Trial Outcomes & Findings for Decitabine Followed by Mitoxantrone Hydrochloride, Etoposide, and Cytarabine in Treating Patients With Relapsed or Refractory Acute Myeloid Leukemia or High-Risk Myelodysplastic Syndromes (NCT NCT01729845)
NCT ID: NCT01729845
Last Updated: 2019-02-07
Results Overview
MTD (most tolerated dose) of decitabine, measured in number of dose limiting toxicities. MTD defined as the highest dose in which the incidence of dose limiting toxicity is \< 33%, graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events version 4.0 (Phase I)
Recruitment status
COMPLETED
Study phase
PHASE1/PHASE2
Target enrollment
52 participants
Primary outcome timeframe
through day 45
Results posted on
2019-02-07
Participant Flow
Participant milestones
| Measure |
Dose Level 1: 5-Days of Decitabine-MEC
Patients receive decitabine IV days -9 to -5 (dose level 1).
INDUCTION THERAPY: Patients receive mitoxantrone hydrochloride IV on days 1-5, etoposide IV on days 1-5, and cytarabine IV on days 1-5. Patients achieving CR or CR with CRp may receive up to 2 courses of induction therapy and up to 2 courses of consolidation therapy.
Cytarabine: Given IV
Decitabine: Given IV
Etoposide: Given IV
Mitoxantrone Hydrochloride: Given IV
|
Dose Level 2: 7-Days of Decitabine-MEC
Patients receive decitabine IV days -11 to -5 (dose level 2).
INDUCTION THERAPY: Patients receive mitoxantrone hydrochloride IV on days 1-5, etoposide IV on days 1-5, and cytarabine IV on days 1-5. Patients achieving CR or CR with CRp may receive up to 2 courses of induction therapy and up to 2 courses of consolidation therapy.
Cytarabine: Given IV
Decitabine: Given IV
Etoposide: Given IV
Mitoxantrone Hydrochloride: Given IV
|
Dose Level 3: 10-days of Decitabine-MEC
Patients receive decitabine IV days -14 to -5 (dose level 3).
INDUCTION THERAPY: Patients receive mitoxantrone hydrochloride IV on days 1-5, etoposide IV on days 1-5, and cytarabine IV on days 1-5. Patients achieving CR or CR with CRp may receive up to 2 courses of induction therapy and up to 2 courses of consolidation therapy.
Cytarabine: Given IV Decitabine: Given IV Etoposide: Given IV Mitoxantrone Hydrochloride: Given IV
|
|---|---|---|---|
|
Safety/Tolerability of Dec/MEC
STARTED
|
6
|
34
|
12
|
|
Safety/Tolerability of Dec/MEC
COMPLETED
|
6
|
34
|
12
|
|
Safety/Tolerability of Dec/MEC
NOT COMPLETED
|
0
|
0
|
0
|
|
Efficacy of Dec/MEC
STARTED
|
0
|
22
|
0
|
|
Efficacy of Dec/MEC
COMPLETED
|
0
|
22
|
0
|
|
Efficacy of Dec/MEC
NOT COMPLETED
|
0
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Decitabine Followed by Mitoxantrone Hydrochloride, Etoposide, and Cytarabine in Treating Patients With Relapsed or Refractory Acute Myeloid Leukemia or High-Risk Myelodysplastic Syndromes
Baseline characteristics by cohort
| Measure |
Dose Level 1: 5-Days of Decitabine-MEC
n=6 Participants
Patients receive decitabine IV days -9 to -5 (dose level 1).
INDUCTION THERAPY: Patients receive mitoxantrone hydrochloride IV on days 1-5, etoposide IV on days 1-5, and cytarabine IV on days 1-5. Patients achieving CR or CR with CRp may receive up to 2 courses of induction therapy and up to 2 courses of consolidation therapy.
Cytarabine: Given IV
Decitabine: Given IV
Etoposide: Given IV
Laboratory Biomarker Analysis: Correlative studies
Mitoxantrone Hydrochloride: Given IV
|
Dose Level 2: 7-Days of Decitabine-MEC
n=34 Participants
Patients receive decitabine IV days -11 to -5 (dose level 2).
INDUCTION THERAPY: Patients receive mitoxantrone hydrochloride IV on days 1-5, etoposide IV on days 1-5, and cytarabine IV on days 1-5. Patients achieving CR or CR with CRp may receive up to 2 courses of induction therapy and up to 2 courses of consolidation therapy.
Cytarabine: Given IV
Decitabine: Given IV
Etoposide: Given IV
Laboratory Biomarker Analysis: Correlative studies
Mitoxantrone Hydrochloride: Given IV
|
Dose Level 3: 10-Days of Decitabine-MEC
n=12 Participants
Patients receive decitabine IV days -14 to -5 (dose level 3).
