Trial Outcomes & Findings for Study to Assess Enzastaurin + R-CHOP in Subjects With DLBCL With the Genomic Biomarker DGM1™ (NCT NCT03263026)
NCT ID: NCT03263026
Last Updated: 2025-01-23
Results Overview
The primary objective of this study is to compare the effect of R-CHOP/enzastaurin versus R-CHOP alone on overall survival in treatment naive, high-risk subjects with DLBCL who possess the DGM1™ biomarker.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
256 participants
Primary outcome timeframe
Primary Outcome evaluated at 12 months.
Results posted on
2025-01-23
Participant Flow
Intent to treat (ITT) population 254 (126 in R-CHOP plus enzastaurin arm and 128 in R-CHOP plus placebo arm). The DGM1 status was not available for two subjects as these subjects either withdrew consent or died prior to sample collection. Total 256 patients were initially randomized but two patients were not dosed.
Participant milestones
| Measure |
R-CHOP + Enzastaurin
The Phase 2 study of enzastaurin used "standard" International Prognostic Index, and therefore the same index will be used in the current study. This index defines 5 variables: age (\> 60), tumor stage (III or IV), number of extranodal sites (\> 1), ECOG performance status (\> 1) and serum lactate dehydrogenase (LDH) (\> 1 times upper limit of normal). One point is assigned for each variable and subjects with 3 points are classified as high-intermediate risk, and subjects with 4 or 5 points are classified as high-risk DLBCL. Subjects must have at least 3 points in order to be eligible for this study.
|
R-CHOP + Placebo
The Phase 2 study of enzastaurin used "standard" International Prognostic Index, and therefore the same index will be used in the current study. This index defines 5 variables: age (\> 60), tumor stage (III or IV), number of extranodal sites (\> 1), ECOG performance status (\> 1) and serum lactate dehydrogenase (LDH) (\> 1 times upper limit of normal). One point is assigned for each variable and subjects with 3 points are classified as high-intermediate risk, and subjects with 4 or 5 points are classified as high-risk DLBCL. Subjects must have at least 3 points in order to be eligible for this study.
|
|---|---|---|
|
Overall Study
STARTED
|
128
|
128
|
|
Overall Study
COMPLETED
|
85
|
99
|
|
Overall Study
NOT COMPLETED
|
43
|
29
|
Reasons for withdrawal
| Measure |
R-CHOP + Enzastaurin
The Phase 2 study of enzastaurin used "standard" International Prognostic Index, and therefore the same index will be used in the current study. This index defines 5 variables: age (\> 60), tumor stage (III or IV), number of extranodal sites (\> 1), ECOG performance status (\> 1) and serum lactate dehydrogenase (LDH) (\> 1 times upper limit of normal). One point is assigned for each variable and subjects with 3 points are classified as high-intermediate risk, and subjects with 4 or 5 points are classified as high-risk DLBCL. Subjects must have at least 3 points in order to be eligible for this study.
|
R-CHOP + Placebo
The Phase 2 study of enzastaurin used "standard" International Prognostic Index, and therefore the same index will be used in the current study. This index defines 5 variables: age (\> 60), tumor stage (III or IV), number of extranodal sites (\> 1), ECOG performance status (\> 1) and serum lactate dehydrogenase (LDH) (\> 1 times upper limit of normal). One point is assigned for each variable and subjects with 3 points are classified as high-intermediate risk, and subjects with 4 or 5 points are classified as high-risk DLBCL. Subjects must have at least 3 points in order to be eligible for this study.
|
|---|---|---|
|
Overall Study
Withdrawal by Subject
|
1
|
0
|
|
Overall Study
Death
|
1
|
0
|
|
Overall Study
Other/ Various
|
41
|
29
|
Baseline Characteristics
Two hundred and fifty-six (256) subjects were enrolled in the study (126 in the treatment group and 128 in the placebo group, including 112 and 121 subjects who had the DGM1 biomarker in each group respectively). The DGM1 status was not available for two subjects as these subjects either withdrew consent or died prior to sample collection, therefore not included in ITT (number analyzed).
