Trial Outcomes & Findings for Chemotherapy With Monoclonal Antibody and Radioimmunotherapy for High-Risk B-Cell Non-Hodgkins Lymphoma (NCT NCT00577629)

Last Updated: 2017-05-30

Results Overview

Progression-free survival is measured from the first day of induction chemotherapy to the date of progression, relapse or death. Definitions of response criteria are as described by Cheson. Progressive Disease: \>50% increase from nadir in the sum of the products of the greatest diameters (SPD) of any previously identified abnormal node for PDs or nonresponders, appearance of any new lesion during or at the end of therapy.

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

39 participants

Primary outcome timeframe

1 year

Results posted on

2017-05-30

Participant Flow

Subjects were recruited between September 2005 and March 2011 at Duke University Medical Center.

Participant milestones

Participant milestones
Measure	All Subjects Induction:Cyclophosphamide, Etoposide, and Rituxan followed by Consolidation:Cytarabine and Doxorubicin followed by radioimmunotherapy:Bexxar
Treatment Period STARTED	39
Treatment Period COMPLETED	38
Treatment Period NOT COMPLETED	1
Long Term Follow-Up STARTED	38
Long Term Follow-Up COMPLETED	13
Long Term Follow-Up NOT COMPLETED	25

Reasons for withdrawal

Reasons for withdrawal
Measure	All Subjects Induction:Cyclophosphamide, Etoposide, and Rituxan followed by Consolidation:Cytarabine and Doxorubicin followed by radioimmunotherapy:Bexxar
Treatment Period Death	1
Long Term Follow-Up Death	15
Long Term Follow-Up Lost to Follow-up	5
Long Term Follow-Up Withdrawal by Subject	4
Long Term Follow-Up Physician Decision	1

Baseline Characteristics

Chemotherapy With Monoclonal Antibody and Radioimmunotherapy for High-Risk B-Cell Non-Hodgkins Lymphoma

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	All Subjects n=39 Participants Induction:Cyclophosphamide, Etoposide, and Rituxan followed by Consolidation:Cytarabine and Doxorubicin followed by radioimmunotherapy:Bexxar
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	25 Participants n=5 Participants
Age, Categorical >=65 years	14 Participants n=5 Participants
Age, Customized	60 Years n=5 Participants
Sex: Female, Male Female	12 Participants n=5 Participants
Sex: Female, Male Male	27 Participants n=5 Participants
Region of Enrollment United States	39 participants n=5 Participants

PRIMARY outcome

Timeframe: 1 year

Outcome measures

Outcome measures
Measure	Experimental: Induction + Consolidation + Bexxar n=39 Participants Induction: Cyclophosphamide, Etoposide, and Rituxan followed by Consolidation: Cytarabine and Doxorubicin followed by radioimmunotherapy: Bexxar
1 Year Progression-free Survival Rate	0.74 percentage of participants Interval 0.635 to 0.91

SECONDARY outcome

Timeframe: 10 years

Population: Subjects who achieved a complete response. 9 patients experienced disease progression; 4 patients died. 4 patients were lost-to-follow-up and 11 patients are still living, so DFS was calculated using the last date of follow-up.

Disease-free survival is measured from the date of CR or CRu to date of relapse or death

Outcome measures

Outcome measures
Measure	Experimental: Induction + Consolidation + Bexxar n=29 Participants Induction: Cyclophosphamide, Etoposide, and Rituxan followed by Consolidation: Cytarabine and Doxorubicin followed by radioimmunotherapy: Bexxar
Disease-free Survival	54.10 months Interval 2.0 to 116.0

SECONDARY outcome

Timeframe: 10 years

Population: All subjects who received chemotherapy

Overall Survival is measured from the first day of chemotherapy until death from any cause.

Outcome measures

Outcome measures
Measure	Experimental: Induction + Consolidation + Bexxar n=39 Participants Induction: Cyclophosphamide, Etoposide, and Rituxan followed by Consolidation: Cytarabine and Doxorubicin followed by radioimmunotherapy: Bexxar
Overall Survival	82 percentage of participants

SECONDARY outcome

Timeframe: up to 1 year

Percent of subjects who achieved a complete response (CR) or partial response (PR) any time during the treatment period. CR = complete disappearance of all detectable clinical evidence of disease and disease-related symptoms if present before therapy. PR = 1. \>/= 50% decrease in sum of the product of the diameters (SPD) of up to six of the largest dominant nodes or nodal masses. 2. No increase should be observed in the size of other nodes, liver, or spleen. 3. Splenic and hepatic nodules must regress by ≥ 50% in their SPD or, for single nodules, in the greatest transverse diameter. 4. Except splenic and hepatic nodules, involvement of other organs is usually assessable and no measurable disease should be present. 5. Patients who achieve a CR by the above criteria, but who have persistent morphologic bone marrow involvement will be considered partial responders. 6. No new sites of disease should be observed.

