Trial Outcomes & Findings for Busulfan, Fludarabine Phosphate, and Anti-Thymocyte Globulin Followed By Donor Stem Cell Transplant and Azacitidine in Treating Patients With High-Risk Myelodysplastic Syndrome and Older Patients With Acute Myeloid Leukemia (NCT NCT01168219)
NCT ID: NCT01168219
Last Updated: 2022-08-04
Results Overview
Progression-free survival rate (percentage) at 2 and 5 years is defined as the percentage of patients who are alive and progression free at 2 and 5 years from date of transplantation respectively. AML progression is defined as: * Reappearance of leukemia blast cells in peripheral blood and \> 5% blasts in marrow * If no circulating blasts, but the marrow contains 5-20% blasts, a repeat bone marrow \>= 1 week later with \> 5% blasts * Development of extramedullary leukemia MDS progression is defined as * For patients with \<5% bone marrow blasts: ≥50% increase in blasts to \>5% blasts * For patients with 5-10% bone marrow blasts: ≥50% increase to \>10% blasts * Any of the following: Reappearance of prior documented characteristic cytogenetic abnormality or refractory cytopenias with unequivocal evidence of dysplasia on bone marrow biopsy/aspirate
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
68 participants
Primary outcome timeframe
Up to 5 years
Results posted on
2022-08-04
Participant Flow
From July 2010 and October 2013, a total of 68 participants were recruited to this study.
Participant milestones
| Measure |
Treatment (Chemotherapy and Transplant)
REDUCED-INTENSITY CONDITIONING: Patients receive fludarabine phosphate IV over 30 minutes on days -7 to -3, busulfan IV over 45 minutes on days -6 to -3, and anti-thymocyte globulin IV over 4-10 hours on days -6 to -5 (matched sibling donor \[MSD\]) or -6 to -4 (matched unrelated donor \[MUD\]).
TRANSPLANTATION: Patients undergo allogeneic hematopoietic stem cell transplantation on day 0 or on days 0-1.
GRAFT-VS-HOST DISEASE PROPHYLAXIS: Patients receive tacrolimus PO or IV on days -2 to 90 with taper on days 150-180. Patients also receive methotrexate IV on days 1, 3, 6 (MSD), and 11 (MUD).
CONSOLIDATION: Beginning on day 42, patients receive azacitidine SC or IV on days 1.
|
|---|---|
|
Overall Study
STARTED
|
68
|
|
Overall Study
COMPLETED
|
63
|
|
Overall Study
NOT COMPLETED
|
5
|
Reasons for withdrawal
| Measure |
Treatment (Chemotherapy and Transplant)
REDUCED-INTENSITY CONDITIONING: Patients receive fludarabine phosphate IV over 30 minutes on days -7 to -3, busulfan IV over 45 minutes on days -6 to -3, and anti-thymocyte globulin IV over 4-10 hours on days -6 to -5 (matched sibling donor \[MSD\]) or -6 to -4 (matched unrelated donor \[MUD\]).
TRANSPLANTATION: Patients undergo allogeneic hematopoietic stem cell transplantation on day 0 or on days 0-1.
GRAFT-VS-HOST DISEASE PROPHYLAXIS: Patients receive tacrolimus PO or IV on days -2 to 90 with taper on days 150-180. Patients also receive methotrexate IV on days 1, 3, 6 (MSD), and 11 (MUD).
CONSOLIDATION: Beginning on day 42, patients receive azacitidine SC or IV on days 1.
|
|---|---|
|
Overall Study
off study before starting treatment
|
2
|
|
Overall Study
withdrew before transplant
|
1
|
|
Overall Study
ineligible due to CML
|
2
|
Baseline Characteristics
Busulfan, Fludarabine Phosphate, and Anti-Thymocyte Globulin Followed By Donor Stem Cell Transplant and Azacitidine in Treating Patients With High-Risk Myelodysplastic Syndrome and Older Patients With Acute Myeloid Leukemia
Baseline characteristics by cohort
| Measure |
Treatment (Chemotherapy and Transplant)
n=68 Participants
REDUCED-INTENSITY CONDITIONING: Patients receive fludarabine phosphate IV over 30 minutes on days -7 to -3, busulfan IV over 45 minutes on days -6 to -3, and anti-thymocyte globulin IV over 4-10 hours on days -6 to -5 (matched sibling donor \[MSD\]) or -6 to -4 (matched unrelated donor \[MUD\]).
TRANSPLANTATION: Patients undergo allogeneic hematopoietic stem cell transplantation on day 0 or on days 0-1.
GRAFT-VS-HOST DISEASE PROPHYLAXIS: Patients receive tacrolimus PO or IV on days -2 to 90 with taper on days 150-180. Patients also receive methotrexate IV on days 1, 3, 6 (MSD), and 11 (MUD).
CONSOLIDATION: Beginning on day 42, patients receive azacitidine SC or IV on days 1.
|
|---|---|
|
Age, Continuous
|
62.9 years
n=99 Participants
|
|
Sex: Female, Male
Female
|
15 Participants
n=99 Participants
|
|
Sex: Female, Male
Male
|
53 Participants
n=99 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
3 Participants
n=99 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
61 Participants
n=99 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
4 Participants
n=99 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
1 Participants
n=99 Participants
|
|
Race (NIH/OMB)
Asian
|
2 Participants
n=99 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=99 Participants
|
|
Race (NIH/OMB)
Black or African American
|
1 Participants
n=99 Participants
|
|
Race (NIH/OMB)
White
|
60 Participants
n=99 Participants
|
|
Race (NIH/OMB)
More than one race
|
2 Participants
n=99 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
2 Participants
n=99 Participants
|
|
Region of Enrollment
United States
|
68 Participants
n=99 Participants
|
|
Disease type
Myelodysplastic Syndrome (MDS)
|
24 Participants
n=99 Participants
|
|
Disease type
Acute Myeloid Leukemia (AML)
|
44 Participants
n=99 Participants
|
PRIMARY outcome
Timeframe: Up to 5 yearsPopulation: Patients who received transplant were evaluable for the primary endpoint.
Progression-free survival rate (percentage) at 2 and 5 years is defined as the percentage of patients who are alive and progression free at 2 and 5 years from date of transplantation respectively. AML progression is defined as: * Reappearance of leukemia blast cells in peripheral blood and \> 5% blasts in marrow * If no circulating blasts, but the marrow contains 5-20% blasts, a repeat bone marrow \>= 1 week later with \> 5% blasts * Development of extramedullary leukemia MDS progression is defined as * For patients with \<5% bone marrow blasts: ≥50% increase in blasts to \>5% blasts * For patients with 5-10% bone marrow blasts: ≥50% increase to \>10% blasts * Any of the following: Reappearance of prior documented characteristic cytogenetic abnormality or refractory cytopenias with unequivocal evidence of dysplasia on bone marrow biopsy/aspirate
Outcome measures
| Measure |
Treatment (Chemotherapy and Transplant)
n=63 Participants
REDUCED-INTENSITY CONDITIONING: Patients receive fludarabine phosphate IV over 30 minutes on days -7 to -3, busulfan IV over 45 minutes on days -6 to -3, and anti-thymocyte globulin IV over 4-10 hours on days -6 to -5 (matched sibling donor \[MSD\]) or -6 to -4 (matched unrelated donor \[MUD\]).
TRANSPLANTATION: Patients undergo allogeneic hematopoietic stem cell transplantation on day 0 or on days 0-1.
GRAFT-VS-HOST DISEASE PROPHYLAXIS: Patients receive tacrolimus PO or IV on days -2 to 90 with taper on days 150-180. Patients also receive methotrexate IV on days 1, 3, 6 (MSD), and 11 (MUD).
CONSOLIDATION: Beginning on day 42, patients receive azacitidine SC or IV on days 1.
|
|---|---|
|
Progression-free Survival
PFS at 2 years
|
41.2 percentage of patients
Interval 33.9 to 49.9
|
|
Progression-free Survival
PFS at 5 years
|
26.9 percentage of patients
Interval 20.4 to 35.5
|
SECONDARY outcome
Timeframe: Up to 5 yearsPopulation: Patients who received transplant were evaluable for this endpoint.
Overall survival rate (percentage) at 2 and 5 years is defined as the percentage of patients who are still alive 2 and 5 years after date of transplantation respectively. Estimated using the Kaplan-Meier product limit estimator.
Outcome measures
| Measure |
Treatment (Chemotherapy and Transplant)
n=63 Participants
REDUCED-INTENSITY CONDITIONING: Patients receive fludarabine phosphate IV over 30 minutes on days -7 to -3, busulfan IV over 45 minutes on days -6 to -3, and anti-thymocyte globulin IV over 4-10 hours on days -6 to -5 (matched sibling donor \[MSD\]) or -6 to -4 (matched unrelated donor \[MUD\]).
TRANSPLANTATION: Patients undergo allogeneic hematopoietic stem cell transplantation on day 0 or on days 0-1.
GRAFT-VS-HOST DISEASE PROPHYLAXIS: Patients receive tacrolimus PO or IV on days -2 to 90 with taper on days 150-180. Patients also receive methotrexate IV on days 1, 3, 6 (MSD), and 11 (MUD).
CONSOLIDATION: Beginning on day 42, patients receive azacitidine SC or IV on days 1.
|
|---|---|
|
Overall Survival (OS)
OS at 2 years
|
45.7 percentage of patients
Interval 34.9 to 59.9
|
|
Overall Survival (OS)
OS at 5 years
|
31.2 percentage of patients
Interval 21.3 to 45.8
|
SECONDARY outcome
Timeframe: Up to 100 days post-treatmentPopulation: Patients who received transplant and died are included in this analysis.
The number of death reported within the first 100 days after transplant.
Outcome measures
| Measure |
Treatment (Chemotherapy and Transplant)
n=63 Participants
REDUCED-INTENSITY CONDITIONING: Patients receive fludarabine phosphate IV over 30 minutes on days -7 to -3, busulfan IV over 45 minutes on days -6 to -3, and anti-thymocyte globulin IV over 4-10 hours on days -6 to -5 (matched sibling donor \[MSD\]) or -6 to -4 (matched unrelated donor \[MUD\]).
TRANSPLANTATION: Patients undergo allogeneic hematopoietic stem cell transplantation on day 0 or on days 0-1.
GRAFT-VS-HOST DISEASE PROPHYLAXIS: Patients receive tacrolimus PO or IV on days -2 to 90 with taper on days 150-180. Patients also receive methotrexate IV on days 1, 3, 6 (MSD), and 11 (MUD).
CONSOLIDATION: Beginning on day 42, patients receive azacitidine SC or IV on days 1.
|
|---|---|
|
100-day Mortality
|
10 Participants
|
Adverse Events
Treatment (Chemotherapy and Transplant)
Serious events: 22 serious events
Other events: 61 other events
Deaths: 42 deaths
Serious adverse events
| Measure |
Treatment (Chemotherapy and Transplant)
n=66 participants at risk
REDUCED-INTENSITY CONDITIONING: Patients receive fludarabine phosphate IV over 30 minutes on days -7 to -3, busulfan IV over 45 minutes on days -6 to -3, and anti-thymocyte globulin IV over 4-10 hours on days -6 to -5 (matched sibling donor \[MSD\]) or -6 to -4 (matched unrelated donor \[MUD\]).
TRANSPLANTATION: Patients undergo allogeneic hematopoietic stem cell transplantation on day 0 or on days 0-1.
