Trial Outcomes & Findings for Multi-center Study of Myeloablative Allo Stem Cell Transplant for Non-remission AML Using CloBu4 Regimen (NCT NCT01457885)
NCT ID: NCT01457885
Last Updated: 2017-06-02
Results Overview
Percentage of patients passed without relapse/recurrence at 1 year.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
75 participants
Primary outcome timeframe
1 year
Results posted on
2017-06-02
Participant Flow
75 Patients were enrolled. Only 74 began treatment. 3 of these patients were pediatric and were left off the subsequent analysis.
Participant milestones
| Measure |
CloBu4 Regimen
After pre-conditioning with CloBu4 (Clofarabine/Busulfan x 4), subjects will receive a peripheral blood stem cell transplant
Clofarabine/Busulfan x 4: - Clofarabine IV, 40 mg/m2/day x 5 days, and Busulfan IV, 3.2 mg/kg daily x 4 days
|
|---|---|
|
Overall Study
STARTED
|
74
|
|
Overall Study
COMPLETED
|
74
|
|
Overall Study
NOT COMPLETED
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Multi-center Study of Myeloablative Allo Stem Cell Transplant for Non-remission AML Using CloBu4 Regimen
Baseline characteristics by cohort
| Measure |
CloBu4 Regimen
n=71 Participants
After pre-conditioning with CloBu4 (Clofarabine/Busulfan x 4), subjects will receive a peripheral blood stem cell transplant
Clofarabine/Busulfan x 4: - Clofarabine IV, 40 mg/m2/day x 5 days, and Busulfan IV, 3.2 mg/kg daily x 4 days
|
|---|---|
|
Age, Continuous
|
56 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
31 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
40 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 1 yearPopulation: 75 patients were enrolled. Only 74 patients were treated. 3 of the 74 patients were pediatric and were therefore left off of analysis.
Percentage of patients passed without relapse/recurrence at 1 year.
Outcome measures
| Measure |
CloBu4 Regimen
n=71 Participants
After pre-conditioning with CloBu4 (Clofarabine/Busulfan x 4), subjects will receive a peripheral blood stem cell transplant
Clofarabine/Busulfan x 4: - Clofarabine IV, 40 mg/m2/day x 5 days, and Busulfan IV, 3.2 mg/kg daily x 4 days
|
|---|---|
|
Cumulative Incidence of Non Relapse Mortality (NRM)
|
21 percentage of patients
Interval 12.0 to 31.0
|
SECONDARY outcome
Timeframe: 1 yearPopulation: 75 patients were enrolled. Only 74 patients were treated. 3 of the 74 patients were pediatric and were therefore left off of analysis.
Overall survival was calculated following transplant using a CloBu4 conditioning regimen for patients with non-remission AML
Outcome measures
| Measure |
CloBu4 Regimen
n=71 Participants
After pre-conditioning with CloBu4 (Clofarabine/Busulfan x 4), subjects will receive a peripheral blood stem cell transplant
Clofarabine/Busulfan x 4: - Clofarabine IV, 40 mg/m2/day x 5 days, and Busulfan IV, 3.2 mg/kg daily x 4 days
|
|---|---|
|
The Percentage of Patients Alive at 1 Year
|
32 percentage of patients
Interval 22.0 to 44.0
|
SECONDARY outcome
Timeframe: 2 yearsPopulation: 75 patients were enrolled. One patient was not treated. 3 patients were pediatric and therefore left off of this analysis.
Outcome measures
| Measure |
CloBu4 Regimen
n=71 Participants
After pre-conditioning with CloBu4 (Clofarabine/Busulfan x 4), subjects will receive a peripheral blood stem cell transplant
Clofarabine/Busulfan x 4: - Clofarabine IV, 40 mg/m2/day x 5 days, and Busulfan IV, 3.2 mg/kg daily x 4 days
|
|---|---|
|
Incidence of Relapse
|
55 percentage of patients
Interval 42.0 to 66.0
|
Adverse Events
CloBu4 Regimen
Serious events: 38 serious events
Other events: 17 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
CloBu4 Regimen
n=74 participants at risk
After pre-conditioning with CloBu4 (Clofarabine/Busulfan x 4), subjects will receive a peripheral blood stem cell transplant
Clofarabine/Busulfan x 4: - Clofarabine IV, 40 mg/m2/day x 5 days, and Busulfan IV, 3.2 mg/kg daily x 4 days
|
|---|---|
|
Blood and lymphatic system disorders
Blood and lymphatic system disorders - Other
|
1.4%
1/74 • Number of events 1
Adverse events were captured for all patients that were treated with study drug. 75 patients were enrolled and 1 patient was not treated. Only 74 patients were treated.