Outcome measures

Outcome measures
Measure	Experimental: Induction + Consolidation + Bexxar n=38 Participants Induction: Cyclophosphamide, Etoposide, and Rituxan followed by Consolidation: Cytarabine and Doxorubicin followed by radioimmunotherapy: Bexxar
Overall Response	92 percentage of participants

SECONDARY outcome

Timeframe: 10 years

Population: All patients who received chemotherapy

The number of patients who develop secondary malignancies including solid tumors, acute leukemia and myelodysplasia or other bone marrow failure syndromes.

Outcome measures

Outcome measures
Measure	Experimental: Induction + Consolidation + Bexxar n=39 Participants Induction: Cyclophosphamide, Etoposide, and Rituxan followed by Consolidation: Cytarabine and Doxorubicin followed by radioimmunotherapy: Bexxar
Secondary Malignancies Myelodysplastic Syndrome (MDS)	3 Participants
Secondary Malignancies Acute Myeloid Leukemia (AML)	1 Participants
Secondary Malignancies Pancreatic Cancer	1 Participants
Secondary Malignancies Hodgkins Lymphoma	1 Participants
Secondary Malignancies Melanoma	1 Participants
Secondary Malignancies Renal Cell Carcinoma	1 Participants

Adverse Events

Experimental: Induction + Consolidation + Bexxar

Serious events: 28 serious events

Other events: 39 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Experimental: Induction + Consolidation + Bexxar n=39 participants at risk Induction:Cyclophosphamide, Etoposide, and Rituxan followed by Consolidation:Cytarabine and Doxorubicin followed by radioimmunotherapy: Bexxar
Cardiac disorders Supraventricular and nodal arrhythmia - Atrial fibrillation	2.6% 1/39 • Number of events 1 • 2 years from the start of treatment with the following exception: data on malignancies/bone marrow failures will be collected for 10 years. All adverse events are reported whether or not they are considered related to study regimen.
Nervous system disorders Speech impairment (e.g., dysphasia or aphasia)	2.6% 1/39 • Number of events 1 • 2 years from the start of treatment with the following exception: data on malignancies/bone marrow failures will be collected for 10 years. All adverse events are reported whether or not they are considered related to study regimen.
Vascular disorders Thrombosis / thrombus / embolism	2.6% 1/39 • Number of events 1 • 2 years from the start of treatment with the following exception: data on malignancies/bone marrow failures will be collected for 10 years. All adverse events are reported whether or not they are considered related to study regimen.
Nervous system disorders Ataxia (incoordination)	2.6% 1/39 • Number of events 1 • 2 years from the start of treatment with the following exception: data on malignancies/bone marrow failures will be collected for 10 years. All adverse events are reported whether or not they are considered related to study regimen.
Surgical and medical procedures Thrombosis / embolism (vascular access-related)	2.6% 1/39 • Number of events 1 • 2 years from the start of treatment with the following exception: data on malignancies/bone marrow failures will be collected for 10 years. All adverse events are reported whether or not they are considered related to study regimen.
Gastrointestinal disorders Gastrointestinal - Other	2.6% 1/39 • Number of events 1 • 2 years from the start of treatment with the following exception: data on malignancies/bone marrow failures will be collected for 10 years. All adverse events are reported whether or not they are considered related to study regimen.
Respiratory, thoracic and mediastinal disorders Hypoxia	2.6% 1/39 • Number of events 1 • 2 years from the start of treatment with the following exception: data on malignancies/bone marrow failures will be collected for 10 years. All adverse events are reported whether or not they are considered related to study regimen.
Vascular disorders Hypotension	2.6% 1/39 • Number of events 1 • 2 years from the start of treatment with the following exception: data on malignancies/bone marrow failures will be collected for 10 years. All adverse events are reported whether or not they are considered related to study regimen.
Skin and subcutaneous tissue disorders Dermatology / Skin - Other	2.6% 1/39 • Number of events 1 • 2 years from the start of treatment with the following exception: data on malignancies/bone marrow failures will be collected for 10 years. All adverse events are reported whether or not they are considered related to study regimen.
