Trial Outcomes & Findings for Lenalidomide With or Without Rituximab in Treating Patients With Relapsed or Refractory Chronic Lymphocytic Leukemia (NCT NCT00096044)
NCT ID: NCT00096044
Last Updated: 2017-07-11
Results Overview
Percentage of patients achieving CR, PR or maintaining SD using the 1996 NCI-WF Criteria. CR: absence of lymph nodes and constitutional symptoms; no hepatomegaly or splenomegaly by physical examination; neutrophil count \>1500/μL; platelet count \>100,000/μL; untransfused hemoglobin concentration \>11.0g/dL; lymphocyte count \<4000/μL; bone marrow sample must be at least normocellular for age; with less than 30% of nucleated cells being lymphocytes and no lymphoid nodules. PR: ≥50% decrease in lymphocyte count from baseline; ≥50% reduction in lymph nodes from baseline; ≥50% reduction in the size of the liver/spleen from baseline; neutrophil count ≥1500/μL or ≥50% improvement from baseline; platelet count ≥100,000/μL or ≥50% improvement from baseline; untransfused hemoglobin concentration ≥11.0g/dL or ≥50% improvement from baseline. Patients have not exhibited as reappearance of malignant CLL clone on flow cytometry or by PCR analysis in blood or bone marrow, are considered to have SD.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
45 participants
Primary outcome timeframe
at 6 Months
Results posted on
2017-07-11
Participant Flow
Participant milestones
| Measure |
Oral Lenalidomide
Patients receive oral lenalidomide (CC-5013) once daily on days 1-21. Treatment repeats every 28 days for up to 12 courses in the absence of disease progression or unacceptable toxicity
rituximab: IV
lenalidomide: Oral
|
|---|---|
|
Overall Study
STARTED
|
45
|
|
Overall Study
COMPLETED
|
11
|
|
Overall Study
NOT COMPLETED
|
34
|
Reasons for withdrawal
| Measure |
Oral Lenalidomide
Patients receive oral lenalidomide (CC-5013) once daily on days 1-21. Treatment repeats every 28 days for up to 12 courses in the absence of disease progression or unacceptable toxicity
rituximab: IV
lenalidomide: Oral
|
|---|---|
|
Overall Study
Withdrawal by Subject
|
9
|
|
Overall Study
Adverse Event
|
21
|
|
Overall Study
Disease Progression
|
4
|
Baseline Characteristics
Lenalidomide With or Without Rituximab in Treating Patients With Relapsed or Refractory Chronic Lymphocytic Leukemia
Baseline characteristics by cohort
| Measure |
Oral Lenalidomide
n=45 Participants
Patients receive oral lenalidomide (CC-5013) once daily on days 1-21. Treatment repeats every 28 days for up to 12 courses in the absence of disease progression or unacceptable toxicity
rituximab: IV
lenalidomide: Oral
|
|---|---|
|
Age, Continuous
|
64.1 years
STANDARD_DEVIATION 7.9 • n=5 Participants
|
|
Sex: Female, Male
Female
|
9 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
36 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: at 6 MonthsPopulation: All treated and eligible patients
Percentage of patients achieving CR, PR or maintaining SD using the 1996 NCI-WF Criteria. CR: absence of lymph nodes and constitutional symptoms; no hepatomegaly or splenomegaly by physical examination; neutrophil count \>1500/μL; platelet count \>100,000/μL; untransfused hemoglobin concentration \>11.0g/dL; lymphocyte count \<4000/μL; bone marrow sample must be at least normocellular for age; with less than 30% of nucleated cells being lymphocytes and no lymphoid nodules. PR: ≥50% decrease in lymphocyte count from baseline; ≥50% reduction in lymph nodes from baseline; ≥50% reduction in the size of the liver/spleen from baseline; neutrophil count ≥1500/μL or ≥50% improvement from baseline; platelet count ≥100,000/μL or ≥50% improvement from baseline; untransfused hemoglobin concentration ≥11.0g/dL or ≥50% improvement from baseline. Patients have not exhibited as reappearance of malignant CLL clone on flow cytometry or by PCR analysis in blood or bone marrow, are considered to have SD.
Outcome measures
| Measure |
Oral Lenalidomide
n=45 Participants
Patients receive oral lenalidomide (CC-5013) once daily on days 1-21. Treatment repeats every 28 days for up to 12 courses in the absence of disease progression or unacceptable toxicity
rituximab: IV
lenalidomide: Oral
|
|---|---|
|
Percentage of Patients Achieving a Complete Response (CR), Partial Response (PR), or Stable Disease (SD) on Single Agent CC-5013 at 6 Months
|
68.9 percentage of participants
Interval 53.4 to 81.8
|
SECONDARY outcome
Timeframe: 5 yearsPopulation: All treated with combination therapy of CC-5013+Rituximab and eligible patients
Percentage of patients achieving CR, PR or maintaining SD using the 1996 NCI-WF Criteria. CR: absence of lymph nodes and constitutional symptoms; no hepatomegaly or splenomegaly by physical examination; neutrophil count \>1500/μL; platelet count \>100,000/μL; untransfused hemoglobin concentration \>11.0g/dL; lymphocyte count \<4000/μL; bone marrow sample must be at least normocellular for age; with less than 30% of nucleated cells being lymphocytes and no lymphoid nodules. PR: ≥50% decrease in lymphocyte count from baseline; ≥50% reduction in lymph nodes from baseline; ≥50% reduction in the size of the liver/spleen from baseline; neutrophil count ≥1500/μL or ≥50% improvement from baseline; platelet count ≥100,000/μL or ≥50% improvement from baseline; untransfused hemoglobin concentration ≥11.0g/dL or ≥50% improvement from baseline. Patients who have not exhibited as reappearance of malignant CLL clone on flow cytometry or by PCR analysis in blood or bone marrow, are considered to have SD.
