Trial Outcomes & Findings for Fludarabine, Rituximab, and Alemtuzumab in Treating Patients With Chronic Lymphocytic Leukemia (NCT NCT00098670)
NCT ID: NCT00098670
Last Updated: 2014-05-21
Results Overview
A complete response, as defined by the National Cancer Institute Working Group (NCIWG): \- CR: no lymphadenopathy, hepatomegaly, splenomegaly or constitutional symptoms; normal complete blood count; confirmed by bone marrow (BM) aspirate \& biopsy
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
102 participants
Primary outcome timeframe
Duration of treatment (up to 13.5 months)
Results posted on
2014-05-21
Participant Flow
Between January 2005 and December 2006, 103 participants were recruited.
One participant was deemed ineligible and is excluded from all analyses per study design.
Participant milestones
| Measure |
Alemtuzumab Consolidation
Alemtuzumab consolidation following fludarabine and rituximab induction in patients with B-cell CLL
|
|---|---|
|
Overall Study
STARTED
|
102
|
|
Overall Study
COMPLETED
|
102
|
|
Overall Study
NOT COMPLETED
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Fludarabine, Rituximab, and Alemtuzumab in Treating Patients With Chronic Lymphocytic Leukemia
Baseline characteristics by cohort
| Measure |
Alemtuzumab Consolidation
n=102 Participants
Alemtuzumab consolidation following fludarabine and rituximab induction in patients with B-cell CLL
|
|---|---|
|
Age, Continuous
|
61 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
27 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
75 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
102 participants
n=5 Participants
|
|
Rai Stage
Stage 0
|
1 participants
n=5 Participants
|
|
Rai Stage
Stage I-II
|
71 participants
n=5 Participants
|
|
Rai Stage
Stage III-IV
|
30 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Duration of treatment (up to 13.5 months)Population: 58 participants were treated with Alemtuzumab.
A complete response, as defined by the National Cancer Institute Working Group (NCIWG): \- CR: no lymphadenopathy, hepatomegaly, splenomegaly or constitutional symptoms; normal complete blood count; confirmed by bone marrow (BM) aspirate \& biopsy
Outcome measures
| Measure |
Alemtuzumab Consolidation
n=58 Participants
Alemtuzumab consolidation following fludarabine and rituximab induction in patients with B-cell CLL
|
|---|---|
|
Number of Participants With a Complete Response After Treatment With Fludarabine & Rituximab Followed by Alemtuzumab
|
38 participants
|
SECONDARY outcome
Timeframe: Up to 9 monthsResponse, as defined by the National Cancer Institute Working Group (NCIWG): CR: no lymphadenopathy, hepatomegaly, splenomegaly or constitutional symptoms; normal complete blood count; confirmed by bone marrow (BM) aspirate \& biopsy PR: 50% decrease in peripheral blood lymphocytes, lymphadenopathy, liver/spleen size, presence/absence of constitutional symptoms; plus ≥1 of the following: ≥1500/μL polymorphonuclear leukocytes, \>100,000/μL platelets, \>11.0 g/dL hemoglobin or 50% improvement for these parameters without transfusions
Outcome measures
| Measure |
Alemtuzumab Consolidation
n=102 Participants
Alemtuzumab consolidation following fludarabine and rituximab induction in patients with B-cell CLL
|
|---|---|
|
Number of Participants With a Complete or Partial Response After Induction Therapy With Fludarabine & Rituximab
|
92 participants
|
SECONDARY outcome
Timeframe: 2 years from registrationPercentage of patients who were alive and progression free at 2 years. The 2-year progression free survival was estimated using the Kaplan Meier method.
Outcome measures
| Measure |
Alemtuzumab Consolidation
n=102 Participants
Alemtuzumab consolidation following fludarabine and rituximab induction in patients with B-cell CLL
|
|---|---|
|
2 Year Progression Free Survival
|
72 percentage of participants
|
SECONDARY outcome
Timeframe: 2 years from registrationPercentage of participants who were alive at 2 years. The 2 year survival was estimated using the Kaplan Meier method.
Outcome measures
| Measure |
Alemtuzumab Consolidation
n=102 Participants
Alemtuzumab consolidation following fludarabine and rituximab induction in patients with B-cell CLL
|
|---|---|
|
2 Year Survival
|
86 percentage of participants
|
SECONDARY outcome
Timeframe: 6 weeks beginning at study week 36Population: 58 participants were treatment with Alemtuzumab.
The National Cancer Institute (NCI) Common Toxicity Criteria (CTC) Version 2.0 was used to evaluate toxicity. Severe Adverse events are defined as grade 3, 4 or 5, at least possibly related to treatment. Grade 1: mild; Grade 2: moderate; Grade 3: Severe; Grade 4: Life Threatening; Grade 5: Death.
Outcome measures
| Measure |
Alemtuzumab Consolidation
n=58 Participants
Alemtuzumab consolidation following fludarabine and rituximab induction in patients with B-cell CLL
|
|---|---|
|
Number of Participants With Severe Non-Hematologic Adverse Events During Treatment With Alemtuzumab
|
23 participants
|
Adverse Events
FR Induction
Serious events: 19 serious events
Other events: 101 other events
Deaths: 0 deaths
Alemtuzumab Consolidation
Serious events: 23 serious events
Other events: 55 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
FR Induction
n=102 participants at risk
Fludarabine and rituximab induction in pts with B-cell CLL
|
Alemtuzumab Consolidation
n=58 participants at risk
Alemtuzumab consolidation following fludarabine and rituximab induction
|
|---|---|---|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
4.9%
5/102 • Number of events 6
|
12.1%
7/58 • Number of events 7
|
|
Blood and lymphatic system disorders
Hemoglobin decreased
|
11.8%
12/102 • Number of events 13
|
34.5%
20/58 • Number of events 26
|
|
Blood and lymphatic system disorders
Hemolysis
|
0.00%
0/102
|
3.4%
2/58 • Number of events 3
|
|
Blood and lymphatic system disorders
Lymphatic disorder
|
0.00%
0/102
|
1.7%
1/58 • Number of events 1
