Trial Outcomes & Findings for Monoclonal Antibody Therapy and Combination Chemotherapy in Treating Patients With Stage II, Stage III, or Stage IV Diffuse Large B-Cell Lymphoma (NCT NCT00301821)
NCT ID: NCT00301821
Last Updated: 2019-10-09
Results Overview
The primary endpoint of the trial was the percentage of the eligible patients who were alive and event-free 12 months after enrollment to the study (EFS12).
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
107 participants
Primary outcome timeframe
From Baseline to 12 months
Results posted on
2019-10-09
Participant Flow
For this study 107 patients with newly diagnosed diffuse large B-cell lymphoma (DLBCL) were enrolled. Twenty-six (24%) patients were declared ineligible based on pathology review; 1 patient canceled before beginning treatment.
Participant milestones
| Measure |
Epratuzumab + Rituximab + CHOP
One arm open label. Epratuzumab, Rituximab, Cyclophosphamide, Doxorubicin hydrochloride, Prednisone, Vincristine sulfate
|
|---|---|
|
Overall Study
STARTED
|
107
|
|
Overall Study
COMPLETED
|
81
|
|
Overall Study
NOT COMPLETED
|
26
|
Reasons for withdrawal
| Measure |
Epratuzumab + Rituximab + CHOP
One arm open label. Epratuzumab, Rituximab, Cyclophosphamide, Doxorubicin hydrochloride, Prednisone, Vincristine sulfate
|
|---|---|
|
Overall Study
Ineligible
|
25
|
|
Overall Study
Cancel
|
1
|
Baseline Characteristics
Monoclonal Antibody Therapy and Combination Chemotherapy in Treating Patients With Stage II, Stage III, or Stage IV Diffuse Large B-Cell Lymphoma
Baseline characteristics by cohort
| Measure |
Epratuzumab + Rituximab + CHOP
n=107 Participants
One arm, open label. Epratuzumab, Rituximab, Cyclophosphamide, Doxorubicin hydrochloride, Prednisone, Vincristine sulfate.
|
|---|---|
|
Age, Continuous
|
62 years
n=99 Participants
|
|
Sex: Female, Male
Female
|
48 Participants
n=99 Participants
|
|
Sex: Female, Male
Male
|
59 Participants
n=99 Participants
|
|
Region of Enrollment
United States
|
107 participants
n=99 Participants
|
PRIMARY outcome
Timeframe: From Baseline to 12 monthsPopulation: First 76 eligible participants were included in this analysis.
The primary endpoint of the trial was the percentage of the eligible patients who were alive and event-free 12 months after enrollment to the study (EFS12).
Outcome measures
| Measure |
Epratuzumab + Rituximab + CHOP
n=76 Participants
One arm, open label. Epratuzumab, Rituximab, Cyclophosphamide, Doxorubicin hydrochloride, Prednisone, Vincristine sulfate.
|
|---|---|
|
Event-free Survival After 12 Months
|
78 percentage of participants
|
SECONDARY outcome
Timeframe: time from study entry to 36 monthsPopulation: Intent To Treat (All Patients)
Percentage of participants alive at different time points
Outcome measures
| Measure |
Epratuzumab + Rituximab + CHOP
n=107 Participants
One arm, open label. Epratuzumab, Rituximab, Cyclophosphamide, Doxorubicin hydrochloride, Prednisone, Vincristine sulfate.
|
|---|---|
|
Overall Survival
Overall Survival at 12 months
|
89 percentage of Participants
|
|
Overall Survival
Overall Survival at 24 months
|
81 percentage of Participants
|
|
Overall Survival
Overall Survival at 36 months
|
80 percentage of Participants
|
SECONDARY outcome
Timeframe: the time from study entry to 36 monthsPopulation: Intent To Treat (All Patients)
Percentage of participants Progression-free at different time points. Response was assessed using International Workshop Response Criteria.38 Response is based on CT alone. Relapse or progression is defined as Enlarging liver/spleen, new sites, New or increased lymph nodes, New or Increased lymph node masses, bone marrow reappearance.
