Trial Outcomes & Findings for First-Line Treatment of A Comparison of 2 Treatments in Elderly Patients With Advanced NSCLC (NCT NCT00456261)
NCT ID: NCT00456261
Last Updated: 2022-05-03
Results Overview
Time to Progression (TTP) is defined as the interval between the date of treatment initiation and the date of progressive disease. Progression is defined using the Response Evaluation Criteria in Solid Tumors (RECIST v1.0). Progressive Disease (PD): At least a 20% increase in the sum of the longest diameter (LD) of target lesions, taking as reference the smallest sum LD recorded since the treatment started or unequivocal progression of non-target lesions or the appearance of one or more new lesions.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
110 participants
Primary outcome timeframe
From the date of treatment initiation until the date of first documented PD or date of last study contact or date of other therapy begins up to 18 months
Results posted on
2022-05-03
Participant Flow
Participant milestones
| Measure |
Bevacizumab/Pemetrexed/Gemcitabine
Cohort A, will receive bevacizumab 10mg/kg by vein over 30-90 minutes followed by pemetrexed 500 mg/m2 by vein over 10 minutes followed by gemcitabine 1500 mg/m2 by vein over 30-60 minutes. This regimen will be given on day 1 and day 15 of each treatment cycle. Each cycle is 28 days long. As long as their disease does not worsen patients can receive up to a maximum of 6 cycles of this combination chemotherapy. Following that they can receive bevacizumab alone once every 2 weeks as long as their disease does not worsen.
|
Bevacizumab/Pemetrexed/Carboplatin
Cohort B, will receive bevacizumab 15mg/kg by vein over 30-90 minutes followed by pemetrexed 500 mg/m2 by vein over approximately 10 minutes followed by carboplatin AUC=5 by vein over 30-60 minutes. This regimen will be given on day 1 of each treatment cycle. Each cycle is 21 days long. As long as their disease does not worsen patients can receive up to a maximum of 6 cycles of this combination chemotherapy. Following that they can receive bevacizumab alone once every 3 weeks as long as their disease does not worsen.
|
|---|---|---|
|
Combination Therapy
STARTED
|
55
|
55
|
|
Combination Therapy
COMPLETED
|
3
|
29
|
|
Combination Therapy
NOT COMPLETED
|
52
|
26
|
|
Maintenance Therapy
STARTED
|
3
|
29
|
|
Maintenance Therapy
COMPLETED
|
3
|
29
|
|
Maintenance Therapy
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
First-Line Treatment of A Comparison of 2 Treatments in Elderly Patients With Advanced NSCLC
Baseline characteristics by cohort
| Measure |
Bevacizumab/Pemetrexed/Gemcitabine
n=55 Participants
Cohort A, will receive bevacizumab 10mg/kg by vein over 30-90 minutes followed by pemetrexed 500 mg/m2 by vein over 10 minutes followed by gemcitabine 1500 mg/m2 by vein over 30-60 minutes. This regimen will be given on day 1 and day 15 of each treatment cycle. Each cycle is 28 days long. As long as their disease does not worsen patients can receive up to a maximum of 6 cycles of this combination chemotherapy. Following that they can receive bevacizumab alone once every 2 weeks as long as their disease does not worsen.
|
Bevacizumab/Pemetrexed/Carboplatin
n=55 Participants
Cohort B, will receive bevacizumab 15mg/kg by vein over 30-90 minutes followed by pemetrexed 500 mg/m2 by vein over approximately 10 minutes followed by carboplatin AUC=5 by vein over 30-60 minutes. This regimen will be given on day 1 of each treatment cycle. Each cycle is 21 days long. As long as their disease does not worsen patients can receive up to a maximum of 6 cycles of this combination chemotherapy. Following that they can receive bevacizumab alone once every 3 weeks as long as their disease does not worsen.
|
Total
n=110 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
76 years
n=5 Participants
|
77 years
n=7 Participants
|
77 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
26 Participants
n=5 Participants
|
29 Participants
n=7 Participants
|
55 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
29 Participants
n=5 Participants
|
26 Participants
n=7 Participants
|
55 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
55 participants
n=5 Participants
|
55 participants
n=7 Participants
|
110 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: From the date of treatment initiation until the date of first documented PD or date of last study contact or date of other therapy begins up to 18 monthsPopulation: All patients were analyzed for a response by RECIST v1.0. Intent to treat efficacy analysis set.
