Trial Outcomes & Findings for Effect of Pembrolizumab With or Without Carboplatin and Paclitaxel on Immune Response in Patients With Recurrent or Stage IIIB-IV Non-small Cell Lung Cancer (NCT NCT02581943)
NCT ID: NCT02581943
Last Updated: 2024-01-05
Results Overview
Duration of response will also be assessed in each group and compared using survival analysis methods. Per response evaluation criteria in Solid Tumors Criteria: Complete Response (irCR): Complete disappearance of all target and new, measurable lesions, with the exceptions of lymph nodes which must decrease to \< 10 mm in short axis; Partial Response (irPR): Decrease in TMTB ≥ 30% relative to baseline; Stable Disease (irSD): Not meeting criteria for irCR or irPR, in absence of irPD; Progressive Disease (irPD): Increase in TMTB ≥ 20% relative to nadir.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
43 participants
Primary outcome timeframe
Up to 2 years
Results posted on
2024-01-05
Participant Flow
Participant milestones
| Measure |
Arm I (Pembrolizumab)
Patients receive pembrolizumab IV over 30 minutes on day 1. Courses repeat every 3 weeks for 2 years in the absence of disease progression or unacceptable toxicity.
Laboratory Biomarker Analysis: Correlative studies
Pembrolizumab: Given IV
Quality-of-Life Assessment: Ancillary studies
|
Arm II (Pembrolizumab, Paclitaxel, Carboplatin)
Patients receive pembrolizumab IV over 30 minutes on day 1, paclitaxel IV over 1 hour and carboplatin IV over 1 hour on days 1, 7 and 14. Courses repeat every 3 weeks for 2 years in the absence of disease progression or unacceptable toxicity.
Carboplatin: Given IV
Laboratory Biomarker Analysis: Correlative studies
Paclitaxel: Given IV
Pembrolizumab: Given IV
Quality-of-Life Assessment: Ancillary studies
|
|---|---|---|
|
Overall Study
STARTED
|
22
|
21
|
|
Overall Study
COMPLETED
|
4
|
2
|
|
Overall Study
NOT COMPLETED
|
18
|
19
|
Reasons for withdrawal
| Measure |
Arm I (Pembrolizumab)
Patients receive pembrolizumab IV over 30 minutes on day 1. Courses repeat every 3 weeks for 2 years in the absence of disease progression or unacceptable toxicity.
Laboratory Biomarker Analysis: Correlative studies
Pembrolizumab: Given IV
Quality-of-Life Assessment: Ancillary studies
|
Arm II (Pembrolizumab, Paclitaxel, Carboplatin)
Patients receive pembrolizumab IV over 30 minutes on day 1, paclitaxel IV over 1 hour and carboplatin IV over 1 hour on days 1, 7 and 14. Courses repeat every 3 weeks for 2 years in the absence of disease progression or unacceptable toxicity.
Carboplatin: Given IV
Laboratory Biomarker Analysis: Correlative studies
Paclitaxel: Given IV
Pembrolizumab: Given IV
Quality-of-Life Assessment: Ancillary studies
|
|---|---|---|
|
Overall Study
Death
|
5
|
2
|
|
Overall Study
Disease Progression
|
12
|
15
|
|
Overall Study
Withdrawal by Subject
|
1
|
2
|
Baseline Characteristics
Effect of Pembrolizumab With or Without Carboplatin and Paclitaxel on Immune Response in Patients With Recurrent or Stage IIIB-IV Non-small Cell Lung Cancer
Baseline characteristics by cohort
| Measure |
Arm I (Pembrolizumab)
n=22 Participants
Patients receive pembrolizumab IV over 30 minutes on day 1. Courses repeat every 3 weeks for 2 years in the absence of disease progression or unacceptable toxicity.