INDUCTION THERAPY: Patients receive mitoxantrone hydrochloride IV on days 1-5, etoposide IV on days 1-5, and cytarabine IV on days 1-5. Patients achieving CR or CR with CRp may receive up to 2 courses of induction therapy and up to 2 courses of consolidation therapy.
Cytarabine: Given IV
Decitabine: Given IV
Etoposide: Given IV
Laboratory Biomarker Analysis: Correlative studies
Mitoxantrone Hydrochloride: Given IV
|
Total
n=52 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
54 years
n=99 Participants
|
55 years
n=107 Participants
|
57 years
n=206 Participants
|
55 years
n=7 Participants
|
|
Sex: Female, Male
Female
|
1 Participants
n=99 Participants
|
16 Participants
n=107 Participants
|
6 Participants
n=206 Participants
|
23 Participants
n=7 Participants
|
|
Sex: Female, Male
Male
|
5 Participants
n=99 Participants
|
18 Participants
n=107 Participants
|
6 Participants
n=206 Participants
|
29 Participants
n=7 Participants
|
PRIMARY outcome
Timeframe: through day 45MTD (most tolerated dose) of decitabine, measured in number of dose limiting toxicities. MTD defined as the highest dose in which the incidence of dose limiting toxicity is \< 33%, graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events version 4.0 (Phase I)
Outcome measures
| Measure |
Dose Level 1: 5-Days of Decitabine-MEC
n=6 Participants
Patients receive decitabine IV days -9 to -5 (dose level 1). INDUCTION THERAPY: Patients receive mitoxantrone hydrochloride IV on days 1-5, etoposide IV on days 1-5, and cytarabine IV on days 1-5. Patients achieving CR or CR with CRp may receive up to 2 courses of induction therapy and up to 2 courses of consolidation therapy.
Cytarabine: Given IV Decitabine: Given IV Etoposide: Given IV Laboratory Biomarker Analysis: Correlative studies Mitoxantrone Hydrochloride: Given IV
Decitabine: Given IV
Etoposide: Given IV
Mitoxantrone Hydrochloride: Given IV
|
Dose Level 2: 7-Days of Decitabine-MEC
n=12 Participants
Patients receive decitabine IV days -11 to -5 (dose level 2). INDUCTION THERAPY: Patients receive mitoxantrone hydrochloride IV on days 1-5, etoposide IV on days 1-5, and cytarabine IV on days 1-5. Patients achieving CR or CR with CRp may receive up to 2 courses of induction therapy and up to 2 courses of consolidation therapy.
Cytarabine: Given IV Decitabine: Given IV Etoposide: Given IV Laboratory Biomarker Analysis: Correlative studies Mitoxantrone Hydrochloride: Given IV
|
Dose Level 3: 10-Days of Decitabine-MEC
n=12 Participants
Patients receive decitabine IV days -14 to -5 (dose level 1).
INDUCTION THERAPY: Patients receive mitoxantrone hydrochloride IV on days 1-5, etoposide IV on days 1-5, and cytarabine IV on days 1-5. Patients achieving CR or CR with CRp may receive up to 2 courses of induction therapy and up to 2 courses of consolidation therapy.
Cytarabine: Given IV Decitabine: Given IV Etoposide: Given IV Laboratory Biomarker Analysis: Correlative studies Mitoxantrone Hydrochloride: Given IV
|
|---|---|---|---|
|
Most Efficacious and Tolerated Dosage of Decitabine (Period 1)
Resistant Disease
|
1 Incidents
|
3 Incidents
|
4 Incidents
|
|
Most Efficacious and Tolerated Dosage of Decitabine (Period 1)
Dose-limiting toxiticies
|
0 Incidents
|
0 Incidents
|
0 Incidents
|
|
Most Efficacious and Tolerated Dosage of Decitabine (Period 1)
Complete Remission
|
1 Incidents
|
5 Incidents
|
3 Incidents
|
|
Most Efficacious and Tolerated Dosage of Decitabine (Period 1)
Complete Remission, incomplete PLT recovery
|
2 Incidents
|
1 Incidents
|
2 Incidents
|
|
Most Efficacious and Tolerated Dosage of Decitabine (Period 1)
Complete Remission, incomplete blood count recover
|
0 Incidents
|
1 Incidents
|
0 Incidents
|
|
Most Efficacious and Tolerated Dosage of Decitabine (Period 1)
Morphologic leukemia-free state
|
0 Incidents
|
0 Incidents
|
3 Incidents
|
|
Most Efficacious and Tolerated Dosage of Decitabine (Period 1)
Death (among those who received MEC)
|
2 Incidents
|
1 Incidents
|
0 Incidents
|
SECONDARY outcome
Timeframe: Up to 5 yearsPopulation: Population includes all Dose Level 2 participants from both periods 1 and 2.