Outcome measures
| Measure |
Oral Lenalidomide
n=8 Participants
Patients receive oral lenalidomide (CC-5013) once daily on days 1-21. Treatment repeats every 28 days for up to 12 courses in the absence of disease progression or unacceptable toxicity
rituximab: IV
lenalidomide: Oral
|
|---|---|
|
Percentage of Patients Achieving a Complete Response (CR), Partial Response (PR), or Stable Disease (SD) on Combination Therapy of CC-5013+Rituximab
|
100 percentage of participants
Interval 63.1 to 100.0
|
SECONDARY outcome
Timeframe: 1 yearPopulation: All treated and eligible patients
Number of Participants with Adverse Events on Single Agent CC-5013, Graded According to NCI CTCAE Version 3.0 Please refer to the adverse event reporting for more detail.
Outcome measures
| Measure |
Oral Lenalidomide
n=45 Participants
Patients receive oral lenalidomide (CC-5013) once daily on days 1-21. Treatment repeats every 28 days for up to 12 courses in the absence of disease progression or unacceptable toxicity
rituximab: IV
lenalidomide: Oral
|
|---|---|
|
Number of Participants With Adverse Events on Single Agent CC-5013
Grade 4
|
33 Participants
|
|
Number of Participants With Adverse Events on Single Agent CC-5013
Grade 1
|
0 Participants
|
|
Number of Participants With Adverse Events on Single Agent CC-5013
Grade 2
|
3 Participants
|
|
Number of Participants With Adverse Events on Single Agent CC-5013
Grade 3
|
7 Participants
|
|
Number of Participants With Adverse Events on Single Agent CC-5013
Grade 5
|
2 Participants
|
SECONDARY outcome
Timeframe: Up to 30 days from last date of institution of combination therapy of CC-5013+Rituximab.Population: All treated with combination therapy of CC-5013+Rituximab and eligible patients
Number of Participants with Adverse Events on Combination Therapy of CC-5013+Rituximab, Graded According to NCI CTCAE Version 3.0
Outcome measures
| Measure |
Oral Lenalidomide
n=8 Participants
Patients receive oral lenalidomide (CC-5013) once daily on days 1-21. Treatment repeats every 28 days for up to 12 courses in the absence of disease progression or unacceptable toxicity
rituximab: IV
lenalidomide: Oral
|
|---|---|
|
Number of Participants With Adverse Events on Combination Therapy of CC-5013+Rituximab
Grade 1
|
1 Participants
|
|
Number of Participants With Adverse Events on Combination Therapy of CC-5013+Rituximab
Grade 2
|
0 Participants
|
|
Number of Participants With Adverse Events on Combination Therapy of CC-5013+Rituximab
Grade 3
|
3 Participants
|
|
Number of Participants With Adverse Events on Combination Therapy of CC-5013+Rituximab
Grade 4
|
3 Participants
|
SECONDARY outcome
Timeframe: 5 yearsPopulation: All treated and eligible patients
Progressive disease is defined as reappearance of malignant CLL clone on flow cytometry or by PCR analysis in blood or bone marrow using the 1996 NCI-WF Criteria.
Outcome measures
| Measure |
Oral Lenalidomide
n=45 Participants
Patients receive oral lenalidomide (CC-5013) once daily on days 1-21. Treatment repeats every 28 days for up to 12 courses in the absence of disease progression or unacceptable toxicity
rituximab: IV
lenalidomide: Oral
|
|---|---|
|
Time to Progression for Single Agent CC-5013
|
23.0 months
Interval 12.1 to 78.7
|
SECONDARY outcome
Timeframe: Every month up to 6 months and every 3 months thereafter up to 5 yearsPopulation: All treated with combination therapy of CC-5013+Rituximab and eligible patients
Progressive disease is defined as reappearance of malignant CLL clone on flow cytometry or by PCR analysis in blood or bone marrow using the 1996 NCI-WF Criteria.
