Trial Outcomes & Findings for Pevonedistat and Azacitidine in MDS or MDS/MPN Patients Who Fail Primary Therapy With DNA Methyl Transferase Inhibitors (NCT NCT03238248)
NCT ID: NCT03238248
Last Updated: 2024-11-04
Results Overview
Overall survival time is defined as time from day 1 in cycle 1 to death for any reason. Patiens alive at last follow up were censored. Overall survival time will be summarized using the method of Kaplan and Meier.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
71 participants
Primary outcome timeframe
up to 2 years after treatment, a maximum possible duration of 38 months.
Results posted on
2024-11-04
Participant Flow
Participant milestones
| Measure |
Pevonedistat and Azacitidine
Participants will receive Azacitidine (via an injection under the skin, or via an intravenous infusion (IV bag) on days 1, 2, 3, 4 and 5 of each 28-day cycle.
Participants will receive Pevonedistat (through a vein in the arm) on Days 1, 3 and 5 of each 28-day cycle.
Azacitidine Subcutaneous Injection or Intravenous Infusion: 75 mg/m2
Pevonedistat Infusion: 20 mg/m2
Bone Marrow Biopsy \& Aspirate: Removal of a small piece of bone and bone marrow by inserting a needle into hip bone.
|
|---|---|
|
Overall Study
STARTED
|
71
|
|
Overall Study
COMPLETED
|
4
|
|
Overall Study
NOT COMPLETED
|
67
|
Reasons for withdrawal
| Measure |
Pevonedistat and Azacitidine
Participants will receive Azacitidine (via an injection under the skin, or via an intravenous infusion (IV bag) on days 1, 2, 3, 4 and 5 of each 28-day cycle.
Participants will receive Pevonedistat (through a vein in the arm) on Days 1, 3 and 5 of each 28-day cycle.
Azacitidine Subcutaneous Injection or Intravenous Infusion: 75 mg/m2
Pevonedistat Infusion: 20 mg/m2
Bone Marrow Biopsy \& Aspirate: Removal of a small piece of bone and bone marrow by inserting a needle into hip bone.
|
|---|---|
|
Overall Study
Death
|
5
|
|
Overall Study
Withdrawal by Subject
|
7
|
|
Overall Study
Participant proceeding to transplant
|
10
|
|
Overall Study
Lack of Efficacy
|
4
|
|
Overall Study
Physician Decision
|
3
|
|
Overall Study
Transitioning to another study
|
1
|
|
Overall Study
No longer benefiting
|
1
|
|
Overall Study
Other complicating disease
|
1
|
|
Overall Study
Adverse Event
|
5
|
|
Overall Study
Disease progression
|
26
|
|
Overall Study
N/A participant is still on treatment
|
1
|
|
Overall Study
Decline in condition
|
1
|
|
Overall Study
Alternative therapy
|
2
|
Baseline Characteristics
Pevonedistat and Azacitidine in MDS or MDS/MPN Patients Who Fail Primary Therapy With DNA Methyl Transferase Inhibitors
Baseline characteristics by cohort
| Measure |
Pevonedistat and Azacitidine
n=71 Participants
Participants will receive Azacitidine (via an injection under the skin, or via an intravenous infusion (IV bag) on days 1, 2, 3, 4 and 5 of each 28-day cycle.
Participants will receive Pevonedistat (through a vein in the arm) on Days 1, 3 and 5 of each 28-day cycle.
Azacitidine Subcutaneous Injection or Intravenous Infusion: 75 mg/m2
Pevonedistat Infusion: 20 mg/m2
Bone Marrow Biopsy \& Aspirate: Removal of a small piece of bone and bone marrow by inserting a needle into hip bone.
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=93 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
18 Participants
n=93 Participants
|
|
Age, Categorical
>=65 years
|
53 Participants
n=93 Participants
|
|
Sex: Female, Male
Female
|
27 Participants
n=93 Participants
|
|
Sex: Female, Male
Male
|
44 Participants
n=93 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
6 Participants
n=93 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
57 Participants
n=93 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
8 Participants
n=93 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=93 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=93 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=93 Participants
|
|
Race (NIH/OMB)
Black or African American
|
1 Participants
n=93 Participants
|
|
Race (NIH/OMB)
White
|
62 Participants
n=93 Participants
|
|
Race (NIH/OMB)
More than one race
|
1 Participants
n=93 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
7 Participants
n=93 Participants
|
|
Region of Enrollment
United States
|
71 participants
n=93 Participants
|
PRIMARY outcome
Timeframe: up to 2 years after treatment, a maximum possible duration of 38 months.Population: Patients diagnosed with MDS or MDS/MPN and received treatment. Excluded one patient who did not start the thearpy.
