Trial Outcomes & Findings for Donor Stem Cell Transplant in Treating Patients With High-Risk Chronic Lymphocytic Leukemia or Small Lymphocytic Lymphoma (NCT NCT01027000)
NCT ID: NCT01027000
Last Updated: 2023-05-06
Results Overview
Percentage of participants who were alive and progression free at 2 years for participants with early disease stage. The 2 year progression free survival, with 95% confidence interval, was estimated using the Kaplan Meier method. A progression is defined as one of the following events: * \>= 50% increase in the products of at least two lymph nodes on two consecutive determinations two weeks apart (at least one lymph node must be \>= 2 cm); appearance of new palpable lymph nodes. * \>= 50% increase in the size of the liver and/or spleen as determined by measurement below the respective costal margin; appearance of palpable hepatomegaly or splenomegaly, which was not previously present. * \> 50% increase in peripheral blood lymphocytes with an absolute increase \> 5000/μL. * Transformation to a more aggressive histology (i.e., Richter's syndrome or prolymphocytic leukemia with \>= 56% prolymphocytes).
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
68 participants
Primary outcome timeframe
2 years post-registration
Results posted on
2023-05-06
Participant Flow
Between February 2010 and January 2014, 68 participants were recruited.
Participant milestones
| Measure |
Treatment (Combination of Chemotherapy and Transplant)
Preparative: Patients receive 1 of 2 preparative regimens (Reg) chosen by the treating institution
* Reg1: Rituximab (RTX) 500 mg/m\^2 IV on days -7, -1, 7, and 14 \& fludarabine phosphate (FP) 30 mg/m\^2 IV \& busulfan 0.8 mg/kg IV on days -5 to -2
* Reg 2: RTX 500 mg/m\^2 IV on days -7, -1, 7, and 14 \& FP 30 mg/m\^2 IV on days -5 to -2 \& cyclophosphamide 1 g/m\^2 IV on days -5 to -3
Graft-vs-host disease (GVHD) prophylaxis: Patients treated with preparative regimen 1 received either GVHD prophylaxis regimen 1 or 2; those given preparative regimen 2 received regimen 2
* Reg 1: Tacrolimus PO or IV \& oral sirolimus 12 mg on day -2 through day 60, followed by taper until day 180 \& methotrexate (MTX) 5 mg/m\^2 IV on days 1, 3, and 6.
* Reg 2: Tacrolimus PO or IV on day -2 through day 60, followed by taper until day 180 \& MTX 5mg/m\^2 IV on days 1, 3, 6, \& 11 Transplantation: allogeneic peripheral blood transplant on day 0 Maintenance: RTX 500 mg/m\^2 IV at 3, 6, 9, \& 12 months post-transplant
|
|---|---|
|
Overall Study
STARTED
|
68
|
|
Overall Study
COMPLETED
|
68
|
|
Overall Study
NOT COMPLETED
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Donor Stem Cell Transplant in Treating Patients With High-Risk Chronic Lymphocytic Leukemia or Small Lymphocytic Lymphoma
Baseline characteristics by cohort
| Measure |
Treatment (Combination of Chemotherapy and Transplant)
n=68 Participants
Preparative: Patients receive 1 of 2 preparative regimens (Reg) chosen by the treating institution
* Reg1: Rituximab (RTX) 500 mg/m\^2 IV on days -7, -1, 7, and 14 \& fludarabine phosphate (FP) 30 mg/m\^2 IV \& busulfan 0.8 mg/kg IV on days -5 to -2
* Reg 2: RTX 500 mg/m\^2 IV on days -7, -1, 7, and 14 \& FP 30 mg/m\^2 IV on days -5 to -2 \& cyclophosphamide 1 g/m\^2 IV on days -5 to -3
Graft-vs-host disease (GVHD) prophylaxis: Patients treated with preparative regimen 1 received either GVHD prophylaxis regimen 1 or 2; those given preparative regimen 2 received regimen 2
* Reg 1: Tacrolimus PO or IV \& oral sirolimus 12 mg on day -2 through day 60, followed by taper until day 180 \& methotrexate (MTX) 5 mg/m\^2 IV on days 1, 3, and 6.
* Reg 2: Tacrolimus PO or IV on day -2 through day 60, followed by taper until day 180 \& MTX 5mg/m\^2 IV on days 1, 3, 6, \& 11 Transplantation: allogeneic peripheral blood transplant on day 0 Maintenance: RTX 500 mg/m\^2 IV at 3, 6, 9, \& 12 months post-transplant
|
|---|---|
|
Age, Continuous
|
56 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
22 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
46 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
2 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
62 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
4 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
66 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
68 participants
n=5 Participants
|
|
Disease stage
Early Disease
|
14 participants
n=5 Participants
|
|
Disease stage
Advanced Disease
|
50 participants
n=5 Participants
|
|
Disease stage
Not reported
|
4 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 2 years post-registrationPopulation: Participants with early disease stage were analyzed. Two participants, who did not start protocol therapy, were excluded from this analysis.
Percentage of participants who were alive and progression free at 2 years for participants with early disease stage. The 2 year progression free survival, with 95% confidence interval, was estimated using the Kaplan Meier method. A progression is defined as one of the following events: * \>= 50% increase in the products of at least two lymph nodes on two consecutive determinations two weeks apart (at least one lymph node must be \>= 2 cm); appearance of new palpable lymph nodes. * \>= 50% increase in the size of the liver and/or spleen as determined by measurement below the respective costal margin; appearance of palpable hepatomegaly or splenomegaly, which was not previously present. * \> 50% increase in peripheral blood lymphocytes with an absolute increase \> 5000/μL. * Transformation to a more aggressive histology (i.e., Richter's syndrome or prolymphocytic leukemia with \>= 56% prolymphocytes).
Outcome measures
| Measure |
Treatment (Combination of Chemotherapy and Transplant)
n=12 Participants
Preparative: Patients receive 1 of 2 preparative regimens (Reg) chosen by the treating institution
* Reg1: Rituximab (RTX) 500 mg/m\^2 IV on days -7, -1, 7, and 14 \& fludarabine phosphate (FP) 30 mg/m\^2 IV \& busulfan 0.8 mg/kg IV on days -5 to -2
* Reg 2: RTX 500 mg/m\^2 IV on days -7, -1, 7, and 14 \& FP 30 mg/m\^2 IV on days -5 to -2 \& cyclophosphamide 1 g/m\^2 IV on days -5 to -3
Graft-vs-host disease (GVHD) prophylaxis: Patients treated with preparative regimen 1 received either GVHD prophylaxis regimen 1 or 2; those given preparative regimen 2 received regimen 2
* Reg 1: Tacrolimus PO or IV \& oral sirolimus 12 mg on day -2 through day 60, followed by taper until day 180 \& methotrexate (MTX) 5 mg/m\^2 IV on days 1, 3, and 6.
* Reg 2: Tacrolimus PO or IV on day -2 through day 60, followed by taper until day 180 \& MTX 5mg/m\^2 IV on days 1, 3, 6, \& 11 Transplantation: allogeneic peripheral blood transplant on day 0 Maintenance: RTX 500 mg/m\^2 IV at 3, 6, 9, \& 12 months post-transplant
|
|---|---|
|
2-year Progression-free Survival in Early Disease Participants
|
79.5 percentage of participants
Interval 39.0 to 94.5
|
SECONDARY outcome
Timeframe: 5 years post-registrationOutcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 5 years post-registrationOutcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 5 years post-registrationOutcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 6 months post-transplantOutcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 5 years post-registrationOutcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 5 years post-registrationOutcome measures
Outcome data not reported
Adverse Events
Treatment (Combination of Chemotherapy and Transplant)
Serious events: 6 serious events
Other events: 58 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Treatment (Combination of Chemotherapy and Transplant)
n=59 participants at risk
Preparative: Patients receive 1 of 2 preparative regimens (Reg) chosen by the treating institution
* Reg1: Rituximab (RTX) 500 mg/m\^2 IV on days -7, -1, 7, and 14 \& fludarabine phosphate (FP) 30 mg/m\^2 IV \& busulfan 0.8 mg/kg IV on days -5 to -2
* Reg 2: RTX 500 mg/m\^2 IV on days -7, -1, 7, and 14 \& FP 30 mg/m\^2 IV on days -5 to -2 \& cyclophosphamide 1 g/m\^2 IV on days -5 to -3
Graft-vs-host disease (GVHD) prophylaxis: Patients treated with preparative regimen 1 received either GVHD prophylaxis regimen 1 or 2; those given preparative regimen 2 received regimen 2
* Reg 1: Tacrolimus PO or IV \& oral sirolimus 12 mg on day -2 through day 60, followed by taper until day 180 \& methotrexate (MTX) 5 mg/m\^2 IV on days 1, 3, and 6.