|
|
Cardiac disorders
Atrial fibrillation
|
0.98%
1/102 • Number of events 1
|
3.4%
2/58 • Number of events 3
|
|
Cardiac disorders
Atrial flutter
|
0.00%
0/102
|
1.7%
1/58 • Number of events 2
|
|
Cardiac disorders
Left ventricular failure
|
0.98%
1/102 • Number of events 1
|
1.7%
1/58 • Number of events 1
|
|
Cardiac disorders
Myocardial ischemia
|
0.00%
0/102
|
1.7%
1/58 • Number of events 1
|
|
Cardiac disorders
Pericardial effusion
|
0.00%
0/102
|
1.7%
1/58 • Number of events 1
|
|
Cardiac disorders
Sinus tachycardia
|
0.00%
0/102
|
6.9%
4/58 • Number of events 5
|
|
Cardiac disorders
Ventricular tachycardia
|
0.00%
0/102
|
1.7%
1/58 • Number of events 1
|
|
Ear and labyrinth disorders
External ear pain
|
0.00%
0/102
|
1.7%
1/58 • Number of events 1
|
|
Eye disorders
Vision blurred
|
0.98%
1/102 • Number of events 1
|
0.00%
0/58
|
|
Gastrointestinal disorders
Abdominal distension
|
0.00%
0/102
|
5.2%
3/58 • Number of events 3
|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/102
|
5.2%
3/58 • Number of events 3
|
|
Gastrointestinal disorders
Ascites
|
0.00%
0/102
|
3.4%
2/58 • Number of events 3
|
|
Gastrointestinal disorders
Colitis
|
2.0%
2/102 • Number of events 2
|
0.00%
0/58
|
|
Gastrointestinal disorders
Constipation
|
0.98%
1/102 • Number of events 1
|
3.4%
2/58 • Number of events 2
|
|
Gastrointestinal disorders
Diarrhea
|
3.9%
4/102 • Number of events 4
|
8.6%
5/58 • Number of events 5
|
|
Gastrointestinal disorders
Dysphagia
|
0.98%
1/102 • Number of events 1
|
1.7%
1/58 • Number of events 1
|
|
Gastrointestinal disorders
Gastritis
|
0.00%
0/102
|
1.7%
1/58 • Number of events 1
|
|
Gastrointestinal disorders
Ileus
|
0.00%
0/102
|
1.7%
1/58 • Number of events 1
|
|
Gastrointestinal disorders
Nausea
|
6.9%
7/102 • Number of events 7
|
12.1%
7/58 • Number of events 8
|
|
Gastrointestinal disorders
Upper gastrointestinal hemorrhage
|
0.00%
0/102
|
1.7%
1/58 • Number of events 1
|
|
Gastrointestinal disorders
Vomiting
|
2.9%
3/102 • Number of events 3
|
6.9%
4/58 • Number of events 4
|
|
General disorders
Chest pain
|
2.0%
2/102 • Number of events 2
|
3.4%
2/58 • Number of events 2
|
|
General disorders
Chills
|
3.9%
4/102 • Number of events 4
|
6.9%
4/58 • Number of events 4
|
|
General disorders
Edema limbs
|
3.9%
4/102 • Number of events 4
|
5.2%
3/58 • Number of events 3
|
|
General disorders
Fatigue
|
11.8%
12/102 • Number of events 12
|
32.8%
19/58 • Number of events 23
|
|
General disorders
Fever
|
4.9%
5/102 • Number of events 5
|
15.5%
9/58 • Number of events 10
|
|
General disorders
Flu-like symptoms
|
0.98%
1/102 • Number of events 1
|
0.00%
0/58
|
|
General disorders
Hypothermia
|
0.00%
0/102
|
1.7%
1/58 • Number of events 1
|
|
General disorders
Localized edema
|
2.9%
3/102 • Number of events 3
|
1.7%
1/58 • Number of events 1
|
|
General disorders
Multi-organ failure
|
0.00%
0/102
|
1.7%
1/58 • Number of events 1
|
|
General disorders
Visceral edema
|
0.00%
0/102
|
1.7%
1/58 • Number of events 2
|
|
Hepatobiliary disorders
Hepatic failure
|
0.00%
0/102
|
1.7%
1/58 • Number of events 1
|
|
Hepatobiliary disorders
Hepatobiliary disease
|
0.00%
0/102
|
1.7%
1/58 • Number of events 1
|
|
Immune system disorders
Hypersensitivity
|
2.0%
2/102 • Number of events 2
|
0.00%
0/58
|
|
Infections and infestations
Bladder infection
|
0.00%
0/102
|
5.2%
3/58 • Number of events 3
|
|
Infections and infestations
Encephalomyelitis infection
|
0.98%
1/102 • Number of events 1
|
1.7%
1/58 • Number of events 1
|
|
Infections and infestations
Infectious meningitis
|
0.00%
0/102
|
3.4%
2/58 • Number of events 2
|
|
Infections and infestations
Mucosal infection
|
0.98%
1/102 • Number of events 1
|
0.00%
0/58
|
|
Infections and infestations
Opportunistic infection
|
0.00%
0/102
|
5.2%
3/58 • Number of events 4
|
|
Infections and infestations
Pneumonia
|
2.0%
2/102 • Number of events 2
|
8.6%
5/58 • Number of events 7
|
|
Infections and infestations
Sepsis
|
0.98%
1/102 • Number of events 1
|
13.8%
8/58 • Number of events 8
|
|
Infections and infestations
Sinusitis
|
0.98%
1/102 • Number of events 1
|
0.00%
0/58
|
|
Infections and infestations
Skin infection
|
0.00%
0/102
|
1.7%
1/58 • Number of events 1
|
|
Infections and infestations
Upper aerodigestive tract infection
|
0.00%
0/102
|
1.7%
1/58 • Number of events 1
|
|
Infections and infestations
Upper respiratory infection
|
2.0%
2/102 • Number of events 2
|
1.7%
1/58 • Number of events 1
|
|
Infections and infestations
Urinary tract infection
|
0.98%
1/102 • Number of events 1
|
5.2%
3/58 • Number of events 3
|
|
Infections and infestations
Vaginal infection
|
0.98%
1/102 • Number of events 1
|
0.00%
0/58
|
|
Injury, poisoning and procedural complications
Bruising
|
0.98%
1/102 • Number of events 1
|
1.7%
1/58 • Number of events 1
|
|
Injury, poisoning and procedural complications
Tracheal hemorrhage
|
0.00%
0/102
|
1.7%
1/58 • Number of events 1
|
|
Investigations
Activated partial thromboplastin time prolonged
|
0.98%
1/102 • Number of events 1
|
1.7%
1/58 • Number of events 1
|
|
Investigations
Alanine aminotransferase increased
|
2.0%
2/102 • Number of events 2
|
15.5%
9/58 • Number of events 11
|
|
Investigations
Alkaline phosphatase increased
|
0.00%
0/102
|
10.3%
6/58 • Number of events 7
|
|
Investigations
Amylase increased
|
0.00%
0/102
|
1.7%
1/58 • Number of events 1
|
|
Investigations
Aspartate aminotransferase increased
|
2.0%
2/102 • Number of events 3
|
15.5%
9/58 • Number of events 11
|
|
Investigations
Blood bilirubin increased
|
2.0%
2/102 • Number of events 2
|
8.6%
5/58 • Number of events 6
|
|
Investigations
CD4 lymphocytes decreased
|
0.00%
0/102
|
1.7%
1/58 • Number of events 1
|
|
Investigations
Creatine phosphokinase increased
|
0.98%
1/102 • Number of events 1
|
1.7%
1/58 • Number of events 1
|
|
Investigations
Creatinine increased
|
2.9%
3/102 • Number of events 4
|
8.6%
5/58 • Number of events 8
|
|
Investigations
Haptoglobin decreased
|
0.00%
0/102