Investigations Leukocytes (total WBC)	2.6% 1/39 • Number of events 1 • 2 years from the start of treatment with the following exception: data on malignancies/bone marrow failures will be collected for 10 years. All adverse events are reported whether or not they are considered related to study regimen.
Cardiac disorders Cardiac Arrhythmia - Other	2.6% 1/39 • Number of events 1 • 2 years from the start of treatment with the following exception: data on malignancies/bone marrow failures will be collected for 10 years. All adverse events are reported whether or not they are considered related to study regimen.
Gastrointestinal disorders Ascites (non-malignant)	2.6% 1/39 • Number of events 1 • 2 years from the start of treatment with the following exception: data on malignancies/bone marrow failures will be collected for 10 years. All adverse events are reported whether or not they are considered related to study regimen.
Infections and infestations Infection with unknown ANC - Lung (pneumonia)	2.6% 1/39 • Number of events 1 • 2 years from the start of treatment with the following exception: data on malignancies/bone marrow failures will be collected for 10 years. All adverse events are reported whether or not they are considered related to study regimen.
Respiratory, thoracic and mediastinal disorders Hemorrhage, pulmonary / upper respiratory - Nose	5.1% 2/39 • Number of events 2 • 2 years from the start of treatment with the following exception: data on malignancies/bone marrow failures will be collected for 10 years. All adverse events are reported whether or not they are considered related to study regimen.
Infections and infestations Infection with normal ANC or Grade 1 or 2 neutrophils	5.1% 2/39 • Number of events 2 • 2 years from the start of treatment with the following exception: data on malignancies/bone marrow failures will be collected for 10 years. All adverse events are reported whether or not they are considered related to study regimen.
Infections and infestations Colitis, infectious (e.g., Clostridium difficile)	5.1% 2/39 • Number of events 2 • 2 years from the start of treatment with the following exception: data on malignancies/bone marrow failures will be collected for 10 years. All adverse events are reported whether or not they are considered related to study regimen.
Gastrointestinal disorders Pain - Abdomen NOS	5.1% 2/39 • Number of events 2 • 2 years from the start of treatment with the following exception: data on malignancies/bone marrow failures will be collected for 10 years. All adverse events are reported whether or not they are considered related to study regimen.
Gastrointestinal disorders Mucositis / Stomatitis (clinical exam)	7.7% 3/39 • Number of events 3 • 2 years from the start of treatment with the following exception: data on malignancies/bone marrow failures will be collected for 10 years. All adverse events are reported whether or not they are considered related to study regimen.
Blood and lymphatic system disorders Febrile neutropenia (fever of unknown origin without documented infection)	10.3% 4/39 • Number of events 4 • 2 years from the start of treatment with the following exception: data on malignancies/bone marrow failures will be collected for 10 years. All adverse events are reported whether or not they are considered related to study regimen.
Infections and infestations Infection - Other	10.3% 4/39 • Number of events 5 • 2 years from the start of treatment with the following exception: data on malignancies/bone marrow failures will be collected for 10 years. All adverse events are reported whether or not they are considered related to study regimen.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Malignancy	20.5% 8/39 • Number of events 8 • 2 years from the start of treatment with the following exception: data on malignancies/bone marrow failures will be collected for 10 years. All adverse events are reported whether or not they are considered related to study regimen.
Infections and infestations Infection (documented clinically or microbiologically) with Grade 3 or 4 neutrophils	12.8% 5/39 • Number of events 6 • 2 years from the start of treatment with the following exception: data on malignancies/bone marrow failures will be collected for 10 years. All adverse events are reported whether or not they are considered related to study regimen.