Outcome measures
| Measure |
Oral Lenalidomide
n=8 Participants
Patients receive oral lenalidomide (CC-5013) once daily on days 1-21. Treatment repeats every 28 days for up to 12 courses in the absence of disease progression or unacceptable toxicity
rituximab: IV
lenalidomide: Oral
|
|---|---|
|
Time to Progression for the Combination Therapy of CC-5013+Rituximab
|
18.7 months
Interval 0.9 to 23.0
|
Adverse Events
Oral Lenalidomide
Serious events: 29 serious events
Other events: 44 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Oral Lenalidomide
n=45 participants at risk
Patients receive oral lenalidomide (CC-5013) once daily on days 1-21. Treatment repeats every 28 days for up to 12 courses in the absence of disease progression or unacceptable toxicity
rituximab: IV
lenalidomide: Oral
|
|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
8.9%
4/45 • Number of events 5
|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
24.4%
11/45 • Number of events 16
|
|
Blood and lymphatic system disorders
Neutropenia
|
11.1%
5/45 • Number of events 6
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
8.9%
4/45 • Number of events 4
|
|
Cardiac disorders
Cardio-respiratory arrest
|
4.4%
2/45 • Number of events 2
|
|
Cardiac disorders
Myocardial ischaemia
|
2.2%
1/45 • Number of events 1
|
|
Cardiac disorders
Palpitations
|
2.2%
1/45 • Number of events 1
|
|
Gastrointestinal disorders
Diarrhoea
|
2.2%
1/45 • Number of events 1
|
|
Gastrointestinal disorders
Nausea
|
2.2%
1/45 • Number of events 1
|
|
General disorders
Chest pain
|
6.7%
3/45 • Number of events 3
|
|
General disorders
Chills
|
2.2%
1/45 • Number of events 1
|
|
General disorders
Death
|
4.4%
2/45 • Number of events 2
|
|
General disorders
Fatigue
|
2.2%
1/45 • Number of events 1
|
|
General disorders
Pyrexia
|
6.7%
3/45 • Number of events 3
|
|
Hepatobiliary disorders
Hyperbilirubinaemia
|
2.2%
1/45 • Number of events 1
|
|
Infections and infestations
Bacteraemia
|
2.2%
1/45 • Number of events 1
|
|
Infections and infestations
Device related infection
|
2.2%
1/45 • Number of events 1
|
|
Infections and infestations
Diverticulitis
|
2.2%
1/45 • Number of events 1
|
|
Infections and infestations
Herpes simplex
|
2.2%
1/45 • Number of events 1
|
|
Infections and infestations
Herpes zoster
|
2.2%
1/45 • Number of events 1
|
|
Infections and infestations
Infection
|
4.4%
2/45 • Number of events 3
|
|
Infections and infestations
Lobar pneumonia
|
2.2%
1/45 • Number of events 1
|
|
Infections and infestations
Pneumonia
|
26.7%
12/45 • Number of events 15
|
|
Infections and infestations
Pseudomonal bacteraemia
|
2.2%
1/45 • Number of events 1
|
|
Infections and infestations
Sepsis
|
4.4%
2/45 • Number of events 2
|
|
Infections and infestations
Sinusitis
|
2.2%
1/45 • Number of events 1
|
|
Infections and infestations
Skin infection
|
2.2%
1/45 • Number of events 1
|
|
Infections and infestations
Staphylococcal infection
|
2.2%
1/45 • Number of events 1
|
|
Infections and infestations
Upper respiratory tract infection
|
4.4%
2/45 • Number of events 2
|
|
Injury, poisoning and procedural complications
Collapse of lung
|
2.2%
1/45 • Number of events 1
|
|
Investigations
Breath sounds abnormal
|
2.2%
1/45 • Number of events 1
|
|
Metabolism and nutrition disorders
Hypercalcaemia
|
2.2%
1/45 • Number of events 1
|
|
Metabolism and nutrition disorders
Hypocalcaemia
|
2.2%
1/45 • Number of events 1
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
2.2%
1/45 • Number of events 1
|
|
Metabolism and nutrition disorders
Tumour lysis syndrome
|
2.2%
1/45 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
2.2%
1/45 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
2.2%
1/45 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
Bone pain
|
2.2%
1/45 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal discomfort
|
2.2%
1/45 • Number of events 1
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Tumour flare
|
6.7%
3/45 • Number of events 3
|
|
Psychiatric disorders
Confusional state
|
2.2%
1/45 • Number of events 1
|
|
Psychiatric disorders
Mental status changes
|
2.2%
1/45 • Number of events 1
|
|
Renal and urinary disorders
Renal failure
|
2.2%
1/45 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Atelectasis
|
2.2%
1/45 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
2.2%
1/45 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
6.7%
3/45 • Number of events 4
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
2.2%
1/45 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Laryngospasm
|
2.2%
1/45 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
6.7%
3/45 • Number of events 5
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonitis
|
2.2%
1/45 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
6.7%
3/45 • Number of events 3
|
|
Skin and subcutaneous tissue disorders
Hyperhidrosis
|
2.2%
