Trial Outcomes & Findings for Cisplatin, Etoposide, and Bevacizumab in Treating Patients With Previously Untreated Extensive Stage Small Cell Lung Cancer (NCT NCT00079040)
NCT ID: NCT00079040
Last Updated: 2014-05-14
Results Overview
Progression-free survival was defined to be the interval in months from the date of registration to the date of documented disease progression or to death without progression. Patients alive without progression at 6 months were included in the numerator when calculating the progression-free rate.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
65 participants
Primary outcome timeframe
6 months
Results posted on
2014-05-14
Participant Flow
Participants were recruited from ECOG member institutions between June 8, 2004 and August 18, 2006.
Participant milestones
| Measure |
Cisplatin, Etoposide, Bevacizumab
Cisplatin 60 mg/m2 IV, Etoposide 120 mg/m2 IV, and Bevacizumab 15 mg/kg IV on Day 1, Etoposide 120 mg/m2 IV on days 2 and 3 of a 21-day cycle for 4 cycles. Bevacizumab continued for 1 year or until progression.
|
|---|---|
|
Overall Study
STARTED
|
65
|
|
Overall Study
COMPLETED
|
63
|
|
Overall Study
NOT COMPLETED
|
2
|
Reasons for withdrawal
| Measure |
Cisplatin, Etoposide, Bevacizumab
Cisplatin 60 mg/m2 IV, Etoposide 120 mg/m2 IV, and Bevacizumab 15 mg/kg IV on Day 1, Etoposide 120 mg/m2 IV on days 2 and 3 of a 21-day cycle for 4 cycles. Bevacizumab continued for 1 year or until progression.
|
|---|---|
|
Overall Study
Withdrew before treatment
|
1
|
|
Overall Study
Ineligible
|
1
|
Baseline Characteristics
Cisplatin, Etoposide, and Bevacizumab in Treating Patients With Previously Untreated Extensive Stage Small Cell Lung Cancer
Baseline characteristics by cohort
| Measure |
Cisplatin, Etoposide, Bevacizumab
n=63 Participants
Cisplatin 60 mg/m2 IV, Etoposide 120 mg/m2 IV, and Bevacizumab 15 mg/kg IV on Day 1, Etoposide 120 mg/m2 IV on days 2 and 3 of a 21-day cycle for 4 cycles. Bevacizumab continued for 1 year or until progression.
|
|---|---|
|
Age, Continuous
|
65 Years
n=99 Participants
|
|
Sex: Female, Male
Female
|
36 Participants
n=99 Participants
|
|
Sex: Female, Male
Male
|
27 Participants
n=99 Participants
|
|
Region of Enrollment
United States
|
63 participants
n=99 Participants
|
PRIMARY outcome
Timeframe: 6 monthsPopulation: Per protocol, the analysis included all eligible, treated patients (n=63). The safety analysis included all treated patients, regardless of eligibility (n=64).
Progression-free survival was defined to be the interval in months from the date of registration to the date of documented disease progression or to death without progression. Patients alive without progression at 6 months were included in the numerator when calculating the progression-free rate.
Outcome measures
| Measure |
Cisplatin, Etoposide, Bevacizumab
n=63 Participants
Cisplatin 60 mg/m2 IV, Etoposide 120 mg/m2 IV, and Bevacizumab 15 mg/kg IV on Day 1, Etoposide 120 mg/m2 IV on days 2 and 3 of a 21-day cycle for 4 cycles. Bevacizumab continued for 1 year or until progression.
|
|---|---|
|
Percentage of Participants Alive and Progression-free (PF) at 6 Months
|
30.2 Percentage of Participants
Interval 19.3 to 43.1
|
SECONDARY outcome
Timeframe: Assessed every 3 months for 2 years, then every 6 months for 1 yearPopulation: Per protocol, the analysis included all eligible, treated patients
Overall survival is defined as the time from registration to death or date last known alive. Patients alive at last follow-up are censored.
Outcome measures
| Measure |
Cisplatin, Etoposide, Bevacizumab
n=63 Participants
Cisplatin 60 mg/m2 IV, Etoposide 120 mg/m2 IV, and Bevacizumab 15 mg/kg IV on Day 1, Etoposide 120 mg/m2 IV on days 2 and 3 of a 21-day cycle for 4 cycles. Bevacizumab continued for 1 year or until progression.
|
|---|---|
|
Overall Survival
|
10.9 months
Interval 7.9 to 12.2
|
SECONDARY outcome
Timeframe: Assessed every 6 weeksPopulation: Per protocol, the analysis included all eligible, treated patients.