Baseline characteristics by cohort
| Measure |
R-CHOP + Enzastaurin
n=126 Participants
The Phase 2 study of enzastaurin used "standard" International Prognostic Index, and therefore the same index will be used in the current study. This index defines 5 variables: age (\> 60), tumor stage (III or IV), number of extranodal sites (\> 1), ECOG performance status (\> 1) and serum lactate dehydrogenase (LDH) (\> 1 times upper limit of normal). One point is assigned for each variable and subjects with 3 points are classified as high-intermediate risk, and subjects with 4 or 5 points are classified as high-risk DLBCL. Subjects must have at least 3 points in order to be eligible for this study.
|
R-CHOP + Placebo
n=128 Participants
The Phase 2 study of enzastaurin used "standard" International Prognostic Index, and therefore the same index will be used in the current study. This index defines 5 variables: age (\> 60), tumor stage (III or IV), number of extranodal sites (\> 1), ECOG performance status (\> 1) and serum lactate dehydrogenase (LDH) (\> 1 times upper limit of normal). One point is assigned for each variable and subjects with 3 points are classified as high-intermediate risk, and subjects with 4 or 5 points are classified as high-risk DLBCL. Subjects must have at least 3 points in order to be eligible for this study.
|
Total
n=254 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
63 years
n=5 Participants
|
65 years
n=7 Participants
|
65 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
63 Participants
n=5 Participants
|
57 Participants
n=7 Participants
|
120 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
63 Participants
n=5 Participants
|
71 Participants
n=7 Participants
|
134 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
88 Participants
n=5 Participants
|
89 Participants
n=7 Participants
|
177 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
38 Participants
n=5 Participants
|
39 Participants
n=7 Participants
|
77 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
DGM1 positive Biomarker status
|
112 Participants
n=5 Participants • Two hundred and fifty-six (256) subjects were enrolled in the study (126 in the treatment group and 128 in the placebo group, including 112 and 121 subjects who had the DGM1 biomarker in each group respectively). The DGM1 status was not available for two subjects as these subjects either withdrew consent or died prior to sample collection, therefore not included in ITT (number analyzed).
|
121 Participants
n=7 Participants • Two hundred and fifty-six (256) subjects were enrolled in the study (126 in the treatment group and 128 in the placebo group, including 112 and 121 subjects who had the DGM1 biomarker in each group respectively). The DGM1 status was not available for two subjects as these subjects either withdrew consent or died prior to sample collection, therefore not included in ITT (number analyzed).
|
233 Participants
n=5 Participants • Two hundred and fifty-six (256) subjects were enrolled in the study (126 in the treatment group and 128 in the placebo group, including 112 and 121 subjects who had the DGM1 biomarker in each group respectively). The DGM1 status was not available for two subjects as these subjects either withdrew consent or died prior to sample collection, therefore not included in ITT (number analyzed).
|
PRIMARY outcome
Timeframe: Primary Outcome evaluated at 12 months.The primary objective of this study is to compare the effect of R-CHOP/enzastaurin versus R-CHOP alone on overall survival in treatment naive, high-risk subjects with DLBCL who possess the DGM1™ biomarker.
Outcome measures
| Measure |
R-CHOP + Enzastaurin
n=112 Participants
The Phase 2 study of enzastaurin used "standard" International Prognostic Index, and therefore the same index will be used in the current study. This index defines 5 variables: age (\> 60), tumor stage (III or IV), number of extranodal sites (\> 1), ECOG performance status (\> 1) and serum lactate dehydrogenase (LDH) (\> 1 times upper limit of normal). One point is assigned for each variable and subjects with 3 points are classified as high-intermediate risk, and subjects with 4 or 5 points are classified as high-risk DLBCL. Subjects must have at least 3 points in order to be eligible for this study.
|
RCHOP + Placebo
n=121 Participants
The Phase 2 study of enzastaurin used "standard" International Prognostic Index, and therefore the same index will be used in the current study. This index defines 5 variables: age (\> 60), tumor stage (III or IV), number of extranodal sites (\> 1), ECOG performance status (\> 1) and serum lactate dehydrogenase (LDH) (\> 1 times upper limit of normal). One point is assigned for each variable and subjects with 3 points are classified as high-intermediate risk, and subjects with 4 or 5 points are classified as high-risk DLBCL. Subjects must have at least 3 points in order to be eligible for this study.
|
|---|---|---|
|
Overall Survival in Subjects Who Possess the DGM1™ Biomarker
|
82 percentage of patients
|
87 percentage of patients
|
SECONDARY outcome
Timeframe: Secondary Outcome evaluated at 12 months.The secondary outcome of this study is to determine the effect on OS of adding enzastaurin to R-CHOP in treatment naïve subjects with high-risk DLBCL regardless of DGM1 biomarker status.
