Trial Outcomes & Findings for Lenalidomide in Comb w/Rituximab for Pts w/CD5+/CD20+ Hem Malignancies Who Relapse/Progress After Rituximab (NCT NCT00609869)
NCT ID: NCT00609869
Last Updated: 2015-09-17
Results Overview
The sum of Complete Remission (CR) plus Partial Remission (PR) rates. Duration of overall response is measured from the time measurement criteria are met for CR or PR (whichever is first recorded) until the first date that recurrent or progressive disease is objectively documented, and must be confirmed greater than 8 weeks after first meeting CR or PR criteria. Response and progression for Chronic Lymphocytic Leukemia (CLL) were evaluated using 2008 updated National Cancer Institute-Sponsored Working Group Guidelines (NCI-WG) for Chronic Lymphocytic Leukemia. CR: all of the criteria must be met, and patients have the lack disease-related constitutional symptoms: PR: at least two of the criteria of Group A plus one of the criteria of group B have to be met. Group A Parameters: Lymphadenopathy; Hepatomegaly; Splenomegaly; Blood; Lymphocytes; Marrow. Group B Parameters: Platelet count; Hemoglobin; Neutrophils.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
29 participants
Primary outcome timeframe
Up to 6 years
Results posted on
2015-09-17
Participant Flow
Participants were recruited at Moffitt Cancer Center from October 31, 2007 to March, 22, 2012.
Participant milestones
| Measure |
Experimental: Lenalidomide and Rituximab
28 day cycles of Lenalidomide administered orally and Rituximab administered intravenously.
Lenalidomide: Escalating doses starting with of 2.5 mg daily on 28-days cycles.
Rituximab: at 375 mg/m\^2 on a weekly basis for the first cycle starting on day 15.
|
|---|---|
|
Overall Study
STARTED
|
29
|
|
Overall Study
COMPLETED
|
18
|
|
Overall Study
NOT COMPLETED
|
11
|
Reasons for withdrawal
| Measure |
Experimental: Lenalidomide and Rituximab
28 day cycles of Lenalidomide administered orally and Rituximab administered intravenously.
Lenalidomide: Escalating doses starting with of 2.5 mg daily on 28-days cycles.
Rituximab: at 375 mg/m\^2 on a weekly basis for the first cycle starting on day 15.
|
|---|---|
|
Overall Study
Withdrawn, ischemic stroke
|
1
|
|
Overall Study
Severe hematologic toxicity
|
1
|
|
Overall Study
Withdrawal by Subject
|
1
|
|
Overall Study
Seizures
|
1
|
|
Overall Study
Severe tumor flare reaction
|
1
|
|
Overall Study
Hepatitis B infection
|
1
|
|
Overall Study
Rituximab reaction prior to lenalidomide
|
1
|
|
Overall Study
Mantle cell: not evaluable
|
4
|
Baseline Characteristics
Lenalidomide in Comb w/Rituximab for Pts w/CD5+/CD20+ Hem Malignancies Who Relapse/Progress After Rituximab
Baseline characteristics by cohort
| Measure |
Experimental: Lenalidomide and Rituximab
n=29 Participants
28 day cycles of Lenalidomide administered orally and Rituximab administered intravenously.
Lenalidomide: Escalating doses starting with of 2.5 mg daily on 28-days cycles.
Rituximab: at 375 mg/m\^2 on a weekly basis for the first cycle starting on day 15.
|
|---|---|
|
Age, Continuous
|
63 years
n=5 Participants
|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
18 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
11 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
10 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
19 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
29 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Up to 6 yearsPopulation: All evaluable chronic lymphocytic leukemia participants
The sum of Complete Remission (CR) plus Partial Remission (PR) rates. Duration of overall response is measured from the time measurement criteria are met for CR or PR (whichever is first recorded) until the first date that recurrent or progressive disease is objectively documented, and must be confirmed greater than 8 weeks after first meeting CR or PR criteria. Response and progression for Chronic Lymphocytic Leukemia (CLL) were evaluated using 2008 updated National Cancer Institute-Sponsored Working Group Guidelines (NCI-WG) for Chronic Lymphocytic Leukemia. CR: all of the criteria must be met, and patients have the lack disease-related constitutional symptoms: PR: at least two of the criteria of Group A plus one of the criteria of group B have to be met. Group A Parameters: Lymphadenopathy; Hepatomegaly; Splenomegaly; Blood; Lymphocytes; Marrow. Group B Parameters: Platelet count; Hemoglobin; Neutrophils.