GRAFT-VS-HOST DISEASE PROPHYLAXIS: Patients receive tacrolimus PO or IV on days -2 to 90 with taper on days 150-180. Patients also receive methotrexate IV on days 1, 3, 6 (MSD), and 11 (MUD).
CONSOLIDATION: Beginning on day 42, patients receive azacitidine SC or IV on days 1.
|
|---|---|
|
Blood and lymphatic system disorders
Anemia
|
27.3%
18/66 • Number of events 19
2 patients who cancelled prior to receiving any study treatment are excluded from this analysis
|
|
Blood and lymphatic system disorders
Blood and lymphatic system disorders - Other, specify
|
1.5%
1/66 • Number of events 1
2 patients who cancelled prior to receiving any study treatment are excluded from this analysis
|
|
Blood and lymphatic system disorders
Disseminated intravascular coagulation
|
1.5%
1/66 • Number of events 1
2 patients who cancelled prior to receiving any study treatment are excluded from this analysis
|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
4.5%
3/66 • Number of events 3
2 patients who cancelled prior to receiving any study treatment are excluded from this analysis
|
|
Cardiac disorders
Atrial fibrillation
|
4.5%
3/66 • Number of events 3
2 patients who cancelled prior to receiving any study treatment are excluded from this analysis
|
|
Cardiac disorders
Cardiac arrest
|
3.0%
2/66 • Number of events 2
2 patients who cancelled prior to receiving any study treatment are excluded from this analysis
|
|
Cardiac disorders
Conduction disorder
|
1.5%
1/66 • Number of events 1
2 patients who cancelled prior to receiving any study treatment are excluded from this analysis
|
|
Cardiac disorders
Heart failure
|
3.0%
2/66 • Number of events 2
2 patients who cancelled prior to receiving any study treatment are excluded from this analysis
|
|
Cardiac disorders
Left ventricular systolic dysfunction
|
1.5%
1/66 • Number of events 1
2 patients who cancelled prior to receiving any study treatment are excluded from this analysis
|
|
Cardiac disorders
Sinus bradycardia
|
6.1%
4/66 • Number of events 4
2 patients who cancelled prior to receiving any study treatment are excluded from this analysis
|
|
Cardiac disorders
Sinus tachycardia
|
10.6%
7/66 • Number of events 7
2 patients who cancelled prior to receiving any study treatment are excluded from this analysis
|
|
Cardiac disorders
Supraventricular tachycardia
|
1.5%
1/66 • Number of events 1
2 patients who cancelled prior to receiving any study treatment are excluded from this analysis
|
|
Ear and labyrinth disorders
Ear and labyrinth disorders - Other, specify
|
1.5%
1/66 • Number of events 1
2 patients who cancelled prior to receiving any study treatment are excluded from this analysis
|
|
Ear and labyrinth disorders
Ear pain
|
4.5%
3/66 • Number of events 3
2 patients who cancelled prior to receiving any study treatment are excluded from this analysis
|
|
Ear and labyrinth disorders
Hearing impaired
|
1.5%
1/66 • Number of events 1
2 patients who cancelled prior to receiving any study treatment are excluded from this analysis
|
|
Endocrine disorders
Cushingoid
|
1.5%
1/66 • Number of events 1
2 patients who cancelled prior to receiving any study treatment are excluded from this analysis
|
|
Endocrine disorders
Growth accelerated
|
1.5%
1/66 • Number of events 1
2 patients who cancelled prior to receiving any study treatment are excluded from this analysis
|
|
Eye disorders
Blurred vision
|
1.5%
1/66 • Number of events 1
2 patients who cancelled prior to receiving any study treatment are excluded from this analysis
|
|
Eye disorders
Cataract
|
1.5%
1/66 • Number of events 1
2 patients who cancelled prior to receiving any study treatment are excluded from this analysis
|
|
Eye disorders
Dry eye
|
1.5%
1/66 • Number of events 1
2 patients who cancelled prior to receiving any study treatment are excluded from this analysis
|
|
Eye disorders
Eye disorders - Other, specify
|
6.1%
4/66 • Number of events 4
2 patients who cancelled prior to receiving any study treatment are excluded from this analysis
|
|
Eye disorders
Scleral disorder
|
1.5%
1/66 • Number of events 1
2 patients who cancelled prior to receiving any study treatment are excluded from this analysis
|
|
Eye disorders
Vitreous hemorrhage
|
1.5%
1/66 • Number of events 1
2 patients who cancelled prior to receiving any study treatment are excluded from this analysis
|
|
Gastrointestinal disorders
Abdominal distension
|
3.0%
2/66 • Number of events 2
2 patients who cancelled prior to receiving any study treatment are excluded from this analysis
|
|
Gastrointestinal disorders
Abdominal pain
|
10.6%
7/66 • Number of events 7
2 patients who cancelled prior to receiving any study treatment are excluded from this analysis
|
|
Gastrointestinal disorders
Ascites
|
1.5%
1/66 • Number of events 1
2 patients who cancelled prior to receiving any study treatment are excluded from this analysis
|
|
Gastrointestinal disorders
Constipation
|
7.6%
5/66 • Number of events 5
2 patients who cancelled prior to receiving any study treatment are excluded from this analysis
|
|
Gastrointestinal disorders
Diarrhea
|
18.2%
12/66 • Number of events 13
2 patients who cancelled prior to receiving any study treatment are excluded from this analysis
|
|
Gastrointestinal disorders
Dry mouth
|
6.1%
4/66 • Number of events 4
2 patients who cancelled prior to receiving any study treatment are excluded from this analysis
|
|
Gastrointestinal disorders
Dyspepsia
|
3.0%
2/66 • Number of events 2
2 patients who cancelled prior to receiving any study treatment are excluded from this analysis
|
|
Gastrointestinal disorders
Enterocolitis
|
1.5%
1/66 • Number of events 1
2 patients who cancelled prior to receiving any study treatment are excluded from this analysis
|
|
Gastrointestinal disorders
Esophagitis
|
1.5%
1/66 • Number of events 1
2 patients who cancelled prior to receiving any study treatment are excluded from this analysis
|
|
Gastrointestinal disorders
Fecal incontinence
|
4.5%
3/66 • Number of events 3
2 patients who cancelled prior to receiving any study treatment are excluded from this analysis
|
|
Gastrointestinal disorders
Gastrointestinal disorders - Other, specify
|
9.1%
6/66 • Number of events 7
2 patients who cancelled prior to receiving any study treatment are excluded from this analysis
|
|
Gastrointestinal disorders
Hemorrhoids
|
4.5%
3/66 • Number of events 3
2 patients who cancelled prior to receiving any study treatment are excluded from this analysis
|
|
Gastrointestinal disorders
Intra-abdominal hemorrhage
|
1.5%
1/66 • Number of events 1
2 patients who cancelled prior to receiving any study treatment are excluded from this analysis
|
|
Gastrointestinal disorders
Lower gastrointestinal hemorrhage
|
1.5%
1/66 • Number of events 1
2 patients who cancelled prior to receiving any study treatment are excluded from this analysis
|
|
Gastrointestinal disorders
Mucositis oral
|
6.1%
4/66 • Number of events 4
2 patients who cancelled prior to receiving any study treatment are excluded from this analysis
|
|
Gastrointestinal disorders
Nausea
|
16.7%
11/66 • Number of events 13
2 patients who cancelled prior to receiving any study treatment are excluded from this analysis
|
|
Gastrointestinal disorders
Oral hemorrhage
|
1.5%
1/66 • Number of events 1
2 patients who cancelled prior to receiving any study treatment are excluded from this analysis
|
|
Gastrointestinal disorders
Oral pain
|
1.5%
1/66 • Number of events 1
2 patients who cancelled prior to receiving any study treatment are excluded from this analysis
|
|
Gastrointestinal disorders
Rectal hemorrhage
|
1.5%
1/66 • Number of events 1
2 patients who cancelled prior to receiving any study treatment are excluded from this analysis
|
|
Gastrointestinal disorders
Rectal pain
|
1.5%
1/66 • Number of events 1
2 patients who cancelled prior to receiving any study treatment are excluded from this analysis
|
|
Gastrointestinal disorders
Vomiting
|
12.1%
8/66 • Number of events 9
2 patients who cancelled prior to receiving any study treatment are excluded from this analysis
|
|
General disorders
Chills
|
6.1%
4/66 • Number of events 4
2 patients who cancelled prior to receiving any study treatment are excluded from this analysis
|
|
General disorders
Death NOS
|
1.5%
1/66 • Number of events 1
2 patients who cancelled prior to receiving any study treatment are excluded from this analysis
|
|
General disorders
Edema face
|
3.0%
2/66 • Number of events 2
2 patients who cancelled prior to receiving any study treatment are excluded from this analysis
|
|
General disorders
Edema limbs
|
15.2%
10/66 • Number of events 12
2 patients who cancelled prior to receiving any study treatment are excluded from this analysis
|
|
General disorders
Edema trunk
|
4.5%
3/66 • Number of events 3
2 patients who cancelled prior to receiving any study treatment are excluded from this analysis
|
|
General disorders
Fatigue
|
18.2%
12/66 • Number of events 13
2 patients who cancelled prior to receiving any study treatment are excluded from this analysis
|
|
General disorders
Fever
|
3.0%
2/66 • Number of events 2
2 patients who cancelled prior to receiving any study treatment are excluded from this analysis
|
|
General disorders
General disorders and administration site conditions - Other, specify
|
3.0%
2/66 • Number of events 2
2 patients who cancelled prior to receiving any study treatment are excluded from this analysis
|
|
General disorders
Hypothermia
|
1.5%
1/66 • Number of events 1
2 patients who cancelled prior to receiving any study treatment are excluded from this analysis
|
|
General disorders
Localized edema
|
1.5%
1/66 • Number of events 1
2 patients who cancelled prior to receiving any study treatment are excluded from this analysis
|
|
General disorders
Malaise
|
3.0%
2/66 • Number of events 2
2 patients who cancelled prior to receiving any study treatment are excluded from this analysis
|
|
General disorders
Non-cardiac chest pain
|
1.5%
1/66 • Number of events 2
2 patients who cancelled prior to receiving any study treatment are excluded from this analysis
|
|
General disorders
Pain
|
4.5%
3/66 • Number of events 3
2 patients who cancelled prior to receiving any study treatment are excluded from this analysis
|
|
Hepatobiliary disorders
Cholecystitis
|
1.5%
1/66 • Number of events 1
2 patients who cancelled prior to receiving any study treatment are excluded from this analysis
|
|
Hepatobiliary disorders
Hepatic failure
|
3.0%
2/66 • Number of events 2
2 patients who cancelled prior to receiving any study treatment are excluded from this analysis
|
|
Hepatobiliary disorders
Hepatic hemorrhage
|
1.5%
1/66 • Number of events 1
2 patients who cancelled prior to receiving any study treatment are excluded from this analysis
|
|
Hepatobiliary disorders
Portal vein thrombosis
|
1.5%
1/66 • Number of events 1
2 patients who cancelled prior to receiving any study treatment are excluded from this analysis
|
|
Infections and infestations