Number of patients with complete or partial response by RECIST criteria.
Outcome measures
| Measure |
Cisplatin, Etoposide, Bevacizumab
n=63 Participants
Cisplatin 60 mg/m2 IV, Etoposide 120 mg/m2 IV, and Bevacizumab 15 mg/kg IV on Day 1, Etoposide 120 mg/m2 IV on days 2 and 3 of a 21-day cycle for 4 cycles. Bevacizumab continued for 1 year or until progression.
|
|---|---|
|
Best Objective Response
|
40 Patients Responding
Interval 50.4 to 75.6
|
Adverse Events
Cisplatin, Etoposide, Bevacizumab
Serious events: 49 serious events
Other events: 63 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Cisplatin, Etoposide, Bevacizumab
n=64 participants at risk
Cisplatin 60 mg/m2 IV, Etoposide 120 mg/m2 IV, and Bevacizumab 15 mg/kg IV on Day 1, Etoposide 120 mg/m2 IV on days 2 and 3 of a 21-day cycle for 4 cycles. Bevacizumab continued for 1 year or until progression.
|
|---|---|
|
Immune system disorders
Allergic Reaction
|
1.6%
1/64 • Adverse events were assessed at each treatment visit (approximately every 3 weeks) and through 30 days following the end of treatment
Assessment was done routinely for the safety population, which consisted of all 64 treated patients.
|
|
Blood and lymphatic system disorders
Low Hemoglobin
|
4.7%
3/64 • Adverse events were assessed at each treatment visit (approximately every 3 weeks) and through 30 days following the end of treatment
Assessment was done routinely for the safety population, which consisted of all 64 treated patients.
|
|
Blood and lymphatic system disorders
Low Leukocytes
|
29.7%
19/64 • Adverse events were assessed at each treatment visit (approximately every 3 weeks) and through 30 days following the end of treatment
Assessment was done routinely for the safety population, which consisted of all 64 treated patients.
|
|
Blood and lymphatic system disorders
Lymphopenia
|
1.6%
1/64 • Adverse events were assessed at each treatment visit (approximately every 3 weeks) and through 30 days following the end of treatment
Assessment was done routinely for the safety population, which consisted of all 64 treated patients.
|
|
Blood and lymphatic system disorders
Low Neutrophils
|
57.8%
37/64 • Adverse events were assessed at each treatment visit (approximately every 3 weeks) and through 30 days following the end of treatment
Assessment was done routinely for the safety population, which consisted of all 64 treated patients.
|
|
Blood and lymphatic system disorders
Low Platelets
|
14.1%
9/64 • Adverse events were assessed at each treatment visit (approximately every 3 weeks) and through 30 days following the end of treatment
Assessment was done routinely for the safety population, which consisted of all 64 treated patients.
|
|
Cardiac disorders
Sinus Bradycardia
|
1.6%
1/64 • Adverse events were assessed at each treatment visit (approximately every 3 weeks) and through 30 days following the end of treatment
Assessment was done routinely for the safety population, which consisted of all 64 treated patients.
|
|
Cardiac disorders
Cardiac ischemia
|
1.6%
1/64 • Adverse events were assessed at each treatment visit (approximately every 3 weeks) and through 30 days following the end of treatment
Assessment was done routinely for the safety population, which consisted of all 64 treated patients.
|
|
Cardiac disorders
Hypertension
|
7.8%
5/64 • Adverse events were assessed at each treatment visit (approximately every 3 weeks) and through 30 days following the end of treatment
Assessment was done routinely for the safety population, which consisted of all 64 treated patients.
|
|
Cardiac disorders
Hypotension
|
1.6%
1/64 • Adverse events were assessed at each treatment visit (approximately every 3 weeks) and through 30 days following the end of treatment
Assessment was done routinely for the safety population, which consisted of all 64 treated patients.
|
|
Cardiac disorders
Left ventricular diastolic dysfunction
|
1.6%
1/64 • Adverse events were assessed at each treatment visit (approximately every 3 weeks) and through 30 days following the end of treatment
Assessment was done routinely for the safety population, which consisted of all 64 treated patients.