* Reg 2: Tacrolimus PO or IV on day -2 through day 60, followed by taper until day 180 \& MTX 5mg/m\^2 IV on days 1, 3, 6, \& 11 Transplantation: allogeneic peripheral blood transplant on day 0 Maintenance: RTX 500 mg/m\^2 IV at 3, 6, 9, \& 12 months post-transplant
|
|---|---|
|
Blood and lymphatic system disorders
Anemia
|
8.5%
5/59 • Number of events 8
Adverse event data is available for 59 participants . The remaining 9 participants cancelled before beginning treatment or withdrew consent for follow-up.
|
|
Ear and labyrinth disorders
Vertigo
|
1.7%
1/59 • Number of events 3
Adverse event data is available for 59 participants . The remaining 9 participants cancelled before beginning treatment or withdrew consent for follow-up.
|
|
Eye disorders
Corneal ulcer
|
1.7%
1/59 • Number of events 1
Adverse event data is available for 59 participants . The remaining 9 participants cancelled before beginning treatment or withdrew consent for follow-up.
|
|
Eye disorders
Eye disorders - Other, specify
|
1.7%
1/59 • Number of events 1
Adverse event data is available for 59 participants . The remaining 9 participants cancelled before beginning treatment or withdrew consent for follow-up.
|
|
Eye disorders
Keratitis
|
1.7%
1/59 • Number of events 1
Adverse event data is available for 59 participants . The remaining 9 participants cancelled before beginning treatment or withdrew consent for follow-up.
|
|
Gastrointestinal disorders
Diarrhea
|
1.7%
1/59 • Number of events 1
Adverse event data is available for 59 participants . The remaining 9 participants cancelled before beginning treatment or withdrew consent for follow-up.
|
|
Gastrointestinal disorders
Mucositis oral
|
1.7%
1/59 • Number of events 1
Adverse event data is available for 59 participants . The remaining 9 participants cancelled before beginning treatment or withdrew consent for follow-up.
|
|
Gastrointestinal disorders
Nausea
|
1.7%
1/59 • Number of events 3
Adverse event data is available for 59 participants . The remaining 9 participants cancelled before beginning treatment or withdrew consent for follow-up.
|
|
Gastrointestinal disorders
Vomiting
|
1.7%
1/59 • Number of events 3
Adverse event data is available for 59 participants . The remaining 9 participants cancelled before beginning treatment or withdrew consent for follow-up.
|
|
General disorders
Edema limbs
|
1.7%
1/59 • Number of events 1
Adverse event data is available for 59 participants . The remaining 9 participants cancelled before beginning treatment or withdrew consent for follow-up.
|
|
General disorders
Fatigue
|
5.1%
3/59 • Number of events 3
Adverse event data is available for 59 participants . The remaining 9 participants cancelled before beginning treatment or withdrew consent for follow-up.
|
|
Infections and infestations
Infections and infestations - Other, specify
|
1.7%
1/59 • Number of events 1
Adverse event data is available for 59 participants . The remaining 9 participants cancelled before beginning treatment or withdrew consent for follow-up.
|
|
Infections and infestations
Lung infection
|
3.4%
2/59 • Number of events 2
Adverse event data is available for 59 participants . The remaining 9 participants cancelled before beginning treatment or withdrew consent for follow-up.
|
|
Infections and infestations
Sepsis
|
1.7%
1/59 • Number of events 1
Adverse event data is available for 59 participants . The remaining 9 participants cancelled before beginning treatment or withdrew consent for follow-up.
|
|
Infections and infestations
Skin infection
|
1.7%
1/59 • Number of events 1
Adverse event data is available for 59 participants . The remaining 9 participants cancelled before beginning treatment or withdrew consent for follow-up.
|
|
Infections and infestations
Urinary tract infection
|
3.4%
2/59 • Number of events 2
Adverse event data is available for 59 participants . The remaining 9 participants cancelled before beginning treatment or withdrew consent for follow-up.
|
|
Infections and infestations
Vaginal infection
|
1.7%
1/59 • Number of events 1
Adverse event data is available for 59 participants . The remaining 9 participants cancelled before beginning treatment or withdrew consent for follow-up.
|
|
Investigations
Alanine aminotransferase increased
|
3.4%
2/59 • Number of events 2
Adverse event data is available for 59 participants . The remaining 9 participants cancelled before beginning treatment or withdrew consent for follow-up.
|
|
Investigations
Aspartate aminotransferase increased
|
1.7%
1/59 • Number of events 1
Adverse event data is available for 59 participants . The remaining 9 participants cancelled before beginning treatment or withdrew consent for follow-up.
|
|
Investigations
Blood bilirubin increased
|
3.4%
2/59 • Number of events 2
Adverse event data is available for 59 participants . The remaining 9 participants cancelled before beginning treatment or withdrew consent for follow-up.
|
|
Investigations
Cholesterol high
|
1.7%
1/59 • Number of events 1
Adverse event data is available for 59 participants . The remaining 9 participants cancelled before beginning treatment or withdrew consent for follow-up.
|
|
Investigations
Creatinine increased
|
6.8%
4/59 • Number of events 5
Adverse event data is available for 59 participants . The remaining 9 participants cancelled before beginning treatment or withdrew consent for follow-up.
|
|
Investigations
Investigations - Other, specify
|
1.7%
1/59 • Number of events 1
Adverse event data is available for 59 participants . The remaining 9 participants cancelled before beginning treatment or withdrew consent for follow-up.
|
|
Investigations
Lymphocyte count decreased
|
5.1%
3/59 • Number of events 5
Adverse event data is available for 59 participants . The remaining 9 participants cancelled before beginning treatment or withdrew consent for follow-up.
|
|
Investigations
Neutrophil count decreased
|
6.8%
4/59 • Number of events 6
Adverse event data is available for 59 participants . The remaining 9 participants cancelled before beginning treatment or withdrew consent for follow-up.
|
|
Investigations
Platelet count decreased
|
10.2%
6/59 • Number of events 7
Adverse event data is available for 59 participants . The remaining 9 participants cancelled before beginning treatment or withdrew consent for follow-up.
|
|
Investigations
White blood cell decreased
|
5.1%
3/59 • Number of events 4
Adverse event data is available for 59 participants . The remaining 9 participants cancelled before beginning treatment or withdrew consent for follow-up.
|
|
Metabolism and nutrition disorders
Anorexia
|
1.7%
1/59 • Number of events 1
Adverse event data is available for 59 participants . The remaining 9 participants cancelled before beginning treatment or withdrew consent for follow-up.
|
|
Metabolism and nutrition disorders
Glucose intolerance
|
1.7%
1/59 • Number of events 2
Adverse event data is available for 59 participants . The remaining 9 participants cancelled before beginning treatment or withdrew consent for follow-up.
|
|
Metabolism and nutrition disorders
Hyperglycemia
|
8.5%
5/59 • Number of events 6
Adverse event data is available for 59 participants . The remaining 9 participants cancelled before beginning treatment or withdrew consent for follow-up.
|
|
Metabolism and nutrition disorders
Hypertriglyceridemia
|
1.7%
1/59 • Number of events 1
Adverse event data is available for 59 participants . The remaining 9 participants cancelled before beginning treatment or withdrew consent for follow-up.
|
|
Metabolism and nutrition disorders
Hypoalbuminemia
|
3.4%
2/59 • Number of events 2
Adverse event data is available for 59 participants . The remaining 9 participants cancelled before beginning treatment or withdrew consent for follow-up.
|
|
Metabolism and nutrition disorders
Hypocalcemia
|
3.4%
2/59 • Number of events 2
Adverse event data is available for 59 participants . The remaining 9 participants cancelled before beginning treatment or withdrew consent for follow-up.
|
|
Metabolism and nutrition disorders
Hypokalemia
|
1.7%
1/59 • Number of events 1
Adverse event data is available for 59 participants . The remaining 9 participants cancelled before beginning treatment or withdrew consent for follow-up.
|
|
Metabolism and nutrition disorders
Hypomagnesemia
|
1.7%
1/59 • Number of events 1
Adverse event data is available for 59 participants . The remaining 9 participants cancelled before beginning treatment or withdrew consent for follow-up.
|
|
Metabolism and nutrition disorders
Hyponatremia
|
1.7%
1/59 • Number of events 1
Adverse event data is available for 59 participants . The remaining 9 participants cancelled before beginning treatment or withdrew consent for follow-up.
|
|
Nervous system disorders
Dizziness
|
1.7%
1/59 • Number of events 3
Adverse event data is available for 59 participants . The remaining 9 participants cancelled before beginning treatment or withdrew consent for follow-up.