Outcome measures
| Measure |
Epratuzumab + Rituximab + CHOP
n=107 Participants
One arm, open label. Epratuzumab, Rituximab, Cyclophosphamide, Doxorubicin hydrochloride, Prednisone, Vincristine sulfate.
|
|---|---|
|
Progression-free Survival (PFS)
Progression Free Survival at 12 months
|
85 percentage of participants
|
|
Progression-free Survival (PFS)
Progression Free Survival at 24 months
|
77 percentage of participants
|
|
Progression-free Survival (PFS)
Progression Free Survival at 36 months
|
76 percentage of participants
|
SECONDARY outcome
Timeframe: Baseline to first 6 cycles of treatmentPopulation: Out of the 107 patients enrolled, Twenty-five patients were declared ineligible based on pathology review; 1 patient canceled before beginning treatment.
Overall response rate will be estimated by the number of patients with objective status of partial response (PR), unconfirmed complete response (CRu), or complete response (CR) during the first 6 cycles of treatment divided by number of evaluable patients (met eligibility criteria, signed consent form, and started treatment). Response was assessed using International Workshop Response Criteria.38 Response is based on CT alone. Relapse or progression is defined as Enlarging liver/spleen, new sites, New or increased lymph nodes, New or Increased lymph node masses, bone marrow reappearance.
Outcome measures
| Measure |
Epratuzumab + Rituximab + CHOP
n=81 Participants
One arm, open label. Epratuzumab, Rituximab, Cyclophosphamide, Doxorubicin hydrochloride, Prednisone, Vincristine sulfate.
|
|---|---|
|
Overall Response Rate (ORR)
|
95 percentage of participants
|
Adverse Events
Epratuzumab + Rituximab + CHOP
Serious events: 72 serious events
Other events: 105 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Epratuzumab + Rituximab + CHOP
n=106 participants at risk
One arm, open label. Epratuzumab, Rituximab, Cyclophosphamide, Doxorubicin hydrochloride, Prednisone, Vincristine sulfate.
|
|---|---|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
11.3%
12/106 • Number of events 16
One patient canceled before beginning treatment.
|
|
Blood and lymphatic system disorders
Hemoglobin decreased
|
6.6%
7/106 • Number of events 8
One patient canceled before beginning treatment.
|
|
Cardiac disorders
Atrial fibrillation
|
0.94%
1/106 • Number of events 1
One patient canceled before beginning treatment.
|
|
Cardiac disorders
Left ventricular failure
|
0.94%
1/106 • Number of events 1
One patient canceled before beginning treatment.
|
|
Cardiac disorders
Sinus tachycardia
|
1.9%
2/106 • Number of events 2
One patient canceled before beginning treatment.
|
|
Gastrointestinal disorders
Cecal hemorrhage
|
0.94%
1/106 • Number of events 1
One patient canceled before beginning treatment.
|
|
Gastrointestinal disorders
Diarrhea
|
1.9%
2/106 • Number of events 2
One patient canceled before beginning treatment.
|
|
Gastrointestinal disorders
Gastic fistula
|
0.94%
1/106 • Number of events 1
One patient canceled before beginning treatment.
|
|
Gastrointestinal disorders
Ileal hemorrhage
|
0.94%
1/106 • Number of events 1
One patient canceled before beginning treatment.
|
|
Gastrointestinal disorders
Lower gastrointestinal hemorrhage
|
0.94%
1/106 • Number of events 1
One patient canceled before beginning treatment.
|
|
Gastrointestinal disorders
Nausea
|
0.94%
1/106 • Number of events 1
One patient canceled before beginning treatment.
|
|
Gastrointestinal disorders
Small intestinal obstruction
|
0.94%
1/106 • Number of events 2
One patient canceled before beginning treatment.
|
|
Gastrointestinal disorders
Stomach pain
|
0.94%
1/106 • Number of events 1
One patient canceled before beginning treatment.
|
|
Gastrointestinal disorders
Vomiting
|
1.9%
2/106 • Number of events 2
One patient canceled before beginning treatment.
|
|
General disorders
Chest pain
|
0.94%
1/106 • Number of events 1
One patient canceled before beginning treatment.