Complete remission (CR) and Complete remission with incomplete platelet recovery (CRp) categorized according to criteria recommended by International Working Groups: Complete resolution of disease-related symptoms and signs including palpable hepatosplenomegaly; hemoglobin level at least 110 g/L, platelet count at least 100x10\^9/L, and absolute neutrophil count at least 1.0 x10\^9/L. In addition, all 3 blood counts should be no higher than the upper normal limit; Normal leukocyte differential; Bone marrow histologic remission defined as the presence of age-adjusted normocellularity, no more than 5% myeloblasts, and an osteomyelofibrosis grade no higher than 1.
Outcome measures
| Measure |
Dose Level 1: 5-Days of Decitabine-MEC
n=34 Participants
Patients receive decitabine IV days -9 to -5 (dose level 1). INDUCTION THERAPY: Patients receive mitoxantrone hydrochloride IV on days 1-5, etoposide IV on days 1-5, and cytarabine IV on days 1-5. Patients achieving CR or CR with CRp may receive up to 2 courses of induction therapy and up to 2 courses of consolidation therapy.
Cytarabine: Given IV Decitabine: Given IV Etoposide: Given IV Laboratory Biomarker Analysis: Correlative studies Mitoxantrone Hydrochloride: Given IV
Decitabine: Given IV
Etoposide: Given IV
Mitoxantrone Hydrochloride: Given IV
|
Dose Level 2: 7-Days of Decitabine-MEC
Patients receive decitabine IV days -11 to -5 (dose level 2). INDUCTION THERAPY: Patients receive mitoxantrone hydrochloride IV on days 1-5, etoposide IV on days 1-5, and cytarabine IV on days 1-5. Patients achieving CR or CR with CRp may receive up to 2 courses of induction therapy and up to 2 courses of consolidation therapy.
Cytarabine: Given IV Decitabine: Given IV Etoposide: Given IV Laboratory Biomarker Analysis: Correlative studies Mitoxantrone Hydrochloride: Given IV
|
Dose Level 3: 10-Days of Decitabine-MEC
Patients receive decitabine IV days -14 to -5 (dose level 1).
INDUCTION THERAPY: Patients receive mitoxantrone hydrochloride IV on days 1-5, etoposide IV on days 1-5, and cytarabine IV on days 1-5. Patients achieving CR or CR with CRp may receive up to 2 courses of induction therapy and up to 2 courses of consolidation therapy.
Cytarabine: Given IV Decitabine: Given IV Etoposide: Given IV Laboratory Biomarker Analysis: Correlative studies Mitoxantrone Hydrochloride: Given IV
|
|---|---|---|---|
|
Remission Rate Including CR and CRp
|
11 Participants
|
—
|
—
|
SECONDARY outcome
Timeframe: Up to 5 yearsPopulation: Population includes all Dose Level 2 participants, from both periods 1 and 2, who achieved CR or CRp
Categorized according to criteria recommended by International Working Groups.
Outcome measures
| Measure |
Dose Level 1: 5-Days of Decitabine-MEC
n=11 Participants
Patients receive decitabine IV days -9 to -5 (dose level 1). INDUCTION THERAPY: Patients receive mitoxantrone hydrochloride IV on days 1-5, etoposide IV on days 1-5, and cytarabine IV on days 1-5. Patients achieving CR or CR with CRp may receive up to 2 courses of induction therapy and up to 2 courses of consolidation therapy.
Cytarabine: Given IV Decitabine: Given IV Etoposide: Given IV Laboratory Biomarker Analysis: Correlative studies Mitoxantrone Hydrochloride: Given IV
Decitabine: Given IV
Etoposide: Given IV
Mitoxantrone Hydrochloride: Given IV
|
Dose Level 2: 7-Days of Decitabine-MEC
Patients receive decitabine IV days -11 to -5 (dose level 2). INDUCTION THERAPY: Patients receive mitoxantrone hydrochloride IV on days 1-5, etoposide IV on days 1-5, and cytarabine IV on days 1-5. Patients achieving CR or CR with CRp may receive up to 2 courses of induction therapy and up to 2 courses of consolidation therapy.
Cytarabine: Given IV Decitabine: Given IV Etoposide: Given IV Laboratory Biomarker Analysis: Correlative studies Mitoxantrone Hydrochloride: Given IV
|
Dose Level 3: 10-Days of Decitabine-MEC
Patients receive decitabine IV days -14 to -5 (dose level 1).