Time to Progression (TTP) is defined as the interval between the date of treatment initiation and the date of progressive disease. Progression is defined using the Response Evaluation Criteria in Solid Tumors (RECIST v1.0). Progressive Disease (PD): At least a 20% increase in the sum of the longest diameter (LD) of target lesions, taking as reference the smallest sum LD recorded since the treatment started or unequivocal progression of non-target lesions or the appearance of one or more new lesions.
Outcome measures
| Measure |
Bevacizumab/Pemetrexed/Gemcitabine
n=55 Participants
Cohort A, will receive bevacizumab 10mg/kg by vein over 30-90 minutes followed by pemetrexed 500 mg/m2 by vein over 10 minutes followed by gemcitabine 1500 mg/m2 by vein over 30-60 minutes. This regimen will be given on day 1 and day 15 of each treatment cycle. Each cycle is 28 days long. As long as their disease does not worsen patients can receive up to a maximum of 6 cycles of this combination chemotherapy. Following that they can receive bevacizumab alone once every 2 weeks as long as their disease does not worsen.
|
Bevacizumab/Pemetrexed/Carboplatin
n=55 Participants
Cohort B, will receive bevacizumab 15mg/kg by vein over 30-90 minutes followed by pemetrexed 500 mg/m2 by vein over approximately 10 minutes followed by carboplatin AUC=5 by vein over 30-60 minutes. This regimen will be given on day 1 of each treatment cycle. Each cycle is 21 days long. As long as their disease does not worsen patients can receive up to a maximum of 6 cycles of this combination chemotherapy. Following that they can receive bevacizumab alone once every 3 weeks as long as their disease does not worsen.
|
|---|---|---|
|
Time to Progression (TTP), the Length of Time, in Months, That Patients Were Alive From Their First Date of Protocol Treatment Until Worsening of Their Disease
|
4.7 months
Interval 3.8 to 5.8
|
10.2 months
Interval 6.3 to 12.7
|
SECONDARY outcome
Timeframe: From date of treatment initiation to end of study treatment up to 18 monthsPopulation: All patients were analyzed for a response by RECIST v1.0. Intent to treat analysis set.
Overall response rate (ORR) is defined as the percentage of patients who have a partial or complete response to therapy. Responses were assessed by the Response Evaluation Criteria in Solid Tumors (RECIST; version 1.0). Complete Response: Disappearance of all target lesions, and disappearance of all non-target lesions. Partial Response: At least a 30% decrease in the sum of the longest diameter of target lesions (taking as reference the baseline sum of longest diameters)
Outcome measures
| Measure |
Bevacizumab/Pemetrexed/Gemcitabine
n=55 Participants
Cohort A, will receive bevacizumab 10mg/kg by vein over 30-90 minutes followed by pemetrexed 500 mg/m2 by vein over 10 minutes followed by gemcitabine 1500 mg/m2 by vein over 30-60 minutes. This regimen will be given on day 1 and day 15 of each treatment cycle. Each cycle is 28 days long. As long as their disease does not worsen patients can receive up to a maximum of 6 cycles of this combination chemotherapy. Following that they can receive bevacizumab alone once every 2 weeks as long as their disease does not worsen.
|
Bevacizumab/Pemetrexed/Carboplatin
n=55 Participants
Cohort B, will receive bevacizumab 15mg/kg by vein over 30-90 minutes followed by pemetrexed 500 mg/m2 by vein over approximately 10 minutes followed by carboplatin AUC=5 by vein over 30-60 minutes. This regimen will be given on day 1 of each treatment cycle. Each cycle is 21 days long. As long as their disease does not worsen patients can receive up to a maximum of 6 cycles of this combination chemotherapy. Following that they can receive bevacizumab alone once every 3 weeks as long as their disease does not worsen.
|
|---|---|---|
|
Overall Response Rate (ORR), the Percentage of Patients Who Experience an Objective Benefit From Treatment
|
35 percentage of patients
Interval 23.0 to 49.0
|
35 percentage of patients
Interval 23.0 to 49.0
|
SECONDARY outcome
Timeframe: From date of study entry until the date of death from any cause or the date the patient was last known alive, up to 18 monthsPopulation: All patients were included in the analysis. Intent to treat analysis set.
OS is defined as the time from the date of study entry until the date of death due to any cause. In the absence of confirmation of death or lack of data beyond follow-up period, the survival time was censored to the last date the participant was known to be alive.