|
|
Cardiac disorders
Cardiac - other
|
1.6%
1/64 • Adverse events were assessed at each treatment visit (approximately every 3 weeks) and through 30 days following the end of treatment
Assessment was done routinely for the safety population, which consisted of all 64 treated patients.
|
|
General disorders
Fatigue
|
12.5%
8/64 • Adverse events were assessed at each treatment visit (approximately every 3 weeks) and through 30 days following the end of treatment
Assessment was done routinely for the safety population, which consisted of all 64 treated patients.
|
|
General disorders
Death - multiorgan failure
|
1.6%
1/64 • Adverse events were assessed at each treatment visit (approximately every 3 weeks) and through 30 days following the end of treatment
Assessment was done routinely for the safety population, which consisted of all 64 treated patients.
|
|
Gastrointestinal disorders
Anorexia
|
1.6%
1/64 • Adverse events were assessed at each treatment visit (approximately every 3 weeks) and through 30 days following the end of treatment
Assessment was done routinely for the safety population, which consisted of all 64 treated patients.
|
|
Gastrointestinal disorders
Dehydration
|
4.7%
3/64 • Adverse events were assessed at each treatment visit (approximately every 3 weeks) and through 30 days following the end of treatment
Assessment was done routinely for the safety population, which consisted of all 64 treated patients.
|
|
Gastrointestinal disorders
Diarrhea w/o prior colostomy
|
1.6%
1/64 • Adverse events were assessed at each treatment visit (approximately every 3 weeks) and through 30 days following the end of treatment
Assessment was done routinely for the safety population, which consisted of all 64 treated patients.
|
|
Gastrointestinal disorders
Muco/stomatitis
|
1.6%
1/64 • Adverse events were assessed at each treatment visit (approximately every 3 weeks) and through 30 days following the end of treatment
Assessment was done routinely for the safety population, which consisted of all 64 treated patients.
|
|
Gastrointestinal disorders
Nausea
|
3.1%
2/64 • Adverse events were assessed at each treatment visit (approximately every 3 weeks) and through 30 days following the end of treatment
Assessment was done routinely for the safety population, which consisted of all 64 treated patients.
|
|
Gastrointestinal disorders
Vomiting
|
3.1%
2/64 • Adverse events were assessed at each treatment visit (approximately every 3 weeks) and through 30 days following the end of treatment
Assessment was done routinely for the safety population, which consisted of all 64 treated patients.
|
|
Gastrointestinal disorders
Abdomen, hemorrhage
|
1.6%
1/64 • Adverse events were assessed at each treatment visit (approximately every 3 weeks) and through 30 days following the end of treatment
Assessment was done routinely for the safety population, which consisted of all 64 treated patients.
|
|
Respiratory, thoracic and mediastinal disorders
Bronchopulmonary, hemorrhage
|
1.6%
1/64 • Adverse events were assessed at each treatment visit (approximately every 3 weeks) and through 30 days following the end of treatment
Assessment was done routinely for the safety population, which consisted of all 64 treated patients.
|
|
Infections and infestations
Febrile Neutropenia
|
4.7%
3/64 • Adverse events were assessed at each treatment visit (approximately every 3 weeks) and through 30 days following the end of treatment
Assessment was done routinely for the safety population, which consisted of all 64 treated patients.
|
|
Infections and infestations
Infection w/ gr 3-4 neutrophils, lung
|
1.6%
1/64 • Adverse events were assessed at each treatment visit (approximately every 3 weeks) and through 30 days following the end of treatment
Assessment was done routinely for the safety population, which consisted of all 64 treated patients.
|
|
Infections and infestations
Infection w/ gr 0-2 neutrophils, lung
|
1.6%
1/64 • Adverse events were assessed at each treatment visit (approximately every 3 weeks) and through 30 days following the end of treatment
Assessment was done routinely for the safety population, which consisted of all 64 treated patients.
|
|
Infections and infestations
Infection w/ gr 3-4 neutrophils, blood
|
3.1%
2/64 • Adverse events were assessed at each treatment visit (approximately every 3 weeks) and through 30 days following the end of treatment
Assessment was done routinely for the safety population, which consisted of all 64 treated patients.
