Trial Outcomes & Findings for Pemetrexed, Carboplatin, and Bevacizumab as First-Line Therapy in Treating Older Patients With Stage IIIB or Stage IV Non-Small Cell Lung Cancer (NCT NCT00798603)

NCT ID: NCT00798603

Last Updated: 2017-01-25

Results Overview

Estimated using the Binomial point estimator (number of successes divided by the total number of evaluable patients). A patient is classified as a success if alive and progression-free at 6 months.

• Recruitment status: COMPLETED
• Study phase: PHASE2
• Target enrollment: 65 participants
• Primary outcome timeframe: 6 months
• Results posted on: 2017-01-25

Participant Flow

Sixty-five (65) participants were enrolled between December 12, 2008 and October 1, 2010. Final analysis as of November 6, 2012, was reported.

Three participants who never received any study treatment are excluded from all analyses.

Participant milestones

Measure	Pemetrexed + Carboplatin + Bevacizumab Patients receive pemetrexed disodium IV over 10 minutes, carboplatin IV over 30 minutes, and bevacizumab IV over 30-90 minutes on day 1.
Overall Study STARTED	62
Overall Study COMPLETED	27
Overall Study NOT COMPLETED	35

Reasons for withdrawal

Measure	Pemetrexed + Carboplatin + Bevacizumab Patients receive pemetrexed disodium IV over 10 minutes, carboplatin IV over 30 minutes, and bevacizumab IV over 30-90 minutes on day 1.
Overall Study Still on treatment as of 11/6/2012	1
Overall Study Withdrawal by Subject	10
Overall Study Adverse Event	22
Overall Study Physician Decision	1
Overall Study Lack of insurance coverage	1

Baseline Characteristics

Pemetrexed, Carboplatin, and Bevacizumab as First-Line Therapy in Treating Older Patients With Stage IIIB or Stage IV Non-Small Cell Lung Cancer

Baseline characteristics by cohort

Measure	Pemetrexed + Carboplatin + Bevacizumab n=62 Participants Patients receive pemetrexed disodium IV over 10 minutes, carboplatin IV over 30 minutes, and bevacizumab IV over 30-90 minutes on day 1.
Age, Continuous	74.5 years n=5 Participants
Gender Female	31 Participants n=5 Participants
Gender Male	31 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	2 Participants n=5 Participants
Race (NIH/OMB) White	58 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	2 Participants n=5 Participants
Region of Enrollment United States	62 participants n=5 Participants
Eastern Cooperative Oncology Group (ECOG) Performance Status 0=Asymptomatic and fully active	30 Participants n=5 Participants
Eastern Cooperative Oncology Group (ECOG) Performance Status 1=Symptomatic and fully ambulatory	32 Participants n=5 Participants
Histologic type Adenocarcinoma	44 Participants n=5 Participants
Histologic type Other	18 Participants n=5 Participants
Non-small-cell lung cancer stage (TNM 6th edition) Stage IIIB	9 Participants n=5 Participants
Non-small-cell lung cancer stage (TNM 6th edition) Stage IV	53 Participants n=5 Participants

PRIMARY outcome

Timeframe: 6 months

Population: The first 55 participants who met the eligibility criteria and have started the study treatment.

Estimated using the Binomial point estimator (number of successes divided by the total number of evaluable patients). A patient is classified as a success if alive and progression-free at 6 months.

Outcome measures

Measure	Pemetrexed + Carboplatin + Bevacizumab n=55 Participants Patients receive pemetrexed disodium IV over 10 minutes, carboplatin IV over 30 minutes, and bevacizumab IV over 30-90 minutes on day 1.
Progression-free Survival at 6 Months	60 percentage of participants Interval 45.9 to 73.0

SECONDARY outcome

Timeframe: Duration of study until progression (up to 5 years)

Population: All participants who met the eligibility criteria, have started the study treatment and have post-baseline disease assessments.

Response was defined using Response Evaluation Criteria In Solid Tumors (RECIST) criteria:

Complete Response (CR): disappearance of all target and non-target lesions and no new lesions.

Partial Response (PR): disappearance of all target lesions, persistence of one or more non-target lesions, and no new lesions; or at least a 30% decrease in the sum of the longest diameter (LD) of target lesions taking as reference the baseline sum LD, no appearance of one/more new lesions, unequivocal progression of existing non-target lesions, and no new lesions.