1/45 • Number of events 1
|
|
Surgical and medical procedures
Intestinal anastomosis
|
2.2%
1/45 • Number of events 1
|
|
Vascular disorders
Deep vein thrombosis
|
4.4%
2/45 • Number of events 2
|
Other adverse events
| Measure |
Oral Lenalidomide
n=45 participants at risk
Patients receive oral lenalidomide (CC-5013) once daily on days 1-21. Treatment repeats every 28 days for up to 12 courses in the absence of disease progression or unacceptable toxicity
rituximab: IV
lenalidomide: Oral
|
|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
77.8%
35/45 • Number of events 51
|
|
Blood and lymphatic system disorders
Anaemia haemolytic autoimmune
|
2.2%
1/45 • Number of events 1
|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
2.2%
1/45 • Number of events 1
|
|
Blood and lymphatic system disorders
Haemolytic anaemia
|
2.2%
1/45 • Number of events 1
|
|
Blood and lymphatic system disorders
Leukopenia
|
44.4%
20/45 • Number of events 44
|
|
Blood and lymphatic system disorders
Lymph node pain
|
2.2%
1/45 • Number of events 1
|
|
Blood and lymphatic system disorders
Lymphadenopathy
|
2.2%
1/45 • Number of events 1
|
|
Blood and lymphatic system disorders
Lymphopenia
|
13.3%
6/45 • Number of events 7
|
|
Blood and lymphatic system disorders
Neutropenia
|
91.1%
41/45 • Number of events 128
|
|
Blood and lymphatic system disorders
Splenomegaly
|
2.2%
1/45 • Number of events 1
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
91.1%
41/45 • Number of events 79
|
|
Cardiac disorders
Bradycardia
|
6.7%
3/45 • Number of events 3
|
|
Cardiac disorders
Cardiac failure congestive
|
4.4%
2/45 • Number of events 2
|
|
Cardiac disorders
Cardiac flutter
|
2.2%
1/45 • Number of events 1
|
|
Cardiac disorders
Myocardial ischaemia
|
2.2%
1/45 • Number of events 1
|
|
Cardiac disorders
Tachycardia
|
2.2%
1/45 • Number of events 1
|
|
Cardiac disorders
Ventricular extrasystoles
|
2.2%
1/45 • Number of events 1
|
|
Ear and labyrinth disorders
Cerumen impaction
|
2.2%
1/45 • Number of events 1
|
|
Ear and labyrinth disorders
Ear congestion
|
2.2%
1/45 • Number of events 1
|
|
Ear and labyrinth disorders
Ear discomfort
|
4.4%
2/45 • Number of events 2
|
|
Ear and labyrinth disorders
Ear pain
|
4.4%
2/45 • Number of events 2
|
|
Ear and labyrinth disorders
Vertigo
|
2.2%
1/45 • Number of events 2
|
|
Eye disorders
Cataract
|
4.4%
2/45 • Number of events 2
|
|
Eye disorders
Eye irritation
|
2.2%
1/45 • Number of events 1
|
|
Eye disorders
Eye oedema
|
4.4%
2/45 • Number of events 2
|
|
Eye disorders
Lacrimation increased
|
6.7%
3/45 • Number of events 3
|
|
Eye disorders
Ocular hyperaemia
|
2.2%
1/45 • Number of events 1
|
|
Eye disorders
Periorbital oedema
|
2.2%
1/45 • Number of events 2
|
|
Eye disorders
Photopsia
|
2.2%
1/45 • Number of events 1
|
|
Eye disorders
Scleral discolouration
|
2.2%
1/45 • Number of events 1
|
|
Eye disorders
Vision blurred
|
13.3%
6/45 • Number of events 7
|
|
Eye disorders
Visual impairment
|
2.2%
1/45 • Number of events 1
|
|
Gastrointestinal disorders
Abdominal discomfort
|
4.4%
2/45 • Number of events 3
|
|
Gastrointestinal disorders
Abdominal distension
|
24.4%
11/45 • Number of events 13
|
|
Gastrointestinal disorders
Abdominal pain
|
22.2%
10/45 • Number of events 12
|
|
Gastrointestinal disorders
Abdominal pain lower
|
2.2%
1/45 • Number of events 1
|
|
Gastrointestinal disorders
Abdominal pain upper
|
11.1%
5/45 • Number of events 6
|
|
Gastrointestinal disorders
Abdominal tenderness
|
2.2%
1/45 • Number of events 1
|
|
Gastrointestinal disorders
Aphthous stomatitis
|
4.4%
2/45 • Number of events 2
|
|
Gastrointestinal disorders
Cheilitis
|
2.2%
1/45 • Number of events 1
|
|
Gastrointestinal disorders
Colitis
|
2.2%
1/45 • Number of events 1
|
|
Gastrointestinal disorders
Colitis ulcerative
|
2.2%
1/45 • Number of events 1
|
|
Gastrointestinal disorders
Constipation
|
42.2%
19/45 • Number of events 21
|
|
Gastrointestinal disorders
Diarrhoea
|
53.3%
24/45 • Number of events 44
|
|
Gastrointestinal disorders
Dry mouth
|
6.7%
3/45 • Number of events 3
|
|
Gastrointestinal disorders
Dyspepsia
|
6.7%
3/45 • Number of events 4
|
|
Gastrointestinal disorders
Dysphagia
|
6.7%
3/45 • Number of events 3
|
|
Gastrointestinal disorders
Eructation
|
4.4%
2/45 • Number of events 2
|
|
Gastrointestinal disorders
Flatulence
|
4.4%
2/45 • Number of events 2
|
|
Gastrointestinal disorders
Gastritis
|
2.2%
1/45 • Number of events 1
|
|
Gastrointestinal disorders
Gingival pain
|
2.2%
1/45 • Number of events 1
|
|
Gastrointestinal disorders
Gingivitis
|
2.2%
1/45 • Number of events 1
|
|
Gastrointestinal disorders
Glossodynia
|
2.2%
1/45 • Number of events 1
|
|
Gastrointestinal disorders
Hypoaesthesia oral
|
2.2%
1/45 • Number of events 1
|
|
Gastrointestinal disorders
Lip pain
|
2.2%
1/45 • Number of events 1
|
|
Gastrointestinal disorders
Lip swelling
|
2.2%