Outcome measures
| Measure |
R-CHOP + Enzastaurin
n=126 Participants
The Phase 2 study of enzastaurin used "standard" International Prognostic Index, and therefore the same index will be used in the current study. This index defines 5 variables: age (\> 60), tumor stage (III or IV), number of extranodal sites (\> 1), ECOG performance status (\> 1) and serum lactate dehydrogenase (LDH) (\> 1 times upper limit of normal). One point is assigned for each variable and subjects with 3 points are classified as high-intermediate risk, and subjects with 4 or 5 points are classified as high-risk DLBCL. Subjects must have at least 3 points in order to be eligible for this study.
|
RCHOP + Placebo
n=128 Participants
The Phase 2 study of enzastaurin used "standard" International Prognostic Index, and therefore the same index will be used in the current study. This index defines 5 variables: age (\> 60), tumor stage (III or IV), number of extranodal sites (\> 1), ECOG performance status (\> 1) and serum lactate dehydrogenase (LDH) (\> 1 times upper limit of normal). One point is assigned for each variable and subjects with 3 points are classified as high-intermediate risk, and subjects with 4 or 5 points are classified as high-risk DLBCL. Subjects must have at least 3 points in order to be eligible for this study.
|
|---|---|---|
|
To Determine the Effect on Overall Survivor of Adding Enzastaurin to R-CHOP in Treatment naïve Subjects With High-risk DLBCL Regardless of DGM1 Biomarker Status.
|
100 Participants
|
100 Participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 3.5 yearsUrine color will be analyzed by the central lab and overall survival will be determined for subjects with reddish discoloration of the urine. Testing may be performed to define the chemical profile of the urine.
Outcome measures
Outcome data not reported
Adverse Events
R-CHOP + Enzastaurin
Serious events: 75 serious events
Other events: 126 other events
Deaths: 68 deaths
R-CHOP + Placebo
Serious events: 59 serious events
Other events: 125 other events
Deaths: 77 deaths
Serious adverse events
| Measure |
R-CHOP + Enzastaurin
n=126 participants at risk
The Phase 2 study of enzastaurin used "standard" International Prognostic Index, and therefore the same index will be used in the current study. This index defines 5 variables: age (\> 60), tumor stage (III or IV), number of extranodal sites (\> 1), ECOG performance status (\> 1) and serum lactate dehydrogenase (LDH) (\> 1 times upper limit of normal). One point is assigned for each variable and subjects with 3 points are classified as high-intermediate risk, and subjects with 4 or 5 points are classified as high-risk DLBCL. Subjects must have at least 3 points in order to be eligible for this study.
|
R-CHOP + Placebo
n=128 participants at risk
The Phase 2 study of enzastaurin used "standard" International Prognostic Index, and therefore the same index will be used in the current study. This index defines 5 variables: age (\> 60), tumor stage (III or IV), number of extranodal sites (\> 1), ECOG performance status (\> 1) and serum lactate dehydrogenase (LDH) (\> 1 times upper limit of normal). One point is assigned for each variable and subjects with 3 points are classified as high-intermediate risk, and subjects with 4 or 5 points are classified as high-risk DLBCL. Subjects must have at least 3 points in order to be eligible for this study.
|
|---|---|---|
|
Product Issues
|
59.5%
75/126 • Adverse events data were collected from enrollment till the end of the study participation or death, whichever comes first, up to 42 months.
|
46.1%
59/128 • Adverse events data were collected from enrollment till the end of the study participation or death, whichever comes first, up to 42 months.
