Trial Outcomes & Findings for 2-Step Approach to Stem Cell Transplant in Treating Participants With Hematological Malignancies (NCT NCT03712878)
NCT ID: NCT03712878
Last Updated: 2026-07-23
Results Overview
Donor T cell chimerism (defined by 98% or greater donor T cell chimerism) by 28 days post HSCT (d+28). All estimates of rates will be presented with corresponding 95% confidence intervals. For chimerism rates, the method of Atkinson and Brown will be used to allow for the two-stage design.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
10 participants
Primary outcome timeframe
At day +28
Results posted on
2026-07-23
Participant Flow
Participant milestones
| Measure |
Treatment (TBI, DLI, Chemotherapy, HSCT, Tacrolimus, MMF)
Description CONDITIONING REGIMEN: Participants undergo TBI BID on days -9 to -6.
TRANSPLANT: Participants receive donor lymphocytes IV on day -6 after the last dose of TBI.
CONDITIONING REGIMEN: Participants receive cyclophosphamide IV on days -3 and -2.
TRANSPLANT: Participants undergo hematopoietic stem cell transplantation on day 0.
GVHD PROPHYLAXIS: Participants receive tacrolimus IV beginning on day -1 with taper beginning on day 42 in the absence of GVHD, a suspicion of GVHD, or previous history of GVHD requiring a taper delay. Participants also receive mycophenolate mofetil IV BID beginning on day -1 through day 28 in the absence of GVHD.
Total-Body Irradiation: Undergo TBI
Donor Lymphocyte Infusion: Given IV
Cyclophosphamide: Given IV
Allogeneic Hematopoietic Stem Cell Transplantation: Undergo HSCT
Tacrolimus: Given IV
Mycophenolate Mofetil: Given IV
|
|---|---|
|
Overall Study
STARTED
|
10
|
|
Overall Study
COMPLETED
|
10
|
|
Overall Study
NOT COMPLETED
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
2-Step Approach to Stem Cell Transplant in Treating Participants With Hematological Malignancies
Baseline characteristics by cohort
| Measure |
Treatment (TBI, DLI, Chemotherapy, HSCT, Tacrolimus, MMF)
n=10 Participants
Description CONDITIONING REGIMEN: Participants undergo TBI BID on days -9 to -6.
TRANSPLANT: Participants receive donor lymphocytes IV on day -6 after the last dose of TBI.
CONDITIONING REGIMEN: Participants receive cyclophosphamide IV on days -3 and -2.
TRANSPLANT: Participants undergo hematopoietic stem cell transplantation on day 0.
GVHD PROPHYLAXIS: Participants receive tacrolimus IV beginning on day -1 with taper beginning on day 42 in the absence of GVHD, a suspicion of GVHD, or previous history of GVHD requiring a taper delay. Participants also receive mycophenolate mofetil IV BID beginning on day -1 through day 28 in the absence of GVHD.
Total-Body Irradiation: Undergo TBI
Donor Lymphocyte Infusion: Given IV
Cyclophosphamide: Given IV
Allogeneic Hematopoietic Stem Cell Transplantation: Undergo HSCT
Tacrolimus: Given IV
Mycophenolate Mofetil: Given IV
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=9 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
7 Participants
n=9 Participants
|
|
Age, Categorical
>=65 years
|
3 Participants
n=9 Participants
|
|
Sex: Female, Male
Female
|
5 Participants
n=9 Participants
|
|
Sex: Female, Male
Male
|
5 Participants
n=9 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=9 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
10 Participants
n=9 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=9 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=9 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=9 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=9 Participants
|
|
Race (NIH/OMB)
Black or African American
|
5 Participants
n=9 Participants
|
|
Race (NIH/OMB)
White
|
5 Participants
n=9 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=9 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=9 Participants
|
|
Region of Enrollment
United States
|
10 participants
n=9 Participants
|
PRIMARY outcome
Timeframe: At day +28Population: Samples were never collected for 1 participant; therefore, outcome data were unavailable for analysis.
Donor T cell chimerism (defined by 98% or greater donor T cell chimerism) by 28 days post HSCT (d+28). All estimates of rates will be presented with corresponding 95% confidence intervals. For chimerism rates, the method of Atkinson and Brown will be used to allow for the two-stage design.
Outcome measures
| Measure |
Treatment (TBI, DLI, Chemotherapy, HSCT, Tacrolimus, MMF)
n=9 Participants
Description CONDITIONING REGIMEN: Participants undergo TBI BID on days -9 to -6.
TRANSPLANT: Participants receive donor lymphocytes IV on day -6 after the last dose of TBI.
CONDITIONING REGIMEN: Participants receive cyclophosphamide IV on days -3 and -2.
TRANSPLANT: Participants undergo hematopoietic stem cell transplantation on day 0.
GVHD PROPHYLAXIS: Participants receive tacrolimus IV beginning on day -1 with taper beginning on day 42 in the absence of GVHD, a suspicion of GVHD, or previous history of GVHD requiring a taper delay. Participants also receive mycophenolate mofetil IV BID beginning on day -1 through day 28 in the absence of GVHD.
Total-Body Irradiation: Undergo TBI
Donor Lymphocyte Infusion: Given IV
Cyclophosphamide: Given IV
Allogeneic Hematopoietic Stem Cell Transplantation: Undergo HSCT
Tacrolimus: Given IV
Mycophenolate Mofetil: Given IV
|
|---|---|
|
Percentage of Participants With Donor T Cell Chimerism Values Greater Than or Equal to 98%
|
22.2 percentage of participants
Interval 3.0 to 60.0
|
SECONDARY outcome
Timeframe: At day +90Population: Samples were never collected for 2 participants; therefore, outcome data were unavailable for analysis.
Will be presented with corresponding 95% confidence intervals. For chimerism rates, the method of Atkinson and Brown will be used to allow for the two-stage design.
Outcome measures
| Measure |
Treatment (TBI, DLI, Chemotherapy, HSCT, Tacrolimus, MMF)
n=8 Participants
Description CONDITIONING REGIMEN: Participants undergo TBI BID on days -9 to -6.
TRANSPLANT: Participants receive donor lymphocytes IV on day -6 after the last dose of TBI.
CONDITIONING REGIMEN: Participants receive cyclophosphamide IV on days -3 and -2.
TRANSPLANT: Participants undergo hematopoietic stem cell transplantation on day 0.
GVHD PROPHYLAXIS: Participants receive tacrolimus IV beginning on day -1 with taper beginning on day 42 in the absence of GVHD, a suspicion of GVHD, or previous history of GVHD requiring a taper delay. Participants also receive mycophenolate mofetil IV BID beginning on day -1 through day 28 in the absence of GVHD.
Total-Body Irradiation: Undergo TBI
Donor Lymphocyte Infusion: Given IV
Cyclophosphamide: Given IV
Allogeneic Hematopoietic Stem Cell Transplantation: Undergo HSCT
Tacrolimus: Given IV
Mycophenolate Mofetil: Given IV
|
|---|---|
|
Percentage of Participants With Donor T Cell Chimerism Values Greater Than or Equal to 98%
|
50 percentage of participants
Interval 16.0 to 84.0
|
SECONDARY outcome
Timeframe: At 1 year post-hematopoietic stem cell transplantation (HSCT)Population: Samples were never collected for 2 participants; therefore, outcome data were unavailable for analysis.
Will be presented with corresponding 95% confidence intervals.
Outcome measures
| Measure |
Treatment (TBI, DLI, Chemotherapy, HSCT, Tacrolimus, MMF)
n=8 Participants
Description CONDITIONING REGIMEN: Participants undergo TBI BID on days -9 to -6.
