Trial Outcomes & Findings for Sirolimus, Tacrolimus, and Antithymocyte Globulin in Preventing Graft-Versus-Host Disease in Patients Undergoing a Donor Stem Cell Transplant For Hematological Cancer (NCT NCT00589563)
NCT ID: NCT00589563
Last Updated: 2014-09-10
Results Overview
Patients were evaluated for the development of acute GVHD within the first 100 days post HSCT. The cumulative incidence of grade II-IV acute GVHD was determined using competing risk analysis. Competing risks for acute GVHD were death and nonengraftment.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
32 participants
Primary outcome timeframe
100 Days Post Hematopoietic Stem Cell Transplant (HSCT)
Results posted on
2014-09-10
Participant Flow
Participant milestones
| Measure |
All Patients
All patients were analyzed as a single population. Stratification by conditioning regimen was not done.
|
|---|---|
|
Overall Study
STARTED
|
32
|
|
Overall Study
COMPLETED
|
32
|
|
Overall Study
NOT COMPLETED
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Sirolimus, Tacrolimus, and Antithymocyte Globulin in Preventing Graft-Versus-Host Disease in Patients Undergoing a Donor Stem Cell Transplant For Hematological Cancer
Baseline characteristics by cohort
| Measure |
All Patients
n=32 Participants
All patients were analyzed as a single population. Stratification by conditioning regimen was not done.
|
|---|---|
|
Age, Continuous
|
59.5 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
19 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
13 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
32 participants
n=5 Participants
|
|
Diagnosis
Acute Myeloid Leukemia
|
14 participants
n=5 Participants
|
|
Diagnosis
Myelodysplastic Syndrome
|
6 participants
n=5 Participants
|
|
Diagnosis
Acute Lymphoblastic Leukemia
|
3 participants
n=5 Participants
|
|
Diagnosis
Chronic Myeloid Leukemia
|
3 participants
n=5 Participants
|
|
Diagnosis
Non-Hodgkin Lymphoma
|
3 participants
n=5 Participants
|
|
Diagnosis
Myeloproliferative Disorder
|
2 participants
n=5 Participants
|
|
Diagnosis
Chronic Lymphocytic Leukemia
|
1 participants
n=5 Participants
|
|
Disease Status (American Society for Blood and Marrow Transplantation Guidelines)
Standard Risk
|
14 participants
n=5 Participants
|
|
Disease Status (American Society for Blood and Marrow Transplantation Guidelines)
High/Intermediate Risk
|
18 participants
n=5 Participants
|
|
Patient/Donor Cytomegalovirus (CMV) infection status
Positive/Negative
|
12 participants
n=5 Participants
|
|
Patient/Donor Cytomegalovirus (CMV) infection status
Positive/Positive
|
12 participants
n=5 Participants
|
|
Patient/Donor Cytomegalovirus (CMV) infection status
Negative/Negative
|
3 participants
n=5 Participants
|
|
Patient/Donor Cytomegalovirus (CMV) infection status
Negative/Positive
|
5 participants
n=5 Participants
|
|
Human Leukocyte Antigen (HLA) Match Type
10/10 Matched
|
18 participants
n=5 Participants
|
|
Human Leukocyte Antigen (HLA) Match Type
1 Mismatch
|
12 participants
n=5 Participants
|
|
Human Leukocyte Antigen (HLA) Match Type
2 Mismatches
|
1 participants
n=5 Participants
|
|
Human Leukocyte Antigen (HLA) Match Type
3 Mismatches
|
1 participants
n=5 Participants
|
|
Conditioning Regimen
Fludarabine/Melphalan
|
23 participants
n=5 Participants
|
|
Conditioning Regimen
Fractionated Total Body Irradiation/Cytoxan
|
4 participants
n=5 Participants
|
|
Conditioning Regimen
Fractionated Total Body Irradiation/Etoposide
|
5 participants
n=5 Participants
|
|
Patient/donor sex match
Male patient/Female donor
|
3 participants
n=5 Participants
|
|
Patient/donor sex match
Others
|
29 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 100 Days Post Hematopoietic Stem Cell Transplant (HSCT)Patients were evaluated for the development of acute GVHD within the first 100 days post HSCT. The cumulative incidence of grade II-IV acute GVHD was determined using competing risk analysis. Competing risks for acute GVHD were death and nonengraftment.
Outcome measures
| Measure |
All Patients
n=32 Participants
All patients were analyzed as a single population. Stratification by conditioning regimen was not done.
|
|---|---|
|
Cumulative Incidence of Grade II-IV Acute Graft-Versus-Host Disease (GVHD) at Day 100
|
37.3 Percentage of patients developing aGVHD
Interval 22.4 to 62.0
|
PRIMARY outcome
Timeframe: 100 Days Post HSCTAll patients were considered for the evaluation of the severity of acute GVHD.
Outcome measures
| Measure |
All Patients
n=32 Participants
All patients were analyzed as a single population. Stratification by conditioning regimen was not done.
|
|---|---|
|
Severity of Acute GVHD
No Acute GVHD
|
9 participants
|
|
Severity of Acute GVHD
Yes - Grade I
|
9 participants
|
|
Severity of Acute GVHD
Yes- Grade II
|
9 participants
|
|
Severity of Acute GVHD
Yes- Grade III
|
1 participants
|
|
Severity of Acute GVHD
Yes - Grade IV
|
0 participants
|
|
Severity of Acute GVHD
No- Inevaluable (graft failures)
|
4 participants
|
PRIMARY outcome
Timeframe: 2 year point estimate was provided.Patients were evaluated for the development of chronic GVHD from 101 days post HSCT to last contact or documented evidence of the disease. The cumulative incidence of chronic GVHD was determined using competing risk analysis. Competing risks for GVHD were death and nonengraftment.