|
|
Nervous system disorders
Dysphasia
|
1.7%
1/59 • Number of events 1
Adverse event data is available for 59 participants . The remaining 9 participants cancelled before beginning treatment or withdrew consent for follow-up.
|
|
Nervous system disorders
Edema cerebral
|
1.7%
1/59 • Number of events 1
Adverse event data is available for 59 participants . The remaining 9 participants cancelled before beginning treatment or withdrew consent for follow-up.
|
|
Nervous system disorders
Intracranial hemorrhage
|
3.4%
2/59 • Number of events 2
Adverse event data is available for 59 participants . The remaining 9 participants cancelled before beginning treatment or withdrew consent for follow-up.
|
|
Nervous system disorders
Nervous system disorders - Other, specify
|
3.4%
2/59 • Number of events 4
Adverse event data is available for 59 participants . The remaining 9 participants cancelled before beginning treatment or withdrew consent for follow-up.
|
|
Nervous system disorders
Stroke
|
1.7%
1/59 • Number of events 1
Adverse event data is available for 59 participants . The remaining 9 participants cancelled before beginning treatment or withdrew consent for follow-up.
|
|
Nervous system disorders
Tremor
|
1.7%
1/59 • Number of events 1
Adverse event data is available for 59 participants . The remaining 9 participants cancelled before beginning treatment or withdrew consent for follow-up.
|
|
Psychiatric disorders
Psychiatric disorders - Other, specify
|
1.7%
1/59 • Number of events 1
Adverse event data is available for 59 participants . The remaining 9 participants cancelled before beginning treatment or withdrew consent for follow-up.
|
|
Renal and urinary disorders
Chronic kidney disease
|
1.7%
1/59 • Number of events 1
Adverse event data is available for 59 participants . The remaining 9 participants cancelled before beginning treatment or withdrew consent for follow-up.
|
|
Reproductive system and breast disorders
Genital edema
|
1.7%
1/59 • Number of events 1
Adverse event data is available for 59 participants . The remaining 9 participants cancelled before beginning treatment or withdrew consent for follow-up.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
1.7%
1/59 • Number of events 1
Adverse event data is available for 59 participants . The remaining 9 participants cancelled before beginning treatment or withdrew consent for follow-up.
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
6.8%
4/59 • Number of events 4
Adverse event data is available for 59 participants . The remaining 9 participants cancelled before beginning treatment or withdrew consent for follow-up.
|
|
Vascular disorders
Hypertension
|
5.1%
3/59 • Number of events 3
Adverse event data is available for 59 participants . The remaining 9 participants cancelled before beginning treatment or withdrew consent for follow-up.
|
|
Vascular disorders
Hypotension
|
3.4%
2/59 • Number of events 2
Adverse event data is available for 59 participants . The remaining 9 participants cancelled before beginning treatment or withdrew consent for follow-up.
|
|
Vascular disorders
Thromboembolic event
|
1.7%
1/59 • Number of events 1
Adverse event data is available for 59 participants . The remaining 9 participants cancelled before beginning treatment or withdrew consent for follow-up.
|
Other adverse events
| Measure |
Treatment (Combination of Chemotherapy and Transplant)
n=59 participants at risk
Preparative: Patients receive 1 of 2 preparative regimens (Reg) chosen by the treating institution
* Reg1: Rituximab (RTX) 500 mg/m\^2 IV on days -7, -1, 7, and 14 \& fludarabine phosphate (FP) 30 mg/m\^2 IV \& busulfan 0.8 mg/kg IV on days -5 to -2
* Reg 2: RTX 500 mg/m\^2 IV on days -7, -1, 7, and 14 \& FP 30 mg/m\^2 IV on days -5 to -2 \& cyclophosphamide 1 g/m\^2 IV on days -5 to -3
Graft-vs-host disease (GVHD) prophylaxis: Patients treated with preparative regimen 1 received either GVHD prophylaxis regimen 1 or 2; those given preparative regimen 2 received regimen 2
* Reg 1: Tacrolimus PO or IV \& oral sirolimus 12 mg on day -2 through day 60, followed by taper until day 180 \& methotrexate (MTX) 5 mg/m\^2 IV on days 1, 3, and 6.
* Reg 2: Tacrolimus PO or IV on day -2 through day 60, followed by taper until day 180 \& MTX 5mg/m\^2 IV on days 1, 3, 6, \& 11 Transplantation: allogeneic peripheral blood transplant on day 0 Maintenance: RTX 500 mg/m\^2 IV at 3, 6, 9, \& 12 months post-transplant
|
|---|---|
|
Blood and lymphatic system disorders
Anemia
|
81.4%
48/59 • Number of events 161
Adverse event data is available for 59 participants . The remaining 9 participants cancelled before beginning treatment or withdrew consent for follow-up.
|
|
Blood and lymphatic system disorders
Blood and lymphatic system disorders - Other, specify
|
3.4%
2/59 • Number of events 4
Adverse event data is available for 59 participants . The remaining 9 participants cancelled before beginning treatment or withdrew consent for follow-up.
|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
10.2%
6/59 • Number of events 7
Adverse event data is available for 59 participants . The remaining 9 participants cancelled before beginning treatment or withdrew consent for follow-up.
|
|
Blood and lymphatic system disorders
Hemolysis
|
1.7%
1/59 • Number of events 1
Adverse event data is available for 59 participants . The remaining 9 participants cancelled before beginning treatment or withdrew consent for follow-up.
|
|
Blood and lymphatic system disorders
Leukocytosis
|
8.5%
5/59 • Number of events 5
Adverse event data is available for 59 participants . The remaining 9 participants cancelled before beginning treatment or withdrew consent for follow-up.
|
|
Cardiac disorders
Atrioventricular block first degree
|
1.7%
1/59 • Number of events 1
Adverse event data is available for 59 participants . The remaining 9 participants cancelled before beginning treatment or withdrew consent for follow-up.
|
|
Cardiac disorders
Palpitations
|
1.7%
1/59 • Number of events 1
Adverse event data is available for 59 participants . The remaining 9 participants cancelled before beginning treatment or withdrew consent for follow-up.
|
|
Cardiac disorders
Restrictive cardiomyopathy
|
1.7%
1/59 • Number of events 1
Adverse event data is available for 59 participants . The remaining 9 participants cancelled before beginning treatment or withdrew consent for follow-up.
|
|
Cardiac disorders
Sinus bradycardia
|
3.4%
2/59 • Number of events 2
Adverse event data is available for 59 participants . The remaining 9 participants cancelled before beginning treatment or withdrew consent for follow-up.
|
|
Cardiac disorders
Sinus tachycardia
|
6.8%
4/59 • Number of events 5
Adverse event data is available for 59 participants . The remaining 9 participants cancelled before beginning treatment or withdrew consent for follow-up.
|
|
Cardiac disorders
Supraventricular tachycardia
|
1.7%
1/59 • Number of events 1
Adverse event data is available for 59 participants . The remaining 9 participants cancelled before beginning treatment or withdrew consent for follow-up.
|
|
Ear and labyrinth disorders
Ear pain
|
1.7%
1/59 • Number of events 4
Adverse event data is available for 59 participants . The remaining 9 participants cancelled before beginning treatment or withdrew consent for follow-up.
|
|
Ear and labyrinth disorders
Tinnitus
|
1.7%
1/59 • Number of events 1
Adverse event data is available for 59 participants . The remaining 9 participants cancelled before beginning treatment or withdrew consent for follow-up.
|
|
Endocrine disorders
Cushingoid
|
5.1%
3/59 • Number of events 4
Adverse event data is available for 59 participants . The remaining 9 participants cancelled before beginning treatment or withdrew consent for follow-up.
|
|
Endocrine disorders
Endocrine disorders - Other, specify
|
1.7%
1/59 • Number of events 4
Adverse event data is available for 59 participants . The remaining 9 participants cancelled before beginning treatment or withdrew consent for follow-up.
|
|
Eye disorders
Blurred vision
|
5.1%
3/59 • Number of events 3
Adverse event data is available for 59 participants . The remaining 9 participants cancelled before beginning treatment or withdrew consent for follow-up.
|
|
Eye disorders
Cataract
|
1.7%
1/59 • Number of events 1
Adverse event data is available for 59 participants . The remaining 9 participants cancelled before beginning treatment or withdrew consent for follow-up.
|
|
Eye disorders
Corneal ulcer
|
1.7%
1/59 • Number of events 2
Adverse event data is available for 59 participants . The remaining 9 participants cancelled before beginning treatment or withdrew consent for follow-up.