TRANSPLANT: Participants receive donor lymphocytes IV on day -6 after the last dose of TBI.
CONDITIONING REGIMEN: Participants receive cyclophosphamide IV on days -3 and -2.
TRANSPLANT: Participants undergo hematopoietic stem cell transplantation on day 0.
GVHD PROPHYLAXIS: Participants receive tacrolimus IV beginning on day -1 with taper beginning on day 42 in the absence of GVHD, a suspicion of GVHD, or previous history of GVHD requiring a taper delay. Participants also receive mycophenolate mofetil IV BID beginning on day -1 through day 28 in the absence of GVHD.
Total-Body Irradiation: Undergo TBI
Donor Lymphocyte Infusion: Given IV
Cyclophosphamide: Given IV
Allogeneic Hematopoietic Stem Cell Transplantation: Undergo HSCT
Tacrolimus: Given IV
Mycophenolate Mofetil: Given IV
|
|---|---|
|
Relapse Rate
|
13 Percentage of Participants
Interval 0.0 to 44.0
|
SECONDARY outcome
Timeframe: Within 1 year of HSCTWill be presented with corresponding 95% confidence intervals.
Outcome measures
| Measure |
Treatment (TBI, DLI, Chemotherapy, HSCT, Tacrolimus, MMF)
n=10 Participants
Description CONDITIONING REGIMEN: Participants undergo TBI BID on days -9 to -6.
TRANSPLANT: Participants receive donor lymphocytes IV on day -6 after the last dose of TBI.
CONDITIONING REGIMEN: Participants receive cyclophosphamide IV on days -3 and -2.
TRANSPLANT: Participants undergo hematopoietic stem cell transplantation on day 0.
GVHD PROPHYLAXIS: Participants receive tacrolimus IV beginning on day -1 with taper beginning on day 42 in the absence of GVHD, a suspicion of GVHD, or previous history of GVHD requiring a taper delay. Participants also receive mycophenolate mofetil IV BID beginning on day -1 through day 28 in the absence of GVHD.
Total-Body Irradiation: Undergo TBI
Donor Lymphocyte Infusion: Given IV
Cyclophosphamide: Given IV
Allogeneic Hematopoietic Stem Cell Transplantation: Undergo HSCT
Tacrolimus: Given IV
Mycophenolate Mofetil: Given IV
|
|---|---|
|
Percentage of Participants With Grades II-IV Graft Versus Host Disease (GVHD)
|
22 percentage of patients
Interval 3.0 to 53.0
|
SECONDARY outcome
Timeframe: At 1 year post-HSCTWill be presented with corresponding 95% confidence intervals.
Outcome measures
| Measure |
Treatment (TBI, DLI, Chemotherapy, HSCT, Tacrolimus, MMF)
n=10 Participants
Description CONDITIONING REGIMEN: Participants undergo TBI BID on days -9 to -6.
TRANSPLANT: Participants receive donor lymphocytes IV on day -6 after the last dose of TBI.
CONDITIONING REGIMEN: Participants receive cyclophosphamide IV on days -3 and -2.
TRANSPLANT: Participants undergo hematopoietic stem cell transplantation on day 0.
GVHD PROPHYLAXIS: Participants receive tacrolimus IV beginning on day -1 with taper beginning on day 42 in the absence of GVHD, a suspicion of GVHD, or previous history of GVHD requiring a taper delay. Participants also receive mycophenolate mofetil IV BID beginning on day -1 through day 28 in the absence of GVHD.
Total-Body Irradiation: Undergo TBI
Donor Lymphocyte Infusion: Given IV
Cyclophosphamide: Given IV
Allogeneic Hematopoietic Stem Cell Transplantation: Undergo HSCT
Tacrolimus: Given IV
Mycophenolate Mofetil: Given IV
|
|---|---|
|
Rate of Treatment-related Mortality (TRM)
|
11 Percentage of Participants
Interval 0.0 to 41.0
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Up to 100 daysPopulation: Samples were never collected for 9 participants; therefore, outcome data were unavailable for analysis.
Rate of cytomegalovirus
Outcome measures
| Measure |
Treatment (TBI, DLI, Chemotherapy, HSCT, Tacrolimus, MMF)
n=1 Participants
Description CONDITIONING REGIMEN: Participants undergo TBI BID on days -9 to -6.
TRANSPLANT: Participants receive donor lymphocytes IV on day -6 after the last dose of TBI.
CONDITIONING REGIMEN: Participants receive cyclophosphamide IV on days -3 and -2.
TRANSPLANT: Participants undergo hematopoietic stem cell transplantation on day 0.
GVHD PROPHYLAXIS: Participants receive tacrolimus IV beginning on day -1 with taper beginning on day 42 in the absence of GVHD, a suspicion of GVHD, or previous history of GVHD requiring a taper delay. Participants also receive mycophenolate mofetil IV BID beginning on day -1 through day 28 in the absence of GVHD.
Total-Body Irradiation: Undergo TBI
Donor Lymphocyte Infusion: Given IV
Cyclophosphamide: Given IV
Allogeneic Hematopoietic Stem Cell Transplantation: Undergo HSCT
Tacrolimus: Given IV
Mycophenolate Mofetil: Given IV
|
|---|---|
|
Rate of Cytomegalovirus
|
0 Percentage of Participants
Interval 0.0 to 98.0
|
Adverse Events
Treatment (TBI, DLI, Chemotherapy, HSCT, Tacrolimus, MMF)
Serious events: 7 serious events
Other events: 10 other events
Deaths: 5 deaths
Serious adverse events
| Measure |
Treatment (TBI, DLI, Chemotherapy, HSCT, Tacrolimus, MMF)
n=10 participants at risk
Description CONDITIONING REGIMEN: Participants undergo TBI BID on days -9 to -6.
TRANSPLANT: Participants receive donor lymphocytes IV on day -6 after the last dose of TBI.
CONDITIONING REGIMEN: Participants receive cyclophosphamide IV on days -3 and -2.
TRANSPLANT: Participants undergo hematopoietic stem cell transplantation on day 0.
GVHD PROPHYLAXIS: Participants receive tacrolimus IV beginning on day -1 with taper beginning on day 42 in the absence of GVHD, a suspicion of GVHD, or previous history of GVHD requiring a taper delay. Participants also receive mycophenolate mofetil IV BID beginning on day -1 through day 28 in the absence of GVHD.
Total-Body Irradiation: Undergo TBI
Donor Lymphocyte Infusion: Given IV
Cyclophosphamide: Given IV
Allogeneic Hematopoietic Stem Cell Transplantation: Undergo HSCT
Tacrolimus: Given IV
Mycophenolate Mofetil: Given IV
|
|---|---|
|
Blood and lymphatic system disorders
Blood Bilirubin increase - Grade 3
|
10.0%
1/10 • Number of events 1 • All patients will be followed for adverse experiences through study completion, an average of 1 year.
Deaths did not occur during study treatment.
|
|
Infections and infestations
cholecystitis - Grade 3
|
10.0%
1/10 • Number of events 1 • All patients will be followed for adverse experiences through study completion, an average of 1 year.
Deaths did not occur during study treatment.
|
|
Psychiatric disorders
Delirium - Grade 3
|
10.0%
1/10 • Number of events 1 • All patients will be followed for adverse experiences through study completion, an average of 1 year.
Deaths did not occur during study treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia - Grade 3
|
20.0%
2/10 • Number of events 2 • All patients will be followed for adverse experiences through study completion, an average of 1 year.
Deaths did not occur during study treatment.
|
|
Blood and lymphatic system disorders
Mixed Chimerism - Grade 3
|
10.0%
1/10 • Number of events 1 • All patients will be followed for adverse experiences through study completion, an average of 1 year.