Outcome measures
| Measure |
Experimental: Lenalidomide and Rituximab
n=18 Participants
28 day cycles of Lenalidomide administered orally and Rituximab administered intravenously.
Lenalidomide: Escalating doses starting with of 2.5 mg daily on 28-days cycles.
Rituximab: at 375 mg/m\^2 on a weekly basis for the first cycle starting on day 15.
|
|---|---|
|
Overall Response Rate (ORR)
|
61 percentage of participants
|
SECONDARY outcome
Timeframe: Up to 6 yearsPopulation: All evaluable chronic lymphocytic leukemia participants
The ORR rate plus Stable Disease (SD). NCI-WG: SD is the absence of progressive disease (PD) and failure to achieve at least a PR; PD: at least one of the criteria of Group A or Group B has to be met.
Outcome measures
| Measure |
Experimental: Lenalidomide and Rituximab
n=18 Participants
28 day cycles of Lenalidomide administered orally and Rituximab administered intravenously.
Lenalidomide: Escalating doses starting with of 2.5 mg daily on 28-days cycles.
Rituximab: at 375 mg/m\^2 on a weekly basis for the first cycle starting on day 15.
|
|---|---|
|
Clinical Benefit Rate
|
83.3 percentage of participants
|
SECONDARY outcome
Timeframe: Up to 6 yearsPopulation: All evaluable chronic lymphocytic leukemia participants
The time from start of therapy to death, Progressive Disease (PD) or initiation of next therapy. PD: at least one of the NCI-WG criteria of Group A or Group B has to be met.
Outcome measures
| Measure |
Experimental: Lenalidomide and Rituximab
n=18 Participants
28 day cycles of Lenalidomide administered orally and Rituximab administered intravenously.
Lenalidomide: Escalating doses starting with of 2.5 mg daily on 28-days cycles.
Rituximab: at 375 mg/m\^2 on a weekly basis for the first cycle starting on day 15.
|
|---|---|
|
Median Time to Treatment Failure (TTF)
|
17.7 months
Interval 5.6 to 29.8
|
Adverse Events
Experimental: Lenalidomide and Rituximab
Serious events: 19 serious events
Other events: 28 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Experimental: Lenalidomide and Rituximab
n=29 participants at risk
28 day cycles of Lenalidomide administered orally and Rituximab administered intravenously.
Lenalidomide: Escalating doses starting with of 2.5 mg daily on 28-days cycles.
Rituximab: at 375 mg/m\^2 on a weekly basis for the first cycle starting on day 15.
|
|---|---|
|
Blood and lymphatic system disorders
Hemoglobin - low
|
17.2%
5/29 • Number of events 5 • 6 years, 3 months
All participants
|
|
Blood and lymphatic system disorders
Neutrophils/granulocytes (ANC/AGC) - low
|
10.3%
3/29 • Number of events 3 • 6 years, 3 months
All participants
|
|
Blood and lymphatic system disorders
Platelets - low
|
6.9%
2/29 • Number of events 2 • 6 years, 3 months
All participants
|
|
Cardiac disorders
Cardiac Arrhythmia - Other, AFib
|
3.4%
1/29 • Number of events 1 • 6 years, 3 months
All participants
|
|
Cardiac disorders
Cardiac General - Other, AFib/AFlu
|
3.4%
1/29 • Number of events 1 • 6 years, 3 months
All participants
|
|
Cardiac disorders
Hypotension
|
3.4%
1/29 • Number of events 1 • 6 years, 3 months
All participants
|
|
Cardiac disorders
Pericardial effusion (non-malignant)
|
3.4%
1/29 • Number of events 1 • 6 years, 3 months
All participants
|
|
General disorders
Fatigue (asthenia, lethargy, malaise)
|
13.8%
4/29 • Number of events 4 • 6 years, 3 months
All participants
|
|
General disorders
Fever (in the absence of neutropenia)
|
10.3%
3/29 • Number of events 3 • 6 years, 3 months
All participants
|
|
General disorders
Rigors/chills
|
6.9%
2/29 • Number of events 2 • 6 years, 3 months
All participants
|
|
General disorders
Death not associated with CTCAE term - Death
|
3.4%
1/29 • Number of events 1 • 6 years, 3 months
All participants
|
|
General disorders
Death not associated with CTCAE term - Disease progression NOS
|
3.4%
1/29 • Number of events 1 • 6 years, 3 months