INDUCTION THERAPY: Patients receive mitoxantrone hydrochloride IV on days 1-5, etoposide IV on days 1-5, and cytarabine IV on days 1-5. Patients achieving CR or CR with CRp may receive up to 2 courses of induction therapy and up to 2 courses of consolidation therapy.
Cytarabine: Given IV Decitabine: Given IV Etoposide: Given IV Laboratory Biomarker Analysis: Correlative studies Mitoxantrone Hydrochloride: Given IV
|
|---|---|---|---|
|
Duration of Relapse-free Survival (for Patients Achieving CR or CRp)
|
150 Days
Interval 20.0 to 1031.0
|
—
|
—
|
SECONDARY outcome
Timeframe: Up to 5 yearsPopulation: Population includes all Dose Level 2 participants, from both periods 1 and 2.
Survival measured as of day of last contact. Categorized according to criteria recommended by International Working Groups.
Outcome measures
| Measure |
Dose Level 1: 5-Days of Decitabine-MEC
n=34 Participants
Patients receive decitabine IV days -9 to -5 (dose level 1). INDUCTION THERAPY: Patients receive mitoxantrone hydrochloride IV on days 1-5, etoposide IV on days 1-5, and cytarabine IV on days 1-5. Patients achieving CR or CR with CRp may receive up to 2 courses of induction therapy and up to 2 courses of consolidation therapy.
Cytarabine: Given IV Decitabine: Given IV Etoposide: Given IV Laboratory Biomarker Analysis: Correlative studies Mitoxantrone Hydrochloride: Given IV
Decitabine: Given IV
Etoposide: Given IV
Mitoxantrone Hydrochloride: Given IV
|
Dose Level 2: 7-Days of Decitabine-MEC
Patients receive decitabine IV days -11 to -5 (dose level 2). INDUCTION THERAPY: Patients receive mitoxantrone hydrochloride IV on days 1-5, etoposide IV on days 1-5, and cytarabine IV on days 1-5. Patients achieving CR or CR with CRp may receive up to 2 courses of induction therapy and up to 2 courses of consolidation therapy.
Cytarabine: Given IV Decitabine: Given IV Etoposide: Given IV Laboratory Biomarker Analysis: Correlative studies Mitoxantrone Hydrochloride: Given IV
|
Dose Level 3: 10-Days of Decitabine-MEC
Patients receive decitabine IV days -14 to -5 (dose level 1).
INDUCTION THERAPY: Patients receive mitoxantrone hydrochloride IV on days 1-5, etoposide IV on days 1-5, and cytarabine IV on days 1-5. Patients achieving CR or CR with CRp may receive up to 2 courses of induction therapy and up to 2 courses of consolidation therapy.
Cytarabine: Given IV Decitabine: Given IV Etoposide: Given IV Laboratory Biomarker Analysis: Correlative studies Mitoxantrone Hydrochloride: Given IV
|
|---|---|---|---|
|
Overall Survival
|
564 days
Interval 165.0 to 1239.0
|
—
|
—
|
Adverse Events
Dose Level 1: 5-Days of Decitabine-MEC
Serious events: 0 serious events
Other events: 6 other events
Deaths: 2 deaths
Dose Level 2: 7-Days of Decitabine-MEC
Serious events: 0 serious events
Other events: 33 other events
Deaths: 1 deaths
Dose Level 3: 10-days of Decitabine-MEC
Serious events: 0 serious events
Other events: 12 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Dose Level 1: 5-Days of Decitabine-MEC
n=6 participants at risk
Patients receive decitabine IV days -9 to -5 (dose level 1).
INDUCTION THERAPY: Patients receive mitoxantrone hydrochloride IV on days 1-5, etoposide IV on days 1-5, and cytarabine IV on days 1-5. Patients achieving CR or CR with CRp may receive up to 2 courses of induction therapy and up to 2 courses of consolidation therapy.
Cytarabine: Given IV Decitabine: Given IV Etoposide: Given IV Mitoxantrone Hydrochloride: Given IV
|
Dose Level 2: 7-Days of Decitabine-MEC
n=34 participants at risk
Patients receive decitabine IV days -11 to -5 (dose level 2).
INDUCTION THERAPY: Patients receive mitoxantrone hydrochloride IV on days 1-5, etoposide IV on days 1-5, and cytarabine IV on days 1-5. Patients achieving CR or CR with CRp may receive up to 2 courses of induction therapy and up to 2 courses of consolidation therapy.
Cytarabine: Given IV Decitabine: Given IV Etoposide: Given IV Mitoxantrone Hydrochloride: Given IV
|
Dose Level 3: 10-days of Decitabine-MEC
n=12 participants at risk
Patients receive decitabine IV days -14 to -5 (dose level 3).