Other adverse events

Other adverse events
Measure	Experimental: Induction + Consolidation + Bexxar n=39 participants at risk Induction:Cyclophosphamide, Etoposide, and Rituxan followed by Consolidation:Cytarabine and Doxorubicin followed by radioimmunotherapy: Bexxar
Respiratory, thoracic and mediastinal disorders Allergic rhinitis (including sneezing, nasal stuffiness, postnasal drip)	5.1% 2/39 • Number of events 2 • 2 years from the start of treatment with the following exception: data on malignancies/bone marrow failures will be collected for 10 years. All adverse events are reported whether or not they are considered related to study regimen.
Cardiac disorders Supraventricular and nodal arrhythmia - Atrial fibrillation	5.1% 2/39 • Number of events 2 • 2 years from the start of treatment with the following exception: data on malignancies/bone marrow failures will be collected for 10 years. All adverse events are reported whether or not they are considered related to study regimen.
Gastrointestinal disorders Esophagitis	5.1% 2/39 • Number of events 2 • 2 years from the start of treatment with the following exception: data on malignancies/bone marrow failures will be collected for 10 years. All adverse events are reported whether or not they are considered related to study regimen.
Respiratory, thoracic and mediastinal disorders Hemorrhage, pulmonary / upper respiratory	5.1% 2/39 • Number of events 2 • 2 years from the start of treatment with the following exception: data on malignancies/bone marrow failures will be collected for 10 years. All adverse events are reported whether or not they are considered related to study regimen.
General disorders Edema	5.1% 2/39 • Number of events 2 • 2 years from the start of treatment with the following exception: data on malignancies/bone marrow failures will be collected for 10 years. All adverse events are reported whether or not they are considered related to study regimen.
General disorders Edema: Other	5.1% 2/39 • Number of events 2 • 2 years from the start of treatment with the following exception: data on malignancies/bone marrow failures will be collected for 10 years. All adverse events are reported whether or not they are considered related to study regimen.
Nervous system disorders Memory Impairment	5.1% 2/39 • Number of events 2 • 2 years from the start of treatment with the following exception: data on malignancies/bone marrow failures will be collected for 10 years. All adverse events are reported whether or not they are considered related to study regimen.
Nervous system disorders Neuropathy: motor	5.1% 2/39 • Number of events 2 • 2 years from the start of treatment with the following exception: data on malignancies/bone marrow failures will be collected for 10 years. All adverse events are reported whether or not they are considered related to study regimen.
Nervous system disorders Speech impairment (e.g., dysphasia or aphasia)	5.1% 2/39 • Number of events 2 • 2 years from the start of treatment with the following exception: data on malignancies/bone marrow failures will be collected for 10 years. All adverse events are reported whether or not they are considered related to study regimen.
Nervous system disorders Tremor	5.1% 2/39 • Number of events 2 • 2 years from the start of treatment with the following exception: data on malignancies/bone marrow failures will be collected for 10 years. All adverse events are reported whether or not they are considered related to study regimen.
General disorders Pain - Chest / thorax NOS	5.1% 2/39 • Number of events 2 • 2 years from the start of treatment with the following exception: data on malignancies/bone marrow failures will be collected for 10 years. All adverse events are reported whether or not they are considered related to study regimen.
Gastrointestinal disorders Pain - Rectum	5.1% 2/39 • Number of events 2 • 2 years from the start of treatment with the following exception: data on malignancies/bone marrow failures will be collected for 10 years. All adverse events are reported whether or not they are considered related to study regimen.
Nervous system disorders Pain - Sinus	5.1% 2/39 • Number of events 2 • 2 years from the start of treatment with the following exception: data on malignancies/bone marrow failures will be collected for 10 years. All adverse events are reported whether or not they are considered related to study regimen.
Respiratory, thoracic and mediastinal disorders Pain-Pulmonary / Upper Respiratory	5.1% 2/39 • Number of events 2 • 2 years from the start of treatment with the following exception: data on malignancies/bone marrow failures will be collected for 10 years. All adverse events are reported whether or not they are considered related to study regimen.
Gastrointestinal disorders Pain-Renal / Genitourinary	5.1% 2/39 • Number of events 2 • 2 years from the start of treatment with the following exception: data on malignancies/bone marrow failures will be collected for 10 years. All adverse events are reported whether or not they are considered related to study regimen.
Respiratory, thoracic and mediastinal disorders Atelectasis	5.1% 2/39 • Number of events 2 • 2 years from the start of treatment with the following exception: data on malignancies/bone marrow failures will be collected for 10 years. All adverse events are reported whether or not they are considered related to study regimen.
Metabolism and nutrition disorders Tumor lysis syndrome	5.1% 2/39 • Number of events 2 • 2 years from the start of treatment with the following exception: data on malignancies/bone marrow failures will be collected for 10 years. All adverse events are reported whether or not they are considered related to study regimen.
Cardiac disorders Left ventricular systolic dysfunction	7.7% 3/39 • Number of events 3 • 2 years from the start of treatment with the following exception: data on malignancies/bone marrow failures will be collected for 10 years. All adverse events are reported whether or not they are considered related to study regimen.
Gastrointestinal disorders Hemorrhage, GI	7.7% 3/39 • Number of events 3 • 2 years from the start of treatment with the following exception: data on malignancies/bone marrow failures will be collected for 10 years. All adverse events are reported whether or not they are considered related to study regimen.
Metabolism and nutrition disorders Glucose, serum-high (hyperglycemia)	7.7% 3/39 • Number of events 3 • 2 years from the start of treatment with the following exception: data on malignancies/bone marrow failures will be collected for 10 years. All adverse events are reported whether or not they are considered related to study regimen.