All participants
|
|
Skin and subcutaneous tissue disorders
Dermatology/Skin - Other, dermatitis
|
3.4%
1/29 • Number of events 1 • 6 years, 3 months
All participants
|
|
Gastrointestinal disorders
Diarrhea
|
3.4%
1/29 • Number of events 1 • 6 years, 3 months
All participants
|
|
Gastrointestinal disorders
Gastrointestinal - Other, cholilethiasis, gallbladder surgery
|
3.4%
1/29 • Number of events 1 • 6 years, 3 months
All participants
|
|
Infections and infestations
Febrile neutropenia
|
3.4%
1/29 • Number of events 1 • 6 years, 3 months
All participants
|
|
Infections and infestations
Infection with Grade 3 or 4 neutrophils - Bladder (urinary)
|
3.4%
1/29 • Number of events 1 • 6 years, 3 months
All participants
|
|
Infections and infestations
Infection with Grade 3 or 4 neutrophils - Blood
|
3.4%
1/29 • Number of events 1 • 6 years, 3 months
All participants
|
|
Infections and infestations
Infection with Grade 3 or 4 neutrophils - Brain + Spinal cord (encephalomyelitis)
|
3.4%
1/29 • Number of events 1 • 6 years, 3 months
All participants
|
|
Infections and infestations
Infection with Grade 3 or 4 neutrophils - Lung (pneumonia)
|
20.7%
6/29 • Number of events 9 • 6 years, 3 months
All participants
|
|
Infections and infestations
Infection with Grade 3 or 4 neutrophils - Upper airway NOS
|
3.4%
1/29 • Number of events 1 • 6 years, 3 months
All participants
|
|
Infections and infestations
Infection - Other, Port A Cath
|
17.2%
5/29 • Number of events 7 • 6 years, 3 months
All participants
|
|
Infections and infestations
Infection - Other, unketiology
|
3.4%
1/29 • Number of events 1 • 6 years, 3 months
All participants
|
|
Infections and infestations
Infection with normal ANC or Grade 1 or 2 neutrophils - Blood
|
6.9%
2/29 • Number of events 2 • 6 years, 3 months
All participants
|
|
Infections and infestations
Infection with normal ANC or Grade 1 or 2 ANC or Grade 1 or 2
|
3.4%
1/29 • Number of events 2 • 6 years, 3 months
All participants
|
|
Infections and infestations
Infection with normal ANC or Grade 1 or 2 neutrophils - Lung (pneumonia)
|
20.7%
6/29 • Number of events 9 • 6 years, 3 months
All participants
|
|
Infections and infestations
Infection with normal ANC or Grade 1 or 2 neutrophils - Skin (cellulitis)
|
3.4%
1/29 • Number of events 1 • 6 years, 3 months
All participants
|
|
Metabolism and nutrition disorders
Calcium, serum-high (hypercalcemia)
|
3.4%
1/29 • Number of events 2 • 6 years, 3 months
All participants
|
|
Nervous system disorders
Memory impairment
|
3.4%
1/29 • Number of events 1 • 6 years, 3 months
All participants
|
|
Psychiatric disorders
Mental status
|
3.4%
1/29 • Number of events 1 • 6 years, 3 months
All participants
|
|
Nervous system disorders
Neuropathy: sensory
|
3.4%
1/29 • Number of events 1 • 6 years, 3 months
All participants
|
|
Nervous system disorders
Seizure
|
3.4%
1/29 • Number of events 1 • 6 years, 3 months
All participants
|
|
Nervous system disorders
Tremor
|
3.4%
1/29 • Number of events 1 • 6 years, 3 months
All participants
|
|
General disorders
Pain - Abdomen NOS
|
6.9%
2/29 • Number of events 4 • 6 years, 3 months
All participants
|
|
General disorders
Pain - Chest wall
|
3.4%
1/29 • Number of events 1 • 6 years, 3 months
All participants
|
|
General disorders
Pain - Chest/thorax NOS
|
6.9%
2/29 • Number of events 2 • 6 years, 3 months
All participants
|
|
General disorders
Pain - Neck
|
6.9%
2/29 • Number of events 2 • 6 years, 3 months
All participants
|
|
General disorders
Pain - Pain NOS
|
3.4%
1/29 • Number of events 1 • 6 years, 3 months
All participants
|
|
General disorders
Pain NOS - Back
|
3.4%
1/29 • Number of events 1 • 6 years, 3 months
All participants
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
10.3%
3/29 • Number of events 3 • 6 years, 3 months
All participants
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea (shortness of breath)
