Trial Outcomes & Findings for Smart Start: A Phase II Study of Rituximab, Lenalidomide, and Ibrutinib (NCT NCT02636322)
NCT ID: NCT02636322
Last Updated: 2024-03-13
Results Overview
After two cycles of RLI
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
60 participants
Primary outcome timeframe
Up to 42 days
Results posted on
2024-03-13
Participant Flow
for testing in up to 60 patients with newly diagnosed ABC DLBCL. Patients will start with RLI alone prior to the use of chemotherapy ("Smart Start") for ≤2 cycles, followed by 6 cycles of RLI with dose adjusted (DA) EPOCH.
Participant milestones
| Measure |
RLI WITH EPOCH/RCHOP
SMART START: Patients receive rituximab IV over 4-6 hours on day 1, lenalidomide PO QD on days 1-10, and ibrutinib PO QD on days 1-21. Treatment repeats every 21 days for 2 cycles in the absence of disease progression or unacceptable toxicity.
After SMART START therapy, patients receive rituximab IV over 4-6 hours on day 1, lenalidomide PO QD on days 1-10, and ibrutinib PO QD on days 1-21. Patients also receive prednisone PO QD on days 1-5, vincristine sulfate IV over 1 hour on day 1, doxorubicin hydrochloride IV over 1 hour on day 1, and cyclophosphamide IV over 1 hour on day 1. Treatment repeats every 21 days for 6 cycles in the absence of disease progression or unacceptable toxicity.
|
|---|---|
|
Overall Study
STARTED
|
58
|
|
Overall Study
Complete Response
|
21
|
|
Overall Study
Partial Response
|
29
|
|
Overall Study
Non Responsive
|
8
|
|
Overall Study
COMPLETED
|
58
|
|
Overall Study
NOT COMPLETED
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Smart Start: A Phase II Study of Rituximab, Lenalidomide, and Ibrutinib
Baseline characteristics by cohort
| Measure |
RLI WITH EPOCH/R-CHOP
n=60 Participants
SMART START: Patients receive rituximab IV over 4-6 hours on day 1, lenalidomide PO QD on days 1-10, and ibrutinib PO QD on days 1-21. Treatment repeats every 21 days for 2 cycles in the absence of disease progression or unacceptable toxicity.
After SMART START therapy, patients receive rituximab IV over 4-6 hours on day 1, lenalidomide PO QD on days 1-10, and ibrutinib PO QD on days 1-21. Patients also receive etoposide IV over 24 hours on days 1-4, prednisone PO QD on days 1-5, vincristine sulfate IV over 24 hours on days 1-4, doxorubicin hydrochloride IV over 24 hours on days 1-4, and cyclophosphamide IV over 1 hour on day 5. Treatment repeats every 21 days for 6 cycles in the absence of disease progression or unacceptable toxicity.
Patients also receive prednisone PO QD on days 1-5, vincristine sulfate IV over 1 hour on day 1, doxorubicin hydrochloride IV over 1 hour on day 1, and cyclophosphamide IV over 1 hour on day 1. Treatment repeats every 21 days for 6 cycles in the absence of disease progression or unacceptable toxicity.
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
32 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
28 Participants
n=5 Participants
|
|
Age, Continuous
|
63.5 Years
n=5 Participants
|
|
Sex: Female, Male
Female
|
28 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
32 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
7 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
53 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
3 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
3 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
47 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
7 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
60 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Up to 42 daysAfter two cycles of RLI
Outcome measures
| Measure |
RLI With EPOCH/CHOP
n=58 Participants
SMART START: Patients receive rituximab IV over 4-6 hours on day 1, lenalidomide PO QD on days 1-10, and ibrutinib PO QD on days 1-21. Treatment repeats every 21 days for 2 cycles in the absence of disease progression or unacceptable toxicity.