1/45 • Number of events 1
|
|
Gastrointestinal disorders
Nausea
|
35.6%
16/45 • Number of events 17
|
|
Gastrointestinal disorders
Odynophagia
|
2.2%
1/45 • Number of events 1
|
|
Gastrointestinal disorders
Oral discomfort
|
2.2%
1/45 • Number of events 1
|
|
Gastrointestinal disorders
Oral pain
|
4.4%
2/45 • Number of events 2
|
|
Gastrointestinal disorders
Painful defaecation
|
2.2%
1/45 • Number of events 1
|
|
Gastrointestinal disorders
Stomatitis
|
2.2%
1/45 • Number of events 1
|
|
Gastrointestinal disorders
Tongue coated
|
4.4%
2/45 • Number of events 2
|
|
Gastrointestinal disorders
Toothache
|
2.2%
1/45 • Number of events 1
|
|
Gastrointestinal disorders
Vomiting
|
24.4%
11/45 • Number of events 12
|
|
General disorders
Asthenia
|
51.1%
23/45 • Number of events 28
|
|
General disorders
Axillary pain
|
2.2%
1/45 • Number of events 1
|
|
General disorders
Chest pain
|
11.1%
5/45 • Number of events 7
|
|
General disorders
Chills
|
2.2%
1/45 • Number of events 1
|
|
General disorders
Crepitations
|
4.4%
2/45 • Number of events 2
|
|
General disorders
Early satiety
|
2.2%
1/45 • Number of events 1
|
|
General disorders
Effusion
|
2.2%
1/45 • Number of events 1
|
|
General disorders
Facial pain
|
2.2%
1/45 • Number of events 1
|
|
General disorders
Fatigue
|
95.6%
43/45 • Number of events 70
|
|
General disorders
Feeling abnormal
|
2.2%
1/45 • Number of events 1
|
|
General disorders
Feeling hot
|
4.4%
2/45 • Number of events 2
|
|
General disorders
Influenza like illness
|
8.9%
4/45 • Number of events 4
|
|
General disorders
Irritability
|
2.2%
1/45 • Number of events 1
|
|
General disorders
Local swelling
|
2.2%
1/45 • Number of events 1
|
|
General disorders
Malaise
|
4.4%
2/45 • Number of events 2
|
|
General disorders
Oedema
|
24.4%
11/45 • Number of events 13
|
|
General disorders
Oedema peripheral
|
35.6%
16/45 • Number of events 26
|
|
General disorders
Pain
|
6.7%
3/45 • Number of events 5
|
|
General disorders
Pyrexia
|
35.6%
16/45 • Number of events 18
|
|
General disorders
Tenderness
|
2.2%
1/45 • Number of events 1
|
|
General disorders
Thirst
|
2.2%
1/45 • Number of events 1
|
|
Hepatobiliary disorders
Hepatic function abnormal
|
2.2%
1/45 • Number of events 1
|
|
Hepatobiliary disorders
Hyperbilirubinaemia
|
24.4%
11/45 • Number of events 19
|
|
Hepatobiliary disorders
Jaundice
|
2.2%
1/45 • Number of events 1
|
|
Immune system disorders
Hypersensitivity
|
2.2%
1/45 • Number of events 1
|
|
Infections and infestations
Bronchitis
|
4.4%
2/45 • Number of events 2
|
|
Infections and infestations
Cellulitis
|
4.4%
2/45 • Number of events 2
|
|
Infections and infestations
Clostridial infection
|
2.2%
1/45 • Number of events 1
|
|
Infections and infestations
Ear infection
|
2.2%
1/45 • Number of events 1
|
|
Infections and infestations
Eye infection staphylococcal
|
2.2%
1/45 • Number of events 1
|
|
Infections and infestations
Fungal infection
|
8.9%
4/45 • Number of events 4
|
|
Infections and infestations
Helicobacter gastritis
|
2.2%
1/45 • Number of events 1
|
|
Infections and infestations
Herpes simplex
|
2.2%
1/45 • Number of events 2
|
|
Infections and infestations
Herpes zoster
|
4.4%
2/45 • Number of events 2
|
|
Infections and infestations
Herpes zoster disseminated
|
2.2%
1/45 • Number of events 1
|
|
Infections and infestations
Infection
|
4.4%
2/45 • Number of events 2
|
|
Infections and infestations
Nasopharyngitis
|
13.3%
6/45 • Number of events 6
|
|
Infections and infestations
Opportunistic infection
|
2.2%
1/45 • Number of events 1
|
|
Infections and infestations
Oral candidiasis
|
6.7%
3/45 • Number of events 3
|
|
Infections and infestations
Otitis media
|
2.2%
1/45 • Number of events 1
|
|
Infections and infestations
Pharyngitis
|
4.4%
2/45 • Number of events 2
|
|
Infections and infestations
Pneumonia
|
11.1%
5/45 • Number of events 6
|
|
Infections and infestations
Respiratory tract infection
|
6.7%
3/45 • Number of events 4
|
|
Infections and infestations
Rhinitis
|
2.2%
1/45 • Number of events 1
|
|
Infections and infestations
Sinusitis
|
22.2%
10/45 • Number of events 18
|
|
Infections and infestations
Tooth abscess
|
4.4%
2/45 • Number of events 2
|
|
Infections and infestations
Tooth infection
|
2.2%
1/45 • Number of events 1
|
|
Infections and infestations
Upper respiratory tract infection
|
26.7%
12/45 • Number of events 35
|
|
Infections and infestations
Urinary tract infection
|
2.2%
1/45 • Number of events 1
|
|
Infections and infestations
Viral infection
|
4.4%
2/45 • Number of events 2
|
|
Infections and infestations
Viral upper respiratory tract infection
|
2.2%
1/45 • Number of events 1
|
|
Infections and infestations
Vulvovaginal mycotic infection
|
2.2%
1/45 • Number of events 1
|
|
Injury, poisoning and procedural complications
Contusion
|
20.0%
9/45 • Number of events 10
|
|
Injury, poisoning and procedural complications