Laboratory Biomarker Analysis: Correlative studies
Pembrolizumab: Given IV
Quality-of-Life Assessment: Ancillary studies
|
Arm II (Pembrolizumab, Paclitaxel, Carboplatin)
n=21 Participants
Patients receive pembrolizumab IV over 30 minutes on day 1, paclitaxel IV over 1 hour and carboplatin IV over 1 hour on days 1, 7 and 14. Courses repeat every 3 weeks for 2 years in the absence of disease progression or unacceptable toxicity.
Carboplatin: Given IV
Laboratory Biomarker Analysis: Correlative studies
Paclitaxel: Given IV
Pembrolizumab: Given IV
Quality-of-Life Assessment: Ancillary studies
|
Total
n=43 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
70.5 years
STANDARD_DEVIATION 8.7 • n=99 Participants
|
70.8 years
STANDARD_DEVIATION 11.1 • n=107 Participants
|
70.7 years
STANDARD_DEVIATION 9.8 • n=206 Participants
|
|
Sex: Female, Male
Female
|
7 Participants
n=99 Participants
|
12 Participants
n=107 Participants
|
19 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
15 Participants
n=99 Participants
|
9 Participants
n=107 Participants
|
24 Participants
n=206 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Black or African American
|
3 Participants
n=99 Participants
|
3 Participants
n=107 Participants
|
6 Participants
n=206 Participants
|
|
Race (NIH/OMB)
White
|
19 Participants
n=99 Participants
|
18 Participants
n=107 Participants
|
37 Participants
n=206 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
PRIMARY outcome
Timeframe: Up to 2 yearsDuration of response will also be assessed in each group and compared using survival analysis methods. Per response evaluation criteria in Solid Tumors Criteria: Complete Response (irCR): Complete disappearance of all target and new, measurable lesions, with the exceptions of lymph nodes which must decrease to \< 10 mm in short axis; Partial Response (irPR): Decrease in TMTB ≥ 30% relative to baseline; Stable Disease (irSD): Not meeting criteria for irCR or irPR, in absence of irPD; Progressive Disease (irPD): Increase in TMTB ≥ 20% relative to nadir.
Outcome measures
| Measure |
Arm I (Pembrolizumab)
n=22 Participants
Patients receive pembrolizumab IV over 30 minutes on day 1. Courses repeat every 3 weeks for 2 years in the absence of disease progression or unacceptable toxicity.
Laboratory Biomarker Analysis: Correlative studies
Pembrolizumab: Given IV
Quality-of-Life Assessment: Ancillary studies
|
Arm II (Pembrolizumab, Paclitaxel, Carboplatin)
n=21 Participants
Patients receive pembrolizumab IV over 30 minutes on day 1, paclitaxel IV over 1 hour and carboplatin IV over 1 hour on days 1, 7 and 14. Courses repeat every 3 weeks for 2 years in the absence of disease progression or unacceptable toxicity.
Carboplatin: Given IV
Laboratory Biomarker Analysis: Correlative studies
Paclitaxel: Given IV
Pembrolizumab: Given IV
Quality-of-Life Assessment: Ancillary studies
|
Progressive Disease
Disease progression with no response to treatment.
|
|---|---|---|---|
|
Duration of Response
|
98 days
Interval 0.0 to 326.0
|
69 days
Interval 0.0 to 252.0
|
—
|
PRIMARY outcome
Timeframe: Baseline and end of treatment (up to 2 years)Immune markers were measured at baseline and post-treatment. Data reported are the difference (post-pre) in these immune markers. Wilcoxon rank-sum tests were used to analyze the effects of the treatments on the change in immune markers.
Outcome measures
| Measure |
Arm I (Pembrolizumab)
n=10 Participants
Patients receive pembrolizumab IV over 30 minutes on day 1. Courses repeat every 3 weeks for 2 years in the absence of disease progression or unacceptable toxicity.
Laboratory Biomarker Analysis: Correlative studies
Pembrolizumab: Given IV
Quality-of-Life Assessment: Ancillary studies
|
Arm II (Pembrolizumab, Paclitaxel, Carboplatin)
n=9 Participants
Patients receive pembrolizumab IV over 30 minutes on day 1, paclitaxel IV over 1 hour and carboplatin IV over 1 hour on days 1, 7 and 14. Courses repeat every 3 weeks for 2 years in the absence of disease progression or unacceptable toxicity.
