Trial Outcomes & Findings for Ruxolitinib for the Treatment of Chronic Myelomonocytic Leukemia (CMML): A Phase 2 Expansion (NCT NCT03722407)
NCT ID: NCT03722407
Last Updated: 2026-01-26
Results Overview
Number of participants achieving clinical benefit defined as hematologic improvement, complete remission, partial remission, or stable disease by the International Working Group Myelodysplastic/Myeloproliferative Neoplasms (MDS/MPN) Criteria.
Recruitment status
ACTIVE_NOT_RECRUITING
Study phase
PHASE2
Target enrollment
29 participants
Primary outcome timeframe
At week 16
Results posted on
2026-01-26
Participant Flow
Participant milestones
| Measure |
Ruxolitinib
All patients will be given their first dose of oral Ruxolitinib, 20 mg at first scheduled visit. After that dose and on all other days patients will self-administer oral Ruxolitinib at a dose of 40 mg daily divided into two equal doses approximately 12 hours apart. Patients will be treated for a total of 16 weeks. After treatment, patients will be followed monthly.
Ruxolitinib: Ruxolitinib 5 mg tablets, 4 per dose
|
|---|---|
|
Overall Study
STARTED
|
29
|
|
Overall Study
COMPLETED
|
29
|
|
Overall Study
NOT COMPLETED
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Ruxolitinib for the Treatment of Chronic Myelomonocytic Leukemia (CMML): A Phase 2 Expansion
Baseline characteristics by cohort
| Measure |
Ruxolitinib
n=29 Participants
All patients will be given their first dose of oral Ruxolitinib, 20 mg at first scheduled visit. After that dose and on all other days patients will self-administer oral Ruxolitinib at a dose of 40 mg daily divided into two equal doses approximately 12 hours apart. Patients will be treated for a total of 16 weeks. After treatment, patients will be followed monthly.
Ruxolitinib: Ruxolitinib 5 mg tablets, 4 per dose
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=25 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
4 Participants
n=25 Participants
|
|
Age, Categorical
>=65 years
|
25 Participants
n=25 Participants
|
|
Sex: Female, Male
Female
|
11 Participants
n=25 Participants
|
|
Sex: Female, Male
Male
|
18 Participants
n=25 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
1 Participants
n=25 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
25 Participants
n=25 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
3 Participants
n=25 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=25 Participants
|
|
Race (NIH/OMB)
Asian
|
1 Participants
n=25 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=25 Participants
|
|
Race (NIH/OMB)
Black or African American
|
1 Participants
n=25 Participants
|
|
Race (NIH/OMB)
White
|
27 Participants
n=25 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=25 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=25 Participants
|
|
Region of Enrollment
United States
|
29 participants
n=25 Participants
|
PRIMARY outcome
Timeframe: At week 16Population: Evaluable participants
Number of participants achieving clinical benefit defined as hematologic improvement, complete remission, partial remission, or stable disease by the International Working Group Myelodysplastic/Myeloproliferative Neoplasms (MDS/MPN) Criteria.
Outcome measures
| Measure |
Ruxolitinib
n=25 Participants
All patients will be given their first dose of oral Ruxolitinib, 20 mg at first scheduled visit. After that dose and on all other days patients will self-administer oral Ruxolitinib at a dose of 40 mg daily divided into two equal doses approximately 12 hours apart. Patients will be treated for a total of 16 weeks. After treatment, patients will be followed monthly.
Ruxolitinib: Ruxolitinib 5 mg tablets, 4 per dose
|
|---|---|
|
Overall Response
Partial Response
|
3 Participants
|
|
Overall Response
Marrow Response
|
2 Participants
|
|
Overall Response
Stable Disease
|
20 Participants
|
SECONDARY outcome
Timeframe: Every 6 months after conclusion of treatment until end of study (40.3 months)Population: Participants who had AML transformation
Time to AML transformation according to World Health Organization (WHO) Critieria
Outcome measures
| Measure |
Ruxolitinib
n=8 Participants
All patients will be given their first dose of oral Ruxolitinib, 20 mg at first scheduled visit. After that dose and on all other days patients will self-administer oral Ruxolitinib at a dose of 40 mg daily divided into two equal doses approximately 12 hours apart. Patients will be treated for a total of 16 weeks. After treatment, patients will be followed monthly.
Ruxolitinib: Ruxolitinib 5 mg tablets, 4 per dose
|
|---|---|
|
Time to Acute Myeloid Leukemia (AML) Transformation
|
5.0 months
Interval 1.2 to 40.3
|
SECONDARY outcome
Timeframe: Up to 2 yearsOverall survival will be from first dose of study drug until failure or death from any cause.
Outcome measures
| Measure |
Ruxolitinib
n=29 Participants
All patients will be given their first dose of oral Ruxolitinib, 20 mg at first scheduled visit. After that dose and on all other days patients will self-administer oral Ruxolitinib at a dose of 40 mg daily divided into two equal doses approximately 12 hours apart. Patients will be treated for a total of 16 weeks. After treatment, patients will be followed monthly.
Ruxolitinib: Ruxolitinib 5 mg tablets, 4 per dose
|
|---|---|
|
Overall Survival
|
23.6 months
Interval 0.2 to 24.0
|
SECONDARY outcome
Timeframe: Up to 2 yearsPopulation: Participants who achieved a clinical response by MDS.MPN IWG response criteria.
Duration of response measured using time to AML transformation according to WHO Critieria
Outcome measures
| Measure |
Ruxolitinib
n=19 Participants
All patients will be given their first dose of oral Ruxolitinib, 20 mg at first scheduled visit. After that dose and on all other days patients will self-administer oral Ruxolitinib at a dose of 40 mg daily divided into two equal doses approximately 12 hours apart. Patients will be treated for a total of 16 weeks. After treatment, patients will be followed monthly.