INDUCTION THERAPY: Patients receive mitoxantrone hydrochloride IV on days 1-5, etoposide IV on days 1-5, and cytarabine IV on days 1-5. Patients achieving CR or CR with CRp may receive up to 2 courses of induction therapy and up to 2 courses of consolidation therapy.
Cytarabine: Given IV Decitabine: Given IV Etoposide: Given IV Mitoxantrone Hydrochloride: Given IV
|
|---|---|---|---|
|
Blood and lymphatic system disorders
Febrile Neutropenia
|
83.3%
5/6
Death's reported were not reportable Serous adverse events per protocol. They were expected, or not related to drug and/or described in the protocol and consent form.
|
79.4%
27/34
Death's reported were not reportable Serous adverse events per protocol. They were expected, or not related to drug and/or described in the protocol and consent form.
|
91.7%
11/12
Death's reported were not reportable Serous adverse events per protocol. They were expected, or not related to drug and/or described in the protocol and consent form.
|
|
Skin and subcutaneous tissue disorders
Maculopapular Rash
|
16.7%
1/6
Death's reported were not reportable Serous adverse events per protocol. They were expected, or not related to drug and/or described in the protocol and consent form.
|
2.9%
1/34
Death's reported were not reportable Serous adverse events per protocol. They were expected, or not related to drug and/or described in the protocol and consent form.
|
8.3%
1/12
Death's reported were not reportable Serous adverse events per protocol. They were expected, or not related to drug and/or described in the protocol and consent form.
|
|
Infections and infestations
Sepsis
|
16.7%
1/6
Death's reported were not reportable Serous adverse events per protocol. They were expected, or not related to drug and/or described in the protocol and consent form.
|
29.4%
10/34
Death's reported were not reportable Serous adverse events per protocol. They were expected, or not related to drug and/or described in the protocol and consent form.
|
41.7%
5/12
Death's reported were not reportable Serous adverse events per protocol. They were expected, or not related to drug and/or described in the protocol and consent form.
|
|
Infections and infestations
Bacteremia
|
16.7%
1/6
Death's reported were not reportable Serous adverse events per protocol. They were expected, or not related to drug and/or described in the protocol and consent form.
|
35.3%
12/34
Death's reported were not reportable Serous adverse events per protocol. They were expected, or not related to drug and/or described in the protocol and consent form.
|
41.7%
5/12
Death's reported were not reportable Serous adverse events per protocol. They were expected, or not related to drug and/or described in the protocol and consent form.
|
|
Infections and infestations
Pneumonia
|
16.7%
1/6
Death's reported were not reportable Serous adverse events per protocol. They were expected, or not related to drug and/or described in the protocol and consent form.
|
2.9%
1/34
Death's reported were not reportable Serous adverse events per protocol. They were expected, or not related to drug and/or described in the protocol and consent form.
|
8.3%
1/12
Death's reported were not reportable Serous adverse events per protocol. They were expected, or not related to drug and/or described in the protocol and consent form.
|
|
Infections and infestations
Fungal Pneumonia
|
16.7%
1/6
Death's reported were not reportable Serous adverse events per protocol. They were expected, or not related to drug and/or described in the protocol and consent form.
|
23.5%
8/34
Death's reported were not reportable Serous adverse events per protocol. They were expected, or not related to drug and/or described in the protocol and consent form.
|
33.3%
4/12
Death's reported were not reportable Serous adverse events per protocol. They were expected, or not related to drug and/or described in the protocol and consent form.
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
16.7%
1/6
Death's reported were not reportable Serous adverse events per protocol. They were expected, or not related to drug and/or described in the protocol and consent form.
|
14.7%
5/34
Death's reported were not reportable Serous adverse events per protocol. They were expected, or not related to drug and/or described in the protocol and consent form.
|
33.3%
4/12
Death's reported were not reportable Serous adverse events per protocol. They were expected, or not related to drug and/or described in the protocol and consent form.
|
|
Respiratory, thoracic and mediastinal disorders
Respitatory Failure
|
16.7%
1/6
Death's reported were not reportable Serous adverse events per protocol. They were expected, or not related to drug and/or described in the protocol and consent form.
|
14.7%
5/34
Death's reported were not reportable Serous adverse events per protocol. They were expected, or not related to drug and/or described in the protocol and consent form.
|
25.0%
3/12
Death's reported were not reportable Serous adverse events per protocol. They were expected, or not related to drug and/or described in the protocol and consent form.
|
|
Infections and infestations
Respiratory Tract infection
|
33.3%
2/6
Death's reported were not reportable Serous adverse events per protocol. They were expected, or not related to drug and/or described in the protocol and consent form.
|
0.00%
0/34
Death's reported were not reportable Serous adverse events per protocol. They were expected, or not related to drug and/or described in the protocol and consent form.