Outcome measures
| Measure |
Bevacizumab/Pemetrexed/Gemcitabine
n=55 Participants
Cohort A, will receive bevacizumab 10mg/kg by vein over 30-90 minutes followed by pemetrexed 500 mg/m2 by vein over 10 minutes followed by gemcitabine 1500 mg/m2 by vein over 30-60 minutes. This regimen will be given on day 1 and day 15 of each treatment cycle. Each cycle is 28 days long. As long as their disease does not worsen patients can receive up to a maximum of 6 cycles of this combination chemotherapy. Following that they can receive bevacizumab alone once every 2 weeks as long as their disease does not worsen.
|
Bevacizumab/Pemetrexed/Carboplatin
n=55 Participants
Cohort B, will receive bevacizumab 15mg/kg by vein over 30-90 minutes followed by pemetrexed 500 mg/m2 by vein over approximately 10 minutes followed by carboplatin AUC=5 by vein over 30-60 minutes. This regimen will be given on day 1 of each treatment cycle. Each cycle is 21 days long. As long as their disease does not worsen patients can receive up to a maximum of 6 cycles of this combination chemotherapy. Following that they can receive bevacizumab alone once every 3 weeks as long as their disease does not worsen.
|
|---|---|---|
|
Overall Survival (OS), the Length of Time, in Months, That Patients Were Alive From Their First Date of Protocol Treatment Until Death
|
7.5 months
Interval 5.6 to 11.3
|
14.8 months
Interval 10.25 to
Upper limit not reached due to patients continuing treatment at time of analysis.
|
Adverse Events
Bevacizumab/Pemetrexed/Gemcitabine
Serious events: 33 serious events
Other events: 55 other events
Deaths: 0 deaths
Bevacizumab/Pemetrexed/Carboplatin
Serious events: 21 serious events
Other events: 55 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Bevacizumab/Pemetrexed/Gemcitabine
n=55 participants at risk
Cohort A, will receive bevacizumab 10mg/kg by vein over 30-90 minutes followed by pemetrexed 500 mg/m2 by vein over 10 minutes followed by gemcitabine 1500 mg/m2 by vein over 30-60 minutes. This regimen will be given on day 1 and day 15 of each treatment cycle. Each cycle is 28 days long. As long as their disease does not worsen patients can receive up to a maximum of 6 cycles of this combination chemotherapy. Following that they can receive bevacizumab alone once every 2 weeks as long as their disease does not worsen.
|
Bevacizumab/Pemetrexed/Carboplatin
n=55 participants at risk
Cohort B, will receive bevacizumab 15mg/kg by vein over 30-90 minutes followed by pemetrexed 500 mg/m2 by vein over approximately 10 minutes followed by carboplatin AUC=5 by vein over 30-60 minutes. This regimen will be given on day 1 of each treatment cycle. Each cycle is 21 days long. As long as their disease does not worsen patients can receive up to a maximum of 6 cycles of this combination chemotherapy. Following that they can receive bevacizumab alone once every 3 weeks as long as their disease does not worsen.
|
|---|---|---|
|
Respiratory, thoracic and mediastinal disorders
Hemorrhage - Pulmonary
|
0.00%
0/55
|
1.8%
1/55 • Number of events 1
|
|
Vascular disorders
Thrombosis/Thrombus/Embolism
|
5.5%
3/55 • Number of events 3
|
1.8%
1/55 • Number of events 1
|
|
Infections and infestations
Infection - Sepsis
|
3.6%
2/55 • Number of events 2
|
0.00%
0/55
|
|
Gastrointestinal disorders
Ileus
|
1.8%
1/55 • Number of events 1
|
0.00%
0/55
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Death - disease progression NOS
|
3.6%
2/55 • Number of events 2
|
3.6%
2/55 • Number of events 2
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary - COPD Exacerbation
|
1.8%
1/55 • Number of events 1