Catheter related infection
|
1.5%
1/66 • Number of events 1
2 patients who cancelled prior to receiving any study treatment are excluded from this analysis
|
|
Infections and infestations
Enterocolitis infectious
|
1.5%
1/66 • Number of events 1
2 patients who cancelled prior to receiving any study treatment are excluded from this analysis
|
|
Infections and infestations
Infections and infestations - Other, specify
|
9.1%
6/66 • Number of events 6
2 patients who cancelled prior to receiving any study treatment are excluded from this analysis
|
|
Infections and infestations
Lung infection
|
9.1%
6/66 • Number of events 7
2 patients who cancelled prior to receiving any study treatment are excluded from this analysis
|
|
Infections and infestations
Mucosal infection
|
3.0%
2/66 • Number of events 2
2 patients who cancelled prior to receiving any study treatment are excluded from this analysis
|
|
Infections and infestations
Sepsis
|
6.1%
4/66 • Number of events 4
2 patients who cancelled prior to receiving any study treatment are excluded from this analysis
|
|
Infections and infestations
Sinusitis
|
1.5%
1/66 • Number of events 1
2 patients who cancelled prior to receiving any study treatment are excluded from this analysis
|
|
Infections and infestations
Upper respiratory infection
|
1.5%
1/66 • Number of events 1
2 patients who cancelled prior to receiving any study treatment are excluded from this analysis
|
|
Infections and infestations
Urinary tract infection
|
1.5%
1/66 • Number of events 1
2 patients who cancelled prior to receiving any study treatment are excluded from this analysis
|
|
Injury, poisoning and procedural complications
Bruising
|
6.1%
4/66 • Number of events 4
2 patients who cancelled prior to receiving any study treatment are excluded from this analysis
|
|
Injury, poisoning and procedural complications
Fall
|
3.0%
2/66 • Number of events 2
2 patients who cancelled prior to receiving any study treatment are excluded from this analysis
|
|
Investigations
Activated partial thromboplastin time prolonged
|
7.6%
5/66 • Number of events 5
2 patients who cancelled prior to receiving any study treatment are excluded from this analysis
|
|
Investigations
Alanine aminotransferase increased
|
16.7%
11/66 • Number of events 11
2 patients who cancelled prior to receiving any study treatment are excluded from this analysis
|
|
Investigations
Alkaline phosphatase increased
|
15.2%
10/66 • Number of events 10
2 patients who cancelled prior to receiving any study treatment are excluded from this analysis
|
|
Investigations
Aspartate aminotransferase increased
|
16.7%
11/66 • Number of events 11
2 patients who cancelled prior to receiving any study treatment are excluded from this analysis
|
|
Investigations
Blood bilirubin increased
|
10.6%
7/66 • Number of events 7
2 patients who cancelled prior to receiving any study treatment are excluded from this analysis
|
|
Investigations
Cholesterol high
|
1.5%
1/66 • Number of events 1
2 patients who cancelled prior to receiving any study treatment are excluded from this analysis
|
|
Investigations
Creatinine increased
|
15.2%
10/66 • Number of events 11
2 patients who cancelled prior to receiving any study treatment are excluded from this analysis
|
|
Investigations
Ejection fraction decreased
|
1.5%
1/66 • Number of events 1
2 patients who cancelled prior to receiving any study treatment are excluded from this analysis
|
|
Investigations
Electrocardiogram QT corrected interval prolonged
|
1.5%
1/66 • Number of events 1
2 patients who cancelled prior to receiving any study treatment are excluded from this analysis
|
|
Investigations
Fibrinogen decreased
|
3.0%
2/66 • Number of events 2
2 patients who cancelled prior to receiving any study treatment are excluded from this analysis
|
|
Investigations
INR increased
|
4.5%
3/66 • Number of events 3
2 patients who cancelled prior to receiving any study treatment are excluded from this analysis
|
|
Investigations
Investigations - Other, specify
|
4.5%
3/66 • Number of events 9
2 patients who cancelled prior to receiving any study treatment are excluded from this analysis
|
|
Investigations
Lymphocyte count decreased
|
7.6%
5/66 • Number of events 5
2 patients who cancelled prior to receiving any study treatment are excluded from this analysis
|
|
Investigations
Neutrophil count decreased
|
15.2%
10/66 • Number of events 11
2 patients who cancelled prior to receiving any study treatment are excluded from this analysis
|
|
Investigations
Platelet count decreased
|
24.2%
16/66 • Number of events 17
2 patients who cancelled prior to receiving any study treatment are excluded from this analysis
|
|
Investigations
Weight gain
|
1.5%
1/66 • Number of events 1
2 patients who cancelled prior to receiving any study treatment are excluded from this analysis
|
|
Investigations
Weight loss
|
7.6%
5/66 • Number of events 7
2 patients who cancelled prior to receiving any study treatment are excluded from this analysis
|
|
Investigations
White blood cell decreased
|
12.1%
8/66 • Number of events 8
2 patients who cancelled prior to receiving any study treatment are excluded from this analysis
|
|
Metabolism and nutrition disorders
Acidosis
|
4.5%
3/66 • Number of events 4
2 patients who cancelled prior to receiving any study treatment are excluded from this analysis
|
|
Metabolism and nutrition disorders
Alkalosis
|
3.0%
2/66 • Number of events 2
2 patients who cancelled prior to receiving any study treatment are excluded from this analysis
|
|
Metabolism and nutrition disorders
Anorexia
|
13.6%
9/66 • Number of events 9
2 patients who cancelled prior to receiving any study treatment are excluded from this analysis
|
|
Metabolism and nutrition disorders
Dehydration
|
1.5%
1/66 • Number of events 1
2 patients who cancelled prior to receiving any study treatment are excluded from this analysis
|
|
Metabolism and nutrition disorders
Hypercalcemia
|
1.5%
1/66 • Number of events 1
2 patients who cancelled prior to receiving any study treatment are excluded from this analysis
|
|
Metabolism and nutrition disorders
Hyperglycemia
|
21.2%
14/66 • Number of events 15
2 patients who cancelled prior to receiving any study treatment are excluded from this analysis
|
|
Metabolism and nutrition disorders
Hyperkalemia
|
7.6%
5/66 • Number of events 5
2 patients who cancelled prior to receiving any study treatment are excluded from this analysis
|
|
Metabolism and nutrition disorders
Hypermagnesemia
|
1.5%
1/66 • Number of events 1
2 patients who cancelled prior to receiving any study treatment are excluded from this analysis
|
|
Metabolism and nutrition disorders
Hypernatremia
|
4.5%
3/66 • Number of events 3
2 patients who cancelled prior to receiving any study treatment are excluded from this analysis
|
|
Metabolism and nutrition disorders
Hypertriglyceridemia
|
1.5%
1/66 • Number of events 1
2 patients who cancelled prior to receiving any study treatment are excluded from this analysis
|
|
Metabolism and nutrition disorders
Hyperuricemia
|
1.5%
1/66 • Number of events 1
2 patients who cancelled prior to receiving any study treatment are excluded from this analysis
|
|
Metabolism and nutrition disorders
Hypoalbuminemia
|
15.2%
10/66 • Number of events 11
2 patients who cancelled prior to receiving any study treatment are excluded from this analysis
|
|
Metabolism and nutrition disorders
Hypocalcemia
|
10.6%
7/66 • Number of events 8
2 patients who cancelled prior to receiving any study treatment are excluded from this analysis
|
|
Metabolism and nutrition disorders
Hypoglycemia
|
4.5%
3/66 • Number of events 3
2 patients who cancelled prior to receiving any study treatment are excluded from this analysis
|
|
Metabolism and nutrition disorders
Hypokalemia
|
6.1%
4/66 • Number of events 4
2 patients who cancelled prior to receiving any study treatment are excluded from this analysis
|
|
Metabolism and nutrition disorders
Hypomagnesemia
|
16.7%
11/66 • Number of events 12
2 patients who cancelled prior to receiving any study treatment are excluded from this analysis
|
|
Metabolism and nutrition disorders
Hyponatremia
|
13.6%
9/66 • Number of events 10
2 patients who cancelled prior to receiving any study treatment are excluded from this analysis
|
|
Metabolism and nutrition disorders
Hypophosphatemia
|
7.6%
5/66 • Number of events 5
2 patients who cancelled prior to receiving any study treatment are excluded from this analysis
|
|
Metabolism and nutrition disorders
Metabolism and nutrition disorders - Other, specify
|
9.1%
6/66 • Number of events 8
2 patients who cancelled prior to receiving any study treatment are excluded from this analysis
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
6.1%
4/66 • Number of events 4
2 patients who cancelled prior to receiving any study treatment are excluded from this analysis
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
4.5%
3/66 • Number of events 3
2 patients who cancelled prior to receiving any study treatment are excluded from this analysis
|
|
Musculoskeletal and connective tissue disorders
Generalized muscle weakness
|
7.6%
5/66 • Number of events 6
2 patients who cancelled prior to receiving any study treatment are excluded from this analysis
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal and connective tissue disorder - Other, specify
|
1.5%
1/66 • Number of events 1
2 patients who cancelled prior to receiving any study treatment are excluded from this analysis
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
3.0%
2/66 • Number of events 2
2 patients who cancelled prior to receiving any study treatment are excluded from this analysis
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
4.5%
3/66 • Number of events 4
2 patients who cancelled prior to receiving any study treatment are excluded from this analysis
|
|
Musculoskeletal and connective tissue disorders
Soft tissue necrosis lower limb
|
1.5%
1/66 • Number of events 1
2 patients who cancelled prior to receiving any study treatment are excluded from this analysis
|
|
Musculoskeletal and connective tissue disorders
Soft tissue necrosis upper limb
|
1.5%
1/66 • Number of events 1
2 patients who cancelled prior to receiving any study treatment are excluded from this analysis
|
|
Nervous system disorders
Akathisia
|
1.5%
1/66 • Number of events 1
2 patients who cancelled prior to receiving any study treatment are excluded from this analysis
|
|
Nervous system disorders
Depressed level of consciousness
|
3.0%
2/66 • Number of events 2
2 patients who cancelled prior to receiving any study treatment are excluded from this analysis
|
|
Nervous system disorders
Dizziness
|
3.0%
2/66 • Number of events 2
2 patients who cancelled prior to receiving any study treatment are excluded from this analysis
|
|
Nervous system disorders
Dysgeusia
|
9.1%
6/66 • Number of events 6
2 patients who cancelled prior to receiving any study treatment are excluded from this analysis