After SMART START therapy, patients receive rituximab IV over 4-6 hours on day 1, lenalidomide PO QD on days 1-10, and ibrutinib PO QD on days 1-21. Patients also receive prednisone PO QD on days 1-5, vincristine sulfate IV over 1 hour on day 1, doxorubicin hydrochloride IV over 1 hour on day 1, and cyclophosphamide IV over 1 hour on day 1. Treatment repeats every 21 days for 6 cycles in the absence of disease progression or unacceptable toxicity.
|
|---|---|
|
Overall Response Rate
|
86.2 percentage of participants
Interval 74.6 to 93.9
|
PRIMARY outcome
Timeframe: up to 84 daysAfter two cycles of RLI plus two cycles of RLI-chemotherapy
Outcome measures
| Measure |
RLI With EPOCH/CHOP
n=58 Participants
SMART START: Patients receive rituximab IV over 4-6 hours on day 1, lenalidomide PO QD on days 1-10, and ibrutinib PO QD on days 1-21. Treatment repeats every 21 days for 2 cycles in the absence of disease progression or unacceptable toxicity.
After SMART START therapy, patients receive rituximab IV over 4-6 hours on day 1, lenalidomide PO QD on days 1-10, and ibrutinib PO QD on days 1-21. Patients also receive prednisone PO QD on days 1-5, vincristine sulfate IV over 1 hour on day 1, doxorubicin hydrochloride IV over 1 hour on day 1, and cyclophosphamide IV over 1 hour on day 1. Treatment repeats every 21 days for 6 cycles in the absence of disease progression or unacceptable toxicity.
|
|---|---|
|
Overall Response Rate
|
100 percentage of participants
Interval 93.6 to 100.0
|
SECONDARY outcome
Timeframe: 2 yearsOutcome measures
| Measure |
RLI With EPOCH/CHOP
n=58 Participants
SMART START: Patients receive rituximab IV over 4-6 hours on day 1, lenalidomide PO QD on days 1-10, and ibrutinib PO QD on days 1-21. Treatment repeats every 21 days for 2 cycles in the absence of disease progression or unacceptable toxicity.
After SMART START therapy, patients receive rituximab IV over 4-6 hours on day 1, lenalidomide PO QD on days 1-10, and ibrutinib PO QD on days 1-21. Patients also receive prednisone PO QD on days 1-5, vincristine sulfate IV over 1 hour on day 1, doxorubicin hydrochloride IV over 1 hour on day 1, and cyclophosphamide IV over 1 hour on day 1. Treatment repeats every 21 days for 6 cycles in the absence of disease progression or unacceptable toxicity.
|
|---|---|
|
Progression Free Survival at 2 Years
|
91.3 percentage of participants
Interval 84.3 to 98.9
|
SECONDARY outcome
Timeframe: 2 yearsOutcome measures
| Measure |
RLI With EPOCH/CHOP
n=58 Participants
SMART START: Patients receive rituximab IV over 4-6 hours on day 1, lenalidomide PO QD on days 1-10, and ibrutinib PO QD on days 1-21. Treatment repeats every 21 days for 2 cycles in the absence of disease progression or unacceptable toxicity.
After SMART START therapy, patients receive rituximab IV over 4-6 hours on day 1, lenalidomide PO QD on days 1-10, and ibrutinib PO QD on days 1-21. Patients also receive prednisone PO QD on days 1-5, vincristine sulfate IV over 1 hour on day 1, doxorubicin hydrochloride IV over 1 hour on day 1, and cyclophosphamide IV over 1 hour on day 1. Treatment repeats every 21 days for 6 cycles in the absence of disease progression or unacceptable toxicity.
|
|---|---|
|
Overall Survival for 2 Years
|
58 Participants
|
Adverse Events
RLI WITH EPOCH/R-CHOP
Serious events: 24 serious events
Other events: 60 other events
Deaths: 2 deaths
Serious adverse events
| Measure |
RLI WITH EPOCH/R-CHOP
n=60 participants at risk
SMART START: Patients receive rituximab IV over 4-6 hours on day 1, lenalidomide PO QD on days 1-10, and ibrutinib PO QD on days 1-21. Treatment repeats every 21 days for 2 cycles in the absence of disease progression or unacceptable toxicity.
After SMART START therapy, patients receive rituximab IV over 4-6 hours on day 1, lenalidomide PO QD on days 1-10, and ibrutinib PO QD on days 1-21. Patients also receive etoposide IV over 24 hours on days 1-4, prednisone PO QD on days 1-5, vincristine sulfate IV over 24 hours on days 1-4, doxorubicin hydrochloride IV over 24 hours on days 1-4, and cyclophosphamide IV over 1 hour on day 5. Treatment repeats every 21 days for 6 cycles in the absence of disease progression or unacceptable toxicity.