|
1.7%
1/58 • Number of events 1
|
|
Investigations
INR increased
|
0.00%
0/102
|
1.7%
1/58 • Number of events 1
|
|
Investigations
Laboratory test abnormal
|
0.98%
1/102 • Number of events 1
|
0.00%
0/58
|
|
Investigations
Leukocyte count decreased
|
2.9%
3/102 • Number of events 3
|
12.1%
7/58 • Number of events 9
|
|
Investigations
Lipase increased
|
0.00%
0/102
|
1.7%
1/58 • Number of events 1
|
|
Investigations
Lymphocyte count decreased
|
0.98%
1/102 • Number of events 1
|
8.6%
5/58 • Number of events 8
|
|
Investigations
Neutrophil count decreased
|
12.7%
13/102 • Number of events 14
|
24.1%
14/58 • Number of events 20
|
|
Investigations
Platelet count decreased
|
12.7%
13/102 • Number of events 14
|
31.0%
18/58 • Number of events 25
|
|
Investigations
Weight gain
|
0.98%
1/102 • Number of events 1
|
0.00%
0/58
|
|
Investigations
Weight loss
|
0.98%
1/102 • Number of events 1
|
1.7%
1/58 • Number of events 1
|
|
Metabolism and nutrition disorders
Anorexia
|
3.9%
4/102 • Number of events 4
|
8.6%
5/58 • Number of events 6
|
|
Metabolism and nutrition disorders
Blood bicarbonate decreased
|
0.00%
0/102
|
1.7%
1/58 • Number of events 1
|
|
Metabolism and nutrition disorders
Blood glucose increased
|
4.9%
5/102 • Number of events 6
|
19.0%
11/58 • Number of events 14
|
|
Metabolism and nutrition disorders
Blood uric acid increased
|
0.98%
1/102 • Number of events 1
|
1.7%
1/58 • Number of events 1
|
|
Metabolism and nutrition disorders
Dehydration
|
0.98%
1/102 • Number of events 1
|
1.7%
1/58 • Number of events 1
|
|
Metabolism and nutrition disorders
Iron overload
|
0.00%
0/102
|
1.7%
1/58 • Number of events 1
|
|
Metabolism and nutrition disorders
Serum albumin decreased
|
2.0%
2/102 • Number of events 2
|
8.6%
5/58 • Number of events 5
|
|
Metabolism and nutrition disorders
Serum calcium decreased
|
2.9%
3/102 • Number of events 3
|
17.2%
10/58 • Number of events 12
|
|
Metabolism and nutrition disorders
Serum glucose decreased
|
2.0%
2/102 • Number of events 2
|
1.7%
1/58 • Number of events 1
|
|
Metabolism and nutrition disorders
Serum magnesium decreased
|
0.98%
1/102 • Number of events 1
|
3.4%
2/58 • Number of events 2
|
|
Metabolism and nutrition disorders
Serum magnesium increased
|
0.00%
0/102
|
5.2%
3/58 • Number of events 3
|
|
Metabolism and nutrition disorders
Serum phosphate decreased
|
2.9%
3/102 • Number of events 3
|
3.4%
2/58 • Number of events 2
|
|
Metabolism and nutrition disorders
Serum potassium decreased
|
2.9%
3/102 • Number of events 3
|
6.9%
4/58 • Number of events 4
|
|
Metabolism and nutrition disorders
Serum potassium increased
|
0.00%
0/102
|
5.2%
3/58 • Number of events 3
|
|
Metabolism and nutrition disorders
Serum sodium decreased
|
2.0%
2/102 • Number of events 2
|
17.2%
10/58 • Number of events 11
|
|
Metabolism and nutrition disorders
Serum sodium increased
|
0.00%
0/102
|
3.4%
2/58 • Number of events 2
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
2.0%
2/102 • Number of events 2
|
1.7%
1/58 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
Arthritis
|
0.00%
0/102
|
1.7%
1/58 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
2.0%
2/102 • Number of events 2
|
1.7%
1/58 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
Chest wall pain
|
0.98%
1/102 • Number of events 1
|
0.00%
0/58
|
|
Musculoskeletal and connective tissue disorders
Muscle weakness
|
0.00%
0/102
|
1.7%
1/58 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
2.0%
2/102 • Number of events 2
|
1.7%
1/58 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
Myositis
|
0.00%
0/102
|
1.7%
1/58 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
0.98%
1/102 • Number of events 1
|
0.00%
0/58
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
0.00%
0/102
|
1.7%
1/58 • Number of events 1
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Treatment related secondary malignancy
|
0.00%
0/102
|
1.7%
1/58 • Number of events 1
|
|
Nervous system disorders
Depressed level of consciousness
|
0.00%
0/102
|
1.7%
1/58 • Number of events 1
|
|
Nervous system disorders
Dizziness
|
0.98%
1/102 • Number of events 1
|
3.4%
2/58 • Number of events 2
|
|
Nervous system disorders
Headache
|
3.9%
4/102 • Number of events 4
|
12.1%
7/58 • Number of events 8
|
|
Nervous system disorders
Intracranial hemorrhage
|
0.98%
1/102 • Number of events 1
|
0.00%
0/58
|
|
Nervous system disorders
Ischemia cerebrovascular
|
0.98%
1/102 • Number of events 1
|
0.00%
0/58
|
|
Nervous system disorders
Memory impairment
|
0.98%
1/102 • Number of events 1
|
0.00%
0/58
|
|
Nervous system disorders
Mini mental status examination abnormal
|
0.00%
0/102
|
1.7%
1/58 • Number of events 1
|
|
Nervous system disorders
Neuralgia
|
0.00%
0/102
|
1.7%
1/58 • Number of events 1
|
|
Nervous system disorders
Peripheral motor neuropathy
|
0.98%
1/102 • Number of events 1
|
0.00%
0/58
|
|
Nervous system disorders
Peripheral sensory neuropathy
|
0.98%
1/102 • Number of events 1
|
1.7%
1/58 • Number of events 1
|
|
Nervous system disorders
Seizure
|
0.00%
0/102
|
1.7%
1/58 • Number of events 1
|
|
Nervous system disorders
Trigeminal nerve disorder
|
0.00%
0/102
|
1.7%
1/58 • Number of events 1
|
|
Psychiatric disorders
Agitation
|
0.98%
1/102 • Number of events 1
|
0.00%
0/58
|
|
Psychiatric disorders
Anxiety
|
0.00%
0/102
|
1.7%
1/58 • Number of events 1
|
|
Psychiatric disorders
Confusion
|
2.0%
2/102 • Number of events 2
|
5.2%
3/58 • Number of events 3
|
|
Psychiatric disorders
Depression
|
0.98%
1/102 • Number of events 1
|
6.9%
4/58 • Number of events 4
|
|
Psychiatric disorders
Insomnia
|
2.9%
3/102 • Number of events 3
|
1.7%
1/58 • Number of events 1
|
|
Renal and urinary disorders
Bladder spasm
|
0.00%
0/102
|
1.7%
1/58 • Number of events 1
|
|
Renal and urinary disorders
Glomerular filtration rate decreased
|
0.00%
0/102
|
1.7%
1/58 • Number of events 1
|
|
Renal and urinary disorders
Hemorrhage urinary tract
|
0.00%
0/102
|
1.7%
1/58 • Number of events 1
|
|