Outcome measures
| Measure |
All Patients
n=32 Participants
All patients were analyzed as a single population. Stratification by conditioning regimen was not done.
|
|---|---|
|
Cumulative Incidence of Chronic GVHD
|
62.5 Percentage of patients developing cGVHD
Interval 47.8 to 81.7
|
PRIMARY outcome
Timeframe: Patients were evaluated until they developed chronic GVHD, a median of 130 days post HSCTAll Patients were considered for the evaluation of chronic GVHD severity.
Outcome measures
| Measure |
All Patients
n=32 Participants
All patients were analyzed as a single population. Stratification by conditioning regimen was not done.
|
|---|---|
|
Severity of Chronic GVHD
No- Inevaluable (graft failure/died <day 100)
|
7 participants
|
|
Severity of Chronic GVHD
No Chronic GVHD
|
4 participants
|
|
Severity of Chronic GVHD
Yes- Limited
|
4 participants
|
|
Severity of Chronic GVHD
Yes - Extensive
|
17 participants
|
SECONDARY outcome
Timeframe: Patients were evaluated until neutrophil recovery, a median of 15 days post HSCTPopulation: 28 of the 32 patients had absolute neutrophil count recovery.
Absolute neutrophil count (ANC) recovery is defined as an ANC of ≥ 0.5 x 10\^9/L (500/mm3) for three consecutive laboratory values obtained on different days
Outcome measures
| Measure |
All Patients
n=28 Participants
All patients were analyzed as a single population. Stratification by conditioning regimen was not done.
|
|---|---|
|
Time to Absolute Neutrophil Count Recovery (Engraftment)
|
14.5 Days
Interval 10.0 to 26.0
|
SECONDARY outcome
Timeframe: Patients were evaluated until platelet recovery, a median of 14 daysPopulation: 27 of the 32 patients had platelet recovery.
Platelet recovery is defined as the first date of three consecutive laboratory values ≥ 25 x 10\^9 L obtained on different days.
Outcome measures
| Measure |
All Patients
n=27 Participants
All patients were analyzed as a single population. Stratification by conditioning regimen was not done.
|
|---|---|
|
Time to Platelet Count Recovery (Engraftment)
|
14 Days
Interval 10.0 to 40.0
|
SECONDARY outcome
Timeframe: Median Follow Up: 28 months (Range: 1-49 months)Participants were monitored throughout the trial (median of 28 months) for various infections/complications.
Outcome measures
| Measure |
All Patients
n=32 Participants
All patients were analyzed as a single population. Stratification by conditioning regimen was not done.
|
|---|---|
|
Occurence of Infections Including Cytomegalovirus and Epstein-Barr Virus Reactivation
Neither CMV or EBV
|
16 participants
|
|
Occurence of Infections Including Cytomegalovirus and Epstein-Barr Virus Reactivation
CMV reactivation only
|
9 participants
|
|
Occurence of Infections Including Cytomegalovirus and Epstein-Barr Virus Reactivation
EBV only
|
3 participants
|
|
Occurence of Infections Including Cytomegalovirus and Epstein-Barr Virus Reactivation
Both CMV and EBV
|
4 participants
|
SECONDARY outcome
Timeframe: Median Follow Up: 28 Months (Range: 1-49 months)Participants were monitored throughout the trial (median of 28 months) for various infections/complications. This is the number of participants who developed TMA.
Outcome measures
| Measure |
All Patients
n=32 Participants
All patients were analyzed as a single population. Stratification by conditioning regimen was not done.
|
|---|---|
|
Occurrence of Thrombotic Microangiopathy
|
7 participants
|
SECONDARY outcome
Timeframe: Median Follow Up: 28 Months (Range: 1-49 Months)Participants were monitored throughout the trial (median of 28 months) for various infections/complications. This is the number of participants who developed SOS.
Outcome measures
| Measure |
All Patients
n=32 Participants
All patients were analyzed as a single population. Stratification by conditioning regimen was not done.
|
|---|---|
|
Occurence of Sinusoidal Obstructive Syndrome (SOS)
|
1 participants
|
SECONDARY outcome
Timeframe: 100 day point estimate was providedPatients were evaluated for non-relapse mortality (NRM) throughout the study. Non-relapse mortality was considered any death not attributable to relapse or disease progression. The cumulative incidence of NRM was determined using competing risk analysis. Competing risks for NRM were death due to disease progression, relapse and nonengraftment.
Outcome measures
| Measure |
All Patients
n=32 Participants
All patients were analyzed as a single population. Stratification by conditioning regimen was not done.
|
|---|---|
|
Non-relapse Mortality at 100 Days Post HSCT
|
9.4 Percentage of patients with a NRM
Interval 3.2 to 27.5
|
SECONDARY outcome
Timeframe: 2 year point estimate was provided.Patients were evaluated for non-relapse mortality (NRM) throughout the study. Non-relapse mortality was considered any death not attributable to relapse or disease progression. The cumulative incidence of NRM was determined using competing risk analysis. Competing risks for NRM were death due to disease progression, relapse and nonengraftment.
