Trial Outcomes & Findings for Lenalidomide, Rituximab, and Combination Chemotherapy in Treating Patients With Newly Diagnosed Stage II, Stage III, or Stage IV Diffuse Large Cell or Follicular B-Cell Lymphoma (NCT NCT00670358)
NCT ID: NCT00670358
Last Updated: 2025-01-10
Results Overview
Recruitment status
COMPLETED
Study phase
PHASE1/PHASE2
Target enrollment
138 participants
Primary outcome timeframe
5 years
Results posted on
2025-01-10
Participant Flow
Participant milestones
| Measure |
Ph 1, DL 1
Phase 1, Dose Level 1 lenalidomide 15 mg
|
Ph1, DL 2
Phase 1, Dose Level 2 lenalidomide 20 mg
|
Ph1, DL 3
Phase 1, Dose Level 3 lenalidomide 25 mg
|
Ph II, DLBCL/Mixed
Phase 2, DLBCL/Mixed Dose Level 3 (accrued before 1/1/13)
|
Ph II, Transformed/Composite
Phase 2, Transformed/Composite
|
Ph II, Additional DLBCL
Phase 2, Additional DLBCL. Accrued after cutoff date
|
|---|---|---|---|---|---|---|
|
Overall Study
STARTED
|
3
|
3
|
6
|
77
|
39
|
10
|
|
Overall Study
COMPLETED
|
3
|
3
|
5
|
59
|
33
|
0
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
1
|
18
|
6
|
10
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Lenalidomide, Rituximab, and Combination Chemotherapy in Treating Patients With Newly Diagnosed Stage II, Stage III, or Stage IV Diffuse Large Cell or Follicular B-Cell Lymphoma
Baseline characteristics by cohort
| Measure |
Ph 1, DL 1
n=3 Participants
Phase 1, Dose Level 1
|
Ph1, DL 2
n=3 Participants
Phase 1, Dose Level 2
|
Ph1, DL 3
n=6 Participants
Phase 1, Dose Level 3
|
Ph II, DLBCL/Mixed
n=77 Participants
Phase 2, DLBCL/Mixed Dose Level 3 (accrued before 1/1/13)
|
Ph II, Transformed/Composite
n=39 Participants
Phase 2, Transformed/Composite
|
Ph II, Additional DLBCL
n=10 Participants
Phase 2, Additional DLBCL. Accrued after cutoff date
|
Total
n=138 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|---|
|
Age, Continuous
|
65.7 years
STANDARD_DEVIATION 16.26 • n=5 Participants
|
65.7 years
STANDARD_DEVIATION 14.36 • n=7 Participants
|
70.2 years
STANDARD_DEVIATION 11.18 • n=5 Participants
|
60.6 years
STANDARD_DEVIATION 15.99 • n=4 Participants
|
64.7 years
STANDARD_DEVIATION 11.38 • n=21 Participants
|
66.1 years
STANDARD_DEVIATION 13.10 • n=8 Participants
|
62.8 years
STANDARD_DEVIATION 14.1 • n=8 Participants
|
|
Sex: Female, Male
Female
|
1 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
29 Participants
n=4 Participants
|
18 Participants
n=21 Participants
|
4 Participants
n=8 Participants
|
56 Participants
n=8 Participants
|
|
Sex: Female, Male
Male
|
2 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
48 Participants
n=4 Participants
|
21 Participants
n=21 Participants
|
6 Participants
n=8 Participants
|
82 Participants
n=8 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
1 Participants
n=8 Participants
|
1 Participants
n=8 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
3 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
75 Participants
n=4 Participants
|
38 Participants
n=21 Participants
|
9 Participants
n=8 Participants
|
134 Participants
n=8 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
3 Participants
n=8 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=8 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
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
1 Participants
n=8 Participants
|
|
Race (NIH/OMB)
White
|
3 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
76 Participants
n=4 Participants
|
39 Participants
n=21 Participants
|
10 Participants
n=8 Participants
|
137 Participants
n=8 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
PRIMARY outcome
Timeframe: 5 yearsOutcome measures
| Measure |
Ph 1, DL 1
n=3 Participants
Phase 1, Dose Level 1
|
Ph1, DL 2
n=3 Participants
Phase 1, Dose Level 2
|
Ph1, DL 3
n=5 Participants
Phase 1, Dose Level 3
|
|---|---|---|---|
|
Toxicity as Assessed by NCI CTCAE v3.0 (Phase I)
Grade 3+ Adverse Event
|
3 Participants
|
3 Participants
|
5 Participants
|
|
Toxicity as Assessed by NCI CTCAE v3.0 (Phase I)
Grade 4+ Adverse Event
|
2 Participants
|
1 Participants
|
4 Participants
|
|
Toxicity as Assessed by NCI CTCAE v3.0 (Phase I)
Grade 3+ Hem Adverse Event
|
3 Participants
|
3 Participants
|
5 Participants
|
|
Toxicity as Assessed by NCI CTCAE v3.0 (Phase I)
Grade 4+ Hem Adverse Event
|
2 Participants
|
1 Participants
|
4 Participants
|
|
Toxicity as Assessed by NCI CTCAE v3.0 (Phase I)
Grade 3+ Non-Hem Adverse Event
|
1 Participants
|
1 Participants
|
2 Participants
|
PRIMARY outcome
Timeframe: 1 yearOther Phase II Cohorts were not evaluable for event-free survival analysis.
Outcome measures
| Measure |
Ph 1, DL 1
n=64 Participants
Phase 1, Dose Level 1
|
Ph1, DL 2
Phase 1, Dose Level 2
|
Ph1, DL 3
Phase 1, Dose Level 3
|
|---|---|---|---|
|
Event-free > Survival at 12 Months (Phase 2, DLBCL/Mixed Dose Level 3)
|
44 Participants
|
—
|
—
|
PRIMARY outcome
Timeframe: 2 yearsProgression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions Other Phase II Cohorts were not evaluable for progression-free survival analysis.