|
3.6%
2/55 • Number of events 3
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
5.5%
3/55 • Number of events 3
|
5.5%
3/55 • Number of events 4
|
|
Gastrointestinal disorders
Perforation - Diverticulum
|
0.00%
0/55
|
1.8%
1/55 • Number of events 1
|
|
Metabolism and nutrition disorders
Hyponatremia
|
0.00%
0/55
|
3.6%
2/55 • Number of events 2
|
|
Infections and infestations
Febrile neutropenia
|
3.6%
2/55 • Number of events 2
|
1.8%
1/55 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Pneumothorax
|
0.00%
0/55
|
1.8%
1/55 • Number of events 1
|
|
Immune system disorders
Neutrophils
|
5.5%
3/55 • Number of events 3
|
0.00%
0/55
|
|
Respiratory, thoracic and mediastinal disorders
Pleural Effusion
|
3.6%
2/55 • Number of events 2
|
0.00%
0/55
|
|
Infections and infestations
Infection - Pneumonia
|
12.7%
7/55 • Number of events 8
|
1.8%
1/55 • Number of events 1
|
|
General disorders
Multi-system Organ Failure
|
0.00%
0/55
|
1.8%
1/55 • Number of events 1
|
|
General disorders
Fever
|
1.8%
1/55 • Number of events 1
|
1.8%
1/55 • Number of events 1
|
|
Cardiac disorders
Hypertension
|
0.00%
0/55
|
1.8%
1/55 • Number of events 1
|
|
General disorders
Fatigue
|
3.6%
2/55 • Number of events 2
|
0.00%
0/55
|
|
Nervous system disorders
CNS Cerebrovascular ischemia
|
3.6%
2/55 • Number of events 2
|
1.8%
1/55 • Number of events 1
|
|
Cardiac disorders
Cardiopulmonary Arrest
|
1.8%
1/55 • Number of events 1
|
1.8%
1/55 • Number of events 1
|
|
Cardiac disorders
Ventricular Arrhythmia - Ventricular Tachycardia
|
1.8%
1/55 • Number of events 1
|
0.00%
0/55
|
|
Infections and infestations
Infection - gangrene
|
1.8%
1/55 • Number of events 1
|
0.00%
0/55
|
|
Infections and infestations
Infection - cellulitis
|
3.6%
2/55 • Number of events 2
|
0.00%
0/55
|
|
Blood and lymphatic system disorders
Platelets
|
1.8%
1/55 • Number of events 1
|
1.8%
1/55 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
ARDS
|
1.8%
1/55 • Number of events 1
|
1.8%
1/55 • Number of events 1
|
|
Gastrointestinal disorders
Perforation - duodenal ulcer
|
0.00%
0/55
|
1.8%
1/55 • Number of events 1
|
|
Nervous system disorders
Confusion
|
1.8%
1/55 • Number of events 1
|
0.00%
0/55
|
|
Cardiac disorders
Supraventricular arrhythmia - Atrial fibrillation
|
1.8%
1/55 • Number of events 1
|
0.00%
0/55
|
|
Infections and infestations
Infection with Normal ANC
|
1.8%
1/55 • Number of events 1
|
0.00%
0/55
|
|
Gastrointestinal disorders
Pain - rectum
|
1.8%
1/55 • Number of events 1
|
0.00%
0/55
|
|
General disorders
Pain - Abdomen
|
1.8%
1/55 • Number of events 1
|
0.00%
0/55
|
|
Gastrointestinal disorders
GI Other - strangulated inguinal hernia
|
1.8%
1/55 • Number of events 1
|
0.00%
0/55
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
0.00%
0/55
|
1.8%
1/55 • Number of events 1
|
|
Gastrointestinal disorders
Vomiting
|
1.8%
1/55 • Number of events 1
|
0.00%
0/55
|
|
Respiratory, thoracic and mediastinal disorders
Pericardial Effusion
|
0.00%
0/55
|
1.8%
1/55 • Number of events 1
|
|
Gastrointestinal disorders
Dehydration
|
1.8%
1/55 • Number of events 1
|
3.6%
2/55 • Number of events 2
|
|
Renal and urinary disorders
Obstruction, GU - Bladder
|
0.00%
0/55
|
1.8%
1/55 • Number of events 1
|
|
Cardiac disorders
Cardiac Ischemia/Infarction
|
0.00%
0/55
|
1.8%
1/55 • Number of events 1
|
|
General disorders
Pain - joint
|
0.00%
0/55
|
1.8%
1/55 • Number of events 1
|
|
General disorders
Dysphagia
|
0.00%
0/55
|
1.8%
1/55 • Number of events 1
|
|
Vascular disorders
Aneurysm
|
1.8%
1/55 • Number of events 1
|
0.00%
0/55
|
|
Infections and infestations
Infection - methicillin-resistant staphylococcus aureas