|
|
Metabolism and nutrition disorders
Hypocalcemia
|
3.1%
2/64 • Adverse events were assessed at each treatment visit (approximately every 3 weeks) and through 30 days following the end of treatment
Assessment was done routinely for the safety population, which consisted of all 64 treated patients.
|
|
Metabolism and nutrition disorders
Hypokalemia
|
1.6%
1/64 • Adverse events were assessed at each treatment visit (approximately every 3 weeks) and through 30 days following the end of treatment
Assessment was done routinely for the safety population, which consisted of all 64 treated patients.
|
|
Metabolism and nutrition disorders
Hyponatremia
|
10.9%
7/64 • Adverse events were assessed at each treatment visit (approximately every 3 weeks) and through 30 days following the end of treatment
Assessment was done routinely for the safety population, which consisted of all 64 treated patients.
|
|
Musculoskeletal and connective tissue disorders
Extremity, lower (gait/walking)
|
1.6%
1/64 • Adverse events were assessed at each treatment visit (approximately every 3 weeks) and through 30 days following the end of treatment
Assessment was done routinely for the safety population, which consisted of all 64 treated patients.
|
|
General disorders
Nonneuropathic generalized weakness
|
1.6%
1/64 • Adverse events were assessed at each treatment visit (approximately every 3 weeks) and through 30 days following the end of treatment
Assessment was done routinely for the safety population, which consisted of all 64 treated patients.
|
|
Nervous system disorders
Ataxia
|
1.6%
1/64 • Adverse events were assessed at each treatment visit (approximately every 3 weeks) and through 30 days following the end of treatment
Assessment was done routinely for the safety population, which consisted of all 64 treated patients.
|
|
Nervous system disorders
Dizziness
|
1.6%
1/64 • Adverse events were assessed at each treatment visit (approximately every 3 weeks) and through 30 days following the end of treatment
Assessment was done routinely for the safety population, which consisted of all 64 treated patients.
|
|
Musculoskeletal and connective tissue disorders
Back, pain
|
1.6%
1/64 • Adverse events were assessed at each treatment visit (approximately every 3 weeks) and through 30 days following the end of treatment
Assessment was done routinely for the safety population, which consisted of all 64 treated patients.
|
|
Musculoskeletal and connective tissue disorders
Bone, pain
|
1.6%
1/64 • Adverse events were assessed at each treatment visit (approximately every 3 weeks) and through 30 days following the end of treatment
Assessment was done routinely for the safety population, which consisted of all 64 treated patients.
|
|
Nervous system disorders
Headache
|
1.6%
1/64 • Adverse events were assessed at each treatment visit (approximately every 3 weeks) and through 30 days following the end of treatment
Assessment was done routinely for the safety population, which consisted of all 64 treated patients.
|
|
Musculoskeletal and connective tissue disorders
Joint, pain
|
4.7%
3/64 • Adverse events were assessed at each treatment visit (approximately every 3 weeks) and through 30 days following the end of treatment
Assessment was done routinely for the safety population, which consisted of all 64 treated patients.
|
|
Musculoskeletal and connective tissue disorders
Muscle, pain
|
1.6%
1/64 • Adverse events were assessed at each treatment visit (approximately every 3 weeks) and through 30 days following the end of treatment
Assessment was done routinely for the safety population, which consisted of all 64 treated patients.
|
|
Nervous system disorders
Pain, other
|
1.6%
1/64 • Adverse events were assessed at each treatment visit (approximately every 3 weeks) and through 30 days following the end of treatment
Assessment was done routinely for the safety population, which consisted of all 64 treated patients.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
1.6%
1/64 • Adverse events were assessed at each treatment visit (approximately every 3 weeks) and through 30 days following the end of treatment
Assessment was done routinely for the safety population, which consisted of all 64 treated patients.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary/upper respiratory, other
|
1.6%
1/64 • Adverse events were assessed at each treatment visit (approximately every 3 weeks) and through 30 days following the end of treatment
Assessment was done routinely for the safety population, which consisted of all 64 treated patients.
|
|
Vascular disorders
Thrombosis/thrombus/embolism
|
1.6%
1/64 • Adverse events were assessed at each treatment visit (approximately every 3 weeks) and through 30 days following the end of treatment
Assessment was done routinely for the safety population, which consisted of all 64 treated patients.