|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
1.4%
1/74 • Number of events 1
Adverse events were captured for all patients that were treated with study drug. 75 patients were enrolled and 1 patient was not treated. Only 74 patients were treated.
|
|
Cardiac disorders
Atrial fibrillation
|
1.4%
1/74 • Number of events 1
Adverse events were captured for all patients that were treated with study drug. 75 patients were enrolled and 1 patient was not treated. Only 74 patients were treated.
|
|
Cardiac disorders
Ventricular tachycardia
|
1.4%
1/74 • Number of events 1
Adverse events were captured for all patients that were treated with study drug. 75 patients were enrolled and 1 patient was not treated. Only 74 patients were treated.
|
|
Eye disorders
Eye pain
|
1.4%
1/74 • Number of events 1
Adverse events were captured for all patients that were treated with study drug. 75 patients were enrolled and 1 patient was not treated. Only 74 patients were treated.
|
|
Eye disorders
Keratitis
|
1.4%
1/74 • Number of events 1
Adverse events were captured for all patients that were treated with study drug. 75 patients were enrolled and 1 patient was not treated. Only 74 patients were treated.
|
|
Gastrointestinal disorders
Ascites
|
1.4%
1/74 • Number of events 1
Adverse events were captured for all patients that were treated with study drug. 75 patients were enrolled and 1 patient was not treated. Only 74 patients were treated.
|
|
Gastrointestinal disorders
Diarrhea
|
6.8%
5/74 • Number of events 5
Adverse events were captured for all patients that were treated with study drug. 75 patients were enrolled and 1 patient was not treated. Only 74 patients were treated.
|
|
Gastrointestinal disorders
Gastric hemorrhage
|
1.4%
1/74 • Number of events 1
Adverse events were captured for all patients that were treated with study drug. 75 patients were enrolled and 1 patient was not treated. Only 74 patients were treated.
|
|
Gastrointestinal disorders
Gastrointestinal pain
|
2.7%
2/74 • Number of events 2
Adverse events were captured for all patients that were treated with study drug. 75 patients were enrolled and 1 patient was not treated. Only 74 patients were treated.
|
|
Gastrointestinal disorders
Mucositis oral
|
2.7%
2/74 • Number of events 2
Adverse events were captured for all patients that were treated with study drug. 75 patients were enrolled and 1 patient was not treated. Only 74 patients were treated.
|
|
Gastrointestinal disorders
Nausea
|
2.7%
2/74 • Number of events 2
Adverse events were captured for all patients that were treated with study drug. 75 patients were enrolled and 1 patient was not treated. Only 74 patients were treated.
|
|
Gastrointestinal disorders
Vomiting
|
1.4%
1/74 • Number of events 1
Adverse events were captured for all patients that were treated with study drug. 75 patients were enrolled and 1 patient was not treated. Only 74 patients were treated.
|
|
General disorders
Death
|
1.4%
1/74 • Number of events 1
Adverse events were captured for all patients that were treated with study drug. 75 patients were enrolled and 1 patient was not treated. Only 74 patients were treated.
|
|
General disorders
Fatigue
|
5.4%
4/74 • Number of events 4
Adverse events were captured for all patients that were treated with study drug. 75 patients were enrolled and 1 patient was not treated. Only 74 patients were treated.
|
|
General disorders
Fever
|
1.4%
1/74 • Number of events 1
Adverse events were captured for all patients that were treated with study drug. 75 patients were enrolled and 1 patient was not treated. Only 74 patients were treated.
|
|
General disorders
General disorders and administration site conditions - Other
|
2.7%
2/74 • Number of events 2
Adverse events were captured for all patients that were treated with study drug. 75 patients were enrolled and 1 patient was not treated. Only 74 patients were treated.
|
|
General disorders
Multi-organ failure
|
1.4%
1/74 • Number of events 1
Adverse events were captured for all patients that were treated with study drug. 75 patients were enrolled and 1 patient was not treated. Only 74 patients were treated.
|
|
Hepatobiliary disorders
Hepatic failure
|
1.4%
1/74 • Number of events 1
Adverse events were captured for all patients that were treated with study drug. 75 patients were enrolled and 1 patient was not treated. Only 74 patients were treated.
|
|
Infections and infestations
Infections and infestations - Other
|
4.1%
3/74 • Number of events 3
Adverse events were captured for all patients that were treated with study drug. 75 patients were enrolled and 1 patient was not treated. Only 74 patients were treated.