|
|
Eye disorders
Dry eye
|
10.2%
6/59 • Number of events 11
Adverse event data is available for 59 participants . The remaining 9 participants cancelled before beginning treatment or withdrew consent for follow-up.
|
|
Eye disorders
Eye disorders - Other, specify
|
8.5%
5/59 • Number of events 7
Adverse event data is available for 59 participants . The remaining 9 participants cancelled before beginning treatment or withdrew consent for follow-up.
|
|
Eye disorders
Eye pain
|
1.7%
1/59 • Number of events 1
Adverse event data is available for 59 participants . The remaining 9 participants cancelled before beginning treatment or withdrew consent for follow-up.
|
|
Eye disorders
Keratitis
|
1.7%
1/59 • Number of events 1
Adverse event data is available for 59 participants . The remaining 9 participants cancelled before beginning treatment or withdrew consent for follow-up.
|
|
Eye disorders
Papilledema
|
1.7%
1/59 • Number of events 1
Adverse event data is available for 59 participants . The remaining 9 participants cancelled before beginning treatment or withdrew consent for follow-up.
|
|
Eye disorders
Photophobia
|
1.7%
1/59 • Number of events 1
Adverse event data is available for 59 participants . The remaining 9 participants cancelled before beginning treatment or withdrew consent for follow-up.
|
|
Eye disorders
Scleral disorder
|
1.7%
1/59 • Number of events 1
Adverse event data is available for 59 participants . The remaining 9 participants cancelled before beginning treatment or withdrew consent for follow-up.
|
|
Gastrointestinal disorders
Abdominal distension
|
6.8%
4/59 • Number of events 7
Adverse event data is available for 59 participants . The remaining 9 participants cancelled before beginning treatment or withdrew consent for follow-up.
|
|
Gastrointestinal disorders
Abdominal pain
|
22.0%
13/59 • Number of events 21
Adverse event data is available for 59 participants . The remaining 9 participants cancelled before beginning treatment or withdrew consent for follow-up.
|
|
Gastrointestinal disorders
Ascites
|
3.4%
2/59 • Number of events 6
Adverse event data is available for 59 participants . The remaining 9 participants cancelled before beginning treatment or withdrew consent for follow-up.
|
|
Gastrointestinal disorders
Colonic ulcer
|
1.7%
1/59 • Number of events 1
Adverse event data is available for 59 participants . The remaining 9 participants cancelled before beginning treatment or withdrew consent for follow-up.
|
|
Gastrointestinal disorders
Constipation
|
18.6%
11/59 • Number of events 14
Adverse event data is available for 59 participants . The remaining 9 participants cancelled before beginning treatment or withdrew consent for follow-up.
|
|
Gastrointestinal disorders
Diarrhea
|
47.5%
28/59 • Number of events 54
Adverse event data is available for 59 participants . The remaining 9 participants cancelled before beginning treatment or withdrew consent for follow-up.
|
|
Gastrointestinal disorders
Dry mouth
|
10.2%
6/59 • Number of events 16
Adverse event data is available for 59 participants . The remaining 9 participants cancelled before beginning treatment or withdrew consent for follow-up.
|
|
Gastrointestinal disorders
Dyspepsia
|
5.1%
3/59 • Number of events 3
Adverse event data is available for 59 participants . The remaining 9 participants cancelled before beginning treatment or withdrew consent for follow-up.
|
|
Gastrointestinal disorders
Dysphagia
|
1.7%
1/59 • Number of events 1
Adverse event data is available for 59 participants . The remaining 9 participants cancelled before beginning treatment or withdrew consent for follow-up.
|
|
Gastrointestinal disorders
Enterocolitis
|
1.7%
1/59 • Number of events 1
Adverse event data is available for 59 participants . The remaining 9 participants cancelled before beginning treatment or withdrew consent for follow-up.
|
|
Gastrointestinal disorders
Esophagitis
|
1.7%
1/59 • Number of events 1
Adverse event data is available for 59 participants . The remaining 9 participants cancelled before beginning treatment or withdrew consent for follow-up.
|
|
Gastrointestinal disorders
Gastritis
|
5.1%
3/59 • Number of events 3
Adverse event data is available for 59 participants . The remaining 9 participants cancelled before beginning treatment or withdrew consent for follow-up.
|
|
Gastrointestinal disorders
Gastrointestinal disorders - Other, specify
|
6.8%
4/59 • Number of events 4
Adverse event data is available for 59 participants . The remaining 9 participants cancelled before beginning treatment or withdrew consent for follow-up.
|
|
Gastrointestinal disorders
Gastrointestinal pain
|
1.7%
1/59 • Number of events 3
Adverse event data is available for 59 participants . The remaining 9 participants cancelled before beginning treatment or withdrew consent for follow-up.
|
|
Gastrointestinal disorders
Hemorrhoids
|
3.4%
2/59 • Number of events 2
Adverse event data is available for 59 participants . The remaining 9 participants cancelled before beginning treatment or withdrew consent for follow-up.
|
|
Gastrointestinal disorders
Ileus
|
1.7%
1/59 • Number of events 1
Adverse event data is available for 59 participants . The remaining 9 participants cancelled before beginning treatment or withdrew consent for follow-up.
|
|
Gastrointestinal disorders
Lip pain
|
1.7%
1/59 • Number of events 1
Adverse event data is available for 59 participants . The remaining 9 participants cancelled before beginning treatment or withdrew consent for follow-up.
|
|
Gastrointestinal disorders
Malabsorption
|
1.7%
1/59 • Number of events 1
Adverse event data is available for 59 participants . The remaining 9 participants cancelled before beginning treatment or withdrew consent for follow-up.
|
|
Gastrointestinal disorders
Mucositis oral
|
15.3%
9/59 • Number of events 9
Adverse event data is available for 59 participants . The remaining 9 participants cancelled before beginning treatment or withdrew consent for follow-up.
|
|
Gastrointestinal disorders
Nausea
|
49.2%
29/59 • Number of events 64
Adverse event data is available for 59 participants . The remaining 9 participants cancelled before beginning treatment or withdrew consent for follow-up.
|
|
Gastrointestinal disorders
Oral pain
|
5.1%
3/59 • Number of events 4
Adverse event data is available for 59 participants . The remaining 9 participants cancelled before beginning treatment or withdrew consent for follow-up.
|
|
Gastrointestinal disorders
Pancreatitis
|
1.7%
1/59 • Number of events 1
Adverse event data is available for 59 participants . The remaining 9 participants cancelled before beginning treatment or withdrew consent for follow-up.
|
|
Gastrointestinal disorders
Rectal pain
|
3.4%
2/59 • Number of events 2
Adverse event data is available for 59 participants . The remaining 9 participants cancelled before beginning treatment or withdrew consent for follow-up.
|
|
Gastrointestinal disorders
Stomach pain
|
1.7%
1/59 • Number of events 1
Adverse event data is available for 59 participants . The remaining 9 participants cancelled before beginning treatment or withdrew consent for follow-up.
|
|
Gastrointestinal disorders
Toothache
|
1.7%
1/59 • Number of events 1
Adverse event data is available for 59 participants . The remaining 9 participants cancelled before beginning treatment or withdrew consent for follow-up.
|
|
Gastrointestinal disorders
Vomiting
|
28.8%
17/59 • Number of events 28
Adverse event data is available for 59 participants . The remaining 9 participants cancelled before beginning treatment or withdrew consent for follow-up.
|
|
General disorders
Chills
|
13.6%
8/59 • Number of events 11
Adverse event data is available for 59 participants . The remaining 9 participants cancelled before beginning treatment or withdrew consent for follow-up.
|
|
General disorders
Edema face
|
8.5%
5/59 • Number of events 5
Adverse event data is available for 59 participants . The remaining 9 participants cancelled before beginning treatment or withdrew consent for follow-up.
|
|
General disorders
Edema limbs
|
28.8%
17/59 • Number of events 42
Adverse event data is available for 59 participants . The remaining 9 participants cancelled before beginning treatment or withdrew consent for follow-up.
|
|
General disorders
Fatigue
|
57.6%
34/59 • Number of events 105
Adverse event data is available for 59 participants . The remaining 9 participants cancelled before beginning treatment or withdrew consent for follow-up.
|
|
General disorders
Fever
|
28.8%
17/59 • Number of events 22
Adverse event data is available for 59 participants . The remaining 9 participants cancelled before beginning treatment or withdrew consent for follow-up.
|
|
General disorders
Infusion related reaction
|
3.4%
2/59 • Number of events 2
Adverse event data is available for 59 participants . The remaining 9 participants cancelled before beginning treatment or withdrew consent for follow-up.
|
|
General disorders
Injection site reaction
|
1.7%
1/59 • Number of events 1
Adverse event data is available for 59 participants . The remaining 9 participants cancelled before beginning treatment or withdrew consent for follow-up.