|
Other adverse events
| Measure |
Cisplatin, Etoposide, Bevacizumab
n=64 participants at risk
Cisplatin 60 mg/m2 IV, Etoposide 120 mg/m2 IV, and Bevacizumab 15 mg/kg IV on Day 1, Etoposide 120 mg/m2 IV on days 2 and 3 of a 21-day cycle for 4 cycles. Bevacizumab continued for 1 year or until progression.
|
|---|---|
|
Blood and lymphatic system disorders
Hemoglobin
|
6.2%
4/64 • Adverse events were assessed at each treatment visit (approximately every 3 weeks) and through 30 days following the end of treatment
Assessment was done routinely for the safety population, which consisted of all 64 treated patients.
|
|
Blood and lymphatic system disorders
Leukocytes
|
62.5%
40/64 • Adverse events were assessed at each treatment visit (approximately every 3 weeks) and through 30 days following the end of treatment
Assessment was done routinely for the safety population, which consisted of all 64 treated patients.
|
|
Blood and lymphatic system disorders
Neutrophils
|
51.6%
33/64 • Adverse events were assessed at each treatment visit (approximately every 3 weeks) and through 30 days following the end of treatment
Assessment was done routinely for the safety population, which consisted of all 64 treated patients.
|
|
Blood and lymphatic system disorders
Platelets
|
43.8%
28/64 • Adverse events were assessed at each treatment visit (approximately every 3 weeks) and through 30 days following the end of treatment
Assessment was done routinely for the safety population, which consisted of all 64 treated patients.
|
|
Cardiac disorders
Hypertension
|
14.1%
9/64 • Adverse events were assessed at each treatment visit (approximately every 3 weeks) and through 30 days following the end of treatment
Assessment was done routinely for the safety population, which consisted of all 64 treated patients.
|
|
Cardiac disorders
Hypotension
|
10.9%
7/64 • Adverse events were assessed at each treatment visit (approximately every 3 weeks) and through 30 days following the end of treatment
Assessment was done routinely for the safety population, which consisted of all 64 treated patients.
|
|
Infections and infestations
Fever w/o neutropenia
|
10.9%
7/64 • Adverse events were assessed at each treatment visit (approximately every 3 weeks) and through 30 days following the end of treatment
Assessment was done routinely for the safety population, which consisted of all 64 treated patients.
|
|
General disorders
Insomnia
|
9.4%
6/64 • Adverse events were assessed at each treatment visit (approximately every 3 weeks) and through 30 days following the end of treatment
Assessment was done routinely for the safety population, which consisted of all 64 treated patients.
|
|
General disorders
Rigors/chills
|
10.9%
7/64 • Adverse events were assessed at each treatment visit (approximately every 3 weeks) and through 30 days following the end of treatment
Assessment was done routinely for the safety population, which consisted of all 64 treated patients.
|
|
General disorders
Weight loss
|
12.5%
8/64 • Adverse events were assessed at each treatment visit (approximately every 3 weeks) and through 30 days following the end of treatment
Assessment was done routinely for the safety population, which consisted of all 64 treated patients.
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
73.4%
47/64 • Adverse events were assessed at each treatment visit (approximately every 3 weeks) and through 30 days following the end of treatment
Assessment was done routinely for the safety population, which consisted of all 64 treated patients.
|
|
Skin and subcutaneous tissue disorders
Injection site reaction
|
6.2%
4/64 • Adverse events were assessed at each treatment visit (approximately every 3 weeks) and through 30 days following the end of treatment
Assessment was done routinely for the safety population, which consisted of all 64 treated patients.
|
|
Skin and subcutaneous tissue disorders
Pruritis/itching
|
6.2%
4/64 • Adverse events were assessed at each treatment visit (approximately every 3 weeks) and through 30 days following the end of treatment
Assessment was done routinely for the safety population, which consisted of all 64 treated patients.
|
|
Skin and subcutaneous tissue disorders
Rash/desquamation
|
9.4%
6/64 • Adverse events were assessed at each treatment visit (approximately every 3 weeks) and through 30 days following the end of treatment
Assessment was done routinely for the safety population, which consisted of all 64 treated patients.