Outcome measures
| Measure |
All Patients
n=32 Participants
All patients were analyzed as a single population. Stratification by conditioning regimen was not done.
|
|---|---|
|
Non-relapse Mortality at Two Years Post HSCT
|
15.6 Percentage of patients with a NRM
Interval 7.0 to 35.0
|
SECONDARY outcome
Timeframe: 2 year point estimate was provided.Patients were evaluated for survival (OS) throughout the study. Kaplan Meier estiamtes were calculated for overall survival using time from HSCT to death of any cause or for surviving patients last contact date.
Outcome measures
| Measure |
All Patients
n=32 Participants
All patients were analyzed as a single population. Stratification by conditioning regimen was not done.
|
|---|---|
|
Overall Survival at Two Years Post HSCT
|
65.6 Percentage of patients who died
Interval 53.7 to 75.2
|
SECONDARY outcome
Timeframe: 2 year point estimate was provided.Patients were evaluated for event free survival (EFS) throughout the study. Events were defined as death, relapse, progression, or nonengraftment. Kaplan Meier estimates were calculated as time from HSCT to event.
Outcome measures
| Measure |
All Patients
n=32 Participants
All patients were analyzed as a single population. Stratification by conditioning regimen was not done.
|
|---|---|
|
Event Free Survival at Two Years Post HSCT
|
61.3 Percentage of patients with an event
Interval 49.9 to 70.8
|
SECONDARY outcome
Timeframe: 2 year point estimate was provided.Patients were evaluated for relapse/progression post transplant throughout the study. The cumulative incidence of relapse/progression was determined using competing risk analysis. Competing risks for relapse were non-relapse mortality and nonengraftment.
Outcome measures
| Measure |
All Patients
n=32 Participants
All patients were analyzed as a single population. Stratification by conditioning regimen was not done.
|
|---|---|
|
Incidence of Disease Relapse/Progression at 2 Years Post HSCT
|
12.5 Percentage of patients who relapsed
Interval 5.0 to 31.3
|
Adverse Events
All Patients
Serious events: 9 serious events
Other events: 31 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
All Patients
n=31 participants at risk
All patients were analyzed as a single population. Stratification by conditioning regimen was not done. One patient did not have adverse event data collected.
|
|---|---|
|
Blood and lymphatic system disorders
Blood disorder
|
3.2%
1/31 • Number of events 1 • 180 days
|
|
Cardiac disorders
Atrial flutter
|
3.2%
1/31 • Number of events 1 • 180 days
|
|
Cardiac disorders
Myocardial ischemia
|
3.2%
1/31 • Number of events 1 • 180 days
|
|
Gastrointestinal disorders
Diarrhea
|
6.5%
2/31 • Number of events 2 • 180 days
|
|
General disorders
Ill-defined disorder
|
3.2%
1/31 • Number of events 1 • 180 days
|
|
General disorders
Multi-organ failure
|
6.5%
2/31 • Number of events 2 • 180 days
|
|
General disorders
Pain
|
3.2%
1/31 • Number of events 1 • 180 days
|
|
Hepatobiliary disorders
Portal hypertension
|
3.2%
1/31 • Number of events 1 • 180 days
|
|
Infections and infestations
Abdominal infection
|
3.2%
1/31 • Number of events 1 • 180 days
|
|
Infections and infestations
Catheter related infection
|
3.2%
1/31 • Number of events 1 • 180 days
|
|
Infections and infestations
Colitis, infectious (e.g., Clostridium difficile)
|
3.2%
1/31 • Number of events 1 • 180 days
|
|
Infections and infestations
Infection
|
3.2%
1/31 • Number of events 1 • 180 days
|
|
Infections and infestations
Opportunistic infection
|
6.5%
2/31 • Number of events 2 • 180 days
|
|
Infections and infestations
Pneumonia
|
3.2%
1/31 • Number of events 1 • 180 days
|
|
Infections and infestations
Sepsis
|
6.5%
2/31 • Number of events 2 • 180 days
|
|
Musculoskeletal and connective tissue disorders
Muscle weakness
|
3.2%
1/31 • Number of events 1 • 180 days
|
|
Renal and urinary disorders
Renal failure
|
6.5%
2/31 • Number of events 2 • 180 days
|
|
Respiratory, thoracic and mediastinal disorders
Adult respiratory distress syndrome
|
3.2%
1/31 • Number of events 1 • 180 days
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary hemorrhage
|
3.2%
1/31 • Number of events 1 • 180 days
|
Other adverse events
| Measure |
All Patients
n=31 participants at risk
All patients were analyzed as a single population. Stratification by conditioning regimen was not done. One patient did not have adverse event data collected.