Outcome measures

Measure	Pemetrexed + Carboplatin + Bevacizumab n=55 Participants Patients receive pemetrexed disodium IV over 10 minutes, carboplatin IV over 30 minutes, and bevacizumab IV over 30-90 minutes on day 1.
Proportion of Confirmed Tumor Response Defined as an Objective Status of Complete Response or Partial Response on Two Consecutive Evaluations	40 percentage of participants Interval 27.0 to 54.1

SECONDARY outcome

Timeframe: Up to 5 years

Population: All participants who met the eligibility criteria, have started the study treatment and had confirmed CR or PR.

Duration of response for responders was defined as the time from the date of the first objective status assessment of a confirmed CR or PR to the first date of disease progression. Duration of response will be censored at the date of last post-therapy follow-up visit for responders who have not had disease progression. Duration of response will be calculated for all evaluable patients who have achieved an objective confirmed response.

Outcome measures

Measure	Pemetrexed + Carboplatin + Bevacizumab n=22 Participants Patients receive pemetrexed disodium IV over 10 minutes, carboplatin IV over 30 minutes, and bevacizumab IV over 30-90 minutes on day 1.
Duration of Response	8.8 months Interval 3.8 to 20.9

SECONDARY outcome

Timeframe: Up to 2.5 years

Population: All participants who received treatment.

Adverse events were assessed by Common Terminology Criteria for Adverse Events (CTCAE) v3.0. Grading: Grade 1=Mild, Grade 2=Moderate, Grade 3=Severe, Grade 4=Life-threatening, Grade 5=Death.

Outcome measures

Measure	Pemetrexed + Carboplatin + Bevacizumab n=62 Participants Patients receive pemetrexed disodium IV over 10 minutes, carboplatin IV over 30 minutes, and bevacizumab IV over 30-90 minutes on day 1.
Number of Grade 3 or Higher Adverse Events Occurring in >=10% of Patients Fatigue	16 particpants
Number of Grade 3 or Higher Adverse Events Occurring in >=10% of Patients Hypertension	7 particpants
Number of Grade 3 or Higher Adverse Events Occurring in >=10% of Patients Neutropenia	18 particpants
Number of Grade 3 or Higher Adverse Events Occurring in >=10% of Patients Thrombocytopenia	11 particpants

SECONDARY outcome

Timeframe: Up to 5 years

Population: All participants who met the eligibility criteria and have started the study treatment.

Time to treatment failure was defined to be the time from date of registration to the date at which the patient is removed from the treatment due to progression, toxicity, refusal or death from any cause.

Outcome measures

Measure	Pemetrexed + Carboplatin + Bevacizumab n=57 Participants Patients receive pemetrexed disodium IV over 10 minutes, carboplatin IV over 30 minutes, and bevacizumab IV over 30-90 minutes on day 1.
Time to Treatment Failure	4.89 months Interval 3.88 to 6.37

SECONDARY outcome

Timeframe: Up to 5 years

Population: All participants who met the eligibility criteria and have started the study treatment.

Progression-free survival was defined as the time from study enrollment to the first date of disease progression or death as a result of any cause, whichever occurs first. Progression-free survival will be censored at the date of the last contact for patients who are still alive and who have not had disease progression.

Outcome measures

Measure	Pemetrexed + Carboplatin + Bevacizumab n=57 Participants Patients receive pemetrexed disodium IV over 10 minutes, carboplatin IV over 30 minutes, and bevacizumab IV over 30-90 minutes on day 1.
Progression-free Survival	7 months Interval 5.9 to 10.1

SECONDARY outcome

Timeframe: Up to 5 years

Population: All participants who met the eligibility criteria and have started the study treatment.

Overall survival was defined as the time from study enrollment to the time of death from any cause. Overall survival will be censored at the date of the last follow-up visit for patients who are still alive or lost to follow-up.

Outcome measures

Measure	Pemetrexed + Carboplatin + Bevacizumab n=57 Participants Patients receive pemetrexed disodium IV over 10 minutes, carboplatin IV over 30 minutes, and bevacizumab IV over 30-90 minutes on day 1.
Overall Survival	13.7 months Interval 9.4 to 16.8

SECONDARY outcome

Timeframe: Baseline and Cycle 3

Population: All participants who met the eligibility criteria, have started the study treatment and had baseline and cycle 3 LCSS data.