Ruxolitinib: Ruxolitinib 5 mg tablets, 4 per dose
|
|---|---|
|
Duration of Response
|
0 months
Interval 0.0 to 9.7
|
Adverse Events
Ruxolitinib
Serious events: 20 serious events
Other events: 29 other events
Deaths: 4 deaths
Serious adverse events
| Measure |
Ruxolitinib
n=29 participants at risk
All patients will be given their first dose of oral Ruxolitinib, 20 mg at first scheduled visit. After that dose and on all other days patients will self-administer oral Ruxolitinib at a dose of 40 mg daily divided into two equal doses approximately 12 hours apart. Patients will be treated for a total of 16 weeks. After treatment, patients will be followed monthly.
Ruxolitinib: Ruxolitinib 5 mg tablets, 4 per dose
|
|---|---|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
3.4%
1/29 • Number of events 1 • Adverse events were collected from on-study date to 30 days after end of treatment, an average of 240 days. Participants will followed for mortality for 2 years after off study date.
|
|
Infections and infestations
Lung infection
|
6.9%
2/29 • Number of events 2 • Adverse events were collected from on-study date to 30 days after end of treatment, an average of 240 days. Participants will followed for mortality for 2 years after off study date.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonitis
|
6.9%
2/29 • Number of events 2 • Adverse events were collected from on-study date to 30 days after end of treatment, an average of 240 days. Participants will followed for mortality for 2 years after off study date.
|
|
Cardiac disorders
Atrial fibrillation
|
3.4%
1/29 • Number of events 1 • Adverse events were collected from on-study date to 30 days after end of treatment, an average of 240 days. Participants will followed for mortality for 2 years after off study date.
|
|
General disorders
Fever
|
6.9%
2/29 • Number of events 2 • Adverse events were collected from on-study date to 30 days after end of treatment, an average of 240 days. Participants will followed for mortality for 2 years after off study date.
|
|
Blood and lymphatic system disorders
Anemia
|
6.9%
2/29 • Number of events 2 • Adverse events were collected from on-study date to 30 days after end of treatment, an average of 240 days. Participants will followed for mortality for 2 years after off study date.
|
|
Gastrointestinal disorders
Abdominal pain
|
10.3%
3/29 • Number of events 4 • Adverse events were collected from on-study date to 30 days after end of treatment, an average of 240 days. Participants will followed for mortality for 2 years after off study date.
|
|
General disorders
Fatigue
|
6.9%
2/29 • Number of events 2 • Adverse events were collected from on-study date to 30 days after end of treatment, an average of 240 days. Participants will followed for mortality for 2 years after off study date.
|
|
General disorders
General disorders and administration site conditions- Other
|
3.4%
1/29 • Number of events 1 • Adverse events were collected from on-study date to 30 days after end of treatment, an average of 240 days. Participants will followed for mortality for 2 years after off study date.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
3.4%
1/29 • Number of events 1 • Adverse events were collected from on-study date to 30 days after end of treatment, an average of 240 days. Participants will followed for mortality for 2 years after off study date.
|
|
Respiratory, thoracic and mediastinal disorders
Productive cough
|
3.4%
1/29 • Number of events 1 • Adverse events were collected from on-study date to 30 days after end of treatment, an average of 240 days. Participants will followed for mortality for 2 years after off study date.
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
3.4%
1/29 • Number of events 3 • Adverse events were collected from on-study date to 30 days after end of treatment, an average of 240 days. Participants will followed for mortality for 2 years after off study date.
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia - related to COPD
|
3.4%
1/29 • Number of events 1 • Adverse events were collected from on-study date to 30 days after end of treatment, an average of 240 days. Participants will followed for mortality for 2 years after off study date.
|
|
Respiratory, thoracic and mediastinal disorders
Sore throat - related to COVID-19 Infection
|
3.4%
1/29 • Number of events 1 • Adverse events were collected from on-study date to 30 days after end of treatment, an average of 240 days. Participants will followed for mortality for 2 years after off study date.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory, thoracic and mediastinal disorders - Other
|
3.4%
1/29 • Number of events 1 • Adverse events were collected from on-study date to 30 days after end of treatment, an average of 240 days. Participants will followed for mortality for 2 years after off study date.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
6.9%
2/29 • Number of events 2 • Adverse events were collected from on-study date to 30 days after end of treatment, an average of 240 days. Participants will followed for mortality for 2 years after off study date.
|
|
Respiratory, thoracic and mediastinal disorders
Hemoptysis
|
3.4%
1/29 • Number of events 1 • Adverse events were collected from on-study date to 30 days after end of treatment, an average of 240 days. Participants will followed for mortality for 2 years after off study date.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumothorax
|
3.4%
1/29 • Number of events 1 • Adverse events were collected from on-study date to 30 days after end of treatment, an average of 240 days. Participants will followed for mortality for 2 years after off study date.
|
|
General disorders
Edema limbs
|
3.4%
1/29 • Number of events 1 • Adverse events were collected from on-study date to 30 days after end of treatment, an average of 240 days. Participants will followed for mortality for 2 years after off study date.
|
|
Skin and subcutaneous tissue disorders
Skin and subcutaneous tissue disorders - Other
|
3.4%
1/29 • Number of events 1 • Adverse events were collected from on-study date to 30 days after end of treatment, an average of 240 days. Participants will followed for mortality for 2 years after off study date.