Patients also receive prednisone PO QD on days 1-5, vincristine sulfate IV over 1 hour on day 1, doxorubicin hydrochloride IV over 1 hour on day 1, and cyclophosphamide IV over 1 hour on day 1. Treatment repeats every 21 days for 6 cycles in the absence of disease progression or unacceptable toxicity.
|
|---|---|
|
Gastrointestinal disorders
Abdominal Pain
|
3.3%
2/60 • Number of events 2 • 2 years
|
|
Renal and urinary disorders
Acute Kidney injury
|
3.3%
2/60 • Number of events 2 • 2 years
|
|
Blood and lymphatic system disorders
Anemia
|
1.7%
1/60 • Number of events 1 • 2 years
|
|
Musculoskeletal and connective tissue disorders
Arthritis
|
1.7%
1/60 • Number of events 1 • 2 years
|
|
Respiratory, thoracic and mediastinal disorders
Aspiration
|
1.7%
1/60 • Number of events 1 • 2 years
|
|
Cardiac disorders
Atrial fibrilation
|
3.3%
2/60 • Number of events 2 • 2 years
|
|
Cardiac disorders
Atrial flutter
|
1.7%
1/60 • Number of events 1 • 2 years
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
3.3%
2/60 • Number of events 2 • 2 years
|
|
Blood and lymphatic system disorders
Blood and Lymphatic other lymphoma tumor abscess, axilla
|
1.7%
1/60 • Number of events 1 • 2 years
|
|
Cardiac disorders
Chest pain
|
1.7%
1/60 • Number of events 1 • 2 years
|
|
Metabolism and nutrition disorders
Dehydration
|
1.7%
1/60 • Number of events 1 • 2 years
|
|
Gastrointestinal disorders
Diarrhea
|
8.3%
5/60 • Number of events 5 • 2 years
|
|
Nervous system disorders
Dizziness
|
1.7%
1/60 • Number of events 1 • 2 years
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
1.7%
1/60 • Number of events 1 • 2 years
|
|
Infections and infestations
Encephalitis infection
|
1.7%
1/60 • Number of events 1 • 2 years
|
|
Infections and infestations
Enterocolitis infectious
|
3.3%
2/60 • Number of events 2 • 2 years
|
|
Injury, poisoning and procedural complications
Fall
|
3.3%
2/60 • Number of events 2 • 2 years
|
|
General disorders
Fatigue
|
3.3%
2/60 • Number of events 2 • 2 years
|
|
Blood and lymphatic system disorders
Febrile Neutropenia
|
40.0%
24/60 • Number of events 31 • 2 years
|
|
General disorders
Fever
|
11.7%
7/60 • Number of events 8 • 2 years
|
|
Infections and infestations
Infections and infestations - Other, Acute kidney infection
|
1.7%
1/60 • Number of events 1 • 2 years
|
|
Infections and infestations
Infections and infestations - Other, Bacteremia
|
1.7%
1/60 • Number of events 1 • 2 years
|
|
Infections and infestations
Lung infection
|
1.7%
1/60 • Number of events 3 • 2 years
|
|
Nervous system disorders
Memory impairment
|
1.7%
1/60 • Number of events 1 • 2 years
|
|
Gastrointestinal disorders
Mucositis oral
|
5.0%
3/60 • Number of events 3 • 2 years
|
|
General disorders
Multi-organ failure
|
1.7%
1/60 • Number of events 1 • 2 years
|
|
Cardiac disorders
Myocardial infarction
|
1.7%
1/60 • Number of events 1 • 2 years
|
|
Gastrointestinal disorders
Nausea
|
1.7%
1/60 • Number of events 2 • 2 years
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
1.7%
1/60 • Number of events 1 • 2 years
|
|
Investigations
Neutrophil count decreased
|
6.7%
4/60 • Number of events 5 • 2 years
|
|
General disorders
Non-cardiac chest pain
|
1.7%
1/60 • Number of events 1 • 2 years
|
|
Investigations
Platelet count decrease
|
1.7%
1/60 • Number of events 1 • 2 years
|
|
Skin and subcutaneous tissue disorders
Rash acneiform
|
1.7%
1/60 • Number of events 1 • 2 years