Lung Cancer Symptom Scale (LCSS) consist of 9 items that assess the symptoms of lung cancer during the past days on a 10-points scale with 0 as no symptoms and 10 as worse symptoms. The individual item score was translated onto a 0-100 point scale with lower values indicating worse symptoms. An average of the aggregate score of all 9 items was used for a total score. Change from baseline to cycle 3 was calculated by subtracting the baseline scores from the scores at cycle 3.

Outcome measures

Measure	Pemetrexed + Carboplatin + Bevacizumab n=46 Participants Patients receive pemetrexed disodium IV over 10 minutes, carboplatin IV over 30 minutes, and bevacizumab IV over 30-90 minutes on day 1.
Change From Baseline to Cycle 3 in Quality of Life (QOL) as Assessed by the Lung Cancer Symptom Scale	1.1 units on a scale Interval -25.6 to 25.6

SECONDARY outcome

Timeframe: Baseline and Cycle 5

Population: All participants who met the eligibility criteria, have started the study treatment and had baseline and cycle 5 LCSS data.

Lung Cancer Symptom Scale (LCSS) consist of 9 items that assess the symptoms of lung cancer during the past days on a 10-points scale with 0 as no symptoms and 10 as worse symptoms. The individual item score was translated onto a 0-100 point scale with lower values indicating worse symptoms. An average of the aggregate score of all 9 items was used for a total score. Change from baseline to cycle 5 was calculated by subtracting the baseline scores from the scores at cycle 5.

Outcome measures

Measure	Pemetrexed + Carboplatin + Bevacizumab n=37 Participants Patients receive pemetrexed disodium IV over 10 minutes, carboplatin IV over 30 minutes, and bevacizumab IV over 30-90 minutes on day 1.
Change From Baseline to Cycle 5 in Quality of Life (QOL) as Assessed by the Lung Cancer Symptom Scale	1.1 units on a scale Interval -21.1 to 33.3

SECONDARY outcome

Timeframe: Baseline and Cycle 3

Population: All participants who met the eligibility criteria, have started the study treatment and had baseline and cycle 3 LASA data.

The overall quality of life (QOL) question was on a 10-points scale with 0=as bad as it can be and 10=as good as it can be. The QOL scores was translated onto a 0 to 100 point scale, with lower values indicating worse symptoms. Change from baseline to cycle 3 was calculated by subtracting the baseline scores from the scores at cycle 3.

Outcome measures

Measure	Pemetrexed + Carboplatin + Bevacizumab n=45 Participants Patients receive pemetrexed disodium IV over 10 minutes, carboplatin IV over 30 minutes, and bevacizumab IV over 30-90 minutes on day 1.
Change From Baseline to Cycle 3 in Overall Quality of Life Assessed by Linear Analogue Self Assessment (LASA)	0 units on a scale Interval -50.0 to 100.0

SECONDARY outcome

Timeframe: Baseline and Cycle 5

Population: All participants who met the eligibility criteria, have started the study treatment and had baseline and cycle 5 LASA data.

The overall quality of life (QOL) question was on a 10-points scale with 0=as bad as it can be and 10=as good as it can be. The QOL scores was translated onto a 0 to 100 point scale, with lower values indicating worse symptoms. Change from baseline to cycle 5 was calculated by subtracting the baseline scores from the scores at cycle 5.

Outcome measures

Measure	Pemetrexed + Carboplatin + Bevacizumab n=37 Participants Patients receive pemetrexed disodium IV over 10 minutes, carboplatin IV over 30 minutes, and bevacizumab IV over 30-90 minutes on day 1.
Change From Baseline to Cycle 5 in Overall Quality of Life Assessed by Linear Analogue Self Assessment (LASA)	0 units on a scale Interval -60.0 to 100.0

SECONDARY outcome

Timeframe: Baseline and Cycle 3

Population: All participants who met the eligibility criteria, have started the study treatment and had baseline and cycle 3 fatigue data.

The single-item fatigue question was on a 10-points scale with 0=no fatigue and 10=as bad as you can imagine. The item scores was translated onto a 0 to 100 point scale, with lower values indicating worse symptoms. Change from baseline to cycle 3 was calculated by subtracting the baseline scores from the scores at cycle 3.