Overall survival time is defined as time from day 1 in cycle 1 to death for any reason. Patiens alive at last follow up were censored. Overall survival time will be summarized using the method of Kaplan and Meier.
Outcome measures
| Measure |
Pevonedistat and Azacitidine
n=70 Participants
Participants will receive Azacitidine (via an injection under the skin, or via an intravenous infusion (IV bag) on days 1, 2, 3, 4 and 5 of each 28-day cycle.
Participants will receive Pevonedistat (through a vein in the arm) on Days 1, 3 and 5 of each 28-day cycle.
Azacitidine Subcutaneous Injection or Intravenous Infusion: 75 mg/m2
Pevonedistat Infusion: 20 mg/m2
Bone Marrow Biopsy \& Aspirate: Removal of a small piece of bone and bone marrow by inserting a needle into hip bone.
|
|---|---|
|
Overall Survial Time
|
18.3 months
Interval 14.4 to 30.9
|
SECONDARY outcome
Timeframe: Up to 24 months, or deathPopulation: Patients diagnosed with MDS or MDS/MPN and received treatment.
Progression-free survival time is defined as time from day1 in cycle 1 to progression or death. Those alive without progression at the last follow up were censored. This survival will be summarized using the method of Kaplan and Meier.
Outcome measures
| Measure |
Pevonedistat and Azacitidine
n=70 Participants
Participants will receive Azacitidine (via an injection under the skin, or via an intravenous infusion (IV bag) on days 1, 2, 3, 4 and 5 of each 28-day cycle.
Participants will receive Pevonedistat (through a vein in the arm) on Days 1, 3 and 5 of each 28-day cycle.
Azacitidine Subcutaneous Injection or Intravenous Infusion: 75 mg/m2
Pevonedistat Infusion: 20 mg/m2
Bone Marrow Biopsy \& Aspirate: Removal of a small piece of bone and bone marrow by inserting a needle into hip bone.
|
|---|---|
|
Time to Progression
|
9.9 months
Interval 6.0 to 17.5
|
SECONDARY outcome
Timeframe: Up to 12 monthsPopulation: Patients with MDS or MDS/MPN received treatment and had been evaluated for response.
Objective response rate is defined as the percentage of patients with best response of Complete remission (CR), Hematologic improvement (HI), Marrow CR (mCR), or Partial remission (PR) among all patients evaluated. The other categories of response are progressive disease, stable disease and inevaluable. The modified recommendations of the International Working Group (IWG) for Response Criteria for altering natural history of MDS , as well as the International Consortium of clinical experts in MDS/MPN devised uniform response criteria and criteria for disease progression in MDS/MPN overlap syndromes based on three independent academic MDS/MPN workshops (Marsh 2013, December 2013 and June 2014) were used for response assessment.
Outcome measures
| Measure |
Pevonedistat and Azacitidine
n=67 Participants
Participants will receive Azacitidine (via an injection under the skin, or via an intravenous infusion (IV bag) on days 1, 2, 3, 4 and 5 of each 28-day cycle.
Participants will receive Pevonedistat (through a vein in the arm) on Days 1, 3 and 5 of each 28-day cycle.
Azacitidine Subcutaneous Injection or Intravenous Infusion: 75 mg/m2
Pevonedistat Infusion: 20 mg/m2
Bone Marrow Biopsy \& Aspirate: Removal of a small piece of bone and bone marrow by inserting a needle into hip bone.
|
|---|---|
|
Objective Response Rate
|
23.9 percentage of participants
Interval 15.3 to 35.3
|
SECONDARY outcome
Timeframe: Up to 24 monthsPopulation: MDS or MDS/MPN patients received treatment and evaluated for response.
Will assess complete and differential blood counts (peripheral blood), and transfusion requirements. The rate of hematologic improvement is defined as the percentage of patients with only hematologic improvement (defined in the protocol) among all patients evaluated for response.
Outcome measures
| Measure |
Pevonedistat and Azacitidine
n=67 Participants
Participants will receive Azacitidine (via an injection under the skin, or via an intravenous infusion (IV bag) on days 1, 2, 3, 4 and 5 of each 28-day cycle.