Psychiatric disorders Confusion	7.7% 3/39 • Number of events 3 • 2 years from the start of treatment with the following exception: data on malignancies/bone marrow failures will be collected for 10 years. All adverse events are reported whether or not they are considered related to study regimen.
Psychiatric disorders Mood Alteration - Agitation	7.7% 3/39 • Number of events 3 • 2 years from the start of treatment with the following exception: data on malignancies/bone marrow failures will be collected for 10 years. All adverse events are reported whether or not they are considered related to study regimen.
Nervous system disorders Somnolence / depressed level of consciousness	7.7% 3/39 • Number of events 3 • 2 years from the start of treatment with the following exception: data on malignancies/bone marrow failures will be collected for 10 years. All adverse events are reported whether or not they are considered related to study regimen.
General disorders Pain	7.7% 3/39 • Number of events 3 • 2 years from the start of treatment with the following exception: data on malignancies/bone marrow failures will be collected for 10 years. All adverse events are reported whether or not they are considered related to study regimen.
Respiratory, thoracic and mediastinal disorders Voice changes / dysarthria (e.g., hoarseness, loss or alteration in voice, laryngitis)	7.7% 3/39 • Number of events 3 • 2 years from the start of treatment with the following exception: data on malignancies/bone marrow failures will be collected for 10 years. All adverse events are reported whether or not they are considered related to study regimen.
Vascular disorders Thrombosis / thrombus / embolism	7.7% 3/39 • Number of events 3 • 2 years from the start of treatment with the following exception: data on malignancies/bone marrow failures will be collected for 10 years. All adverse events are reported whether or not they are considered related to study regimen.
Investigations Weight gain	10.3% 4/39 • Number of events 4 • 2 years from the start of treatment with the following exception: data on malignancies/bone marrow failures will be collected for 10 years. All adverse events are reported whether or not they are considered related to study regimen.
Gastrointestinal disorders Dry mouth / salivary gland (xerostomia)	7.7% 3/39 • Number of events 4 • 2 years from the start of treatment with the following exception: data on malignancies/bone marrow failures will be collected for 10 years. All adverse events are reported whether or not they are considered related to study regimen.
Respiratory, thoracic and mediastinal disorders Hemorrhage, pulmonary / upper respiratory - Nose	7.7% 3/39 • Number of events 4 • 2 years from the start of treatment with the following exception: data on malignancies/bone marrow failures will be collected for 10 years. All adverse events are reported whether or not they are considered related to study regimen.
Infections and infestations Infection with normal ANC or Grade 1 or 2 neutrophils	10.3% 4/39 • Number of events 4 • 2 years from the start of treatment with the following exception: data on malignancies/bone marrow failures will be collected for 10 years. All adverse events are reported whether or not they are considered related to study regimen.
Nervous system disorders Ataxia (incoordination)	7.7% 3/39 • Number of events 4 • 2 years from the start of treatment with the following exception: data on malignancies/bone marrow failures will be collected for 10 years. All adverse events are reported whether or not they are considered related to study regimen.
Psychiatric disorders Psychosis (hallucinations / delusions)	10.3% 4/39 • Number of events 4 • 2 years from the start of treatment with the following exception: data on malignancies/bone marrow failures will be collected for 10 years. All adverse events are reported whether or not they are considered related to study regimen.
Gastrointestinal disorders Pain - Oral cavity	7.7% 3/39 • Number of events 4 • 2 years from the start of treatment with the following exception: data on malignancies/bone marrow failures will be collected for 10 years. All adverse events are reported whether or not they are considered related to study regimen.
Cardiac disorders Palpitations	12.8% 5/39 • Number of events 5 • 2 years from the start of treatment with the following exception: data on malignancies/bone marrow failures will be collected for 10 years. All adverse events are reported whether or not they are considered related to study regimen.
Investigations Metabolic / Laboratory - Other	7.7% 3/39 • Number of events 5 • 2 years from the start of treatment with the following exception: data on malignancies/bone marrow failures will be collected for 10 years. All adverse events are reported whether or not they are considered related to study regimen.
Respiratory, thoracic and mediastinal disorders Pain - Throat / pharynx / larynx	7.7% 3/39 • Number of events 5 • 2 years from the start of treatment with the following exception: data on malignancies/bone marrow failures will be collected for 10 years. All adverse events are reported whether or not they are considered related to study regimen.
Renal and urinary disorders Renal / Genitourinary - Other	10.3% 4/39 • Number of events 5 • 2 years from the start of treatment with the following exception: data on malignancies/bone marrow failures will be collected for 10 years. All adverse events are reported whether or not they are considered related to study regimen.
Cardiac disorders Supraventricular and nodal arrhythmia	10.3% 4/39 • Number of events 6 • 2 years from the start of treatment with the following exception: data on malignancies/bone marrow failures will be collected for 10 years. All adverse events are reported whether or not they are considered related to study regimen.
Vascular disorders Hot flashes / flushes	12.8% 5/39 • Number of events 6 • 2 years from the start of treatment with the following exception: data on malignancies/bone marrow failures will be collected for 10 years. All adverse events are reported whether or not they are considered related to study regimen.
Gastrointestinal disorders Mucositis / stomatitis (clinical exam) - Oral cavity	12.8% 5/39 • Number of events 6 • 2 years from the start of treatment with the following exception: data on malignancies/bone marrow failures will be collected for 10 years. All adverse events are reported whether or not they are considered related to study regimen.