Deaths did not occur during study treatment.
|
|
Cardiac disorders
Paricardial effusion - Grade 3
|
10.0%
1/10 • Number of events 1 • All patients will be followed for adverse experiences through study completion, an average of 1 year.
Deaths did not occur during study treatment.
|
|
Vascular disorders
Syncope - Grade 3
|
20.0%
2/10 • Number of events 2 • All patients will be followed for adverse experiences through study completion, an average of 1 year.
Deaths did not occur during study treatment.
|
|
Infections and infestations
URI - Grade 3
|
10.0%
1/10 • Number of events 1 • All patients will be followed for adverse experiences through study completion, an average of 1 year.
Deaths did not occur during study treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory Failure
|
20.0%
2/10 • Number of events 2 • All patients will be followed for adverse experiences through study completion, an average of 1 year.
Deaths did not occur during study treatment.
|
|
Infections and infestations
Sepsis
|
10.0%
1/10 • Number of events 1 • All patients will be followed for adverse experiences through study completion, an average of 1 year.
Deaths did not occur during study treatment.
|
|
Vascular disorders
Stroke
|
10.0%
1/10 • Number of events 1 • All patients will be followed for adverse experiences through study completion, an average of 1 year.
Deaths did not occur during study treatment.
|
|
Immune system disorders
Liver GVHD
|
10.0%
1/10 • Number of events 1 • All patients will be followed for adverse experiences through study completion, an average of 1 year.
Deaths did not occur during study treatment.
|
Other adverse events
| Measure |
Treatment (TBI, DLI, Chemotherapy, HSCT, Tacrolimus, MMF)
n=10 participants at risk
Description CONDITIONING REGIMEN: Participants undergo TBI BID on days -9 to -6.
TRANSPLANT: Participants receive donor lymphocytes IV on day -6 after the last dose of TBI.
CONDITIONING REGIMEN: Participants receive cyclophosphamide IV on days -3 and -2.
TRANSPLANT: Participants undergo hematopoietic stem cell transplantation on day 0.
GVHD PROPHYLAXIS: Participants receive tacrolimus IV beginning on day -1 with taper beginning on day 42 in the absence of GVHD, a suspicion of GVHD, or previous history of GVHD requiring a taper delay. Participants also receive mycophenolate mofetil IV BID beginning on day -1 through day 28 in the absence of GVHD.
Total-Body Irradiation: Undergo TBI
Donor Lymphocyte Infusion: Given IV
Cyclophosphamide: Given IV
Allogeneic Hematopoietic Stem Cell Transplantation: Undergo HSCT
Tacrolimus: Given IV
Mycophenolate Mofetil: Given IV
|
|---|---|
|
Gastrointestinal disorders
Abdominal Pain - Grade 1
|
50.0%
5/10 • Number of events 5 • All patients will be followed for adverse experiences through study completion, an average of 1 year.
Deaths did not occur during study treatment.
|
|
Gastrointestinal disorders
Abdominal Pain - Grade 2
|
10.0%
1/10 • Number of events 1 • All patients will be followed for adverse experiences through study completion, an average of 1 year.
Deaths did not occur during study treatment.
|
|
Renal and urinary disorders
Acute Kidney Injury - Grade 2
|
10.0%
1/10 • Number of events 1 • All patients will be followed for adverse experiences through study completion, an average of 1 year.
Deaths did not occur during study treatment.
|
|
Psychiatric disorders
Agitation - Grade 1
|
10.0%
1/10 • Number of events 1 • All patients will be followed for adverse experiences through study completion, an average of 1 year.
Deaths did not occur during study treatment.
|
|
Blood and lymphatic system disorders
Akabube aminoreansferase increase - Grade 1
|
10.0%
1/10 • Number of events 1 • All patients will be followed for adverse experiences through study completion, an average of 1 year.
Deaths did not occur during study treatment.
|
|
Renal and urinary disorders
AKI - Grade 1
|
20.0%
2/10 • Number of events 2 • All patients will be followed for adverse experiences through study completion, an average of 1 year.
Deaths did not occur during study treatment.
|
|
Blood and lymphatic system disorders
Alkaline phosphate increase - Grade 1
|
10.0%
1/10 • Number of events 1 • All patients will be followed for adverse experiences through study completion, an average of 1 year.
Deaths did not occur during study treatment.
|
|
Skin and subcutaneous tissue disorders
Alopecia - Grade 1
|
70.0%
7/10 • Number of events 7 • All patients will be followed for adverse experiences through study completion, an average of 1 year.
Deaths did not occur during study treatment.
|
|
Gastrointestinal disorders
Altered Taste - Grade 1
|
10.0%
1/10 • Number of events 1 • All patients will be followed for adverse experiences through study completion, an average of 1 year.
Deaths did not occur during study treatment.
|
|
Vascular disorders
Anasarca - Grade 2
|
10.0%
1/10 • Number of events 1 • All patients will be followed for adverse experiences through study completion, an average of 1 year.
Deaths did not occur during study treatment.
|
|
Metabolism and nutrition disorders
Anorexia - Grade 1
|
20.0%
2/10 • Number of events 2 • All patients will be followed for adverse experiences through study completion, an average of 1 year.
Deaths did not occur during study treatment.
|
|
Metabolism and nutrition disorders
Anorexia - Grade 2
|
50.0%
5/10 • Number of events 5 • All patients will be followed for adverse experiences through study completion, an average of 1 year.
Deaths did not occur during study treatment.
|
|
Metabolism and nutrition disorders
Anorexia - Grade 3
|
30.0%
3/10 • Number of events 3 • All patients will be followed for adverse experiences through study completion, an average of 1 year.
Deaths did not occur during study treatment.
|
|
Psychiatric disorders
Anxiety - Grade 2
|
20.0%
2/10 • Number of events 2 • All patients will be followed for adverse experiences through study completion, an average of 1 year.
Deaths did not occur during study treatment.
|
|
Musculoskeletal and connective tissue disorders
Arm Pain - Grade 2
|
10.0%
1/10 • Number of events 1 • All patients will be followed for adverse experiences through study completion, an average of 1 year.
Deaths did not occur during study treatment.
|
|
Musculoskeletal and connective tissue disorders
Arthalgia - Grade 1
|
30.0%
3/10 • Number of events 3 • All patients will be followed for adverse experiences through study completion, an average of 1 year.
Deaths did not occur during study treatment.
|
|
Musculoskeletal and connective tissue disorders
Arthalgia - Grade 2
|
10.0%
1/10 • Number of events 1 • All patients will be followed for adverse experiences through study completion, an average of 1 year.
Deaths did not occur during study treatment.
|
|
Cardiac disorders
Atrial Fibrillation - Grade 2
|
10.0%
1/10 • Number of events 1 • All patients will be followed for adverse experiences through study completion, an average of 1 year.
Deaths did not occur during study treatment.
|
|
Cardiac disorders
Atrial Flutter - Grade 2
|
10.0%
1/10 • Number of events 1 • All patients will be followed for adverse experiences through study completion, an average of 1 year.
Deaths did not occur during study treatment.
|
|
Musculoskeletal and connective tissue disorders
Back Pain - Grade 1
|
20.0%
2/10 • Number of events 2 • All patients will be followed for adverse experiences through study completion, an average of 1 year.
Deaths did not occur during study treatment.
|
|
Blood and lymphatic system disorders
Bacteremia - Grade 2
|
10.0%
1/10 • Number of events 1 • All patients will be followed for adverse experiences through study completion, an average of 1 year.