Participants will receive Pevonedistat (through a vein in the arm) on Days 1, 3 and 5 of each 28-day cycle.
Azacitidine Subcutaneous Injection or Intravenous Infusion: 75 mg/m2
Pevonedistat Infusion: 20 mg/m2
Bone Marrow Biopsy \& Aspirate: Removal of a small piece of bone and bone marrow by inserting a needle into hip bone.
|
|---|---|
|
Rate of Hematologic Response Per IWG
|
7.5 percentage of participants
Interval 3.2 to 16.3
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Up to 24 months.Population: MDS or MDS/MPN patients received treatment and evaluated for response.
Will assess morphologic features (e.g. presence of dysplastic features), presence of cytogenetic and/or molecular aberrancies, and myeloblast count. mCR is defined as the percentage of patients with only marrow CR among all patients evaluated.
Outcome measures
| Measure |
Pevonedistat and Azacitidine
n=67 Participants
Participants will receive Azacitidine (via an injection under the skin, or via an intravenous infusion (IV bag) on days 1, 2, 3, 4 and 5 of each 28-day cycle.
Participants will receive Pevonedistat (through a vein in the arm) on Days 1, 3 and 5 of each 28-day cycle.
Azacitidine Subcutaneous Injection or Intravenous Infusion: 75 mg/m2
Pevonedistat Infusion: 20 mg/m2
Bone Marrow Biopsy \& Aspirate: Removal of a small piece of bone and bone marrow by inserting a needle into hip bone.
|
|---|---|
|
Rate of Marrow Complete Response (mCR)
|
11.9 percentage of participants
Interval 6.2 to 21.8
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Up to 24 monthsNumber of specific molecular mutations in a NGS panel of 37 genes frequently mutated in myeloid malignancies will be determined by next generation sequencing before and after protocol-directed therapy. Results will be correlated with response. Clonal evolution and the relationship between response rates and mutations will be explored.
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: Up to 24 monthsAllele frequency of specific molecular mutations in a NGS panel of 37 genes frequently mutated in myeloid malignancies will be determined by next generation sequencing before and after protocol-directed therapy. Results will be correlated with response. Clonal evolution and the relationship between response rates and mutations will be explored.
Outcome measures
Outcome data not reported
Adverse Events
Pevonedistat and Azacitidine
Serious events: 29 serious events
Other events: 0 other events
Deaths: 49 deaths
Serious adverse events
| Measure |
Pevonedistat and Azacitidine
n=71 participants at risk
Participants will receive Azacitidine (via an injection under the skin, or via an intravenous infusion (IV bag) on days 1, 2, 3, 4 and 5 of each 28-day cycle.
Participants will receive Pevonedistat (through a vein in the arm) on Days 1, 3 and 5 of each 28-day cycle.
Azacitidine Subcutaneous Injection or Intravenous Infusion: 75 mg/m2
Pevonedistat Infusion: 20 mg/m2
Bone Marrow Biopsy \& Aspirate: Removal of a small piece of bone and bone marrow by inserting a needle into hip bone.
|
|---|---|
|
Blood and lymphatic system disorders
Anemia
|
2.8%
2/71 • Number of events 2 • Serious and other (not including serious) adverse events were assessed from initiation of investigational treatment (to also include events preceding initiation of study) through 30 days after last dose of investigational treatment up to a maximum duration of 2 years. All-Cause Mortality was assessed up to 38 months.
|
|
Blood and lymphatic system disorders
Febrile Neutropenia
|
12.7%
9/71 • Number of events 9 • Serious and other (not including serious) adverse events were assessed from initiation of investigational treatment (to also include events preceding initiation of study) through 30 days after last dose of investigational treatment up to a maximum duration of 2 years. All-Cause Mortality was assessed up to 38 months.
|
|
Gastrointestinal disorders
Lower gastrointestinal hemorrhage
|
1.4%
1/71 • Number of events 1 • Serious and other (not including serious) adverse events were assessed from initiation of investigational treatment (to also include events preceding initiation of study) through 30 days after last dose of investigational treatment up to a maximum duration of 2 years. All-Cause Mortality was assessed up to 38 months.