Outcome measures

Measure	Pemetrexed + Carboplatin + Bevacizumab n=45 Participants Patients receive pemetrexed disodium IV over 10 minutes, carboplatin IV over 30 minutes, and bevacizumab IV over 30-90 minutes on day 1.
Change From Baseline to Cycle 3 in Fatigue Assessed by Treatment-specific Adverse Events Scale	0 units on a scale Interval -50.0 to 50.0

SECONDARY outcome

Timeframe: Baseline and Cycle 5

Population: All participants who met the eligibility criteria, have started the study treatment and had baseline and cycle 5 fatigue data.

The single-item fatigue question was on a 10-points scale with 0=no fatigue and 10=as bad as you can imagine. The item scores was translated onto a 0 to 100 point scale, with lower values indicating worse symptoms. Change from baseline to cycle 5 was calculated by subtracting the baseline scores from the scores at cycle 5.

Outcome measures

Measure	Pemetrexed + Carboplatin + Bevacizumab n=37 Participants Patients receive pemetrexed disodium IV over 10 minutes, carboplatin IV over 30 minutes, and bevacizumab IV over 30-90 minutes on day 1.
Change From Baseline to Cycle 5 in Fatigue Assessed by Treatment-specific Adverse Events Scale	-10 units on a scale Interval -60.0 to 40.0

SECONDARY outcome

Timeframe: Baseline and Cycle 3

Population: All participants who met the eligibility criteria, have started the study treatment and had baseline and cycle 3 neuropathy data.

The single-item neuropathy question was on a 10-points scale with 0=no numbness or tingling in fingers and toes and 10=worst numbness or tingling in fingers and toes imaginable. The item scores was translated onto a 0 to 100 point scale, with lower values indicating worse symptoms. Change from baseline to cycle 3 was calculated by subtracting the baseline scores from the scores at cycle 3.

Outcome measures

Measure	Pemetrexed + Carboplatin + Bevacizumab n=45 Participants Patients receive pemetrexed disodium IV over 10 minutes, carboplatin IV over 30 minutes, and bevacizumab IV over 30-90 minutes on day 1.
Change From Baseline to Cycle 3 in Neuropathy Assessed by Treatment-specific Adverse Events Scale	0 units on a scale Interval -50.0 to 60.0

SECONDARY outcome

Timeframe: Baseline and Cycle 5

Population: All participants who met the eligibility criteria, have started the study treatment and had baseline and cycle 5 neuropathy data.

The single-item neuropathy question was on a 10-points scale with 0=no numbness or tingling in fingers and toes and 10=worst numbness or tingling in fingers and toes imaginable. The item scores was translated onto a 0 to 100 point scale, with lower values indicating worse symptoms. Change from baseline to cycle 5 was calculated by subtracting the baseline scores from the scores at cycle 5.

Outcome measures

Measure	Pemetrexed + Carboplatin + Bevacizumab n=37 Participants Patients receive pemetrexed disodium IV over 10 minutes, carboplatin IV over 30 minutes, and bevacizumab IV over 30-90 minutes on day 1.
Change From Baseline to Cycle 5 in Neuropathy Assessed by Treatment-specific Adverse Events Scale	0 units on a scale Interval -60.0 to 50.0

SECONDARY outcome

Timeframe: Baseline and Cycle 3

Population: All participants who met the eligibility criteria, have started the study treatment and had baseline and cycle 3 nausea data.

The single-item nausea question was on a 10-points scale with 0=no nausea and 10=as bad as you can imagine. The item scores was translated onto a 0 to 100 point scale, with lower values indicating worse symptoms. Change from baseline to cycle 3 was calculated by subtracting the baseline scores from the scores at cycle 3.

Outcome measures

Measure	Pemetrexed + Carboplatin + Bevacizumab n=45 Participants Patients receive pemetrexed disodium IV over 10 minutes, carboplatin IV over 30 minutes, and bevacizumab IV over 30-90 minutes on day 1.
Change From Baseline to Cycle 3 in Nausea Assessed by Treatment-specific Adverse Events Scale	0 units on a scale Interval -70.0 to 40.0

SECONDARY outcome

Timeframe: Baseline and Cycle 5

Population: All participants who met the eligibility criteria, have started the study treatment and had baseline and cycle 5 nausea data.

The single-item nausea question was on a 10-points scale with 0=no nausea and 10=as bad as you can imagine. The item scores was translated onto a 0 to 100 point scale, with lower values indicating worse symptoms. Change from baseline to cycle 5 was calculated by subtracting the baseline scores from the scores at cycle 5.