Deaths did not occur during study treatment.
|
|
Eye disorders
Bilateral eye pain - Grade 1
|
10.0%
1/10 • Number of events 1 • All patients will be followed for adverse experiences through study completion, an average of 1 year.
Deaths did not occur during study treatment.
|
|
Gastrointestinal disorders
Bloating - Grade 1
|
10.0%
1/10 • Number of events 1 • All patients will be followed for adverse experiences through study completion, an average of 1 year.
Deaths did not occur during study treatment.
|
|
Gastrointestinal disorders
Bloating - Grade 2
|
10.0%
1/10 • Number of events 1 • All patients will be followed for adverse experiences through study completion, an average of 1 year.
Deaths did not occur during study treatment.
|
|
Blood and lymphatic system disorders
Blood bilirubin increase - Grade 1
|
20.0%
2/10 • Number of events 2 • All patients will be followed for adverse experiences through study completion, an average of 1 year.
Deaths did not occur during study treatment.
|
|
Blood and lymphatic system disorders
Blood bilirubin increase - Grade 2
|
10.0%
1/10 • Number of events 1 • All patients will be followed for adverse experiences through study completion, an average of 1 year.
Deaths did not occur during study treatment.
|
|
Gastrointestinal disorders
Blood in Stool - Grade 1
|
10.0%
1/10 • Number of events 1 • All patients will be followed for adverse experiences through study completion, an average of 1 year.
Deaths did not occur during study treatment.
|
|
Eye disorders
Blurred Vision - Grade 1
|
20.0%
2/10 • Number of events 2 • All patients will be followed for adverse experiences through study completion, an average of 1 year.
Deaths did not occur during study treatment.
|
|
Eye disorders
Blurred Vision - Grade 2
|
10.0%
1/10 • Number of events 1 • All patients will be followed for adverse experiences through study completion, an average of 1 year.
Deaths did not occur during study treatment.
|
|
Injury, poisoning and procedural complications
Bruising - Grade 1
|
20.0%
2/10 • Number of events 2 • All patients will be followed for adverse experiences through study completion, an average of 1 year.
Deaths did not occur during study treatment.
|
|
Skin and subcutaneous tissue disorders
Bullous dermatitis - Grade 2
|
10.0%
1/10 • Number of events 1 • All patients will be followed for adverse experiences through study completion, an average of 1 year.
Deaths did not occur during study treatment.
|
|
Eye disorders
Cataract - Grade 2
|
10.0%
1/10 • Number of events 1 • All patients will be followed for adverse experiences through study completion, an average of 1 year.
Deaths did not occur during study treatment.
|
|
Gastrointestinal disorders
C-diff carier - Grade 1
|
10.0%
1/10 • Number of events 1 • All patients will be followed for adverse experiences through study completion, an average of 1 year.
Deaths did not occur during study treatment.
|
|
Gastrointestinal disorders
Cheilltis - Grade 1
|
10.0%
1/10 • Number of events 1 • All patients will be followed for adverse experiences through study completion, an average of 1 year.
Deaths did not occur during study treatment.
|
|
Cardiac disorders
Chest Pain - Grade 1
|
20.0%
2/10 • Number of events 2 • All patients will be followed for adverse experiences through study completion, an average of 1 year.
Deaths did not occur during study treatment.
|
|
General disorders
Chills - Grade 1
|
20.0%
2/10 • Number of events 2 • All patients will be followed for adverse experiences through study completion, an average of 1 year.
Deaths did not occur during study treatment.
|
|
Psychiatric disorders
Confusion - Grade 1
|
30.0%
3/10 • Number of events 3 • All patients will be followed for adverse experiences through study completion, an average of 1 year.
Deaths did not occur during study treatment.
|
|
Gastrointestinal disorders
Constipation - Grade 1
|
50.0%
5/10 • Number of events 5 • All patients will be followed for adverse experiences through study completion, an average of 1 year.
Deaths did not occur during study treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Cough - Grade 1
|
30.0%
3/10 • Number of events 3 • All patients will be followed for adverse experiences through study completion, an average of 1 year.
Deaths did not occur during study treatment.
|
|
Blood and lymphatic system disorders
Creatinine increase - Grade 1
|
10.0%
1/10 • Number of events 1 • All patients will be followed for adverse experiences through study completion, an average of 1 year.
Deaths did not occur during study treatment.
|
|
Vascular disorders
Darkening of Nails - Grade 1
|
10.0%
1/10 • Number of events 1 • All patients will be followed for adverse experiences through study completion, an average of 1 year.
Deaths did not occur during study treatment.
|
|
Musculoskeletal and connective tissue disorders
Deconditioning - Grade 2
|
10.0%
1/10 • Number of events 1 • All patients will be followed for adverse experiences through study completion, an average of 1 year.
Deaths did not occur during study treatment.
|
|
Renal and urinary disorders
Decreased urinary output - Grade 2
|
20.0%
2/10 • Number of events 2 • All patients will be followed for adverse experiences through study completion, an average of 1 year.
Deaths did not occur during study treatment.
|
|
Metabolism and nutrition disorders
Dehydration - Grade 1
|
10.0%
1/10 • Number of events 1 • All patients will be followed for adverse experiences through study completion, an average of 1 year.
Deaths did not occur during study treatment.
|
|
Metabolism and nutrition disorders
Dehydration - Grade 2
|
20.0%
2/10 • Number of events 2 • All patients will be followed for adverse experiences through study completion, an average of 1 year.
Deaths did not occur during study treatment.
|
|
Psychiatric disorders
Delerium - Grade 1
|
10.0%
1/10 • Number of events 1 • All patients will be followed for adverse experiences through study completion, an average of 1 year.
Deaths did not occur during study treatment.
|
|
Metabolism and nutrition disorders
Delerium - Grade 2
|
10.0%
1/10 • Number of events 1 • All patients will be followed for adverse experiences through study completion, an average of 1 year.
Deaths did not occur during study treatment.
|
|
Nervous system disorders
Depressed level of consciousness - Grade 2
|
10.0%
1/10 • Number of events 1 • All patients will be followed for adverse experiences through study completion, an average of 1 year.
Deaths did not occur during study treatment.
|
|
Psychiatric disorders
Depression - Grade 1
|
30.0%
3/10 • Number of events 3 • All patients will be followed for adverse experiences through study completion, an average of 1 year.
Deaths did not occur during study treatment.
|
|
Psychiatric disorders
Depression - Grade 2
|
10.0%
1/10 • Number of events 1 • All patients will be followed for adverse experiences through study completion, an average of 1 year.
Deaths did not occur during study treatment.
|
|
Skin and subcutaneous tissue disorders
Desquanmation - Grade 1
|
10.0%
1/10 • Number of events 1 • All patients will be followed for adverse experiences through study completion, an average of 1 year.
Deaths did not occur during study treatment.
|
|
General disorders
Diaphoresis - Grade 1
|
20.0%
2/10 • Number of events 2 • All patients will be followed for adverse experiences through study completion, an average of 1 year.
Deaths did not occur during study treatment.
|
|
Gastrointestinal disorders
Diarrhea - Grade 1
|
40.0%
4/10 • Number of events 4 • All patients will be followed for adverse experiences through study completion, an average of 1 year.
Deaths did not occur during study treatment.
|
|
Gastrointestinal disorders
Diarrhea - Grade 2
|
40.0%
4/10 • Number of events 4 • All patients will be followed for adverse experiences through study completion, an average of 1 year.
Deaths did not occur during study treatment.
|
|
Gastrointestinal disorders
Diarrhea - Grade 3
|
30.0%
3/10 • Number of events 3 • All patients will be followed for adverse experiences through study completion, an average of 1 year.