Muscle strain
|
2.2%
1/45 • Number of events 1
|
|
Injury, poisoning and procedural complications
Splenosis
|
2.2%
1/45 • Number of events 1
|
|
Injury, poisoning and procedural complications
Tendon injury
|
2.2%
1/45 • Number of events 1
|
|
Injury, poisoning and procedural complications
Thermal burn
|
2.2%
1/45 • Number of events 1
|
|
Injury, poisoning and procedural complications
Wound
|
2.2%
1/45 • Number of events 1
|
|
Investigations
Activated partial thromboplastin time prolonged
|
2.2%
1/45 • Number of events 2
|
|
Investigations
Alanine aminotransferase increased
|
31.1%
14/45 • Number of events 27
|
|
Investigations
Aspartate aminotransferase
|
2.2%
1/45 • Number of events 1
|
|
Investigations
Aspartate aminotransferase decreased
|
15.6%
7/45 • Number of events 7
|
|
Investigations
Aspartate aminotransferase increased
|
33.3%
15/45 • Number of events 26
|
|
Investigations
Blood alkaline phosphatase increased
|
40.0%
18/45 • Number of events 18
|
|
Investigations
Blood bilirubin increased
|
6.7%
3/45 • Number of events 5
|
|
Investigations
Blood creatine decreased
|
4.4%
2/45 • Number of events 2
|
|
Investigations
Blood creatinine
|
8.9%
4/45 • Number of events 4
|
|
Investigations
Blood creatinine decreased
|
6.7%
3/45 • Number of events 3
|
|
Investigations
Blood creatinine increased
|
6.7%
3/45 • Number of events 5
|
|
Investigations
Blood glucose increased
|
2.2%
1/45 • Number of events 1
|
|
Investigations
Blood phosphorus
|
8.9%
4/45 • Number of events 4
|
|
Investigations
Blood phosphorus decreased
|
2.2%
1/45 • Number of events 1
|
|
Investigations
Blood phosphorus increased
|
2.2%
1/45 • Number of events 1
|
|
Investigations
Blood potassium decreased
|
2.2%
1/45 • Number of events 1
|
|
Investigations
Blood pressure increased
|
2.2%
1/45 • Number of events 1
|
|
Investigations
Blood urea decreased
|
8.9%
4/45 • Number of events 4
|
|
Investigations
Blood urea increased
|
33.3%
15/45 • Number of events 15
|
|
Investigations
Blood uric acid decreased
|
11.1%
5/45 • Number of events 5
|
|
Investigations
Blood uric acid increased
|
6.7%
3/45 • Number of events 3
|
|
Investigations
Breath sounds abnormal
|
4.4%
2/45 • Number of events 2
|
|
Investigations
Immunoglobulins decreased
|
2.2%
1/45 • Number of events 1
|
|
Investigations
Liver function test abnormal
|
4.4%
2/45 • Number of events 3
|
|
Investigations
Platelet count decreased
|
4.4%
2/45 • Number of events 3
|
|
Investigations
Protein total decreased
|
2.2%
1/45 • Number of events 1
|
|
Investigations
Prothrombin time prolonged
|
2.2%
1/45 • Number of events 3
|
|
Investigations
Troponin
|
2.2%
1/45 • Number of events 1
|
|
Investigations
Weight decreased
|
28.9%
13/45 • Number of events 15
|
|
Investigations
Weight increased
|
2.2%
1/45 • Number of events 1
|
|
Investigations
pH urine abnormal
|
2.2%
1/45 • Number of events 1
|
|
Metabolism and nutrition disorders
Cachexia
|
2.2%
1/45 • Number of events 1
|
|
Metabolism and nutrition disorders
Decreased appetite
|
37.8%
17/45 • Number of events 19
|
|
Metabolism and nutrition disorders
Dehydration
|
2.2%
1/45 • Number of events 1
|
|
Metabolism and nutrition disorders
Hypercalcaemia
|
2.2%
1/45 • Number of events 2
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
26.7%
12/45 • Number of events 16
|
|
Metabolism and nutrition disorders
Hyperkalaemia
|
24.4%
11/45 • Number of events 14
|
|
Metabolism and nutrition disorders
Hypermagnesaemia
|
2.2%
1/45 • Number of events 1
|
|
Metabolism and nutrition disorders
Hypernatraemia
|
15.6%
7/45 • Number of events 7
|
|
Metabolism and nutrition disorders
Hyperphosphataemia
|
15.6%
7/45 • Number of events 7
|
|
Metabolism and nutrition disorders
Hyperproteinaemia
|
2.2%
1/45 • Number of events 1
|
|
Metabolism and nutrition disorders
Hyperuricaemia
|
2.2%
1/45 • Number of events 1
|
|
Metabolism and nutrition disorders
Hypoalbuminaemia
|
44.4%
20/45 • Number of events 31
|
|
Metabolism and nutrition disorders
Hypocalcaemia
|
60.0%
27/45 • Number of events 43
|
|
Metabolism and nutrition disorders
Hypoglycaemia
|
6.7%
3/45 • Number of events 5
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
37.8%
17/45 • Number of events 20
|
|
Metabolism and nutrition disorders
Hypomagnesaemia
|
2.2%
1/45 • Number of events 1
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
44.4%
20/45 • Number of events 22
|
|
Metabolism and nutrition disorders
Hypophagia
|
2.2%
1/45 • Number of events 1
|
|
Metabolism and nutrition disorders
Hypophosphataemia
|
11.1%
5/45 • Number of events 5
|
|
Metabolism and nutrition disorders
Hypoproteinaemia
|
46.7%
21/45 • Number of events 21
|
|
Metabolism and nutrition disorders
Hypouricaemia
|
6.7%
3/45 • Number of events 4
|
|
Metabolism and nutrition disorders
Tumour lysis syndrome
|
2.2%
1/45 • Number of events 2
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
20.0%