|
|
Gastrointestinal disorders
Anorexia
|
43.8%
28/64 • Adverse events were assessed at each treatment visit (approximately every 3 weeks) and through 30 days following the end of treatment
Assessment was done routinely for the safety population, which consisted of all 64 treated patients.
|
|
Gastrointestinal disorders
Constipation
|
46.9%
30/64 • Adverse events were assessed at each treatment visit (approximately every 3 weeks) and through 30 days following the end of treatment
Assessment was done routinely for the safety population, which consisted of all 64 treated patients.
|
|
Gastrointestinal disorders
Diarrhea w/o prior colostomy
|
26.6%
17/64 • Adverse events were assessed at each treatment visit (approximately every 3 weeks) and through 30 days following the end of treatment
Assessment was done routinely for the safety population, which consisted of all 64 treated patients.
|
|
Gastrointestinal disorders
Dysphagia
|
6.2%
4/64 • Adverse events were assessed at each treatment visit (approximately every 3 weeks) and through 30 days following the end of treatment
Assessment was done routinely for the safety population, which consisted of all 64 treated patients.
|
|
Gastrointestinal disorders
Dyspepsia
|
15.6%
10/64 • Adverse events were assessed at each treatment visit (approximately every 3 weeks) and through 30 days following the end of treatment
Assessment was done routinely for the safety population, which consisted of all 64 treated patients.
|
|
Gastrointestinal disorders
Muco/stomatitis by exam, oral cavity
|
21.9%
14/64 • Adverse events were assessed at each treatment visit (approximately every 3 weeks) and through 30 days following the end of treatment
Assessment was done routinely for the safety population, which consisted of all 64 treated patients.
|
|
Gastrointestinal disorders
Muco/stomatitis (symptom), oral cavity
|
17.2%
11/64 • Adverse events were assessed at each treatment visit (approximately every 3 weeks) and through 30 days following the end of treatment
Assessment was done routinely for the safety population, which consisted of all 64 treated patients.
|
|
Gastrointestinal disorders
Nausea
|
67.2%
43/64 • Adverse events were assessed at each treatment visit (approximately every 3 weeks) and through 30 days following the end of treatment
Assessment was done routinely for the safety population, which consisted of all 64 treated patients.
|
|
Gastrointestinal disorders
Taste disturbance
|
14.1%
9/64 • Adverse events were assessed at each treatment visit (approximately every 3 weeks) and through 30 days following the end of treatment
Assessment was done routinely for the safety population, which consisted of all 64 treated patients.
|
|
Gastrointestinal disorders
Vomiting
|
28.1%
18/64 • Adverse events were assessed at each treatment visit (approximately every 3 weeks) and through 30 days following the end of treatment
Assessment was done routinely for the safety population, which consisted of all 64 treated patients.
|
|
Respiratory, thoracic and mediastinal disorders
Nose, hemorrhage
|
9.4%
6/64 • Adverse events were assessed at each treatment visit (approximately every 3 weeks) and through 30 days following the end of treatment
Assessment was done routinely for the safety population, which consisted of all 64 treated patients.
|
|
Metabolism and nutrition disorders
Alkaline phosphatase
|
18.8%
12/64 • Adverse events were assessed at each treatment visit (approximately every 3 weeks) and through 30 days following the end of treatment
Assessment was done routinely for the safety population, which consisted of all 64 treated patients.
|
|
Metabolism and nutrition disorders
AST, SGOT
|
20.3%
13/64 • Adverse events were assessed at each treatment visit (approximately every 3 weeks) and through 30 days following the end of treatment
Assessment was done routinely for the safety population, which consisted of all 64 treated patients.
|
|
Metabolism and nutrition disorders
Hypercalcemia
|
10.9%
7/64 • Adverse events were assessed at each treatment visit (approximately every 3 weeks) and through 30 days following the end of treatment
Assessment was done routinely for the safety population, which consisted of all 64 treated patients.
|
|
Metabolism and nutrition disorders
Hypocalcemia
|
14.1%
9/64 • Adverse events were assessed at each treatment visit (approximately every 3 weeks) and through 30 days following the end of treatment
Assessment was done routinely for the safety population, which consisted of all 64 treated patients.