Outcome measures
| Measure |
Ph 1, DL 1
n=33 Participants
Phase 1, Dose Level 1
|
Ph1, DL 2
Phase 1, Dose Level 2
|
Ph1, DL 3
Phase 1, Dose Level 3
|
|---|---|---|---|
|
Progression-free > Survival at 24 Months (Phase 2, Transformed/Composite)
|
27 Participants
|
—
|
—
|
SECONDARY outcome
Timeframe: When all patients either have a CR or have completed observation.Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: When all patients either have a CR or have completed observation.Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 5 yearsOutcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 5 yearsOutcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 5 yearsOutcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 5 yearsOutcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 5 yearsOutcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 5 yearsOutcome measures
Outcome data not reported
Adverse Events
Ph 1, DL 1
Serious events: 2 serious events
Other events: 3 other events
Deaths: 0 deaths
Ph1, DL 2
Serious events: 1 serious events
Other events: 3 other events
Deaths: 0 deaths
Ph1, DL 3
Serious events: 2 serious events
Other events: 6 other events
Deaths: 0 deaths
Ph II, DLBCL/Mixed
Serious events: 26 serious events
Other events: 76 other events
Deaths: 1 deaths
Ph II, Transformed/Composite
Serious events: 15 serious events
Other events: 39 other events
Deaths: 0 deaths
Ph II, Additional DLBCL
Serious events: 7 serious events
Other events: 10 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Ph 1, DL 1
n=3 participants at risk
Phase 1, Dose Level 1
|
Ph1, DL 2
n=3 participants at risk
Phase 1, Dose Level 2
|
Ph1, DL 3
n=6 participants at risk
Phase 1, Dose Level 3
|
Ph II, DLBCL/Mixed
n=76 participants at risk
Phase 2, DLBCL/Mixed Dose Level 3 (accrued before 1/1/13)
|
Ph II, Transformed/Composite
n=39 participants at risk
Phase 2, Transformed/Composite
|
Ph II, Additional DLBCL
n=10 participants at risk
Phase 2, Additional DLBCL. Accrued after cutoff date
|
|---|---|---|---|---|---|---|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
0.00%
0/3 • 5 years
|
0.00%
0/3 • 5 years
|
0.00%
0/6 • 5 years
|
2.6%
2/76 • Number of events 2 • 5 years
|
17.9%
7/39 • Number of events 9 • 5 years
|
0.00%
0/10 • 5 years
|
|
Blood and lymphatic system disorders
Hemoglobin decreased
|
0.00%
0/3 • 5 years
|
0.00%
0/3 • 5 years
|
16.7%
1/6 • Number of events 1 • 5 years
|
2.6%
2/76 • Number of events 2 • 5 years
|
0.00%
0/39 • 5 years
|
10.0%
1/10 • Number of events 1 • 5 years
|
|
Cardiac disorders
Atrial fibrillation
|
0.00%
0/3 • 5 years
|
0.00%
0/3 • 5 years
|
0.00%
0/6 • 5 years
|
1.3%
1/76 • Number of events 1 • 5 years
|
0.00%
0/39 • 5 years
|
10.0%
1/10 • Number of events 1 • 5 years
|
|
Cardiac disorders
Cardiac disorder
|
0.00%
0/3 • 5 years
|
0.00%
0/3 • 5 years
|
0.00%
0/6 • 5 years
|
0.00%
0/76 • 5 years
|
0.00%
0/39 • 5 years
|
10.0%
1/10 • Number of events 1 • 5 years
|
|
Cardiac disorders
Left ventricular failure
|
0.00%
0/3 • 5 years
|
0.00%
0/3 • 5 years
|
0.00%
0/6 • 5 years
|
1.3%
1/76 • Number of events 1 • 5 years
|
0.00%
0/39 • 5 years
|
0.00%
0/10 • 5 years
|
|
Cardiac disorders
Myocardial ischemia
|
0.00%
0/3 • 5 years
|
0.00%
0/3 • 5 years
|
0.00%
0/6 • 5 years
|
1.3%
1/76 • Number of events 1 • 5 years
|
0.00%
0/39 • 5 years
|
0.00%
0/10 • 5 years
|
|
Cardiac disorders
Pericardial effusion
|
33.3%
1/3 • Number of events 1 • 5 years
|
0.00%
0/3 • 5 years
|
0.00%
0/6 • 5 years
|
0.00%
0/76 • 5 years
|
0.00%
0/39 • 5 years
|
0.00%
0/10 • 5 years
|
|
Cardiac disorders
Restrictive cardiomyopathy
|
0.00%
0/3 • 5 years
|
0.00%
0/3 • 5 years
|
0.00%
0/6 • 5 years
|
1.3%
1/76 • Number of events 1 • 5 years
|
0.00%
0/39 • 5 years
|
0.00%
0/10 • 5 years
|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/3 • 5 years
|
0.00%
0/3 • 5 years
|
0.00%
0/6 • 5 years
|
1.3%
1/76 • Number of events 1 • 5 years
|
2.6%
1/39 • Number of events 1 • 5 years
|
0.00%
0/10 • 5 years
|
|
Gastrointestinal disorders
Diarrhea
|
0.00%
0/3 • 5 years
|
0.00%
0/3 • 5 years
|
0.00%
0/6 • 5 years
|
1.3%
1/76 • Number of events 1 • 5 years
|
0.00%
0/39 • 5 years
|
0.00%
0/10 • 5 years
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/3 • 5 years
|
0.00%
0/3 • 5 years
|
0.00%
0/6 • 5 years
|
1.3%
1/76 • Number of events 1 • 5 years
|
0.00%
0/39 • 5 years
|
0.00%
0/10 • 5 years
|
|
Gastrointestinal disorders
Small intestinal obstruction
|
0.00%
0/3 • 5 years
|
0.00%
0/3 • 5 years
|
0.00%
0/6 • 5 years
|
1.3%
1/76 • Number of events 1 • 5 years
|
0.00%
0/39 • 5 years
|
0.00%
0/10 • 5 years
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/3 • 5 years
|
0.00%
0/3 • 5 years
|
0.00%
0/6 • 5 years
|
1.3%
1/76 • Number of events 1 • 5 years
|
0.00%
0/39 • 5 years
|
0.00%
0/10 • 5 years
|
|
General disorders
Chest pain
|
0.00%
0/3 • 5 years
|
0.00%
0/3 • 5 years
|
0.00%
0/6 • 5 years
|
2.6%
2/76 • Number of events 2 • 5 years
|
0.00%
0/39 • 5 years
|
0.00%
0/10 • 5 years
|
|
General disorders
Fatigue
|
0.00%
0/3 • 5 years
|
0.00%
0/3 • 5 years
|
0.00%
0/6 • 5 years
|
0.00%
0/76 • 5 years
|
0.00%
0/39 • 5 years
|
10.0%
1/10 • Number of events 1 • 5 years
|
|
General disorders
Fever
|
0.00%
0/3 • 5 years
|
0.00%
0/3 • 5 years
|
0.00%
0/6 • 5 years
|
2.6%
2/76 • Number of events 2 • 5 years
|
2.6%
1/39 • Number of events 1 • 5 years
|
0.00%
0/10 • 5 years
|
|
General disorders
Pain
|
0.00%
0/3 • 5 years
|
0.00%
0/3 • 5 years
|
0.00%
0/6 • 5 years
|
0.00%
0/76 • 5 years
|
2.6%