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
3.3%
2/60 • Number of events 2 • 2 years
|
|
Gastrointestinal disorders
Rectal pain
|
3.3%
2/60 • Number of events 2 • 2 years
|
|
Cardiac disorders
Sinus tachycardia
|
1.7%
1/60 • Number of events 1 • 2 years
|
|
Skin and subcutaneous tissue disorders
Skin and subcutaneous Cellulitis right foot
|
1.7%
1/60 • Number of events 1 • 2 years
|
|
Nervous system disorders
Syncope
|
8.3%
5/60 • Number of events 5 • 2 years
|
|
Respiratory, thoracic and mediastinal disorders
Upper respiratory infection
|
3.3%
2/60 • Number of events 2 • 2 years
|
|
Infections and infestations
Urinary tract infection
|
3.3%
2/60 • Number of events 2 • 2 years
|
|
Gastrointestinal disorders
Vomiting
|
1.7%
1/60 • Number of events 2 • 2 years
|
|
Investigations
White blood cell decrease
|
1.7%
1/60 • Number of events 1 • 2 years
|
|
Infections and infestations
Wound infection
|
1.7%
1/60 • Number of events 1 • 2 years
|
Other adverse events
| Measure |
RLI WITH EPOCH/R-CHOP
n=60 participants at risk
SMART START: Patients receive rituximab IV over 4-6 hours on day 1, lenalidomide PO QD on days 1-10, and ibrutinib PO QD on days 1-21. Treatment repeats every 21 days for 2 cycles in the absence of disease progression or unacceptable toxicity.
After SMART START therapy, patients receive rituximab IV over 4-6 hours on day 1, lenalidomide PO QD on days 1-10, and ibrutinib PO QD on days 1-21. Patients also receive etoposide IV over 24 hours on days 1-4, prednisone PO QD on days 1-5, vincristine sulfate IV over 24 hours on days 1-4, doxorubicin hydrochloride IV over 24 hours on days 1-4, and cyclophosphamide IV over 1 hour on day 5. Treatment repeats every 21 days for 6 cycles in the absence of disease progression or unacceptable toxicity.
Patients also receive prednisone PO QD on days 1-5, vincristine sulfate IV over 1 hour on day 1, doxorubicin hydrochloride IV over 1 hour on day 1, and cyclophosphamide IV over 1 hour on day 1. Treatment repeats every 21 days for 6 cycles in the absence of disease progression or unacceptable toxicity.
|
|---|---|
|
Gastrointestinal disorders
Abdominal pain
|
13.3%
8/60 • Number of events 8 • 2 years
|
|
Renal and urinary disorders
Acute Kidney injury
|
1.7%
1/60 • Number of events 1 • 2 years
|
|
Investigations
Alanine aminotransferase increased
|
13.3%
8/60 • Number of events 15 • 2 years
|
|
Immune system disorders
Allergic reaction
|
1.7%
1/60 • Number of events 1 • 2 years
|
|
Respiratory, thoracic and mediastinal disorders
Allergic rhinitis
|
8.3%
5/60 • Number of events 5 • 2 years
|
|
Nervous system disorders
Amnesia
|
1.7%
1/60 • Number of events 1 • 2 years
|
|
Blood and lymphatic system disorders
Anemia
|
70.0%
42/60 • Number of events 141 • 2 years
|
|
Metabolism and nutrition disorders
Anorexia
|
3.3%
2/60 • Number of events 2 • 2 years
|
|
Psychiatric disorders
Anxiety
|
6.7%
4/60 • Number of events 4 • 2 years
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
8.3%
5/60 • Number of events 5 • 2 years
|
|
Investigations
Aspartate aminotransferase increased
|
13.3%
8/60 • Number of events 8 • 2 years
|
|
Cardiac disorders
Artrial fibliration
|
8.3%
5/60 • Number of events 6 • 2 years
|
|
Cardiac disorders
Atrial Flutter
|
1.7%
1/60 • Number of events 1 • 2 years
|
|
Musculoskeletal and connective tissue disorders
Back Pain
|
10.0%
6/60 • Number of events 8 • 2 years
|
|
Infections and infestations
Bacteremia
|
1.7%
1/60 • Number of events 1 • 2 years