|
|---|---|
|
Blood and lymphatic system disorders
Blood disorder
|
6.5%
2/31 • Number of events 2 • 180 days
|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
51.6%
16/31 • Number of events 16 • 180 days
|
|
Blood and lymphatic system disorders
Hemoglobin decreased
|
100.0%
31/31 • Number of events 31 • 180 days
|
|
Blood and lymphatic system disorders
Hemolysis
|
6.5%
2/31 • Number of events 2 • 180 days
|
|
Blood and lymphatic system disorders
Lymph node pain
|
3.2%
1/31 • Number of events 1 • 180 days
|
|
Blood and lymphatic system disorders
Lymphatic disorder
|
9.7%
3/31 • Number of events 3 • 180 days
|
|
Blood and lymphatic system disorders
Thrombotic microangiopathy
|
19.4%
6/31 • Number of events 6 • 180 days
|
|
Cardiac disorders
Atrial fibrillation
|
3.2%
1/31 • Number of events 1 • 180 days
|
|
Cardiac disorders
Atrial flutter
|
3.2%
1/31 • Number of events 1 • 180 days
|
|
Cardiac disorders
Cardiac disorder
|
3.2%
1/31 • Number of events 1 • 180 days
|
|
Cardiac disorders
Left ventricular dysfunction
|
6.5%
2/31 • Number of events 2 • 180 days
|
|
Cardiac disorders
Left ventricular failure
|
3.2%
1/31 • Number of events 1 • 180 days
|
|
Cardiac disorders
Pericardial effusion
|
9.7%
3/31 • Number of events 3 • 180 days
|
|
Cardiac disorders
Pericarditis
|
3.2%
1/31 • Number of events 1 • 180 days
|
|
Cardiac disorders
Restrictive cardiomyopathy
|
3.2%
1/31 • Number of events 1 • 180 days
|
|
Cardiac disorders
Sinus bradycardia
|
6.5%
2/31 • Number of events 2 • 180 days
|
|
Cardiac disorders
Sinus tachycardia
|
74.2%
23/31 • Number of events 23 • 180 days
|
|
Cardiac disorders
Supraventricular tachycardia
|
3.2%
1/31 • Number of events 1 • 180 days
|
|
Cardiac disorders
Ventricular tachycardia
|
3.2%
1/31 • Number of events 1 • 180 days
|
|
Ear and labyrinth disorders
Ear disorder
|
3.2%
1/31 • Number of events 1 • 180 days
|
|
Ear and labyrinth disorders
External ear inflammation
|
3.2%
1/31 • Number of events 1 • 180 days
|
|
Ear and labyrinth disorders
Middle ear inflammation
|
3.2%
1/31 • Number of events 1 • 180 days
|
|
Endocrine disorders
Cushingoid
|
9.7%
3/31 • Number of events 3 • 180 days
|
|
Endocrine disorders
Hyperthyroidism
|
3.2%
1/31 • Number of events 1 • 180 days
|
|
Eye disorders
Dry eye syndrome
|
9.7%
3/31 • Number of events 3 • 180 days
|
|
Eye disorders
Eye disorder
|
12.9%
4/31 • Number of events 4 • 180 days
|
|
Eye disorders
Eye pain
|
3.2%
1/31 • Number of events 1 • 180 days
|
|
Eye disorders
Photophobia
|
3.2%
1/31 • Number of events 1 • 180 days
|
|
Eye disorders
Vision blurred
|
9.7%
3/31 • Number of events 3 • 180 days
|
|
Eye disorders
Watering eyes
|
3.2%
1/31 • Number of events 1 • 180 days
|
|
Gastrointestinal disorders
Abdominal distension
|
61.3%
19/31 • Number of events 19 • 180 days
|
|
Gastrointestinal disorders
Abdominal pain
|
74.2%
23/31 • Number of events 23 • 180 days
|
|
Gastrointestinal disorders
Anal pain
|
9.7%
3/31 • Number of events 3 • 180 days
|
|
Gastrointestinal disorders
Ascites
|
3.2%
1/31 • Number of events 1 • 180 days
|
|
Gastrointestinal disorders
Colonic hemorrhage
|
3.2%
1/31 • Number of events 1 • 180 days
|
|
Gastrointestinal disorders
Constipation
|
29.0%
9/31 • Number of events 9 • 180 days
|
|
Gastrointestinal disorders
Diarrhea
|
93.5%
29/31 • Number of events 29 • 180 days
|
|
Gastrointestinal disorders
Diarrhea associated with GVHD for BMT studies, if specified in the protocol.