1/39 • Number of events 1 • 5 years
|
0.00%
0/10 • 5 years
|
|
Infections and infestations
Pneumonia(gr 0/1/2 ANC)
|
0.00%
0/3 • 5 years
|
0.00%
0/3 • 5 years
|
0.00%
0/6 • 5 years
|
1.3%
1/76 • Number of events 1 • 5 years
|
2.6%
1/39 • Number of events 1 • 5 years
|
0.00%
0/10 • 5 years
|
|
Infections and infestations
Pneumonia(gr 3/4 ANC)
|
0.00%
0/3 • 5 years
|
0.00%
0/3 • 5 years
|
0.00%
0/6 • 5 years
|
2.6%
2/76 • Number of events 2 • 5 years
|
2.6%
1/39 • Number of events 1 • 5 years
|
0.00%
0/10 • 5 years
|
|
Infections and infestations
Sepsis(gr 3/4 ANC)
|
0.00%
0/3 • 5 years
|
0.00%
0/3 • 5 years
|
0.00%
0/6 • 5 years
|
2.6%
2/76 • Number of events 2 • 5 years
|
2.6%
1/39 • Number of events 2 • 5 years
|
0.00%
0/10 • 5 years
|
|
Infections and infestations
Skin infection(gr 0/1/2 ANC)
|
0.00%
0/3 • 5 years
|
0.00%
0/3 • 5 years
|
0.00%
0/6 • 5 years
|
1.3%
1/76 • Number of events 1 • 5 years
|
0.00%
0/39 • 5 years
|
0.00%
0/10 • 5 years
|
|
Infections and infestations
Skin infection(gr 3/4 ANC)
|
0.00%
0/3 • 5 years
|
0.00%
0/3 • 5 years
|
0.00%
0/6 • 5 years
|
1.3%
1/76 • Number of events 1 • 5 years
|
2.6%
1/39 • Number of events 1 • 5 years
|
0.00%
0/10 • 5 years
|
|
Infections and infestations
Urinary tract infection(gr 3/4 ANC)
|
0.00%
0/3 • 5 years
|
0.00%
0/3 • 5 years
|
0.00%
0/6 • 5 years
|
1.3%
1/76 • Number of events 1 • 5 years
|
2.6%
1/39 • Number of events 1 • 5 years
|
0.00%
0/10 • 5 years
|
|
Investigations
Leukocyte count decreased
|
66.7%
2/3 • Number of events 3 • 5 years
|
33.3%
1/3 • Number of events 2 • 5 years
|
16.7%
1/6 • Number of events 1 • 5 years
|
10.5%
8/76 • Number of events 9 • 5 years
|
10.3%
4/39 • Number of events 4 • 5 years
|
20.0%
2/10 • Number of events 2 • 5 years
|
|
Investigations
Lymphocyte count decreased
|
0.00%
0/3 • 5 years
|
0.00%
0/3 • 5 years
|
0.00%
0/6 • 5 years
|
0.00%
0/76 • 5 years
|
2.6%
1/39 • Number of events 1 • 5 years
|
10.0%
1/10 • Number of events 1 • 5 years
|
|
Investigations
Neutrophil count decreased
|
66.7%
2/3 • Number of events 3 • 5 years
|
33.3%
1/3 • Number of events 3 • 5 years
|
0.00%
0/6 • 5 years
|
14.5%
11/76 • Number of events 18 • 5 years
|
10.3%
4/39 • Number of events 4 • 5 years
|
70.0%
7/10 • Number of events 10 • 5 years
|
|
Investigations
Platelet count decreased
|
0.00%
0/3 • 5 years
|
0.00%
0/3 • 5 years
|
0.00%
0/6 • 5 years
|
5.3%
4/76 • Number of events 5 • 5 years
|
0.00%
0/39 • 5 years
|
10.0%
1/10 • Number of events 1 • 5 years
|
|
Metabolism and nutrition disorders
Blood glucose increased
|
0.00%
0/3 • 5 years
|
0.00%
0/3 • 5 years
|
0.00%
0/6 • 5 years
|
0.00%
0/76 • 5 years
|
2.6%
1/39 • Number of events 1 • 5 years
|
0.00%
0/10 • 5 years
|
|
Metabolism and nutrition disorders
Dehydration
|
0.00%
0/3 • 5 years
|
0.00%
0/3 • 5 years
|
0.00%
0/6 • 5 years
|
0.00%
0/76 • 5 years
|
2.6%
1/39 • Number of events 1 • 5 years
|
0.00%
0/10 • 5 years
|
|
Metabolism and nutrition disorders
Serum potassium decreased
|
0.00%
0/3 • 5 years
|
0.00%
0/3 • 5 years
|
0.00%
0/6 • 5 years
|
0.00%
0/76 • 5 years
|
2.6%
1/39 • Number of events 1 • 5 years
|
0.00%
0/10 • 5 years
|
|
Musculoskeletal and connective tissue disorders
Arthritis
|
0.00%
0/3 • 5 years
|
0.00%
0/3 • 5 years
|
0.00%
0/6 • 5 years
|
0.00%
0/76 • 5 years
|
2.6%
1/39 • Number of events 1 • 5 years
|
0.00%
0/10 • 5 years
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.00%
0/3 • 5 years
|
0.00%
0/3 • 5 years
|
0.00%
0/6 • 5 years
|
0.00%
0/76 • 5 years
|
2.6%
1/39 • Number of events 1 • 5 years
|
0.00%
0/10 • 5 years
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
0.00%
0/3 • 5 years
|
0.00%
0/3 • 5 years
|
0.00%
0/6 • 5 years
|
0.00%
0/76 • 5 years
|
0.00%
0/39 • 5 years
|
10.0%
1/10 • Number of events 1 • 5 years
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
0.00%
0/3 • 5 years
|
0.00%
0/3 • 5 years
|
0.00%
0/6 • 5 years
|
0.00%
0/76 • 5 years
|
0.00%
0/39 • 5 years
|
10.0%
1/10 • Number of events 1 • 5 years
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
33.3%
1/3 • Number of events 1 • 5 years
|
0.00%
0/3 • 5 years
|
0.00%
0/6 • 5 years
|
0.00%
0/76 • 5 years
|
0.00%
0/39 • 5 years
|
0.00%
0/10 • 5 years
|
|
Vascular disorders
Thrombosis
|
0.00%
0/3 • 5 years
|
0.00%
0/3 • 5 years
|
0.00%
0/6 • 5 years
|
1.3%
1/76 • Number of events 1 • 5 years
|
5.1%
2/39 • Number of events 2 • 5 years
|
0.00%
0/10 • 5 years
|
|
Vascular disorders
Vascular disorder
|
0.00%
0/3 • 5 years
|
0.00%
0/3 • 5 years
|
0.00%
0/6 • 5 years
|
1.3%
1/76 • Number of events 1 • 5 years
|
0.00%
0/39 • 5 years
|
0.00%
0/10 • 5 years
|
Other adverse events
| Measure |
Ph 1, DL 1
n=3 participants at risk
Phase 1, Dose Level 1
|
Ph1, DL 2
n=3 participants at risk
Phase 1, Dose Level 2
|
Ph1, DL 3
n=6 participants at risk
Phase 1, Dose Level 3
|
Ph II, DLBCL/Mixed
n=76 participants at risk
Phase 2, DLBCL/Mixed Dose Level 3 (accrued before 1/1/13)
|
Ph II, Transformed/Composite
n=39 participants at risk
Phase 2, Transformed/Composite
|
Ph II, Additional DLBCL
n=10 participants at risk
Phase 2, Additional DLBCL. Accrued after cutoff date
|
|---|---|---|---|---|---|---|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
0.00%
0/3 • 5 years
|
0.00%
0/3 • 5 years
|
0.00%
0/6 • 5 years
|
7.9%
6/76 • Number of events 6 • 5 years
|
7.7%
3/39 • Number of events 5 • 5 years
|
0.00%
0/10 • 5 years
|
|
Blood and lymphatic system disorders
Hemoglobin decreased
|
100.0%
3/3 • Number of events 22 • 5 years
|
100.0%
3/3 • Number of events 20 • 5 years