|
24.1%
7/29 • Number of events 9 • 6 years, 3 months
All participants
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion (non-malignant)
|
3.4%
1/29 • Number of events 1 • 6 years, 3 months
All participants
|
|
Renal and urinary disorders
Renal failure
|
3.4%
1/29 • Number of events 1 • 6 years, 3 months
All participants
|
|
Renal and urinary disorders
Renal/Genitourinary - Other, chronic renal insufficiency
|
3.4%
1/29 • Number of events 1 • 6 years, 3 months
All participants
|
|
General disorders
Syndromes - Other, tumor fever
|
3.4%
1/29 • Number of events 1 • 6 years, 3 months
All participants
|
|
General disorders
Tumor flare
|
3.4%
1/29 • Number of events 1 • 6 years, 3 months
All participants
|
|
Metabolism and nutrition disorders
Tumor lysis syndrome
|
3.4%
1/29 • Number of events 1 • 6 years, 3 months
All participants
|
|
Vascular disorders
Thrombosis/embolism (vascular access-related)
|
3.4%
1/29 • Number of events 1 • 6 years, 3 months
All participants
|
|
Vascular disorders
Vascular - Other, CVA/CNS ischemia
|
3.4%
1/29 • Number of events 2 • 6 years, 3 months
All participants
|
Other adverse events
| Measure |
Experimental: Lenalidomide and Rituximab
n=29 participants at risk
28 day cycles of Lenalidomide administered orally and Rituximab administered intravenously.
Lenalidomide: Escalating doses starting with of 2.5 mg daily on 28-days cycles.
Rituximab: at 375 mg/m\^2 on a weekly basis for the first cycle starting on day 15.
|
|---|---|
|
General disorders
Fatigue (asthenia, lethargy, malaise)
|
79.3%
23/29 • Number of events 70 • 6 years, 3 months
All participants
|
|
General disorders
Rigors/chills
|
41.4%
12/29 • Number of events 17 • 6 years, 3 months
All participants
|
|
General disorders
Fever (in the absence of neutropenia)
|
37.9%
11/29 • Number of events 14 • 6 years, 3 months
All participants
|
|
General disorders
Sweating (diaphoresis)
|
37.9%
11/29 • Number of events 19 • 6 years, 3 months
All participants
|
|
General disorders
Insomnia
|
24.1%
7/29 • Number of events 11 • 6 years, 3 months
All participants
|
|
General disorders
Weight loss
|
13.8%
4/29 • Number of events 6 • 6 years, 3 months
All participants
|
|
Gastrointestinal disorders
Constitutional Symptoms -
|
62.1%
18/29 • Number of events 36 • 6 years, 3 months
All participants
|
|
Gastrointestinal disorders
Nausea
|
41.4%
12/29 • Number of events 16 • 6 years, 3 months
All participants
|
|
Gastrointestinal disorders
Gastrointestinal - Other
|
34.5%
10/29 • Number of events 13 • 6 years, 3 months
All participants
|
|
Gastrointestinal disorders
Constipation
|
27.6%
8/29 • Number of events 11 • 6 years, 3 months
All participants
|
|
Gastrointestinal disorders
Vomiting
|
24.1%
7/29 • Number of events 9 • 6 years, 3 months
All participants
|
|
Gastrointestinal disorders
Anorexia
|
17.2%
5/29 • Number of events 7 • 6 years, 3 months
All participants
|
|
Gastrointestinal disorders
Distension/bloating, abdominal
|
6.9%
2/29 • Number of events 3 • 6 years, 3 months
All participants
|
|
Gastrointestinal disorders
Mucositis/stomatitis (functional/symptomatic) - Oral cavity
|
6.9%
2/29 • Number of events 2 • 6 years, 3 months
All participants
|
|
General disorders
Pain - Other
|
48.3%
14/29 • Number of events 43 • 6 years, 3 months
All participants
|
|
General disorders
Pain - Back
|
34.5%
10/29 • Number of events 21 • 6 years, 3 months
All participants
|
|
General disorders
Pain - Head/headache
|
34.5%
10/29 • Number of events 16 • 6 years, 3 months
All participants
|
|
General disorders
Pain - Abdomen NOS
|
20.7%
6/29 • Number of events 11 • 6 years, 3 months
All participants
|
|
General disorders
Pain - Chest/thorax NOS
|
17.2%
5/29 • Number of events 8 • 6 years, 3 months
All participants
|
|
General disorders
Pain - Lymph node
|
17.2%
5/29 • Number of events 9 • 6 years, 3 months