Renal and urinary disorders
Proteinuria
|
0.98%
1/102 • Number of events 1
|
0.00%
0/58
|
|
Renal and urinary disorders
Renal failure
|
0.00%
0/102
|
3.4%
2/58 • Number of events 3
|
|
Renal and urinary disorders
Renal hemorrhage
|
0.00%
0/102
|
1.7%
1/58 • Number of events 1
|
|
Renal and urinary disorders
Urinary frequency
|
0.98%
1/102 • Number of events 1
|
0.00%
0/58
|
|
Renal and urinary disorders
Urinary incontinence
|
0.98%
1/102 • Number of events 1
|
0.00%
0/58
|
|
Renal and urinary disorders
Urinary retention
|
0.00%
0/102
|
1.7%
1/58 • Number of events 1
|
|
Renal and urinary disorders
Urine discoloration
|
0.00%
0/102
|
1.7%
1/58 • Number of events 1
|
|
Renal and urinary disorders
Urogenital disorder
|
0.00%
0/102
|
3.4%
2/58 • Number of events 2
|
|
Reproductive system and breast disorders
Prostatic obstruction
|
0.00%
0/102
|
1.7%
1/58 • Number of events 1
|
|
Reproductive system and breast disorders
Testicular pain
|
0.00%
0/102
|
1.7%
1/58 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Adult respiratory distress syndrome
|
0.00%
0/102
|
3.4%
2/58 • Number of events 3
|
|
Respiratory, thoracic and mediastinal disorders
Allergic rhinitis
|
0.00%
0/102
|
1.7%
1/58 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Bronchospasm
|
0.98%
1/102 • Number of events 1
|
0.00%
0/58
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
4.9%
5/102 • Number of events 5
|
6.9%
4/58 • Number of events 4
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
7.8%
8/102 • Number of events 9
|
17.2%
10/58 • Number of events 12
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
0.00%
0/102
|
1.7%
1/58 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
0.00%
0/102
|
3.4%
2/58 • Number of events 3
|
|
Respiratory, thoracic and mediastinal disorders
Pharyngolaryngeal pain
|
0.98%
1/102 • Number of events 1
|
0.00%
0/58
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
0.00%
0/102
|
5.2%
3/58 • Number of events 4
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonitis
|
0.98%
1/102 • Number of events 1
|
3.4%
2/58 • Number of events 3
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory disorder
|
0.98%
1/102 • Number of events 1
|
1.7%
1/58 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Voice alteration
|
0.98%
1/102 • Number of events 1
|
0.00%
0/58
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
0.98%
1/102 • Number of events 1
|
0.00%
0/58
|
|
Skin and subcutaneous tissue disorders
Petechiae
|
0.00%
0/102
|
3.4%
2/58 • Number of events 2
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
0.98%
1/102 • Number of events 2
|
3.4%
2/58 • Number of events 2
|
|
Skin and subcutaneous tissue disorders
Rash desquamating
|
5.9%
6/102 • Number of events 6
|
13.8%
8/58 • Number of events 9
|
|
Skin and subcutaneous tissue disorders
Skin hypopigmentation
|
0.98%
1/102 • Number of events 1
|
0.00%
0/58
|
|
Skin and subcutaneous tissue disorders
Sweating
|
0.98%
1/102 • Number of events 1
|
3.4%
2/58 • Number of events 2
|
|
Skin and subcutaneous tissue disorders
Urticaria
|
0.00%
0/102
|
3.4%
2/58 • Number of events 2
|
|
Vascular disorders
Hematoma
|
0.00%
0/102
|
3.4%
2/58 • Number of events 2
|
|
Vascular disorders
Hemorrhage
|
0.00%
0/102
|
1.7%
1/58 • Number of events 1
|
|
Vascular disorders
Hot flashes
|
0.98%
1/102 • Number of events 1
|
1.7%
1/58 • Number of events 1
|
|
Vascular disorders
Hypertension
|
0.98%
1/102 • Number of events 1
|
1.7%
1/58 • Number of events 1
|
|
Vascular disorders
Hypotension
|
2.9%
3/102 • Number of events 3
|
10.3%
6/58 • Number of events 9
|
|
Vascular disorders
Thrombosis
|
0.00%
0/102
|
3.4%
2/58 • Number of events 2
|
Other adverse events
| Measure |
FR Induction
n=102 participants at risk
Fludarabine and rituximab induction in pts with B-cell CLL
|
Alemtuzumab Consolidation
n=58 participants at risk
Alemtuzumab consolidation following fludarabine and rituximab induction
|
|---|---|---|
|
Eye disorders
Cataract
|
2.0%
2/102 • Number of events 5
|
1.7%
1/58 • Number of events 1
|
|
Eye disorders
Dry eye syndrome
|
0.98%
1/102 • Number of events 1
|
1.7%
1/58 • Number of events 1
|
|
Eye disorders
Eye disorder
|
3.9%
4/102 • Number of events 4
|
1.7%
1/58 • Number of events 1
|
|
Eye disorders
Eye pain
|
0.98%
1/102 • Number of events 1
|
0.00%
0/58
|
|
Eye disorders
Eyelid function disorder
|
0.00%
0/102
|
1.7%
1/58 • Number of events 1
|
|
Eye disorders
Glaucoma
|
0.98%
1/102 • Number of events 1
|
0.00%
0/58
|
|
Eye disorders
Optic nerve edema
|
0.00%
0/102
|
1.7%
1/58 • Number of events 1
|
|
Eye disorders
Photophobia
|
0.98%
1/102 • Number of events 1
|
1.7%
1/58 • Number of events 2
|
|
Eye disorders
Vision blurred
|
2.9%
3/102 • Number of events 3
|
1.7%
1/58 • Number of events 1
|
|
Eye disorders
Watering eyes
|
3.9%
4/102 • Number of events 5
|
0.00%
0/58
|
|
Gastrointestinal disorders
Abdominal distension
|
2.9%
3/102 • Number of events 6
|
1.7%
1/58 • Number of events 1
|
|
Blood and lymphatic system disorders
Blood disorder
|
0.98%
1/102 • Number of events 9
|
0.00%
0/58
|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
11.8%
12/102 • Number of events 13
|
8.6%
5/58 • Number of events 6
|
|
Blood and lymphatic system disorders
Hemoglobin decreased
|
71.6%
73/102 • Number of events 183
|
65.5%
38/58 • Number of events 89
|
|
Blood and lymphatic system disorders
Hemolysis
|
2.0%
2/102 • Number of events 5
|
3.4%
2/58 • Number of events 2
|
|
Blood and lymphatic system disorders
Lymph node pain
|
2.0%
2/102 • Number of events 3
|
3.4%
2/58 • Number of events 2
|
|
Blood and lymphatic system disorders
Lymphatic disorder
|
0.98%
1/102 • Number of events 1
|
0.00%
0/58
|
|
Cardiac disorders
Atrial fibrillation
|
2.0%
2/102 • Number of events 2
|
0.00%
0/58
|
|
Cardiac disorders
Cardiac disorder
|
0.98%
1/102 • Number of events 2
|
5.2%
3/58 • Number of events 6
|
|
Cardiac disorders
Myocardial ischemia
|
0.00%
0/102
|
1.7%
1/58 • Number of events 1
|
|
Cardiac disorders