|
|
Nervous system disorders
Encephalopathy
|
1.5%
1/66 • Number of events 1
2 patients who cancelled prior to receiving any study treatment are excluded from this analysis
|
|
Nervous system disorders
Extrapyramidal disorder
|
1.5%
1/66 • Number of events 1
2 patients who cancelled prior to receiving any study treatment are excluded from this analysis
|
|
Nervous system disorders
Headache
|
3.0%
2/66 • Number of events 2
2 patients who cancelled prior to receiving any study treatment are excluded from this analysis
|
|
Nervous system disorders
Hypersomnia
|
1.5%
1/66 • Number of events 1
2 patients who cancelled prior to receiving any study treatment are excluded from this analysis
|
|
Nervous system disorders
Lethargy
|
1.5%
1/66 • Number of events 1
2 patients who cancelled prior to receiving any study treatment are excluded from this analysis
|
|
Nervous system disorders
Neuralgia
|
1.5%
1/66 • Number of events 1
2 patients who cancelled prior to receiving any study treatment are excluded from this analysis
|
|
Nervous system disorders
Paresthesia
|
1.5%
1/66 • Number of events 1
2 patients who cancelled prior to receiving any study treatment are excluded from this analysis
|
|
Nervous system disorders
Peripheral sensory neuropathy
|
4.5%
3/66 • Number of events 3
2 patients who cancelled prior to receiving any study treatment are excluded from this analysis
|
|
Nervous system disorders
Presyncope
|
1.5%
1/66 • Number of events 1
2 patients who cancelled prior to receiving any study treatment are excluded from this analysis
|
|
Nervous system disorders
Sinus pain
|
1.5%
1/66 • Number of events 1
2 patients who cancelled prior to receiving any study treatment are excluded from this analysis
|
|
Nervous system disorders
Somnolence
|
1.5%
1/66 • Number of events 1
2 patients who cancelled prior to receiving any study treatment are excluded from this analysis
|
|
Nervous system disorders
Syncope
|
1.5%
1/66 • Number of events 1
2 patients who cancelled prior to receiving any study treatment are excluded from this analysis
|
|
Nervous system disorders
Tremor
|
1.5%
1/66 • Number of events 1
2 patients who cancelled prior to receiving any study treatment are excluded from this analysis
|
|
Psychiatric disorders
Anxiety
|
6.1%
4/66 • Number of events 4
2 patients who cancelled prior to receiving any study treatment are excluded from this analysis
|
|
Psychiatric disorders
Confusion
|
3.0%
2/66 • Number of events 2
2 patients who cancelled prior to receiving any study treatment are excluded from this analysis
|
|
Psychiatric disorders
Delirium
|
1.5%
1/66 • Number of events 1
2 patients who cancelled prior to receiving any study treatment are excluded from this analysis
|
|
Psychiatric disorders
Depression
|
4.5%
3/66 • Number of events 3
2 patients who cancelled prior to receiving any study treatment are excluded from this analysis
|
|
Psychiatric disorders
Hallucinations
|
1.5%
1/66 • Number of events 1
2 patients who cancelled prior to receiving any study treatment are excluded from this analysis
|
|
Psychiatric disorders
Insomnia
|
6.1%
4/66 • Number of events 4
2 patients who cancelled prior to receiving any study treatment are excluded from this analysis
|
|
Psychiatric disorders
Psychiatric disorders - Other, specify
|
1.5%
1/66 • Number of events 1
2 patients who cancelled prior to receiving any study treatment are excluded from this analysis
|
|
Renal and urinary disorders
Acute kidney injury
|
6.1%
4/66 • Number of events 4
2 patients who cancelled prior to receiving any study treatment are excluded from this analysis
|
|
Renal and urinary disorders
Chronic kidney disease
|
3.0%
2/66 • Number of events 2
2 patients who cancelled prior to receiving any study treatment are excluded from this analysis
|
|
Renal and urinary disorders
Hematuria
|
1.5%
1/66 • Number of events 1
2 patients who cancelled prior to receiving any study treatment are excluded from this analysis
|
|
Renal and urinary disorders
Renal and urinary disorders - Other, specify
|
3.0%
2/66 • Number of events 2
2 patients who cancelled prior to receiving any study treatment are excluded from this analysis
|
|
Renal and urinary disorders
Urinary frequency
|
1.5%
1/66 • Number of events 1
2 patients who cancelled prior to receiving any study treatment are excluded from this analysis
|
|
Renal and urinary disorders
Urinary incontinence
|
1.5%
1/66 • Number of events 1
2 patients who cancelled prior to receiving any study treatment are excluded from this analysis
|
|
Renal and urinary disorders
Urinary retention
|
1.5%
1/66 • Number of events 1
2 patients who cancelled prior to receiving any study treatment are excluded from this analysis
|
|
Respiratory, thoracic and mediastinal disorders
Atelectasis
|
4.5%
3/66 • Number of events 3
2 patients who cancelled prior to receiving any study treatment are excluded from this analysis
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
9.1%
6/66 • Number of events 6
2 patients who cancelled prior to receiving any study treatment are excluded from this analysis
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
12.1%
8/66 • Number of events 8
2 patients who cancelled prior to receiving any study treatment are excluded from this analysis
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
4.5%
3/66 • Number of events 3
2 patients who cancelled prior to receiving any study treatment are excluded from this analysis
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
10.6%
7/66 • Number of events 8
2 patients who cancelled prior to receiving any study treatment are excluded from this analysis
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
4.5%
3/66 • Number of events 3
2 patients who cancelled prior to receiving any study treatment are excluded from this analysis
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
3.0%
2/66 • Number of events 2
2 patients who cancelled prior to receiving any study treatment are excluded from this analysis
|
|
Respiratory, thoracic and mediastinal disorders
Pleural hemorrhage
|
1.5%
1/66 • Number of events 1
2 patients who cancelled prior to receiving any study treatment are excluded from this analysis
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonitis
|
4.5%
3/66 • Number of events 3
2 patients who cancelled prior to receiving any study treatment are excluded from this analysis
|
|
Respiratory, thoracic and mediastinal disorders
Pneumothorax
|
4.5%
3/66 • Number of events 3
2 patients who cancelled prior to receiving any study treatment are excluded from this analysis
|
|
Respiratory, thoracic and mediastinal disorders
Postnasal drip
|
1.5%
1/66 • Number of events 1
2 patients who cancelled prior to receiving any study treatment are excluded from this analysis
|
|
Respiratory, thoracic and mediastinal disorders
Productive cough
|
3.0%
2/66 • Number of events 2
2 patients who cancelled prior to receiving any study treatment are excluded from this analysis
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary fibrosis
|
1.5%
1/66 • Number of events 1
2 patients who cancelled prior to receiving any study treatment are excluded from this analysis
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary hypertension
|
1.5%
1/66 • Number of events 1
2 patients who cancelled prior to receiving any study treatment are excluded from this analysis
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure
|
7.6%
5/66 • Number of events 5
2 patients who cancelled prior to receiving any study treatment are excluded from this analysis
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory, thoracic and mediastinal disorders - Other, specify
|
4.5%
3/66 • Number of events 5
2 patients who cancelled prior to receiving any study treatment are excluded from this analysis
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
6.1%
4/66 • Number of events 4
2 patients who cancelled prior to receiving any study treatment are excluded from this analysis
|
|
Skin and subcutaneous tissue disorders
Nail loss
|
1.5%
1/66 • Number of events 1
2 patients who cancelled prior to receiving any study treatment are excluded from this analysis
|
|
Skin and subcutaneous tissue disorders
Pain of skin
|
4.5%
3/66 • Number of events 3
2 patients who cancelled prior to receiving any study treatment are excluded from this analysis
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
7.6%
5/66 • Number of events 6
2 patients who cancelled prior to receiving any study treatment are excluded from this analysis
|
|
Skin and subcutaneous tissue disorders
Skin and subcutaneous tissue disorders - Other, specify
|
4.5%
3/66 • Number of events 9
2 patients who cancelled prior to receiving any study treatment are excluded from this analysis
|
|
Skin and subcutaneous tissue disorders
Skin hypopigmentation
|
1.5%
1/66 • Number of events 1
2 patients who cancelled prior to receiving any study treatment are excluded from this analysis
|
|
Skin and subcutaneous tissue disorders
Skin ulceration
|
1.5%
1/66 • Number of events 1
2 patients who cancelled prior to receiving any study treatment are excluded from this analysis
|
|
Surgical and medical procedures
Surgical and medical procedures - Other, specify
|
1.5%
1/66 • Number of events 1
2 patients who cancelled prior to receiving any study treatment are excluded from this analysis
|
|
Vascular disorders
Flushing
|
1.5%
1/66 • Number of events 1
2 patients who cancelled prior to receiving any study treatment are excluded from this analysis
|
|
Vascular disorders
Hot flashes
|
1.5%
1/66 • Number of events 1
2 patients who cancelled prior to receiving any study treatment are excluded from this analysis
|
|
Vascular disorders
Hypertension
|
13.6%
9/66 • Number of events 9
2 patients who cancelled prior to receiving any study treatment are excluded from this analysis
|
|
Vascular disorders
Hypotension
|
15.2%
10/66 • Number of events 12
2 patients who cancelled prior to receiving any study treatment are excluded from this analysis
|
|
Vascular disorders
Thromboembolic event
|
4.5%
3/66 • Number of events 3
2 patients who cancelled prior to receiving any study treatment are excluded from this analysis
|
Other adverse events
| Measure |
Treatment (Chemotherapy and Transplant)
n=66 participants at risk
REDUCED-INTENSITY CONDITIONING: Patients receive fludarabine phosphate IV over 30 minutes on days -7 to -3, busulfan IV over 45 minutes on days -6 to -3, and anti-thymocyte globulin IV over 4-10 hours on days -6 to -5 (matched sibling donor \[MSD\]) or -6 to -4 (matched unrelated donor \[MUD\]).
TRANSPLANTATION: Patients undergo allogeneic hematopoietic stem cell transplantation on day 0 or on days 0-1.
GRAFT-VS-HOST DISEASE PROPHYLAXIS: Patients receive tacrolimus PO or IV on days -2 to 90 with taper on days 150-180. Patients also receive methotrexate IV on days 1, 3, 6 (MSD), and 11 (MUD).
CONSOLIDATION: Beginning on day 42, patients receive azacitidine SC or IV on days 1.