|
8.3%
1/12
Death's reported were not reportable Serous adverse events per protocol. They were expected, or not related to drug and/or described in the protocol and consent form.
|
|
Gastrointestinal disorders
Diarrhea
|
0.00%
0/6
Death's reported were not reportable Serous adverse events per protocol. They were expected, or not related to drug and/or described in the protocol and consent form.
|
5.9%
2/34
Death's reported were not reportable Serous adverse events per protocol. They were expected, or not related to drug and/or described in the protocol and consent form.
|
16.7%
2/12
Death's reported were not reportable Serous adverse events per protocol. They were expected, or not related to drug and/or described in the protocol and consent form.
|
|
Metabolism and nutrition disorders
Anorexia
|
0.00%
0/6
Death's reported were not reportable Serous adverse events per protocol. They were expected, or not related to drug and/or described in the protocol and consent form.
|
5.9%
2/34
Death's reported were not reportable Serous adverse events per protocol. They were expected, or not related to drug and/or described in the protocol and consent form.
|
16.7%
2/12
Death's reported were not reportable Serous adverse events per protocol. They were expected, or not related to drug and/or described in the protocol and consent form.
|
|
Respiratory, thoracic and mediastinal disorders
Mucositis
|
16.7%
1/6
Death's reported were not reportable Serous adverse events per protocol. They were expected, or not related to drug and/or described in the protocol and consent form.
|
35.3%
12/34
Death's reported were not reportable Serous adverse events per protocol. They were expected, or not related to drug and/or described in the protocol and consent form.
|
0.00%
0/12
Death's reported were not reportable Serous adverse events per protocol. They were expected, or not related to drug and/or described in the protocol and consent form.
|
|
Gastrointestinal disorders
C Diff
|
0.00%
0/6
Death's reported were not reportable Serous adverse events per protocol. They were expected, or not related to drug and/or described in the protocol and consent form.
|
5.9%
2/34
Death's reported were not reportable Serous adverse events per protocol. They were expected, or not related to drug and/or described in the protocol and consent form.
|
16.7%
2/12
Death's reported were not reportable Serous adverse events per protocol. They were expected, or not related to drug and/or described in the protocol and consent form.
|
|
Metabolism and nutrition disorders
Hypokalemia
|
0.00%
0/6
Death's reported were not reportable Serous adverse events per protocol. They were expected, or not related to drug and/or described in the protocol and consent form.
|
5.9%
2/34
Death's reported were not reportable Serous adverse events per protocol. They were expected, or not related to drug and/or described in the protocol and consent form.
|
16.7%
2/12
Death's reported were not reportable Serous adverse events per protocol. They were expected, or not related to drug and/or described in the protocol and consent form.
|
|
Metabolism and nutrition disorders
Hyponatremia
|
33.3%
2/6
Death's reported were not reportable Serous adverse events per protocol. They were expected, or not related to drug and/or described in the protocol and consent form.
|
2.9%
1/34
Death's reported were not reportable Serous adverse events per protocol. They were expected, or not related to drug and/or described in the protocol and consent form.
|
25.0%
3/12
Death's reported were not reportable Serous adverse events per protocol. They were expected, or not related to drug and/or described in the protocol and consent form.
|
|
Nervous system disorders
Syncope
|
0.00%
0/6
Death's reported were not reportable Serous adverse events per protocol. They were expected, or not related to drug and/or described in the protocol and consent form.
|
5.9%
2/34
Death's reported were not reportable Serous adverse events per protocol. They were expected, or not related to drug and/or described in the protocol and consent form.
|
0.00%
0/12
Death's reported were not reportable Serous adverse events per protocol. They were expected, or not related to drug and/or described in the protocol and consent form.
|
|
Infections and infestations
Soft Tissue Infection
|
0.00%
0/6
Death's reported were not reportable Serous adverse events per protocol. They were expected, or not related to drug and/or described in the protocol and consent form.
|
11.8%
4/34
Death's reported were not reportable Serous adverse events per protocol. They were expected, or not related to drug and/or described in the protocol and consent form.
|
0.00%
0/12
Death's reported were not reportable Serous adverse events per protocol. They were expected, or not related to drug and/or described in the protocol and consent form.
|
|
Infections and infestations
Sinusitis
|
0.00%
0/6
Death's reported were not reportable Serous adverse events per protocol. They were expected, or not related to drug and/or described in the protocol and consent form.
|
8.8%
3/34
Death's reported were not reportable Serous adverse events per protocol. They were expected, or not related to drug and/or described in the protocol and consent form.
|
0.00%
0/12
Death's reported were not reportable Serous adverse events per protocol. They were expected, or not related to drug and/or described in the protocol and consent form.