|
100.0%
6/6 • Number of events 40 • 5 years
|
98.7%
75/76 • Number of events 434 • 5 years
|
100.0%
39/39 • Number of events 260 • 5 years
|
100.0%
10/10 • Number of events 72 • 5 years
|
|
Cardiac disorders
Atrial tachycardia
|
0.00%
0/3 • 5 years
|
0.00%
0/3 • 5 years
|
0.00%
0/6 • 5 years
|
1.3%
1/76 • Number of events 1 • 5 years
|
0.00%
0/39 • 5 years
|
0.00%
0/10 • 5 years
|
|
Cardiac disorders
Left ventricular dysfunction
|
0.00%
0/3 • 5 years
|
0.00%
0/3 • 5 years
|
0.00%
0/6 • 5 years
|
1.3%
1/76 • Number of events 1 • 5 years
|
0.00%
0/39 • 5 years
|
0.00%
0/10 • 5 years
|
|
Cardiac disorders
Myocardial ischemia
|
0.00%
0/3 • 5 years
|
0.00%
0/3 • 5 years
|
0.00%
0/6 • 5 years
|
0.00%
0/76 • 5 years
|
2.6%
1/39 • Number of events 1 • 5 years
|
0.00%
0/10 • 5 years
|
|
Cardiac disorders
Restrictive cardiomyopathy
|
0.00%
0/3 • 5 years
|
0.00%
0/3 • 5 years
|
0.00%
0/6 • 5 years
|
1.3%
1/76 • Number of events 8 • 5 years
|
0.00%
0/39 • 5 years
|
0.00%
0/10 • 5 years
|
|
Cardiac disorders
Sinus tachycardia
|
0.00%
0/3 • 5 years
|
0.00%
0/3 • 5 years
|
0.00%
0/6 • 5 years
|
1.3%
1/76 • Number of events 1 • 5 years
|
0.00%
0/39 • 5 years
|
0.00%
0/10 • 5 years
|
|
Ear and labyrinth disorders
Hearing loss
|
0.00%
0/3 • 5 years
|
0.00%
0/3 • 5 years
|
0.00%
0/6 • 5 years
|
0.00%
0/76 • 5 years
|
0.00%
0/39 • 5 years
|
10.0%
1/10 • Number of events 7 • 5 years
|
|
Eye disorders
Cataract
|
0.00%
0/3 • 5 years
|
0.00%
0/3 • 5 years
|
0.00%
0/6 • 5 years
|
0.00%
0/76 • 5 years
|
2.6%
1/39 • Number of events 1 • 5 years
|
0.00%
0/10 • 5 years
|
|
Eye disorders
Vision blurred
|
0.00%
0/3 • 5 years
|
0.00%
0/3 • 5 years
|
0.00%
0/6 • 5 years
|
1.3%
1/76 • Number of events 4 • 5 years
|
0.00%
0/39 • 5 years
|
0.00%
0/10 • 5 years
|
|
Gastrointestinal disorders
Abdominal distension
|
0.00%
0/3 • 5 years
|
0.00%
0/3 • 5 years
|
0.00%
0/6 • 5 years
|
2.6%
2/76 • Number of events 3 • 5 years
|
0.00%
0/39 • 5 years
|
0.00%
0/10 • 5 years
|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/3 • 5 years
|
0.00%
0/3 • 5 years
|
0.00%
0/6 • 5 years
|
5.3%
4/76 • Number of events 6 • 5 years
|
0.00%
0/39 • 5 years
|
0.00%
0/10 • 5 years
|
|
Gastrointestinal disorders
Colonic obstruction
|
0.00%
0/3 • 5 years
|
0.00%
0/3 • 5 years
|
0.00%
0/6 • 5 years
|
1.3%
1/76 • Number of events 1 • 5 years
|
0.00%
0/39 • 5 years
|
0.00%
0/10 • 5 years
|
|
Gastrointestinal disorders
Constipation
|
0.00%
0/3 • 5 years
|
0.00%
0/3 • 5 years
|
0.00%
0/6 • 5 years
|
10.5%
8/76 • Number of events 10 • 5 years
|
7.7%
3/39 • Number of events 5 • 5 years
|
10.0%
1/10 • Number of events 1 • 5 years
|
|
Gastrointestinal disorders
Diarrhea
|
0.00%
0/3 • 5 years
|
0.00%
0/3 • 5 years
|
16.7%
1/6 • Number of events 1 • 5 years
|
5.3%
4/76 • Number of events 4 • 5 years
|
5.1%
2/39 • Number of events 2 • 5 years
|
0.00%
0/10 • 5 years
|
|
Gastrointestinal disorders
Dry mouth
|
0.00%
0/3 • 5 years
|
0.00%
0/3 • 5 years
|
0.00%
0/6 • 5 years
|
1.3%
1/76 • Number of events 3 • 5 years
|
0.00%
0/39 • 5 years
|
0.00%
0/10 • 5 years
|
|
Gastrointestinal disorders
Dyspepsia
|
0.00%
0/3 • 5 years
|
0.00%
0/3 • 5 years
|
0.00%
0/6 • 5 years
|
1.3%
1/76 • Number of events 1 • 5 years
|
2.6%
1/39 • Number of events 1 • 5 years
|
0.00%
0/10 • 5 years
|
|
Gastrointestinal disorders
Esophagitis
|
0.00%
0/3 • 5 years
|
0.00%
0/3 • 5 years
|
0.00%
0/6 • 5 years
|
1.3%
1/76 • Number of events 1 • 5 years
|
0.00%
0/39 • 5 years
|
0.00%
0/10 • 5 years
|
|
Gastrointestinal disorders
Gastric mucositis (clin exam)
|
0.00%
0/3 • 5 years
|
0.00%
0/3 • 5 years
|
0.00%
0/6 • 5 years
|
1.3%
1/76 • Number of events 1 • 5 years
|
0.00%
0/39 • 5 years
|
0.00%
0/10 • 5 years
|
|
Gastrointestinal disorders
Gastric mucositis (funct/sympt)
|
0.00%
0/3 • 5 years
|
0.00%
0/3 • 5 years
|
0.00%
0/6 • 5 years
|
0.00%
0/76 • 5 years
|
7.7%
3/39 • Number of events 6 • 5 years
|
0.00%
0/10 • 5 years
|
|
Gastrointestinal disorders
Gastritis
|
0.00%
0/3 • 5 years
|
0.00%
0/3 • 5 years
|
0.00%
0/6 • 5 years
|
0.00%
0/76 • 5 years
|
2.6%
1/39 • Number of events 2 • 5 years
|
0.00%
0/10 • 5 years
|
|
Gastrointestinal disorders
Gastrointestinal disorder
|
0.00%
0/3 • 5 years
|
0.00%
0/3 • 5 years
|
0.00%
0/6 • 5 years
|
0.00%
0/76 • 5 years
|
5.1%
2/39 • Number of events 2 • 5 years
|
0.00%
0/10 • 5 years
|
|
Gastrointestinal disorders
Intra-abdominal hemorrhage
|
0.00%
0/3 • 5 years
|
0.00%
0/3 • 5 years
|
0.00%
0/6 • 5 years
|
1.3%
1/76 • Number of events 1 • 5 years
|
0.00%
0/39 • 5 years
|
0.00%
0/10 • 5 years
|
|
Gastrointestinal disorders
Mucositis oral
|
33.3%
1/3 • Number of events 1 • 5 years
|
33.3%
1/3 • Number of events 1 • 5 years
|
0.00%
0/6 • 5 years
|
3.9%
3/76 • Number of events 4 • 5 years
|
5.1%
2/39 • Number of events 2 • 5 years
|
0.00%
0/10 • 5 years
|
|
Gastrointestinal disorders
Mucositis oral (clin exam)
|
0.00%
0/3 • 5 years
|
0.00%
0/3 • 5 years
|
0.00%
0/6 • 5 years
|
2.6%
2/76 • Number of events 5 • 5 years
|
5.1%
2/39 • Number of events 2 • 5 years
|
0.00%
0/10 • 5 years
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/3 • 5 years
|
33.3%
1/3 • Number of events 1 • 5 years
|
16.7%
1/6 • Number of events 1 • 5 years
|
13.2%
10/76 • Number of events 16 • 5 years
|
12.8%
5/39 • Number of events 5 • 5 years
|
0.00%
0/10 • 5 years
|
|
Gastrointestinal disorders
Small intestinal mucositis
|
0.00%
0/3 • 5 years
|
0.00%
0/3 • 5 years
|
0.00%
0/6 • 5 years
|
1.3%
1/76 • Number of events 1 • 5 years
|
0.00%
0/39 • 5 years
|
0.00%