Carboplatin: Given IV
Laboratory Biomarker Analysis: Correlative studies
Paclitaxel: Given IV
Pembrolizumab: Given IV
Quality-of-Life Assessment: Ancillary studies
|
Progressive Disease
Disease progression with no response to treatment.
|
|---|---|---|---|
|
Change in Effect of Treatment in Immune Markers From Baseline to End of Treatment (up to 2 Years)
CD4+FoxP3
|
1.82 cells
Interval -2.11 to 4.73
|
-1.34 cells
Interval -3.37 to 269.0
|
—
|
|
Change in Effect of Treatment in Immune Markers From Baseline to End of Treatment (up to 2 Years)
MDSC
|
-3.83 cells
Interval -6.47 to 0.92
|
5.41 cells
Interval 1.64 to 9.65
|
—
|
|
Change in Effect of Treatment in Immune Markers From Baseline to End of Treatment (up to 2 Years)
CD4+ICOS
|
1.07 cells
Interval 0.02 to 2.1
|
5.41 cells
Interval -0.64 to 5.7
|
—
|
|
Change in Effect of Treatment in Immune Markers From Baseline to End of Treatment (up to 2 Years)
CD8+ICOS
|
0.7 cells
Interval 0.01 to 0.97
|
0.77 cells
Interval -0.02 to 2.91
|
—
|
|
Change in Effect of Treatment in Immune Markers From Baseline to End of Treatment (up to 2 Years)
Plamacytoid DC
|
-0.17 cells
Interval -1.85 to 0.04
|
-0.02 cells
Interval -0.38 to 0.19
|
—
|
|
Change in Effect of Treatment in Immune Markers From Baseline to End of Treatment (up to 2 Years)
Monocytes
|
-2.05 cells
Interval -8.4 to -0.08
|
0.65 cells
Interval -0.98 to 3.4
|
—
|
|
Change in Effect of Treatment in Immune Markers From Baseline to End of Treatment (up to 2 Years)
T cells (CD3+)
|
-13.06 cells
Interval -25.72 to 22.62
|
-0.01 cells
Interval -16.6 to 12.16
|
—
|
PRIMARY outcome
Timeframe: Up to 2 yearsThe Fisher's exact test methods will be used to estimate ORR between groups. The Exact Clopper-Pearson 95% confidence intervals will be calculated for each group. Per response evaluation criteria in Solid Tumors Criteria: Complete Response (irCR): Complete disappearance of all target and new, measurable lesions, with the exceptions of lymph nodes which must decrease to \< 10 mm in short axis; Partial Response (irPR): Decrease in TMTB ≥ 30% relative to baseline; Stable Disease (irSD): Not meeting criteria for irCR or irPR, in absence of irPD; Progressive Disease (irPD): Increase in TMTB ≥ 20% relative to nadir.
Outcome measures
| Measure |
Arm I (Pembrolizumab)
n=22 Participants
Patients receive pembrolizumab IV over 30 minutes on day 1. Courses repeat every 3 weeks for 2 years in the absence of disease progression or unacceptable toxicity.
Laboratory Biomarker Analysis: Correlative studies
Pembrolizumab: Given IV
Quality-of-Life Assessment: Ancillary studies
|
Arm II (Pembrolizumab, Paclitaxel, Carboplatin)
n=21 Participants
Patients receive pembrolizumab IV over 30 minutes on day 1, paclitaxel IV over 1 hour and carboplatin IV over 1 hour on days 1, 7 and 14. Courses repeat every 3 weeks for 2 years in the absence of disease progression or unacceptable toxicity.