|
|---|---|
|
Blood and lymphatic system disorders
Anemia
|
87.9%
58/66 • Number of events 219
2 patients who cancelled prior to receiving any study treatment are excluded from this analysis
|
|
Blood and lymphatic system disorders
Blood and lymphatic system disorders - Other, specify
|
3.0%
2/66 • Number of events 3
2 patients who cancelled prior to receiving any study treatment are excluded from this analysis
|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
31.8%
21/66 • Number of events 24
2 patients who cancelled prior to receiving any study treatment are excluded from this analysis
|
|
Blood and lymphatic system disorders
Hemolysis
|
1.5%
1/66 • Number of events 5
2 patients who cancelled prior to receiving any study treatment are excluded from this analysis
|
|
Blood and lymphatic system disorders
Leukocytosis
|
6.1%
4/66 • Number of events 5
2 patients who cancelled prior to receiving any study treatment are excluded from this analysis
|
|
Blood and lymphatic system disorders
Thrombotic thrombocytopenic purpura
|
1.5%
1/66 • Number of events 2
2 patients who cancelled prior to receiving any study treatment are excluded from this analysis
|
|
Cardiac disorders
Atrial fibrillation
|
12.1%
8/66 • Number of events 21
2 patients who cancelled prior to receiving any study treatment are excluded from this analysis
|
|
Cardiac disorders
Atrial flutter
|
1.5%
1/66 • Number of events 1
2 patients who cancelled prior to receiving any study treatment are excluded from this analysis
|
|
Cardiac disorders
Cardiac disorders - Other, specify
|
1.5%
1/66 • Number of events 1
2 patients who cancelled prior to receiving any study treatment are excluded from this analysis
|
|
Cardiac disorders
Chest pain - cardiac
|
3.0%
2/66 • Number of events 2
2 patients who cancelled prior to receiving any study treatment are excluded from this analysis
|
|
Cardiac disorders
Heart failure
|
1.5%
1/66 • Number of events 1
2 patients who cancelled prior to receiving any study treatment are excluded from this analysis
|
|
Cardiac disorders
Left ventricular systolic dysfunction
|
1.5%
1/66 • Number of events 1
2 patients who cancelled prior to receiving any study treatment are excluded from this analysis
|
|
Cardiac disorders
Myocarditis
|
1.5%
1/66 • Number of events 1
2 patients who cancelled prior to receiving any study treatment are excluded from this analysis
|
|
Cardiac disorders
Palpitations
|
1.5%
1/66 • Number of events 1
2 patients who cancelled prior to receiving any study treatment are excluded from this analysis
|
|
Cardiac disorders
Paroxysmal atrial tachycardia
|
1.5%
1/66 • Number of events 1
2 patients who cancelled prior to receiving any study treatment are excluded from this analysis
|
|
Cardiac disorders
Pericardial effusion
|
1.5%
1/66 • Number of events 1
2 patients who cancelled prior to receiving any study treatment are excluded from this analysis
|
|
Cardiac disorders
Restrictive cardiomyopathy
|
1.5%
1/66 • Number of events 1
2 patients who cancelled prior to receiving any study treatment are excluded from this analysis
|
|
Cardiac disorders
Sinus bradycardia
|
22.7%
15/66 • Number of events 20
2 patients who cancelled prior to receiving any study treatment are excluded from this analysis
|
|
Cardiac disorders
Sinus tachycardia
|
25.8%
17/66 • Number of events 28
2 patients who cancelled prior to receiving any study treatment are excluded from this analysis
|
|
Cardiac disorders
Supraventricular tachycardia
|
1.5%
1/66 • Number of events 1
2 patients who cancelled prior to receiving any study treatment are excluded from this analysis
|
|
Cardiac disorders
Ventricular arrhythmia
|
1.5%
1/66 • Number of events 1
2 patients who cancelled prior to receiving any study treatment are excluded from this analysis
|
|
Cardiac disorders
Ventricular tachycardia
|
1.5%
1/66 • Number of events 1
2 patients who cancelled prior to receiving any study treatment are excluded from this analysis
|
|
Ear and labyrinth disorders
Ear and labyrinth disorders - Other, specify
|
1.5%
1/66 • Number of events 2
2 patients who cancelled prior to receiving any study treatment are excluded from this analysis
|
|
Ear and labyrinth disorders
Ear pain
|
4.5%
3/66 • Number of events 3
2 patients who cancelled prior to receiving any study treatment are excluded from this analysis
|
|
Ear and labyrinth disorders
Hearing impaired
|
4.5%
3/66 • Number of events 13
2 patients who cancelled prior to receiving any study treatment are excluded from this analysis
|
|
Ear and labyrinth disorders
Vertigo
|
1.5%
1/66 • Number of events 1
2 patients who cancelled prior to receiving any study treatment are excluded from this analysis
|
|
Endocrine disorders
Adrenal insufficiency
|
1.5%
1/66 • Number of events 2
2 patients who cancelled prior to receiving any study treatment are excluded from this analysis
|
|
Endocrine disorders
Endocrine disorders - Other, specify
|
4.5%
3/66 • Number of events 3
2 patients who cancelled prior to receiving any study treatment are excluded from this analysis
|
|
Endocrine disorders
Hypothyroidism
|
1.5%
1/66 • Number of events 7
2 patients who cancelled prior to receiving any study treatment are excluded from this analysis
|
|
Eye disorders
Blurred vision
|
27.3%
18/66 • Number of events 45
2 patients who cancelled prior to receiving any study treatment are excluded from this analysis
|
|
Eye disorders
Cataract
|
3.0%
2/66 • Number of events 4
2 patients who cancelled prior to receiving any study treatment are excluded from this analysis
|
|
Eye disorders
Conjunctivitis
|
3.0%
2/66 • Number of events 2
2 patients who cancelled prior to receiving any study treatment are excluded from this analysis
|
|
Eye disorders
Dry eye
|
15.2%
10/66 • Number of events 21
2 patients who cancelled prior to receiving any study treatment are excluded from this analysis
|
|
Eye disorders
Eye disorders - Other, specify
|
12.1%
8/66 • Number of events 8
2 patients who cancelled prior to receiving any study treatment are excluded from this analysis
|
|
Eye disorders
Eye pain
|
6.1%
4/66 • Number of events 5
2 patients who cancelled prior to receiving any study treatment are excluded from this analysis
|
|
Eye disorders
Glaucoma
|
3.0%
2/66 • Number of events 9
2 patients who cancelled prior to receiving any study treatment are excluded from this analysis
|
|
Eye disorders
Photophobia
|
3.0%
2/66 • Number of events 2
2 patients who cancelled prior to receiving any study treatment are excluded from this analysis
|
|
Eye disorders
Scleral disorder
|
1.5%
1/66 • Number of events 1
2 patients who cancelled prior to receiving any study treatment are excluded from this analysis
|
|
Eye disorders
Uveitis
|
1.5%
1/66 • Number of events 4
2 patients who cancelled prior to receiving any study treatment are excluded from this analysis
|
|
Eye disorders
Vitreous hemorrhage
|
1.5%
1/66 • Number of events 1
2 patients who cancelled prior to receiving any study treatment are excluded from this analysis
|
|
Eye disorders
Watering eyes
|
7.6%
5/66 • Number of events 6
2 patients who cancelled prior to receiving any study treatment are excluded from this analysis
|
|
Gastrointestinal disorders
Abdominal distension
|
7.6%
5/66 • Number of events 8
2 patients who cancelled prior to receiving any study treatment are excluded from this analysis
|
|
Gastrointestinal disorders
Abdominal pain
|
34.8%
23/66 • Number of events 36
2 patients who cancelled prior to receiving any study treatment are excluded from this analysis
|
|
Gastrointestinal disorders
Anal pain
|
1.5%
1/66 • Number of events 1
2 patients who cancelled prior to receiving any study treatment are excluded from this analysis
|
|
Gastrointestinal disorders
Bloating
|
4.5%
3/66 • Number of events 6
2 patients who cancelled prior to receiving any study treatment are excluded from this analysis
|
|
Gastrointestinal disorders
Colitis
|
1.5%
1/66 • Number of events 1
2 patients who cancelled prior to receiving any study treatment are excluded from this analysis
|
|
Gastrointestinal disorders
Constipation
|
48.5%
32/66 • Number of events 54
2 patients who cancelled prior to receiving any study treatment are excluded from this analysis
|
|
Gastrointestinal disorders
Diarrhea
|
78.8%
52/66 • Number of events 87
2 patients who cancelled prior to receiving any study treatment are excluded from this analysis
|
|
Gastrointestinal disorders
Dry mouth
|
28.8%
19/66 • Number of events 42
2 patients who cancelled prior to receiving any study treatment are excluded from this analysis
|
|
Gastrointestinal disorders
Dyspepsia
|
16.7%
11/66 • Number of events 28
2 patients who cancelled prior to receiving any study treatment are excluded from this analysis
|
|
Gastrointestinal disorders
Dysphagia
|
15.2%
10/66 • Number of events 10
2 patients who cancelled prior to receiving any study treatment are excluded from this analysis
|
|
Gastrointestinal disorders
Esophageal pain
|
1.5%
1/66 • Number of events 1
2 patients who cancelled prior to receiving any study treatment are excluded from this analysis
|
|
Gastrointestinal disorders
Fecal incontinence
|
4.5%
3/66 • Number of events 3
2 patients who cancelled prior to receiving any study treatment are excluded from this analysis
|
|
Gastrointestinal disorders
Flatulence
|
4.5%
3/66 • Number of events 3
2 patients who cancelled prior to receiving any study treatment are excluded from this analysis
|
|
Gastrointestinal disorders
Gastritis
|
3.0%
2/66 • Number of events 2
2 patients who cancelled prior to receiving any study treatment are excluded from this analysis
|
|
Gastrointestinal disorders
Gastroesophageal reflux disease
|
13.6%
9/66 • Number of events 15
2 patients who cancelled prior to receiving any study treatment are excluded from this analysis
|
|
Gastrointestinal disorders
Gastrointestinal disorders - Other, specify
|
18.2%
12/66 • Number of events 22
2 patients who cancelled prior to receiving any study treatment are excluded from this analysis
|
|
Gastrointestinal disorders
Gastrointestinal pain
|
1.5%
1/66 • Number of events 1
2 patients who cancelled prior to receiving any study treatment are excluded from this analysis
|
|
Gastrointestinal disorders
Hemorrhoidal hemorrhage
|
6.1%
4/66 • Number of events 4
2 patients who cancelled prior to receiving any study treatment are excluded from this analysis
|
|
Gastrointestinal disorders
Hemorrhoids
|
9.1%
6/66 • Number of events 7
2 patients who cancelled prior to receiving any study treatment are excluded from this analysis
|
|
Gastrointestinal disorders
Ileus
|
1.5%
1/66 • Number of events 1
2 patients who cancelled prior to receiving any study treatment are excluded from this analysis
|
|
Gastrointestinal disorders
Mucositis oral
|
71.2%
47/66 • Number of events 56
2 patients who cancelled prior to receiving any study treatment are excluded from this analysis
|
|
Gastrointestinal disorders
Nausea
|
72.7%
48/66 • Number of events 111
2 patients who cancelled prior to receiving any study treatment are excluded from this analysis
|
|
Gastrointestinal disorders
Oral hemorrhage
|
10.6%
7/66 • Number of events 7
2 patients who cancelled prior to receiving any study treatment are excluded from this analysis
|
|
Gastrointestinal disorders
Oral pain
|
16.7%
11/66 • Number of events 14
2 patients who cancelled prior to receiving any study treatment are excluded from this analysis
|
|
Gastrointestinal disorders
Periodontal disease
|
1.5%
1/66 • Number of events 1
2 patients who cancelled prior to receiving any study treatment are excluded from this analysis
|
|
Gastrointestinal disorders
Proctitis
|
1.5%
1/66 • Number of events 1
2 patients who cancelled prior to receiving any study treatment are excluded from this analysis
|
|
Gastrointestinal disorders
Rectal hemorrhage
|
1.5%
1/66 • Number of events 1
2 patients who cancelled prior to receiving any study treatment are excluded from this analysis
|
|
Gastrointestinal disorders
Rectal pain
|
4.5%
3/66 • Number of events 4
2 patients who cancelled prior to receiving any study treatment are excluded from this analysis
|
|
Gastrointestinal disorders
Rectal ulcer
|
1.5%
1/66 • Number of events 1
2 patients who cancelled prior to receiving any study treatment are excluded from this analysis
|
|
Gastrointestinal disorders