|
|
Infections and infestations
Joint infection
|
1.4%
1/74 • Number of events 1
Adverse events were captured for all patients that were treated with study drug. 75 patients were enrolled and 1 patient was not treated. Only 74 patients were treated.
|
|
Infections and infestations
Lung infection
|
4.1%
3/74 • Number of events 3
Adverse events were captured for all patients that were treated with study drug. 75 patients were enrolled and 1 patient was not treated. Only 74 patients were treated.
|
|
Infections and infestations
Sepsis
|
9.5%
7/74 • Number of events 7
Adverse events were captured for all patients that were treated with study drug. 75 patients were enrolled and 1 patient was not treated. Only 74 patients were treated.
|
|
Infections and infestations
Sinusitis
|
1.4%
1/74 • Number of events 1
Adverse events were captured for all patients that were treated with study drug. 75 patients were enrolled and 1 patient was not treated. Only 74 patients were treated.
|
|
Infections and infestations
Upper respiratory infection
|
2.7%
2/74 • Number of events 2
Adverse events were captured for all patients that were treated with study drug. 75 patients were enrolled and 1 patient was not treated. Only 74 patients were treated.
|
|
Infections and infestations
Urinary tract infection
|
1.4%
1/74 • Number of events 1
Adverse events were captured for all patients that were treated with study drug. 75 patients were enrolled and 1 patient was not treated. Only 74 patients were treated.
|
|
Injury, poisoning and procedural complications
Fall
|
1.4%
1/74 • Number of events 1
Adverse events were captured for all patients that were treated with study drug. 75 patients were enrolled and 1 patient was not treated. Only 74 patients were treated.
|
|
Investigations
Blood bilirubin increased
|
2.7%
2/74 • Number of events 2
Adverse events were captured for all patients that were treated with study drug. 75 patients were enrolled and 1 patient was not treated. Only 74 patients were treated.
|
|
Metabolism and nutrition disorders
Anorexia
|
1.4%
1/74 • Number of events 1
Adverse events were captured for all patients that were treated with study drug. 75 patients were enrolled and 1 patient was not treated. Only 74 patients were treated.
|
|
Musculoskeletal and connective tissue disorders
Generalized muscle weakness
|
1.4%
1/74 • Number of events 1
Adverse events were captured for all patients that were treated with study drug. 75 patients were enrolled and 1 patient was not treated. Only 74 patients were treated.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal and connective tissue disorder - Othe
|
1.4%
1/74 • Number of events 1
Adverse events were captured for all patients that were treated with study drug. 75 patients were enrolled and 1 patient was not treated. Only 74 patients were treated.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Leukemia secondary to oncology chemotherapy
|
2.7%
2/74 • Number of events 2
Adverse events were captured for all patients that were treated with study drug. 75 patients were enrolled and 1 patient was not treated. Only 74 patients were treated.
|
|
Nervous system disorders
Dizziness
|
2.7%
2/74 • Number of events 2
Adverse events were captured for all patients that were treated with study drug. 75 patients were enrolled and 1 patient was not treated. Only 74 patients were treated.
|
|
Psychiatric disorders
Anxiety
|
1.4%
1/74 • Number of events 1
Adverse events were captured for all patients that were treated with study drug. 75 patients were enrolled and 1 patient was not treated. Only 74 patients were treated.
|
|
Psychiatric disorders
Confusion
|
2.7%
2/74 • Number of events 3
Adverse events were captured for all patients that were treated with study drug. 75 patients were enrolled and 1 patient was not treated. Only 74 patients were treated.
|
|
Renal and urinary disorders
Acute kidney injury
|
4.1%
3/74 • Number of events 3
Adverse events were captured for all patients that were treated with study drug. 75 patients were enrolled and 1 patient was not treated. Only 74 patients were treated.
|
|
Respiratory, thoracic and mediastinal disorders
Adult respiratory distress syndrome
|
1.4%
1/74 • Number of events 1
Adverse events were captured for all patients that were treated with study drug. 75 patients were enrolled and 1 patient was not treated. Only 74 patients were treated.