|
|
Renal and urinary disorders
Bladder infection
|
1.7%
1/60 • Number of events 2 • 2 years
|
|
Investigations
Blood bilirubin increase
|
6.7%
4/60 • Number of events 5 • 2 years
|
|
Eye disorders
Blurred vision
|
35.0%
21/60 • Number of events 23 • 2 years
|
|
Musculoskeletal and connective tissue disorders
Bone pain
|
1.7%
1/60 • Number of events 2 • 2 years
|
|
Injury, poisoning and procedural complications
Bruising
|
1.7%
1/60 • Number of events 1 • 2 years
|
|
Cardiac disorders
Cardiac disorders - Other, specify increase heart rate
|
1.7%
1/60 • Number of events 1 • 2 years
|
|
Musculoskeletal and connective tissue disorders
Chest wall pain
|
1.7%
1/60 • Number of events 1 • 2 years
|
|
General disorders
Chills
|
1.7%
1/60 • Number of events 1 • 2 years
|
|
Gastrointestinal disorders
Colitis
|
1.7%
1/60 • Number of events 1 • 2 years
|
|
Psychiatric disorders
Confusion
|
1.7%
1/60 • Number of events 1 • 2 years
|
|
Eye disorders
Conjunctivitis
|
1.7%
1/60 • Number of events 1 • 2 years
|
|
Gastrointestinal disorders
Constipation
|
70.0%
42/60 • Number of events 54 • 2 years
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
18.3%
11/60 • Number of events 12 • 2 years
|
|
Investigations
Creatinine increase
|
10.0%
6/60 • Number of events 7 • 2 years
|
|
Metabolism and nutrition disorders
Dehydration
|
5.0%
3/60 • Number of events 3 • 2 years
|
|
Psychiatric disorders
Depression
|
1.7%
1/60 • Number of events 1 • 2 years
|
|
Gastrointestinal disorders
Diarrhea
|
78.3%
47/60 • Number of events 81 • 2 years
|
|
Nervous system disorders
Dizziness
|
53.3%
32/60 • Number of events 38 • 2 years
|
|
Eye disorders
Dry Eye
|
28.3%
17/60 • Number of events 18 • 2 years
|
|
Skin and subcutaneous tissue disorders
Dry Skin
|
1.7%
1/60 • Number of events 1 • 2 years
|
|
Gastrointestinal disorders
Dyspepsia
|
1.7%
1/60 • Number of events 1 • 2 years
|
|
Gastrointestinal disorders
Dysphagia
|
1.7%
1/60 • Number of events 1 • 2 years
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
43.3%
26/60 • Number of events 32 • 2 years
|
|
Renal and urinary disorders
Dysuria
|
1.7%
1/60 • Number of events 1 • 2 years
|
|
Ear and labyrinth disorders
"Ear and labyrinth disorders - Other Ear discharge bilateral"
|
1.7%
1/60 • Number of events 1 • 2 years
|
|
General disorders
Edema face
|
3.3%
2/60 • Number of events 2 • 2 years
|
|
General disorders
Edema Limbs
|
50.0%
30/60 • Number of events 38 • 2 years
|
|
General disorders
Edema trunk
|
1.7%
1/60 • Number of events 2 • 2 years
|
|
Endocrine disorders
Endocrine disorder Polydipsia
|
1.7%
1/60 • Number of events 1 • 2 years
|
|
Endocrine disorders
Endocrine disorder Polyuria
|
1.7%
1/60 • Number of events 1 • 2 years
|
|
Gastrointestinal disorders
Enterocolitis
|
3.3%
2/60 • Number of events 2 • 2 years
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
5.0%
3/60 • Number of events 3 • 2 years
|
|
Eye disorders
Eye disorder Blepharitis of right eye
|
1.7%
1/60 • Number of events 1 • 2 years
|
|
Eye disorders
Eye disorder light sensitivity
|
1.7%
1/60 • Number of events 1 • 2 years
|
|
Eye disorders
Eye infection
|
1.7%
1/60 • Number of events 1 • 2 years
|
|
General disorders
Facila pain
|
1.7%
1/60 • Number of events 1 • 2 years
|
|
General disorders
Fatigue
|
96.7%
58/60 • Number of events 80 • 2 years
|
|
Blood and lymphatic system disorders
Febrile Neutorpenia
|
3.3%
2/60 • Number of events 2 • 2 years
|
|
General disorders