|
|
Gastrointestinal disorders
Rectal fistula
|
1.4%
1/71 • Number of events 1 • Serious and other (not including serious) adverse events were assessed from initiation of investigational treatment (to also include events preceding initiation of study) through 30 days after last dose of investigational treatment up to a maximum duration of 2 years. All-Cause Mortality was assessed up to 38 months.
|
|
General disorders
Death NOS
|
1.4%
1/71 • Number of events 1 • Serious and other (not including serious) adverse events were assessed from initiation of investigational treatment (to also include events preceding initiation of study) through 30 days after last dose of investigational treatment up to a maximum duration of 2 years. All-Cause Mortality was assessed up to 38 months.
|
|
General disorders
Fever
|
4.2%
3/71 • Number of events 3 • Serious and other (not including serious) adverse events were assessed from initiation of investigational treatment (to also include events preceding initiation of study) through 30 days after last dose of investigational treatment up to a maximum duration of 2 years. All-Cause Mortality was assessed up to 38 months.
|
|
Immune system disorders
Allergic reaction
|
1.4%
1/71 • Number of events 1 • Serious and other (not including serious) adverse events were assessed from initiation of investigational treatment (to also include events preceding initiation of study) through 30 days after last dose of investigational treatment up to a maximum duration of 2 years. All-Cause Mortality was assessed up to 38 months.
|
|
Infections and infestations
Endocarditis infective
|
1.4%
1/71 • Number of events 1 • Serious and other (not including serious) adverse events were assessed from initiation of investigational treatment (to also include events preceding initiation of study) through 30 days after last dose of investigational treatment up to a maximum duration of 2 years. All-Cause Mortality was assessed up to 38 months.
|
|
Infections and infestations
Lung infection
|
2.8%
2/71 • Number of events 2 • Serious and other (not including serious) adverse events were assessed from initiation of investigational treatment (to also include events preceding initiation of study) through 30 days after last dose of investigational treatment up to a maximum duration of 2 years. All-Cause Mortality was assessed up to 38 months.
|
|
Infections and infestations
Sepsis
|
2.8%
2/71 • Number of events 2 • Serious and other (not including serious) adverse events were assessed from initiation of investigational treatment (to also include events preceding initiation of study) through 30 days after last dose of investigational treatment up to a maximum duration of 2 years. All-Cause Mortality was assessed up to 38 months.
|
|
Infections and infestations
Sinusitis
|
1.4%
1/71 • Number of events 1 • Serious and other (not including serious) adverse events were assessed from initiation of investigational treatment (to also include events preceding initiation of study) through 30 days after last dose of investigational treatment up to a maximum duration of 2 years. All-Cause Mortality was assessed up to 38 months.
|
|
Infections and infestations
Upper respiratory infection
|
1.4%
1/71 • Number of events 1 • Serious and other (not including serious) adverse events were assessed from initiation of investigational treatment (to also include events preceding initiation of study) through 30 days after last dose of investigational treatment up to a maximum duration of 2 years. All-Cause Mortality was assessed up to 38 months.
|
|
Injury, poisoning and procedural complications
Fall
|
4.2%
3/71 • Number of events 3 • Serious and other (not including serious) adverse events were assessed from initiation of investigational treatment (to also include events preceding initiation of study) through 30 days after last dose of investigational treatment up to a maximum duration of 2 years. All-Cause Mortality was assessed up to 38 months.
|
|
Investigations
Neutrophil count decreased
|
2.8%
2/71 • Number of events 2 • Serious and other (not including serious) adverse events were assessed from initiation of investigational treatment (to also include events preceding initiation of study) through 30 days after last dose of investigational treatment up to a maximum duration of 2 years. All-Cause Mortality was assessed up to 38 months.
|
|
Investigations
Platelet count decreased
|
2.8%
2/71 • Number of events 3 • Serious and other (not including serious) adverse events were assessed from initiation of investigational treatment (to also include events preceding initiation of study) through 30 days after last dose of investigational treatment up to a maximum duration of 2 years. All-Cause Mortality was assessed up to 38 months.
|
|
Metabolism and nutrition disorders
Dehydration
|
2.8%
2/71 • Number of events 2 • Serious and other (not including serious) adverse events were assessed from initiation of investigational treatment (to also include events preceding initiation of study) through 30 days after last dose of investigational treatment up to a maximum duration of 2 years. All-Cause Mortality was assessed up to 38 months.