|
|
Vascular disorders
Hematoma
|
10.3%
3/29 • Number of events 3 • Adverse events were collected from on-study date to 30 days after end of treatment, an average of 240 days. Participants will followed for mortality for 2 years after off study date.
|
|
Gastrointestinal disorders
Diarrhea
|
3.4%
1/29 • Number of events 1 • Adverse events were collected from on-study date to 30 days after end of treatment, an average of 240 days. Participants will followed for mortality for 2 years after off study date.
|
|
Gastrointestinal disorders
Nausea
|
3.4%
1/29 • Number of events 1 • Adverse events were collected from on-study date to 30 days after end of treatment, an average of 240 days. Participants will followed for mortality for 2 years after off study date.
|
|
Gastrointestinal disorders
Vomitting
|
3.4%
1/29 • Number of events 1 • Adverse events were collected from on-study date to 30 days after end of treatment, an average of 240 days. Participants will followed for mortality for 2 years after off study date.
|
|
General disorders
Chills
|
3.4%
1/29 • Number of events 1 • Adverse events were collected from on-study date to 30 days after end of treatment, an average of 240 days. Participants will followed for mortality for 2 years after off study date.
|
|
Renal and urinary disorders
Urinary tract infection
|
6.9%
2/29 • Number of events 2 • Adverse events were collected from on-study date to 30 days after end of treatment, an average of 240 days. Participants will followed for mortality for 2 years after off study date.
|
|
Infections and infestations
Sepsis
|
3.4%
1/29 • Number of events 1 • Adverse events were collected from on-study date to 30 days after end of treatment, an average of 240 days. Participants will followed for mortality for 2 years after off study date.
|
|
Nervous system disorders
Dizziness
|
3.4%
1/29 • Number of events 1 • Adverse events were collected from on-study date to 30 days after end of treatment, an average of 240 days. Participants will followed for mortality for 2 years after off study date.
|
|
Blood and lymphatic system disorders
Leukocytosis
|
3.4%
1/29 • Number of events 2 • Adverse events were collected from on-study date to 30 days after end of treatment, an average of 240 days. Participants will followed for mortality for 2 years after off study date.
|
|
General disorders
Death, NOS
|
13.8%
4/29 • Number of events 4 • Adverse events were collected from on-study date to 30 days after end of treatment, an average of 240 days. Participants will followed for mortality for 2 years after off study date.
|
|
Infections and infestations
Infections and infestations- Other
|
6.9%
2/29 • Number of events 2 • Adverse events were collected from on-study date to 30 days after end of treatment, an average of 240 days. Participants will followed for mortality for 2 years after off study date.
|
|
Gastrointestinal disorders
Gastric obstruction
|
3.4%
1/29 • Number of events 1 • Adverse events were collected from on-study date to 30 days after end of treatment, an average of 240 days. Participants will followed for mortality for 2 years after off study date.
|
|
Renal and urinary disorders
Acute kidney injury
|
3.4%
1/29 • Number of events 1 • Adverse events were collected from on-study date to 30 days after end of treatment, an average of 240 days. Participants will followed for mortality for 2 years after off study date.
|
Other adverse events
| Measure |
Ruxolitinib
n=29 participants at risk
All patients will be given their first dose of oral Ruxolitinib, 20 mg at first scheduled visit. After that dose and on all other days patients will self-administer oral Ruxolitinib at a dose of 40 mg daily divided into two equal doses approximately 12 hours apart. Patients will be treated for a total of 16 weeks. After treatment, patients will be followed monthly.
Ruxolitinib: Ruxolitinib 5 mg tablets, 4 per dose
|
|---|---|
|
Investigations
Neutrophil count decreased
|
20.7%
6/29 • Number of events 19 • Adverse events were collected from on-study date to 30 days after end of treatment, an average of 240 days. Participants will followed for mortality for 2 years after off study date.
|
|
Investigations
Platelet count decreased
|
44.8%
13/29 • Number of events 43 • Adverse events were collected from on-study date to 30 days after end of treatment, an average of 240 days. Participants will followed for mortality for 2 years after off study date.
|
|
Investigations
Aspartate aminotransferase increased
|
37.9%
11/29 • Number of events 25 • Adverse events were collected from on-study date to 30 days after end of treatment, an average of 240 days. Participants will followed for mortality for 2 years after off study date.
|
|
Investigations
Creatinine increased
|
27.6%
8/29 • Number of events 26 • Adverse events were collected from on-study date to 30 days after end of treatment, an average of 240 days. Participants will followed for mortality for 2 years after off study date.
|
|
Investigations
Alanine aminotransferase increased
|
24.1%
7/29 • Number of events 17 • Adverse events were collected from on-study date to 30 days after end of treatment, an average of 240 days. Participants will followed for mortality for 2 years after off study date.
|
|
Investigations
Alkaline phosphatase increased
|
20.7%
6/29 • Number of events 18 • Adverse events were collected from on-study date to 30 days after end of treatment, an average of 240 days. Participants will followed for mortality for 2 years after off study date.
|
|
Investigations
Blood bilirubin increased
|
10.3%
3/29 • Number of events 7 • Adverse events were collected from on-study date to 30 days after end of treatment, an average of 240 days. Participants will followed for mortality for 2 years after off study date.
|
|
Investigations
Investigations - Other
|
17.2%
5/29 • Number of events 17 • Adverse events were collected from on-study date to 30 days after end of treatment, an average of 240 days. Participants will followed for mortality for 2 years after off study date.
|
|
Investigations
White blood cell decreased
|
10.3%
3/29 • Number of events 5 • Adverse events were collected from on-study date to 30 days after end of treatment, an average of 240 days. Participants will followed for mortality for 2 years after off study date.
