3.2%
1/31 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment, and up to 5 years in follow-up
|
|
Metabolism and nutrition disorders
Hypophosphatemia
|
9.7%
3/31 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment, and up to 5 years in follow-up
|
|
Metabolism and nutrition disorders
Hyponatremia
|
22.6%
7/31 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment, and up to 5 years in follow-up
|
|
Metabolism and nutrition disorders
Hypomagnesemia
|
25.8%
8/31 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment, and up to 5 years in follow-up
|
|
Metabolism and nutrition disorders
Hypokalemia
|
16.1%
5/31 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment, and up to 5 years in follow-up
|
|
Metabolism and nutrition disorders
Hypoglycemia
|
3.2%
1/31 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment, and up to 5 years in follow-up
|
|
Metabolism and nutrition disorders
Hypocalcemia
|
16.1%
5/31 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment, and up to 5 years in follow-up
|
|
Metabolism and nutrition disorders
Hypoalbuminemia
|
22.6%
7/31 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment, and up to 5 years in follow-up
|
|
Metabolism and nutrition disorders
Hypernatremia
|
3.2%
1/31 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment, and up to 5 years in follow-up
|
|
Metabolism and nutrition disorders
Hyperkalemia
|
3.2%
1/31 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment, and up to 5 years in follow-up
|
|
Metabolism and nutrition disorders
Hyperglycemia
|
12.9%
4/31 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment, and up to 5 years in follow-up
|
|
Metabolism and nutrition disorders
Dehydration
|
6.5%
2/31 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment, and up to 5 years in follow-up
|
|
Metabolism and nutrition disorders
Anorexia
|
25.8%
8/31 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment, and up to 5 years in follow-up
|
|
Musculoskeletal and connective tissue disorders
Pain In Extremity
|
9.7%
3/31 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment, and up to 5 years in follow-up
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
6.5%
2/31 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment, and up to 5 years in follow-up
|
|
Musculoskeletal and connective tissue disorders
Generalized Muscle Weakness
|
3.2%
1/31 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment, and up to 5 years in follow-up
|
|
Musculoskeletal and connective tissue disorders
Buttock Pain
|
3.2%
1/31 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment, and up to 5 years in follow-up
|
|
Musculoskeletal and connective tissue disorders
Back Pain
|
6.5%
2/31 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment, and up to 5 years in follow-up
|
|
Musculoskeletal and connective tissue disorders
Arthritis
|
3.2%
1/31 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment, and up to 5 years in follow-up
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
9.7%
3/31 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment, and up to 5 years in follow-up
|
|
Nervous system disorders
Peripheral Sensory Neuropathy
|
25.8%
8/31 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment, and up to 5 years in follow-up
|
|
Nervous system disorders
Peripheral Motor Neuropathy
|
3.2%
1/31 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment, and up to 5 years in follow-up
|
|
Nervous system disorders
Neuralgia
|
3.2%
1/31 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment, and up to 5 years in follow-up
|
|
Nervous system disorders
Memory Impairment
|
3.2%
1/31 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment, and up to 5 years in follow-up
|
|
Nervous system disorders
Headache
|
3.2%
1/31 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment, and up to 5 years in follow-up
|
|
Nervous system disorders
Dysgeusia
|
3.2%
1/31 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment, and up to 5 years in follow-up
|
|
Nervous system disorders
Dizziness
|
12.9%
4/31 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment, and up to 5 years in follow-up
|
|
Psychiatric disorders
Insomnia
|
6.5%
2/31 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment, and up to 5 years in follow-up
|
|
Psychiatric disorders
Depression
|
6.5%
2/31 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment, and up to 5 years in follow-up
|
|
Psychiatric disorders
Confusion
|
3.2%
1/31 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment, and up to 5 years in follow-up
|
|
Psychiatric disorders
Anxiety
|
3.2%
1/31 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment, and up to 5 years in follow-up
|
|
Renal and urinary disorders
Urinary Incontinence
|
3.2%
1/31 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment, and up to 5 years in follow-up
|
|
Renal and urinary disorders
Urinary Tract Pain
|
3.2%
1/31 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment, and up to 5 years in follow-up
|
|
Renal and urinary disorders
Proteinuria
|
6.5%
2/31 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment, and up to 5 years in follow-up
|
|
Reproductive system and breast disorders
Reproductive System And Breast Disorders - Other
|
3.2%
1/31 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment, and up to 5 years in follow-up
|
|
Reproductive system and breast disorders
Pelvic Pain
|
3.2%
1/31 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment, and up to 5 years in follow-up
|
|
Respiratory, thoracic and mediastinal disorders
Pleural Effusion
|
9.7%
3/31 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment, and up to 5 years in follow-up
|
|
Respiratory, thoracic and mediastinal disorders
Nasal Congestion
|
3.2%
1/31 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment, and up to 5 years in follow-up
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
3.2%
1/31 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment, and up to 5 years in follow-up
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
29.0%
9/31 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment, and up to 5 years in follow-up
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
6.5%
2/31 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment, and up to 5 years in follow-up
|
|
Skin and subcutaneous tissue disorders
Skin And Subcutaneous Tissue Disorders - Other
|
3.2%
1/31 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment, and up to 5 years in follow-up
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
6.5%
2/31 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment, and up to 5 years in follow-up
|
|
Skin and subcutaneous tissue disorders
Rash Maculo-Papular
|
3.2%
1/31 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment, and up to 5 years in follow-up
|
|
Skin and subcutaneous tissue disorders
Nail Ridging
|
3.2%
1/31 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment, and up to 5 years in follow-up
|
|
Skin and subcutaneous tissue disorders
Nail Loss
|
3.2%
1/31 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment, and up to 5 years in follow-up
|
|
Skin and subcutaneous tissue disorders
Nail Discoloration
|
6.5%
2/31 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment, and up to 5 years in follow-up
|
|
Skin and subcutaneous tissue disorders
Dry Skin
|
3.2%
1/31 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment, and up to 5 years in follow-up
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
6.5%
2/31 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment, and up to 5 years in follow-up
|
|
Vascular disorders
Lymphedema
|
3.2%
1/31 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment, and up to 5 years in follow-up
|
|
Vascular disorders
Hypotension
|
3.2%
1/31 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment, and up to 5 years in follow-up
|
|
Vascular disorders
Hypertension
|
3.2%
1/31 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment, and up to 5 years in follow-up
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: LTE60