|
|
Metabolism and nutrition disorders
Hyperuricemia
|
1.4%
1/71 • Number of events 2 • Serious and other (not including serious) adverse events were assessed from initiation of investigational treatment (to also include events preceding initiation of study) through 30 days after last dose of investigational treatment up to a maximum duration of 2 years. All-Cause Mortality was assessed up to 38 months.
|
|
Metabolism and nutrition disorders
Hyponatremia
|
1.4%
1/71 • Number of events 1 • Serious and other (not including serious) adverse events were assessed from initiation of investigational treatment (to also include events preceding initiation of study) through 30 days after last dose of investigational treatment up to a maximum duration of 2 years. All-Cause Mortality was assessed up to 38 months.
|
|
Musculoskeletal and connective tissue disorders
Flank pain
|
1.4%
1/71 • Number of events 1 • Serious and other (not including serious) adverse events were assessed from initiation of investigational treatment (to also include events preceding initiation of study) through 30 days after last dose of investigational treatment up to a maximum duration of 2 years. All-Cause Mortality was assessed up to 38 months.
|
|
Musculoskeletal and connective tissue disorders
Generalized muscle weakness
|
1.4%
1/71 • Number of events 1 • Serious and other (not including serious) adverse events were assessed from initiation of investigational treatment (to also include events preceding initiation of study) through 30 days after last dose of investigational treatment up to a maximum duration of 2 years. All-Cause Mortality was assessed up to 38 months.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
1.4%
1/71 • Number of events 1 • Serious and other (not including serious) adverse events were assessed from initiation of investigational treatment (to also include events preceding initiation of study) through 30 days after last dose of investigational treatment up to a maximum duration of 2 years. All-Cause Mortality was assessed up to 38 months.
|
|
Nervous system disorders
Headache
|
1.4%
1/71 • Number of events 1 • Serious and other (not including serious) adverse events were assessed from initiation of investigational treatment (to also include events preceding initiation of study) through 30 days after last dose of investigational treatment up to a maximum duration of 2 years. All-Cause Mortality was assessed up to 38 months.
|
|
Nervous system disorders
Syncope
|
1.4%
1/71 • Number of events 1 • Serious and other (not including serious) adverse events were assessed from initiation of investigational treatment (to also include events preceding initiation of study) through 30 days after last dose of investigational treatment up to a maximum duration of 2 years. All-Cause Mortality was assessed up to 38 months.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
2.8%
2/71 • Number of events 2 • Serious and other (not including serious) adverse events were assessed from initiation of investigational treatment (to also include events preceding initiation of study) through 30 days after last dose of investigational treatment up to a maximum duration of 2 years. All-Cause Mortality was assessed up to 38 months.
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
1.4%
1/71 • Number of events 1 • Serious and other (not including serious) adverse events were assessed from initiation of investigational treatment (to also include events preceding initiation of study) through 30 days after last dose of investigational treatment up to a maximum duration of 2 years. All-Cause Mortality was assessed up to 38 months.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary edema
|
1.4%
1/71 • Number of events 1 • Serious and other (not including serious) adverse events were assessed from initiation of investigational treatment (to also include events preceding initiation of study) through 30 days after last dose of investigational treatment up to a maximum duration of 2 years. All-Cause Mortality was assessed up to 38 months.
|
|
Infections and infestations
Skin infection
|
1.4%
1/71 • Number of events 1 • Serious and other (not including serious) adverse events were assessed from initiation of investigational treatment (to also include events preceding initiation of study) through 30 days after last dose of investigational treatment up to a maximum duration of 2 years. All-Cause Mortality was assessed up to 38 months.
|
|
Investigations
Pancytopenia
|
1.4%
1/71 • Number of events 1 • Serious and other (not including serious) adverse events were assessed from initiation of investigational treatment (to also include events preceding initiation of study) through 30 days after last dose of investigational treatment up to a maximum duration of 2 years. All-Cause Mortality was assessed up to 38 months.
|
|
Infections and infestations
Pseudomonas Bacteremia
|
1.4%
1/71 • Number of events 1 • Serious and other (not including serious) adverse events were assessed from initiation of investigational treatment (to also include events preceding initiation of study) through 30 days after last dose of investigational treatment up to a maximum duration of 2 years. All-Cause Mortality was assessed up to 38 months.