|
|
Investigations
Lymphocyte count decreased
|
6.9%
2/29 • Number of events 5 • Adverse events were collected from on-study date to 30 days after end of treatment, an average of 240 days. Participants will followed for mortality for 2 years after off study date.
|
|
Investigations
Cardiac troponin I increased
|
3.4%
1/29 • Number of events 1 • Adverse events were collected from on-study date to 30 days after end of treatment, an average of 240 days. Participants will followed for mortality for 2 years after off study date.
|
|
Investigations
Weight loss
|
3.4%
1/29 • Number of events 1 • Adverse events were collected from on-study date to 30 days after end of treatment, an average of 240 days. Participants will followed for mortality for 2 years after off study date.
|
|
General disorders
Edema limbs
|
27.6%
8/29 • Number of events 8 • Adverse events were collected from on-study date to 30 days after end of treatment, an average of 240 days. Participants will followed for mortality for 2 years after off study date.
|
|
General disorders
Fever
|
27.6%
8/29 • Number of events 9 • Adverse events were collected from on-study date to 30 days after end of treatment, an average of 240 days. Participants will followed for mortality for 2 years after off study date.
|
|
General disorders
Fatigue
|
24.1%
7/29 • Number of events 7 • Adverse events were collected from on-study date to 30 days after end of treatment, an average of 240 days. Participants will followed for mortality for 2 years after off study date.
|
|
General disorders
Pain
|
17.2%
5/29 • Number of events 5 • Adverse events were collected from on-study date to 30 days after end of treatment, an average of 240 days. Participants will followed for mortality for 2 years after off study date.
|
|
General disorders
Non-cardiac chest pain
|
13.8%
4/29 • Number of events 4 • Adverse events were collected from on-study date to 30 days after end of treatment, an average of 240 days. Participants will followed for mortality for 2 years after off study date.
|
|
General disorders
Flu like symptoms
|
10.3%
3/29 • Number of events 6 • Adverse events were collected from on-study date to 30 days after end of treatment, an average of 240 days. Participants will followed for mortality for 2 years after off study date.
|
|
General disorders
Chills
|
3.4%
1/29 • Number of events 1 • Adverse events were collected from on-study date to 30 days after end of treatment, an average of 240 days. Participants will followed for mortality for 2 years after off study date.
|
|
General disorders
Malaise
|
3.4%
1/29 • Number of events 1 • Adverse events were collected from on-study date to 30 days after end of treatment, an average of 240 days. Participants will followed for mortality for 2 years after off study date.
|
|
Gastrointestinal disorders
Diarrhea
|
27.6%
8/29 • Number of events 9 • Adverse events were collected from on-study date to 30 days after end of treatment, an average of 240 days. Participants will followed for mortality for 2 years after off study date.
|
|
Gastrointestinal disorders
Abdominal Pain
|
13.8%
4/29 • Number of events 5 • Adverse events were collected from on-study date to 30 days after end of treatment, an average of 240 days. Participants will followed for mortality for 2 years after off study date.
|
|
Gastrointestinal disorders
Constipation
|
13.8%
4/29 • Number of events 4 • Adverse events were collected from on-study date to 30 days after end of treatment, an average of 240 days. Participants will followed for mortality for 2 years after off study date.
|
|
Gastrointestinal disorders
Nausea
|
13.8%
4/29 • Number of events 4 • Adverse events were collected from on-study date to 30 days after end of treatment, an average of 240 days. Participants will followed for mortality for 2 years after off study date.
|
|
Gastrointestinal disorders
Gastrointestinal disorders -Other
|
10.3%
3/29 • Number of events 4 • Adverse events were collected from on-study date to 30 days after end of treatment, an average of 240 days. Participants will followed for mortality for 2 years after off study date.
|
|
Gastrointestinal disorders
Oral pain
|
10.3%
3/29 • Number of events 4 • Adverse events were collected from on-study date to 30 days after end of treatment, an average of 240 days. Participants will followed for mortality for 2 years after off study date.
|
|
Gastrointestinal disorders
Vomiting
|
10.3%
3/29 • Number of events 3 • Adverse events were collected from on-study date to 30 days after end of treatment, an average of 240 days. Participants will followed for mortality for 2 years after off study date.
|
|
Gastrointestinal disorders
Bloating
|
3.4%
1/29 • Number of events 1 • Adverse events were collected from on-study date to 30 days after end of treatment, an average of 240 days. Participants will followed for mortality for 2 years after off study date.
|
|
Gastrointestinal disorders
Dental caries
|
3.4%
1/29 • Number of events 1 • Adverse events were collected from on-study date to 30 days after end of treatment, an average of 240 days. Participants will followed for mortality for 2 years after off study date.
|
|
Gastrointestinal disorders
Dry mouth
|
3.4%
1/29 • Number of events 1 • Adverse events were collected from on-study date to 30 days after end of treatment, an average of 240 days. Participants will followed for mortality for 2 years after off study date.
|
|
Gastrointestinal disorders
Dyspepsia
|
3.4%
1/29 • Number of events 1 • Adverse events were collected from on-study date to 30 days after end of treatment, an average of 240 days. Participants will followed for mortality for 2 years after off study date.
|
|
Gastrointestinal disorders
Dysphagia
|
3.4%
1/29 • Number of events 1 • Adverse events were collected from on-study date to 30 days after end of treatment, an average of 240 days. Participants will followed for mortality for 2 years after off study date.
|
|
Gastrointestinal disorders
Obstruction gastric
|
3.4%
1/29 • Number of events 1 • Adverse events were collected from on-study date to 30 days after end of treatment, an average of 240 days. Participants will followed for mortality for 2 years after off study date.