|
3.2%
1/31 • Number of events 1 • 180 days
|
|
Gastrointestinal disorders
Dry mouth
|
22.6%
7/31 • Number of events 7 • 180 days
|
|
Gastrointestinal disorders
Dyspepsia
|
38.7%
12/31 • Number of events 12 • 180 days
|
|
Gastrointestinal disorders
Dysphagia
|
16.1%
5/31 • Number of events 5 • 180 days
|
|
Gastrointestinal disorders
Ear, nose and throat examination abnormal
|
71.0%
22/31 • Number of events 22 • 180 days
|
|
Gastrointestinal disorders
Esophageal pain
|
3.2%
1/31 • Number of events 1 • 180 days
|
|
Gastrointestinal disorders
Esophagitis
|
6.5%
2/31 • Number of events 2 • 180 days
|
|
Gastrointestinal disorders
Fecal incontinence
|
12.9%
4/31 • Number of events 4 • 180 days
|
|
Gastrointestinal disorders
Flatulence
|
12.9%
4/31 • Number of events 4 • 180 days
|
|
Gastrointestinal disorders
Gastritis
|
9.7%
3/31 • Number of events 3 • 180 days
|
|
Gastrointestinal disorders
Gastrointestinal disorder
|
6.5%
2/31 • Number of events 2 • 180 days
|
|
Gastrointestinal disorders
Gingival pain
|
3.2%
1/31 • Number of events 1 • 180 days
|
|
Gastrointestinal disorders
Hemorrhoids
|
12.9%
4/31 • Number of events 4 • 180 days
|
|
Gastrointestinal disorders
Mucositis oral
|
58.1%
18/31 • Number of events 18 • 180 days
|
|
Gastrointestinal disorders
Nausea
|
93.5%
29/31 • Number of events 29 • 180 days
|
|
Gastrointestinal disorders
Oral hemorrhage
|
3.2%
1/31 • Number of events 1 • 180 days
|
|
Gastrointestinal disorders
Oral pain
|
9.7%
3/31 • Number of events 3 • 180 days
|
|
Gastrointestinal disorders
Proctitis
|
3.2%
1/31 • Number of events 1 • 180 days
|
|
Gastrointestinal disorders
Rectal hemorrhage
|
6.5%
2/31 • Number of events 2 • 180 days
|
|
Gastrointestinal disorders
Rectal pain
|
9.7%
3/31 • Number of events 3 • 180 days
|
|
Gastrointestinal disorders
Upper gastrointestinal hemorrhage
|
3.2%
1/31 • Number of events 1 • 180 days
|
|
Gastrointestinal disorders
Vomiting
|
80.6%
25/31 • Number of events 25 • 180 days
|
|
General disorders
Chest pain
|
9.7%
3/31 • Number of events 3 • 180 days
|
|
General disorders
Chills
|
80.6%
25/31 • Number of events 25 • 180 days
|
|
General disorders
Edema
|
3.2%
1/31 • Number of events 1 • 180 days
|
|
General disorders
Edema limbs
|
80.6%
25/31 • Number of events 25 • 180 days
|
|
General disorders
Facial pain
|
12.9%
4/31 • Number of events 4 • 180 days
|
|
General disorders
Fatigue
|
96.8%
30/31 • Number of events 30 • 180 days
|
|
General disorders
Fever
|
61.3%
19/31 • Number of events 19 • 180 days
|
|
General disorders
Flu-like symptoms
|
3.2%
1/31 • Number of events 1 • 180 days
|
|
General disorders
Gait abnormal
|
6.5%
2/31 • Number of events 2 • 180 days
|
|
General disorders
General symptom
|
9.7%
3/31 • Number of events 3 • 180 days
|
|
General disorders
Ill-defined disorder
|
12.9%
4/31 • Number of events 4 • 180 days
|
|
General disorders
Injection site reaction
|
35.5%
11/31 • Number of events 11 • 180 days
|
|
General disorders
Irritability
|
3.2%
1/31 • Number of events 1 • 180 days
|
|
General disorders
Localized edema
|
25.8%
8/31 • Number of events 8 • 180 days
|
|
General disorders
Pain
|
54.8%
17/31 • Number of events 17 • 180 days
|
|
Immune system disorders
Cytokine release syndrome
|
3.2%
1/31 • Number of events 1 • 180 days
|
|
Immune system disorders
Hypersensitivity
|
9.7%
3/31 • Number of events 3 • 180 days
|
|
Infections and infestations
Bladder infection
|
9.7%
3/31 • Number of events 3 • 180 days
|
|
Infections and infestations
Bronchitis
|
3.2%
1/31 • Number of events 1 • 180 days
|
|
Infections and infestations
Catheter related infection
|
3.2%
1/31 • Number of events 1 • 180 days
|
|
Infections and infestations
Colitis, infectious (e.g., Clostridium difficile)
|
12.9%
4/31 • Number of events 4 • 180 days
|
|
Infections and infestations
Conjunctivitis infective
|
3.2%
1/31 • Number of events 1 • 180 days
|
|
Infections and infestations
Infection
|
25.8%
8/31 • Number of events 8 • 180 days
|
|
Infections and infestations
Infectious colitis
|
6.5%
2/31 • Number of events 2 • 180 days
|
|
Infections and infestations
Lip infection
|
3.2%
1/31 • Number of events 1 • 180 days
|
|
Infections and infestations
Opportunistic infection
|
35.5%
11/31 • Number of events 11 • 180 days
|
|
Infections and infestations
Pancreas infection
|
6.5%
2/31 • Number of events 2 • 180 days
|
|
Infections and infestations
Paranasal sinus infection
|
3.2%
1/31 • Number of events 1 • 180 days
|
|
Infections and infestations
Pneumonia
|
19.4%
6/31 • Number of events 6 • 180 days
|
|
Infections and infestations
Sepsis
|
48.4%
15/31 • Number of events 15 • 180 days
|
|
Infections and infestations
Sinusitis
|
3.2%