Palpitations
|
0.00%
0/102
|
3.4%
2/58 • Number of events 2
|
|
Cardiac disorders
Pericarditis
|
0.98%
1/102 • Number of events 1
|
0.00%
0/58
|
|
Cardiac disorders
Sinus tachycardia
|
0.98%
1/102 • Number of events 1
|
0.00%
0/58
|
|
Ear and labyrinth disorders
Ear pain
|
2.0%
2/102 • Number of events 2
|
1.7%
1/58 • Number of events 1
|
|
Ear and labyrinth disorders
External ear inflammation
|
2.0%
2/102 • Number of events 2
|
0.00%
0/58
|
|
Ear and labyrinth disorders
Hearing impaired
|
0.98%
1/102 • Number of events 1
|
1.7%
1/58 • Number of events 1
|
|
Ear and labyrinth disorders
Tinnitus
|
2.0%
2/102 • Number of events 2
|
1.7%
1/58 • Number of events 4
|
|
Endocrine disorders
Hypothyroidism
|
0.00%
0/102
|
1.7%
1/58 • Number of events 1
|
|
Gastrointestinal disorders
Abdominal pain
|
10.8%
11/102 • Number of events 18
|
5.2%
3/58 • Number of events 4
|
|
Gastrointestinal disorders
Ascites
|
0.98%
1/102 • Number of events 3
|
0.00%
0/58
|
|
Gastrointestinal disorders
Colitis
|
0.98%
1/102 • Number of events 1
|
0.00%
0/58
|
|
Gastrointestinal disorders
Colonic hemorrhage
|
0.98%
1/102 • Number of events 1
|
0.00%
0/58
|
|
Gastrointestinal disorders
Constipation
|
28.4%
29/102 • Number of events 51
|
5.2%
3/58 • Number of events 3
|
|
Gastrointestinal disorders
Diarrhea
|
24.5%
25/102 • Number of events 34
|
31.0%
18/58 • Number of events 29
|
|
Gastrointestinal disorders
Dry mouth
|
3.9%
4/102 • Number of events 4
|
1.7%
1/58 • Number of events 1
|
|
Gastrointestinal disorders
Dyspepsia
|
4.9%
5/102 • Number of events 6
|
3.4%
2/58 • Number of events 2
|
|
Gastrointestinal disorders
Dysphagia
|
2.0%
2/102 • Number of events 3
|
0.00%
0/58
|
|
Gastrointestinal disorders
Ear, nose and throat examination abnormal
|
2.9%
3/102 • Number of events 5
|
6.9%
4/58 • Number of events 5
|
|
Gastrointestinal disorders
Esophageal pain
|
0.98%
1/102 • Number of events 1
|
0.00%
0/58
|
|
Gastrointestinal disorders
Flatulence
|
2.9%
3/102 • Number of events 3
|
1.7%
1/58 • Number of events 1
|
|
Gastrointestinal disorders
Gastrointestinal disorder
|
3.9%
4/102 • Number of events 6
|
1.7%
1/58 • Number of events 1
|
|
Gastrointestinal disorders
Hemorrhoids
|
0.98%
1/102 • Number of events 1
|
0.00%
0/58
|
|
Gastrointestinal disorders
Lower gastrointestinal hemorrhage
|
0.98%
1/102 • Number of events 1
|
0.00%
0/58
|
|
Gastrointestinal disorders
Mucositis oral
|
3.9%
4/102 • Number of events 4
|
1.7%
1/58 • Number of events 2
|
|
Gastrointestinal disorders
Nausea
|
56.9%
58/102 • Number of events 104
|
34.5%
20/58 • Number of events 24
|
|
Gastrointestinal disorders
Oral pain
|
0.98%
1/102 • Number of events 1
|
0.00%
0/58
|
|
Gastrointestinal disorders
Periodontal disease
|
0.98%
1/102 • Number of events 1
|
0.00%
0/58
|
|
Gastrointestinal disorders
Rectal hemorrhage
|
0.98%
1/102 • Number of events 1
|
0.00%
0/58
|
|
Gastrointestinal disorders
Rectal pain
|
0.98%
1/102 • Number of events 1
|
0.00%
0/58
|
|
Gastrointestinal disorders
Small intestinal obstruction
|
0.98%
1/102 • Number of events 1
|
0.00%
0/58
|
|
Gastrointestinal disorders
Stomach pain
|
0.00%
0/102
|
1.7%
1/58 • Number of events 2
|
|
Gastrointestinal disorders
Tooth disorder
|
0.98%
1/102 • Number of events 1
|
0.00%
0/58
|
|
Gastrointestinal disorders
Toothache
|
2.0%
2/102 • Number of events 3
|
0.00%
0/58
|
|
Gastrointestinal disorders
Vomiting
|
23.5%
24/102 • Number of events 30
|
12.1%
7/58 • Number of events 7
|
|
General disorders
Chest pain
|
7.8%
8/102 • Number of events 11
|
3.4%
2/58 • Number of events 4
|
|
General disorders
Chills
|
27.5%
28/102 • Number of events 32
|
22.4%
13/58 • Number of events 15
|
|
General disorders
Edema limbs
|
5.9%
6/102 • Number of events 9
|
10.3%
6/58 • Number of events 6
|
|
General disorders
Facial pain
|
0.98%
1/102 • Number of events 1
|
0.00%
0/58
|
|
General disorders
Fatigue
|
82.4%
84/102 • Number of events 200
|
75.9%
44/58 • Number of events 106
|
|
General disorders
Fever
|
25.5%
26/102 • Number of events 33
|
24.1%
14/58 • Number of events 18
|
|
General disorders
Flu-like symptoms
|
2.9%
3/102 • Number of events 4
|
0.00%
0/58
|
|
General disorders
Gait abnormal
|
0.98%
1/102 • Number of events 1
|
0.00%
0/58
|
|
General disorders
General symptom
|
0.98%
1/102 • Number of events 1
|
0.00%
0/58
|
|
General disorders
Ill-defined disorder
|
0.00%
0/102
|
1.7%
1/58 • Number of events 1
|
|
General disorders
Injection site reaction
|
0.98%
1/102 • Number of events 1
|
12.1%
7/58 • Number of events 7
|
|
General disorders
Localized edema
|
2.0%
2/102 • Number of events 2
|
0.00%
0/58
|
|
General disorders
Pain
|
10.8%
11/102 • Number of events 11
|
10.3%
6/58 • Number of events 10
|
|
Hepatobiliary disorders
Hepatic failure
|
0.00%
0/102
|
1.7%
1/58 • Number of events 1
|
|
Immune system disorders
Hypersensitivity
|
8.8%
9/102 • Number of events 9
|
6.9%
4/58 • Number of events 5
|
|
Immune system disorders
Immune system disorder
|
0.98%
1/102 • Number of events 1
|
0.00%
0/58
|
|
Infections and infestations
Bladder infection
|
2.0%
2/102 • Number of events 3
|
1.7%
1/58 • Number of events 1
|
|
Infections and infestations
Bronchitis
|
3.9%
4/102 • Number of events 4
|
8.6%
5/58 • Number of events 5
|
|
Infections and infestations
Catheter related infection
|
0.00%
0/102
|
3.4%
2/58 • Number of events 3
|
|
Infections and infestations
Conjunctivitis infective
|
2.0%
2/102 • Number of events 2
|
3.4%
2/58 • Number of events 2
|
|
Infections and infestations
Cranial nerve infection
|
0.00%
0/102
|
1.7%
1/58 • Number of events 1
|
|
Infections and infestations
Eye infection
|
2.0%
2/102 • Number of events 2
|
1.7%
1/58 • Number of events 1
|
|
Infections and infestations
Gallbladder infection
|
0.98%
1/102 • Number of events 1
|
0.00%
0/58
|
|
Infections and infestations
Gastric infection
|
0.98%
1/102 • Number of events 1
|
0.00%
0/58
|
|
Infections and infestations
Gingival infection
|
0.98%
1/102 • Number of events 1
|
1.7%