|
|
Gastrointestinal disorders
Stomach pain
|
3.4%
1/29 • Number of events 1 • Adverse events were collected from on-study date to 30 days after end of treatment, an average of 240 days. Participants will followed for mortality for 2 years after off study date.
|
|
Gastrointestinal disorders
Toothache
|
3.4%
1/29 • Number of events 1 • Adverse events were collected from on-study date to 30 days after end of treatment, an average of 240 days. Participants will followed for mortality for 2 years after off study date.
|
|
Blood and lymphatic system disorders
Anemia
|
58.6%
17/29 • Number of events 47 • Adverse events were collected from on-study date to 30 days after end of treatment, an average of 240 days. Participants will followed for mortality for 2 years after off study date.
|
|
Blood and lymphatic system disorders
Blood and lymphatic system disorders -Other
|
13.8%
4/29 • Number of events 10 • Adverse events were collected from on-study date to 30 days after end of treatment, an average of 240 days. Participants will followed for mortality for 2 years after off study date.
|
|
Blood and lymphatic system disorders
Leukocytosis
|
6.9%
2/29 • Number of events 2 • Adverse events were collected from on-study date to 30 days after end of treatment, an average of 240 days. Participants will followed for mortality for 2 years after off study date.
|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
3.4%
1/29 • Number of events 1 • Adverse events were collected from on-study date to 30 days after end of treatment, an average of 240 days. Participants will followed for mortality for 2 years after off study date.
|
|
Blood and lymphatic system disorders
Lymph node pain
|
3.4%
1/29 • Number of events 1 • Adverse events were collected from on-study date to 30 days after end of treatment, an average of 240 days. Participants will followed for mortality for 2 years after off study date.
|
|
Metabolism and nutrition disorders
Anorexia
|
13.8%
4/29 • Number of events 4 • Adverse events were collected from on-study date to 30 days after end of treatment, an average of 240 days. Participants will followed for mortality for 2 years after off study date.
|
|
Metabolism and nutrition disorders
Hypocalcemia
|
24.1%
7/29 • Number of events 16 • Adverse events were collected from on-study date to 30 days after end of treatment, an average of 240 days. Participants will followed for mortality for 2 years after off study date.
|
|
Metabolism and nutrition disorders
Metabolism and nutrition disorders -Other
|
13.8%
4/29 • Number of events 6 • Adverse events were collected from on-study date to 30 days after end of treatment, an average of 240 days. Participants will followed for mortality for 2 years after off study date.
|
|
Metabolism and nutrition disorders
Hyperuricemia
|
10.3%
3/29 • Number of events 4 • Adverse events were collected from on-study date to 30 days after end of treatment, an average of 240 days. Participants will followed for mortality for 2 years after off study date.
|
|
Metabolism and nutrition disorders
Hyponatremia
|
10.3%
3/29 • Number of events 14 • Adverse events were collected from on-study date to 30 days after end of treatment, an average of 240 days. Participants will followed for mortality for 2 years after off study date.
|
|
Metabolism and nutrition disorders
Hyperglycemia
|
6.9%
2/29 • Number of events 3 • Adverse events were collected from on-study date to 30 days after end of treatment, an average of 240 days. Participants will followed for mortality for 2 years after off study date.
|
|
Metabolism and nutrition disorders
Hypermagnesemia
|
6.9%
2/29 • Number of events 2 • Adverse events were collected from on-study date to 30 days after end of treatment, an average of 240 days. Participants will followed for mortality for 2 years after off study date.
|
|
Metabolism and nutrition disorders
Hypokalemia
|
6.9%
2/29 • Number of events 2 • Adverse events were collected from on-study date to 30 days after end of treatment, an average of 240 days. Participants will followed for mortality for 2 years after off study date.
|
|
Metabolism and nutrition disorders
Dehydration
|
3.4%
1/29 • Number of events 3 • Adverse events were collected from on-study date to 30 days after end of treatment, an average of 240 days. Participants will followed for mortality for 2 years after off study date.
|
|
Metabolism and nutrition disorders
Hypomagnesemia
|
3.4%
1/29 • Number of events 4 • Adverse events were collected from on-study date to 30 days after end of treatment, an average of 240 days. Participants will followed for mortality for 2 years after off study date.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
24.1%
7/29 • Number of events 8 • Adverse events were collected from on-study date to 30 days after end of treatment, an average of 240 days. Participants will followed for mortality for 2 years after off study date.
|
|
Musculoskeletal and connective tissue disorders
Bone pain
|
17.2%
5/29 • Number of events 6 • Adverse events were collected from on-study date to 30 days after end of treatment, an average of 240 days. Participants will followed for mortality for 2 years after off study date.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal and connective tissue disorder - Other
|
17.2%
5/29 • Number of events 5 • Adverse events were collected from on-study date to 30 days after end of treatment, an average of 240 days. Participants will followed for mortality for 2 years after off study date.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
10.3%
3/29 • Number of events 4 • Adverse events were collected from on-study date to 30 days after end of treatment, an average of 240 days. Participants will followed for mortality for 2 years after off study date.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
6.9%
2/29 • Number of events 2 • Adverse events were collected from on-study date to 30 days after end of treatment, an average of 240 days. Participants will followed for mortality for 2 years after off study date.
|
|
Musculoskeletal and connective tissue disorders
Flank pain
|
6.9%
2/29 • Number of events 2 • Adverse events were collected from on-study date to 30 days after end of treatment, an average of 240 days. Participants will followed for mortality for 2 years after off study date.
|
|
Musculoskeletal and connective tissue disorders
Generalized muscle weakness
|
6.9%
2/29 • Number of events 2 • Adverse events were collected from on-study date to 30 days after end of treatment, an average of 240 days. Participants will followed for mortality for 2 years after off study date.