All participants
|
|
General disorders
Pain - Neck
|
17.2%
5/29 • Number of events 9 • 6 years, 3 months
All participants
|
|
General disorders
Pain - Extremity-limb
|
13.8%
4/29 • Number of events 8 • 6 years, 3 months
All participants
|
|
General disorders
Pain - Throat/pharynx/larynx
|
13.8%
4/29 • Number of events 4 • 6 years, 3 months
All participants
|
|
General disorders
Pain - Chest wall
|
10.3%
3/29 • Number of events 4 • 6 years, 3 months
All participants
|
|
General disorders
Pain - Joint
|
10.3%
3/29 • Number of events 5 • 6 years, 3 months
All participants
|
|
General disorders
Pain - Oral cavity
|
6.9%
2/29 • Number of events 3 • 6 years, 3 months
All participants
|
|
General disorders
Pain - Pain NOS
|
6.9%
2/29 • Number of events 2 • 6 years, 3 months
All participants
|
|
General disorders
Pain - Stomach
|
6.9%
2/29 • Number of events 2 • 6 years, 3 months
All participants
|
|
Skin and subcutaneous tissue disorders
Dermatology/Skin - Other
|
41.4%
12/29 • Number of events 28 • 6 years, 3 months
All participants
|
|
Skin and subcutaneous tissue disorders
Pruritus/itching
|
31.0%
9/29 • Number of events 23 • 6 years, 3 months
All participants
|
|
Skin and subcutaneous tissue disorders
Bruising (in absence of Grade 3 or 4 thrombocytopenia)
|
13.8%
4/29 • Number of events 4 • 6 years, 3 months
All participants
|
|
Skin and subcutaneous tissue disorders
Rash/desquamation
|
13.8%
4/29 • Number of events 6 • 6 years, 3 months
All participants
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
6.9%
2/29 • Number of events 2 • 6 years, 3 months
All participants
|
|
Skin and subcutaneous tissue disorders
Rash: acne/acneiform
|
6.9%
2/29 • Number of events 2 • 6 years, 3 months
All participants
|
|
Skin and subcutaneous tissue disorders
Rash: hand-foot skin reaction
|
6.9%
2/29 • Number of events 2 • 6 years, 3 months
All participants
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
51.7%
15/29 • Number of events 34 • 6 years, 3 months
All participants
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea (shortness of breath)
|
37.9%
11/29 • Number of events 14 • 6 years, 3 months
All participants
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary/Upper Respiratory - Other
|
27.6%
8/29 • Number of events 21 • 6 years, 3 months
All participants
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
6.9%
2/29 • Number of events 3 • 6 years, 3 months
All participants
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion (non-malignant)
|
6.9%
2/29 • Number of events 2 • 6 years, 3 months
All participants
|
|
Respiratory, thoracic and mediastinal disorders
Voice changes/dysarthria
|
6.9%
2/29 • Number of events 2 • 6 years, 3 months
All participants
|
|
Blood and lymphatic system disorders
Neutrophils/granulocytes (ANC/AGC) - low
|
37.9%
11/29 • Number of events 52 • 6 years, 3 months
All participants
|
|
Blood and lymphatic system disorders
Hemoglobin low
|
27.6%
8/29 • Number of events 13 • 6 years, 3 months
All participants
|
|
Blood and lymphatic system disorders
Platelets - low
|
27.6%
8/29 • Number of events 23 • 6 years, 3 months
All participants
|
|
Blood and lymphatic system disorders
Lymphopenia
|
6.9%
2/29 • Number of events 17 • 6 years, 3 months
All participants
|
|
Infections and infestations
Infection - Other
|
34.5%
10/29 • Number of events 19 • 6 years, 3 months
All participants
|
|
Infections and infestations
Febrile neutropenia
|
27.6%
8/29 • Number of events 10 • 6 years, 3 months
All participants
|
|
Infections and infestations
Infection with normal ANC or Grade 1 or 2 neutrophils - Lung (pneumonia)
|
20.7%
6/29 • Number of events 6 • 6 years, 3 months
All participants
|
|
Infections and infestations
Infection with unknown ANC - Lung (pneumonia)
|
13.8%
4/29 • Number of events 6 • 6 years, 3 months
All participants
|
|
Infections and infestations