Infections and infestations Colitis, infectious (e.g., Clostridium difficile)	15.4% 6/39 • Number of events 6 • 2 years from the start of treatment with the following exception: data on malignancies/bone marrow failures will be collected for 10 years. All adverse events are reported whether or not they are considered related to study regimen.
Metabolism and nutrition disorders Sodium, serum-low (hyponatremia)	15.4% 6/39 • Number of events 6 • 2 years from the start of treatment with the following exception: data on malignancies/bone marrow failures will be collected for 10 years. All adverse events are reported whether or not they are considered related to study regimen.
Eye disorders Vision - blurred vision	15.4% 6/39 • Number of events 6 • 2 years from the start of treatment with the following exception: data on malignancies/bone marrow failures will be collected for 10 years. All adverse events are reported whether or not they are considered related to study regimen.
Musculoskeletal and connective tissue disorders Pain - Extremity-limb	12.8% 5/39 • Number of events 6 • 2 years from the start of treatment with the following exception: data on malignancies/bone marrow failures will be collected for 10 years. All adverse events are reported whether or not they are considered related to study regimen.
Surgical and medical procedures Thrombosis / embolism (vascular access-related)	12.8% 5/39 • Number of events 6 • 2 years from the start of treatment with the following exception: data on malignancies/bone marrow failures will be collected for 10 years. All adverse events are reported whether or not they are considered related to study regimen.
Investigations Weight loss	17.9% 7/39 • Number of events 7 • 2 years from the start of treatment with the following exception: data on malignancies/bone marrow failures will be collected for 10 years. All adverse events are reported whether or not they are considered related to study regimen.
Skin and subcutaneous tissue disorders Pruritus / itching	15.4% 6/39 • Number of events 7 • 2 years from the start of treatment with the following exception: data on malignancies/bone marrow failures will be collected for 10 years. All adverse events are reported whether or not they are considered related to study regimen.
Gastrointestinal disorders Pain - Abdomen NOS	12.8% 5/39 • Number of events 7 • 2 years from the start of treatment with the following exception: data on malignancies/bone marrow failures will be collected for 10 years. All adverse events are reported whether or not they are considered related to study regimen.
Musculoskeletal and connective tissue disorders Pain - Back	12.8% 5/39 • Number of events 7 • 2 years from the start of treatment with the following exception: data on malignancies/bone marrow failures will be collected for 10 years. All adverse events are reported whether or not they are considered related to study regimen.
Gastrointestinal disorders Dysphagia (difficulty swallowing)	20.5% 8/39 • Number of events 8 • 2 years from the start of treatment with the following exception: data on malignancies/bone marrow failures will be collected for 10 years. All adverse events are reported whether or not they are considered related to study regimen.
Gastrointestinal disorders Gastrointestinal - Other	17.9% 7/39 • Number of events 8 • 2 years from the start of treatment with the following exception: data on malignancies/bone marrow failures will be collected for 10 years. All adverse events are reported whether or not they are considered related to study regimen.
Nervous system disorders Taste Alteration (dysgeusia)	20.5% 8/39 • Number of events 8 • 2 years from the start of treatment with the following exception: data on malignancies/bone marrow failures will be collected for 10 years. All adverse events are reported whether or not they are considered related to study regimen.
Metabolism and nutrition disorders Potassium, serum-low (hypokalemia)	15.4% 6/39 • Number of events 8 • 2 years from the start of treatment with the following exception: data on malignancies/bone marrow failures will be collected for 10 years. All adverse events are reported whether or not they are considered related to study regimen.
Nervous system disorders Pain - Head / headache	17.9% 7/39 • Number of events 8 • 2 years from the start of treatment with the following exception: data on malignancies/bone marrow failures will be collected for 10 years. All adverse events are reported whether or not they are considered related to study regimen.
General disorders Fever (in the absence of neutropenia, where neutropenia is defined as ANC <1.0 x 10e9/L)	15.4% 6/39 • Number of events 9 • 2 years from the start of treatment with the following exception: data on malignancies/bone marrow failures will be collected for 10 years. All adverse events are reported whether or not they are considered related to study regimen.
Gastrointestinal disorders Heartburn / dyspepsia	23.1% 9/39 • Number of events 9 • 2 years from the start of treatment with the following exception: data on malignancies/bone marrow failures will be collected for 10 years. All adverse events are reported whether or not they are considered related to study regimen.
Psychiatric disorders Mood Alteration - Anxiety	17.9% 7/39 • Number of events 9 • 2 years from the start of treatment with the following exception: data on malignancies/bone marrow failures will be collected for 10 years. All adverse events are reported whether or not they are considered related to study regimen.
Respiratory, thoracic and mediastinal disorders Hypoxia	15.4% 6/39 • Number of events 9 • 2 years from the start of treatment with the following exception: data on malignancies/bone marrow failures will be collected for 10 years. All adverse events are reported whether or not they are considered related to study regimen.
General disorders Rigors / chills	23.1% 9/39 • Number of events 10 • 2 years from the start of treatment with the following exception: data on malignancies/bone marrow failures will be collected for 10 years. All adverse events are reported whether or not they are considered related to study regimen.
Skin and subcutaneous tissue disorders Sweating (diaphoresis)	25.6% 10/39 • Number of events 10 • 2 years from the start of treatment with the following exception: data on malignancies/bone marrow failures will be collected for 10 years. All adverse events are reported whether or not they are considered related to study regimen.