0/10 • 5 years
|
|
Gastrointestinal disorders
Small intestinal obstruction
|
0.00%
0/3 • 5 years
|
0.00%
0/3 • 5 years
|
0.00%
0/6 • 5 years
|
1.3%
1/76 • Number of events 1 • 5 years
|
0.00%
0/39 • 5 years
|
0.00%
0/10 • 5 years
|
|
Gastrointestinal disorders
Tooth disorder
|
0.00%
0/3 • 5 years
|
0.00%
0/3 • 5 years
|
0.00%
0/6 • 5 years
|
0.00%
0/76 • 5 years
|
2.6%
1/39 • Number of events 1 • 5 years
|
0.00%
0/10 • 5 years
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/3 • 5 years
|
0.00%
0/3 • 5 years
|
16.7%
1/6 • Number of events 1 • 5 years
|
7.9%
6/76 • Number of events 9 • 5 years
|
0.00%
0/39 • 5 years
|
0.00%
0/10 • 5 years
|
|
General disorders
Edema limbs
|
0.00%
0/3 • 5 years
|
0.00%
0/3 • 5 years
|
0.00%
0/6 • 5 years
|
1.3%
1/76 • Number of events 2 • 5 years
|
2.6%
1/39 • Number of events 1 • 5 years
|
0.00%
0/10 • 5 years
|
|
General disorders
Fatigue
|
33.3%
1/3 • Number of events 1 • 5 years
|
0.00%
0/3 • 5 years
|
0.00%
0/6 • 5 years
|
26.3%
20/76 • Number of events 45 • 5 years
|
25.6%
10/39 • Number of events 26 • 5 years
|
10.0%
1/10 • Number of events 1 • 5 years
|
|
General disorders
Fever
|
0.00%
0/3 • 5 years
|
0.00%
0/3 • 5 years
|
0.00%
0/6 • 5 years
|
0.00%
0/76 • 5 years
|
0.00%
0/39 • 5 years
|
10.0%
1/10 • Number of events 1 • 5 years
|
|
General disorders
Pain
|
0.00%
0/3 • 5 years
|
0.00%
0/3 • 5 years
|
0.00%
0/6 • 5 years
|
1.3%
1/76 • Number of events 1 • 5 years
|
0.00%
0/39 • 5 years
|
0.00%
0/10 • 5 years
|
|
Immune system disorders
Cytokine release syndrome
|
0.00%
0/3 • 5 years
|
33.3%
1/3 • Number of events 1 • 5 years
|
0.00%
0/6 • 5 years
|
1.3%
1/76 • Number of events 1 • 5 years
|
0.00%
0/39 • 5 years
|
0.00%
0/10 • 5 years
|
|
Immune system disorders
Hypersensitivity
|
0.00%
0/3 • 5 years
|
0.00%
0/3 • 5 years
|
0.00%
0/6 • 5 years
|
0.00%
0/76 • 5 years
|
0.00%
0/39 • 5 years
|
10.0%
1/10 • Number of events 2 • 5 years
|
|
Infections and infestations
Bladder infection(gr 3/4 ANC)
|
0.00%
0/3 • 5 years
|
0.00%
0/3 • 5 years
|
0.00%
0/6 • 5 years
|
1.3%
1/76 • Number of events 2 • 5 years
|
0.00%
0/39 • 5 years
|
0.00%
0/10 • 5 years
|
|
Infections and infestations
Colitis, infectious
|
0.00%
0/3 • 5 years
|
0.00%
0/3 • 5 years
|
0.00%
0/6 • 5 years
|
1.3%
1/76 • Number of events 1 • 5 years
|
2.6%
1/39 • Number of events 1 • 5 years
|
0.00%
0/10 • 5 years
|
|
Infections and infestations
Infection(gr 0/1/2 ANC)
|
0.00%
0/3 • 5 years
|
0.00%
0/3 • 5 years
|
0.00%
0/6 • 5 years
|
0.00%
0/76 • 5 years
|
5.1%
2/39 • Number of events 3 • 5 years
|
0.00%
0/10 • 5 years
|
|
Infections and infestations
Kidney infection(gr 0/1/2 ANC)
|
0.00%
0/3 • 5 years
|
0.00%
0/3 • 5 years
|
0.00%
0/6 • 5 years
|
0.00%
0/76 • 5 years
|
2.6%
1/39 • Number of events 1 • 5 years
|
0.00%
0/10 • 5 years
|
|
Infections and infestations
Lip infection(gr 3/4 ANC)
|
0.00%
0/3 • 5 years
|
0.00%
0/3 • 5 years
|
16.7%
1/6 • Number of events 1 • 5 years
|
0.00%
0/76 • 5 years
|
0.00%
0/39 • 5 years
|
0.00%
0/10 • 5 years
|
|
Infections and infestations
Otitis media(gr 0/1/2 ANC)
|
0.00%
0/3 • 5 years
|
33.3%
1/3 • Number of events 1 • 5 years
|
0.00%
0/6 • 5 years
|
0.00%
0/76 • 5 years
|
0.00%
0/39 • 5 years
|
0.00%
0/10 • 5 years
|
|
Infections and infestations
Peripheral nerve infection(gr 0/1/2 ANC)
|
0.00%
0/3 • 5 years
|
0.00%
0/3 • 5 years
|
0.00%
0/6 • 5 years
|
0.00%
0/76 • 5 years
|
5.1%
2/39 • Number of events 2 • 5 years
|
0.00%
0/10 • 5 years
|
|
Infections and infestations
Peripheral nerve infection(gr 3/4 ANC)
|
0.00%
0/3 • 5 years
|
0.00%
0/3 • 5 years
|
0.00%
0/6 • 5 years
|
0.00%
0/76 • 5 years
|
2.6%
1/39 • Number of events 1 • 5 years
|
0.00%
0/10 • 5 years
|
|
Infections and infestations
Pneumonia(gr 0/1/2 ANC)
|
0.00%
0/3 • 5 years
|
0.00%
0/3 • 5 years
|
0.00%
0/6 • 5 years
|
1.3%
1/76 • Number of events 1 • 5 years
|
0.00%
0/39 • 5 years
|
0.00%
0/10 • 5 years
|
|
Infections and infestations
Pneumonia(gr 3/4 ANC)
|
0.00%
0/3 • 5 years
|
0.00%
0/3 • 5 years
|
0.00%
0/6 • 5 years
|
0.00%
0/76 • 5 years
|
5.1%
2/39 • Number of events 2 • 5 years
|
0.00%
0/10 • 5 years
|
|
Infections and infestations
Sepsis(gr 3/4 ANC)
|
0.00%
0/3 • 5 years
|
0.00%
0/3 • 5 years
|
0.00%
0/6 • 5 years
|
0.00%
0/76 • 5 years
|
2.6%
1/39 • Number of events 1 • 5 years
|
0.00%
0/10 • 5 years
|
|
Infections and infestations
Sinusitis
|
0.00%
0/3 • 5 years
|
0.00%
0/3 • 5 years
|
0.00%
0/6 • 5 years
|
1.3%
1/76 • Number of events 1 • 5 years
|
0.00%
0/39 • 5 years
|
0.00%
0/10 • 5 years
|
|
Infections and infestations
Sinusitis(gr 0/1/2 ANC)
|
0.00%
0/3 • 5 years
|
0.00%
0/3 • 5 years
|
0.00%
0/6 • 5 years
|
1.3%
1/76 • Number of events 1 • 5 years
|
7.7%
3/39 • Number of events 5 • 5 years
|
0.00%
0/10 • 5 years
|
|
Infections and infestations
Sinusitis(gr 3/4 ANC)
|
0.00%
0/3 • 5 years
|
0.00%
0/3 • 5 years
|
0.00%
0/6 • 5 years
|
1.3%
1/76 • Number of events 1 • 5 years
|
2.6%
1/39 • Number of events 1 • 5 years
|
0.00%
0/10 • 5 years
|
|
Infections and infestations
Skin infection(gr 0/1/2 ANC)
|
0.00%
0/3 • 5 years
|
0.00%
0/3 • 5 years
|
16.7%
1/6 • Number of events 1 • 5 years
|
3.9%
3/76 • Number of events 3 • 5 years
|
2.6%
1/39 • Number of events 1 • 5 years
|
0.00%
0/10 • 5 years
|
|
Infections and infestations
Skin infection(gr 3/4 ANC)
|
0.00%
0/3 • 5 years
|
0.00%
0/3 • 5 years
|
0.00%
0/6 • 5 years
|
2.6%
2/76 • Number of events 2 • 5 years
|
0.00%
0/39 • 5 years
|
0.00%
0/10 • 5 years
|
|
Infections and infestations
Tooth infection(gr 0/1/2 ANC)