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
1.4%
1/74 • Number of events 1
Adverse events were captured for all patients that were treated with study drug. 75 patients were enrolled and 1 patient was not treated. Only 74 patients were treated.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonitis
|
1.4%
1/74 • Number of events 1
Adverse events were captured for all patients that were treated with study drug. 75 patients were enrolled and 1 patient was not treated. Only 74 patients were treated.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumothorax
|
1.4%
1/74 • Number of events 1
Adverse events were captured for all patients that were treated with study drug. 75 patients were enrolled and 1 patient was not treated. Only 74 patients were treated.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary fibrosis
|
1.4%
1/74 • Number of events 1
Adverse events were captured for all patients that were treated with study drug. 75 patients were enrolled and 1 patient was not treated. Only 74 patients were treated.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure
|
5.4%
4/74 • Number of events 4
Adverse events were captured for all patients that were treated with study drug. 75 patients were enrolled and 1 patient was not treated. Only 74 patients were treated.
|
|
Skin and subcutaneous tissue disorders
Erythema multiforme
|
1.4%
1/74 • Number of events 1
Adverse events were captured for all patients that were treated with study drug. 75 patients were enrolled and 1 patient was not treated. Only 74 patients were treated.
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
1.4%
1/74 • Number of events 1
Adverse events were captured for all patients that were treated with study drug. 75 patients were enrolled and 1 patient was not treated. Only 74 patients were treated.
|
|
Vascular disorders
Hematoma
|
1.4%
1/74 • Number of events 1
Adverse events were captured for all patients that were treated with study drug. 75 patients were enrolled and 1 patient was not treated. Only 74 patients were treated.
|
|
Vascular disorders
Hypotension
|
2.7%
2/74 • Number of events 2
Adverse events were captured for all patients that were treated with study drug. 75 patients were enrolled and 1 patient was not treated. Only 74 patients were treated.
|
Other adverse events
| Measure |
CloBu4 Regimen
n=74 participants at risk
After pre-conditioning with CloBu4 (Clofarabine/Busulfan x 4), subjects will receive a peripheral blood stem cell transplant
Clofarabine/Busulfan x 4: - Clofarabine IV, 40 mg/m2/day x 5 days, and Busulfan IV, 3.2 mg/kg daily x 4 days
|
|---|---|
|
Blood and lymphatic system disorders
Blood and lymphatic system disorders - Other
|
1.4%
1/74 • Number of events 1
Adverse events were captured for all patients that were treated with study drug. 75 patients were enrolled and 1 patient was not treated. Only 74 patients were treated.
|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
6.8%
5/74 • Number of events 5
Adverse events were captured for all patients that were treated with study drug. 75 patients were enrolled and 1 patient was not treated. Only 74 patients were treated.
|
|
Cardiac disorders
Cardiac disorders - Other
|
1.4%
1/74 • Number of events 1
Adverse events were captured for all patients that were treated with study drug. 75 patients were enrolled and 1 patient was not treated. Only 74 patients were treated.
|
|
Cardiac disorders
Pericardial effusion
|
1.4%
1/74 • Number of events 1
Adverse events were captured for all patients that were treated with study drug. 75 patients were enrolled and 1 patient was not treated. Only 74 patients were treated.
|
|
Cardiac disorders
Pericarditis
|
1.4%
1/74 • Number of events 1
Adverse events were captured for all patients that were treated with study drug. 75 patients were enrolled and 1 patient was not treated. Only 74 patients were treated.
|
|
Ear and labyrinth disorders
Ear pain
|
1.4%
1/74 • Number of events 1
Adverse events were captured for all patients that were treated with study drug. 75 patients were enrolled and 1 patient was not treated. Only 74 patients were treated.
|
|
Eye disorders
Blurred vision
|
1.4%
1/74 • Number of events 1
Adverse events were captured for all patients that were treated with study drug. 75 patients were enrolled and 1 patient was not treated. Only 74 patients were treated.
|
|
Eye disorders
Dry eye
|
2.7%
2/74 • Number of events 2
Adverse events were captured for all patients that were treated with study drug. 75 patients were enrolled and 1 patient was not treated. Only 74 patients were treated.
|
|
Gastrointestinal disorders
Abdominal distension
|
1.4%
1/74 • Number of events 1
Adverse events were captured for all patients that were treated with study drug. 75 patients were enrolled and 1 patient was not treated. Only 74 patients were treated.
|
|
Gastrointestinal disorders
Abdominal pain
|
1.4%
1/74 • Number of events 1
Adverse events were captured for all patients that were treated with study drug. 75 patients were enrolled and 1 patient was not treated. Only 74 patients were treated.
|
|
Gastrointestinal disorders
Constipation
|
1.4%
1/74 • Number of events 1
Adverse events were captured for all patients that were treated with study drug. 75 patients were enrolled and 1 patient was not treated. Only 74 patients were treated.