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
6.9%
2/29 • Number of events 2 • Adverse events were collected from on-study date to 30 days after end of treatment, an average of 240 days. Participants will followed for mortality for 2 years after off study date.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
3.4%
1/29 • Number of events 1 • Adverse events were collected from on-study date to 30 days after end of treatment, an average of 240 days. Participants will followed for mortality for 2 years after off study date.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
37.9%
11/29 • Number of events 16 • Adverse events were collected from on-study date to 30 days after end of treatment, an average of 240 days. Participants will followed for mortality for 2 years after off study date.
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
17.2%
5/29 • Number of events 8 • Adverse events were collected from on-study date to 30 days after end of treatment, an average of 240 days. Participants will followed for mortality for 2 years after off study date.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
13.8%
4/29 • Number of events 5 • Adverse events were collected from on-study date to 30 days after end of treatment, an average of 240 days. Participants will followed for mortality for 2 years after off study date.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory, thoracic and mediastinal disorders - Other
|
13.8%
4/29 • Number of events 4 • Adverse events were collected from on-study date to 30 days after end of treatment, an average of 240 days. Participants will followed for mortality for 2 years after off study date.
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
10.3%
3/29 • Number of events 5 • Adverse events were collected from on-study date to 30 days after end of treatment, an average of 240 days. Participants will followed for mortality for 2 years after off study date.
|
|
Respiratory, thoracic and mediastinal disorders
Productive cough
|
10.3%
3/29 • Number of events 3 • Adverse events were collected from on-study date to 30 days after end of treatment, an average of 240 days. Participants will followed for mortality for 2 years after off study date.
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
6.9%
2/29 • Number of events 2 • Adverse events were collected from on-study date to 30 days after end of treatment, an average of 240 days. Participants will followed for mortality for 2 years after off study date.
|
|
Respiratory, thoracic and mediastinal disorders
Sore throat
|
6.9%
2/29 • Number of events 2 • Adverse events were collected from on-study date to 30 days after end of treatment, an average of 240 days. Participants will followed for mortality for 2 years after off study date.
|
|
Respiratory, thoracic and mediastinal disorders
Adult respiratory distress syndrome
|
3.4%
1/29 • Number of events 1 • Adverse events were collected from on-study date to 30 days after end of treatment, an average of 240 days. Participants will followed for mortality for 2 years after off study date.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonitis
|
3.4%
1/29 • Number of events 1 • Adverse events were collected from on-study date to 30 days after end of treatment, an average of 240 days. Participants will followed for mortality for 2 years after off study date.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumothorax
|
3.4%
1/29 • Number of events 2 • Adverse events were collected from on-study date to 30 days after end of treatment, an average of 240 days. Participants will followed for mortality for 2 years after off study date.
|
|
Respiratory, thoracic and mediastinal disorders
Voice alteration
|
3.4%
1/29 • Number of events 1 • Adverse events were collected from on-study date to 30 days after end of treatment, an average of 240 days. Participants will followed for mortality for 2 years after off study date.
|
|
Infections and infestations
Lung infection
|
13.8%
4/29 • Number of events 4 • Adverse events were collected from on-study date to 30 days after end of treatment, an average of 240 days. Participants will followed for mortality for 2 years after off study date.
|
|
Infections and infestations
Infections and infestations - Other
|
10.3%
3/29 • Number of events 3 • Adverse events were collected from on-study date to 30 days after end of treatment, an average of 240 days. Participants will followed for mortality for 2 years after off study date.
|
|
Infections and infestations
Upper respiratory infection
|
10.3%
3/29 • Number of events 3 • Adverse events were collected from on-study date to 30 days after end of treatment, an average of 240 days. Participants will followed for mortality for 2 years after off study date.
|
|
Infections and infestations
Rash pustular
|
6.9%
2/29 • Number of events 2 • Adverse events were collected from on-study date to 30 days after end of treatment, an average of 240 days. Participants will followed for mortality for 2 years after off study date.
|
|
Infections and infestations
Urinary tract infection
|
6.9%
2/29 • Number of events 3 • Adverse events were collected from on-study date to 30 days after end of treatment, an average of 240 days. Participants will followed for mortality for 2 years after off study date.
|
|
Infections and infestations
Bladder infection
|
3.4%
1/29 • Number of events 1 • Adverse events were collected from on-study date to 30 days after end of treatment, an average of 240 days. Participants will followed for mortality for 2 years after off study date.
|
|
Infections and infestations
Bronchial infection
|
3.4%
1/29 • Number of events 1 • Adverse events were collected from on-study date to 30 days after end of treatment, an average of 240 days. Participants will followed for mortality for 2 years after off study date.
|
|
Infections and infestations
Catheter related infection
|
3.4%
1/29 • Number of events 1 • Adverse events were collected from on-study date to 30 days after end of treatment, an average of 240 days. Participants will followed for mortality for 2 years after off study date.
|
|
Infections and infestations
Gum infection
|
3.4%
1/29 • Number of events 1 • Adverse events were collected from on-study date to 30 days after end of treatment, an average of 240 days. Participants will followed for mortality for 2 years after off study date.
|
|
Infections and infestations
Laryngitis
|
3.4%
1/29 • Number of events 1 • Adverse events were collected from on-study date to 30 days after end of treatment, an average of 240 days. Participants will followed for mortality for 2 years after off study date.