Carboplatin: Given IV
Laboratory Biomarker Analysis: Correlative studies
Paclitaxel: Given IV
Pembrolizumab: Given IV
Quality-of-Life Assessment: Ancillary studies
|
Progressive Disease
Disease progression with no response to treatment.
|
|---|---|---|---|
|
Objective Response Rate (ORR), Assessed Using RECIST
|
6 Participants
|
9 Participants
|
—
|
PRIMARY outcome
Timeframe: Duration of time from randomization to the time of death due to any cause, or the date the subject was last confirmed to be alive, assessed up to 3 yearsThe Kaplan Meier curves will be used to estimate overall survival rates.
Outcome measures
| Measure |
Arm I (Pembrolizumab)
n=22 Participants
Patients receive pembrolizumab IV over 30 minutes on day 1. Courses repeat every 3 weeks for 2 years in the absence of disease progression or unacceptable toxicity.
Laboratory Biomarker Analysis: Correlative studies
Pembrolizumab: Given IV
Quality-of-Life Assessment: Ancillary studies
|
Arm II (Pembrolizumab, Paclitaxel, Carboplatin)
n=21 Participants
Patients receive pembrolizumab IV over 30 minutes on day 1, paclitaxel IV over 1 hour and carboplatin IV over 1 hour on days 1, 7 and 14. Courses repeat every 3 weeks for 2 years in the absence of disease progression or unacceptable toxicity.
Carboplatin: Given IV
Laboratory Biomarker Analysis: Correlative studies
Paclitaxel: Given IV
Pembrolizumab: Given IV
Quality-of-Life Assessment: Ancillary studies
|
Progressive Disease
Disease progression with no response to treatment.
|
|---|---|---|---|
|
Overall Survival
|
8.4 months
Interval 5.0 to 29.8
|
7.5 months
Interval 3.9 to 25.1
|
—
|
PRIMARY outcome
Timeframe: Duration of time from randomization to the time of immune-related progressive disease or death, whichever comes first, assessed up to 3 yearsThe Kaplan Meier curves will be used to estimate progression free survival rates. Per response evaluation criteria in Solid Tumors Criteria: Progressive Disease (irPD): Increase in TMTB ≥ 20% relative to nadir.
Outcome measures
| Measure |
Arm I (Pembrolizumab)
n=22 Participants
Patients receive pembrolizumab IV over 30 minutes on day 1. Courses repeat every 3 weeks for 2 years in the absence of disease progression or unacceptable toxicity.
Laboratory Biomarker Analysis: Correlative studies
Pembrolizumab: Given IV
Quality-of-Life Assessment: Ancillary studies
|
Arm II (Pembrolizumab, Paclitaxel, Carboplatin)
n=21 Participants
Patients receive pembrolizumab IV over 30 minutes on day 1, paclitaxel IV over 1 hour and carboplatin IV over 1 hour on days 1, 7 and 14. Courses repeat every 3 weeks for 2 years in the absence of disease progression or unacceptable toxicity.
Carboplatin: Given IV
Laboratory Biomarker Analysis: Correlative studies
Paclitaxel: Given IV
Pembrolizumab: Given IV
Quality-of-Life Assessment: Ancillary studies
|
Progressive Disease
Disease progression with no response to treatment.
|
|---|---|---|---|
|
Progression Free Survival
|
4.3 months
Interval 1.9 to 12.0
|
5.0 months
Interval 1.9 to 10.4
|
—
|
SECONDARY outcome
Timeframe: At baseline, at week 8, week 12, week 20 and up to 30 days after last study drug is administeredAdverse events will be categorized by organ system and severity and summarized as frequency counts and percentages. A treatment will be considered too toxic if ≥6 of 20 patients in a cohort are removed from study because of toxicity.
Outcome measures
| Measure |
Arm I (Pembrolizumab)
n=22 Participants
Patients receive pembrolizumab IV over 30 minutes on day 1. Courses repeat every 3 weeks for 2 years in the absence of disease progression or unacceptable toxicity.