1/31 • Number of events 1 • 180 days
|
|
Infections and infestations
Skin infection
|
3.2%
1/31 • Number of events 1 • 180 days
|
|
Infections and infestations
Tracheitis
|
3.2%
1/31 • Number of events 1 • 180 days
|
|
Infections and infestations
Upper respiratory infection
|
12.9%
4/31 • Number of events 4 • 180 days
|
|
Infections and infestations
Urinary tract infection
|
9.7%
3/31 • Number of events 3 • 180 days
|
|
Injury, poisoning and procedural complications
Bruising
|
45.2%
14/31 • Number of events 14 • 180 days
|
|
Injury, poisoning and procedural complications
Dermatitis radiation
|
6.5%
2/31 • Number of events 2 • 180 days
|
|
Injury, poisoning and procedural complications
Intraoperative venous injury - Vein-portal vein
|
3.2%
1/31 • Number of events 1 • 180 days
|
|
Injury, poisoning and procedural complications
Postoperative hemorrhage
|
3.2%
1/31 • Number of events 1 • 180 days
|
|
Injury, poisoning and procedural complications
Radiation recall reaction (dermatologic)
|
6.5%
2/31 • Number of events 2 • 180 days
|
|
Injury, poisoning and procedural complications
Vascular access complication
|
3.2%
1/31 • Number of events 1 • 180 days
|
|
Injury, poisoning and procedural complications
Wound dehiscence
|
6.5%
2/31 • Number of events 2 • 180 days
|
|
Investigations
Activated partial thromboplastin time prolonged
|
3.2%
1/31 • Number of events 1 • 180 days
|
|
Investigations
Alanine aminotransferase increased
|
93.5%
29/31 • Number of events 29 • 180 days
|
|
Investigations
Alkaline phosphatase increased
|
74.2%
23/31 • Number of events 23 • 180 days
|
|
Investigations
Amylase increased
|
6.5%
2/31 • Number of events 2 • 180 days
|
|
Investigations
Aspartate aminotransferase increased
|
96.8%
30/31 • Number of events 30 • 180 days
|
|
Investigations
Bilirubin increased
|
22.6%
7/31 • Number of events 7 • 180 days
|
|
Investigations
Creatine phosphokinase increased
|
3.2%
1/31 • Number of events 1 • 180 days
|
|
Investigations
Creatinine increased
|
67.7%
21/31 • Number of events 21 • 180 days
|
|
Investigations
Gamma-glutamyltransferase increased
|
3.2%
1/31 • Number of events 1 • 180 days
|
|
Investigations
Laboratory test abnormal
|
12.9%
4/31 • Number of events 4 • 180 days
|
|
Investigations
Leukocyte count decreased
|
100.0%
31/31 • Number of events 31 • 180 days
|
|
Investigations
Lipase increased
|
6.5%
2/31 • Number of events 2 • 180 days
|
|
Investigations
Lymphocyte count decreased
|
83.9%
26/31 • Number of events 26 • 180 days
|
|
Investigations
Neutrophil count decreased
|
100.0%
31/31 • Number of events 31 • 180 days
|
|
Investigations
Neutrophils/granulocytes (ANC/AGC) for BMT studies, if specified in the protocol.
|
3.2%
1/31 • Number of events 1 • 180 days
|
|
Investigations
Platelet count decreased
|
100.0%
31/31 • Number of events 31 • 180 days
|
|
Investigations
Serum cholesterol increased
|
64.5%
20/31 • Number of events 20 • 180 days
|
|
Investigations
Weight gain
|
35.5%
11/31 • Number of events 11 • 180 days
|
|
Investigations
Weight loss
|
54.8%
17/31 • Number of events 17 • 180 days
|
|
Metabolism and nutrition disorders
Acidosis
|
12.9%
4/31 • Number of events 4 • 180 days
|
|
Metabolism and nutrition disorders
Alkalosis
|
16.1%
5/31 • Number of events 5 • 180 days
|
|
Metabolism and nutrition disorders
Anorexia
|
83.9%
26/31 • Number of events 26 • 180 days
|
|
Metabolism and nutrition disorders
Blood bicarbonate decreased
|
64.5%
20/31 • Number of events 20 • 180 days
|
|
Metabolism and nutrition disorders
Blood glucose increased
|
100.0%
31/31 • Number of events 31 • 180 days
|
|
Metabolism and nutrition disorders
Blood uric acid increased
|
3.2%
1/31 • Number of events 1 • 180 days
|
|
Metabolism and nutrition disorders
Dehydration
|
6.5%
2/31 • Number of events 2 • 180 days
|
|
Metabolism and nutrition disorders
Iron overload
|
3.2%
1/31 • Number of events 1 • 180 days
|
|
Metabolism and nutrition disorders
Serum albumin decreased
|
96.8%
30/31 • Number of events 30 • 180 days
|
|
Metabolism and nutrition disorders
Serum calcium decreased
|
100.0%
31/31 • Number of events 31 • 180 days
|
|
Metabolism and nutrition disorders
Serum calcium increased
|
22.6%
7/31 • Number of events 7 • 180 days
|
|
Metabolism and nutrition disorders
Serum glucose decreased
|
9.7%
3/31 • Number of events 3 • 180 days
|
|
Metabolism and nutrition disorders
Serum magnesium decreased
|
100.0%
31/31 • Number of events 31 • 180 days
|
|
Metabolism and nutrition disorders
Serum magnesium increased
|
19.4%
6/31 • Number of events 6 • 180 days
|
|
Metabolism and nutrition disorders
Serum phosphate decreased
|
90.3%
28/31 • Number of events 28 • 180 days
|
|
Metabolism and nutrition disorders