|
|
Gastrointestinal disorders
Nausea
|
16.7%
1/6
Death's reported were not reportable Serous adverse events per protocol. They were expected, or not related to drug and/or described in the protocol and consent form.
|
8.8%
3/34
Death's reported were not reportable Serous adverse events per protocol. They were expected, or not related to drug and/or described in the protocol and consent form.
|
8.3%
1/12
Death's reported were not reportable Serous adverse events per protocol. They were expected, or not related to drug and/or described in the protocol and consent form.
|
|
Gastrointestinal disorders
Esophagitis
|
0.00%
0/6
Death's reported were not reportable Serous adverse events per protocol. They were expected, or not related to drug and/or described in the protocol and consent form.
|
11.8%
4/34
Death's reported were not reportable Serous adverse events per protocol. They were expected, or not related to drug and/or described in the protocol and consent form.
|
0.00%
0/12
Death's reported were not reportable Serous adverse events per protocol. They were expected, or not related to drug and/or described in the protocol and consent form.
|
|
Cardiac disorders
Atrial Tachycardia
|
16.7%
1/6
Death's reported were not reportable Serous adverse events per protocol. They were expected, or not related to drug and/or described in the protocol and consent form.
|
0.00%
0/34
Death's reported were not reportable Serous adverse events per protocol. They were expected, or not related to drug and/or described in the protocol and consent form.
|
0.00%
0/12
Death's reported were not reportable Serous adverse events per protocol. They were expected, or not related to drug and/or described in the protocol and consent form.
|
|
Vascular disorders
Hypotension
|
0.00%
0/6
Death's reported were not reportable Serous adverse events per protocol. They were expected, or not related to drug and/or described in the protocol and consent form.
|
5.9%
2/34
Death's reported were not reportable Serous adverse events per protocol. They were expected, or not related to drug and/or described in the protocol and consent form.
|
0.00%
0/12
Death's reported were not reportable Serous adverse events per protocol. They were expected, or not related to drug and/or described in the protocol and consent form.
|
|
Cardiac disorders
Tropinemia/NSTEMI
|
0.00%
0/6
Death's reported were not reportable Serous adverse events per protocol. They were expected, or not related to drug and/or described in the protocol and consent form.
|
5.9%
2/34
Death's reported were not reportable Serous adverse events per protocol. They were expected, or not related to drug and/or described in the protocol and consent form.
|
0.00%
0/12
Death's reported were not reportable Serous adverse events per protocol. They were expected, or not related to drug and/or described in the protocol and consent form.
|
|
Metabolism and nutrition disorders
Tumor Lysis
|
0.00%
0/6
Death's reported were not reportable Serous adverse events per protocol. They were expected, or not related to drug and/or described in the protocol and consent form.
|
2.9%
1/34
Death's reported were not reportable Serous adverse events per protocol. They were expected, or not related to drug and/or described in the protocol and consent form.
|
8.3%
1/12
Death's reported were not reportable Serous adverse events per protocol. They were expected, or not related to drug and/or described in the protocol and consent form.
|
|
Gastrointestinal disorders
Colitis
|
0.00%
0/6
Death's reported were not reportable Serous adverse events per protocol. They were expected, or not related to drug and/or described in the protocol and consent form.
|
0.00%
0/34
Death's reported were not reportable Serous adverse events per protocol. They were expected, or not related to drug and/or described in the protocol and consent form.
|
8.3%
1/12
Death's reported were not reportable Serous adverse events per protocol. They were expected, or not related to drug and/or described in the protocol and consent form.
|
|
Respiratory, thoracic and mediastinal disorders
Elevated BR
|
0.00%
0/6
Death's reported were not reportable Serous adverse events per protocol. They were expected, or not related to drug and/or described in the protocol and consent form.
|
5.9%
2/34
Death's reported were not reportable Serous adverse events per protocol. They were expected, or not related to drug and/or described in the protocol and consent form.
|
0.00%
0/12
Death's reported were not reportable Serous adverse events per protocol. They were expected, or not related to drug and/or described in the protocol and consent form.
|
|
General disorders
Edema limbs
|
0.00%
0/6
Death's reported were not reportable Serous adverse events per protocol. They were expected, or not related to drug and/or described in the protocol and consent form.
|
0.00%
0/34
Death's reported were not reportable Serous adverse events per protocol. They were expected, or not related to drug and/or described in the protocol and consent form.
|
8.3%
1/12
Death's reported were not reportable Serous adverse events per protocol. They were expected, or not related to drug and/or described in the protocol and consent form.
|
|
Gastrointestinal disorders
Cholecystitis
|
0.00%
0/6
Death's reported were not reportable Serous adverse events per protocol. They were expected, or not related to drug and/or described in the protocol and consent form.