|
|
Infections and infestations
Sepsis
|
3.4%
1/29 • Number of events 1 • Adverse events were collected from on-study date to 30 days after end of treatment, an average of 240 days. Participants will followed for mortality for 2 years after off study date.
|
|
Infections and infestations
Sinusitis
|
3.4%
1/29 • Number of events 1 • Adverse events were collected from on-study date to 30 days after end of treatment, an average of 240 days. Participants will followed for mortality for 2 years after off study date.
|
|
Infections and infestations
Skin infection
|
3.4%
1/29 • Number of events 1 • Adverse events were collected from on-study date to 30 days after end of treatment, an average of 240 days. Participants will followed for mortality for 2 years after off study date.
|
|
Infections and infestations
Tooth infection
|
3.4%
1/29 • Number of events 1 • Adverse events were collected from on-study date to 30 days after end of treatment, an average of 240 days. Participants will followed for mortality for 2 years after off study date.
|
|
Infections and infestations
Vaginal infection
|
3.4%
1/29 • Number of events 1 • Adverse events were collected from on-study date to 30 days after end of treatment, an average of 240 days. Participants will followed for mortality for 2 years after off study date.
|
|
Nervous system disorders
Headache
|
41.4%
12/29 • Number of events 13 • Adverse events were collected from on-study date to 30 days after end of treatment, an average of 240 days. Participants will followed for mortality for 2 years after off study date.
|
|
Nervous system disorders
Dizziness
|
13.8%
4/29 • Number of events 5 • Adverse events were collected from on-study date to 30 days after end of treatment, an average of 240 days. Participants will followed for mortality for 2 years after off study date.
|
|
Nervous system disorders
Peripheral sensory neuropathy
|
13.8%
4/29 • Number of events 7 • Adverse events were collected from on-study date to 30 days after end of treatment, an average of 240 days. Participants will followed for mortality for 2 years after off study date.
|
|
Nervous system disorders
Paresthesia
|
6.9%
2/29 • Number of events 3 • Adverse events were collected from on-study date to 30 days after end of treatment, an average of 240 days. Participants will followed for mortality for 2 years after off study date.
|
|
Nervous system disorders
Sinus pain
|
6.9%
2/29 • Number of events 2 • Adverse events were collected from on-study date to 30 days after end of treatment, an average of 240 days. Participants will followed for mortality for 2 years after off study date.
|
|
Nervous system disorders
Tremor
|
3.4%
1/29 • Number of events 1 • Adverse events were collected from on-study date to 30 days after end of treatment, an average of 240 days. Participants will followed for mortality for 2 years after off study date.
|
|
Injury, poisoning and procedural complications
Bruising
|
20.7%
6/29 • Number of events 6 • Adverse events were collected from on-study date to 30 days after end of treatment, an average of 240 days. Participants will followed for mortality for 2 years after off study date.
|
|
Injury, poisoning and procedural complications
Fall
|
20.7%
6/29 • Number of events 7 • Adverse events were collected from on-study date to 30 days after end of treatment, an average of 240 days. Participants will followed for mortality for 2 years after off study date.
|
|
Injury, poisoning and procedural complications
Fracture
|
10.3%
3/29 • Number of events 3 • Adverse events were collected from on-study date to 30 days after end of treatment, an average of 240 days. Participants will followed for mortality for 2 years after off study date.
|
|
Injury, poisoning and procedural complications
Ankle fracture
|
3.4%
1/29 • Number of events 1 • Adverse events were collected from on-study date to 30 days after end of treatment, an average of 240 days. Participants will followed for mortality for 2 years after off study date.
|
|
Injury, poisoning and procedural complications
Intraoperative hemorrhage
|
3.4%
1/29 • Number of events 1 • Adverse events were collected from on-study date to 30 days after end of treatment, an average of 240 days. Participants will followed for mortality for 2 years after off study date.
|
|
Skin and subcutaneous tissue disorders
Skin and subcutaneous tissue disorders - Other
|
37.9%
11/29 • Number of events 16 • Adverse events were collected from on-study date to 30 days after end of treatment, an average of 240 days. Participants will followed for mortality for 2 years after off study date.
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
10.3%
3/29 • Number of events 3 • Adverse events were collected from on-study date to 30 days after end of treatment, an average of 240 days. Participants will followed for mortality for 2 years after off study date.
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
10.3%
3/29 • Number of events 6 • Adverse events were collected from on-study date to 30 days after end of treatment, an average of 240 days. Participants will followed for mortality for 2 years after off study date.
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
3.4%
1/29 • Number of events 1 • Adverse events were collected from on-study date to 30 days after end of treatment, an average of 240 days. Participants will followed for mortality for 2 years after off study date.
|
|
Skin and subcutaneous tissue disorders
Hyperhidrosis
|
3.4%
1/29 • Number of events 1 • Adverse events were collected from on-study date to 30 days after end of treatment, an average of 240 days. Participants will followed for mortality for 2 years after off study date.
|
|
Skin and subcutaneous tissue disorders
Purpura
|
3.4%
1/29 • Number of events 1 • Adverse events were collected from on-study date to 30 days after end of treatment, an average of 240 days. Participants will followed for mortality for 2 years after off study date.
|
|
Skin and subcutaneous tissue disorders
Skin ulceration
|
3.4%
1/29 • Number of events 1 • Adverse events were collected from on-study date to 30 days after end of treatment, an average of 240 days. Participants will followed for mortality for 2 years after off study date.
|
|
Vascular disorders
Hematoma
|
17.2%
5/29 • Number of events 5 • Adverse events were collected from on-study date to 30 days after end of treatment, an average of 240 days. Participants will followed for mortality for 2 years after off study date.