|
|
General disorders
Fatigue
|
2.8%
3/106 • Number of events 3
One patient canceled before beginning treatment.
|
|
General disorders
Fever
|
0.94%
1/106 • Number of events 1
One patient canceled before beginning treatment.
|
|
Immune system disorders
Cytokine release syndrome
|
0.94%
1/106 • Number of events 1
One patient canceled before beginning treatment.
|
|
Infections and infestations
Abdominal infection
|
0.94%
1/106 • Number of events 1
One patient canceled before beginning treatment.
|
|
Infections and infestations
Bladder infection
|
0.94%
1/106 • Number of events 1
One patient canceled before beginning treatment.
|
|
Infections and infestations
Eye infection
|
0.94%
1/106 • Number of events 1
One patient canceled before beginning treatment.
|
|
Infections and infestations
Peritoneal infection
|
0.94%
1/106 • Number of events 1
One patient canceled before beginning treatment.
|
|
Infections and infestations
Pneumonia
|
5.7%
6/106 • Number of events 6
One patient canceled before beginning treatment.
|
|
Infections and infestations
Sepsis
|
0.94%
1/106 • Number of events 1
One patient canceled before beginning treatment.
|
|
Infections and infestations
Skin infection
|
0.94%
1/106 • Number of events 1
One patient canceled before beginning treatment.
|
|
Injury, poisoning and procedural complications
Vascular access complication
|
0.94%
1/106 • Number of events 1
One patient canceled before beginning treatment.
|
|
Investigations
Leukocyte count decreased
|
58.5%
62/106 • Number of events 136
One patient canceled before beginning treatment.
|
|
Investigations
Lymphocyte count decreased
|
1.9%
2/106 • Number of events 3
One patient canceled before beginning treatment.
|
|
Investigations
Neutrophil count decreased
|
63.2%
67/106 • Number of events 149
One patient canceled before beginning treatment.
|
|
Investigations
Platelet count decreased
|
8.5%
9/106 • Number of events 10
One patient canceled before beginning treatment.
|
|
Metabolism and nutrition disorders
Anorexia
|
0.94%
1/106 • Number of events 1
One patient canceled before beginning treatment.
|
|
Metabolism and nutrition disorders
Blood glucose increased
|
1.9%
2/106 • Number of events 4
One patient canceled before beginning treatment.
|
|
Metabolism and nutrition disorders
Dehydration
|
2.8%
3/106 • Number of events 3
One patient canceled before beginning treatment.
|
|
Metabolism and nutrition disorders
Serum potassium decreased
|
1.9%
2/106 • Number of events 2
One patient canceled before beginning treatment.
|
|
Metabolism and nutrition disorders
Serum sodium decreased
|
1.9%
2/106 • Number of events 2
One patient canceled before beginning treatment.
|
|
Metabolism and nutrition disorders
Tumor lysis syndrome
|
0.94%
1/106 • Number of events 1
One patient canceled before beginning treatment.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.94%
1/106 • Number of events 1
One patient canceled before beginning treatment.
|
|
Musculoskeletal and connective tissue disorders
Muscle weakness
|
0.94%
1/106 • Number of events 1
One patient canceled before beginning treatment.
|
|
Nervous system disorders
Ischemia cerebrovascular
|
0.94%
1/106 • Number of events 1
One patient canceled before beginning treatment.
|
|
Nervous system disorders
Syncope
|
0.94%
1/106 • Number of events 1
One patient canceled before beginning treatment.
|
|
Psychiatric disorders
Confusion
|
1.9%
2/106 • Number of events 2
One patient canceled before beginning treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
3.8%
4/106 • Number of events 4
One patient canceled before beginning treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
3.8%
4/106 • Number of events 4
One patient canceled before beginning treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
0.94%
1/106 • Number of events 1
One patient canceled before beginning treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonitis
|
1.9%
2/106 • Number of events 2
One patient canceled before beginning treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory disorder
|
0.94%
1/106 • Number of events 1
One patient canceled before beginning treatment.
|
|
Skin and subcutaneous tissue disorders
Erythema multiforme
|
0.94%
1/106 • Number of events 1
One patient canceled before beginning treatment.