Stomach pain
|
1.5%
1/66 • Number of events 1
2 patients who cancelled prior to receiving any study treatment are excluded from this analysis
|
|
Gastrointestinal disorders
Toothache
|
1.5%
1/66 • Number of events 1
2 patients who cancelled prior to receiving any study treatment are excluded from this analysis
|
|
Gastrointestinal disorders
Vomiting
|
60.6%
40/66 • Number of events 57
2 patients who cancelled prior to receiving any study treatment are excluded from this analysis
|
|
General disorders
Chills
|
31.8%
21/66 • Number of events 30
2 patients who cancelled prior to receiving any study treatment are excluded from this analysis
|
|
General disorders
Edema face
|
10.6%
7/66 • Number of events 8
2 patients who cancelled prior to receiving any study treatment are excluded from this analysis
|
|
General disorders
Edema limbs
|
36.4%
24/66 • Number of events 56
2 patients who cancelled prior to receiving any study treatment are excluded from this analysis
|
|
General disorders
Edema trunk
|
4.5%
3/66 • Number of events 3
2 patients who cancelled prior to receiving any study treatment are excluded from this analysis
|
|
General disorders
Facial pain
|
1.5%
1/66 • Number of events 1
2 patients who cancelled prior to receiving any study treatment are excluded from this analysis
|
|
General disorders
Fatigue
|
75.8%
50/66 • Number of events 155
2 patients who cancelled prior to receiving any study treatment are excluded from this analysis
|
|
General disorders
Fever
|
39.4%
26/66 • Number of events 28
2 patients who cancelled prior to receiving any study treatment are excluded from this analysis
|
|
General disorders
Flu like symptoms
|
1.5%
1/66 • Number of events 1
2 patients who cancelled prior to receiving any study treatment are excluded from this analysis
|
|
General disorders
General disorders and administration site conditions - Other, specify
|
7.6%
5/66 • Number of events 5
2 patients who cancelled prior to receiving any study treatment are excluded from this analysis
|
|
General disorders
Infusion related reaction
|
7.6%
5/66 • Number of events 7
2 patients who cancelled prior to receiving any study treatment are excluded from this analysis
|
|
General disorders
Injection site reaction
|
12.1%
8/66 • Number of events 13
2 patients who cancelled prior to receiving any study treatment are excluded from this analysis
|
|
General disorders
Localized edema
|
3.0%
2/66 • Number of events 2
2 patients who cancelled prior to receiving any study treatment are excluded from this analysis
|
|
General disorders
Malaise
|
1.5%
1/66 • Number of events 1
2 patients who cancelled prior to receiving any study treatment are excluded from this analysis
|
|
General disorders
Neck edema
|
1.5%
1/66 • Number of events 1
2 patients who cancelled prior to receiving any study treatment are excluded from this analysis
|
|
General disorders
Non-cardiac chest pain
|
18.2%
12/66 • Number of events 16
2 patients who cancelled prior to receiving any study treatment are excluded from this analysis
|
|
General disorders
Pain
|
16.7%
11/66 • Number of events 20
2 patients who cancelled prior to receiving any study treatment are excluded from this analysis
|
|
Hepatobiliary disorders
Hepatobiliary disorders - Other, specify
|
4.5%
3/66 • Number of events 10
2 patients who cancelled prior to receiving any study treatment are excluded from this analysis
|
|
Immune system disorders
Immune system disorders - Other, specify
|
1.5%
1/66 • Number of events 4
2 patients who cancelled prior to receiving any study treatment are excluded from this analysis
|
|
Infections and infestations
Bladder infection
|
4.5%
3/66 • Number of events 4
2 patients who cancelled prior to receiving any study treatment are excluded from this analysis
|
|
Infections and infestations
Bronchial infection
|
1.5%
1/66 • Number of events 1
2 patients who cancelled prior to receiving any study treatment are excluded from this analysis
|
|
Infections and infestations
Catheter related infection
|
1.5%
1/66 • Number of events 1
2 patients who cancelled prior to receiving any study treatment are excluded from this analysis
|
|
Infections and infestations
Device related infection
|
1.5%
1/66 • Number of events 1
2 patients who cancelled prior to receiving any study treatment are excluded from this analysis
|
|
Infections and infestations
Enterocolitis infectious
|
3.0%
2/66 • Number of events 2
2 patients who cancelled prior to receiving any study treatment are excluded from this analysis
|
|
Infections and infestations
Infections and infestations - Other, specify
|
43.9%
29/66 • Number of events 46
2 patients who cancelled prior to receiving any study treatment are excluded from this analysis
|
|
Infections and infestations
Lip infection
|
1.5%
1/66 • Number of events 1
2 patients who cancelled prior to receiving any study treatment are excluded from this analysis
|
|
Infections and infestations
Lung infection
|
9.1%
6/66 • Number of events 8
2 patients who cancelled prior to receiving any study treatment are excluded from this analysis
|
|
Infections and infestations
Meningitis
|
1.5%
1/66 • Number of events 1
2 patients who cancelled prior to receiving any study treatment are excluded from this analysis
|
|
Infections and infestations
Mucosal infection
|
9.1%
6/66 • Number of events 16
2 patients who cancelled prior to receiving any study treatment are excluded from this analysis
|
|
Infections and infestations
Nail infection
|
1.5%
1/66 • Number of events 1
2 patients who cancelled prior to receiving any study treatment are excluded from this analysis
|
|
Infections and infestations
Papulopustular rash
|
4.5%
3/66 • Number of events 3
2 patients who cancelled prior to receiving any study treatment are excluded from this analysis
|
|
Infections and infestations
Rash pustular
|
1.5%
1/66 • Number of events 1
2 patients who cancelled prior to receiving any study treatment are excluded from this analysis
|
|
Infections and infestations
Sepsis
|
7.6%
5/66 • Number of events 7
2 patients who cancelled prior to receiving any study treatment are excluded from this analysis
|
|
Infections and infestations
Sinusitis
|
1.5%
1/66 • Number of events 4
2 patients who cancelled prior to receiving any study treatment are excluded from this analysis
|
|
Infections and infestations
Skin infection
|
4.5%
3/66 • Number of events 3
2 patients who cancelled prior to receiving any study treatment are excluded from this analysis
|
|
Infections and infestations
Soft tissue infection
|
3.0%
2/66 • Number of events 3
2 patients who cancelled prior to receiving any study treatment are excluded from this analysis
|
|
Infections and infestations
Tooth infection
|
1.5%
1/66 • Number of events 1
2 patients who cancelled prior to receiving any study treatment are excluded from this analysis
|
|
Infections and infestations
Upper respiratory infection
|
10.6%
7/66 • Number of events 8
2 patients who cancelled prior to receiving any study treatment are excluded from this analysis
|
|
Infections and infestations
Urinary tract infection
|
6.1%
4/66 • Number of events 5
2 patients who cancelled prior to receiving any study treatment are excluded from this analysis
|
|
Injury, poisoning and procedural complications
Bruising
|
18.2%
12/66 • Number of events 21
2 patients who cancelled prior to receiving any study treatment are excluded from this analysis
|
|
Injury, poisoning and procedural complications
Fall
|
3.0%
2/66 • Number of events 2
2 patients who cancelled prior to receiving any study treatment are excluded from this analysis
|
|
Injury, poisoning and procedural complications
Injury, poisoning and procedural complications - Other, specify
|
1.5%
1/66 • Number of events 1
2 patients who cancelled prior to receiving any study treatment are excluded from this analysis
|
|
Injury, poisoning and procedural complications
Spinal fracture
|
1.5%
1/66 • Number of events 1
2 patients who cancelled prior to receiving any study treatment are excluded from this analysis
|
|
Investigations
Activated partial thromboplastin time prolonged
|
10.6%
7/66 • Number of events 15
2 patients who cancelled prior to receiving any study treatment are excluded from this analysis
|
|
Investigations
Alanine aminotransferase increased
|
60.6%
40/66 • Number of events 99
2 patients who cancelled prior to receiving any study treatment are excluded from this analysis
|
|
Investigations
Alkaline phosphatase increased
|
34.8%
23/66 • Number of events 48
2 patients who cancelled prior to receiving any study treatment are excluded from this analysis
|
|
Investigations
Aspartate aminotransferase increased
|
54.5%
36/66 • Number of events 90
2 patients who cancelled prior to receiving any study treatment are excluded from this analysis
|
|
Investigations
Blood bilirubin increased
|
31.8%
21/66 • Number of events 26
2 patients who cancelled prior to receiving any study treatment are excluded from this analysis
|
|
Investigations
Cholesterol high
|
1.5%
1/66 • Number of events 1
2 patients who cancelled prior to receiving any study treatment are excluded from this analysis
|
|
Investigations
Creatinine increased
|
53.0%
35/66 • Number of events 74
2 patients who cancelled prior to receiving any study treatment are excluded from this analysis
|
|
Investigations
Fibrinogen decreased
|
1.5%
1/66 • Number of events 1
2 patients who cancelled prior to receiving any study treatment are excluded from this analysis
|
|
Investigations
GGT increased
|
4.5%
3/66 • Number of events 10
2 patients who cancelled prior to receiving any study treatment are excluded from this analysis
|
|
Investigations
INR increased
|
9.1%
6/66 • Number of events 11
2 patients who cancelled prior to receiving any study treatment are excluded from this analysis
|
|
Investigations
Investigations - Other, specify
|
6.1%
4/66 • Number of events 32
2 patients who cancelled prior to receiving any study treatment are excluded from this analysis
|
|
Investigations
Lymphocyte count decreased
|
42.4%
28/66 • Number of events 92
2 patients who cancelled prior to receiving any study treatment are excluded from this analysis
|
|
Investigations
Neutrophil count decreased
|
84.8%
56/66 • Number of events 115
2 patients who cancelled prior to receiving any study treatment are excluded from this analysis
|
|
Investigations
Platelet count decreased
|
84.8%
56/66 • Number of events 194
2 patients who cancelled prior to receiving any study treatment are excluded from this analysis
|
|
Investigations
Weight gain
|
4.5%
3/66 • Number of events 5
2 patients who cancelled prior to receiving any study treatment are excluded from this analysis
|
|
Investigations
Weight loss
|
30.3%
20/66 • Number of events 44
2 patients who cancelled prior to receiving any study treatment are excluded from this analysis
|
|
Investigations
White blood cell decreased
|
53.0%
35/66 • Number of events 77
2 patients who cancelled prior to receiving any study treatment are excluded from this analysis
|
|
Metabolism and nutrition disorders
Anorexia
|
59.1%
39/66 • Number of events 91
2 patients who cancelled prior to receiving any study treatment are excluded from this analysis
|
|
Metabolism and nutrition disorders
Dehydration
|
12.1%
8/66 • Number of events 9
2 patients who cancelled prior to receiving any study treatment are excluded from this analysis
|
|
Metabolism and nutrition disorders
Glucose intolerance
|
1.5%
1/66 • Number of events 1
2 patients who cancelled prior to receiving any study treatment are excluded from this analysis
|
|
Metabolism and nutrition disorders
Hypercalcemia
|
7.6%
5/66 • Number of events 10
2 patients who cancelled prior to receiving any study treatment are excluded from this analysis
|
|
Metabolism and nutrition disorders
Hyperglycemia
|
81.8%
54/66 • Number of events 156
2 patients who cancelled prior to receiving any study treatment are excluded from this analysis
|
|
Metabolism and nutrition disorders
Hyperkalemia
|
36.4%
24/66 • Number of events 36
2 patients who cancelled prior to receiving any study treatment are excluded from this analysis
|
|
Metabolism and nutrition disorders
Hypermagnesemia
|
3.0%
2/66 • Number of events 2
2 patients who cancelled prior to receiving any study treatment are excluded from this analysis