|
Other adverse events
| Measure |
R-CHOP + Enzastaurin
n=126 participants at risk
The Phase 2 study of enzastaurin used "standard" International Prognostic Index, and therefore the same index will be used in the current study. This index defines 5 variables: age (\> 60), tumor stage (III or IV), number of extranodal sites (\> 1), ECOG performance status (\> 1) and serum lactate dehydrogenase (LDH) (\> 1 times upper limit of normal). One point is assigned for each variable and subjects with 3 points are classified as high-intermediate risk, and subjects with 4 or 5 points are classified as high-risk DLBCL. Subjects must have at least 3 points in order to be eligible for this study.
|
R-CHOP + Placebo
n=128 participants at risk
The Phase 2 study of enzastaurin used "standard" International Prognostic Index, and therefore the same index will be used in the current study. This index defines 5 variables: age (\> 60), tumor stage (III or IV), number of extranodal sites (\> 1), ECOG performance status (\> 1) and serum lactate dehydrogenase (LDH) (\> 1 times upper limit of normal). One point is assigned for each variable and subjects with 3 points are classified as high-intermediate risk, and subjects with 4 or 5 points are classified as high-risk DLBCL. Subjects must have at least 3 points in order to be eligible for this study.
|
|---|---|---|
|
Investigations
WBC Decreased
|
67.5%
85/126 • Adverse events data were collected from enrollment till the end of the study participation or death, whichever comes first, up to 42 months.
|
56.2%
72/128 • Adverse events data were collected from enrollment till the end of the study participation or death, whichever comes first, up to 42 months.
|
|
Investigations
Neutrophil Count Decreased
|
63.5%
80/126 • Adverse events data were collected from enrollment till the end of the study participation or death, whichever comes first, up to 42 months.
|
63.3%
81/128 • Adverse events data were collected from enrollment till the end of the study participation or death, whichever comes first, up to 42 months.
|
|
Investigations
Platelet Count Decreased
|
49.2%
62/126 • Adverse events data were collected from enrollment till the end of the study participation or death, whichever comes first, up to 42 months.
|
39.1%
50/128 • Adverse events data were collected from enrollment till the end of the study participation or death, whichever comes first, up to 42 months.
|
|
Investigations
Lymphocyte Count Decreased
|
24.6%
31/126 • Adverse events data were collected from enrollment till the end of the study participation or death, whichever comes first, up to 42 months.
|
23.4%
30/128 • Adverse events data were collected from enrollment till the end of the study participation or death, whichever comes first, up to 42 months.
|
|
Investigations
Alanine Amino Transferase Increased
|
18.3%
23/126 • Adverse events data were collected from enrollment till the end of the study participation or death, whichever comes first, up to 42 months.
|
21.9%
28/128 • Adverse events data were collected from enrollment till the end of the study participation or death, whichever comes first, up to 42 months.
|
|
Investigations
Weight decreased
|
15.9%
20/126 • Adverse events data were collected from enrollment till the end of the study participation or death, whichever comes first, up to 42 months.
|
14.8%
19/128 • Adverse events data were collected from enrollment till the end of the study participation or death, whichever comes first, up to 42 months.
|
|
Investigations
Aspartate Amino Transferase Increased
|
14.3%
18/126 • Adverse events data were collected from enrollment till the end of the study participation or death, whichever comes first, up to 42 months.
|
21.1%
27/128 • Adverse events data were collected from enrollment till the end of the study participation or death, whichever comes first, up to 42 months.
|
|
Investigations
Blood Bilirubin Increased
|
13.5%
17/126 • Adverse events data were collected from enrollment till the end of the study participation or death, whichever comes first, up to 42 months.
|
9.4%
12/128 • Adverse events data were collected from enrollment till the end of the study participation or death, whichever comes first, up to 42 months.
|
|
Investigations
Electrocardiogram QT prolonged
|
13.5%
17/126 • Adverse events data were collected from enrollment till the end of the study participation or death, whichever comes first, up to 42 months.
|
8.6%
11/128 • Adverse events data were collected from enrollment till the end of the study participation or death, whichever comes first, up to 42 months.
|
|
Investigations
GGT increased
|
7.1%
9/126 • Adverse events data were collected from enrollment till the end of the study participation or death, whichever comes first, up to 42 months.
|
5.5%
7/128 • Adverse events data were collected from enrollment till the end of the study participation or death, whichever comes first, up to 42 months.