Deaths did not occur during study treatment.
|
|
Nervous system disorders
Dizziness - Grade 1
|
50.0%
5/10 • Number of events 5 • All patients will be followed for adverse experiences through study completion, an average of 1 year.
Deaths did not occur during study treatment.
|
|
Eye disorders
Dry Eye - Grade 1
|
20.0%
2/10 • Number of events 2 • All patients will be followed for adverse experiences through study completion, an average of 1 year.
Deaths did not occur during study treatment.
|
|
Gastrointestinal disorders
Dry Mouth - Grade 1
|
70.0%
7/10 • Number of events 7 • All patients will be followed for adverse experiences through study completion, an average of 1 year.
Deaths did not occur during study treatment.
|
|
Gastrointestinal disorders
Dry Mouth - Grade 2
|
20.0%
2/10 • Number of events 2 • All patients will be followed for adverse experiences through study completion, an average of 1 year.
Deaths did not occur during study treatment.
|
|
Skin and subcutaneous tissue disorders
Dry Skin - Grade 1
|
40.0%
4/10 • Number of events 4 • All patients will be followed for adverse experiences through study completion, an average of 1 year.
Deaths did not occur during study treatment.
|
|
Metabolism and nutrition disorders
Dysgeusia - Grade 1
|
20.0%
2/10 • Number of events 2 • All patients will be followed for adverse experiences through study completion, an average of 1 year.
Deaths did not occur during study treatment.
|
|
Metabolism and nutrition disorders
Dysgeusia - Grade 2
|
10.0%
1/10 • Number of events 1 • All patients will be followed for adverse experiences through study completion, an average of 1 year.
Deaths did not occur during study treatment.
|
|
Gastrointestinal disorders
Dyspepsia - Grade 1
|
10.0%
1/10 • Number of events 1 • All patients will be followed for adverse experiences through study completion, an average of 1 year.
Deaths did not occur during study treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea - Grade 1
|
20.0%
2/10 • Number of events 2 • All patients will be followed for adverse experiences through study completion, an average of 1 year.
Deaths did not occur during study treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea - Grade 2
|
10.0%
1/10 • Number of events 1 • All patients will be followed for adverse experiences through study completion, an average of 1 year.
Deaths did not occur during study treatment.
|
|
Injury, poisoning and procedural complications
Dystonic drug reaction - Grade 1
|
10.0%
1/10 • Number of events 1 • All patients will be followed for adverse experiences through study completion, an average of 1 year.
Deaths did not occur during study treatment.
|
|
Vascular disorders
Edema limbs - Grade 1
|
40.0%
4/10 • Number of events 4 • All patients will be followed for adverse experiences through study completion, an average of 1 year.
Deaths did not occur during study treatment.
|
|
Vascular disorders
Edema limbs - Grade 2
|
10.0%
1/10 • Number of events 1 • All patients will be followed for adverse experiences through study completion, an average of 1 year.
Deaths did not occur during study treatment.
|
|
Gastrointestinal disorders
Edentia; surgical - Grade 1
|
10.0%
1/10 • Number of events 1 • All patients will be followed for adverse experiences through study completion, an average of 1 year.
Deaths did not occur during study treatment.
|
|
Cardiac disorders
Ejection fraction decrease - GRade 2
|
10.0%
1/10 • Number of events 1 • All patients will be followed for adverse experiences through study completion, an average of 1 year.
Deaths did not occur during study treatment.
|
|
Blood and lymphatic system disorders
Elevated ferritin - Grade 1
|
10.0%
1/10 • Number of events 1 • All patients will be followed for adverse experiences through study completion, an average of 1 year.
Deaths did not occur during study treatment.
|
|
General disorders
Epistaxis - Grade 1
|
20.0%
2/10 • Number of events 2 • All patients will be followed for adverse experiences through study completion, an average of 1 year.
Deaths did not occur during study treatment.
|
|
General disorders
Epistaxis - Grade 2
|
10.0%
1/10 • Number of events 1 • All patients will be followed for adverse experiences through study completion, an average of 1 year.
Deaths did not occur during study treatment.
|
|
Skin and subcutaneous tissue disorders
Erythematous rash - Grade 1
|
10.0%
1/10 • Number of events 1 • All patients will be followed for adverse experiences through study completion, an average of 1 year.
Deaths did not occur during study treatment.
|
|
Musculoskeletal and connective tissue disorders
Extremity weakness - Grade
|
10.0%
1/10 • Number of events 1 • All patients will be followed for adverse experiences through study completion, an average of 1 year.
Deaths did not occur during study treatment.
|
|
Vascular disorders
Facial Edema - Grade 1
|
10.0%
1/10 • Number of events 1 • All patients will be followed for adverse experiences through study completion, an average of 1 year.
Deaths did not occur during study treatment.
|
|
Injury, poisoning and procedural complications
Fall - Grade 1
|
40.0%
4/10 • Number of events 4 • All patients will be followed for adverse experiences through study completion, an average of 1 year.
Deaths did not occur during study treatment.
|
|
Injury, poisoning and procedural complications
Fall - Grade 2
|
10.0%
1/10 • Number of events 1 • All patients will be followed for adverse experiences through study completion, an average of 1 year.
Deaths did not occur during study treatment.
|
|
General disorders
Fatigue - Grade 1
|
30.0%
3/10 • Number of events 3 • All patients will be followed for adverse experiences through study completion, an average of 1 year.
Deaths did not occur during study treatment.
|
|
General disorders
Fatigue - Grade 2
|
30.0%
3/10 • Number of events 3 • All patients will be followed for adverse experiences through study completion, an average of 1 year.
Deaths did not occur during study treatment.
|
|
General disorders
Fatigue - Grade 3
|
30.0%
3/10 • Number of events 3 • All patients will be followed for adverse experiences through study completion, an average of 1 year.
Deaths did not occur during study treatment.
|
|
General disorders
Fever - Grade 1
|
60.0%
6/10 • Number of events 6 • All patients will be followed for adverse experiences through study completion, an average of 1 year.
Deaths did not occur during study treatment.
|
|
General disorders
Fever - Grade 3
|
10.0%
1/10 • Number of events 1 • All patients will be followed for adverse experiences through study completion, an average of 1 year.
Deaths did not occur during study treatment.
|
|
Eye disorders
Flashing Light - Grade 1
|
10.0%
1/10 • Number of events 1 • All patients will be followed for adverse experiences through study completion, an average of 1 year.
Deaths did not occur during study treatment.
|
|
Psychiatric disorders
Flat Affect - Grade 1
|
10.0%
1/10 • Number of events 1 • All patients will be followed for adverse experiences through study completion, an average of 1 year.
Deaths did not occur during study treatment.
|
|
General disorders
Fluid Overload - Grade 2
|
20.0%
2/10 • Number of events 2 • All patients will be followed for adverse experiences through study completion, an average of 1 year.
Deaths did not occur during study treatment.
|
|
Skin and subcutaneous tissue disorders
Folliculitis - Grade 2
|
10.0%
1/10 • Number of events 1 • All patients will be followed for adverse experiences through study completion, an average of 1 year.
Deaths did not occur during study treatment.
|
|
Musculoskeletal and connective tissue disorders
Foot Pain - Grade 1
|
10.0%
1/10 • Number of events 1 • All patients will be followed for adverse experiences through study completion, an average of 1 year.
Deaths did not occur during study treatment.
|
|
Musculoskeletal and connective tissue disorders
Gait disturbance - Grade 1
|
10.0%
1/10 • Number of events 1 • All patients will be followed for adverse experiences through study completion, an average of 1 year.