Fever
|
33.3%
20/60 • Number of events 23 • 2 years
|
|
General disorders
Flu like symptoms
|
1.7%
1/60 • Number of events 1 • 2 years
|
|
General disorders
Gait disturbance
|
3.3%
2/60 • Number of events 2 • 2 years
|
|
Gastrointestinal disorders
Gastroesophageal reflux disease
|
6.7%
4/60 • Number of events 4 • 2 years
|
|
Gastrointestinal disorders
Gastrointestinal disorders - Other, Ulcer on left oral cavity
|
1.7%
1/60 • Number of events 1 • 2 years
|
|
Gastrointestinal disorders
Gastrointestinal disorders - Other, bloody stool
|
1.7%
1/60 • Number of events 1 • 2 years
|
|
Gastrointestinal disorders
Gastrointestinal disorders - Other, indigestion
|
1.7%
1/60 • Number of events 1 • 2 years
|
|
General disorders
Generalized edema
|
1.7%
1/60 • Number of events 1 • 2 years
|
|
Nervous system disorders
Headache
|
21.7%
13/60 • Number of events 17 • 2 years
|
|
Renal and urinary disorders
Hematuria
|
1.7%
1/60 • Number of events 2 • 2 years
|
|
Gastrointestinal disorders
Hemorrhoids
|
1.7%
1/60 • Number of events 1 • 2 years
|
|
Reproductive system and breast disorders
Hoarseness
|
1.7%
1/60 • Number of events 1 • 2 years
|
|
Vascular disorders
Hot flashes
|
3.3%
2/60 • Number of events 2 • 2 years
|
|
Investigations
Hypercalcemia
|
3.3%
2/60 • Number of events 2 • 2 years
|
|
Investigations
Hyperglycemia
|
1.7%
1/60 • Number of events 4 • 2 years
|
|
Skin and subcutaneous tissue disorders
Hyperhidrosis
|
1.7%
1/60 • Number of events 1 • 2 years
|
|
Skin and subcutaneous tissue disorders
Hyperkalemia
|
1.7%
1/60 • Number of events 1 • 2 years
|
|
Investigations
Hyperuricemia
|
1.7%
1/60 • Number of events 1 • 2 years
|
|
Investigations
Hypoalbuminemia
|
3.3%
2/60 • Number of events 2 • 2 years
|
|
Investigations
Hypocalcemia
|
3.3%
2/60 • Number of events 5 • 2 years
|
|
Investigations
Hypokalemia
|
21.7%
13/60 • Number of events 31 • 2 years
|
|
Investigations
Hypomagnesemia
|
11.7%
7/60 • Number of events 8 • 2 years
|
|
Investigations
Hyponatremia
|
11.7%
7/60 • Number of events 10 • 2 years
|
|
Investigations
Hypophosphatemia
|
10.0%
6/60 • Number of events 12 • 2 years
|
|
Vascular disorders
Hypotension
|
6.7%
4/60 • Number of events 4 • 2 years
|
|
Vascular disorders
Ileus
|
1.7%
1/60 • Number of events 1 • 2 years
|
|
Infections and infestations
Infections and infestations others right great toe
|
3.3%
2/60 • Number of events 2 • 2 years
|
|
Infections and infestations
Infections and infestations others
|
1.7%
1/60 • Number of events 1 • 2 years
|
|
Infections and infestations
Infections other Clostridium Difficile infection
|
1.7%
1/60 • Number of events 1 • 2 years
|
|
Infections and infestations
Infections and infestations others vaginal yeast
|
1.7%
1/60 • Number of events 1 • 2 years
|
|
Infections and infestations
Infections and infestations others Coronavirus
|
1.7%
1/60 • Number of events 1 • 2 years
|
|
Infections and infestations
Infections and infestations others Oral Candidiasis
|
1.7%
1/60 • Number of events 1 • 2 years
|
|
Infections and infestations
Infections and infestations others left great toe
|
1.7%
1/60 • Number of events 1 • 2 years
|
|
Psychiatric disorders
insomnia
|
15.0%
9/60 • Number of events 9 • 2 years
|
|
Blood and lymphatic system disorders
Leukocytosis
|
3.3%
2/60 • Number of events 5 • 2 years
|
|
General disorders
Localized edema
|
1.7%
1/60 • Number of events 1 • 2 years
|
|
Reproductive system and breast disorders
lung infection