|
|
Vascular disorders
Hypotension
|
1.9%
2/106 • Number of events 2
One patient canceled before beginning treatment.
|
|
Vascular disorders
Thrombosis
|
4.7%
5/106 • Number of events 5
One patient canceled before beginning treatment.
|
Other adverse events
| Measure |
Epratuzumab + Rituximab + CHOP
n=106 participants at risk
One arm, open label. Epratuzumab, Rituximab, Cyclophosphamide, Doxorubicin hydrochloride, Prednisone, Vincristine sulfate.
|
|---|---|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
7.5%
8/106 • Number of events 9
One patient canceled before beginning treatment.
|
|
Blood and lymphatic system disorders
Hemoglobin decreased
|
28.3%
30/106 • Number of events 68
One patient canceled before beginning treatment.
|
|
Cardiac disorders
Atrial fibrillation
|
0.94%
1/106 • Number of events 1
One patient canceled before beginning treatment.
|
|
Cardiac disorders
Left ventricular dysfunction
|
0.94%
1/106 • Number of events 1
One patient canceled before beginning treatment.
|
|
Cardiac disorders
Left ventricular failure
|
0.94%
1/106 • Number of events 1
One patient canceled before beginning treatment.
|
|
Cardiac disorders
Myocardial ischemia
|
0.94%
1/106 • Number of events 1
One patient canceled before beginning treatment.
|
|
Cardiac disorders
Sinus tachycardia
|
0.94%
1/106 • Number of events 1
One patient canceled before beginning treatment.
|
|
Ear and labyrinth disorders
Hearing impaired
|
0.94%
1/106 • Number of events 1
One patient canceled before beginning treatment.
|
|
Endocrine disorders
Hypothyroidism
|
0.94%
1/106 • Number of events 1
One patient canceled before beginning treatment.
|
|
Eye disorders
Vision blurred
|
0.94%
1/106 • Number of events 1
One patient canceled before beginning treatment.
|
|
Gastrointestinal disorders
Abdominal distension
|
0.94%
1/106 • Number of events 1
One patient canceled before beginning treatment.
|
|
Gastrointestinal disorders
Abdominal pain
|
2.8%
3/106 • Number of events 4
One patient canceled before beginning treatment.
|
|
Gastrointestinal disorders
Constipation
|
5.7%
6/106 • Number of events 7
One patient canceled before beginning treatment.
|
|
Gastrointestinal disorders
Diarrhea
|
8.5%
9/106 • Number of events 12
One patient canceled before beginning treatment.
|
|
Gastrointestinal disorders
Dry mouth
|
0.94%
1/106 • Number of events 1
One patient canceled before beginning treatment.
|
|
Gastrointestinal disorders
Dyspepsia
|
3.8%
4/106 • Number of events 6
One patient canceled before beginning treatment.
|
|
Gastrointestinal disorders
Dysphagia
|
0.94%
1/106 • Number of events 1
One patient canceled before beginning treatment.
|
|
Gastrointestinal disorders
Esophageal hemorrhage
|
0.94%
1/106 • Number of events 1
One patient canceled before beginning treatment.
|
|
Gastrointestinal disorders
Flatulence
|
0.94%
1/106 • Number of events 6
One patient canceled before beginning treatment.
|
|
Gastrointestinal disorders
Ileus
|
0.94%
1/106 • Number of events 1
One patient canceled before beginning treatment.
|
|
Gastrointestinal disorders
Lower gastrointestinal hemorrhage
|
0.94%
1/106 • Number of events 1
One patient canceled before beginning treatment.
|
|
Gastrointestinal disorders
Mucositis oral
|
8.5%
9/106 • Number of events 11
One patient canceled before beginning treatment.
|
|
Gastrointestinal disorders
Nausea
|
11.3%
12/106 • Number of events 17
One patient canceled before beginning treatment.
|
|
Gastrointestinal disorders
Oral pain
|
0.94%
1/106 • Number of events 1
One patient canceled before beginning treatment.