|
|
Vascular disorders
Hot flashes
|
3.4%
1/29 • Number of events 1 • Adverse events were collected from on-study date to 30 days after end of treatment, an average of 240 days. Participants will followed for mortality for 2 years after off study date.
|
|
Vascular disorders
Hypotension
|
3.4%
1/29 • Number of events 1 • Adverse events were collected from on-study date to 30 days after end of treatment, an average of 240 days. Participants will followed for mortality for 2 years after off study date.
|
|
Vascular disorders
Superficial thrombophlebitis
|
3.4%
1/29 • Number of events 1 • Adverse events were collected from on-study date to 30 days after end of treatment, an average of 240 days. Participants will followed for mortality for 2 years after off study date.
|
|
Vascular disorders
Vascular disorders - Other
|
3.4%
1/29 • Number of events 1 • Adverse events were collected from on-study date to 30 days after end of treatment, an average of 240 days. Participants will followed for mortality for 2 years after off study date.
|
|
Renal and urinary disorders
Acute kidney injury
|
6.9%
2/29 • Number of events 4 • Adverse events were collected from on-study date to 30 days after end of treatment, an average of 240 days. Participants will followed for mortality for 2 years after off study date.
|
|
Renal and urinary disorders
Urinary tract obstruction
|
6.9%
2/29 • Number of events 2 • Adverse events were collected from on-study date to 30 days after end of treatment, an average of 240 days. Participants will followed for mortality for 2 years after off study date.
|
|
Renal and urinary disorders
Urinary tract pain
|
6.9%
2/29 • Number of events 2 • Adverse events were collected from on-study date to 30 days after end of treatment, an average of 240 days. Participants will followed for mortality for 2 years after off study date.
|
|
Renal and urinary disorders
Urinary frequency
|
3.4%
1/29 • Number of events 1 • Adverse events were collected from on-study date to 30 days after end of treatment, an average of 240 days. Participants will followed for mortality for 2 years after off study date.
|
|
Renal and urinary disorders
Urinary incontinence
|
3.4%
1/29 • Number of events 1 • Adverse events were collected from on-study date to 30 days after end of treatment, an average of 240 days. Participants will followed for mortality for 2 years after off study date.
|
|
Renal and urinary disorders
Urinary retention
|
3.4%
1/29 • Number of events 1 • Adverse events were collected from on-study date to 30 days after end of treatment, an average of 240 days. Participants will followed for mortality for 2 years after off study date.
|
|
Psychiatric disorders
Confusion
|
6.9%
2/29 • Number of events 2 • Adverse events were collected from on-study date to 30 days after end of treatment, an average of 240 days. Participants will followed for mortality for 2 years after off study date.
|
|
Psychiatric disorders
Insomnia
|
6.9%
2/29 • Number of events 2 • Adverse events were collected from on-study date to 30 days after end of treatment, an average of 240 days. Participants will followed for mortality for 2 years after off study date.
|
|
Psychiatric disorders
Anxiety
|
3.4%
1/29 • Number of events 1 • Adverse events were collected from on-study date to 30 days after end of treatment, an average of 240 days. Participants will followed for mortality for 2 years after off study date.
|
|
Cardiac disorders
Cardiac arrest
|
3.4%
1/29 • Number of events 1 • Adverse events were collected from on-study date to 30 days after end of treatment, an average of 240 days. Participants will followed for mortality for 2 years after off study date.
|
|
Cardiac disorders
Cardiac disorders -Other
|
3.4%
1/29 • Number of events 1 • Adverse events were collected from on-study date to 30 days after end of treatment, an average of 240 days. Participants will followed for mortality for 2 years after off study date.
|
|
Cardiac disorders
Sinus tachycardia
|
3.4%
1/29 • Number of events 1 • Adverse events were collected from on-study date to 30 days after end of treatment, an average of 240 days. Participants will followed for mortality for 2 years after off study date.
|
|
Ear and labyrinth disorders
Tinnitus
|
3.4%
1/29 • Number of events 1 • Adverse events were collected from on-study date to 30 days after end of treatment, an average of 240 days. Participants will followed for mortality for 2 years after off study date.
|
|
Ear and labyrinth disorders
Vertigo
|
3.4%
1/29 • Number of events 1 • Adverse events were collected from on-study date to 30 days after end of treatment, an average of 240 days. Participants will followed for mortality for 2 years after off study date.
|
|
Eye disorders
Cataract
|
3.4%
1/29 • Number of events 1 • Adverse events were collected from on-study date to 30 days after end of treatment, an average of 240 days. Participants will followed for mortality for 2 years after off study date.
|
|
Eye disorders
Eye disorders-Other
|
3.4%
1/29 • Number of events 1 • Adverse events were collected from on-study date to 30 days after end of treatment, an average of 240 days. Participants will followed for mortality for 2 years after off study date.
|
|
Endocrine disorders
Hyperparathyroidism
|
3.4%
1/29 • Number of events 1 • Adverse events were collected from on-study date to 30 days after end of treatment, an average of 240 days. Participants will followed for mortality for 2 years after off study date.
|
|
Reproductive system and breast disorders
Reproductive system and breast disorders - Other
|
3.4%
1/29 • Number of events 1 • Adverse events were collected from on-study date to 30 days after end of treatment, an average of 240 days. Participants will followed for mortality for 2 years after off study date.
|
|
Surgical and medical procedures
Surgical and medical procedures -Other
|
3.4%
1/29 • Number of events 1 • Adverse events were collected from on-study date to 30 days after end of treatment, an average of 240 days. Participants will followed for mortality for 2 years after off study date.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place