|
1.7%
1/60 • Number of events 1 • 2 years
|
|
Psychiatric disorders
memory impairment
|
38.3%
23/60 • Number of events 23 • 2 years
|
|
Metabolism and nutrition disorders
Metabolism and nutrition disorders other diaphoresis
|
1.7%
1/60 • Number of events 1 • 2 years
|
|
Gastrointestinal disorders
Mucositis oral
|
75.0%
45/60 • Number of events 61 • 2 years
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal and connective tissue disorder - Other, Restless leg syndrome
|
1.7%
1/60 • Number of events 1 • 2 years
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal and connective tissue disorder - Other, Arthralgia
|
1.7%
1/60 • Number of events 1 • 2 years
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal and connective tissue disorder - Other,Leg Cramps
|
1.7%
1/60 • Number of events 1 • 2 years
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal and connective tissue disorder - Other, Hand cramp
|
1.7%
1/60 • Number of events 1 • 2 years
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
58.3%
35/60 • Number of events 45 • 2 years
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestionres
|
10.0%
6/60 • Number of events 6 • 2 years
|
|
Gastrointestinal disorders
Nausea
|
85.0%
51/60 • Number of events 72 • 2 years
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
1.7%
1/60 • Number of events 1 • 2 years
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Neoplasms Benign, Malignant and Unspecified (Incl Cysts and Polyps) Left thigh nodule
|
1.7%
1/60 • Number of events 1 • 2 years
|
|
Nervous system disorders
Nervous system disorders - Other, neck stiffness
|
1.7%
1/60 • Number of events 1 • 2 years
|
|
Investigations
Neutrophil count decrease
|
60.0%
36/60 • Number of events 95 • 2 years
|
|
General disorders
Non-cardiac chest pain
|
3.3%
2/60 • Number of events 2 • 2 years
|
|
Gastrointestinal disorders
Oral dysesthesia
|
1.7%
1/60 • Number of events 1 • 2 years
|
|
General disorders
Pain
|
5.0%
3/60 • Number of events 3 • 2 years
|
|
Musculoskeletal and connective tissue disorders
Pain extremity
|
5.0%
3/60 • Number of events 3 • 2 years
|
|
Nervous system disorders
Paresthesia
|
6.7%
4/60 • Number of events 4 • 2 years
|
|
Cardiac disorders
Palpatations
|
5.0%
3/60 • Number of events 4 • 2 years
|
|
Infections and infestations
Paronychia
|
1.7%
1/60 • Number of events 1 • 2 years
|
|
Nervous system disorders
Peripheral motor neuropathy
|
1.7%
1/60 • Number of events 1 • 2 years
|
|
Nervous system disorders
Peripheral sensory neuropathy
|
81.7%
49/60 • Number of events 78 • 2 years
|
|
Gastrointestinal disorders
Pharyngitis
|
1.7%
1/60 • Number of events 1 • 2 years
|
|
Investigations
Platelet count decrease
|
66.7%
40/60 • Number of events 146 • 2 years
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
1.7%
1/60 • Number of events 1 • 2 years
|
|
Respiratory, thoracic and mediastinal disorders
postnasal drip
|
8.3%
5/60 • Number of events 5 • 2 years
|
|
Nervous system disorders
presyncope
|
1.7%
1/60 • Number of events 1 • 2 years
|
|
Respiratory, thoracic and mediastinal disorders
Productive cough
|
5.0%
3/60 • Number of events 3 • 2 years
|
|
Skin and subcutaneous tissue disorders
Pruritis
|
1.7%
1/60 • Number of events 1 • 2 years
|
|
Skin and subcutaneous tissue disorders
Purpura
|
1.7%
1/60 • Number of events 1 • 2 years
|
|
Skin and subcutaneous tissue disorders
Rash acneiform
|
18.3%
11/60 • Number of events 15 • 2 years
|
|