|
|
General disorders
Irritability
|
3.4%
2/59 • Number of events 2
Adverse event data is available for 59 participants . The remaining 9 participants cancelled before beginning treatment or withdrew consent for follow-up.
|
|
General disorders
Localized edema
|
1.7%
1/59 • Number of events 1
Adverse event data is available for 59 participants . The remaining 9 participants cancelled before beginning treatment or withdrew consent for follow-up.
|
|
General disorders
Malaise
|
5.1%
3/59 • Number of events 3
Adverse event data is available for 59 participants . The remaining 9 participants cancelled before beginning treatment or withdrew consent for follow-up.
|
|
General disorders
Neck edema
|
1.7%
1/59 • Number of events 1
Adverse event data is available for 59 participants . The remaining 9 participants cancelled before beginning treatment or withdrew consent for follow-up.
|
|
General disorders
Non-cardiac chest pain
|
3.4%
2/59 • Number of events 2
Adverse event data is available for 59 participants . The remaining 9 participants cancelled before beginning treatment or withdrew consent for follow-up.
|
|
General disorders
Pain
|
6.8%
4/59 • Number of events 8
Adverse event data is available for 59 participants . The remaining 9 participants cancelled before beginning treatment or withdrew consent for follow-up.
|
|
Hepatobiliary disorders
Cholecystitis
|
3.4%
2/59 • Number of events 3
Adverse event data is available for 59 participants . The remaining 9 participants cancelled before beginning treatment or withdrew consent for follow-up.
|
|
Hepatobiliary disorders
Hepatic failure
|
1.7%
1/59 • Number of events 1
Adverse event data is available for 59 participants . The remaining 9 participants cancelled before beginning treatment or withdrew consent for follow-up.
|
|
Hepatobiliary disorders
Hepatobiliary disorders - Other, specify
|
8.5%
5/59 • Number of events 10
Adverse event data is available for 59 participants . The remaining 9 participants cancelled before beginning treatment or withdrew consent for follow-up.
|
|
Immune system disorders
Allergic reaction
|
3.4%
2/59 • Number of events 2
Adverse event data is available for 59 participants . The remaining 9 participants cancelled before beginning treatment or withdrew consent for follow-up.
|
|
Infections and infestations
Abdominal infection
|
1.7%
1/59 • Number of events 1
Adverse event data is available for 59 participants . The remaining 9 participants cancelled before beginning treatment or withdrew consent for follow-up.
|
|
Infections and infestations
Bronchial infection
|
1.7%
1/59 • Number of events 1
Adverse event data is available for 59 participants . The remaining 9 participants cancelled before beginning treatment or withdrew consent for follow-up.
|
|
Infections and infestations
Catheter related infection
|
3.4%
2/59 • Number of events 2
Adverse event data is available for 59 participants . The remaining 9 participants cancelled before beginning treatment or withdrew consent for follow-up.
|
|
Infections and infestations
Eye infection
|
1.7%
1/59 • Number of events 1
Adverse event data is available for 59 participants . The remaining 9 participants cancelled before beginning treatment or withdrew consent for follow-up.
|
|
Infections and infestations
Hepatic infection
|
1.7%
1/59 • Number of events 1
Adverse event data is available for 59 participants . The remaining 9 participants cancelled before beginning treatment or withdrew consent for follow-up.
|
|
Infections and infestations
Infections and infestations - Other, specify
|
15.3%
9/59 • Number of events 14
Adverse event data is available for 59 participants . The remaining 9 participants cancelled before beginning treatment or withdrew consent for follow-up.
|
|
Infections and infestations
Joint infection
|
1.7%
1/59 • Number of events 1
Adverse event data is available for 59 participants . The remaining 9 participants cancelled before beginning treatment or withdrew consent for follow-up.
|
|
Infections and infestations
Lip infection
|
1.7%
1/59 • Number of events 1
Adverse event data is available for 59 participants . The remaining 9 participants cancelled before beginning treatment or withdrew consent for follow-up.
|
|
Infections and infestations
Lung infection
|
13.6%
8/59 • Number of events 9
Adverse event data is available for 59 participants . The remaining 9 participants cancelled before beginning treatment or withdrew consent for follow-up.
|
|
Infections and infestations
Meningitis
|
1.7%
1/59 • Number of events 1
Adverse event data is available for 59 participants . The remaining 9 participants cancelled before beginning treatment or withdrew consent for follow-up.
|
|
Infections and infestations
Mucosal infection
|
3.4%
2/59 • Number of events 4
Adverse event data is available for 59 participants . The remaining 9 participants cancelled before beginning treatment or withdrew consent for follow-up.
|
|
Infections and infestations
Rhinitis infective
|
1.7%
1/59 • Number of events 1
Adverse event data is available for 59 participants . The remaining 9 participants cancelled before beginning treatment or withdrew consent for follow-up.
|
|
Infections and infestations
Sepsis
|
3.4%
2/59 • Number of events 2
Adverse event data is available for 59 participants . The remaining 9 participants cancelled before beginning treatment or withdrew consent for follow-up.
|
|
Infections and infestations
Sinusitis
|
3.4%
2/59 • Number of events 9
Adverse event data is available for 59 participants . The remaining 9 participants cancelled before beginning treatment or withdrew consent for follow-up.
|
|
Infections and infestations
Skin infection
|
1.7%
1/59 • Number of events 1
Adverse event data is available for 59 participants . The remaining 9 participants cancelled before beginning treatment or withdrew consent for follow-up.
|
|
Infections and infestations
Upper respiratory infection
|
15.3%
9/59 • Number of events 15
Adverse event data is available for 59 participants . The remaining 9 participants cancelled before beginning treatment or withdrew consent for follow-up.
|
|
Infections and infestations
Urinary tract infection
|
1.7%
1/59 • Number of events 1
Adverse event data is available for 59 participants . The remaining 9 participants cancelled before beginning treatment or withdrew consent for follow-up.
|
|
Infections and infestations
Vaginal infection
|
1.7%
1/59 • Number of events 1
Adverse event data is available for 59 participants . The remaining 9 participants cancelled before beginning treatment or withdrew consent for follow-up.
|
|
Injury, poisoning and procedural complications
Bruising
|
1.7%
1/59 • Number of events 3
Adverse event data is available for 59 participants . The remaining 9 participants cancelled before beginning treatment or withdrew consent for follow-up.
|
|
Injury, poisoning and procedural complications
Fall
|
1.7%
1/59 • Number of events 1
Adverse event data is available for 59 participants . The remaining 9 participants cancelled before beginning treatment or withdrew consent for follow-up.
|
|
Injury, poisoning and procedural complications
Fracture
|
3.4%
2/59 • Number of events 2
Adverse event data is available for 59 participants . The remaining 9 participants cancelled before beginning treatment or withdrew consent for follow-up.
|
|
Injury, poisoning and procedural complications
Hip fracture
|
1.7%
1/59 • Number of events 1
Adverse event data is available for 59 participants . The remaining 9 participants cancelled before beginning treatment or withdrew consent for follow-up.
|
|
Injury, poisoning and procedural complications
Intraoperative renal injury
|
1.7%
1/59 • Number of events 1
Adverse event data is available for 59 participants . The remaining 9 participants cancelled before beginning treatment or withdrew consent for follow-up.
|
|
Investigations
Activated partial thromboplastin time prolonged
|
11.9%
7/59 • Number of events 8
Adverse event data is available for 59 participants . The remaining 9 participants cancelled before beginning treatment or withdrew consent for follow-up.
|
|
Investigations
Alanine aminotransferase increased
|
44.1%
26/59 • Number of events 65
Adverse event data is available for 59 participants . The remaining 9 participants cancelled before beginning treatment or withdrew consent for follow-up.
|
|
Investigations
Alkaline phosphatase increased
|
28.8%
17/59 • Number of events 37
Adverse event data is available for 59 participants . The remaining 9 participants cancelled before beginning treatment or withdrew consent for follow-up.
|
|
Investigations
Aspartate aminotransferase increased
|
42.4%
25/59 • Number of events 71
Adverse event data is available for 59 participants . The remaining 9 participants cancelled before beginning treatment or withdrew consent for follow-up.
|
|
Investigations
Blood bilirubin increased
|
35.6%
21/59 • Number of events 44
Adverse event data is available for 59 participants . The remaining 9 participants cancelled before beginning treatment or withdrew consent for follow-up.
|
|
Investigations
Cholesterol high
|
13.6%
8/59 • Number of events 12
Adverse event data is available for 59 participants . The remaining 9 participants cancelled before beginning treatment or withdrew consent for follow-up.