Serum potassium decreased
|
93.5%
29/31 • Number of events 29 • 180 days
|
|
Metabolism and nutrition disorders
Serum potassium increased
|
19.4%
6/31 • Number of events 6 • 180 days
|
|
Metabolism and nutrition disorders
Serum sodium decreased
|
100.0%
31/31 • Number of events 31 • 180 days
|
|
Metabolism and nutrition disorders
Serum sodium increased
|
3.2%
1/31 • Number of events 1 • 180 days
|
|
Metabolism and nutrition disorders
Serum triglycerides increased
|
90.3%
28/31 • Number of events 28 • 180 days
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
51.6%
16/31 • Number of events 16 • 180 days
|
|
Musculoskeletal and connective tissue disorders
Bone pain
|
22.6%
7/31 • Number of events 7 • 180 days
|
|
Musculoskeletal and connective tissue disorders
Buttock pain
|
6.5%
2/31 • Number of events 2 • 180 days
|
|
Musculoskeletal and connective tissue disorders
Joint pain
|
35.5%
11/31 • Number of events 11 • 180 days
|
|
Musculoskeletal and connective tissue disorders
Muscle weakness
|
64.5%
20/31 • Number of events 20 • 180 days
|
|
Musculoskeletal and connective tissue disorders
Muscle weakness lower limb
|
19.4%
6/31 • Number of events 6 • 180 days
|
|
Musculoskeletal and connective tissue disorders
Muscle weakness upper limb
|
3.2%
1/31 • Number of events 1 • 180 days
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal disorder
|
9.7%
3/31 • Number of events 3 • 180 days
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
16.1%
5/31 • Number of events 5 • 180 days
|
|
Musculoskeletal and connective tissue disorders
Myositis
|
3.2%
1/31 • Number of events 1 • 180 days
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
29.0%
9/31 • Number of events 9 • 180 days
|
|
Musculoskeletal and connective tissue disorders
Osteoporosis
|
3.2%
1/31 • Number of events 1 • 180 days
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
61.3%
19/31 • Number of events 19 • 180 days
|
|
Nervous system disorders
Depressed level of consciousness
|
16.1%
5/31 • Number of events 5 • 180 days
|
|
Nervous system disorders
Dizziness
|
51.6%
16/31 • Number of events 16 • 180 days
|
|
Nervous system disorders
Encephalopathy
|
3.2%
1/31 • Number of events 1 • 180 days
|
|
Nervous system disorders
Headache
|
87.1%
27/31 • Number of events 27 • 180 days
|
|
Nervous system disorders
Memory impairment
|
12.9%
4/31 • Number of events 4 • 180 days
|
|
Nervous system disorders
Neuralgia
|
6.5%
2/31 • Number of events 2 • 180 days
|
|
Nervous system disorders
Neurological disorder NOS
|
6.5%
2/31 • Number of events 2 • 180 days
|
|
Nervous system disorders
Nystagmus
|
3.2%
1/31 • Number of events 1 • 180 days
|
|
Nervous system disorders
Peripheral motor neuropathy
|
9.7%
3/31 • Number of events 3 • 180 days
|
|
Nervous system disorders
Peripheral sensory neuropathy
|
32.3%
10/31 • Number of events 10 • 180 days
|
|
Nervous system disorders
Sinus pain
|
6.5%
2/31 • Number of events 2 • 180 days
|
|
Nervous system disorders
Taste alteration
|
19.4%
6/31 • Number of events 6 • 180 days
|
|
Nervous system disorders
Tremor
|
29.0%
9/31 • Number of events 9 • 180 days
|
|
Psychiatric disorders
Agitation
|
22.6%
7/31 • Number of events 7 • 180 days
|
|
Psychiatric disorders
Anxiety
|
80.6%
25/31 • Number of events 25 • 180 days
|
|
Psychiatric disorders
Confusion
|
19.4%
6/31 • Number of events 6 • 180 days
|
|
Psychiatric disorders
Depression
|
38.7%
12/31 • Number of events 12 • 180 days
|
|
Psychiatric disorders
Insomnia
|
77.4%
24/31 • Number of events 24 • 180 days
|
|
Psychiatric disorders
Psychosis
|
3.2%
1/31 • Number of events 1 • 180 days
|
|
Renal and urinary disorders
Bladder obstruction
|
3.2%
1/31 • Number of events 1 • 180 days
|
|
Renal and urinary disorders
Bladder pain
|
9.7%
3/31 • Number of events 3 • 180 days
|
|
Renal and urinary disorders
Bladder spasm
|
9.7%
3/31 • Number of events 3 • 180 days
|
|
Renal and urinary disorders
Bladder stenosis
|
3.2%
1/31 • Number of events 1 • 180 days
|
|
Renal and urinary disorders
Cystitis
|
3.2%
1/31 • Number of events 1 • 180 days
|
|
Renal and urinary disorders
Hemorrhage urinary tract
|
22.6%
7/31 • Number of events 7 • 180 days
|
|
Renal and urinary disorders
Protein urine positive
|
35.5%
11/31 • Number of events 11 • 180 days
|
|
Renal and urinary disorders
Renal failure
|
3.2%
1/31 • Number of events 1 • 180 days
|
|
Renal and urinary disorders
Urethral pain
|
16.1%
5/31 • Number of events 5 • 180 days
|
|
Renal and urinary disorders
Urinary frequency
|
22.6%
7/31 • Number of events 7 • 180 days
|
|
Renal and urinary disorders
Urinary incontinence
|
9.7%
3/31 • Number of events 3 • 180 days
|
|
Renal and urinary disorders