Outcome measures

Measure	Pemetrexed + Carboplatin + Bevacizumab n=37 Participants Patients receive pemetrexed disodium IV over 10 minutes, carboplatin IV over 30 minutes, and bevacizumab IV over 30-90 minutes on day 1.
Change From Baseline to Cycle 5 in Nausea Assessed by Treatment-specific Adverse Events Scale	0 units on a scale Interval -90.0 to 20.0

Adverse Events

Pemetrexed + Carboplatin + Bevacizumab

Serious events: 10 serious events

Other events: 62 other events

Deaths: 0 deaths

Serious adverse events

Measure	Pemetrexed + Carboplatin + Bevacizumab n=62 participants at risk Patients receive pemetrexed disodium IV over 10 minutes, carboplatin IV over 30 minutes, and bevacizumab IV over 30-90 minutes on day 1.
Cardiac disorders Myocardial ischemia	1.6% 1/62 • Number of events 1 • 2.5 years
Gastrointestinal disorders Diarrhea	1.6% 1/62 • Number of events 1 • 2.5 years
Gastrointestinal disorders Lower gastrointestinal hemorrhage	1.6% 1/62 • Number of events 1 • 2.5 years
General disorders Fatigue	3.2% 2/62 • Number of events 2 • 2.5 years
Infections and infestations Abdominal infection	1.6% 1/62 • Number of events 1 • 2.5 years
Injury, poisoning and procedural complications Fracture	1.6% 1/62 • Number of events 1 • 2.5 years
Investigations Creatinine increased	1.6% 1/62 • Number of events 1 • 2.5 years
Investigations Leukocyte count decreased	1.6% 1/62 • Number of events 1 • 2.5 years
Investigations Neutrophil count decreased	1.6% 1/62 • Number of events 1 • 2.5 years
Investigations Platelet count decreased	3.2% 2/62 • Number of events 2 • 2.5 years
Metabolism and nutrition disorders Dehydration	1.6% 1/62 • Number of events 1 • 2.5 years
Respiratory, thoracic and mediastinal disorders Pulmonary hemorrhage	1.6% 1/62 • Number of events 1 • 2.5 years