|
|
Investigations
Blood LDH Increased
|
6.3%
8/126 • Adverse events data were collected from enrollment till the end of the study participation or death, whichever comes first, up to 42 months.
|
3.9%
5/128 • Adverse events data were collected from enrollment till the end of the study participation or death, whichever comes first, up to 42 months.
|
|
Investigations
EKG T wave abnormal
|
6.3%
8/126 • Adverse events data were collected from enrollment till the end of the study participation or death, whichever comes first, up to 42 months.
|
1.6%
2/128 • Adverse events data were collected from enrollment till the end of the study participation or death, whichever comes first, up to 42 months.
|
|
Investigations
Neutrophil Count Increased
|
4.8%
6/126 • Adverse events data were collected from enrollment till the end of the study participation or death, whichever comes first, up to 42 months.
|
5.5%
7/128 • Adverse events data were collected from enrollment till the end of the study participation or death, whichever comes first, up to 42 months.
|
|
Investigations
Blood Creatinine Increased
|
4.0%
5/126 • Adverse events data were collected from enrollment till the end of the study participation or death, whichever comes first, up to 42 months.
|
7.0%
9/128 • Adverse events data were collected from enrollment till the end of the study participation or death, whichever comes first, up to 42 months.
|
|
Blood and lymphatic system disorders
Anemia
|
72.2%
91/126 • Adverse events data were collected from enrollment till the end of the study participation or death, whichever comes first, up to 42 months.
|
62.5%
80/128 • Adverse events data were collected from enrollment till the end of the study participation or death, whichever comes first, up to 42 months.
|
|
Blood and lymphatic system disorders
Neutropenia
|
22.2%
28/126 • Adverse events data were collected from enrollment till the end of the study participation or death, whichever comes first, up to 42 months.
|
19.5%
25/128 • Adverse events data were collected from enrollment till the end of the study participation or death, whichever comes first, up to 42 months.
|
|
Blood and lymphatic system disorders
Febrile Neutropenia
|
15.9%
20/126 • Adverse events data were collected from enrollment till the end of the study participation or death, whichever comes first, up to 42 months.
|
16.4%
21/128 • Adverse events data were collected from enrollment till the end of the study participation or death, whichever comes first, up to 42 months.
|
|
Blood and lymphatic system disorders
Leucopenia
|
11.9%
15/126 • Adverse events data were collected from enrollment till the end of the study participation or death, whichever comes first, up to 42 months.
|
17.2%
22/128 • Adverse events data were collected from enrollment till the end of the study participation or death, whichever comes first, up to 42 months.
|
|
Blood and lymphatic system disorders
Thrombocitopenia
|
11.1%
14/126 • Adverse events data were collected from enrollment till the end of the study participation or death, whichever comes first, up to 42 months.
|
13.3%
17/128 • Adverse events data were collected from enrollment till the end of the study participation or death, whichever comes first, up to 42 months.
|
|
Gastrointestinal disorders
Nausea
|
40.5%
51/126 • Adverse events data were collected from enrollment till the end of the study participation or death, whichever comes first, up to 42 months.
|
30.5%
39/128 • Adverse events data were collected from enrollment till the end of the study participation or death, whichever comes first, up to 42 months.
|
|
Gastrointestinal disorders
Vomiting
|
21.4%
27/126 • Adverse events data were collected from enrollment till the end of the study participation or death, whichever comes first, up to 42 months.
|
15.6%
20/128 • Adverse events data were collected from enrollment till the end of the study participation or death, whichever comes first, up to 42 months.
|
|
Gastrointestinal disorders
Constipation
|
20.6%
26/126 • Adverse events data were collected from enrollment till the end of the study participation or death, whichever comes first, up to 42 months.
|
23.4%
30/128 • Adverse events data were collected from enrollment till the end of the study participation or death, whichever comes first, up to 42 months.
|
|
Gastrointestinal disorders
Diarrhea
|
18.3%
23/126 • Adverse events data were collected from enrollment till the end of the study participation or death, whichever comes first, up to 42 months.
|
15.6%
20/128 • Adverse events data were collected from enrollment till the end of the study participation or death, whichever comes first, up to 42 months.