1/58 • Number of events 1
|
|
Infections and infestations
Hepatic infection
|
0.00%
0/102
|
1.7%
1/58 • Number of events 1
|
|
Infections and infestations
Infection
|
3.9%
4/102 • Number of events 7
|
13.8%
8/58 • Number of events 11
|
|
Infections and infestations
Infectious colitis
|
2.0%
2/102 • Number of events 2
|
1.7%
1/58 • Number of events 1
|
|
Infections and infestations
Lip infection
|
2.9%
3/102 • Number of events 5
|
0.00%
0/58
|
|
Infections and infestations
Lymph gland infection
|
0.98%
1/102 • Number of events 1
|
0.00%
0/58
|
|
Infections and infestations
Opportunistic infection
|
0.98%
1/102 • Number of events 1
|
3.4%
2/58 • Number of events 2
|
|
Infections and infestations
Otitis externa
|
0.98%
1/102 • Number of events 1
|
0.00%
0/58
|
|
Infections and infestations
Otitis media
|
0.98%
1/102 • Number of events 2
|
1.7%
1/58 • Number of events 1
|
|
Infections and infestations
Pancreas infection
|
0.98%
1/102 • Number of events 1
|
0.00%
0/58
|
|
Infections and infestations
Paranasal sinus infection
|
0.98%
1/102 • Number of events 1
|
0.00%
0/58
|
|
Infections and infestations
Penile infection
|
0.00%
0/102
|
1.7%
1/58 • Number of events 1
|
|
Infections and infestations
Peripheral nerve infection
|
0.98%
1/102 • Number of events 1
|
0.00%
0/58
|
|
Infections and infestations
Pharyngitis
|
3.9%
4/102 • Number of events 5
|
0.00%
0/58
|
|
Infections and infestations
Pneumonia
|
6.9%
7/102 • Number of events 11
|
8.6%
5/58 • Number of events 6
|
|
Infections and infestations
Rhinitis infective
|
0.00%
0/102
|
1.7%
1/58 • Number of events 1
|
|
Infections and infestations
Scrotal infection
|
0.98%
1/102 • Number of events 1
|
0.00%
0/58
|
|
Infections and infestations
Sepsis
|
0.98%
1/102 • Number of events 1
|
17.2%
10/58 • Number of events 11
|
|
Infections and infestations
Sinusitis
|
9.8%
10/102 • Number of events 15
|
8.6%
5/58 • Number of events 8
|
|
Infections and infestations
Skin infection
|
3.9%
4/102 • Number of events 5
|
3.4%
2/58 • Number of events 2
|
|
Infections and infestations
Soft tissue infection
|
0.98%
1/102 • Number of events 1
|
5.2%
3/58 • Number of events 3
|
|
Infections and infestations
Stoma site infection
|
0.98%
1/102 • Number of events 1
|
0.00%
0/58
|
|
Infections and infestations
Tooth infection
|
0.98%
1/102 • Number of events 1
|
0.00%
0/58
|
|
Infections and infestations
Upper respiratory infection
|
13.7%
14/102 • Number of events 18
|
19.0%
11/58 • Number of events 15
|
|
Infections and infestations
Ureteritis
|
2.9%
3/102 • Number of events 4
|
1.7%
1/58 • Number of events 1
|
|
Infections and infestations
Urinary tract infection
|
5.9%
6/102 • Number of events 7
|
3.4%
2/58 • Number of events 3
|
|
Infections and infestations
Vaginal infection
|
0.98%
1/102 • Number of events 1
|
0.00%
0/58
|
|
Injury, poisoning and procedural complications
Biliary anastomotic leak
|
0.98%
1/102 • Number of events 1
|
0.00%
0/58
|
|
Injury, poisoning and procedural complications
Bruising
|
2.0%
2/102 • Number of events 2
|
0.00%
0/58
|
|
Injury, poisoning and procedural complications
Postoperative hemorrhage
|
2.0%
2/102 • Number of events 2
|
0.00%
0/58
|
|
Injury, poisoning and procedural complications
Small intestinal anastomotic leak
|
0.98%
1/102 • Number of events 1
|
0.00%
0/58
|
|
Injury, poisoning and procedural complications
Thermal burn
|
0.98%
1/102 • Number of events 1
|
0.00%
0/58
|
|
Injury, poisoning and procedural complications
Venous injury - Extremity-upper
|
0.98%
1/102 • Number of events 1
|
0.00%
0/58
|
|
Investigations
Alanine aminotransferase increased
|
17.6%
18/102 • Number of events 41
|
15.5%
9/58 • Number of events 19
|
|
Investigations
Alkaline phosphatase increased
|
8.8%
9/102 • Number of events 11
|
13.8%
8/58 • Number of events 13
|
|
Investigations
Aspartate aminotransferase increased
|
27.5%
28/102 • Number of events 60
|
17.2%
10/58 • Number of events 19
|
|
Investigations
Blood bilirubin increased
|
15.7%
16/102 • Number of events 37
|
12.1%
7/58 • Number of events 16
|
|
Investigations
CD4 lymphocytes decreased
|
0.00%
0/102
|
1.7%
1/58 • Number of events 1
|
|
Investigations
Creatine phosphokinase increased
|
0.98%
1/102 • Number of events 1
|
0.00%
0/58
|
|
Investigations
Creatinine increased
|
19.6%
20/102 • Number of events 41
|
17.2%
10/58 • Number of events 23
|
|
Investigations
Gamma-glutamyltransferase increased
|
0.00%
0/102
|
1.7%
1/58 • Number of events 1
|
|
Investigations
Haptoglobin decreased
|
0.98%
1/102 • Number of events 1
|
0.00%
0/58
|
|
Investigations
Laboratory test abnormal
|
8.8%
9/102 • Number of events 11
|
6.9%
4/58 • Number of events 6
|
|
Investigations
Leukocyte count decreased
|
40.2%
41/102 • Number of events 97
|
37.9%
22/58 • Number of events 37
|
|
Investigations
Lymphocyte count decreased
|
25.5%
26/102 • Number of events 68
|
25.9%
15/58 • Number of events 32
|
|
Investigations
Neutrophil count decreased
|
76.5%
78/102 • Number of events 215
|
67.2%
39/58 • Number of events 96
|
|
Investigations
Platelet count decreased
|
67.6%
69/102 • Number of events 194
|
56.9%
33/58 • Number of events 113
|
|
Investigations
Serum cholesterol increased
|
0.98%
1/102 • Number of events 1
|
0.00%
0/58
|
|
Investigations
Weight gain
|
2.0%
2/102 • Number of events 5
|
0.00%
0/58
|
|
Investigations
Weight loss
|
2.9%
3/102 • Number of events 3
|
5.2%
3/58 • Number of events 3
|
|
Metabolism and nutrition disorders
Alkalosis
|
2.0%
2/102 • Number of events 2
|
1.7%
1/58 • Number of events 1
|
|
Metabolism and nutrition disorders
Anorexia
|
13.7%
14/102 • Number of events 15
|
13.8%
8/58 • Number of events 8
|
|
Metabolism and nutrition disorders
Blood bicarbonate decreased
|
0.98%
1/102 • Number of events 1
|
0.00%
0/58
|
|
Metabolism and nutrition disorders
Blood glucose increased
|
42.2%
43/102 • Number of events 118
|
31.0%
18/58 • Number of events 51
|
|
Metabolism and nutrition disorders
Blood uric acid increased
|
5.9%
6/102 • Number of events 8