Other adverse events

Measure	Pemetrexed + Carboplatin + Bevacizumab n=62 participants at risk Patients receive pemetrexed disodium IV over 10 minutes, carboplatin IV over 30 minutes, and bevacizumab IV over 30-90 minutes on day 1.
Respiratory, thoracic and mediastinal disorders Bronchial hemorrhage	1.6% 1/62 • Number of events 2 • 2.5 years
Respiratory, thoracic and mediastinal disorders Cough	1.6% 1/62 • Number of events 1 • 2.5 years
Respiratory, thoracic and mediastinal disorders Dyspnea	17.7% 11/62 • Number of events 33 • 2.5 years
Respiratory, thoracic and mediastinal disorders Hemorrhage nasal	3.2% 2/62 • Number of events 2 • 2.5 years
Blood and lymphatic system disorders Febrile neutropenia	3.2% 2/62 • Number of events 2 • 2.5 years
Blood and lymphatic system disorders Hemoglobin decreased	30.6% 19/62 • Number of events 48 • 2.5 years
Blood and lymphatic system disorders Hemolysis	3.2% 2/62 • Number of events 2 • 2.5 years
Cardiac disorders Atrial fibrillation	1.6% 1/62 • Number of events 1 • 2.5 years
Cardiac disorders Cardiac disorder	1.6% 1/62 • Number of events 1 • 2.5 years
Cardiac disorders Myocardial ischemia	1.6% 1/62 • Number of events 1 • 2.5 years
Cardiac disorders Ventricular tachycardia	1.6% 1/62 • Number of events 1 • 2.5 years
Cardiac disorders Wolff-Parkinson-White syndrome	1.6% 1/62 • Number of events 1 • 2.5 years
Ear and labyrinth disorders Tinnitus	1.6% 1/62 • Number of events 2 • 2.5 years
Eye disorders Dry eye syndrome	1.6% 1/62 • Number of events 1 • 2.5 years
Gastrointestinal disorders Abdominal distension	1.6% 1/62 • Number of events 1 • 2.5 years
Gastrointestinal disorders Abdominal pain	27.4% 17/62 • Number of events 25 • 2.5 years
Gastrointestinal disorders Colonic obstruction	1.6% 1/62 • Number of events 1 • 2.5 years
Gastrointestinal disorders Colonic perforation	1.6% 1/62 • Number of events 1 • 2.5 years
Gastrointestinal disorders Constipation	19.4% 12/62 • Number of events 26 • 2.5 years
Gastrointestinal disorders Diarrhea	38.7% 24/62 • Number of events 113 • 2.5 years
Gastrointestinal disorders Ear, nose and throat examination abnormal	30.6% 19/62 • Number of events 39 • 2.5 years
Gastrointestinal disorders Flatulence	1.6% 1/62 • Number of events 1 • 2.5 years
Gastrointestinal disorders Ileus	1.6% 1/62 • Number of events 1 • 2.5 years
Gastrointestinal disorders Jejunal hemorrhage	1.6% 1/62 • Number of events 1 • 2.5 years
Gastrointestinal disorders Mucositis oral	35.5% 22/62 • Number of events 66 • 2.5 years
Gastrointestinal disorders Nausea	64.5% 40/62 • Number of events 108 • 2.5 years
Gastrointestinal disorders Rectal pain	1.6% 1/62 • Number of events 2 • 2.5 years
Gastrointestinal disorders Typhlitis	1.6% 1/62 • Number of events 1 • 2.5 years
Gastrointestinal disorders Vomiting	35.5% 22/62 • Number of events 38 • 2.5 years
General disorders Disease progression	3.2% 2/62 • Number of events 2 • 2.5 years
General disorders Edema limbs	1.6% 1/62 • Number of events 2 • 2.5 years
General disorders Fatigue	96.8% 60/62 • Number of events 444 • 2.5 years
General disorders Fever	1.6% 1/62 • Number of events 1 • 2.5 years
Hepatobiliary disorders Gallbladder obstruction	1.6% 1/62 • Number of events 1 • 2.5 years
Immune system disorders Hypersensitivity	1.6% 1/62 • Number of events 1 • 2.5 years
Infections and infestations Infection	1.6% 1/62 • Number of events 1 • 2.5 years
Infections and infestations Pneumonia	6.5% 4/62 • Number of events 4 • 2.5 years
Infections and infestations Sepsis	1.6% 1/62 • Number of events 1 • 2.5 years
Infections and infestations Skin infection	3.2% 2/62 • Number of events 2 • 2.5 years
Infections and infestations Upper respiratory infection	1.6% 1/62 • Number of events 1 • 2.5 years
Infections and infestations Urinary tract infection	3.2% 2/62 • Number of events 2 • 2.5 years
Injury, poisoning and procedural complications Bruising	1.6% 1/62 • Number of events 1 • 2.5 years
Injury, poisoning and procedural complications Wound dehiscence	1.6% 1/62 • Number of events 1 • 2.5 years
Investigations Alanine aminotransferase increased	1.6% 1/62 • Number of events 1 • 2.5 years
Investigations Creatinine increased	4.8% 3/62 • Number of events 4 • 2.5 years
Investigations Laboratory test abnormal	1.6% 1/62 • Number of events 1 • 2.5 years
Investigations Leukocyte count decreased	19.4% 12/62 • Number of events 23 • 2.5 years
Investigations Lymphocyte count decreased	9.7% 6/62 • Number of events 28 • 2.5 years