|
|
Gastrointestinal disorders
Stomatitis
|
13.5%
17/126 • Adverse events data were collected from enrollment till the end of the study participation or death, whichever comes first, up to 42 months.
|
9.4%
12/128 • Adverse events data were collected from enrollment till the end of the study participation or death, whichever comes first, up to 42 months.
|
|
Gastrointestinal disorders
Abdominal Pain
|
12.7%
16/126 • Adverse events data were collected from enrollment till the end of the study participation or death, whichever comes first, up to 42 months.
|
6.2%
8/128 • Adverse events data were collected from enrollment till the end of the study participation or death, whichever comes first, up to 42 months.
|
|
Gastrointestinal disorders
Abdominal Distension
|
5.6%
7/126 • Adverse events data were collected from enrollment till the end of the study participation or death, whichever comes first, up to 42 months.
|
5.5%
7/128 • Adverse events data were collected from enrollment till the end of the study participation or death, whichever comes first, up to 42 months.
|
|
Gastrointestinal disorders
Abdominal Pain Upper
|
5.6%
7/126 • Adverse events data were collected from enrollment till the end of the study participation or death, whichever comes first, up to 42 months.
|
5.5%
7/128 • Adverse events data were collected from enrollment till the end of the study participation or death, whichever comes first, up to 42 months.
|
|
Metabolism and nutrition disorders
Hypokalemia
|
18.3%
23/126 • Adverse events data were collected from enrollment till the end of the study participation or death, whichever comes first, up to 42 months.
|
26.6%
34/128 • Adverse events data were collected from enrollment till the end of the study participation or death, whichever comes first, up to 42 months.
|
|
Metabolism and nutrition disorders
Hyponatremia
|
18.3%
23/126 • Adverse events data were collected from enrollment till the end of the study participation or death, whichever comes first, up to 42 months.
|
12.5%
16/128 • Adverse events data were collected from enrollment till the end of the study participation or death, whichever comes first, up to 42 months.
|
|
Metabolism and nutrition disorders
Hypoalbuminemia
|
15.9%
20/126 • Adverse events data were collected from enrollment till the end of the study participation or death, whichever comes first, up to 42 months.
|
10.9%
14/128 • Adverse events data were collected from enrollment till the end of the study participation or death, whichever comes first, up to 42 months.
|
|
Metabolism and nutrition disorders
Decreased Apetite
|
13.5%
17/126 • Adverse events data were collected from enrollment till the end of the study participation or death, whichever comes first, up to 42 months.
|
8.6%
11/128 • Adverse events data were collected from enrollment till the end of the study participation or death, whichever comes first, up to 42 months.
|
|
Metabolism and nutrition disorders
Hypokalcemia
|
8.7%
11/126 • Adverse events data were collected from enrollment till the end of the study participation or death, whichever comes first, up to 42 months.
|
11.7%
15/128 • Adverse events data were collected from enrollment till the end of the study participation or death, whichever comes first, up to 42 months.
|
|
Metabolism and nutrition disorders
Hyperuricemia
|
7.9%
10/126 • Adverse events data were collected from enrollment till the end of the study participation or death, whichever comes first, up to 42 months.
|
3.1%
4/128 • Adverse events data were collected from enrollment till the end of the study participation or death, whichever comes first, up to 42 months.
|
|
Metabolism and nutrition disorders
Hypophosphatemia
|
5.6%
7/126 • Adverse events data were collected from enrollment till the end of the study participation or death, whichever comes first, up to 42 months.
|
2.3%
3/128 • Adverse events data were collected from enrollment till the end of the study participation or death, whichever comes first, up to 42 months.
|
|
General disorders
Pyrexia
|
27.0%
34/126 • Adverse events data were collected from enrollment till the end of the study participation or death, whichever comes first, up to 42 months.
|
23.4%
30/128 • Adverse events data were collected from enrollment till the end of the study participation or death, whichever comes first, up to 42 months.
|
|
General disorders
Fatigue
|
17.5%
22/126 • Adverse events data were collected from enrollment till the end of the study participation or death, whichever comes first, up to 42 months.
|
16.4%
21/128 • Adverse events data were collected from enrollment till the end of the study participation or death, whichever comes first, up to 42 months.