Deaths did not occur during study treatment.
|
|
Musculoskeletal and connective tissue disorders
Generalized muscle weakness - Grade 2
|
20.0%
2/10 • Number of events 2 • All patients will be followed for adverse experiences through study completion, an average of 1 year.
Deaths did not occur during study treatment.
|
|
Gastrointestinal disorders
GERD - Grade 1
|
10.0%
1/10 • Number of events 1 • All patients will be followed for adverse experiences through study completion, an average of 1 year.
Deaths did not occur during study treatment.
|
|
Skin and subcutaneous tissue disorders
Goosebumps - Grade 1
|
10.0%
1/10 • Number of events 1 • All patients will be followed for adverse experiences through study completion, an average of 1 year.
Deaths did not occur during study treatment.
|
|
Immune system disorders
GVHD - Grade 2
|
10.0%
1/10 • Number of events 1 • All patients will be followed for adverse experiences through study completion, an average of 1 year.
Deaths did not occur during study treatment.
|
|
Psychiatric disorders
Hallucination - Grade 1
|
10.0%
1/10 • Number of events 1 • All patients will be followed for adverse experiences through study completion, an average of 1 year.
Deaths did not occur during study treatment.
|
|
Psychiatric disorders
Hallucination - Grade 2
|
10.0%
1/10 • Number of events 1 • All patients will be followed for adverse experiences through study completion, an average of 1 year.
Deaths did not occur during study treatment.
|
|
Nervous system disorders
Headache - Grade 1
|
10.0%
1/10 • Number of events 1 • All patients will be followed for adverse experiences through study completion, an average of 1 year.
Deaths did not occur during study treatment.
|
|
Renal and urinary disorders
Hematuria - Grade 1
|
10.0%
1/10 • Number of events 1 • All patients will be followed for adverse experiences through study completion, an average of 1 year.
Deaths did not occur during study treatment.
|
|
Renal and urinary disorders
Hematuria - Grade 2
|
10.0%
1/10 • Number of events 1 • All patients will be followed for adverse experiences through study completion, an average of 1 year.
Deaths did not occur during study treatment.
|
|
Vascular disorders
Hemorrhoidal Hemorrhage - Grade 1
|
10.0%
1/10 • Number of events 1 • All patients will be followed for adverse experiences through study completion, an average of 1 year.
Deaths did not occur during study treatment.
|
|
Vascular disorders
Hemorrhoids - Grade 2
|
20.0%
2/10 • Number of events 2 • All patients will be followed for adverse experiences through study completion, an average of 1 year.
Deaths did not occur during study treatment.
|
|
Gastrointestinal disorders
Hiccups - Grade 2
|
10.0%
1/10 • Number of events 1 • All patients will be followed for adverse experiences through study completion, an average of 1 year.
Deaths did not occur during study treatment.
|
|
Gastrointestinal disorders
Hyperethesia related to mesna - Grade 1
|
10.0%
1/10 • Number of events 1 • All patients will be followed for adverse experiences through study completion, an average of 1 year.
Deaths did not occur during study treatment.
|
|
Blood and lymphatic system disorders
Hyperglycemia - Grade 1
|
10.0%
1/10 • Number of events 1 • All patients will be followed for adverse experiences through study completion, an average of 1 year.
Deaths did not occur during study treatment.
|
|
Blood and lymphatic system disorders
Hypernatremia - Grade 2
|
10.0%
1/10 • Number of events 1 • All patients will be followed for adverse experiences through study completion, an average of 1 year.
Deaths did not occur during study treatment.
|
|
Vascular disorders
Hypertension - Grade 2
|
10.0%
1/10 • Number of events 1 • All patients will be followed for adverse experiences through study completion, an average of 1 year.
Deaths did not occur during study treatment.
|
|
Blood and lymphatic system disorders
Hypokalemia - Grade 1
|
20.0%
2/10 • Number of events 2 • All patients will be followed for adverse experiences through study completion, an average of 1 year.
Deaths did not occur during study treatment.
|
|
Blood and lymphatic system disorders
Hypokalemia - Grade 3
|
30.0%
3/10 • Number of events 3 • All patients will be followed for adverse experiences through study completion, an average of 1 year.
Deaths did not occur during study treatment.
|
|
Blood and lymphatic system disorders
Hypomagnesemia - Grade 2
|
30.0%
3/10 • Number of events 3 • All patients will be followed for adverse experiences through study completion, an average of 1 year.
Deaths did not occur during study treatment.
|
|
Blood and lymphatic system disorders
Hypomagnesemia - Grade 3
|
10.0%
1/10 • Number of events 1 • All patients will be followed for adverse experiences through study completion, an average of 1 year.
Deaths did not occur during study treatment.
|
|
Blood and lymphatic system disorders
Hyponatremia - Grade 1
|
10.0%
1/10 • Number of events 1 • All patients will be followed for adverse experiences through study completion, an average of 1 year.
Deaths did not occur during study treatment.
|
|
Blood and lymphatic system disorders
Hypophosphatemia - Grade 3
|
10.0%
1/10 • Number of events 1 • All patients will be followed for adverse experiences through study completion, an average of 1 year.
Deaths did not occur during study treatment.
|
|
Vascular disorders
Hypotension - Grade 1
|
10.0%
1/10 • Number of events 1 • All patients will be followed for adverse experiences through study completion, an average of 1 year.
Deaths did not occur during study treatment.
|
|
Vascular disorders
Hypotension - Grade 2
|
20.0%
2/10 • Number of events 2 • All patients will be followed for adverse experiences through study completion, an average of 1 year.
Deaths did not occur during study treatment.
|
|
Injury, poisoning and procedural complications
Infusion related reaction - Grade 1
|
10.0%
1/10 • Number of events 1 • All patients will be followed for adverse experiences through study completion, an average of 1 year.
Deaths did not occur during study treatment.
|
|
Injury, poisoning and procedural complications
Infusion related reaction - Grade 2
|
20.0%
2/10 • Number of events 2 • All patients will be followed for adverse experiences through study completion, an average of 1 year.
Deaths did not occur during study treatment.
|
|
Psychiatric disorders
Insomnia - Grade 1
|
40.0%
4/10 • Number of events 4 • All patients will be followed for adverse experiences through study completion, an average of 1 year.
Deaths did not occur during study treatment.
|
|
Psychiatric disorders
Insomnia - Grade 2
|
20.0%
2/10 • Number of events 2 • All patients will be followed for adverse experiences through study completion, an average of 1 year.
Deaths did not occur during study treatment.
|
|
Injury, poisoning and procedural complications
Laceration - Grade 1
|
10.0%
1/10 • Number of events 1 • All patients will be followed for adverse experiences through study completion, an average of 1 year.
Deaths did not occur during study treatment.
|
|
General disorders
Lip Pain - Grade 1
|
10.0%
1/10 • Number of events 1 • All patients will be followed for adverse experiences through study completion, an average of 1 year.
Deaths did not occur during study treatment.
|
|
Vascular disorders
Localized edema - Grade 2
|
10.0%
1/10 • Number of events 1 • All patients will be followed for adverse experiences through study completion, an average of 1 year.
Deaths did not occur during study treatment.
|
|
Renal and urinary disorders
Low Urine Output - Grade 2
|
10.0%
1/10 • Number of events 1 • All patients will be followed for adverse experiences through study completion, an average of 1 year.
Deaths did not occur during study treatment.
|
|
Musculoskeletal and connective tissue disorders
Malaise - Grade 1
|
10.0%
1/10 • Number of events 1 • All patients will be followed for adverse experiences through study completion, an average of 1 year.