Investigations Neutrophil count decreased	74.2% 46/62 • Number of events 148 • 2.5 years
Investigations Platelet count decreased	72.6% 45/62 • Number of events 172 • 2.5 years
Investigations Weight loss	11.3% 7/62 • Number of events 24 • 2.5 years
Metabolism and nutrition disorders Anorexia	17.7% 11/62 • Number of events 23 • 2.5 years
Metabolism and nutrition disorders Blood glucose increased	16.1% 10/62 • Number of events 16 • 2.5 years
Metabolism and nutrition disorders Dehydration	11.3% 7/62 • Number of events 9 • 2.5 years
Metabolism and nutrition disorders Serum magnesium decreased	1.6% 1/62 • Number of events 1 • 2.5 years
Metabolism and nutrition disorders Serum potassium increased	1.6% 1/62 • Number of events 1 • 2.5 years
Metabolism and nutrition disorders Serum sodium decreased	1.6% 1/62 • Number of events 3 • 2.5 years
Musculoskeletal and connective tissue disorders Back pain	3.2% 2/62 • Number of events 2 • 2.5 years
Musculoskeletal and connective tissue disorders Bone pain	1.6% 1/62 • Number of events 1 • 2.5 years
Musculoskeletal and connective tissue disorders Joint pain	3.2% 2/62 • Number of events 2 • 2.5 years
Musculoskeletal and connective tissue disorders Muscle weakness	3.2% 2/62 • Number of events 3 • 2.5 years
Musculoskeletal and connective tissue disorders Neck pain	1.6% 1/62 • Number of events 1 • 2.5 years
Nervous system disorders Dizziness	3.2% 2/62 • Number of events 2 • 2.5 years
Nervous system disorders Headache	1.6% 1/62 • Number of events 1 • 2.5 years
Nervous system disorders Ischemia cerebrovascular	3.2% 2/62 • Number of events 2 • 2.5 years
Nervous system disorders Leukoencephalopathy	1.6% 1/62 • Number of events 1 • 2.5 years
Nervous system disorders Peripheral motor neuropathy	1.6% 1/62 • Number of events 3 • 2.5 years
Nervous system disorders Peripheral sensory neuropathy	37.1% 23/62 • Number of events 84 • 2.5 years
Nervous system disorders Seizure	1.6% 1/62 • Number of events 1 • 2.5 years
Nervous system disorders Taste alteration	4.8% 3/62 • Number of events 3 • 2.5 years
Psychiatric disorders Anxiety	3.2% 2/62 • Number of events 2 • 2.5 years
Psychiatric disorders Depression	1.6% 1/62 • Number of events 2 • 2.5 years
Psychiatric disorders Insomnia	1.6% 1/62 • Number of events 1 • 2.5 years
Renal and urinary disorders Glomerular filtration rate decreased	3.2% 2/62 • Number of events 7 • 2.5 years
Renal and urinary disorders Protein urine positive	30.6% 19/62 • Number of events 54 • 2.5 years
Respiratory, thoracic and mediastinal disorders Allergic rhinitis	1.6% 1/62 • Number of events 1 • 2.5 years
Respiratory, thoracic and mediastinal disorders Hiccough	1.6% 1/62 • Number of events 1 • 2.5 years
Respiratory, thoracic and mediastinal disorders Hypoxia	1.6% 1/62 • Number of events 2 • 2.5 years
Respiratory, thoracic and mediastinal disorders Pharyngeal examination abnormal	1.6% 1/62 • Number of events 3 • 2.5 years
Respiratory, thoracic and mediastinal disorders Pharyngeal mucositis	9.7% 6/62 • Number of events 10 • 2.5 years
Respiratory, thoracic and mediastinal disorders Pleural effusion	1.6% 1/62 • Number of events 2 • 2.5 years
Respiratory, thoracic and mediastinal disorders Pleuritic pain	1.6% 1/62 • Number of events 1 • 2.5 years
Respiratory, thoracic and mediastinal disorders Pulmonary hemorrhage	4.8% 3/62 • Number of events 6 • 2.5 years
Respiratory, thoracic and mediastinal disorders Voice alteration	3.2% 2/62 • Number of events 11 • 2.5 years
Skin and subcutaneous tissue disorders Alopecia	3.2% 2/62 • Number of events 4 • 2.5 years
Skin and subcutaneous tissue disorders Erythema multiforme	1.6% 1/62 • Number of events 1 • 2.5 years
Skin and subcutaneous tissue disorders Rash desquamating	14.5% 9/62 • Number of events 29 • 2.5 years
Skin and subcutaneous tissue disorders Skin ulceration	1.6% 1/62 • Number of events 1 • 2.5 years
Vascular disorders Hypertension	43.5% 27/62 • Number of events 128 • 2.5 years
Vascular disorders Hypotension	4.8% 3/62 • Number of events 3 • 2.5 years
Vascular disorders Peripheral ischemia	1.6% 1/62 • Number of events 1 • 2.5 years
Vascular disorders Thrombosis	4.8% 3/62 • Number of events 3 • 2.5 years

Additional Information

Grace K. Dy, M.D.

Roswell Park Cancer Institute

Phone: 507-284-9265

Email: grace.dy@roswellpark.org

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place

Restriction type: LTE60