Laboratory Biomarker Analysis: Correlative studies
Pembrolizumab: Given IV
Quality-of-Life Assessment: Ancillary studies
|
Arm II (Pembrolizumab, Paclitaxel, Carboplatin)
n=21 Participants
Patients receive pembrolizumab IV over 30 minutes on day 1, paclitaxel IV over 1 hour and carboplatin IV over 1 hour on days 1, 7 and 14. Courses repeat every 3 weeks for 2 years in the absence of disease progression or unacceptable toxicity.
Carboplatin: Given IV
Laboratory Biomarker Analysis: Correlative studies
Paclitaxel: Given IV
Pembrolizumab: Given IV
Quality-of-Life Assessment: Ancillary studies
|
Progressive Disease
Disease progression with no response to treatment.
|
|---|---|---|---|
|
Number of Participants With Reported Adverse Events - CTCAE Version 4.0
|
21 participants with adverse event
|
18 participants with adverse event
|
—
|
SECONDARY outcome
Timeframe: At baseline and post-treatmentTreatment response will be grouped into 3 categories as defined earlier in the protocol (complete or partial response, stable disease, progressive disease). The immune responses for patients within each of these 3 groups will be examined to determine whether there is evidence of an association. Immune markers were measured at baseline and post-treatment. Data reported are the difference (post-pre) in these immune markers. The change in markers (post-pre) are summarized and compared between treatment groups using a Kruskal Wallis test.
Outcome measures
| Measure |
Arm I (Pembrolizumab)
n=9 Participants
Patients receive pembrolizumab IV over 30 minutes on day 1. Courses repeat every 3 weeks for 2 years in the absence of disease progression or unacceptable toxicity.
Laboratory Biomarker Analysis: Correlative studies
Pembrolizumab: Given IV
Quality-of-Life Assessment: Ancillary studies
|
Arm II (Pembrolizumab, Paclitaxel, Carboplatin)
n=4 Participants
Patients receive pembrolizumab IV over 30 minutes on day 1, paclitaxel IV over 1 hour and carboplatin IV over 1 hour on days 1, 7 and 14. Courses repeat every 3 weeks for 2 years in the absence of disease progression or unacceptable toxicity.
Carboplatin: Given IV
Laboratory Biomarker Analysis: Correlative studies
Paclitaxel: Given IV
Pembrolizumab: Given IV
Quality-of-Life Assessment: Ancillary studies
|
Progressive Disease
n=5 Participants
Disease progression with no response to treatment.
|
|---|---|---|---|
|
Change in Immune Markers From Baseline to End of Treatment (up to 2 Years) With Treatment Response
CD4+FoxP3
|
-0.54 Cells
Interval -2.8 to 3.7
|
-1.4 Cells
Interval -2.8 to 1.7
|
-2.1 Cells
Interval -5.1 to 4.2
|
|
Change in Immune Markers From Baseline to End of Treatment (up to 2 Years) With Treatment Response
MDSC
|
5.3 Cells
Interval -6.5 to 9.7
|
-1.5 Cells
Interval -7.6 to 3.5
|
-0.9 Cells
Interval -4.1 to 0.9
|
|
Change in Immune Markers From Baseline to End of Treatment (up to 2 Years) With Treatment Response
CD4+ICOS
|
2.1 Cells
Interval 1.2 to 5.6
|
3.2 Cells
Interval 0.5 to 11.0
|
0.02 Cells
Interval -1.9 to 0.8
|
|
Change in Immune Markers From Baseline to End of Treatment (up to 2 Years) With Treatment Response
CD8+ICOS
|
1.0 Cells
Interval 0.01 to 3.5
|
1.9 Cells
Interval -0.9 to 6.4
|
-0.02 Cells
Interval -0.3 to 0.1
|
|
Change in Immune Markers From Baseline to End of Treatment (up to 2 Years) With Treatment Response
Plamacytoid DC
|
-0.24 Cells
Interval -1.03 to 0.04
|
0.20 Cells
Interval -0.91 to 4.38
|
-0.22 Cells
Interval -0.38 to -0.12
|
|
Change in Immune Markers From Baseline to End of Treatment (up to 2 Years) With Treatment Response
Monocytes
|
0.65 Cells
Interval -2.71 to 3.4
|
-0.36 Cells
Interval -4.5 to 6.17
|
-1.75 Cells
Interval -11.47 to -0.08
|
|
Change in Immune Markers From Baseline to End of Treatment (up to 2 Years) With Treatment Response
T cells (CD3+)
|
-16.6 Cells
Interval -23.6 to -2.5
|
8.3 Cells
Interval 2.2 to 17.4
|
1.4 Cells
Interval -23.9 to 32.0
|
Adverse Events
Arm I (Pembrolizumab)
Serious events: 3 serious events
Other events: 21 other events
Deaths: 18 deaths
Arm II (Pembrolizumab, Paclitaxel, Carboplatin)
Serious events: 3 serious events
Other events: 18 other events
Deaths: 18 deaths
Serious adverse events
| Measure |
Arm I (Pembrolizumab)
n=22 participants at risk
Patients receive pembrolizumab IV over 30 minutes on day 1. Courses repeat every 3 weeks for 2 years in the absence of disease progression or unacceptable toxicity.