|
|
Investigations
Creatinine increased
|
61.0%
36/59 • Number of events 70
Adverse event data is available for 59 participants . The remaining 9 participants cancelled before beginning treatment or withdrew consent for follow-up.
|
|
Investigations
INR increased
|
1.7%
1/59 • Number of events 1
Adverse event data is available for 59 participants . The remaining 9 participants cancelled before beginning treatment or withdrew consent for follow-up.
|
|
Investigations
Investigations - Other, specify
|
22.0%
13/59 • Number of events 51
Adverse event data is available for 59 participants . The remaining 9 participants cancelled before beginning treatment or withdrew consent for follow-up.
|
|
Investigations
Lymphocyte count decreased
|
59.3%
35/59 • Number of events 97
Adverse event data is available for 59 participants . The remaining 9 participants cancelled before beginning treatment or withdrew consent for follow-up.
|
|
Investigations
Lymphocyte count increased
|
11.9%
7/59 • Number of events 9
Adverse event data is available for 59 participants . The remaining 9 participants cancelled before beginning treatment or withdrew consent for follow-up.
|
|
Investigations
Neutrophil count decreased
|
86.4%
51/59 • Number of events 137
Adverse event data is available for 59 participants . The remaining 9 participants cancelled before beginning treatment or withdrew consent for follow-up.
|
|
Investigations
Platelet count decreased
|
88.1%
52/59 • Number of events 143
Adverse event data is available for 59 participants . The remaining 9 participants cancelled before beginning treatment or withdrew consent for follow-up.
|
|
Investigations
Weight gain
|
1.7%
1/59 • Number of events 1
Adverse event data is available for 59 participants . The remaining 9 participants cancelled before beginning treatment or withdrew consent for follow-up.
|
|
Investigations
Weight loss
|
11.9%
7/59 • Number of events 9
Adverse event data is available for 59 participants . The remaining 9 participants cancelled before beginning treatment or withdrew consent for follow-up.
|
|
Investigations
White blood cell decreased
|
55.9%
33/59 • Number of events 80
Adverse event data is available for 59 participants . The remaining 9 participants cancelled before beginning treatment or withdrew consent for follow-up.
|
|
Metabolism and nutrition disorders
Anorexia
|
16.9%
10/59 • Number of events 14
Adverse event data is available for 59 participants . The remaining 9 participants cancelled before beginning treatment or withdrew consent for follow-up.
|
|
Metabolism and nutrition disorders
Dehydration
|
1.7%
1/59 • Number of events 1
Adverse event data is available for 59 participants . The remaining 9 participants cancelled before beginning treatment or withdrew consent for follow-up.
|
|
Metabolism and nutrition disorders
Hypercalcemia
|
1.7%
1/59 • Number of events 1
Adverse event data is available for 59 participants . The remaining 9 participants cancelled before beginning treatment or withdrew consent for follow-up.
|
|
Metabolism and nutrition disorders
Hyperglycemia
|
67.8%
40/59 • Number of events 153
Adverse event data is available for 59 participants . The remaining 9 participants cancelled before beginning treatment or withdrew consent for follow-up.
|
|
Metabolism and nutrition disorders
Hyperkalemia
|
23.7%
14/59 • Number of events 22
Adverse event data is available for 59 participants . The remaining 9 participants cancelled before beginning treatment or withdrew consent for follow-up.
|
|
Metabolism and nutrition disorders
Hypermagnesemia
|
6.8%
4/59 • Number of events 4
Adverse event data is available for 59 participants . The remaining 9 participants cancelled before beginning treatment or withdrew consent for follow-up.
|
|
Metabolism and nutrition disorders
Hypernatremia
|
11.9%
7/59 • Number of events 9
Adverse event data is available for 59 participants . The remaining 9 participants cancelled before beginning treatment or withdrew consent for follow-up.
|
|
Metabolism and nutrition disorders
Hypertriglyceridemia
|
23.7%
14/59 • Number of events 19
Adverse event data is available for 59 participants . The remaining 9 participants cancelled before beginning treatment or withdrew consent for follow-up.
|
|
Metabolism and nutrition disorders
Hyperuricemia
|
1.7%
1/59 • Number of events 1
Adverse event data is available for 59 participants . The remaining 9 participants cancelled before beginning treatment or withdrew consent for follow-up.
|
|
Metabolism and nutrition disorders
Hypoalbuminemia
|
32.2%
19/59 • Number of events 34
Adverse event data is available for 59 participants . The remaining 9 participants cancelled before beginning treatment or withdrew consent for follow-up.
|
|
Metabolism and nutrition disorders
Hypocalcemia
|
44.1%
26/59 • Number of events 50
Adverse event data is available for 59 participants . The remaining 9 participants cancelled before beginning treatment or withdrew consent for follow-up.
|
|
Metabolism and nutrition disorders
Hypoglycemia
|
6.8%
4/59 • Number of events 5
Adverse event data is available for 59 participants . The remaining 9 participants cancelled before beginning treatment or withdrew consent for follow-up.
|
|
Metabolism and nutrition disorders
Hypokalemia
|
22.0%
13/59 • Number of events 18
Adverse event data is available for 59 participants . The remaining 9 participants cancelled before beginning treatment or withdrew consent for follow-up.
|
|
Metabolism and nutrition disorders
Hypomagnesemia
|
42.4%
25/59 • Number of events 52
Adverse event data is available for 59 participants . The remaining 9 participants cancelled before beginning treatment or withdrew consent for follow-up.
|
|
Metabolism and nutrition disorders
Hyponatremia
|
30.5%
18/59 • Number of events 39
Adverse event data is available for 59 participants . The remaining 9 participants cancelled before beginning treatment or withdrew consent for follow-up.
|
|
Metabolism and nutrition disorders
Hypophosphatemia
|
20.3%
12/59 • Number of events 22
Adverse event data is available for 59 participants . The remaining 9 participants cancelled before beginning treatment or withdrew consent for follow-up.
|
|
Metabolism and nutrition disorders
Metabolism and nutrition disorders - Other, specify
|
6.8%
4/59 • Number of events 9
Adverse event data is available for 59 participants . The remaining 9 participants cancelled before beginning treatment or withdrew consent for follow-up.
|
|
Metabolism and nutrition disorders
Obesity
|
15.3%
9/59 • Number of events 27
Adverse event data is available for 59 participants . The remaining 9 participants cancelled before beginning treatment or withdrew consent for follow-up.
|
|
Musculoskeletal and connective tissue disorders
Abdominal soft tissue necrosis
|
1.7%
1/59 • Number of events 1
Adverse event data is available for 59 participants . The remaining 9 participants cancelled before beginning treatment or withdrew consent for follow-up.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
13.6%
8/59 • Number of events 12
Adverse event data is available for 59 participants . The remaining 9 participants cancelled before beginning treatment or withdrew consent for follow-up.
|
|
Musculoskeletal and connective tissue disorders
Arthritis
|
6.8%
4/59 • Number of events 7
Adverse event data is available for 59 participants . The remaining 9 participants cancelled before beginning treatment or withdrew consent for follow-up.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
25.4%
15/59 • Number of events 21
Adverse event data is available for 59 participants . The remaining 9 participants cancelled before beginning treatment or withdrew consent for follow-up.
|
|
Musculoskeletal and connective tissue disorders
Bone pain
|
3.4%
2/59 • Number of events 2
Adverse event data is available for 59 participants . The remaining 9 participants cancelled before beginning treatment or withdrew consent for follow-up.
|
|
Musculoskeletal and connective tissue disorders
Chest wall pain
|
1.7%
1/59 • Number of events 1
Adverse event data is available for 59 participants . The remaining 9 participants cancelled before beginning treatment or withdrew consent for follow-up.
|
|
Musculoskeletal and connective tissue disorders
Flank pain
|
6.8%
4/59 • Number of events 4
Adverse event data is available for 59 participants . The remaining 9 participants cancelled before beginning treatment or withdrew consent for follow-up.
|
|
Musculoskeletal and connective tissue disorders
Generalized muscle weakness
|
6.8%
4/59 • Number of events 6
Adverse event data is available for 59 participants . The remaining 9 participants cancelled before beginning treatment or withdrew consent for follow-up.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal and connective tissue disorder - Other, specify
|
6.8%
4/59 • Number of events 6
Adverse event data is available for 59 participants . The remaining 9 participants cancelled before beginning treatment or withdrew consent for follow-up.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
11.9%
7/59 • Number of events 9
Adverse event data is available for 59 participants . The remaining 9 participants cancelled before beginning treatment or withdrew consent for follow-up.