|
3.4%
2/58 • Number of events 2
|
|
Metabolism and nutrition disorders
Dehydration
|
4.9%
5/102 • Number of events 6
|
1.7%
1/58 • Number of events 2
|
|
Metabolism and nutrition disorders
Glucose intolerance
|
2.0%
2/102 • Number of events 7
|
1.7%
1/58 • Number of events 1
|
|
Metabolism and nutrition disorders
Serum albumin decreased
|
5.9%
6/102 • Number of events 8
|
6.9%
4/58 • Number of events 4
|
|
Metabolism and nutrition disorders
Serum calcium decreased
|
20.6%
21/102 • Number of events 34
|
22.4%
13/58 • Number of events 17
|
|
Metabolism and nutrition disorders
Serum calcium increased
|
0.98%
1/102 • Number of events 1
|
0.00%
0/58
|
|
Metabolism and nutrition disorders
Serum glucose decreased
|
7.8%
8/102 • Number of events 8
|
5.2%
3/58 • Number of events 7
|
|
Metabolism and nutrition disorders
Serum magnesium decreased
|
0.98%
1/102 • Number of events 2
|
0.00%
0/58
|
|
Metabolism and nutrition disorders
Serum magnesium increased
|
0.98%
1/102 • Number of events 1
|
0.00%
0/58
|
|
Metabolism and nutrition disorders
Serum phosphate decreased
|
7.8%
8/102 • Number of events 9
|
6.9%
4/58 • Number of events 4
|
|
Metabolism and nutrition disorders
Serum potassium decreased
|
8.8%
9/102 • Number of events 20
|
10.3%
6/58 • Number of events 6
|
|
Metabolism and nutrition disorders
Serum potassium increased
|
6.9%
7/102 • Number of events 9
|
6.9%
4/58 • Number of events 4
|
|
Metabolism and nutrition disorders
Serum sodium decreased
|
11.8%
12/102 • Number of events 18
|
12.1%
7/58 • Number of events 8
|
|
Metabolism and nutrition disorders
Serum sodium increased
|
2.9%
3/102 • Number of events 3
|
0.00%
0/58
|
|
Metabolism and nutrition disorders
Serum triglycerides increased
|
2.0%
2/102 • Number of events 3
|
1.7%
1/58 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
20.6%
21/102 • Number of events 34
|
13.8%
8/58 • Number of events 12
|
|
Musculoskeletal and connective tissue disorders
Arthritis
|
3.9%
4/102 • Number of events 5
|
0.00%
0/58
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
17.6%
18/102 • Number of events 25
|
8.6%
5/58 • Number of events 11
|
|
Musculoskeletal and connective tissue disorders
Bone pain
|
5.9%
6/102 • Number of events 8
|
5.2%
3/58 • Number of events 3
|
|
Musculoskeletal and connective tissue disorders
Chest wall pain
|
2.9%
3/102 • Number of events 5
|
0.00%
0/58
|
|
Musculoskeletal and connective tissue disorders
Joint disorder
|
0.00%
0/102
|
1.7%
1/58 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
Muscle weakness
|
0.98%
1/102 • Number of events 1
|
1.7%
1/58 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
Muscle weakness lower limb
|
0.98%
1/102 • Number of events 1
|
1.7%
1/58 • Number of events 2
|
|
Musculoskeletal and connective tissue disorders
Muscle weakness upper limb
|
0.98%
1/102 • Number of events 1
|
1.7%
1/58 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal disorder
|
0.00%
0/102
|
3.4%
2/58 • Number of events 2
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
18.6%
19/102 • Number of events 24
|
17.2%
10/58 • Number of events 12
|
|
Musculoskeletal and connective tissue disorders
Myositis
|
0.98%
1/102 • Number of events 1
|
0.00%
0/58
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
4.9%
5/102 • Number of events 7
|
3.4%
2/58 • Number of events 2
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
12.7%
13/102 • Number of events 20
|
5.2%
3/58 • Number of events 4
|
|
Musculoskeletal and connective tissue disorders
Upper extremity dysfunction
|
0.00%
0/102
|
1.7%
1/58 • Number of events 1
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Treatment related secondary malignancy
|
0.00%
0/102
|
3.4%
2/58 • Number of events 2
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Tumor flare
|
0.98%
1/102 • Number of events 1
|
0.00%
0/58
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Tumor pain
|
2.0%
2/102 • Number of events 2
|
0.00%
0/58
|
|
Nervous system disorders
Dizziness
|
10.8%
11/102 • Number of events 16
|
6.9%
4/58 • Number of events 5
|
|
Nervous system disorders
Dysgeusia
|
0.98%
1/102 • Number of events 1
|
3.4%
2/58 • Number of events 2
|
|
Nervous system disorders
Extrapyramidal disorder
|
0.98%
1/102 • Number of events 1
|
0.00%
0/58
|
|
Nervous system disorders
Headache
|
26.5%
27/102 • Number of events 47
|
25.9%
15/58 • Number of events 19
|
|
Nervous system disorders
Memory impairment
|
2.0%
2/102 • Number of events 2
|
0.00%
0/58
|
|
Nervous system disorders
Neuralgia
|
0.98%
1/102 • Number of events 1
|
3.4%
2/58 • Number of events 6
|
|
Nervous system disorders
Neurological disorder NOS
|
2.9%
3/102 • Number of events 3
|
5.2%
3/58 • Number of events 3
|
|
Nervous system disorders
Peripheral motor neuropathy
|
4.9%
5/102 • Number of events 5
|
5.2%
3/58 • Number of events 3
|
|
Nervous system disorders
Peripheral sensory neuropathy
|
10.8%
11/102 • Number of events 16
|
5.2%
3/58 • Number of events 3
|
|
Nervous system disorders
Sinus pain
|
0.98%
1/102 • Number of events 2
|
1.7%
1/58 • Number of events 2
|
|
Nervous system disorders
Speech disorder
|
0.00%
0/102
|
1.7%
1/58 • Number of events 1
|
|
Nervous system disorders
Syncope
|
0.98%
1/102 • Number of events 2
|
0.00%
0/58
|
|
Nervous system disorders
Syncope vasovagal
|
0.00%
0/102
|
1.7%
1/58 • Number of events 1
|
|
Nervous system disorders
Tremor
|
0.00%
0/102
|
1.7%
1/58 • Number of events 1
|
|
Nervous system disorders
Trigeminal nerve disorder
|
0.00%
0/102
|
1.7%
1/58 • Number of events 1
|
|
Psychiatric disorders
Anxiety
|
6.9%
7/102 • Number of events 10
|
6.9%
4/58 • Number of events 7
|
|
Psychiatric disorders
Confusion
|
0.00%
0/102
|
1.7%
1/58 • Number of events 1
|
|
Psychiatric disorders
Depression
|
12.7%
13/102 • Number of events 16
|
12.1%
7/58 • Number of events 10
|
|
Psychiatric disorders
Insomnia
|
16.7%
17/102 • Number of events 26
|
15.5%
9/58 • Number of events 10
|
|
Renal and urinary disorders
Urinary retention
|