|
|
Gastrointestinal disorders
Small intestinal obstruction
|
0.94%
1/106 • Number of events 1
One patient canceled before beginning treatment.
|
|
Gastrointestinal disorders
Vomiting
|
26.4%
28/106 • Number of events 47
One patient canceled before beginning treatment.
|
|
General disorders
Chest pain
|
0.94%
1/106 • Number of events 1
One patient canceled before beginning treatment.
|
|
General disorders
Edema limbs
|
1.9%
2/106 • Number of events 2
One patient canceled before beginning treatment.
|
|
General disorders
Fatigue
|
34.0%
36/106 • Number of events 89
One patient canceled before beginning treatment.
|
|
General disorders
Fever
|
1.9%
2/106 • Number of events 2
One patient canceled before beginning treatment.
|
|
General disorders
General symptom
|
1.9%
2/106 • Number of events 2
One patient canceled before beginning treatment.
|
|
Hepatobiliary disorders
Cholecystitis
|
0.94%
1/106 • Number of events 1
One patient canceled before beginning treatment.
|
|
Immune system disorders
Cytokine release syndrome
|
13.2%
14/106 • Number of events 14
One patient canceled before beginning treatment.
|
|
Immune system disorders
Hypersensitivity
|
1.9%
2/106 • Number of events 2
One patient canceled before beginning treatment.
|
|
Infections and infestations
Appendicitis
|
0.94%
1/106 • Number of events 1
One patient canceled before beginning treatment.
|
|
Infections and infestations
Appendicitis perforated
|
0.94%
1/106 • Number of events 1
One patient canceled before beginning treatment.
|
|
Infections and infestations
Bladder infection
|
1.9%
2/106 • Number of events 2
One patient canceled before beginning treatment.
|
|
Infections and infestations
Conjunctivitis infective
|
0.94%
1/106 • Number of events 1
One patient canceled before beginning treatment.
|
|
Infections and infestations
Gastric infection
|
0.94%
1/106 • Number of events 1
One patient canceled before beginning treatment.
|
|
Infections and infestations
Gingival infection
|
2.8%
3/106 • Number of events 4
One patient canceled before beginning treatment.
|
|
Infections and infestations
Infection
|
0.94%
1/106 • Number of events 1
One patient canceled before beginning treatment.
|
|
Infections and infestations
Mucosal infection
|
0.94%
1/106 • Number of events 1
One patient canceled before beginning treatment.
|
|
Infections and infestations
Pneumonia
|
3.8%
4/106 • Number of events 4
One patient canceled before beginning treatment.
|
|
Infections and infestations
Skin infection
|
2.8%
3/106 • Number of events 3
One patient canceled before beginning treatment.
|
|
Infections and infestations
Tooth infection
|
0.94%
1/106 • Number of events 1
One patient canceled before beginning treatment.
|
|
Infections and infestations
Upper respiratory infection
|
2.8%
3/106 • Number of events 3
One patient canceled before beginning treatment.
|
|
Infections and infestations
Urinary tract infection
|
0.94%
1/106 • Number of events 1
One patient canceled before beginning treatment.
|
|
Infections and infestations
Viral hepatitis
|
0.94%
1/106 • Number of events 1
One patient canceled before beginning treatment.
|
|
Injury, poisoning and procedural complications
Vascular access complication
|
0.94%
1/106 • Number of events 1
One patient canceled before beginning treatment.
|
|
Investigations
Activated partial thromboplastin time prolonged
|
0.94%
1/106 • Number of events 1
One patient canceled before beginning treatment.
|
|
Investigations
Alanine aminotransferase increased
|
0.94%
1/106 • Number of events 1
One patient canceled before beginning treatment.
|
|
Investigations
Alkaline phosphatase increased
|
0.94%
1/106 • Number of events 2
One patient canceled before beginning treatment.
|
|
Investigations
Aspartate aminotransferase increased
|
1.9%
2/106 • Number of events 3
One patient canceled before beginning treatment.
|
|
Investigations
Blood bilirubin increased
|
0.94%
1/106 • Number of events 1
One patient canceled before beginning treatment.