|
|
Infections and infestations
Left Hip Cellulitis
|
1.4%
1/71 • Number of events 1 • Serious and other (not including serious) adverse events were assessed from initiation of investigational treatment (to also include events preceding initiation of study) through 30 days after last dose of investigational treatment up to a maximum duration of 2 years. All-Cause Mortality was assessed up to 38 months.
|
|
Skin and subcutaneous tissue disorders
Rash
|
1.4%
1/71 • Number of events 1 • Serious and other (not including serious) adverse events were assessed from initiation of investigational treatment (to also include events preceding initiation of study) through 30 days after last dose of investigational treatment up to a maximum duration of 2 years. All-Cause Mortality was assessed up to 38 months.
|
|
Investigations
Alkaline phosphatase Increased
|
1.4%
1/71 • Number of events 1 • Serious and other (not including serious) adverse events were assessed from initiation of investigational treatment (to also include events preceding initiation of study) through 30 days after last dose of investigational treatment up to a maximum duration of 2 years. All-Cause Mortality was assessed up to 38 months.
|
|
Investigations
Aspartate aminotransferase Increased
|
1.4%
1/71 • Number of events 1 • Serious and other (not including serious) adverse events were assessed from initiation of investigational treatment (to also include events preceding initiation of study) through 30 days after last dose of investigational treatment up to a maximum duration of 2 years. All-Cause Mortality was assessed up to 38 months.
|
|
Investigations
Alanine aminotransferase increased
|
1.4%
1/71 • Number of events 1 • Serious and other (not including serious) adverse events were assessed from initiation of investigational treatment (to also include events preceding initiation of study) through 30 days after last dose of investigational treatment up to a maximum duration of 2 years. All-Cause Mortality was assessed up to 38 months.
|
|
Investigations
Blood bilirubin increased
|
1.4%
1/71 • Number of events 1 • Serious and other (not including serious) adverse events were assessed from initiation of investigational treatment (to also include events preceding initiation of study) through 30 days after last dose of investigational treatment up to a maximum duration of 2 years. All-Cause Mortality was assessed up to 38 months.
|
|
Infections and infestations
Pneumonia
|
7.0%
5/71 • Number of events 6 • Serious and other (not including serious) adverse events were assessed from initiation of investigational treatment (to also include events preceding initiation of study) through 30 days after last dose of investigational treatment up to a maximum duration of 2 years. All-Cause Mortality was assessed up to 38 months.
|
|
Nervous system disorders
Hemorrhagic metastatic disease
|
1.4%
1/71 • Number of events 1 • Serious and other (not including serious) adverse events were assessed from initiation of investigational treatment (to also include events preceding initiation of study) through 30 days after last dose of investigational treatment up to a maximum duration of 2 years. All-Cause Mortality was assessed up to 38 months.
|
|
Infections and infestations
Face infection
|
1.4%
1/71 • Number of events 1 • Serious and other (not including serious) adverse events were assessed from initiation of investigational treatment (to also include events preceding initiation of study) through 30 days after last dose of investigational treatment up to a maximum duration of 2 years. All-Cause Mortality was assessed up to 38 months.
|
|
Infections and infestations
Labia infection
|
1.4%
1/71 • Number of events 1 • Serious and other (not including serious) adverse events were assessed from initiation of investigational treatment (to also include events preceding initiation of study) through 30 days after last dose of investigational treatment up to a maximum duration of 2 years. All-Cause Mortality was assessed up to 38 months.
|
|
Vascular disorders
Thromboembolic event - Related to vascular access device removal
|
1.4%
1/71 • Number of events 1 • Serious and other (not including serious) adverse events were assessed from initiation of investigational treatment (to also include events preceding initiation of study) through 30 days after last dose of investigational treatment up to a maximum duration of 2 years. All-Cause Mortality was assessed up to 38 months.
|
|
General disorders
Seronegative inflammatory migratory arthritis
|
1.4%
1/71 • Number of events 1 • Serious and other (not including serious) adverse events were assessed from initiation of investigational treatment (to also include events preceding initiation of study) through 30 days after last dose of investigational treatment up to a maximum duration of 2 years. All-Cause Mortality was assessed up to 38 months.
|
|
Infections and infestations
Facial Cellulitis
|
1.4%
1/71 • Number of events 1 • Serious and other (not including serious) adverse events were assessed from initiation of investigational treatment (to also include events preceding initiation of study) through 30 days after last dose of investigational treatment up to a maximum duration of 2 years. All-Cause Mortality was assessed up to 38 months.