Infections and infestations Infection - Other	23.1% 9/39 • Number of events 10 • 2 years from the start of treatment with the following exception: data on malignancies/bone marrow failures will be collected for 10 years. All adverse events are reported whether or not they are considered related to study regimen.
Vascular disorders Hypotension	23.1% 9/39 • Number of events 11 • 2 years from the start of treatment with the following exception: data on malignancies/bone marrow failures will be collected for 10 years. All adverse events are reported whether or not they are considered related to study regimen.
Musculoskeletal and connective tissue disorders Pain-Musculoskeletal	20.5% 8/39 • Number of events 11 • 2 years from the start of treatment with the following exception: data on malignancies/bone marrow failures will be collected for 10 years. All adverse events are reported whether or not they are considered related to study regimen.
Metabolism and nutrition disorders Calcium, serum-low (hypocalcemia)	28.2% 11/39 • Number of events 12 • 2 years from the start of treatment with the following exception: data on malignancies/bone marrow failures will be collected for 10 years. All adverse events are reported whether or not they are considered related to study regimen.
Investigations Creatinine	23.1% 9/39 • Number of events 12 • 2 years from the start of treatment with the following exception: data on malignancies/bone marrow failures will be collected for 10 years. All adverse events are reported whether or not they are considered related to study regimen.
Skin and subcutaneous tissue disorders Dry Skin	28.2% 11/39 • Number of events 13 • 2 years from the start of treatment with the following exception: data on malignancies/bone marrow failures will be collected for 10 years. All adverse events are reported whether or not they are considered related to study regimen.
Metabolism and nutrition disorders Albumin, serum-low (hypoalbuminemia)	30.8% 12/39 • Number of events 13 • 2 years from the start of treatment with the following exception: data on malignancies/bone marrow failures will be collected for 10 years. All adverse events are reported whether or not they are considered related to study regimen.
Musculoskeletal and connective tissue disorders Muscle weakness, generalized or specific area (not due to neuropathy)	30.8% 12/39 • Number of events 13 • 2 years from the start of treatment with the following exception: data on malignancies/bone marrow failures will be collected for 10 years. All adverse events are reported whether or not they are considered related to study regimen.
Nervous system disorders Neurology - Other	20.5% 8/39 • Number of events 13 • 2 years from the start of treatment with the following exception: data on malignancies/bone marrow failures will be collected for 10 years. All adverse events are reported whether or not they are considered related to study regimen.
Musculoskeletal and connective tissue disorders Joint-function	23.1% 9/39 • Number of events 14 • 2 years from the start of treatment with the following exception: data on malignancies/bone marrow failures will be collected for 10 years. All adverse events are reported whether or not they are considered related to study regimen.
Skin and subcutaneous tissue disorders Dermatology / Skin - Other	25.6% 10/39 • Number of events 15 • 2 years from the start of treatment with the following exception: data on malignancies/bone marrow failures will be collected for 10 years. All adverse events are reported whether or not they are considered related to study regimen.
Skin and subcutaneous tissue disorders Nail Changes	35.9% 14/39 • Number of events 15 • 2 years from the start of treatment with the following exception: data on malignancies/bone marrow failures will be collected for 10 years. All adverse events are reported whether or not they are considered related to study regimen.
Investigations Bilirubin (hyperbilirubinemia)	20.5% 8/39 • Number of events 15 • 2 years from the start of treatment with the following exception: data on malignancies/bone marrow failures will be collected for 10 years. All adverse events are reported whether or not they are considered related to study regimen.
Renal and urinary disorders Urinary frequency / urgency	33.3% 13/39 • Number of events 15 • 2 years from the start of treatment with the following exception: data on malignancies/bone marrow failures will be collected for 10 years. All adverse events are reported whether or not they are considered related to study regimen.
General disorders Edema: limb	33.3% 13/39 • Number of events 17 • 2 years from the start of treatment with the following exception: data on malignancies/bone marrow failures will be collected for 10 years. All adverse events are reported whether or not they are considered related to study regimen.
Nervous system disorders Dizziness	30.8% 12/39 • Number of events 19 • 2 years from the start of treatment with the following exception: data on malignancies/bone marrow failures will be collected for 10 years. All adverse events are reported whether or not they are considered related to study regimen.
Nervous system disorders Neuropathy: sensory	28.2% 11/39 • Number of events 19 • 2 years from the start of treatment with the following exception: data on malignancies/bone marrow failures will be collected for 10 years. All adverse events are reported whether or not they are considered related to study regimen.
Psychiatric disorders Insomnia	38.5% 15/39 • Number of events 20 • 2 years from the start of treatment with the following exception: data on malignancies/bone marrow failures will be collected for 10 years. All adverse events are reported whether or not they are considered related to study regimen.
Metabolism and nutrition disorders Anorexia	46.2% 18/39 • Number of events 22 • 2 years from the start of treatment with the following exception: data on malignancies/bone marrow failures will be collected for 10 years. All adverse events are reported whether or not they are considered related to study regimen.
Respiratory, thoracic and mediastinal disorders Dyspnea (shortness of breath)	43.6% 17/39 • Number of events 22 • 2 years from the start of treatment with the following exception: data on malignancies/bone marrow failures will be collected for 10 years. All adverse events are reported whether or not they are considered related to study regimen.