Deaths did not occur during study treatment.
|
|
Gastrointestinal disorders
Mucositis - Grade 1
|
10.0%
1/10 • Number of events 1 • All patients will be followed for adverse experiences through study completion, an average of 1 year.
Deaths did not occur during study treatment.
|
|
Gastrointestinal disorders
Mucositis - Grade 2
|
30.0%
3/10 • Number of events 3 • All patients will be followed for adverse experiences through study completion, an average of 1 year.
Deaths did not occur during study treatment.
|
|
Gastrointestinal disorders
Mucositis - Grade 3
|
60.0%
6/10 • Number of events 6 • All patients will be followed for adverse experiences through study completion, an average of 1 year.
Deaths did not occur during study treatment.
|
|
Cardiac disorders
Murmur - Grade 1
|
10.0%
1/10 • Number of events 1 • All patients will be followed for adverse experiences through study completion, an average of 1 year.
Deaths did not occur during study treatment.
|
|
Musculoskeletal and connective tissue disorders
Muscle weakness - Grade 2
|
10.0%
1/10 • Number of events 1 • All patients will be followed for adverse experiences through study completion, an average of 1 year.
Deaths did not occur during study treatment.
|
|
Musculoskeletal and connective tissue disorders
Myalgia - Grade 1
|
30.0%
3/10 • Number of events 3 • All patients will be followed for adverse experiences through study completion, an average of 1 year.
Deaths did not occur during study treatment.
|
|
Musculoskeletal and connective tissue disorders
Myalgia - Grade 2
|
10.0%
1/10 • Number of events 1 • All patients will be followed for adverse experiences through study completion, an average of 1 year.
Deaths did not occur during study treatment.
|
|
Gastrointestinal disorders
Nasal Congestion - Grade 1
|
20.0%
2/10 • Number of events 2 • All patients will be followed for adverse experiences through study completion, an average of 1 year.
Deaths did not occur during study treatment.
|
|
Gastrointestinal disorders
Nasal Congestion - Grade 2
|
10.0%
1/10 • Number of events 1 • All patients will be followed for adverse experiences through study completion, an average of 1 year.
Deaths did not occur during study treatment.
|
|
Gastrointestinal disorders
Nausea - Grade 1
|
50.0%
5/10 • Number of events 5 • All patients will be followed for adverse experiences through study completion, an average of 1 year.
Deaths did not occur during study treatment.
|
|
Gastrointestinal disorders
Nausea - Grade 2
|
50.0%
5/10 • Number of events 5 • All patients will be followed for adverse experiences through study completion, an average of 1 year.
Deaths did not occur during study treatment.
|
|
Musculoskeletal and connective tissue disorders
Neck Pain - Grade 1
|
10.0%
1/10 • Number of events 1 • All patients will be followed for adverse experiences through study completion, an average of 1 year.
Deaths did not occur during study treatment.
|
|
General disorders
Neutropenic fever - Grade 1
|
10.0%
1/10 • Number of events 1 • All patients will be followed for adverse experiences through study completion, an average of 1 year.
Deaths did not occur during study treatment.
|
|
Vascular disorders
Orthostatic hypotension - Grade 2
|
10.0%
1/10 • Number of events 1 • All patients will be followed for adverse experiences through study completion, an average of 1 year.
Deaths did not occur during study treatment.
|
|
General disorders
Pain - Grade 2
|
20.0%
2/10 • Number of events 2 • All patients will be followed for adverse experiences through study completion, an average of 1 year.
Deaths did not occur during study treatment.
|
|
Skin and subcutaneous tissue disorders
Pale Skin - Grade 1
|
10.0%
1/10 • Number of events 1 • All patients will be followed for adverse experiences through study completion, an average of 1 year.
Deaths did not occur during study treatment.
|
|
Skin and subcutaneous tissue disorders
Pallor - Grade 1
|
10.0%
1/10 • Number of events 1 • All patients will be followed for adverse experiences through study completion, an average of 1 year.
Deaths did not occur during study treatment.
|
|
Vascular disorders
Parasthesia - Grade 2
|
10.0%
1/10 • Number of events 1 • All patients will be followed for adverse experiences through study completion, an average of 1 year.
Deaths did not occur during study treatment.
|
|
Injury, poisoning and procedural complications
Parotitis - Grade 1
|
10.0%
1/10 • Number of events 1 • All patients will be followed for adverse experiences through study completion, an average of 1 year.
Deaths did not occur during study treatment.
|
|
Musculoskeletal and connective tissue disorders
Pelvic Pain - Grade 1
|
10.0%
1/10 • Number of events 1 • All patients will be followed for adverse experiences through study completion, an average of 1 year.
Deaths did not occur during study treatment.
|
|
Cardiac disorders
Pericardial effusion - Grade 1
|
10.0%
1/10 • Number of events 1 • All patients will be followed for adverse experiences through study completion, an average of 1 year.
Deaths did not occur during study treatment.
|
|
Skin and subcutaneous tissue disorders
Petechiae - Grade 1
|
10.0%
1/10 • Number of events 1 • All patients will be followed for adverse experiences through study completion, an average of 1 year.
Deaths did not occur during study treatment.
|
|
Musculoskeletal and connective tissue disorders
Physical Deconditioning - Grade 2
|
10.0%
1/10 • Number of events 1 • All patients will be followed for adverse experiences through study completion, an average of 1 year.
Deaths did not occur during study treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion - Grade 1
|
10.0%
1/10 • Number of events 1 • All patients will be followed for adverse experiences through study completion, an average of 1 year.
Deaths did not occur during study treatment.
|
|
Metabolism and nutrition disorders
Polydipsia - Grade 1
|
10.0%
1/10 • Number of events 1 • All patients will be followed for adverse experiences through study completion, an average of 1 year.
Deaths did not occur during study treatment.
|
|
Metabolism and nutrition disorders
Polyphagia - Grade 1
|
10.0%
1/10 • Number of events 1 • All patients will be followed for adverse experiences through study completion, an average of 1 year.
Deaths did not occur during study treatment.
|
|
Renal and urinary disorders
Polyuria - Grade 1
|
10.0%
1/10 • Number of events 1 • All patients will be followed for adverse experiences through study completion, an average of 1 year.
Deaths did not occur during study treatment.
|
|
Respiratory, thoracic and mediastinal disorders
post nasal drip - Grade 1
|
10.0%
1/10 • Number of events 1 • All patients will be followed for adverse experiences through study completion, an average of 1 year.
Deaths did not occur during study treatment.
|
|
Skin and subcutaneous tissue disorders
Pruritis - Grade 1
|
10.0%
1/10 • Number of events 1 • All patients will be followed for adverse experiences through study completion, an average of 1 year.
Deaths did not occur during study treatment.
|
|
Vascular disorders
Pulmonary hypertension - Grade 2
|
10.0%
1/10 • Number of events 1 • All patients will be followed for adverse experiences through study completion, an average of 1 year.
Deaths did not occur during study treatment.
|
|
Skin and subcutaneous tissue disorders
Rash - Grade 1
|
20.0%
2/10 • Number of events 2 • All patients will be followed for adverse experiences through study completion, an average of 1 year.
Deaths did not occur during study treatment.
|
|
Skin and subcutaneous tissue disorders
Rash - Grade 2
|
20.0%
2/10 • Number of events 2 • All patients will be followed for adverse experiences through study completion, an average of 1 year.
Deaths did not occur during study treatment.
|
|
Skin and subcutaneous tissue disorders
Rash maculo papular - Grade 1
|
10.0%
1/10 • Number of events 1 • All patients will be followed for adverse experiences through study completion, an average of 1 year.