Infection with Grade 3 or 4 neutrophils - Lung (pneumonia)
|
10.3%
3/29 • Number of events 3 • 6 years, 3 months
All participants
|
|
Infections and infestations
Infection with unknown ANC - Bronchus
|
6.9%
2/29 • Number of events 2 • 6 years, 3 months
All participants
|
|
Infections and infestations
Infection with unknown ANC - Sinus
|
6.9%
2/29 • Number of events 2 • 6 years, 3 months
All participants
|
|
Infections and infestations
Infection with unknown ANC - Skin (cellulitis)
|
6.9%
2/29 • Number of events 2 • 6 years, 3 months
All participants
|
|
Nervous system disorders
Dizziness
|
24.1%
7/29 • Number of events 9 • 6 years, 3 months
All participants
|
|
Nervous system disorders
Neuropathy: sensory
|
24.1%
7/29 • Number of events 14 • 6 years, 3 months
All participants
|
|
Nervous system disorders
Neurology - Other
|
20.7%
6/29 • Number of events 11 • 6 years, 3 months
All participants
|
|
Psychiatric disorders
Mood alteration - Anxiety
|
13.8%
4/29 • Number of events 5 • 6 years, 3 months
All participants
|
|
Psychiatric disorders
Mood alteration - Depression
|
13.8%
4/29 • Number of events 4 • 6 years, 3 months
All participants
|
|
Nervous system disorders
Memory impairment
|
10.3%
3/29 • Number of events 3 • 6 years, 3 months
All participants
|
|
Nervous system disorders
Tremor
|
10.3%
3/29 • Number of events 3 • 6 years, 3 months
All participants
|
|
Blood and lymphatic system disorders
Edema: limb
|
44.8%
13/29 • Number of events 21 • 6 years, 3 months
All participants
|
|
Blood and lymphatic system disorders
Lymphatics - Other
|
13.8%
4/29 • Number of events 4 • 6 years, 3 months
All participants
|
|
Blood and lymphatic system disorders
Edema: head and neck
|
6.9%
2/29 • Number of events 6 • 6 years, 3 months
All participants
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal/Soft Tissue - Other
|
27.6%
8/29 • Number of events 14 • 6 years, 3 months
All participants
|
|
Metabolism and nutrition disorders
Glucose, serum-high (hyperglycemia)
|
10.3%
3/29 • Number of events 3 • 6 years, 3 months
All participants
|
|
Metabolism and nutrition disorders
Calcium, serum-high (hypercalcemia)
|
6.9%
2/29 • Number of events 6 • 6 years, 3 months
All participants
|
|
Eye disorders
Vision-blurred vision
|
17.2%
5/29 • Number of events 6 • 6 years, 3 months
All participants
|
|
Eye disorders
Ocular/Visual - Other
|
13.8%
4/29 • Number of events 5 • 6 years, 3 months
All participants
|
|
Respiratory, thoracic and mediastinal disorders
Allergic rhinitis
|
10.3%
3/29 • Number of events 4 • 6 years, 3 months
All participants
|
|
Immune system disorders
Allergic reaction/hypersensitivity
|
6.9%
2/29 • Number of events 2 • 6 years, 3 months
All participants
|
|
Endocrine disorders
Hot flashes/flushes
|
13.8%
4/29 • Number of events 6 • 6 years, 3 months
All participants
|
|
Endocrine disorders
Thyroid function, low (hypothyroidism)
|
6.9%
2/29 • Number of events 2 • 6 years, 3 months
All participants
|
|
Renal and urinary disorders
Renal/Genitourinary - Other
|
10.3%
3/29 • Number of events 5 • 6 years, 3 months
All participants
|
|
Renal and urinary disorders
Urinary frequency/urgency
|
6.9%
2/29 • Number of events 4 • 6 years, 3 months
All participants
|
|
Cardiac disorders
Hypotension
|
10.3%
3/29 • Number of events 3 • 6 years, 3 months
All participants
|
|
General disorders
Tumor flare
|
10.3%
3/29 • Number of events 4 • 6 years, 3 months
All participants
|
|
Ear and labyrinth disorders
Auditory/Ear - Other
|
10.3%
3/29 • Number of events 6 • 6 years, 3 months
All participants
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Secondary Malignancy - possibly related to cancer treatment
|
6.9%
2/29 • Number of events 2 • 6 years, 3 months
All participants
|
Additional Information
Javier Pinilla-Ibarz
H. Lee Moffitt Cancer Center and Research Institute
Phone: 813-745-1387
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place