|
|
Metabolism and nutrition disorders
Creatinine
|
29.7%
19/64 • Adverse events were assessed at each treatment visit (approximately every 3 weeks) and through 30 days following the end of treatment
Assessment was done routinely for the safety population, which consisted of all 64 treated patients.
|
|
Metabolism and nutrition disorders
Hypomagnesemia
|
32.8%
21/64 • Adverse events were assessed at each treatment visit (approximately every 3 weeks) and through 30 days following the end of treatment
Assessment was done routinely for the safety population, which consisted of all 64 treated patients.
|
|
Metabolism and nutrition disorders
Hyperkalemia
|
15.6%
10/64 • Adverse events were assessed at each treatment visit (approximately every 3 weeks) and through 30 days following the end of treatment
Assessment was done routinely for the safety population, which consisted of all 64 treated patients.
|
|
Metabolism and nutrition disorders
Hypokalemia
|
17.2%
11/64 • Adverse events were assessed at each treatment visit (approximately every 3 weeks) and through 30 days following the end of treatment
Assessment was done routinely for the safety population, which consisted of all 64 treated patients.
|
|
Metabolism and nutrition disorders
Proteinuria
|
12.5%
8/64 • Adverse events were assessed at each treatment visit (approximately every 3 weeks) and through 30 days following the end of treatment
Assessment was done routinely for the safety population, which consisted of all 64 treated patients.
|
|
Metabolism and nutrition disorders
Hyponatremia
|
40.6%
26/64 • Adverse events were assessed at each treatment visit (approximately every 3 weeks) and through 30 days following the end of treatment
Assessment was done routinely for the safety population, which consisted of all 64 treated patients.
|
|
Nervous system disorders
Dizziness
|
9.4%
6/64 • Adverse events were assessed at each treatment visit (approximately every 3 weeks) and through 30 days following the end of treatment
Assessment was done routinely for the safety population, which consisted of all 64 treated patients.
|
|
Nervous system disorders
Neuropathy, motor
|
7.8%
5/64 • Adverse events were assessed at each treatment visit (approximately every 3 weeks) and through 30 days following the end of treatment
Assessment was done routinely for the safety population, which consisted of all 64 treated patients.
|
|
Nervous system disorders
Neuropathy, sensory
|
26.6%
17/64 • Adverse events were assessed at each treatment visit (approximately every 3 weeks) and through 30 days following the end of treatment
Assessment was done routinely for the safety population, which consisted of all 64 treated patients.
|
|
Eye disorders
Vision - blurred
|
7.8%
5/64 • Adverse events were assessed at each treatment visit (approximately every 3 weeks) and through 30 days following the end of treatment
Assessment was done routinely for the safety population, which consisted of all 64 treated patients.
|
|
Musculoskeletal and connective tissue disorders
Back, pain
|
9.4%
6/64 • Adverse events were assessed at each treatment visit (approximately every 3 weeks) and through 30 days following the end of treatment
Assessment was done routinely for the safety population, which consisted of all 64 treated patients.
|
|
Nervous system disorders
Headache
|
15.6%
10/64 • Adverse events were assessed at each treatment visit (approximately every 3 weeks) and through 30 days following the end of treatment
Assessment was done routinely for the safety population, which consisted of all 64 treated patients.
|
|
Musculoskeletal and connective tissue disorders
Muscle, pain
|
17.2%
11/64 • Adverse events were assessed at each treatment visit (approximately every 3 weeks) and through 30 days following the end of treatment
Assessment was done routinely for the safety population, which consisted of all 64 treated patients.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
14.1%
9/64 • Adverse events were assessed at each treatment visit (approximately every 3 weeks) and through 30 days following the end of treatment
Assessment was done routinely for the safety population, which consisted of all 64 treated patients.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
18.8%
12/64 • Adverse events were assessed at each treatment visit (approximately every 3 weeks) and through 30 days following the end of treatment
Assessment was done routinely for the safety population, which consisted of all 64 treated patients.
|
|
Respiratory, thoracic and mediastinal disorders
Voice changes/dysarthria
|
10.9%
7/64 • Adverse events were assessed at each treatment visit (approximately every 3 weeks) and through 30 days following the end of treatment
Assessment was done routinely for the safety population, which consisted of all 64 treated patients.
|
Additional Information
Study Statistician
ECOG Statistical Office
Phone: 617-632-3012
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: LTE60