|
|
Metabolism and nutrition disorders
Hypernatremia
|
7.6%
5/66 • Number of events 5
2 patients who cancelled prior to receiving any study treatment are excluded from this analysis
|
|
Metabolism and nutrition disorders
Hypertriglyceridemia
|
1.5%
1/66 • Number of events 1
2 patients who cancelled prior to receiving any study treatment are excluded from this analysis
|
|
Metabolism and nutrition disorders
Hyperuricemia
|
4.5%
3/66 • Number of events 9
2 patients who cancelled prior to receiving any study treatment are excluded from this analysis
|
|
Metabolism and nutrition disorders
Hypoalbuminemia
|
57.6%
38/66 • Number of events 69
2 patients who cancelled prior to receiving any study treatment are excluded from this analysis
|
|
Metabolism and nutrition disorders
Hypocalcemia
|
60.6%
40/66 • Number of events 64
2 patients who cancelled prior to receiving any study treatment are excluded from this analysis
|
|
Metabolism and nutrition disorders
Hypoglycemia
|
7.6%
5/66 • Number of events 6
2 patients who cancelled prior to receiving any study treatment are excluded from this analysis
|
|
Metabolism and nutrition disorders
Hypokalemia
|
50.0%
33/66 • Number of events 45
2 patients who cancelled prior to receiving any study treatment are excluded from this analysis
|
|
Metabolism and nutrition disorders
Hypomagnesemia
|
62.1%
41/66 • Number of events 104
2 patients who cancelled prior to receiving any study treatment are excluded from this analysis
|
|
Metabolism and nutrition disorders
Hyponatremia
|
54.5%
36/66 • Number of events 72
2 patients who cancelled prior to receiving any study treatment are excluded from this analysis
|
|
Metabolism and nutrition disorders
Hypophosphatemia
|
27.3%
18/66 • Number of events 22
2 patients who cancelled prior to receiving any study treatment are excluded from this analysis
|
|
Metabolism and nutrition disorders
Metabolism and nutrition disorders - Other, specify
|
18.2%
12/66 • Number of events 37
2 patients who cancelled prior to receiving any study treatment are excluded from this analysis
|
|
Metabolism and nutrition disorders
Obesity
|
1.5%
1/66 • Number of events 6
2 patients who cancelled prior to receiving any study treatment are excluded from this analysis
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
13.6%
9/66 • Number of events 21
2 patients who cancelled prior to receiving any study treatment are excluded from this analysis
|
|
Musculoskeletal and connective tissue disorders
Arthritis
|
1.5%
1/66 • Number of events 7
2 patients who cancelled prior to receiving any study treatment are excluded from this analysis
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
21.2%
14/66 • Number of events 29
2 patients who cancelled prior to receiving any study treatment are excluded from this analysis
|
|
Musculoskeletal and connective tissue disorders
Bone pain
|
12.1%
8/66 • Number of events 10
2 patients who cancelled prior to receiving any study treatment are excluded from this analysis
|
|
Musculoskeletal and connective tissue disorders
Buttock pain
|
3.0%
2/66 • Number of events 4
2 patients who cancelled prior to receiving any study treatment are excluded from this analysis
|
|
Musculoskeletal and connective tissue disorders
Flank pain
|
6.1%
4/66 • Number of events 7
2 patients who cancelled prior to receiving any study treatment are excluded from this analysis
|
|
Musculoskeletal and connective tissue disorders
Generalized muscle weakness
|
31.8%
21/66 • Number of events 41
2 patients who cancelled prior to receiving any study treatment are excluded from this analysis
|
|
Musculoskeletal and connective tissue disorders
Muscle weakness left-sided
|
1.5%
1/66 • Number of events 1
2 patients who cancelled prior to receiving any study treatment are excluded from this analysis
|
|
Musculoskeletal and connective tissue disorders
Muscle weakness lower limb
|
3.0%
2/66 • Number of events 2
2 patients who cancelled prior to receiving any study treatment are excluded from this analysis
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal and connective tissue disorder - Other, specify
|
16.7%
11/66 • Number of events 22
2 patients who cancelled prior to receiving any study treatment are excluded from this analysis
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
10.6%
7/66 • Number of events 12
2 patients who cancelled prior to receiving any study treatment are excluded from this analysis
|
|
Musculoskeletal and connective tissue disorders
Myositis
|
1.5%
1/66 • Number of events 1
2 patients who cancelled prior to receiving any study treatment are excluded from this analysis
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
6.1%
4/66 • Number of events 5
2 patients who cancelled prior to receiving any study treatment are excluded from this analysis
|
|
Musculoskeletal and connective tissue disorders
Osteoporosis
|
1.5%
1/66 • Number of events 1
2 patients who cancelled prior to receiving any study treatment are excluded from this analysis
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
16.7%
11/66 • Number of events 31
2 patients who cancelled prior to receiving any study treatment are excluded from this analysis
|
|
Nervous system disorders
Akathisia
|
3.0%
2/66 • Number of events 2
2 patients who cancelled prior to receiving any study treatment are excluded from this analysis
|
|
Nervous system disorders
Amnesia
|
1.5%
1/66 • Number of events 3
2 patients who cancelled prior to receiving any study treatment are excluded from this analysis
|
|
Nervous system disorders
Dizziness
|
24.2%
16/66 • Number of events 24
2 patients who cancelled prior to receiving any study treatment are excluded from this analysis
|
|
Nervous system disorders
Dysgeusia
|
37.9%
25/66 • Number of events 51
2 patients who cancelled prior to receiving any study treatment are excluded from this analysis
|
|
Nervous system disorders
Encephalopathy
|
1.5%
1/66 • Number of events 1
2 patients who cancelled prior to receiving any study treatment are excluded from this analysis
|
|
Nervous system disorders
Headache
|
43.9%
29/66 • Number of events 42
2 patients who cancelled prior to receiving any study treatment are excluded from this analysis
|
|
Nervous system disorders
Hydrocephalus
|
1.5%
1/66 • Number of events 1
2 patients who cancelled prior to receiving any study treatment are excluded from this analysis
|
|
Nervous system disorders
Hypersomnia
|
1.5%
1/66 • Number of events 1
2 patients who cancelled prior to receiving any study treatment are excluded from this analysis
|
|
Nervous system disorders
Intracranial hemorrhage
|
1.5%
1/66 • Number of events 1
2 patients who cancelled prior to receiving any study treatment are excluded from this analysis
|
|
Nervous system disorders
Lethargy
|
6.1%
4/66 • Number of events 4
2 patients who cancelled prior to receiving any study treatment are excluded from this analysis
|
|
Nervous system disorders
Memory impairment
|
3.0%
2/66 • Number of events 3
2 patients who cancelled prior to receiving any study treatment are excluded from this analysis
|
|
Nervous system disorders
Nervous system disorders - Other, specify
|
1.5%
1/66 • Number of events 1
2 patients who cancelled prior to receiving any study treatment are excluded from this analysis
|
|
Nervous system disorders
Neuralgia
|
1.5%
1/66 • Number of events 2
2 patients who cancelled prior to receiving any study treatment are excluded from this analysis
|
|
Nervous system disorders
Paresthesia
|
3.0%
2/66 • Number of events 3
2 patients who cancelled prior to receiving any study treatment are excluded from this analysis
|
|
Nervous system disorders
Peripheral motor neuropathy
|
7.6%
5/66 • Number of events 6
2 patients who cancelled prior to receiving any study treatment are excluded from this analysis
|
|
Nervous system disorders
Peripheral sensory neuropathy
|
19.7%
13/66 • Number of events 36
2 patients who cancelled prior to receiving any study treatment are excluded from this analysis
|
|
Nervous system disorders
Presyncope
|
1.5%
1/66 • Number of events 1
2 patients who cancelled prior to receiving any study treatment are excluded from this analysis
|
|
Nervous system disorders
Sinus pain
|
4.5%
3/66 • Number of events 4
2 patients who cancelled prior to receiving any study treatment are excluded from this analysis
|
|
Nervous system disorders
Somnolence
|
4.5%
3/66 • Number of events 3
2 patients who cancelled prior to receiving any study treatment are excluded from this analysis
|
|
Nervous system disorders
Stroke
|
1.5%
1/66 • Number of events 1
2 patients who cancelled prior to receiving any study treatment are excluded from this analysis
|
|
Nervous system disorders
Syncope
|
3.0%
2/66 • Number of events 2
2 patients who cancelled prior to receiving any study treatment are excluded from this analysis
|
|
Nervous system disorders
Transient ischemic attacks
|
1.5%
1/66 • Number of events 2
2 patients who cancelled prior to receiving any study treatment are excluded from this analysis
|
|
Nervous system disorders
Tremor
|
19.7%
13/66 • Number of events 20
2 patients who cancelled prior to receiving any study treatment are excluded from this analysis
|
|
Nervous system disorders
Vasovagal reaction
|
1.5%
1/66 • Number of events 1
2 patients who cancelled prior to receiving any study treatment are excluded from this analysis
|
|
Psychiatric disorders
Agitation
|
1.5%
1/66 • Number of events 3
2 patients who cancelled prior to receiving any study treatment are excluded from this analysis
|
|
Psychiatric disorders
Anxiety
|
27.3%
18/66 • Number of events 39
2 patients who cancelled prior to receiving any study treatment are excluded from this analysis
|
|
Psychiatric disorders
Confusion
|
19.7%
13/66 • Number of events 14
2 patients who cancelled prior to receiving any study treatment are excluded from this analysis
|
|
Psychiatric disorders
Delirium
|
1.5%
1/66 • Number of events 1
2 patients who cancelled prior to receiving any study treatment are excluded from this analysis
|
|
Psychiatric disorders
Depression
|
16.7%
11/66 • Number of events 35
2 patients who cancelled prior to receiving any study treatment are excluded from this analysis
|
|
Psychiatric disorders
Hallucinations
|
3.0%
2/66 • Number of events 2
2 patients who cancelled prior to receiving any study treatment are excluded from this analysis
|
|
Psychiatric disorders
Insomnia
|
36.4%
24/66 • Number of events 54
2 patients who cancelled prior to receiving any study treatment are excluded from this analysis
|
|
Psychiatric disorders
Psychiatric disorders - Other, specify
|
1.5%
1/66 • Number of events 1
2 patients who cancelled prior to receiving any study treatment are excluded from this analysis
|
|
Renal and urinary disorders
Acute kidney injury
|
18.2%
12/66 • Number of events 23
2 patients who cancelled prior to receiving any study treatment are excluded from this analysis
|
|
Renal and urinary disorders
Bladder spasm
|
3.0%
2/66 • Number of events 2
2 patients who cancelled prior to receiving any study treatment are excluded from this analysis
|
|
Renal and urinary disorders
Chronic kidney disease
|
3.0%
2/66 • Number of events 3
2 patients who cancelled prior to receiving any study treatment are excluded from this analysis
|
|
Renal and urinary disorders
Cystitis noninfective
|
3.0%
2/66 • Number of events 2
2 patients who cancelled prior to receiving any study treatment are excluded from this analysis
|
|
Renal and urinary disorders
Hematuria
|
9.1%
6/66 • Number of events 6
2 patients who cancelled prior to receiving any study treatment are excluded from this analysis
|
|
Renal and urinary disorders
Proteinuria
|
4.5%
3/66 • Number of events 4
2 patients who cancelled prior to receiving any study treatment are excluded from this analysis
|
|
Renal and urinary disorders
Renal and urinary disorders - Other, specify
|
4.5%
3/66 • Number of events 4
2 patients who cancelled prior to receiving any study treatment are excluded from this analysis
|
|
Renal and urinary disorders
Renal calculi
|
1.5%
1/66 • Number of events 2
2 patients who cancelled prior to receiving any study treatment are excluded from this analysis
|
|
Renal and urinary disorders
Urinary frequency
|
15.2%
10/66 • Number of events 18