2.9%
3/102 • Number of events 4
|
0.00%
0/58
|
|
Psychiatric disorders
Psychosis
|
0.00%
0/102
|
1.7%
1/58 • Number of events 1
|
|
Renal and urinary disorders
Bladder hemorrhage
|
0.98%
1/102 • Number of events 1
|
3.4%
2/58 • Number of events 2
|
|
Renal and urinary disorders
Bladder pain
|
0.98%
1/102 • Number of events 1
|
0.00%
0/58
|
|
Renal and urinary disorders
Dysuria (painful urination)
|
0.98%
1/102 • Number of events 1
|
0.00%
0/58
|
|
Renal and urinary disorders
Glomerular filtration rate decreased
|
4.9%
5/102 • Number of events 7
|
0.00%
0/58
|
|
Renal and urinary disorders
Hemorrhage urinary tract
|
0.98%
1/102 • Number of events 1
|
0.00%
0/58
|
|
Renal and urinary disorders
Urine discoloration
|
0.00%
0/102
|
1.7%
1/58 • Number of events 1
|
|
Renal and urinary disorders
Proteinuria
|
0.98%
1/102 • Number of events 1
|
3.4%
2/58 • Number of events 2
|
|
Renal and urinary disorders
Renal failure
|
0.00%
0/102
|
1.7%
1/58 • Number of events 1
|
|
Renal and urinary disorders
Urinary frequency
|
5.9%
6/102 • Number of events 8
|
6.9%
4/58 • Number of events 4
|
|
Renal and urinary disorders
Urogenital disorder
|
0.00%
0/102
|
3.4%
2/58 • Number of events 2
|
|
Reproductive system and breast disorders
Erectile dysfunction
|
0.98%
1/102 • Number of events 3
|
1.7%
1/58 • Number of events 2
|
|
Reproductive system and breast disorders
Pelvic pain
|
0.98%
1/102 • Number of events 2
|
0.00%
0/58
|
|
Reproductive system and breast disorders
Testicular pain
|
0.98%
1/102 • Number of events 1
|
0.00%
0/58
|
|
Reproductive system and breast disorders
Vaginal dryness
|
0.98%
1/102 • Number of events 1
|
0.00%
0/58
|
|
Respiratory, thoracic and mediastinal disorders
Allergic rhinitis
|
13.7%
14/102 • Number of events 17
|
12.1%
7/58 • Number of events 9
|
|
Respiratory, thoracic and mediastinal disorders
Bronchospasm
|
0.00%
0/102
|
1.7%
1/58 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
24.5%
25/102 • Number of events 44
|
50.0%
29/58 • Number of events 43
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
18.6%
19/102 • Number of events 31
|
27.6%
16/58 • Number of events 27
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
2.9%
3/102 • Number of events 4
|
10.3%
6/58 • Number of events 9
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
2.9%
3/102 • Number of events 3
|
1.7%
1/58 • Number of events 2
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
2.0%
2/102 • Number of events 3
|
3.4%
2/58 • Number of events 2
|
|
Respiratory, thoracic and mediastinal disorders
Pharyngeal examination abnormal
|
0.98%
1/102 • Number of events 1
|
0.00%
0/58
|
|
Respiratory, thoracic and mediastinal disorders
Pharyngolaryngeal pain
|
4.9%
5/102 • Number of events 9
|
6.9%
4/58 • Number of events 4
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
0.00%
0/102
|
1.7%
1/58 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Pleuritic pain
|
0.98%
1/102 • Number of events 1
|
0.00%
0/58
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonitis
|
2.0%
2/102 • Number of events 2
|
3.4%
2/58 • Number of events 2
|
|
Respiratory, thoracic and mediastinal disorders
Pneumothorax
|
0.00%
0/102
|
1.7%
1/58 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory disorder
|
2.0%
2/102 • Number of events 2
|
1.7%
1/58 • Number of events 1
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
4.9%
5/102 • Number of events 6
|
0.00%
0/58
|
|
Skin and subcutaneous tissue disorders
Decubitus ulcer
|
0.00%
0/102
|
1.7%
1/58 • Number of events 1
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
4.9%
5/102 • Number of events 8
|
5.2%
3/58 • Number of events 4
|
|
Skin and subcutaneous tissue disorders
Hand-and-foot syndrome
|
0.98%
1/102 • Number of events 2
|
1.7%
1/58 • Number of events 2
|
|
Skin and subcutaneous tissue disorders
Nail disorder
|
0.98%
1/102 • Number of events 2
|
0.00%
0/58
|
|
Skin and subcutaneous tissue disorders
Pain of skin
|
0.98%
1/102 • Number of events 1
|
1.7%
1/58 • Number of events 1
|
|
Skin and subcutaneous tissue disorders
Petechiae
|
0.00%
0/102
|
3.4%
2/58 • Number of events 2
|
|
Skin and subcutaneous tissue disorders
Photosensitivity
|
0.98%
1/102 • Number of events 1
|
3.4%
2/58 • Number of events 2
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
14.7%
15/102 • Number of events 19
|
24.1%
14/58 • Number of events 20
|
|
Skin and subcutaneous tissue disorders
Rash acneiform
|
0.98%
1/102 • Number of events 1
|
0.00%
0/58
|
|
Skin and subcutaneous tissue disorders
Rash desquamating
|
47.1%
48/102 • Number of events 69
|
56.9%
33/58 • Number of events 57
|
|
Skin and subcutaneous tissue disorders
Scalp pain
|
0.98%
1/102 • Number of events 1
|
0.00%
0/58
|
|
Skin and subcutaneous tissue disorders
Skin disorder
|
3.9%
4/102 • Number of events 4
|
3.4%
2/58 • Number of events 5
|
|
Skin and subcutaneous tissue disorders
Skin induration
|
0.98%
1/102 • Number of events 2
|
0.00%
0/58
|
|
Skin and subcutaneous tissue disorders
Sweating
|
20.6%
21/102 • Number of events 29
|
22.4%
13/58 • Number of events 22
|
|
Skin and subcutaneous tissue disorders
Urticaria
|
2.9%
3/102 • Number of events 3
|
8.6%
5/58 • Number of events 5
|
|
Vascular disorders
Flushing
|
2.0%
2/102 • Number of events 2
|
0.00%
0/58
|
|
Vascular disorders
Hematoma
|
0.98%
1/102 • Number of events 1
|
1.7%
1/58 • Number of events 1
|
|
Vascular disorders
Hemorrhage
|
0.00%
0/102
|
1.7%
1/58 • Number of events 1
|
|
Vascular disorders
Hot flashes
|
3.9%
4/102 • Number of events 7
|
5.2%
3/58 • Number of events 6
|
|
Vascular disorders
Hypertension
|
5.9%
6/102 • Number of events 11
|
6.9%
4/58 • Number of events 8
|
|
Vascular disorders
Hypotension
|
16.7%
17/102 • Number of events 24
|
10.3%
6/58 • Number of events 6
|
|
Vascular disorders
Phlebitis
|
0.98%
1/102 • Number of events 2
|
0.00%
0/58
|
|
Vascular disorders
Thrombosis
|
0.00%
0/102
|
1.7%
1/58 • Number of events 1
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: LTE60