Skin and subcutaneous tissue disorders
rash maculo-papular
|
30.0%
18/60 • Number of events 26 • 2 years
|
|
Gastrointestinal disorders
Rectal hemorrhage
|
1.7%
1/60 • Number of events 1 • 2 years
|
|
Gastrointestinal disorders
Rectal Pain
|
1.7%
1/60 • Number of events 1 • 2 years
|
|
Reproductive system and breast disorders
Reproductive System and Breast Disorders vaginal bleeding
|
3.3%
2/60 • Number of events 3 • 2 years
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure
|
1.7%
1/60 • Number of events 1 • 2 years
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory, thoracicand mediastinal disorder thoat pain
|
1.7%
1/60 • Number of events 1 • 2 years
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory, thoracicand mediastinal disorder Bronchitis
|
1.7%
1/60 • Number of events 1 • 2 years
|
|
Respiratory, thoracic and mediastinal disorders
Rhinitis infective
|
1.7%
1/60 • Number of events 1 • 2 years
|
|
Respiratory, thoracic and mediastinal disorders
Rhinorrhea
|
8.3%
5/60 • Number of events 5 • 2 years
|
|
Infections and infestations
Sepsis
|
1.7%
1/60 • Number of events 1 • 2 years
|
|
Cardiac disorders
Sinus tachycardia
|
3.3%
2/60 • Number of events 2 • 2 years
|
|
Respiratory, thoracic and mediastinal disorders
Sinusitis
|
5.0%
3/60 • Number of events 3 • 2 years
|
|
Skin and subcutaneous tissue disorders
Skin and subcutaneous tissue disorders Fungal rash on feet
|
1.7%
1/60 • Number of events 1 • 2 years
|
|
Skin and subcutaneous tissue disorders
Skin and subcutaneous tissue disorders left areola redness
|
1.7%
1/60 • Number of events 1 • 2 years
|
|
Skin and subcutaneous tissue disorders
Skin and subcutaneous tissue disorders blisters on hands and feet bilateral
|
1.7%
1/60 • Number of events 1 • 2 years
|
|
Skin and subcutaneous tissue disorders
Skin and subcutaneous tissue disorders itchy scalp
|
1.7%
1/60 • Number of events 1 • 2 years
|
|
Skin and subcutaneous tissue disorders
Skin and subcutaneous tissue disorders rash on torso and feet
|
1.7%
1/60 • Number of events 1 • 2 years
|
|
Skin and subcutaneous tissue disorders
Skin and subcutaneous tissue disorders Scalp tenderness
|
1.7%
1/60 • Number of events 1 • 2 years
|
|
Gastrointestinal disorders
Sore throat
|
5.0%
3/60 • Number of events 3 • 2 years
|
|
Cardiac disorders
Superior vena cava syndrome
|
1.7%
1/60 • Number of events 1 • 2 years
|
|
Nervous system disorders
Syncope
|
3.3%
2/60 • Number of events 2 • 2 years
|
|
Ear and labyrinth disorders
Tinnitus
|
8.3%
5/60 • Number of events 5 • 2 years
|
|
Infections and infestations
upper respiratory infection
|
3.3%
2/60 • Number of events 2 • 2 years
|
|
Renal and urinary disorders
Urinary tract infection
|
13.3%
8/60 • Number of events 11 • 2 years
|
|
Reproductive system and breast disorders
Vaginal infection
|
1.7%
1/60 • Number of events 1 • 2 years
|
|
Vascular disorders
Vascular access complication
|
1.7%
1/60 • Number of events 1 • 2 years
|
|
Vascular disorders
vascular other Thrombus non occlusive
|
1.7%
1/60 • Number of events 1 • 2 years
|
|
Gastrointestinal disorders
Vomiting
|
35.0%
21/60 • Number of events 24 • 2 years
|
|
Eye disorders
Watering eyes
|
23.3%
14/60 • Number of events 14 • 2 years
|
|
Investigations
Weight loss
|
6.7%
4/60 • Number of events 5 • 2 years
|
Additional Information
Dr. Jason Westin
University of Texas M D Anderson Cancer Center
Phone: (713) 792-3750
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place