9/45 • Number of events 9
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
20.0%
9/45 • Number of events 12
|
|
Musculoskeletal and connective tissue disorders
Bone pain
|
4.4%
2/45 • Number of events 3
|
|
Musculoskeletal and connective tissue disorders
Flank pain
|
2.2%
1/45 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
Groin pain
|
4.4%
2/45 • Number of events 2
|
|
Musculoskeletal and connective tissue disorders
Joint swelling
|
2.2%
1/45 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
Limb discomfort
|
2.2%
1/45 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
Muscle spasms
|
17.8%
8/45 • Number of events 19
|
|
Musculoskeletal and connective tissue disorders
Muscle tightness
|
2.2%
1/45 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
Muscular weakness
|
11.1%
5/45 • Number of events 5
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal chest pain
|
2.2%
1/45 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal discomfort
|
2.2%
1/45 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
6.7%
3/45 • Number of events 4
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
6.7%
3/45 • Number of events 3
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
13.3%
6/45 • Number of events 9
|
|
Musculoskeletal and connective tissue disorders
Pain in jaw
|
4.4%
2/45 • Number of events 2
|
|
Musculoskeletal and connective tissue disorders
Tendonitis
|
2.2%
1/45 • Number of events 1
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Tumour flare
|
64.4%
29/45 • Number of events 35
|
|
Nervous system disorders
Burning sensation
|
2.2%
1/45 • Number of events 1
|
|
Nervous system disorders
Dementia
|
2.2%
1/45 • Number of events 1
|
|
Nervous system disorders
Disturbance in attention
|
4.4%
2/45 • Number of events 3
|
|
Nervous system disorders
Dizziness
|
35.6%
16/45 • Number of events 23
|
|
Nervous system disorders
Headache
|
31.1%
14/45 • Number of events 17
|
|
Nervous system disorders
Hypoaesthesia
|
11.1%
5/45 • Number of events 6
|
|
Nervous system disorders
Lethargy
|
4.4%
2/45 • Number of events 2
|
|
Nervous system disorders
Memory impairment
|
6.7%
3/45 • Number of events 3
|
|
Nervous system disorders
Migraine with aura
|
2.2%
1/45 • Number of events 1
|
|
Nervous system disorders
Neuropathy peripheral
|
26.7%
12/45 • Number of events 13
|
|
Nervous system disorders
Paraesthesia
|
2.2%
1/45 • Number of events 1
|
|
Nervous system disorders
Peripheral sensory neuropathy
|
2.2%
1/45 • Number of events 1
|
|
Nervous system disorders
Post herpetic neuralgia
|
2.2%
1/45 • Number of events 1
|
|
Nervous system disorders
Sinus headache
|
4.4%
2/45 • Number of events 2
|
|
Nervous system disorders
Somnolence
|
2.2%
1/45 • Number of events 1
|
|
Nervous system disorders
Syncope
|
2.2%
1/45 • Number of events 1
|
|
Nervous system disorders
Tremor
|
4.4%
2/45 • Number of events 3
|
|
Psychiatric disorders
Agitation
|
2.2%
1/45 • Number of events 1
|
|
Psychiatric disorders
Anxiety
|
6.7%
3/45 • Number of events 3
|
|
Psychiatric disorders
Confusional state
|
4.4%
2/45 • Number of events 2
|
|
Psychiatric disorders
Depression
|
8.9%
4/45 • Number of events 5
|
|
Psychiatric disorders
Disorientation
|
2.2%
1/45 • Number of events 1
|
|
Psychiatric disorders
Hallucination
|
2.2%
1/45 • Number of events 1
|
|
Psychiatric disorders
Insomnia
|
20.0%
9/45 • Number of events 9
|
|
Psychiatric disorders
Mood altered
|
2.2%
1/45 • Number of events 1
|
|
Psychiatric disorders
Panic attack
|
2.2%
1/45 • Number of events 1
|
|
Psychiatric disorders
Psychotic disorder
|
2.2%
1/45 • Number of events 1
|
|
Psychiatric disorders
Restlessness
|
2.2%
1/45 • Number of events 1
|
|
Renal and urinary disorders
Dysuria
|
2.2%
1/45 • Number of events 1
|
|
Renal and urinary disorders
Haematuria
|
4.4%
2/45 • Number of events 2
|
|
Renal and urinary disorders
Haemorrhage urinary tract
|
2.2%
1/45 • Number of events 1
|
|
Renal and urinary disorders
Nocturia
|
8.9%
4/45 • Number of events 4
|
|
Renal and urinary disorders
Pollakiuria
|
2.2%
1/45 • Number of events 1
|
|
Renal and urinary disorders
Renal failure
|
4.4%
2/45 • Number of events 2
|
|
Renal and urinary disorders
Urethral pain
|
2.2%
1/45 • Number of events 1
|
|
Renal and urinary disorders
Urethral spasm
|
2.2%
1/45 • Number of events 1
|
|
Renal and urinary disorders
Urinary hesitation
|
2.2%
1/45 • Number of events 1
|
|
Renal and urinary disorders
Urinary incontinence
|
2.2%
1/45 • Number of events 1
|
|
Renal and urinary disorders
Urinary retention
|
4.4%
2/45 • Number of events 2
|
|
Respiratory, thoracic and mediastinal disorders
Atelectasis
|
2.2%
1/45 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Bronchiectasis
|
2.2%
1/45 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
42.2%
19/45 • Number of events 30
|
|
Respiratory, thoracic and mediastinal disorders
Dysphonia
|
8.9%