|
|
Investigations
Creatinine increased
|
1.9%
2/106 • Number of events 2
One patient canceled before beginning treatment.
|
|
Investigations
Leukocyte count decreased
|
83.0%
88/106 • Number of events 326
One patient canceled before beginning treatment.
|
|
Investigations
Lymphocyte count decreased
|
6.6%
7/106 • Number of events 23
One patient canceled before beginning treatment.
|
|
Investigations
Neutrophil count decreased
|
73.6%
78/106 • Number of events 200
One patient canceled before beginning treatment.
|
|
Investigations
Platelet count decreased
|
67.0%
71/106 • Number of events 260
One patient canceled before beginning treatment.
|
|
Investigations
Weight gain
|
2.8%
3/106 • Number of events 10
One patient canceled before beginning treatment.
|
|
Investigations
Weight loss
|
3.8%
4/106 • Number of events 7
One patient canceled before beginning treatment.
|
|
Metabolism and nutrition disorders
Anorexia
|
8.5%
9/106 • Number of events 12
One patient canceled before beginning treatment.
|
|
Metabolism and nutrition disorders
Blood glucose increased
|
17.0%
18/106 • Number of events 32
One patient canceled before beginning treatment.
|
|
Metabolism and nutrition disorders
Dehydration
|
4.7%
5/106 • Number of events 5
One patient canceled before beginning treatment.
|
|
Metabolism and nutrition disorders
Serum albumin decreased
|
2.8%
3/106 • Number of events 3
One patient canceled before beginning treatment.
|
|
Metabolism and nutrition disorders
Serum calcium decreased
|
5.7%
6/106 • Number of events 6
One patient canceled before beginning treatment.
|
|
Metabolism and nutrition disorders
Serum glucose decreased
|
0.94%
1/106 • Number of events 1
One patient canceled before beginning treatment.
|
|
Metabolism and nutrition disorders
Serum phosphate decreased
|
0.94%
1/106 • Number of events 1
One patient canceled before beginning treatment.
|
|
Metabolism and nutrition disorders
Serum potassium decreased
|
0.94%
1/106 • Number of events 1
One patient canceled before beginning treatment.
|
|
Metabolism and nutrition disorders
Serum sodium decreased
|
0.94%
1/106 • Number of events 1
One patient canceled before beginning treatment.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
2.8%
3/106 • Number of events 3
One patient canceled before beginning treatment.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
1.9%
2/106 • Number of events 2
One patient canceled before beginning treatment.
|
|
Musculoskeletal and connective tissue disorders
Bone pain
|
3.8%
4/106 • Number of events 4
One patient canceled before beginning treatment.
|
|
Musculoskeletal and connective tissue disorders
Muscle weakness
|
1.9%
2/106 • Number of events 2
One patient canceled before beginning treatment.
|
|
Musculoskeletal and connective tissue disorders
Muscle weakness lower limb
|
0.94%
1/106 • Number of events 2
One patient canceled before beginning treatment.
|
|
Musculoskeletal and connective tissue disorders
Muscle weakness right-sided
|
0.94%
1/106 • Number of events 1
One patient canceled before beginning treatment.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
3.8%
4/106 • Number of events 4
One patient canceled before beginning treatment.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
0.94%
1/106 • Number of events 1
One patient canceled before beginning treatment.
|
|
Musculoskeletal and connective tissue disorders
Trismus
|
0.94%
1/106 • Number of events 1
One patient canceled before beginning treatment.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Myelodysplasia
|
0.94%
1/106 • Number of events 8
One patient canceled before beginning treatment.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Tumor pain
|
0.94%
1/106 • Number of events 1
One patient canceled before beginning treatment.
|
|
Nervous system disorders
Dysgeusia
|
2.8%
3/106 • Number of events 8
One patient canceled before beginning treatment.
|
|
Nervous system disorders
Headache
|
0.94%
1/106 • Number of events 2
One patient canceled before beginning treatment.
|
|
Nervous system disorders
Memory impairment
|
0.94%
1/106 • Number of events 2
One patient canceled before beginning treatment.
|
|
Nervous system disorders
Neurological disorder NOS
|
0.94%
1/106 • Number of events 1
One patient canceled before beginning treatment.