|
|
Gastrointestinal disorders
Diarrhea
|
9.5%
7/74 • Number of events 8
Adverse events were captured for all patients that were treated with study drug. 75 patients were enrolled and 1 patient was not treated. Only 74 patients were treated.
|
|
Gastrointestinal disorders
Dry mouth
|
1.4%
1/74 • Number of events 1
Adverse events were captured for all patients that were treated with study drug. 75 patients were enrolled and 1 patient was not treated. Only 74 patients were treated.
|
|
Gastrointestinal disorders
Dysphagia
|
1.4%
1/74 • Number of events 1
Adverse events were captured for all patients that were treated with study drug. 75 patients were enrolled and 1 patient was not treated. Only 74 patients were treated.
|
|
Gastrointestinal disorders
Enterocolitis
|
2.7%
2/74 • Number of events 2
Adverse events were captured for all patients that were treated with study drug. 75 patients were enrolled and 1 patient was not treated. Only 74 patients were treated.
|
|
Gastrointestinal disorders
Esophageal pain
|
1.4%
1/74 • Number of events 1
Adverse events were captured for all patients that were treated with study drug. 75 patients were enrolled and 1 patient was not treated. Only 74 patients were treated.
|
|
Gastrointestinal disorders
Esophagitis
|
1.4%
1/74 • Number of events 1
Adverse events were captured for all patients that were treated with study drug. 75 patients were enrolled and 1 patient was not treated. Only 74 patients were treated.
|
|
Gastrointestinal disorders
Gastrointestinal disorders - Other
|
2.7%
2/74 • Number of events 2
Adverse events were captured for all patients that were treated with study drug. 75 patients were enrolled and 1 patient was not treated. Only 74 patients were treated.
|
|
Gastrointestinal disorders
Hemorrhoids
|
1.4%
1/74 • Number of events 1
Adverse events were captured for all patients that were treated with study drug. 75 patients were enrolled and 1 patient was not treated. Only 74 patients were treated.
|
|
Gastrointestinal disorders
Ileus
|
1.4%
1/74 • Number of events 1
Adverse events were captured for all patients that were treated with study drug. 75 patients were enrolled and 1 patient was not treated. Only 74 patients were treated.
|
|
Gastrointestinal disorders
Mucositis oral
|
13.5%
10/74 • Number of events 12
Adverse events were captured for all patients that were treated with study drug. 75 patients were enrolled and 1 patient was not treated. Only 74 patients were treated.
|
|
Gastrointestinal disorders
Nausea
|
16.2%
12/74 • Number of events 15
Adverse events were captured for all patients that were treated with study drug. 75 patients were enrolled and 1 patient was not treated. Only 74 patients were treated.
|
|
Gastrointestinal disorders
Vomiting
|
6.8%
5/74 • Number of events 5
Adverse events were captured for all patients that were treated with study drug. 75 patients were enrolled and 1 patient was not treated. Only 74 patients were treated.
|
|
General disorders
Chills
|
1.4%
1/74 • Number of events 1
Adverse events were captured for all patients that were treated with study drug. 75 patients were enrolled and 1 patient was not treated. Only 74 patients were treated.
|
|
General disorders
Edema limbs
|
2.7%
2/74 • Number of events 2
Adverse events were captured for all patients that were treated with study drug. 75 patients were enrolled and 1 patient was not treated. Only 74 patients were treated.
|
|
General disorders
Fatigue
|
4.1%
3/74 • Number of events 5
Adverse events were captured for all patients that were treated with study drug. 75 patients were enrolled and 1 patient was not treated. Only 74 patients were treated.
|
|
General disorders
Fever
|
1.4%
1/74 • Number of events 1
Adverse events were captured for all patients that were treated with study drug. 75 patients were enrolled and 1 patient was not treated. Only 74 patients were treated.
|
|
General disorders
General disorders and administration site conditions - Other
|
1.4%
1/74 • Number of events 1
Adverse events were captured for all patients that were treated with study drug. 75 patients were enrolled and 1 patient was not treated. Only 74 patients were treated.
|
|
General disorders
Localized edema
|
1.4%
1/74 • Number of events 1
Adverse events were captured for all patients that were treated with study drug. 75 patients were enrolled and 1 patient was not treated. Only 74 patients were treated.
|
|
General disorders
Pain
|
1.4%
1/74 • Number of events 1
Adverse events were captured for all patients that were treated with study drug. 75 patients were enrolled and 1 patient was not treated. Only 74 patients were treated.
|
|
Hepatobiliary disorders
Hepatobiliary disorders - Other
|
1.4%
1/74 • Number of events 2
Adverse events were captured for all patients that were treated with study drug. 75 patients were enrolled and 1 patient was not treated. Only 74 patients were treated.