|
0.00%
0/55
|
1.8%
1/55 • Number of events 1
|
|
Infections and infestations
Infection - urinary tract
|
1.8%
1/55 • Number of events 1
|
0.00%
0/55
|
|
Gastrointestinal disorders
Ulcer - stomach
|
1.8%
1/55 • Number of events 1
|
0.00%
0/55
|
|
General disorders
Consitutional symptoms, other - failure to thrive
|
1.8%
1/55 • Number of events 1
|
0.00%
0/55
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Disease progression NOS
|
1.8%
1/55 • Number of events 1
|
0.00%
0/55
|
|
Blood and lymphatic system disorders
Hemoglobin
|
1.8%
1/55 • Number of events 1
|
0.00%
0/55
|
|
Blood and lymphatic system disorders
Leukocytes
|
1.8%
1/55 • Number of events 1
|
0.00%
0/55
|
Other adverse events
| Measure |
Bevacizumab/Pemetrexed/Gemcitabine
n=55 participants at risk
Cohort A, will receive bevacizumab 10mg/kg by vein over 30-90 minutes followed by pemetrexed 500 mg/m2 by vein over 10 minutes followed by gemcitabine 1500 mg/m2 by vein over 30-60 minutes. This regimen will be given on day 1 and day 15 of each treatment cycle. Each cycle is 28 days long. As long as their disease does not worsen patients can receive up to a maximum of 6 cycles of this combination chemotherapy. Following that they can receive bevacizumab alone once every 2 weeks as long as their disease does not worsen.
|
Bevacizumab/Pemetrexed/Carboplatin
n=55 participants at risk
Cohort B, will receive bevacizumab 15mg/kg by vein over 30-90 minutes followed by pemetrexed 500 mg/m2 by vein over approximately 10 minutes followed by carboplatin AUC=5 by vein over 30-60 minutes. This regimen will be given on day 1 of each treatment cycle. Each cycle is 21 days long. As long as their disease does not worsen patients can receive up to a maximum of 6 cycles of this combination chemotherapy. Following that they can receive bevacizumab alone once every 3 weeks as long as their disease does not worsen.
|
|---|---|---|
|
Metabolism and nutrition disorders
Alkaline Phosphatase
|
16.4%
9/55 • Number of events 13
|
10.9%
6/55 • Number of events 11
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
7.3%
4/55 • Number of events 5
|
10.9%
6/55 • Number of events 17
|
|
Respiratory, thoracic and mediastinal disorders
Rhinitis
|
0.00%
0/55
|
16.4%
9/55 • Number of events 34
|
|
Metabolism and nutrition disorders
ALT
|
18.2%
10/55 • Number of events 17
|
9.1%
5/55 • Number of events 7
|
|
Gastrointestinal disorders
Anorexia
|
45.5%
25/55 • Number of events 55
|
47.3%
26/55 • Number of events 65
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
9.1%
5/55 • Number of events 12
|
25.5%
14/55 • Number of events 33
|
|
Metabolism and nutrition disorders
AST
|
23.6%
13/55 • Number of events 27
|
12.7%
7/55 • Number of events 7
|
|
Respiratory, thoracic and mediastinal disorders
Bronchospasm
|
5.5%
3/55 • Number of events 5
|
12.7%
7/55 • Number of events 12
|
|
Nervous system disorders
Confusion
|
9.1%
5/55 • Number of events 7
|
0.00%
0/55
|
|
Gastrointestinal disorders
Constipation
|
38.2%
21/55 • Number of events 34
|
40.0%
22/55 • Number of events 77
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
38.2%
21/55 • Number of events 36
|
36.4%
20/55 • Number of events 68
|
|
Metabolism and nutrition disorders
Creatinine
|
5.5%
3/55 • Number of events 5
|
14.5%
8/55 • Number of events 11
|
|
Gastrointestinal disorders
Dehydration
|
25.5%
14/55 • Number of events 18
|
14.5%
8/55 • Number of events 16
|
|
Skin and subcutaneous tissue disorders
Dermatology - Other
|
0.00%
0/55
|
5.5%
3/55 • Number of events 4
|
|
Gastrointestinal disorders
Diarrhea
|
25.5%
14/55 • Number of events 22
|
34.5%