|
|
Nervous system disorders
Peripheral motor neuropathy
|
2.8%
3/106 • Number of events 3
One patient canceled before beginning treatment.
|
|
Nervous system disorders
Peripheral sensory neuropathy
|
47.2%
50/106 • Number of events 199
One patient canceled before beginning treatment.
|
|
Nervous system disorders
Syncope vasovagal
|
0.94%
1/106 • Number of events 1
One patient canceled before beginning treatment.
|
|
Nervous system disorders
Taste alteration
|
0.94%
1/106 • Number of events 2
One patient canceled before beginning treatment.
|
|
Nervous system disorders
Tremor
|
0.94%
1/106 • Number of events 1
One patient canceled before beginning treatment.
|
|
Psychiatric disorders
Agitation
|
0.94%
1/106 • Number of events 1
One patient canceled before beginning treatment.
|
|
Psychiatric disorders
Depression
|
2.8%
3/106 • Number of events 4
One patient canceled before beginning treatment.
|
|
Psychiatric disorders
Insomnia
|
3.8%
4/106 • Number of events 4
One patient canceled before beginning treatment.
|
|
Renal and urinary disorders
Bladder obstruction
|
0.94%
1/106 • Number of events 1
One patient canceled before beginning treatment.
|
|
Renal and urinary disorders
Cystitis
|
0.94%
1/106 • Number of events 2
One patient canceled before beginning treatment.
|
|
Renal and urinary disorders
Kidney pain
|
0.94%
1/106 • Number of events 1
One patient canceled before beginning treatment.
|
|
Renal and urinary disorders
Urinary frequency
|
0.94%
1/106 • Number of events 1
One patient canceled before beginning treatment.
|
|
Renal and urinary disorders
Urinary incontinence
|
1.9%
2/106 • Number of events 2
One patient canceled before beginning treatment.
|
|
Reproductive system and breast disorders
Prostatic obstruction
|
0.94%
1/106 • Number of events 1
One patient canceled before beginning treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Allergic rhinitis
|
0.94%
1/106 • Number of events 1
One patient canceled before beginning treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Bronchospasm
|
0.94%
1/106 • Number of events 1
One patient canceled before beginning treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.94%
1/106 • Number of events 1
One patient canceled before beginning treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
6.6%
7/106 • Number of events 7
One patient canceled before beginning treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Hiccups
|
0.94%
1/106 • Number of events 1
One patient canceled before beginning treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
2.8%
3/106 • Number of events 3
One patient canceled before beginning treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Pharyngolaryngeal pain
|
0.94%
1/106 • Number of events 1
One patient canceled before beginning treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
2.8%
3/106 • Number of events 3
One patient canceled before beginning treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonitis
|
2.8%
3/106 • Number of events 3
One patient canceled before beginning treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory disorder
|
0.94%
1/106 • Number of events 1
One patient canceled before beginning treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Voice alteration
|
0.94%
1/106 • Number of events 1
One patient canceled before beginning treatment.
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
37.7%
40/106 • Number of events 150
One patient canceled before beginning treatment.
|
|
Skin and subcutaneous tissue disorders
Hand-and-foot syndrome
|
0.94%
1/106 • Number of events 1
One patient canceled before beginning treatment.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
0.94%
1/106 • Number of events 1
One patient canceled before beginning treatment.
|
|
Skin and subcutaneous tissue disorders
Skin disorder
|
0.94%
1/106 • Number of events 2
One patient canceled before beginning treatment.
|
|
Skin and subcutaneous tissue disorders
Sweating
|
1.9%
2/106 • Number of events 4
One patient canceled before beginning treatment.
|
|
Vascular disorders
Hypertension
|
0.94%
1/106 • Number of events 1
One patient canceled before beginning treatment.
|
|
Vascular disorders
Hypotension
|
2.8%
3/106 • Number of events 3
One patient canceled before beginning treatment.
|
|
Vascular disorders
Thrombosis
|
2.8%
3/106 • Number of events 3
One patient canceled before beginning treatment.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place