Urinary retention
|
19.4%
6/31 • Number of events 6 • 180 days
|
|
Renal and urinary disorders
Urogenital disorder
|
12.9%
4/31 • Number of events 4 • 180 days
|
|
Reproductive system and breast disorders
Pelvic pain
|
3.2%
1/31 • Number of events 1 • 180 days
|
|
Reproductive system and breast disorders
Perineal pain
|
6.5%
2/31 • Number of events 2 • 180 days
|
|
Reproductive system and breast disorders
Scrotal pain
|
3.2%
1/31 • Number of events 1 • 180 days
|
|
Reproductive system and breast disorders
Vaginal discharge
|
3.2%
1/31 • Number of events 1 • 180 days
|
|
Reproductive system and breast disorders
Vaginal dryness
|
3.2%
1/31 • Number of events 1 • 180 days
|
|
Reproductive system and breast disorders
Vaginal hemorrhage
|
6.5%
2/31 • Number of events 2 • 180 days
|
|
Reproductive system and breast disorders
Vaginal pain
|
6.5%
2/31 • Number of events 2 • 180 days
|
|
Respiratory, thoracic and mediastinal disorders
Adult respiratory distress syndrome
|
6.5%
2/31 • Number of events 2 • 180 days
|
|
Respiratory, thoracic and mediastinal disorders
Allergic rhinitis
|
12.9%
4/31 • Number of events 4 • 180 days
|
|
Respiratory, thoracic and mediastinal disorders
Atelectasis
|
25.8%
8/31 • Number of events 8 • 180 days
|
|
Respiratory, thoracic and mediastinal disorders
Bronchopulmonary hemorrhage
|
12.9%
4/31 • Number of events 4 • 180 days
|
|
Respiratory, thoracic and mediastinal disorders
Bronchospasm
|
6.5%
2/31 • Number of events 2 • 180 days
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
74.2%
23/31 • Number of events 23 • 180 days
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
61.3%
19/31 • Number of events 19 • 180 days
|
|
Respiratory, thoracic and mediastinal disorders
Hemorrhage nasal
|
35.5%
11/31 • Number of events 11 • 180 days
|
|
Respiratory, thoracic and mediastinal disorders
Hiccough
|
12.9%
4/31 • Number of events 4 • 180 days
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
25.8%
8/31 • Number of events 8 • 180 days
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
25.8%
8/31 • Number of events 8 • 180 days
|
|
Respiratory, thoracic and mediastinal disorders
Pharyngeal examination abnormal
|
3.2%
1/31 • Number of events 1 • 180 days
|
|
Respiratory, thoracic and mediastinal disorders
Pharyngeal mucositis
|
3.2%
1/31 • Number of events 1 • 180 days
|
|
Respiratory, thoracic and mediastinal disorders
Pharyngolaryngeal pain
|
6.5%
2/31 • Number of events 2 • 180 days
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
38.7%
12/31 • Number of events 12 • 180 days
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonitis
|
35.5%
11/31 • Number of events 11 • 180 days
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory disorder
|
16.1%
5/31 • Number of events 5 • 180 days
|
|
Respiratory, thoracic and mediastinal disorders
Voice alteration
|
9.7%
3/31 • Number of events 3 • 180 days
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
58.1%
18/31 • Number of events 18 • 180 days
|
|
Skin and subcutaneous tissue disorders
Decubitus ulcer
|
12.9%
4/31 • Number of events 4 • 180 days
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
48.4%
15/31 • Number of events 15 • 180 days
|
|
Skin and subcutaneous tissue disorders
Hand-and-foot syndrome
|
3.2%
1/31 • Number of events 1 • 180 days
|
|
Skin and subcutaneous tissue disorders
Petechiae
|
38.7%
12/31 • Number of events 12 • 180 days
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
61.3%
19/31 • Number of events 19 • 180 days
|
|
Skin and subcutaneous tissue disorders
Rash desquamating
|
90.3%
28/31 • Number of events 28 • 180 days
|
|
Skin and subcutaneous tissue disorders
Skin disorder
|
32.3%
10/31 • Number of events 10 • 180 days
|
|
Skin and subcutaneous tissue disorders
Skin hyperpigmentation
|
35.5%
11/31 • Number of events 11 • 180 days
|
|
Skin and subcutaneous tissue disorders
Skin ulceration
|
3.2%
1/31 • Number of events 1 • 180 days
|
|
Skin and subcutaneous tissue disorders
Sweating
|
6.5%
2/31 • Number of events 2 • 180 days
|
|
Skin and subcutaneous tissue disorders
Urticaria
|
3.2%
1/31 • Number of events 1 • 180 days
|
|
Vascular disorders
Flushing
|
45.2%
14/31 • Number of events 14 • 180 days
|
|
Vascular disorders
Hematoma
|
19.4%
6/31 • Number of events 6 • 180 days
|
|
Vascular disorders
Hemorrhage
|
12.9%
4/31 • Number of events 4 • 180 days
|
|
Vascular disorders
Hypertension
|
64.5%
20/31 • Number of events 20 • 180 days
|
|
Vascular disorders
Hypotension
|
54.8%
17/31 • Number of events 17 • 180 days
|
|
Vascular disorders
Peripheral ischemia
|
3.2%
1/31 • Number of events 1 • 180 days
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place