19/55 • Number of events 40
|
|
Nervous system disorders
Dizziness
|
20.0%
11/55 • Number of events 16
|
29.1%
16/55 • Number of events 22
|
|
Eye disorders
Dry Eye
|
5.5%
3/55 • Number of events 4
|
0.00%
0/55
|
|
Skin and subcutaneous tissue disorders
Dry Skin
|
7.3%
4/55 • Number of events 6
|
0.00%
0/55
|
|
Gastrointestinal disorders
Dysphagia
|
0.00%
0/55
|
7.3%
4/55 • Number of events 9
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
61.8%
34/55 • Number of events 69
|
52.7%
29/55 • Number of events 109
|
|
Blood and lymphatic system disorders
Edema - Limb
|
29.1%
16/55 • Number of events 33
|
18.2%
10/55 • Number of events 26
|
|
Skin and subcutaneous tissue disorders
Erythema
|
5.5%
3/55 • Number of events 3
|
9.1%
5/55 • Number of events 7
|
|
General disorders
Fatigue
|
83.6%
46/55 • Number of events 158
|
87.3%
48/55 • Number of events 298
|
|
General disorders
Fever
|
29.1%
16/55 • Number of events 17
|
5.5%
3/55 • Number of events 3
|
|
Infections and infestations
Febrile Neutropenia
|
7.3%
4/55 • Number of events 4
|
0.00%
0/55
|
|
General disorders
Pain - Head
|
14.5%
8/55 • Number of events 10
|
25.5%
14/55 • Number of events 41
|
|
Blood and lymphatic system disorders
Neutrophils
|
70.9%
39/55 • Number of events 84
|
76.4%
42/55 • Number of events 118
|
|
Blood and lymphatic system disorders
Hemoglobin
|
81.8%
45/55 • Number of events 128
|
81.8%
45/55 • Number of events 243
|
|
Blood and lymphatic system disorders
Platelets
|
54.5%
30/55 • Number of events 55
|
72.7%
40/55 • Number of events 153
|
|
Blood and lymphatic system disorders
Leukocytes
|
70.9%
39/55 • Number of events 89
|
85.5%
47/55 • Number of events 151
|
|
Respiratory, thoracic and mediastinal disorders
Respiratary - Other
|
7.3%
4/55 • Number of events 5
|
0.00%
0/55
|
|
Blood and lymphatic system disorders
Hemorrhage - Nose
|
18.2%
10/55 • Number of events 21
|
27.3%
15/55 • Number of events 26
|
|
Respiratory, thoracic and mediastinal disorders
Voice Changes
|
0.00%
0/55
|
9.1%
5/55 • Number of events 8
|
|
Metabolism and nutrition disorders
Hypercalcemia
|
0.00%
0/55
|
7.3%
4/55 • Number of events 6
|
|
Metabolism and nutrition disorders
Hyperglycemia
|
27.3%
15/55 • Number of events 28
|
27.3%
15/55 • Number of events 32
|
|
Metabolism and nutrition disorders
Hyperkalemia
|
0.00%
0/55
|
10.9%
6/55 • Number of events 18
|
|
Cardiac disorders
Hypertension
|
12.7%
7/55 • Number of events 13
|
32.7%
18/55 • Number of events 42
|
|
Metabolism and nutrition disorders
Hypoalbuminemia
|
20.0%
11/55 • Number of events 19
|
16.4%
9/55 • Number of events 21
|
|
Metabolism and nutrition disorders
Hypocalcemia
|
12.7%
7/55 • Number of events 9
|
7.3%
4/55 • Number of events 7
|
|
Metabolism and nutrition disorders
Hypoglycemia
|
0.00%
0/55
|
27.3%
15/55 • Number of events 32
|
|
Metabolism and nutrition disorders
Hypokalemia
|
5.5%
3/55 • Number of events 4
|
10.9%
6/55 • Number of events 14
|
|
Metabolism and nutrition disorders
Hyponatremia
|
12.7%
7/55 • Number of events 18
|
18.2%
10/55 • Number of events 14
|
|
Cardiac disorders
Hypotension
|
5.5%
3/55 • Number of events 3
|
0.00%
0/55
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
7.3%
4/55 • Number of events 6
|
0.00%
0/55
|
|
Infections and infestations
Infection - NOS
|
54.5%
30/55 • Number of events 61
|
30.9%
17/55 • Number of events 31
|
|
General disorders
Insomnia
|
18.2%
10/55 • Number of events 19
|
12.7%
7/55 • Number of events 12
|
|
Blood and lymphatic system disorders
INR
|
5.5%
3/55 • Number of events 3
|
0.00%
0/55
|
|
Psychiatric disorders
Mood Alteration - Anxiety
|
7.3%
4/55 • Number of events 4
|