4/45 • Number of events 4
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
60.0%
27/45 • Number of events 34
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea exertional
|
17.8%
8/45 • Number of events 8
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
11.1%
5/45 • Number of events 6
|
|
Respiratory, thoracic and mediastinal disorders
Hyperventilation
|
2.2%
1/45 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Hypopnoea
|
2.2%
1/45 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
4.4%
2/45 • Number of events 3
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
20.0%
9/45 • Number of events 10
|
|
Respiratory, thoracic and mediastinal disorders
Nasal discomfort
|
4.4%
2/45 • Number of events 2
|
|
Respiratory, thoracic and mediastinal disorders
Nasal obstruction
|
2.2%
1/45 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
22.2%
10/45 • Number of events 13
|
|
Respiratory, thoracic and mediastinal disorders
Pharyngeal oedema
|
2.2%
1/45 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
11.1%
5/45 • Number of events 5
|
|
Respiratory, thoracic and mediastinal disorders
Pleurisy
|
2.2%
1/45 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Productive cough
|
20.0%
9/45 • Number of events 10
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary hypertension
|
2.2%
1/45 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Rales
|
4.4%
2/45 • Number of events 2
|
|
Respiratory, thoracic and mediastinal disorders
Rhinorrhoea
|
17.8%
8/45 • Number of events 11
|
|
Respiratory, thoracic and mediastinal disorders
Rhonchi
|
2.2%
1/45 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Sinus congestion
|
8.9%
4/45 • Number of events 4
|
|
Respiratory, thoracic and mediastinal disorders
Tonsillar inflammation
|
2.2%
1/45 • Number of events 2
|
|
Respiratory, thoracic and mediastinal disorders
Upper respiratory tract congestion
|
2.2%
1/45 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Upper-airway cough syndrome
|
4.4%
2/45 • Number of events 2
|
|
Respiratory, thoracic and mediastinal disorders
Wheezing
|
11.1%
5/45 • Number of events 5
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
2.2%
1/45 • Number of events 1
|
|
Skin and subcutaneous tissue disorders
Blister
|
2.2%
1/45 • Number of events 1
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
22.2%
10/45 • Number of events 10
|
|
Skin and subcutaneous tissue disorders
Erythema
|
6.7%
3/45 • Number of events 4
|
|
Skin and subcutaneous tissue disorders
Hyperhidrosis
|
11.1%
5/45 • Number of events 5
|
|
Skin and subcutaneous tissue disorders
Hypoaesthesia facial
|
2.2%
1/45 • Number of events 2
|
|
Skin and subcutaneous tissue disorders
Nail discolouration
|
2.2%
1/45 • Number of events 1
|
|
Skin and subcutaneous tissue disorders
Night sweats
|
26.7%
12/45 • Number of events 16
|
|
Skin and subcutaneous tissue disorders
Pain of skin
|
2.2%
1/45 • Number of events 1
|
|
Skin and subcutaneous tissue disorders
Petechiae
|
4.4%
2/45 • Number of events 2
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
28.9%
13/45 • Number of events 15
|
|
Skin and subcutaneous tissue disorders
Pyoderma gangrenosum
|
2.2%
1/45 • Number of events 2
|
|
Skin and subcutaneous tissue disorders
Rash
|
60.0%
27/45 • Number of events 40
|
|
Skin and subcutaneous tissue disorders
Rash erythematous
|
2.2%
1/45 • Number of events 2
|
|
Skin and subcutaneous tissue disorders
Rash generalised
|
4.4%
2/45 • Number of events 2
|
|
Skin and subcutaneous tissue disorders
Rash pruritic
|
15.6%
7/45 • Number of events 8
|
|
Skin and subcutaneous tissue disorders
Skin discolouration
|
2.2%
1/45 • Number of events 1
|
|
Skin and subcutaneous tissue disorders
Skin hyperpigmentation
|
8.9%
4/45 • Number of events 4
|
|
Skin and subcutaneous tissue disorders
Skin lesion
|
15.6%
7/45 • Number of events 8
|
|
Skin and subcutaneous tissue disorders
Swelling face
|
2.2%
1/45 • Number of events 1
|
|
Skin and subcutaneous tissue disorders
Urticaria
|
4.4%
2/45 • Number of events 2
|
|
Surgical and medical procedures
Glaucoma drug therapy
|
2.2%
1/45 • Number of events 1
|
|
Surgical and medical procedures
Sinus operation
|
2.2%
1/45 • Number of events 1
|
|
Surgical and medical procedures
Tooth repair
|
2.2%
1/45 • Number of events 1
|
|
Vascular disorders
Deep vein thrombosis
|
2.2%
1/45 • Number of events 1
|
|
Vascular disorders
Haematoma
|
2.2%
1/45 • Number of events 1
|
|
Vascular disorders
Hot flush
|
4.4%
2/45 • Number of events 2
|
|
Vascular disorders
Hypotension
|
8.9%
4/45 • Number of events 4
|
|
Vascular disorders
Lymphoedema
|
2.2%
1/45 • Number of events 1
|
|
Vascular disorders
Pallor
|
11.1%
5/45 • Number of events 6
|
Additional Information
Senior Administrator, Compliance - Clinical Research Services
Roswell Park Cancer Institute
Phone: 716-845-2300
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place