|
|
Immune system disorders
Allergic reaction
|
4.1%
3/74 • Number of events 3
Adverse events were captured for all patients that were treated with study drug. 75 patients were enrolled and 1 patient was not treated. Only 74 patients were treated.
|
|
Infections and infestations
Catheter related infection
|
1.4%
1/74 • Number of events 1
Adverse events were captured for all patients that were treated with study drug. 75 patients were enrolled and 1 patient was not treated. Only 74 patients were treated.
|
|
Infections and infestations
Enterocolitis infectious
|
5.4%
4/74 • Number of events 4
Adverse events were captured for all patients that were treated with study drug. 75 patients were enrolled and 1 patient was not treated. Only 74 patients were treated.
|
|
Infections and infestations
Infections and infestations - Other
|
4.1%
3/74 • Number of events 9
Adverse events were captured for all patients that were treated with study drug. 75 patients were enrolled and 1 patient was not treated. Only 74 patients were treated.
|
|
Infections and infestations
Lung infection
|
2.7%
2/74 • Number of events 2
Adverse events were captured for all patients that were treated with study drug. 75 patients were enrolled and 1 patient was not treated. Only 74 patients were treated.
|
|
Infections and infestations
Nail infection
|
1.4%
1/74 • Number of events 1
Adverse events were captured for all patients that were treated with study drug. 75 patients were enrolled and 1 patient was not treated. Only 74 patients were treated.
|
|
Infections and infestations
Pleural infection
|
1.4%
1/74 • Number of events 1
Adverse events were captured for all patients that were treated with study drug. 75 patients were enrolled and 1 patient was not treated. Only 74 patients were treated.
|
|
Infections and infestations
Skin infection
|
4.1%
3/74 • Number of events 3
Adverse events were captured for all patients that were treated with study drug. 75 patients were enrolled and 1 patient was not treated. Only 74 patients were treated.
|
|
Infections and infestations
Soft tissue infection
|
2.7%
2/74 • Number of events 2
Adverse events were captured for all patients that were treated with study drug. 75 patients were enrolled and 1 patient was not treated. Only 74 patients were treated.
|
|
Investigations
Alanine aminotransferase increased
|
5.4%
4/74 • Number of events 5
Adverse events were captured for all patients that were treated with study drug. 75 patients were enrolled and 1 patient was not treated. Only 74 patients were treated.
|
|
Investigations
Aspartate aminotransferase increased
|
4.1%
3/74 • Number of events 3
Adverse events were captured for all patients that were treated with study drug. 75 patients were enrolled and 1 patient was not treated. Only 74 patients were treated.
|
|
Investigations
Creatinine increased
|
1.4%
1/74 • Number of events 2
Adverse events were captured for all patients that were treated with study drug. 75 patients were enrolled and 1 patient was not treated. Only 74 patients were treated.
|
|
Investigations
Investigations - Other, specify
|
2.7%
2/74 • Number of events 2
Adverse events were captured for all patients that were treated with study drug. 75 patients were enrolled and 1 patient was not treated. Only 74 patients were treated.
|
|
Investigations
Lymphocyte count decreased
|
1.4%
1/74 • Number of events 3
Adverse events were captured for all patients that were treated with study drug. 75 patients were enrolled and 1 patient was not treated. Only 74 patients were treated.
|
|
Investigations
Platelet count decreased
|
2.7%
2/74 • Number of events 8
Adverse events were captured for all patients that were treated with study drug. 75 patients were enrolled and 1 patient was not treated. Only 74 patients were treated.
|
|
Investigations
Weight gain
|
1.4%
1/74 • Number of events 1
Adverse events were captured for all patients that were treated with study drug. 75 patients were enrolled and 1 patient was not treated. Only 74 patients were treated.
|
|
Investigations
White blood cell decreased
|
2.7%
2/74 • Number of events 2
Adverse events were captured for all patients that were treated with study drug. 75 patients were enrolled and 1 patient was not treated. Only 74 patients were treated.
|
|
Metabolism and nutrition disorders
Acidosis
|
1.4%
1/74 • Number of events 1
Adverse events were captured for all patients that were treated with study drug. 75 patients were enrolled and 1 patient was not treated. Only 74 patients were treated.
|
|
Metabolism and nutrition disorders
Anorexia
|
4.1%
3/74 • Number of events 3
Adverse events were captured for all patients that were treated with study drug. 75 patients were enrolled and 1 patient was not treated. Only 74 patients were treated.