|
5.9%
2/34
Death's reported were not reportable Serous adverse events per protocol. They were expected, or not related to drug and/or described in the protocol and consent form.
|
0.00%
0/12
Death's reported were not reportable Serous adverse events per protocol. They were expected, or not related to drug and/or described in the protocol and consent form.
|
|
Gastrointestinal disorders
Enteritis
|
0.00%
0/6
Death's reported were not reportable Serous adverse events per protocol. They were expected, or not related to drug and/or described in the protocol and consent form.
|
0.00%
0/34
Death's reported were not reportable Serous adverse events per protocol. They were expected, or not related to drug and/or described in the protocol and consent form.
|
8.3%
1/12
Death's reported were not reportable Serous adverse events per protocol. They were expected, or not related to drug and/or described in the protocol and consent form.
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/6
Death's reported were not reportable Serous adverse events per protocol. They were expected, or not related to drug and/or described in the protocol and consent form.
|
8.8%
3/34
Death's reported were not reportable Serous adverse events per protocol. They were expected, or not related to drug and/or described in the protocol and consent form.
|
8.3%
1/12
Death's reported were not reportable Serous adverse events per protocol. They were expected, or not related to drug and/or described in the protocol and consent form.
|
|
Vascular disorders
Pulmonary Embolism
|
0.00%
0/6
Death's reported were not reportable Serous adverse events per protocol. They were expected, or not related to drug and/or described in the protocol and consent form.
|
5.9%
2/34
Death's reported were not reportable Serous adverse events per protocol. They were expected, or not related to drug and/or described in the protocol and consent form.
|
8.3%
1/12
Death's reported were not reportable Serous adverse events per protocol. They were expected, or not related to drug and/or described in the protocol and consent form.
|
|
Psychiatric disorders
Anxiety
|
0.00%
0/6
Death's reported were not reportable Serous adverse events per protocol. They were expected, or not related to drug and/or described in the protocol and consent form.
|
2.9%
1/34
Death's reported were not reportable Serous adverse events per protocol. They were expected, or not related to drug and/or described in the protocol and consent form.
|
8.3%
1/12
Death's reported were not reportable Serous adverse events per protocol. They were expected, or not related to drug and/or described in the protocol and consent form.
|
|
Renal and urinary disorders
Acute Kidney Injury
|
0.00%
0/6
Death's reported were not reportable Serous adverse events per protocol. They were expected, or not related to drug and/or described in the protocol and consent form.
|
5.9%
2/34
Death's reported were not reportable Serous adverse events per protocol. They were expected, or not related to drug and/or described in the protocol and consent form.
|
8.3%
1/12
Death's reported were not reportable Serous adverse events per protocol. They were expected, or not related to drug and/or described in the protocol and consent form.
|
|
Investigations
Elevated Liver Function Tests
|
0.00%
0/6
Death's reported were not reportable Serous adverse events per protocol. They were expected, or not related to drug and/or described in the protocol and consent form.
|
2.9%
1/34
Death's reported were not reportable Serous adverse events per protocol. They were expected, or not related to drug and/or described in the protocol and consent form.
|
16.7%
2/12
Death's reported were not reportable Serous adverse events per protocol. They were expected, or not related to drug and/or described in the protocol and consent form.
|
|
Metabolism and nutrition disorders
Hypophosphatemia
|
0.00%
0/6
Death's reported were not reportable Serous adverse events per protocol. They were expected, or not related to drug and/or described in the protocol and consent form.
|
5.9%
2/34
Death's reported were not reportable Serous adverse events per protocol. They were expected, or not related to drug and/or described in the protocol and consent form.
|
8.3%
1/12
Death's reported were not reportable Serous adverse events per protocol. They were expected, or not related to drug and/or described in the protocol and consent form.
|
|
Metabolism and nutrition disorders
Hypocalcemia
|
0.00%
0/6
Death's reported were not reportable Serous adverse events per protocol. They were expected, or not related to drug and/or described in the protocol and consent form.
|
0.00%
0/34
Death's reported were not reportable Serous adverse events per protocol. They were expected, or not related to drug and/or described in the protocol and consent form.
|
8.3%
1/12
Death's reported were not reportable Serous adverse events per protocol. They were expected, or not related to drug and/or described in the protocol and consent form.
|
|
Infections and infestations
Catheter Infection
|
0.00%
0/6
Death's reported were not reportable Serous adverse events per protocol. They were expected, or not related to drug and/or described in the protocol and consent form.
|
5.9%
2/34
Death's reported were not reportable Serous adverse events per protocol. They were expected, or not related to drug and/or described in the protocol and consent form.
|
0.00%
0/12
Death's reported were not reportable Serous adverse events per protocol. They were expected, or not related to drug and/or described in the protocol and consent form.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place