|
|
General disorders
Malaise
|
14.3%
18/126 • Adverse events data were collected from enrollment till the end of the study participation or death, whichever comes first, up to 42 months.
|
11.7%
15/128 • Adverse events data were collected from enrollment till the end of the study participation or death, whichever comes first, up to 42 months.
|
|
General disorders
Edema Peripheral
|
10.3%
13/126 • Adverse events data were collected from enrollment till the end of the study participation or death, whichever comes first, up to 42 months.
|
13.3%
17/128 • Adverse events data were collected from enrollment till the end of the study participation or death, whichever comes first, up to 42 months.
|
|
General disorders
Chills
|
4.8%
6/126 • Adverse events data were collected from enrollment till the end of the study participation or death, whichever comes first, up to 42 months.
|
7.8%
10/128 • Adverse events data were collected from enrollment till the end of the study participation or death, whichever comes first, up to 42 months.
|
|
General disorders
Non-Cardiac Chest Pain
|
1.6%
2/126 • Adverse events data were collected from enrollment till the end of the study participation or death, whichever comes first, up to 42 months.
|
9.4%
12/128 • Adverse events data were collected from enrollment till the end of the study participation or death, whichever comes first, up to 42 months.
|
|
Nervous system disorders
Peripheral Neuropathy
|
15.1%
19/126 • Adverse events data were collected from enrollment till the end of the study participation or death, whichever comes first, up to 42 months.
|
9.4%
12/128 • Adverse events data were collected from enrollment till the end of the study participation or death, whichever comes first, up to 42 months.
|
|
Nervous system disorders
Hypoaesthesia
|
11.1%
14/126 • Adverse events data were collected from enrollment till the end of the study participation or death, whichever comes first, up to 42 months.
|
9.4%
12/128 • Adverse events data were collected from enrollment till the end of the study participation or death, whichever comes first, up to 42 months.
|
|
Nervous system disorders
Dizziness
|
10.3%
13/126 • Adverse events data were collected from enrollment till the end of the study participation or death, whichever comes first, up to 42 months.
|
14.1%
18/128 • Adverse events data were collected from enrollment till the end of the study participation or death, whichever comes first, up to 42 months.
|
|
Nervous system disorders
Headache
|
10.3%
13/126 • Adverse events data were collected from enrollment till the end of the study participation or death, whichever comes first, up to 42 months.
|
8.6%
11/128 • Adverse events data were collected from enrollment till the end of the study participation or death, whichever comes first, up to 42 months.
|
|
Infections and infestations
URTI
|
11.9%
15/126 • Adverse events data were collected from enrollment till the end of the study participation or death, whichever comes first, up to 42 months.
|
14.1%
18/128 • Adverse events data were collected from enrollment till the end of the study participation or death, whichever comes first, up to 42 months.
|
|
Infections and infestations
Pneumonia
|
9.5%
12/126 • Adverse events data were collected from enrollment till the end of the study participation or death, whichever comes first, up to 42 months.
|
8.6%
11/128 • Adverse events data were collected from enrollment till the end of the study participation or death, whichever comes first, up to 42 months.
|
|
Infections and infestations
Lung Infection
|
6.3%
8/126 • Adverse events data were collected from enrollment till the end of the study participation or death, whichever comes first, up to 42 months.
|
9.4%
12/128 • Adverse events data were collected from enrollment till the end of the study participation or death, whichever comes first, up to 42 months.
|
|
Infections and infestations
UTI
|
5.6%
7/126 • Adverse events data were collected from enrollment till the end of the study participation or death, whichever comes first, up to 42 months.
|
6.2%
8/128 • Adverse events data were collected from enrollment till the end of the study participation or death, whichever comes first, up to 42 months.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
9.5%
12/126 • Adverse events data were collected from enrollment till the end of the study participation or death, whichever comes first, up to 42 months.
|
3.9%
5/128 • Adverse events data were collected from enrollment till the end of the study participation or death, whichever comes first, up to 42 months.
|
|
Respiratory, thoracic and mediastinal disorders
Productive Cough
|
8.7%
11/126 • Adverse events data were collected from enrollment till the end of the study participation or death, whichever comes first, up to 42 months.