|
0.00%
0/3 • 5 years
|
0.00%
0/3 • 5 years
|
0.00%
0/6 • 5 years
|
0.00%
0/76 • 5 years
|
5.1%
2/39 • Number of events 2 • 5 years
|
0.00%
0/10 • 5 years
|
|
Infections and infestations
Tooth infection(gr 3/4 ANC)
|
0.00%
0/3 • 5 years
|
0.00%
0/3 • 5 years
|
0.00%
0/6 • 5 years
|
0.00%
0/76 • 5 years
|
2.6%
1/39 • Number of events 2 • 5 years
|
0.00%
0/10 • 5 years
|
|
Infections and infestations
Upper respiratory infection(gr 3/4 ANC)
|
0.00%
0/3 • 5 years
|
0.00%
0/3 • 5 years
|
16.7%
1/6 • Number of events 1 • 5 years
|
2.6%
2/76 • Number of events 3 • 5 years
|
5.1%
2/39 • Number of events 2 • 5 years
|
0.00%
0/10 • 5 years
|
|
Infections and infestations
Upper respiratory infectn(gr 0/1/2 ANC)
|
0.00%
0/3 • 5 years
|
0.00%
0/3 • 5 years
|
0.00%
0/6 • 5 years
|
1.3%
1/76 • Number of events 1 • 5 years
|
0.00%
0/39 • 5 years
|
0.00%
0/10 • 5 years
|
|
Infections and infestations
Urinary tract infection(gr 0/1/2 ANC)
|
0.00%
0/3 • 5 years
|
33.3%
1/3 • Number of events 1 • 5 years
|
0.00%
0/6 • 5 years
|
0.00%
0/76 • 5 years
|
2.6%
1/39 • Number of events 1 • 5 years
|
0.00%
0/10 • 5 years
|
|
Infections and infestations
Urinary tract infection(gr 3/4 ANC)
|
0.00%
0/3 • 5 years
|
0.00%
0/3 • 5 years
|
0.00%
0/6 • 5 years
|
2.6%
2/76 • Number of events 2 • 5 years
|
2.6%
1/39 • Number of events 2 • 5 years
|
0.00%
0/10 • 5 years
|
|
Infections and infestations
Vaginal infection(gr 3/4 ANC)
|
0.00%
0/3 • 5 years
|
0.00%
0/3 • 5 years
|
0.00%
0/6 • 5 years
|
0.00%
0/76 • 5 years
|
2.6%
1/39 • Number of events 1 • 5 years
|
0.00%
0/10 • 5 years
|
|
Infections and infestations
Wound infection(gr 3/4 ANC)
|
0.00%
0/3 • 5 years
|
0.00%
0/3 • 5 years
|
0.00%
0/6 • 5 years
|
0.00%
0/76 • 5 years
|
2.6%
1/39 • Number of events 1 • 5 years
|
0.00%
0/10 • 5 years
|
|
Injury, poisoning and procedural complications
Fracture
|
0.00%
0/3 • 5 years
|
0.00%
0/3 • 5 years
|
0.00%
0/6 • 5 years
|
0.00%
0/76 • 5 years
|
2.6%
1/39 • Number of events 1 • 5 years
|
10.0%
1/10 • Number of events 1 • 5 years
|
|
Injury, poisoning and procedural complications
Intraop. inj. - Colon
|
0.00%
0/3 • 5 years
|
0.00%
0/3 • 5 years
|
0.00%
0/6 • 5 years
|
1.3%
1/76 • Number of events 2 • 5 years
|
0.00%
0/39 • 5 years
|
0.00%
0/10 • 5 years
|
|
Injury, poisoning and procedural complications
Vascular access complication
|
0.00%
0/3 • 5 years
|
33.3%
1/3 • Number of events 1 • 5 years
|
16.7%
1/6 • Number of events 1 • 5 years
|
2.6%
2/76 • Number of events 2 • 5 years
|
0.00%
0/39 • 5 years
|
0.00%
0/10 • 5 years
|
|
Investigations
Alanine aminotransferase increased
|
0.00%
0/3 • 5 years
|
0.00%
0/3 • 5 years
|
0.00%
0/6 • 5 years
|
1.3%
1/76 • Number of events 1 • 5 years
|
0.00%
0/39 • 5 years
|
0.00%
0/10 • 5 years
|
|
Investigations
Alkaline phosphatase increased
|
0.00%
0/3 • 5 years
|
0.00%
0/3 • 5 years
|
0.00%
0/6 • 5 years
|
1.3%
1/76 • Number of events 1 • 5 years
|
0.00%
0/39 • 5 years
|
0.00%
0/10 • 5 years
|
|
Investigations
Aspartate aminotransferase increased
|
0.00%
0/3 • 5 years
|
0.00%
0/3 • 5 years
|
16.7%
1/6 • Number of events 1 • 5 years
|
1.3%
1/76 • Number of events 1 • 5 years
|
2.6%
1/39 • Number of events 1 • 5 years
|
0.00%
0/10 • 5 years
|
|
Investigations
Bilirubin increased
|
0.00%
0/3 • 5 years
|
0.00%
0/3 • 5 years
|
0.00%
0/6 • 5 years
|
0.00%
0/76 • 5 years
|
2.6%
1/39 • Number of events 4 • 5 years
|
0.00%
0/10 • 5 years
|
|
Investigations
CD4 lymphocytes decreased
|
0.00%
0/3 • 5 years
|
0.00%
0/3 • 5 years
|
0.00%
0/6 • 5 years
|
0.00%
0/76 • 5 years
|
2.6%
1/39 • Number of events 1 • 5 years
|
0.00%
0/10 • 5 years
|
|
Investigations
Creatinine increased
|
0.00%
0/3 • 5 years
|
0.00%
0/3 • 5 years
|
0.00%
0/6 • 5 years
|
1.3%
1/76 • Number of events 1 • 5 years
|
0.00%
0/39 • 5 years
|
0.00%
0/10 • 5 years
|
|
Investigations
Leukocyte count decreased
|
100.0%
3/3 • Number of events 10 • 5 years
|
100.0%
3/3 • Number of events 13 • 5 years
|
100.0%
6/6 • Number of events 27 • 5 years
|
97.4%
74/76 • Number of events 357 • 5 years
|
97.4%
38/39 • Number of events 200 • 5 years
|
100.0%
10/10 • Number of events 47 • 5 years
|
|
Investigations
Lymphocyte count decreased
|
0.00%
0/3 • 5 years
|
0.00%
0/3 • 5 years
|
0.00%
0/6 • 5 years
|
1.3%
1/76 • Number of events 5 • 5 years
|
84.6%
33/39 • Number of events 174 • 5 years
|
30.0%
3/10 • Number of events 7 • 5 years
|
|
Investigations
Neutrophil count decreased
|
100.0%
3/3 • Number of events 8 • 5 years
|
100.0%
3/3 • Number of events 10 • 5 years
|
100.0%
6/6 • Number of events 25 • 5 years
|
93.4%
71/76 • Number of events 318 • 5 years
|
92.3%
36/39 • Number of events 176 • 5 years
|
90.0%
9/10 • Number of events 36 • 5 years
|
|
Investigations
Platelet count decreased
|
100.0%
3/3 • Number of events 15 • 5 years
|
100.0%
3/3 • Number of events 14 • 5 years
|
100.0%
6/6 • Number of events 27 • 5 years
|
92.1%
70/76 • Number of events 318 • 5 years
|
97.4%
38/39 • Number of events 196 • 5 years
|
90.0%
9/10 • Number of events 50 • 5 years
|
|
Investigations
Weight gain
|
0.00%
0/3 • 5 years
|
0.00%
0/3 • 5 years
|
0.00%
0/6 • 5 years
|
1.3%
1/76 • Number of events 3 • 5 years
|
0.00%
0/39 • 5 years
|
0.00%
0/10 • 5 years
|
|
Investigations
Weight loss
|
0.00%
0/3 • 5 years
|
0.00%
0/3 • 5 years
|
0.00%
0/6 • 5 years
|
3.9%
3/76 • Number of events 10 • 5 years
|
2.6%
1/39 • Number of events 1 • 5 years
|
0.00%
0/10 • 5 years
|
|
Metabolism and nutrition disorders
Anorexia
|
0.00%
0/3 • 5 years
|
0.00%
0/3 • 5 years
|
0.00%