Laboratory Biomarker Analysis: Correlative studies
Pembrolizumab: Given IV
|
Arm II (Pembrolizumab, Paclitaxel, Carboplatin)
n=21 participants at risk
Patients receive pembrolizumab IV over 30 minutes on day 1, paclitaxel IV over 1 hour and carboplatin IV over 1 hour on days 1, 7 and 14. Courses repeat every 3 weeks for 2 years in the absence of disease progression or unacceptable toxicity.
Carboplatin: Given IV
Laboratory Biomarker Analysis: Correlative studies
Paclitaxel: Given IV
Pembrolizumab: Given IV
|
|---|---|---|
|
General disorders
Death
|
13.6%
3/22 • Number of events 3 • 3 years
|
9.5%
2/21 • Number of events 2 • 3 years
|
|
Cardiac disorders
Atrial Fibrillation
|
0.00%
0/22 • 3 years
|
4.8%
1/21 • Number of events 1 • 3 years
|
Other adverse events
| Measure |
Arm I (Pembrolizumab)
n=22 participants at risk
Patients receive pembrolizumab IV over 30 minutes on day 1. Courses repeat every 3 weeks for 2 years in the absence of disease progression or unacceptable toxicity.
Laboratory Biomarker Analysis: Correlative studies
Pembrolizumab: Given IV
|
Arm II (Pembrolizumab, Paclitaxel, Carboplatin)
n=21 participants at risk
Patients receive pembrolizumab IV over 30 minutes on day 1, paclitaxel IV over 1 hour and carboplatin IV over 1 hour on days 1, 7 and 14. Courses repeat every 3 weeks for 2 years in the absence of disease progression or unacceptable toxicity.
Carboplatin: Given IV
Laboratory Biomarker Analysis: Correlative studies
Paclitaxel: Given IV
Pembrolizumab: Given IV
|
|---|---|---|
|
Renal and urinary disorders
Chronic Kidney disease
|
9.1%
2/22 • Number of events 5 • 3 years
|
14.3%
3/21 • Number of events 13 • 3 years
|
|
Blood and lymphatic system disorders
WBC decreased
|
45.5%
10/22 • Number of events 109 • 3 years
|
47.6%
10/21 • Number of events 129 • 3 years
|
|
Blood and lymphatic system disorders
Platelets decreased
|
45.5%
10/22 • Number of events 111 • 3 years
|
47.6%
10/21 • Number of events 129 • 3 years
|
|
Blood and lymphatic system disorders
Anemia
|
50.0%
11/22 • Number of events 112 • 3 years
|
52.4%
11/21 • Number of events 130 • 3 years
|
|
Gastrointestinal disorders
Nausea
|
22.7%
5/22 • Number of events 13 • 3 years
|
38.1%
8/21 • Number of events 47 • 3 years
|
|
Gastrointestinal disorders
Vomiting
|
9.1%
2/22 • Number of events 2 • 3 years
|
14.3%
3/21 • Number of events 3 • 3 years
|
|
Gastrointestinal disorders
Diarrhea
|
13.6%
3/22 • Number of events 6 • 3 years
|
28.6%
6/21 • Number of events 9 • 3 years
|
|
Metabolism and nutrition disorders
Anorexia
|
18.2%
4/22 • Number of events 9 • 3 years
|
23.8%
5/21 • Number of events 9 • 3 years
|
|
Investigations
Alkaline phosphatase increased
|
45.5%
10/22 • Number of events 110 • 3 years
|
52.4%
11/21 • Number of events 130 • 3 years
|
|
Investigations
Creatinine increased
|
9.1%
2/22 • Number of events 2 • 3 years