Blood and lymphatic system disorders Febrile neutropenia (fever of unknown origin without documented infection)	48.7% 19/39 • Number of events 24 • 2 years from the start of treatment with the following exception: data on malignancies/bone marrow failures will be collected for 10 years. All adverse events are reported whether or not they are considered related to study regimen.
Skin and subcutaneous tissue disorders Hair Loss / Alopecia (scalp or body)	66.7% 26/39 • Number of events 26 • 2 years from the start of treatment with the following exception: data on malignancies/bone marrow failures will be collected for 10 years. All adverse events are reported whether or not they are considered related to study regimen.
Gastrointestinal disorders Constipation	38.5% 15/39 • Number of events 26 • 2 years from the start of treatment with the following exception: data on malignancies/bone marrow failures will be collected for 10 years. All adverse events are reported whether or not they are considered related to study regimen.
Skin and subcutaneous tissue disorders Rash / desquamation	48.7% 19/39 • Number of events 27 • 2 years from the start of treatment with the following exception: data on malignancies/bone marrow failures will be collected for 10 years. All adverse events are reported whether or not they are considered related to study regimen.
Respiratory, thoracic and mediastinal disorders Pulmonary / Upper Respiratory - Other	41.0% 16/39 • Number of events 27 • 2 years from the start of treatment with the following exception: data on malignancies/bone marrow failures will be collected for 10 years. All adverse events are reported whether or not they are considered related to study regimen.
Respiratory, thoracic and mediastinal disorders Cough	48.7% 19/39 • Number of events 31 • 2 years from the start of treatment with the following exception: data on malignancies/bone marrow failures will be collected for 10 years. All adverse events are reported whether or not they are considered related to study regimen.
Investigations Neutrophils / granulocytes (ANC / AGC)	56.4% 22/39 • Number of events 32 • 2 years from the start of treatment with the following exception: data on malignancies/bone marrow failures will be collected for 10 years. All adverse events are reported whether or not they are considered related to study regimen.
General disorders Pain - Other	43.6% 17/39 • Number of events 38 • 2 years from the start of treatment with the following exception: data on malignancies/bone marrow failures will be collected for 10 years. All adverse events are reported whether or not they are considered related to study regimen.
Investigations Alkaline phosphatase	53.8% 21/39 • Number of events 40 • 2 years from the start of treatment with the following exception: data on malignancies/bone marrow failures will be collected for 10 years. All adverse events are reported whether or not they are considered related to study regimen.
Gastrointestinal disorders Vomiting	64.1% 25/39 • Number of events 42 • 2 years from the start of treatment with the following exception: data on malignancies/bone marrow failures will be collected for 10 years. All adverse events are reported whether or not they are considered related to study regimen.
Investigations ALT, SGPT (serum glutamic pyruvic transaminase)	69.2% 27/39 • Number of events 42 • 2 years from the start of treatment with the following exception: data on malignancies/bone marrow failures will be collected for 10 years. All adverse events are reported whether or not they are considered related to study regimen.
Infections and infestations Infection (documented clinically or microbiologically) with Grade 3 or 4 neutrophils	69.2% 27/39 • Number of events 44 • 2 years from the start of treatment with the following exception: data on malignancies/bone marrow failures will be collected for 10 years. All adverse events are reported whether or not they are considered related to study regimen.
Gastrointestinal disorders Mucositis / Stomatitis (clinical exam)	71.8% 28/39 • Number of events 48 • 2 years from the start of treatment with the following exception: data on malignancies/bone marrow failures will be collected for 10 years. All adverse events are reported whether or not they are considered related to study regimen.
Gastrointestinal disorders Nausea	79.5% 31/39 • Number of events 49 • 2 years from the start of treatment with the following exception: data on malignancies/bone marrow failures will be collected for 10 years. All adverse events are reported whether or not they are considered related to study regimen.
General disorders Fatigue (asthenia, lethargy, malaise)	82.1% 32/39 • Number of events 52 • 2 years from the start of treatment with the following exception: data on malignancies/bone marrow failures will be collected for 10 years. All adverse events are reported whether or not they are considered related to study regimen.
Investigations AST, SGOT (serum glutamic oxaloacetic transaminase)	76.9% 30/39 • Number of events 57 • 2 years from the start of treatment with the following exception: data on malignancies/bone marrow failures will be collected for 10 years. All adverse events are reported whether or not they are considered related to study regimen.
Gastrointestinal disorders Diarrhea	71.8% 28/39 • Number of events 58 • 2 years from the start of treatment with the following exception: data on malignancies/bone marrow failures will be collected for 10 years. All adverse events are reported whether or not they are considered related to study regimen.
Blood and lymphatic system disorders Hemoglobin	100.0% 39/39 • Number of events 96 • 2 years from the start of treatment with the following exception: data on malignancies/bone marrow failures will be collected for 10 years. All adverse events are reported whether or not they are considered related to study regimen.
Investigations Platelets	100.0% 39/39 • Number of events 121 • 2 years from the start of treatment with the following exception: data on malignancies/bone marrow failures will be collected for 10 years. All adverse events are reported whether or not they are considered related to study regimen.
Investigations Leukocytes (total WBC)	100.0% 39/39 • Number of events 139 • 2 years from the start of treatment with the following exception: data on malignancies/bone marrow failures will be collected for 10 years. All adverse events are reported whether or not they are considered related to study regimen.

Additional Information

Anne Beaven, MD

Duke University Medical Center

Phone: 919-684-8964

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place