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
5.1%
3/59 • Number of events 5
Adverse event data is available for 59 participants . The remaining 9 participants cancelled before beginning treatment or withdrew consent for follow-up.
|
|
Musculoskeletal and connective tissue disorders
Osteoporosis
|
1.7%
1/59 • Number of events 1
Adverse event data is available for 59 participants . The remaining 9 participants cancelled before beginning treatment or withdrew consent for follow-up.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
8.5%
5/59 • Number of events 5
Adverse event data is available for 59 participants . The remaining 9 participants cancelled before beginning treatment or withdrew consent for follow-up.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Neoplasms benign, malignant and unspecified (incl cysts and polyps) - Other, specify
|
1.7%
1/59 • Number of events 3
Adverse event data is available for 59 participants . The remaining 9 participants cancelled before beginning treatment or withdrew consent for follow-up.
|
|
Nervous system disorders
Ataxia
|
1.7%
1/59 • Number of events 1
Adverse event data is available for 59 participants . The remaining 9 participants cancelled before beginning treatment or withdrew consent for follow-up.
|
|
Nervous system disorders
Dizziness
|
11.9%
7/59 • Number of events 11
Adverse event data is available for 59 participants . The remaining 9 participants cancelled before beginning treatment or withdrew consent for follow-up.
|
|
Nervous system disorders
Dysesthesia
|
1.7%
1/59 • Number of events 1
Adverse event data is available for 59 participants . The remaining 9 participants cancelled before beginning treatment or withdrew consent for follow-up.
|
|
Nervous system disorders
Dysgeusia
|
5.1%
3/59 • Number of events 4
Adverse event data is available for 59 participants . The remaining 9 participants cancelled before beginning treatment or withdrew consent for follow-up.
|
|
Nervous system disorders
Headache
|
39.0%
23/59 • Number of events 31
Adverse event data is available for 59 participants . The remaining 9 participants cancelled before beginning treatment or withdrew consent for follow-up.
|
|
Nervous system disorders
Lethargy
|
1.7%
1/59 • Number of events 1
Adverse event data is available for 59 participants . The remaining 9 participants cancelled before beginning treatment or withdrew consent for follow-up.
|
|
Nervous system disorders
Nervous system disorders - Other, specify
|
1.7%
1/59 • Number of events 1
Adverse event data is available for 59 participants . The remaining 9 participants cancelled before beginning treatment or withdrew consent for follow-up.
|
|
Nervous system disorders
Neuralgia
|
3.4%
2/59 • Number of events 3
Adverse event data is available for 59 participants . The remaining 9 participants cancelled before beginning treatment or withdrew consent for follow-up.
|
|
Nervous system disorders
Paresthesia
|
3.4%
2/59 • Number of events 3
Adverse event data is available for 59 participants . The remaining 9 participants cancelled before beginning treatment or withdrew consent for follow-up.
|
|
Nervous system disorders
Peripheral motor neuropathy
|
5.1%
3/59 • Number of events 3
Adverse event data is available for 59 participants . The remaining 9 participants cancelled before beginning treatment or withdrew consent for follow-up.
|
|
Nervous system disorders
Peripheral sensory neuropathy
|
11.9%
7/59 • Number of events 14
Adverse event data is available for 59 participants . The remaining 9 participants cancelled before beginning treatment or withdrew consent for follow-up.
|
|
Nervous system disorders
Sinus pain
|
5.1%
3/59 • Number of events 5
Adverse event data is available for 59 participants . The remaining 9 participants cancelled before beginning treatment or withdrew consent for follow-up.
|
|
Nervous system disorders
Stroke
|
1.7%
1/59 • Number of events 2
Adverse event data is available for 59 participants . The remaining 9 participants cancelled before beginning treatment or withdrew consent for follow-up.
|
|
Nervous system disorders
Syncope
|
1.7%
1/59 • Number of events 1
Adverse event data is available for 59 participants . The remaining 9 participants cancelled before beginning treatment or withdrew consent for follow-up.
|
|
Nervous system disorders
Transient ischemic attacks
|
1.7%
1/59 • Number of events 1
Adverse event data is available for 59 participants . The remaining 9 participants cancelled before beginning treatment or withdrew consent for follow-up.
|
|
Nervous system disorders
Tremor
|
23.7%
14/59 • Number of events 25
Adverse event data is available for 59 participants . The remaining 9 participants cancelled before beginning treatment or withdrew consent for follow-up.
|
|
Psychiatric disorders
Agitation
|
1.7%
1/59 • Number of events 4
Adverse event data is available for 59 participants . The remaining 9 participants cancelled before beginning treatment or withdrew consent for follow-up.
|
|
Psychiatric disorders
Anxiety
|
11.9%
7/59 • Number of events 16
Adverse event data is available for 59 participants . The remaining 9 participants cancelled before beginning treatment or withdrew consent for follow-up.
|
|
Psychiatric disorders
Confusion
|
1.7%
1/59 • Number of events 1
Adverse event data is available for 59 participants . The remaining 9 participants cancelled before beginning treatment or withdrew consent for follow-up.
|
|
Psychiatric disorders
Delirium
|
1.7%
1/59 • Number of events 1
Adverse event data is available for 59 participants . The remaining 9 participants cancelled before beginning treatment or withdrew consent for follow-up.
|
|
Psychiatric disorders
Depression
|
11.9%
7/59 • Number of events 12
Adverse event data is available for 59 participants . The remaining 9 participants cancelled before beginning treatment or withdrew consent for follow-up.
|
|
Psychiatric disorders
Hallucinations
|
1.7%
1/59 • Number of events 1
Adverse event data is available for 59 participants . The remaining 9 participants cancelled before beginning treatment or withdrew consent for follow-up.
|
|
Psychiatric disorders
Insomnia
|
13.6%
8/59 • Number of events 9
Adverse event data is available for 59 participants . The remaining 9 participants cancelled before beginning treatment or withdrew consent for follow-up.
|
|
Psychiatric disorders
Libido decreased
|
3.4%
2/59 • Number of events 2
Adverse event data is available for 59 participants . The remaining 9 participants cancelled before beginning treatment or withdrew consent for follow-up.
|
|
Psychiatric disorders
Psychiatric disorders - Other, specify
|
1.7%
1/59 • Number of events 1
Adverse event data is available for 59 participants . The remaining 9 participants cancelled before beginning treatment or withdrew consent for follow-up.
|
|
Renal and urinary disorders
Acute kidney injury
|
3.4%
2/59 • Number of events 2
Adverse event data is available for 59 participants . The remaining 9 participants cancelled before beginning treatment or withdrew consent for follow-up.
|
|
Renal and urinary disorders
Cystitis noninfective
|
3.4%
2/59 • Number of events 2
Adverse event data is available for 59 participants . The remaining 9 participants cancelled before beginning treatment or withdrew consent for follow-up.
|
|
Renal and urinary disorders
Hematuria
|
3.4%
2/59 • Number of events 3
Adverse event data is available for 59 participants . The remaining 9 participants cancelled before beginning treatment or withdrew consent for follow-up.
|
|
Renal and urinary disorders
Renal and urinary disorders - Other, specify
|
3.4%
2/59 • Number of events 2
Adverse event data is available for 59 participants . The remaining 9 participants cancelled before beginning treatment or withdrew consent for follow-up.
|
|
Renal and urinary disorders
Urinary frequency
|
5.1%
3/59 • Number of events 6
Adverse event data is available for 59 participants . The remaining 9 participants cancelled before beginning treatment or withdrew consent for follow-up.
|
|
Renal and urinary disorders
Urinary urgency
|
1.7%
1/59 • Number of events 1
Adverse event data is available for 59 participants . The remaining 9 participants cancelled before beginning treatment or withdrew consent for follow-up.
|
|
Renal and urinary disorders
Urine discoloration
|
1.7%
1/59 • Number of events 2
Adverse event data is available for 59 participants . The remaining 9 participants cancelled before beginning treatment or withdrew consent for follow-up.
|
|
Reproductive system and breast disorders
Erectile dysfunction
|
1.7%
1/59 • Number of events 1
Adverse event data is available for 59 participants . The remaining 9 participants cancelled before beginning treatment or withdrew consent for follow-up.
|
|
Respiratory, thoracic and mediastinal disorders
Allergic rhinitis
|
3.4%
2/59 • Number of events 9
Adverse event data is available for 59 participants . The remaining 9 participants cancelled before beginning treatment or withdrew consent for follow-up.
|
|
Respiratory, thoracic and mediastinal disorders
Apnea
|
3.4%
2/59 • Number of events 3
Adverse event data is available for 59 participants . The remaining 9 participants cancelled before beginning treatment or withdrew consent for follow-up.
|
|
Respiratory, thoracic and mediastinal disorders
Aspiration
|
3.4%
2/59 • Number of events 3
Adverse event data is available for 59 participants . The remaining 9 participants cancelled before beginning treatment or withdrew consent for follow-up.
|
|
Respiratory, thoracic and mediastinal disorders
Atelectasis
|
1.7%
1/59 • Number of events 2
Adverse event data is available for 59 participants . The remaining 9 participants cancelled before beginning treatment or withdrew consent for follow-up.
|
|
Respiratory, thoracic and mediastinal disorders
Bronchopleural fistula
|
1.7%
1/59 • Number of events 1
Adverse event data is available for 59 participants . The remaining 9 participants cancelled before beginning treatment or withdrew consent for follow-up.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
37.3%
22/59 • Number of events 44
Adverse event data is available for 59 participants . The remaining 9 participants cancelled before beginning treatment or withdrew consent for follow-up.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
25.4%
15/59 • Number of events 28
Adverse event data is available for 59 participants . The remaining 9 participants cancelled before beginning treatment or withdrew consent for follow-up.