|
|
Metabolism and nutrition disorders
Dehydration
|
1.4%
1/74 • Number of events 1
Adverse events were captured for all patients that were treated with study drug. 75 patients were enrolled and 1 patient was not treated. Only 74 patients were treated.
|
|
Metabolism and nutrition disorders
Hyperglycemia
|
2.7%
2/74 • Number of events 2
Adverse events were captured for all patients that were treated with study drug. 75 patients were enrolled and 1 patient was not treated. Only 74 patients were treated.
|
|
Metabolism and nutrition disorders
Hyperkalemia
|
2.7%
2/74 • Number of events 2
Adverse events were captured for all patients that were treated with study drug. 75 patients were enrolled and 1 patient was not treated. Only 74 patients were treated.
|
|
Metabolism and nutrition disorders
Hypoalbuminemia
|
2.7%
2/74 • Number of events 2
Adverse events were captured for all patients that were treated with study drug. 75 patients were enrolled and 1 patient was not treated. Only 74 patients were treated.
|
|
Metabolism and nutrition disorders
Hypocalcemia
|
1.4%
1/74 • Number of events 1
Adverse events were captured for all patients that were treated with study drug. 75 patients were enrolled and 1 patient was not treated. Only 74 patients were treated.
|
|
Metabolism and nutrition disorders
Hypokalemia
|
4.1%
3/74 • Number of events 3
Adverse events were captured for all patients that were treated with study drug. 75 patients were enrolled and 1 patient was not treated. Only 74 patients were treated.
|
|
Metabolism and nutrition disorders
Hypomagnesemia
|
10.8%
8/74 • Number of events 9
Adverse events were captured for all patients that were treated with study drug. 75 patients were enrolled and 1 patient was not treated. Only 74 patients were treated.
|
|
Metabolism and nutrition disorders
Hyponatremia
|
5.4%
4/74 • Number of events 4
Adverse events were captured for all patients that were treated with study drug. 75 patients were enrolled and 1 patient was not treated. Only 74 patients were treated.
|
|
Metabolism and nutrition disorders
Hypophosphatemia
|
1.4%
1/74 • Number of events 1
Adverse events were captured for all patients that were treated with study drug. 75 patients were enrolled and 1 patient was not treated. Only 74 patients were treated.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
1.4%
1/74 • Number of events 1
Adverse events were captured for all patients that were treated with study drug. 75 patients were enrolled and 1 patient was not treated. Only 74 patients were treated.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal and connective tissue disorder - Other
|
1.4%
1/74 • Number of events 2
Adverse events were captured for all patients that were treated with study drug. 75 patients were enrolled and 1 patient was not treated. Only 74 patients were treated.
|
|
Nervous system disorders
Dizziness
|
1.4%
1/74 • Number of events 1
Adverse events were captured for all patients that were treated with study drug. 75 patients were enrolled and 1 patient was not treated. Only 74 patients were treated.
|
|
Nervous system disorders
Dysgeusia
|
2.7%
2/74 • Number of events 2
Adverse events were captured for all patients that were treated with study drug. 75 patients were enrolled and 1 patient was not treated. Only 74 patients were treated.
|
|
Nervous system disorders
Headache
|
2.7%
2/74 • Number of events 2
Adverse events were captured for all patients that were treated with study drug. 75 patients were enrolled and 1 patient was not treated. Only 74 patients were treated.
|
|
Nervous system disorders
Peripheral sensory neuropathy
|
1.4%
1/74 • Number of events 1
Adverse events were captured for all patients that were treated with study drug. 75 patients were enrolled and 1 patient was not treated. Only 74 patients were treated.
|
|
Nervous system disorders
Somnolence
|
1.4%
1/74 • Number of events 1
Adverse events were captured for all patients that were treated with study drug. 75 patients were enrolled and 1 patient was not treated. Only 74 patients were treated.
|
|
Psychiatric disorders
Anxiety
|
1.4%
1/74 • Number of events 1
Adverse events were captured for all patients that were treated with study drug. 75 patients were enrolled and 1 patient was not treated. Only 74 patients were treated.
|
|
Psychiatric disorders
Delirium
|
1.4%
1/74 • Number of events 1
Adverse events were captured for all patients that were treated with study drug. 75 patients were enrolled and 1 patient was not treated. Only 74 patients were treated.
|
|
Renal and urinary disorders
Acute kidney injury
|
2.7%
2/74 • Number of events 2
Adverse events were captured for all patients that were treated with study drug. 75 patients were enrolled and 1 patient was not treated. Only 74 patients were treated.