0/6 • 5 years
|
6.6%
5/76 • Number of events 8 • 5 years
|
0.00%
0/39 • 5 years
|
10.0%
1/10 • Number of events 2 • 5 years
|
|
Metabolism and nutrition disorders
Blood glucose increased
|
0.00%
0/3 • 5 years
|
0.00%
0/3 • 5 years
|
0.00%
0/6 • 5 years
|
1.3%
1/76 • Number of events 1 • 5 years
|
7.7%
3/39 • Number of events 3 • 5 years
|
0.00%
0/10 • 5 years
|
|
Metabolism and nutrition disorders
Dehydration
|
0.00%
0/3 • 5 years
|
0.00%
0/3 • 5 years
|
0.00%
0/6 • 5 years
|
6.6%
5/76 • Number of events 7 • 5 years
|
7.7%
3/39 • Number of events 7 • 5 years
|
20.0%
2/10 • Number of events 2 • 5 years
|
|
Metabolism and nutrition disorders
Serum albumin decreased
|
0.00%
0/3 • 5 years
|
0.00%
0/3 • 5 years
|
0.00%
0/6 • 5 years
|
1.3%
1/76 • Number of events 1 • 5 years
|
0.00%
0/39 • 5 years
|
0.00%
0/10 • 5 years
|
|
Metabolism and nutrition disorders
Serum calcium decreased
|
0.00%
0/3 • 5 years
|
0.00%
0/3 • 5 years
|
0.00%
0/6 • 5 years
|
3.9%
3/76 • Number of events 3 • 5 years
|
0.00%
0/39 • 5 years
|
0.00%
0/10 • 5 years
|
|
Metabolism and nutrition disorders
Serum calcium increased
|
0.00%
0/3 • 5 years
|
0.00%
0/3 • 5 years
|
0.00%
0/6 • 5 years
|
1.3%
1/76 • Number of events 1 • 5 years
|
0.00%
0/39 • 5 years
|
0.00%
0/10 • 5 years
|
|
Metabolism and nutrition disorders
Serum magnesium increased
|
0.00%
0/3 • 5 years
|
0.00%
0/3 • 5 years
|
0.00%
0/6 • 5 years
|
0.00%
0/76 • 5 years
|
2.6%
1/39 • Number of events 1 • 5 years
|
0.00%
0/10 • 5 years
|
|
Metabolism and nutrition disorders
Serum phosphate decreased
|
0.00%
0/3 • 5 years
|
0.00%
0/3 • 5 years
|
0.00%
0/6 • 5 years
|
1.3%
1/76 • Number of events 1 • 5 years
|
2.6%
1/39 • Number of events 1 • 5 years
|
0.00%
0/10 • 5 years
|
|
Metabolism and nutrition disorders
Serum potassium decreased
|
0.00%
0/3 • 5 years
|
0.00%
0/3 • 5 years
|
0.00%
0/6 • 5 years
|
3.9%
3/76 • Number of events 5 • 5 years
|
5.1%
2/39 • Number of events 3 • 5 years
|
0.00%
0/10 • 5 years
|
|
Metabolism and nutrition disorders
Serum potassium increased
|
0.00%
0/3 • 5 years
|
0.00%
0/3 • 5 years
|
0.00%
0/6 • 5 years
|
1.3%
1/76 • Number of events 2 • 5 years
|
2.6%
1/39 • Number of events 1 • 5 years
|
0.00%
0/10 • 5 years
|
|
Metabolism and nutrition disorders
Serum sodium decreased
|
0.00%
0/3 • 5 years
|
0.00%
0/3 • 5 years
|
0.00%
0/6 • 5 years
|
2.6%
2/76 • Number of events 3 • 5 years
|
0.00%
0/39 • 5 years
|
0.00%
0/10 • 5 years
|
|
Metabolism and nutrition disorders
Serum sodium increased
|
0.00%
0/3 • 5 years
|
0.00%
0/3 • 5 years
|
0.00%
0/6 • 5 years
|
0.00%
0/76 • 5 years
|
2.6%
1/39 • Number of events 1 • 5 years
|
0.00%
0/10 • 5 years
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.00%
0/3 • 5 years
|
33.3%
1/3 • Number of events 2 • 5 years
|
0.00%
0/6 • 5 years
|
1.3%
1/76 • Number of events 1 • 5 years
|
0.00%
0/39 • 5 years
|
0.00%
0/10 • 5 years
|
|
Musculoskeletal and connective tissue disorders
Bone pain
|
0.00%
0/3 • 5 years
|
0.00%
0/3 • 5 years
|
0.00%
0/6 • 5 years
|
1.3%
1/76 • Number of events 2 • 5 years
|
0.00%
0/39 • 5 years
|
0.00%
0/10 • 5 years
|
|
Musculoskeletal and connective tissue disorders
Chest wall pain
|
0.00%
0/3 • 5 years
|
0.00%
0/3 • 5 years
|
0.00%
0/6 • 5 years
|
1.3%
1/76 • Number of events 1 • 5 years
|
0.00%
0/39 • 5 years
|
0.00%
0/10 • 5 years
|
|
Musculoskeletal and connective tissue disorders
Joint pain
|
0.00%
0/3 • 5 years
|
0.00%
0/3 • 5 years
|
0.00%
0/6 • 5 years
|
2.6%
2/76 • Number of events 3 • 5 years
|
0.00%
0/39 • 5 years
|
0.00%
0/10 • 5 years
|
|
Musculoskeletal and connective tissue disorders
Muscle weakness
|
0.00%
0/3 • 5 years
|
0.00%
0/3 • 5 years
|
0.00%
0/6 • 5 years
|
2.6%
2/76 • Number of events 2 • 5 years
|
2.6%
1/39 • Number of events 1 • 5 years
|
0.00%
0/10 • 5 years
|
|
Musculoskeletal and connective tissue disorders
Muscle weakness lower limb
|
0.00%
0/3 • 5 years
|
0.00%
0/3 • 5 years
|
0.00%
0/6 • 5 years
|
1.3%
1/76 • Number of events 1 • 5 years
|
0.00%
0/39 • 5 years
|
0.00%
0/10 • 5 years
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
0.00%
0/3 • 5 years
|
33.3%
1/3 • Number of events 1 • 5 years
|
0.00%
0/6 • 5 years
|
2.6%
2/76 • Number of events 2 • 5 years
|
0.00%
0/39 • 5 years
|
0.00%
0/10 • 5 years
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
0.00%
0/3 • 5 years
|
0.00%
0/3 • 5 years
|
0.00%
0/6 • 5 years
|
2.6%
2/76 • Number of events 2 • 5 years
|
0.00%
0/39 • 5 years
|
10.0%
1/10 • Number of events 1 • 5 years
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
0.00%
0/3 • 5 years
|
0.00%
0/3 • 5 years
|
0.00%
0/6 • 5 years
|
0.00%
0/76 • 5 years
|
2.6%
1/39 • Number of events 1 • 5 years
|
0.00%
0/10 • 5 years
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Treatment related secondary malignancy
|
0.00%
0/3 • 5 years
|
0.00%
0/3 • 5 years
|
0.00%
0/6 • 5 years
|
0.00%
0/76 • 5 years
|
2.6%
1/39 • Number of events 1 • 5 years
|
0.00%
0/10 • 5 years
|
|
Nervous system disorders
Dizziness
|
0.00%
0/3 • 5 years
|
0.00%
0/3 • 5 years
|
0.00%
0/6 • 5 years
|
1.3%
1/76 • Number of events 1 • 5 years
|
0.00%
0/39 • 5 years
|
0.00%
0/10 • 5 years
|
|
Nervous system disorders
Headache
|
0.00%
0/3 • 5 years
|
0.00%
0/3 • 5 years
|
0.00%
0/6 • 5 years
|
6.6%
5/76 • Number of events 5 • 5 years
|
0.00%
0/39 • 5 years
|
0.00%
0/10 • 5 years
|
|
Nervous system disorders
Peripheral motor neuropathy
|
33.3%
1/3 • Number of events 2 • 5 years
|
0.00%
0/3 • 5 years
|
0.00%
0/6 • 5 years
|
2.6%
2/76 • Number of events 2 • 5 years