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
6.8%
4/59 • Number of events 5
Adverse event data is available for 59 participants . The remaining 9 participants cancelled before beginning treatment or withdrew consent for follow-up.
|
|
Respiratory, thoracic and mediastinal disorders
Hoarseness
|
1.7%
1/59 • Number of events 1
Adverse event data is available for 59 participants . The remaining 9 participants cancelled before beginning treatment or withdrew consent for follow-up.
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
6.8%
4/59 • Number of events 5
Adverse event data is available for 59 participants . The remaining 9 participants cancelled before beginning treatment or withdrew consent for follow-up.
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
11.9%
7/59 • Number of events 8
Adverse event data is available for 59 participants . The remaining 9 participants cancelled before beginning treatment or withdrew consent for follow-up.
|
|
Respiratory, thoracic and mediastinal disorders
Pharyngolaryngeal pain
|
3.4%
2/59 • Number of events 2
Adverse event data is available for 59 participants . The remaining 9 participants cancelled before beginning treatment or withdrew consent for follow-up.
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
5.1%
3/59 • Number of events 3
Adverse event data is available for 59 participants . The remaining 9 participants cancelled before beginning treatment or withdrew consent for follow-up.
|
|
Respiratory, thoracic and mediastinal disorders
Pleuritic pain
|
3.4%
2/59 • Number of events 3
Adverse event data is available for 59 participants . The remaining 9 participants cancelled before beginning treatment or withdrew consent for follow-up.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonitis
|
10.2%
6/59 • Number of events 8
Adverse event data is available for 59 participants . The remaining 9 participants cancelled before beginning treatment or withdrew consent for follow-up.
|
|
Respiratory, thoracic and mediastinal disorders
Postnasal drip
|
3.4%
2/59 • Number of events 3
Adverse event data is available for 59 participants . The remaining 9 participants cancelled before beginning treatment or withdrew consent for follow-up.
|
|
Respiratory, thoracic and mediastinal disorders
Productive cough
|
5.1%
3/59 • Number of events 3
Adverse event data is available for 59 participants . The remaining 9 participants cancelled before beginning treatment or withdrew consent for follow-up.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure
|
3.4%
2/59 • Number of events 2
Adverse event data is available for 59 participants . The remaining 9 participants cancelled before beginning treatment or withdrew consent for follow-up.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory, thoracic and mediastinal disorders - Other, specify
|
8.5%
5/59 • Number of events 10
Adverse event data is available for 59 participants . The remaining 9 participants cancelled before beginning treatment or withdrew consent for follow-up.
|
|
Respiratory, thoracic and mediastinal disorders
Sinus disorder
|
1.7%
1/59 • Number of events 1
Adverse event data is available for 59 participants . The remaining 9 participants cancelled before beginning treatment or withdrew consent for follow-up.
|
|
Respiratory, thoracic and mediastinal disorders
Sleep apnea
|
3.4%
2/59 • Number of events 3
Adverse event data is available for 59 participants . The remaining 9 participants cancelled before beginning treatment or withdrew consent for follow-up.
|
|
Respiratory, thoracic and mediastinal disorders
Sore throat
|
11.9%
7/59 • Number of events 7
Adverse event data is available for 59 participants . The remaining 9 participants cancelled before beginning treatment or withdrew consent for follow-up.
|
|
Respiratory, thoracic and mediastinal disorders
Wheezing
|
1.7%
1/59 • Number of events 1
Adverse event data is available for 59 participants . The remaining 9 participants cancelled before beginning treatment or withdrew consent for follow-up.
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
1.7%
1/59 • Number of events 2
Adverse event data is available for 59 participants . The remaining 9 participants cancelled before beginning treatment or withdrew consent for follow-up.
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
8.5%
5/59 • Number of events 12
Adverse event data is available for 59 participants . The remaining 9 participants cancelled before beginning treatment or withdrew consent for follow-up.
|
|
Skin and subcutaneous tissue disorders
Erythema multiforme
|
1.7%
1/59 • Number of events 1
Adverse event data is available for 59 participants . The remaining 9 participants cancelled before beginning treatment or withdrew consent for follow-up.
|
|
Skin and subcutaneous tissue disorders
Pain of skin
|
1.7%
1/59 • Number of events 1
Adverse event data is available for 59 participants . The remaining 9 participants cancelled before beginning treatment or withdrew consent for follow-up.
|
|
Skin and subcutaneous tissue disorders
Periorbital edema
|
3.4%
2/59 • Number of events 2
Adverse event data is available for 59 participants . The remaining 9 participants cancelled before beginning treatment or withdrew consent for follow-up.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
18.6%
11/59 • Number of events 20
Adverse event data is available for 59 participants . The remaining 9 participants cancelled before beginning treatment or withdrew consent for follow-up.
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
55.9%
33/59 • Number of events 68
Adverse event data is available for 59 participants . The remaining 9 participants cancelled before beginning treatment or withdrew consent for follow-up.
|
|
Skin and subcutaneous tissue disorders
Skin and subcutaneous tissue disorders - Other, specify
|
16.9%
10/59 • Number of events 12
Adverse event data is available for 59 participants . The remaining 9 participants cancelled before beginning treatment or withdrew consent for follow-up.
|
|
Skin and subcutaneous tissue disorders
Skin hyperpigmentation
|
6.8%
4/59 • Number of events 5
Adverse event data is available for 59 participants . The remaining 9 participants cancelled before beginning treatment or withdrew consent for follow-up.
|
|
Skin and subcutaneous tissue disorders
Skin hypopigmentation
|
1.7%
1/59 • Number of events 1
Adverse event data is available for 59 participants . The remaining 9 participants cancelled before beginning treatment or withdrew consent for follow-up.
|
|
Skin and subcutaneous tissue disorders
Skin ulceration
|
3.4%
2/59 • Number of events 2
Adverse event data is available for 59 participants . The remaining 9 participants cancelled before beginning treatment or withdrew consent for follow-up.
|
|
Skin and subcutaneous tissue disorders
Urticaria
|
1.7%
1/59 • Number of events 1
Adverse event data is available for 59 participants . The remaining 9 participants cancelled before beginning treatment or withdrew consent for follow-up.
|
|
Surgical and medical procedures
Surgical and medical procedures - Other, specify
|
1.7%
1/59 • Number of events 2
Adverse event data is available for 59 participants . The remaining 9 participants cancelled before beginning treatment or withdrew consent for follow-up.
|
|
Vascular disorders
Flushing
|
3.4%
2/59 • Number of events 2
Adverse event data is available for 59 participants . The remaining 9 participants cancelled before beginning treatment or withdrew consent for follow-up.
|
|
Vascular disorders
Hot flashes
|
3.4%
2/59 • Number of events 4
Adverse event data is available for 59 participants . The remaining 9 participants cancelled before beginning treatment or withdrew consent for follow-up.
|
|
Vascular disorders
Hypertension
|
42.4%
25/59 • Number of events 76
Adverse event data is available for 59 participants . The remaining 9 participants cancelled before beginning treatment or withdrew consent for follow-up.
|
|
Vascular disorders
Hypotension
|
8.5%
5/59 • Number of events 5
Adverse event data is available for 59 participants . The remaining 9 participants cancelled before beginning treatment or withdrew consent for follow-up.
|
|
Vascular disorders
Superficial thrombophlebitis
|
1.7%
1/59 • Number of events 1
Adverse event data is available for 59 participants . The remaining 9 participants cancelled before beginning treatment or withdrew consent for follow-up.
|
|
Vascular disorders
Thromboembolic event
|
6.8%
4/59 • Number of events 4
Adverse event data is available for 59 participants . The remaining 9 participants cancelled before beginning treatment or withdrew consent for follow-up.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: LTE60