|
|
Renal and urinary disorders
Cystitis noninfective
|
1.4%
1/74 • Number of events 1
Adverse events were captured for all patients that were treated with study drug. 75 patients were enrolled and 1 patient was not treated. Only 74 patients were treated.
|
|
Renal and urinary disorders
Urinary tract pain
|
1.4%
1/74 • Number of events 1
Adverse events were captured for all patients that were treated with study drug. 75 patients were enrolled and 1 patient was not treated. Only 74 patients were treated.
|
|
Reproductive system and breast disorders
Genital edema
|
1.4%
1/74 • Number of events 1
Adverse events were captured for all patients that were treated with study drug. 75 patients were enrolled and 1 patient was not treated. Only 74 patients were treated.
|
|
Reproductive system and breast disorders
Menorrhagia
|
2.7%
2/74 • Number of events 2
Adverse events were captured for all patients that were treated with study drug. 75 patients were enrolled and 1 patient was not treated. Only 74 patients were treated.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
2.7%
2/74 • Number of events 2
Adverse events were captured for all patients that were treated with study drug. 75 patients were enrolled and 1 patient was not treated. Only 74 patients were treated.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
1.4%
1/74 • Number of events 1
Adverse events were captured for all patients that were treated with study drug. 75 patients were enrolled and 1 patient was not treated. Only 74 patients were treated.
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
1.4%
1/74 • Number of events 1
Adverse events were captured for all patients that were treated with study drug. 75 patients were enrolled and 1 patient was not treated. Only 74 patients were treated.
|
|
Respiratory, thoracic and mediastinal disorders
Productive cough
|
1.4%
1/74 • Number of events 1
Adverse events were captured for all patients that were treated with study drug. 75 patients were enrolled and 1 patient was not treated. Only 74 patients were treated.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary edema
|
1.4%
1/74 • Number of events 1
Adverse events were captured for all patients that were treated with study drug. 75 patients were enrolled and 1 patient was not treated. Only 74 patients were treated.
|
|
Respiratory, thoracic and mediastinal disorders
Tracheal mucositis
|
1.4%
1/74 • Number of events 1
Adverse events were captured for all patients that were treated with study drug. 75 patients were enrolled and 1 patient was not treated. Only 74 patients were treated.
|
|
Skin and subcutaneous tissue disorders
Palmar-plantar erythrodysesthesia syndrome
|
5.4%
4/74 • Number of events 4
Adverse events were captured for all patients that were treated with study drug. 75 patients were enrolled and 1 patient was not treated. Only 74 patients were treated.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
4.1%
3/74 • Number of events 3
Adverse events were captured for all patients that were treated with study drug. 75 patients were enrolled and 1 patient was not treated. Only 74 patients were treated.
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
5.4%
4/74 • Number of events 4
Adverse events were captured for all patients that were treated with study drug. 75 patients were enrolled and 1 patient was not treated. Only 74 patients were treated.
|
|
Skin and subcutaneous tissue disorders
Skin and subcutaneous tissue disorders - Other
|
2.7%
2/74 • Number of events 2
Adverse events were captured for all patients that were treated with study drug. 75 patients were enrolled and 1 patient was not treated. Only 74 patients were treated.
|
|
Vascular disorders
Capillary leak syndrome
|
1.4%
1/74 • Number of events 1
Adverse events were captured for all patients that were treated with study drug. 75 patients were enrolled and 1 patient was not treated. Only 74 patients were treated.
|
|
Vascular disorders
Flushing
|
1.4%
1/74 • Number of events 1
Adverse events were captured for all patients that were treated with study drug. 75 patients were enrolled and 1 patient was not treated. Only 74 patients were treated.
|
|
Vascular disorders
Hypertension
|
5.4%
4/74 • Number of events 4
Adverse events were captured for all patients that were treated with study drug. 75 patients were enrolled and 1 patient was not treated. Only 74 patients were treated.
|
|
Vascular disorders
Hypotension
|
2.7%
2/74 • Number of events 2
Adverse events were captured for all patients that were treated with study drug. 75 patients were enrolled and 1 patient was not treated. Only 74 patients were treated.
|
|
Vascular disorders
Vascular disorders - Other
|
1.4%
1/74 • Number of events 1
Adverse events were captured for all patients that were treated with study drug. 75 patients were enrolled and 1 patient was not treated. Only 74 patients were treated.
|
Additional Information
Dr. John Magenau, M.D.
University of Michigan Comprehensive Cancer Center
Phone: 734-936-8785
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place