2 patients who cancelled prior to receiving any study treatment are excluded from this analysis
|
|
Renal and urinary disorders
Urinary incontinence
|
4.5%
3/66 • Number of events 3
2 patients who cancelled prior to receiving any study treatment are excluded from this analysis
|
|
Renal and urinary disorders
Urinary retention
|
7.6%
5/66 • Number of events 6
2 patients who cancelled prior to receiving any study treatment are excluded from this analysis
|
|
Renal and urinary disorders
Urinary tract obstruction
|
1.5%
1/66 • Number of events 2
2 patients who cancelled prior to receiving any study treatment are excluded from this analysis
|
|
Renal and urinary disorders
Urinary tract pain
|
10.6%
7/66 • Number of events 8
2 patients who cancelled prior to receiving any study treatment are excluded from this analysis
|
|
Renal and urinary disorders
Urinary urgency
|
6.1%
4/66 • Number of events 4
2 patients who cancelled prior to receiving any study treatment are excluded from this analysis
|
|
Reproductive system and breast disorders
Genital edema
|
4.5%
3/66 • Number of events 3
2 patients who cancelled prior to receiving any study treatment are excluded from this analysis
|
|
Reproductive system and breast disorders
Irregular menstruation
|
1.5%
1/66 • Number of events 1
2 patients who cancelled prior to receiving any study treatment are excluded from this analysis
|
|
Reproductive system and breast disorders
Penile pain
|
4.5%
3/66 • Number of events 3
2 patients who cancelled prior to receiving any study treatment are excluded from this analysis
|
|
Reproductive system and breast disorders
Prostatic obstruction
|
1.5%
1/66 • Number of events 1
2 patients who cancelled prior to receiving any study treatment are excluded from this analysis
|
|
Reproductive system and breast disorders
Reproductive system and breast disorders - Other, specify
|
1.5%
1/66 • Number of events 2
2 patients who cancelled prior to receiving any study treatment are excluded from this analysis
|
|
Reproductive system and breast disorders
Scrotal pain
|
1.5%
1/66 • Number of events 1
2 patients who cancelled prior to receiving any study treatment are excluded from this analysis
|
|
Reproductive system and breast disorders
Vaginal discharge
|
1.5%
1/66 • Number of events 1
2 patients who cancelled prior to receiving any study treatment are excluded from this analysis
|
|
Reproductive system and breast disorders
Vaginal dryness
|
3.0%
2/66 • Number of events 2
2 patients who cancelled prior to receiving any study treatment are excluded from this analysis
|
|
Reproductive system and breast disorders
Vaginal hemorrhage
|
1.5%
1/66 • Number of events 1
2 patients who cancelled prior to receiving any study treatment are excluded from this analysis
|
|
Reproductive system and breast disorders
Vaginal inflammation
|
4.5%
3/66 • Number of events 3
2 patients who cancelled prior to receiving any study treatment are excluded from this analysis
|
|
Respiratory, thoracic and mediastinal disorders
Allergic rhinitis
|
9.1%
6/66 • Number of events 11
2 patients who cancelled prior to receiving any study treatment are excluded from this analysis
|
|
Respiratory, thoracic and mediastinal disorders
Atelectasis
|
1.5%
1/66 • Number of events 1
2 patients who cancelled prior to receiving any study treatment are excluded from this analysis
|
|
Respiratory, thoracic and mediastinal disorders
Bronchopulmonary hemorrhage
|
1.5%
1/66 • Number of events 1
2 patients who cancelled prior to receiving any study treatment are excluded from this analysis
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
31.8%
21/66 • Number of events 30
2 patients who cancelled prior to receiving any study treatment are excluded from this analysis
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
43.9%
29/66 • Number of events 52
2 patients who cancelled prior to receiving any study treatment are excluded from this analysis
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
18.2%
12/66 • Number of events 13
2 patients who cancelled prior to receiving any study treatment are excluded from this analysis
|
|
Respiratory, thoracic and mediastinal disorders
Hiccups
|
7.6%
5/66 • Number of events 5
2 patients who cancelled prior to receiving any study treatment are excluded from this analysis
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
13.6%
9/66 • Number of events 9
2 patients who cancelled prior to receiving any study treatment are excluded from this analysis
|
|
Respiratory, thoracic and mediastinal disorders
Laryngeal hemorrhage
|
3.0%
2/66 • Number of events 2
2 patients who cancelled prior to receiving any study treatment are excluded from this analysis
|
|
Respiratory, thoracic and mediastinal disorders
Laryngeal mucositis
|
1.5%
1/66 • Number of events 1
2 patients who cancelled prior to receiving any study treatment are excluded from this analysis
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
22.7%
15/66 • Number of events 21
2 patients who cancelled prior to receiving any study treatment are excluded from this analysis
|
|
Respiratory, thoracic and mediastinal disorders
Pharyngeal mucositis
|
4.5%
3/66 • Number of events 4
2 patients who cancelled prior to receiving any study treatment are excluded from this analysis
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
6.1%
4/66 • Number of events 4
2 patients who cancelled prior to receiving any study treatment are excluded from this analysis
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonitis
|
3.0%
2/66 • Number of events 2
2 patients who cancelled prior to receiving any study treatment are excluded from this analysis
|
|
Respiratory, thoracic and mediastinal disorders
Postnasal drip
|
6.1%
4/66 • Number of events 4
2 patients who cancelled prior to receiving any study treatment are excluded from this analysis
|
|
Respiratory, thoracic and mediastinal disorders
Productive cough
|
4.5%
3/66 • Number of events 3
2 patients who cancelled prior to receiving any study treatment are excluded from this analysis
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary edema
|
6.1%
4/66 • Number of events 4
2 patients who cancelled prior to receiving any study treatment are excluded from this analysis
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure
|
1.5%
1/66 • Number of events 1
2 patients who cancelled prior to receiving any study treatment are excluded from this analysis
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory, thoracic and mediastinal disorders - Other, specify
|
10.6%
7/66 • Number of events 9
2 patients who cancelled prior to receiving any study treatment are excluded from this analysis
|
|
Respiratory, thoracic and mediastinal disorders
Sneezing
|
1.5%
1/66 • Number of events 1
2 patients who cancelled prior to receiving any study treatment are excluded from this analysis
|
|
Respiratory, thoracic and mediastinal disorders
Sore throat
|
24.2%
16/66 • Number of events 24
2 patients who cancelled prior to receiving any study treatment are excluded from this analysis
|
|
Respiratory, thoracic and mediastinal disorders
Wheezing
|
4.5%
3/66 • Number of events 3
2 patients who cancelled prior to receiving any study treatment are excluded from this analysis
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
7.6%
5/66 • Number of events 16
2 patients who cancelled prior to receiving any study treatment are excluded from this analysis
|
|
Skin and subcutaneous tissue disorders
Bullous dermatitis
|
4.5%
3/66 • Number of events 4
2 patients who cancelled prior to receiving any study treatment are excluded from this analysis
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
31.8%
21/66 • Number of events 43
2 patients who cancelled prior to receiving any study treatment are excluded from this analysis
|
|
Skin and subcutaneous tissue disorders
Erythema multiforme
|
7.6%
5/66 • Number of events 11
2 patients who cancelled prior to receiving any study treatment are excluded from this analysis
|
|
Skin and subcutaneous tissue disorders
Erythroderma
|
1.5%
1/66 • Number of events 2
2 patients who cancelled prior to receiving any study treatment are excluded from this analysis
|
|
Skin and subcutaneous tissue disorders
Hyperhidrosis
|
4.5%
3/66 • Number of events 3
2 patients who cancelled prior to receiving any study treatment are excluded from this analysis
|
|
Skin and subcutaneous tissue disorders
Nail loss
|
4.5%
3/66 • Number of events 9
2 patients who cancelled prior to receiving any study treatment are excluded from this analysis
|
|
Skin and subcutaneous tissue disorders
Pain of skin
|
9.1%
6/66 • Number of events 8
2 patients who cancelled prior to receiving any study treatment are excluded from this analysis
|
|
Skin and subcutaneous tissue disorders
Palmar-plantar erythrodysesthesia syndrome
|
1.5%
1/66 • Number of events 1
2 patients who cancelled prior to receiving any study treatment are excluded from this analysis
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
47.0%
31/66 • Number of events 50
2 patients who cancelled prior to receiving any study treatment are excluded from this analysis
|
|
Skin and subcutaneous tissue disorders
Purpura
|
4.5%
3/66 • Number of events 4
2 patients who cancelled prior to receiving any study treatment are excluded from this analysis
|
|
Skin and subcutaneous tissue disorders
Rash acneiform
|
9.1%
6/66 • Number of events 7
2 patients who cancelled prior to receiving any study treatment are excluded from this analysis
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
51.5%
34/66 • Number of events 58
2 patients who cancelled prior to receiving any study treatment are excluded from this analysis
|
|
Skin and subcutaneous tissue disorders
Skin and subcutaneous tissue disorders - Other, specify
|
30.3%
20/66 • Number of events 55
2 patients who cancelled prior to receiving any study treatment are excluded from this analysis
|
|
Skin and subcutaneous tissue disorders
Skin hyperpigmentation
|
12.1%
8/66 • Number of events 25
2 patients who cancelled prior to receiving any study treatment are excluded from this analysis
|
|
Skin and subcutaneous tissue disorders
Skin hypopigmentation
|
4.5%
3/66 • Number of events 10
2 patients who cancelled prior to receiving any study treatment are excluded from this analysis
|
|
Skin and subcutaneous tissue disorders
Skin ulceration
|
12.1%
8/66 • Number of events 12
2 patients who cancelled prior to receiving any study treatment are excluded from this analysis
|
|
Skin and subcutaneous tissue disorders
Urticaria
|
4.5%
3/66 • Number of events 3
2 patients who cancelled prior to receiving any study treatment are excluded from this analysis
|
|
Surgical and medical procedures
Surgical and medical procedures - Other, specify
|
1.5%
1/66 • Number of events 1
2 patients who cancelled prior to receiving any study treatment are excluded from this analysis
|
|
Vascular disorders
Flushing
|
3.0%
2/66 • Number of events 2
2 patients who cancelled prior to receiving any study treatment are excluded from this analysis
|
|
Vascular disorders
Hot flashes
|
3.0%
2/66 • Number of events 2
2 patients who cancelled prior to receiving any study treatment are excluded from this analysis
|
|
Vascular disorders
Hypertension
|
60.6%
40/66 • Number of events 106
2 patients who cancelled prior to receiving any study treatment are excluded from this analysis
|
|
Vascular disorders
Hypotension
|
31.8%
21/66 • Number of events 39
2 patients who cancelled prior to receiving any study treatment are excluded from this analysis
|
|
Vascular disorders
Phlebitis
|
1.5%
1/66 • Number of events 1
2 patients who cancelled prior to receiving any study treatment are excluded from this analysis
|
|
Vascular disorders
Superficial thrombophlebitis
|
1.5%
1/66 • Number of events 1
2 patients who cancelled prior to receiving any study treatment are excluded from this analysis
|
|
Vascular disorders
Thromboembolic event
|
10.6%
7/66 • Number of events 21
2 patients who cancelled prior to receiving any study treatment are excluded from this analysis
|
|
Vascular disorders
Vascular disorders - Other, specify
|
1.5%
1/66 • Number of events 1
2 patients who cancelled prior to receiving any study treatment are excluded from this analysis
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: LTE60