|
|
Infections and infestations
Suprapubic cellulitis
|
1.4%
1/71 • Number of events 1 • Serious and other (not including serious) adverse events were assessed from initiation of investigational treatment (to also include events preceding initiation of study) through 30 days after last dose of investigational treatment up to a maximum duration of 2 years. All-Cause Mortality was assessed up to 38 months.
|
|
Gastrointestinal disorders
C.Diff Diarrhea, positive GI panel
|
1.4%
1/71 • Number of events 1 • Serious and other (not including serious) adverse events were assessed from initiation of investigational treatment (to also include events preceding initiation of study) through 30 days after last dose of investigational treatment up to a maximum duration of 2 years. All-Cause Mortality was assessed up to 38 months.
|
|
General disorders
Dental abscesses
|
1.4%
1/71 • Number of events 1 • Serious and other (not including serious) adverse events were assessed from initiation of investigational treatment (to also include events preceding initiation of study) through 30 days after last dose of investigational treatment up to a maximum duration of 2 years. All-Cause Mortality was assessed up to 38 months.
|
|
Skin and subcutaneous tissue disorders
Acute febrile neutrophillic dermatosis
|
1.4%
1/71 • Number of events 1 • Serious and other (not including serious) adverse events were assessed from initiation of investigational treatment (to also include events preceding initiation of study) through 30 days after last dose of investigational treatment up to a maximum duration of 2 years. All-Cause Mortality was assessed up to 38 months.
|
|
General disorders
Progressive disease
|
1.4%
1/71 • Number of events 1 • Serious and other (not including serious) adverse events were assessed from initiation of investigational treatment (to also include events preceding initiation of study) through 30 days after last dose of investigational treatment up to a maximum duration of 2 years. All-Cause Mortality was assessed up to 38 months.
|
|
Blood and lymphatic system disorders
Enlarged spleen
|
1.4%
1/71 • Number of events 1 • Serious and other (not including serious) adverse events were assessed from initiation of investigational treatment (to also include events preceding initiation of study) through 30 days after last dose of investigational treatment up to a maximum duration of 2 years. All-Cause Mortality was assessed up to 38 months.
|
|
Gastrointestinal disorders
Peri-rectal Abscess
|
1.4%
1/71 • Number of events 1 • Serious and other (not including serious) adverse events were assessed from initiation of investigational treatment (to also include events preceding initiation of study) through 30 days after last dose of investigational treatment up to a maximum duration of 2 years. All-Cause Mortality was assessed up to 38 months.
|
|
Musculoskeletal and connective tissue disorders
Shoulder pain
|
1.4%
1/71 • Number of events 1 • Serious and other (not including serious) adverse events were assessed from initiation of investigational treatment (to also include events preceding initiation of study) through 30 days after last dose of investigational treatment up to a maximum duration of 2 years. All-Cause Mortality was assessed up to 38 months.
|
|
Respiratory, thoracic and mediastinal disorders
Sinus infection
|
1.4%
1/71 • Number of events 1 • Serious and other (not including serious) adverse events were assessed from initiation of investigational treatment (to also include events preceding initiation of study) through 30 days after last dose of investigational treatment up to a maximum duration of 2 years. All-Cause Mortality was assessed up to 38 months.
|
|
Renal and urinary disorders
Acute renal failure
|
1.4%
1/71 • Number of events 1 • Serious and other (not including serious) adverse events were assessed from initiation of investigational treatment (to also include events preceding initiation of study) through 30 days after last dose of investigational treatment up to a maximum duration of 2 years. All-Cause Mortality was assessed up to 38 months.
|
|
Nervous system disorders
Cortical Laminar Necrosis
|
1.4%
1/71 • Number of events 1 • Serious and other (not including serious) adverse events were assessed from initiation of investigational treatment (to also include events preceding initiation of study) through 30 days after last dose of investigational treatment up to a maximum duration of 2 years. All-Cause Mortality was assessed up to 38 months.
|
|
Nervous system disorders
Multiple Chronic Infarcts
|
1.4%
1/71 • Number of events 1 • Serious and other (not including serious) adverse events were assessed from initiation of investigational treatment (to also include events preceding initiation of study) through 30 days after last dose of investigational treatment up to a maximum duration of 2 years. All-Cause Mortality was assessed up to 38 months.
|
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place