Deaths did not occur during study treatment.
|
|
Eye disorders
Scleral icterus - Grade 1
|
10.0%
1/10 • Number of events 1 • All patients will be followed for adverse experiences through study completion, an average of 1 year.
Deaths did not occur during study treatment.
|
|
Reproductive system and breast disorders
Scrotal edema - Grade 2
|
10.0%
1/10 • Number of events 1 • All patients will be followed for adverse experiences through study completion, an average of 1 year.
Deaths did not occur during study treatment.
|
|
Reproductive system and breast disorders
Scrotal pain - Grade 2
|
10.0%
1/10 • Number of events 1 • All patients will be followed for adverse experiences through study completion, an average of 1 year.
Deaths did not occur during study treatment.
|
|
Infections and infestations
Sepsis - Grade 3
|
10.0%
1/10 • Number of events 1 • All patients will be followed for adverse experiences through study completion, an average of 1 year.
Deaths did not occur during study treatment.
|
|
Cardiac disorders
Sinus Tachycardia - Grade 1
|
60.0%
6/10 • Number of events 6 • All patients will be followed for adverse experiences through study completion, an average of 1 year.
Deaths did not occur during study treatment.
|
|
Cardiac disorders
Sinus Tachycardia - Grade 2
|
10.0%
1/10 • Number of events 1 • All patients will be followed for adverse experiences through study completion, an average of 1 year.
Deaths did not occur during study treatment.
|
|
Skin and subcutaneous tissue disorders
Skin hyperpigmentation - Grade 1
|
20.0%
2/10 • Number of events 2 • All patients will be followed for adverse experiences through study completion, an average of 1 year.
Deaths did not occur during study treatment.
|
|
Skin and subcutaneous tissue disorders
Skin Peeling - Grade 1
|
10.0%
1/10 • Number of events 1 • All patients will be followed for adverse experiences through study completion, an average of 1 year.
Deaths did not occur during study treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Sleep apnea - Grade 2
|
10.0%
1/10 • Number of events 1 • All patients will be followed for adverse experiences through study completion, an average of 1 year.
Deaths did not occur during study treatment.
|
|
Psychiatric disorders
Somnolence - Grade 1
|
20.0%
2/10 • Number of events 2 • All patients will be followed for adverse experiences through study completion, an average of 1 year.
Deaths did not occur during study treatment.
|
|
Psychiatric disorders
Somnolence - Grade 2
|
10.0%
1/10 • Number of events 1 • All patients will be followed for adverse experiences through study completion, an average of 1 year.
Deaths did not occur during study treatment.
|
|
Cardiac disorders
Supraventicular Tachycardia - Grade 2
|
10.0%
1/10 • Number of events 1 • All patients will be followed for adverse experiences through study completion, an average of 1 year.
Deaths did not occur during study treatment.
|
|
Skin and subcutaneous tissue disorders
Thin Skin - Grade 1
|
10.0%
1/10 • Number of events 1 • All patients will be followed for adverse experiences through study completion, an average of 1 year.
Deaths did not occur during study treatment.
|
|
Blood and lymphatic system disorders
Thromboembolic event - Grade 2
|
10.0%
1/10 • Number of events 1 • All patients will be followed for adverse experiences through study completion, an average of 1 year.
Deaths did not occur during study treatment.
|
|
Eye disorders
Tired vision - Grade 1
|
10.0%
1/10 • Number of events 1 • All patients will be followed for adverse experiences through study completion, an average of 1 year.
Deaths did not occur during study treatment.
|
|
Infections and infestations
Toe infection - Grade 1
|
10.0%
1/10 • Number of events 1 • All patients will be followed for adverse experiences through study completion, an average of 1 year.
Deaths did not occur during study treatment.
|
|
Renal and urinary disorders
Urinary frequency - Grade 1
|
20.0%
2/10 • Number of events 2 • All patients will be followed for adverse experiences through study completion, an average of 1 year.
Deaths did not occur during study treatment.
|
|
Renal and urinary disorders
Urinary frequency - Grade 2
|
20.0%
2/10 • Number of events 2 • All patients will be followed for adverse experiences through study completion, an average of 1 year.
Deaths did not occur during study treatment.
|
|
Renal and urinary disorders
Urinary incontinence - Grade 1
|
10.0%
1/10 • Number of events 1 • All patients will be followed for adverse experiences through study completion, an average of 1 year.
Deaths did not occur during study treatment.
|
|
Renal and urinary disorders
Urinary incontinence - Grade 2
|
20.0%
2/10 • Number of events 2 • All patients will be followed for adverse experiences through study completion, an average of 1 year.
Deaths did not occur during study treatment.
|
|
Renal and urinary disorders
Urinary retention - Grade 1
|
10.0%
1/10 • Number of events 1 • All patients will be followed for adverse experiences through study completion, an average of 1 year.
Deaths did not occur during study treatment.
|
|
Renal and urinary disorders
Urinary retention - Grade 2
|
10.0%
1/10 • Number of events 1 • All patients will be followed for adverse experiences through study completion, an average of 1 year.
Deaths did not occur during study treatment.
|
|
Renal and urinary disorders
Urinary tract pain - Grade 1
|
20.0%
2/10 • Number of events 2 • All patients will be followed for adverse experiences through study completion, an average of 1 year.
Deaths did not occur during study treatment.
|
|
Psychiatric disorders
Vivid Dreams - Grade 1
|
10.0%
1/10 • Number of events 1 • All patients will be followed for adverse experiences through study completion, an average of 1 year.
Deaths did not occur during study treatment.
|
|
General disorders
Voice alteration - Grade 1
|
10.0%
1/10 • Number of events 1 • All patients will be followed for adverse experiences through study completion, an average of 1 year.
Deaths did not occur during study treatment.
|
|
General disorders
Volume overload - Grade 2
|
10.0%
1/10 • Number of events 1 • All patients will be followed for adverse experiences through study completion, an average of 1 year.
Deaths did not occur during study treatment.
|
|
Gastrointestinal disorders
Vomiting - Grade 1
|
70.0%
7/10 • Number of events 7 • All patients will be followed for adverse experiences through study completion, an average of 1 year.
Deaths did not occur during study treatment.
|
|
Gastrointestinal disorders
Vomiting - Grade 2
|
10.0%
1/10 • Number of events 1 • All patients will be followed for adverse experiences through study completion, an average of 1 year.
Deaths did not occur during study treatment.
|
|
Eye disorders
Watering Eyes - Grade 2
|
10.0%
1/10 • Number of events 1 • All patients will be followed for adverse experiences through study completion, an average of 1 year.
Deaths did not occur during study treatment.
|
|
General disorders
Weight Gain - Grade 1
|
10.0%
1/10 • Number of events 1 • All patients will be followed for adverse experiences through study completion, an average of 1 year.
Deaths did not occur during study treatment.
|
|
Metabolism and nutrition disorders
Weight Loss - Grade 1
|
50.0%
5/10 • Number of events 5 • All patients will be followed for adverse experiences through study completion, an average of 1 year.
Deaths did not occur during study treatment.
|
|
Metabolism and nutrition disorders
Weight Loss - Grade 2
|
10.0%
1/10 • Number of events 1 • All patients will be followed for adverse experiences through study completion, an average of 1 year.
Deaths did not occur during study treatment.
|
|
Skin and subcutaneous tissue disorders
Wound - Grade 1
|
10.0%
1/10 • Number of events 1 • All patients will be followed for adverse experiences through study completion, an average of 1 year.
Deaths did not occur during study treatment.
|
|
Nervous system disorders
Light Headedness - Grade 1
|
20.0%
2/10 • Number of events 2 • All patients will be followed for adverse experiences through study completion, an average of 1 year.
Deaths did not occur during study treatment.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place