|
2.6%
1/39 • Number of events 5 • 5 years
|
20.0%
2/10 • Number of events 4 • 5 years
|
|
Nervous system disorders
Peripheral sensory neuropathy
|
33.3%
1/3 • Number of events 2 • 5 years
|
66.7%
2/3 • Number of events 2 • 5 years
|
16.7%
1/6 • Number of events 3 • 5 years
|
11.8%
9/76 • Number of events 19 • 5 years
|
10.3%
4/39 • Number of events 11 • 5 years
|
0.00%
0/10 • 5 years
|
|
Nervous system disorders
Syncope
|
0.00%
0/3 • 5 years
|
0.00%
0/3 • 5 years
|
0.00%
0/6 • 5 years
|
1.3%
1/76 • Number of events 1 • 5 years
|
2.6%
1/39 • Number of events 1 • 5 years
|
0.00%
0/10 • 5 years
|
|
Nervous system disorders
Taste alteration
|
0.00%
0/3 • 5 years
|
0.00%
0/3 • 5 years
|
0.00%
0/6 • 5 years
|
1.3%
1/76 • Number of events 1 • 5 years
|
0.00%
0/39 • 5 years
|
10.0%
1/10 • Number of events 1 • 5 years
|
|
Psychiatric disorders
Anxiety
|
0.00%
0/3 • 5 years
|
0.00%
0/3 • 5 years
|
0.00%
0/6 • 5 years
|
1.3%
1/76 • Number of events 1 • 5 years
|
2.6%
1/39 • Number of events 1 • 5 years
|
0.00%
0/10 • 5 years
|
|
Psychiatric disorders
Depression
|
0.00%
0/3 • 5 years
|
0.00%
0/3 • 5 years
|
0.00%
0/6 • 5 years
|
1.3%
1/76 • Number of events 1 • 5 years
|
0.00%
0/39 • 5 years
|
0.00%
0/10 • 5 years
|
|
Psychiatric disorders
Insomnia
|
0.00%
0/3 • 5 years
|
0.00%
0/3 • 5 years
|
0.00%
0/6 • 5 years
|
2.6%
2/76 • Number of events 4 • 5 years
|
5.1%
2/39 • Number of events 2 • 5 years
|
0.00%
0/10 • 5 years
|
|
Renal and urinary disorders
Urinary frequency
|
0.00%
0/3 • 5 years
|
0.00%
0/3 • 5 years
|
0.00%
0/6 • 5 years
|
1.3%
1/76 • Number of events 1 • 5 years
|
0.00%
0/39 • 5 years
|
0.00%
0/10 • 5 years
|
|
Renal and urinary disorders
Urinary incontinence
|
0.00%
0/3 • 5 years
|
0.00%
0/3 • 5 years
|
0.00%
0/6 • 5 years
|
0.00%
0/76 • 5 years
|
2.6%
1/39 • Number of events 2 • 5 years
|
0.00%
0/10 • 5 years
|
|
Renal and urinary disorders
Urogenital disorder
|
0.00%
0/3 • 5 years
|
0.00%
0/3 • 5 years
|
0.00%
0/6 • 5 years
|
1.3%
1/76 • Number of events 1 • 5 years
|
0.00%
0/39 • 5 years
|
0.00%
0/10 • 5 years
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.00%
0/3 • 5 years
|
0.00%
0/3 • 5 years
|
0.00%
0/6 • 5 years
|
3.9%
3/76 • Number of events 4 • 5 years
|
2.6%
1/39 • Number of events 2 • 5 years
|
0.00%
0/10 • 5 years
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
0.00%
0/3 • 5 years
|
0.00%
0/3 • 5 years
|
0.00%
0/6 • 5 years
|
5.3%
4/76 • Number of events 5 • 5 years
|
0.00%
0/39 • 5 years
|
0.00%
0/10 • 5 years
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
0.00%
0/3 • 5 years
|
0.00%
0/3 • 5 years
|
0.00%
0/6 • 5 years
|
1.3%
1/76 • Number of events 1 • 5 years
|
0.00%
0/39 • 5 years
|
0.00%
0/10 • 5 years
|
|
Respiratory, thoracic and mediastinal disorders
Pharyngolaryngeal pain
|
0.00%
0/3 • 5 years
|
0.00%
0/3 • 5 years
|
0.00%
0/6 • 5 years
|
1.3%
1/76 • Number of events 2 • 5 years
|
0.00%
0/39 • 5 years
|
0.00%
0/10 • 5 years
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonitis
|
0.00%
0/3 • 5 years
|
0.00%
0/3 • 5 years
|
0.00%
0/6 • 5 years
|
5.3%
4/76 • Number of events 4 • 5 years
|
0.00%
0/39 • 5 years
|
0.00%
0/10 • 5 years
|
|
Respiratory, thoracic and mediastinal disorders
Voice alteration
|
0.00%
0/3 • 5 years
|
0.00%
0/3 • 5 years
|
0.00%
0/6 • 5 years
|
1.3%
1/76 • Number of events 1 • 5 years
|
0.00%
0/39 • 5 years
|
0.00%
0/10 • 5 years
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
33.3%
1/3 • Number of events 5 • 5 years
|
66.7%
2/3 • Number of events 9 • 5 years
|
50.0%
3/6 • Number of events 13 • 5 years
|
57.9%
44/76 • Number of events 178 • 5 years
|
69.2%
27/39 • Number of events 102 • 5 years
|
40.0%
4/10 • Number of events 17 • 5 years
|
|
Skin and subcutaneous tissue disorders
Hand-and-foot syndrome/reaction
|
0.00%
0/3 • 5 years
|
0.00%
0/3 • 5 years
|
0.00%
0/6 • 5 years
|
1.3%
1/76 • Number of events 1 • 5 years
|
0.00%
0/39 • 5 years
|
0.00%
0/10 • 5 years
|
|
Skin and subcutaneous tissue disorders
Nail disorder
|
0.00%
0/3 • 5 years
|
0.00%
0/3 • 5 years
|
0.00%
0/6 • 5 years
|
1.3%
1/76 • Number of events 2 • 5 years
|
0.00%
0/39 • 5 years
|
0.00%
0/10 • 5 years
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
0.00%
0/3 • 5 years
|
0.00%
0/3 • 5 years
|
0.00%
0/6 • 5 years
|
1.3%
1/76 • Number of events 1 • 5 years
|
0.00%
0/39 • 5 years
|
0.00%
0/10 • 5 years
|
|
Skin and subcutaneous tissue disorders
Rash acneiform
|
0.00%
0/3 • 5 years
|
0.00%
0/3 • 5 years
|
0.00%
0/6 • 5 years
|
0.00%
0/76 • 5 years
|
2.6%
1/39 • Number of events 1 • 5 years
|
10.0%
1/10 • Number of events 2 • 5 years
|
|
Skin and subcutaneous tissue disorders
Rash desquamating
|
33.3%
1/3 • Number of events 1 • 5 years
|
0.00%
0/3 • 5 years
|
0.00%
0/6 • 5 years
|
0.00%
0/76 • 5 years
|
5.1%
2/39 • Number of events 2 • 5 years
|
0.00%
0/10 • 5 years
|
|
Skin and subcutaneous tissue disorders
Skin disorder
|
0.00%
0/3 • 5 years
|
0.00%
0/3 • 5 years
|
0.00%
0/6 • 5 years
|
0.00%
0/76 • 5 years
|
5.1%
2/39 • Number of events 3 • 5 years
|
0.00%
0/10 • 5 years
|
|
Vascular disorders
Hypertension
|
0.00%
0/3 • 5 years
|
0.00%
0/3 • 5 years
|
0.00%
0/6 • 5 years
|
0.00%
0/76 • 5 years
|
5.1%
2/39 • Number of events 3 • 5 years
|
0.00%
0/10 • 5 years
|
|
Vascular disorders
Hypotension
|
0.00%
0/3 • 5 years
|
0.00%
0/3 • 5 years
|
0.00%
0/6 • 5 years
|
3.9%
3/76 • Number of events 4 • 5 years
|
2.6%
1/39 • Number of events 2 • 5 years
|
0.00%
0/10 • 5 years
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place