5.5%
3/55 • Number of events 7
|
|
Psychiatric disorders
Mood Alteration - Depression
|
5.5%
3/55 • Number of events 5
|
7.3%
4/55 • Number of events 14
|
|
Gastrointestinal disorders
Mucositis/Stomatitis
|
10.9%
6/55 • Number of events 8
|
20.0%
11/55 • Number of events 20
|
|
Musculoskeletal and connective tissue disorders
Muscle Weakness
|
0.00%
0/55
|
7.3%
4/55 • Number of events 4
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
10.9%
6/55 • Number of events 7
|
32.7%
18/55 • Number of events 35
|
|
Respiratory, thoracic and mediastinal disorders
Nasal/Paranasal Reactions
|
16.4%
9/55 • Number of events 20
|
5.5%
3/55 • Number of events 9
|
|
Gastrointestinal disorders
Nausea
|
52.7%
29/55 • Number of events 46
|
52.7%
29/55 • Number of events 66
|
|
Nervous system disorders
Neuropathy - Sensory
|
9.1%
5/55 • Number of events 10
|
7.3%
4/55 • Number of events 5
|
|
General disorders
Pain - NOS
|
0.00%
0/55
|
7.3%
4/55 • Number of events 14
|
|
General disorders
Pain - Abdomen
|
12.7%
7/55 • Number of events 17
|
7.3%
4/55 • Number of events 5
|
|
General disorders
Pain - Back
|
0.00%
0/55
|
7.3%
4/55 • Number of events 6
|
|
General disorders
Pain - Bone
|
0.00%
0/55
|
5.5%
3/55 • Number of events 5
|
|
General disorders
Pain - Chest
|
7.3%
4/55 • Number of events 5
|
20.0%
11/55 • Number of events 23
|
|
General disorders
Pain - Limb
|
7.3%
4/55 • Number of events 4
|
10.9%
6/55 • Number of events 12
|
|
General disorders
Pain - Mouth
|
5.5%
3/55 • Number of events 9
|
5.5%
3/55 • Number of events 9
|
|
General disorders
Pain - Neck
|
0.00%
0/55
|
5.5%
3/55 • Number of events 9
|
|
Renal and urinary disorders
Proteinuria
|
40.0%
22/55 • Number of events 42
|
50.9%
28/55 • Number of events 119
|
|
Skin and subcutaneous tissue disorders
Pruritis
|
7.3%
4/55 • Number of events 4
|
9.1%
5/55 • Number of events 6
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary - COPD Exacerbation
|
7.3%
4/55 • Number of events 5
|
0.00%
0/55
|
|
Skin and subcutaneous tissue disorders
Rash/Desquamation
|
27.3%
15/55 • Number of events 25
|
29.1%
16/55 • Number of events 32
|
|
Respiratory, thoracic and mediastinal disorders
ARDS
|
5.5%
3/55 • Number of events 3
|
0.00%
0/55
|
|
General disorders
Rigor/Chills
|
12.7%
7/55 • Number of events 13
|
0.00%
0/55
|
|
Gastrointestinal disorders
Taste Alteration
|
9.1%
5/55 • Number of events 8
|
21.8%
12/55 • Number of events 40
|
|
Vascular disorders
Thrombosis/Thrombus/Embolism
|
10.9%
6/55 • Number of events 10
|
7.3%
4/55 • Number of events 5
|
|
Renal and urinary disorders
Urinary Retention
|
0.00%
0/55
|
5.5%
3/55 • Number of events 6
|
|
General disorders
Voice Changes
|
0.00%
0/55
|
16.4%
9/55 • Number of events 36
|
|
Gastrointestinal disorders
Vomiting
|
10.9%
6/55 • Number of events 7
|
23.6%
13/55 • Number of events 18
|
|
Eye disorders
Watery Eye
|
0.00%
0/55
|
9.1%
5/55 • Number of events 15
|
|
Metabolism and nutrition disorders
Weight Loss
|
16.4%
9/55 • Number of events 15
|
16.4%
9/55 • Number of events 29
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee The sponsor can review/embargo results communications prior to public release for a period that is \>60 days but ≤180 days from date submitted to sponsor, who may require changes to the communication in order to remove specifically identified confidential information (other than study data) and/or delay the proposed publication to enable the sponsor to seek patent protection for inventions. The PI may not publish its results until 18 mos. after the trial has been completed at all sites
- Publication restrictions are in place
Restriction type: OTHER