|
4.8%
1/21 • Number of events 2 • 3 years
|
|
Vascular disorders
Hypotension
|
13.6%
3/22 • Number of events 4 • 3 years
|
4.8%
1/21 • Number of events 2 • 3 years
|
|
Investigations
Neutrophil count decreased
|
45.5%
10/22 • Number of events 108 • 3 years
|
47.6%
10/21 • Number of events 129 • 3 years
|
|
General disorders
Pain at administration site
|
36.4%
8/22 • Number of events 44 • 3 years
|
38.1%
8/21 • Number of events 46 • 3 years
|
|
Psychiatric disorders
Insomnia
|
13.6%
3/22 • Number of events 6 • 3 years
|
19.0%
4/21 • Number of events 22 • 3 years
|
|
General disorders
Fatigue
|
54.5%
12/22 • Number of events 51 • 3 years
|
47.6%
10/21 • Number of events 58 • 3 years
|
|
Metabolism and nutrition disorders
Hyperglycemia
|
45.5%
10/22 • Number of events 39 • 3 years
|
57.1%
12/21 • Number of events 66 • 3 years
|
|
Metabolism and nutrition disorders
Hypocalcemia
|
13.6%
3/22 • Number of events 5 • 3 years
|
38.1%
8/21 • Number of events 25 • 3 years
|
|
Metabolism and nutrition disorders
Hypomagnesemia
|
4.5%
1/22 • Number of events 1 • 3 years
|
19.0%
4/21 • Number of events 4 • 3 years
|
|
Metabolism and nutrition disorders
Hyponatremia
|
18.2%
4/22 • Number of events 7 • 3 years
|
33.3%
7/21 • Number of events 20 • 3 years
|
|
Metabolism and nutrition disorders
Hypokalemia
|
4.5%
1/22 • Number of events 2 • 3 years
|
33.3%
7/21 • Number of events 17 • 3 years
|
|
Metabolism and nutrition disorders
Hypoalbuminemia
|
36.4%
8/22 • Number of events 22 • 3 years
|
61.9%
13/21 • Number of events 63 • 3 years
|
|
Investigations
Bilirubin increased
|
45.5%
10/22 • Number of events 50 • 3 years
|
47.6%
10/21 • Number of events 55 • 3 years
|
|
Investigations
Alanine aminotranspherase increased
|
45.5%
10/22 • Number of events 53 • 3 years
|
52.4%
11/21 • Number of events 56 • 3 years
|
|
Gastrointestinal disorders
Constipation
|
13.6%
3/22 • Number of events 10 • 3 years
|
23.8%
5/21 • Number of events 9 • 3 years
|
|
Investigations
Aspartate aminotranspherase increased
|
45.5%
10/22 • Number of events 54 • 3 years
|
52.4%
11/21 • Number of events 56 • 3 years
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
22.7%
5/22 • Number of events 12 • 3 years
|
28.6%
6/21 • Number of events 17 • 3 years
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
9.1%
2/22 • Number of events 2 • 3 years
|
4.8%
1/21 • Number of events 1 • 3 years
|
|
Psychiatric disorders
Confusion
|
9.1%
2/22 • Number of events 3 • 3 years
|
9.5%
2/21 • Number of events 3 • 3 years
|
|
Musculoskeletal and connective tissue disorders
Back Pain
|
13.6%
3/22 • Number of events 3 • 3 years
|
4.8%
1/21 • Number of events 1 • 3 years
|
|
Investigations
CD4 lymphocytes decreased
|
4.5%
1/22 • Number of events 1 • 3 years
|
19.0%
4/21 • Number of events 8 • 3 years
|
|
Investigations
Lymphocyte count decreased
|
18.2%