|
5.5%
7/128 • Adverse events data were collected from enrollment till the end of the study participation or death, whichever comes first, up to 42 months.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
7.9%
10/126 • Adverse events data were collected from enrollment till the end of the study participation or death, whichever comes first, up to 42 months.
|
8.6%
11/128 • Adverse events data were collected from enrollment till the end of the study participation or death, whichever comes first, up to 42 months.
|
|
Respiratory, thoracic and mediastinal disorders
ILD
|
7.1%
9/126 • Adverse events data were collected from enrollment till the end of the study participation or death, whichever comes first, up to 42 months.
|
5.5%
7/128 • Adverse events data were collected from enrollment till the end of the study participation or death, whichever comes first, up to 42 months.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonitis
|
7.1%
9/126 • Adverse events data were collected from enrollment till the end of the study participation or death, whichever comes first, up to 42 months.
|
2.3%
3/128 • Adverse events data were collected from enrollment till the end of the study participation or death, whichever comes first, up to 42 months.
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal Pain
|
6.3%
8/126 • Adverse events data were collected from enrollment till the end of the study participation or death, whichever comes first, up to 42 months.
|
2.3%
3/128 • Adverse events data were collected from enrollment till the end of the study participation or death, whichever comes first, up to 42 months.
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
27.8%
35/126 • Adverse events data were collected from enrollment till the end of the study participation or death, whichever comes first, up to 42 months.
|
33.6%
43/128 • Adverse events data were collected from enrollment till the end of the study participation or death, whichever comes first, up to 42 months.
|
|
Injury, poisoning and procedural complications
Infusion Related Reactions
|
22.2%
28/126 • Adverse events data were collected from enrollment till the end of the study participation or death, whichever comes first, up to 42 months.
|
21.9%
28/128 • Adverse events data were collected from enrollment till the end of the study participation or death, whichever comes first, up to 42 months.
|
|
Cardiac disorders
Sinus Tachycardia
|
11.1%
14/126 • Adverse events data were collected from enrollment till the end of the study participation or death, whichever comes first, up to 42 months.
|
3.9%
5/128 • Adverse events data were collected from enrollment till the end of the study participation or death, whichever comes first, up to 42 months.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
6.3%
8/126 • Adverse events data were collected from enrollment till the end of the study participation or death, whichever comes first, up to 42 months.
|
4.7%
6/128 • Adverse events data were collected from enrollment till the end of the study participation or death, whichever comes first, up to 42 months.
|
|
Musculoskeletal and connective tissue disorders
Pain in Extremity
|
6.3%
8/126 • Adverse events data were collected from enrollment till the end of the study participation or death, whichever comes first, up to 42 months.
|
3.9%
5/128 • Adverse events data were collected from enrollment till the end of the study participation or death, whichever comes first, up to 42 months.
|
|
Vascular disorders
Hypertension
|
5.6%
7/126 • Adverse events data were collected from enrollment till the end of the study participation or death, whichever comes first, up to 42 months.
|
8.6%
11/128 • Adverse events data were collected from enrollment till the end of the study participation or death, whichever comes first, up to 42 months.
|
|
Vascular disorders
Hypotension
|
5.6%
7/126 • Adverse events data were collected from enrollment till the end of the study participation or death, whichever comes first, up to 42 months.
|
3.1%
4/128 • Adverse events data were collected from enrollment till the end of the study participation or death, whichever comes first, up to 42 months.
|
|
Renal and urinary disorders
Chromaturia
|
7.1%
9/126 • Adverse events data were collected from enrollment till the end of the study participation or death, whichever comes first, up to 42 months.
|
0.00%
0/128 • Adverse events data were collected from enrollment till the end of the study participation or death, whichever comes first, up to 42 months.
|
|
Psychiatric disorders
Insomnia
|
12.7%
16/126 • Adverse events data were collected from enrollment till the end of the study participation or death, whichever comes first, up to 42 months.
|
18.8%
24/128 • Adverse events data were collected from enrollment till the end of the study participation or death, whichever comes first, up to 42 months.
|
Additional Information
Gracielli Hage-Kautz, Associate Director Clinical Operations
DeNovo Biopharma
Phone: 858-799-1021
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place