4/22 • Number of events 6 • 3 years
|
28.6%
6/21 • Number of events 29 • 3 years
|
|
Cardiac disorders
Sinus tachycardia
|
4.5%
1/22 • Number of events 1 • 3 years
|
9.5%
2/21 • Number of events 2 • 3 years
|
|
Eye disorders
Blurred Vision
|
9.1%
2/22 • Number of events 2 • 3 years
|
4.8%
1/21 • Number of events 1 • 3 years
|
|
General disorders
Edema limbs
|
9.1%
2/22 • Number of events 7 • 3 years
|
33.3%
7/21 • Number of events 26 • 3 years
|
|
Gastrointestinal disorders
Abdominal Pain
|
13.6%
3/22 • Number of events 4 • 3 years
|
0.00%
0/21 • 3 years
|
|
Gastrointestinal disorders
Mucositis Oral
|
4.5%
1/22 • Number of events 4 • 3 years
|
0.00%
0/21 • 3 years
|
|
General disorders
Non-cardiac chest pain
|
22.7%
5/22 • Number of events 12 • 3 years
|
4.8%
1/21 • Number of events 2 • 3 years
|
|
Infections and infestations
Sinusitis
|
9.1%
2/22 • Number of events 3 • 3 years
|
4.8%
1/21 • Number of events 1 • 3 years
|
|
Injury, poisoning and procedural complications
Fall
|
13.6%
3/22 • Number of events 4 • 3 years
|
14.3%
3/21 • Number of events 3 • 3 years
|
|
Musculoskeletal and connective tissue disorders
Generalized muscle weakness
|
18.2%
4/22 • Number of events 8 • 3 years
|
19.0%
4/21 • Number of events 5 • 3 years
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
4.5%
1/22 • Number of events 1 • 3 years
|
14.3%
3/21 • Number of events 4 • 3 years
|
|
Nervous system disorders
Headache
|
9.1%
2/22 • Number of events 2 • 3 years
|
33.3%
7/21 • Number of events 12 • 3 years
|
|
Nervous system disorders
Peripheral Sensory Neuropathy
|
4.5%
1/22 • Number of events 1 • 3 years
|
14.3%
3/21 • Number of events 9 • 3 years
|
|
Renal and urinary disorders
Acute Kidney Injury
|
13.6%
3/22 • Number of events 3 • 3 years
|
14.3%
3/21 • Number of events 4 • 3 years
|
|
Respiratory, thoracic and mediastinal disorders
Allergic rhinitis
|
4.5%
1/22 • Number of events 5 • 3 years
|
9.5%
2/21 • Number of events 3 • 3 years
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
59.1%
13/22 • Number of events 37 • 3 years
|
33.3%
7/21 • Number of events 32 • 3 years
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonitis
|
4.5%
1/22 • Number of events 1 • 3 years
|
9.5%
2/21 • Number of events 4 • 3 years
|
|
Skin and subcutaneous tissue disorders
Rash acneiform
|
13.6%
3/22 • Number of events 7 • 3 years
|
19.0%
4/21 • Number of events 17 • 3 years
|
|
Vascular disorders
Superficial thrombophlebitis
|
9.1%
2/22 • Number of events 3 • 3 years
|
4.8%
1/21 • Number of events 9 • 3 years
|
|
Infections and infestations
Urinary tract infection
|
13.6%
3/22 • Number of events 6 • 3 years
|
0.00%
0/21 • 3 years
|
Additional Information
Assistant Director of Clinical Research Operations
Wake Forest Baptist Comprehensive Cancer Center
Phone: 336-713-6913
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place