Trial Outcomes & Findings for Topotecan Hydrochloride and Carboplatin With or Without Veliparib in Treating Advanced Myeloproliferative Disorders and Acute Myeloid Leukemia or Chronic Myelomonocytic Leukemia (NCT NCT03289910)
NCT ID: NCT03289910
Last Updated: 2026-04-13
Results Overview
Based on published standards for acute leukemias, Complete Response (CR) means less than 5% leukemic blasts in the bone marrow, no blasts in the blood, no longer presence of cytogenetic abnormalities, no longer presence of extramedullary disease, with or without absolute neutrophil count or platelet count recovery; Partial Remission (PR) includes the criteria for Complete Remission except there are 5-25% leukemic blasts in the bone marrow and there is absolute neutrophil count and platelet count recovery; Hematologic Improvement (HI) means the disease has not gotten worse and there is at least a 20% decrease in the leukemic blasts in the bone marrow and/or a decrease in leukemia symptoms. Response = CR, PR, or HI.
Recruitment status
ACTIVE_NOT_RECRUITING
Study phase
PHASE2
Target enrollment
25 participants
Primary outcome timeframe
Up to 7 months
Results posted on
2026-04-13
Participant Flow
Participant milestones
| Measure |
Arm A (Veliparib, Topotecan Hydrochloride, Carboplatin)
Patients receive veliparib PO BID on days 1-21 and topotecan hydrochloride IV continuously over 24 hours and carboplatin IV continuously over 24 hours on days 3-7. Treatment repeats every 28-63 days for up to 4 cycles in the absence of disease progression or unacceptable toxicity.
Carboplatin: Given IV
Topotecan: Given IV
Topotecan Hydrochloride: Given IV
Veliparib: Given PO
|
Arm B (Topotecan Hydrochloride, Carboplatin)
Patients receive topotecan hydrochloride IV continuously over 24 hours and carboplatin IV continuously over 24 hours on days 1-5. Treatment repeats every 28-63 days for up to 4 cycles in the absence of disease progression or unacceptable toxicity.
Carboplatin: Given IV
Topotecan: Given IV
Topotecan Hydrochloride: Given IV
|
|---|---|---|
|
Overall Study
STARTED
|
16
|
9
|
|
Overall Study
COMPLETED
|
16
|
9
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Topotecan Hydrochloride and Carboplatin With or Without Veliparib in Treating Advanced Myeloproliferative Disorders and Acute Myeloid Leukemia or Chronic Myelomonocytic Leukemia
Baseline characteristics by cohort
| Measure |
Arm A (Veliparib, Topotecan Hydrochloride, Carboplatin)
n=16 Participants
Patients receive veliparib PO BID on days 1-21 and topotecan hydrochloride IV continuously over 24 hours and carboplatin IV continuously over 24 hours on days 3-7. Treatment repeats every 28-63 days for up to 4 cycles in the absence of disease progression or unacceptable toxicity.
|
Arm B (Topotecan Hydrochloride, Carboplatin)
n=9 Participants
Patients receive topotecan hydrochloride IV continuously over 24 hours and carboplatin IV continuously over 24 hours on days 1-5. Treatment repeats every 28-63 days for up to 4 cycles in the absence of disease progression or unacceptable toxicity.
|
Total
n=25 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=193 Participants
|
0 Participants
n=193 Participants
|
0 Participants
n=386 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
8 Participants
n=193 Participants
|
4 Participants
n=193 Participants
|
12 Participants
n=386 Participants
|
|
Age, Categorical
>=65 years
|
8 Participants
n=193 Participants
|
5 Participants
n=193 Participants
|
13 Participants
n=386 Participants
|
|
Age, Continuous
|
65 years
n=193 Participants
|
69 years
n=193 Participants
|
66 years
n=386 Participants
|
|
Sex: Female, Male
Female
|
4 Participants
n=193 Participants
|
1 Participants
n=193 Participants
|
5 Participants
n=386 Participants
|
|
Sex: Female, Male
Male
|
12 Participants
n=193 Participants
|
8 Participants
n=193 Participants
|
20 Participants
n=386 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=193 Participants
|
0 Participants
n=193 Participants
|
0 Participants
n=386 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
16 Participants
n=193 Participants
|
8 Participants
n=193 Participants
|
24 Participants
n=386 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=193 Participants
|
1 Participants
n=193 Participants
|
1 Participants
n=386 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=193 Participants
|
0 Participants
n=193 Participants
|
0 Participants
n=386 Participants
|
|
Race (NIH/OMB)
Asian
|
2 Participants
n=193 Participants
|
2 Participants
n=193 Participants
|
4 Participants
n=386 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=193 Participants
|
0 Participants
n=193 Participants
|
0 Participants
n=386 Participants
|
|
Race (NIH/OMB)
Black or African American
|
4 Participants
n=193 Participants
|
0 Participants
n=193 Participants
|
4 Participants
n=386 Participants
|
|
Race (NIH/OMB)
White
|
10 Participants
n=193 Participants
|
7 Participants
n=193 Participants
|
17 Participants
n=386 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=193 Participants
|
0 Participants
n=193 Participants
|
0 Participants
n=386 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=193 Participants
|
0 Participants
n=193 Participants
|
0 Participants
n=386 Participants
|
|
Region of Enrollment
United States
|
16 participants
n=193 Participants
|
9 participants
n=193 Participants
|
25 participants
n=386 Participants
|
PRIMARY outcome
Timeframe: Up to 7 monthsBased on published standards for acute leukemias, Complete Response (CR) means less than 5% leukemic blasts in the bone marrow, no blasts in the blood, no longer presence of cytogenetic abnormalities, no longer presence of extramedullary disease, with or without absolute neutrophil count or platelet count recovery; Partial Remission (PR) includes the criteria for Complete Remission except there are 5-25% leukemic blasts in the bone marrow and there is absolute neutrophil count and platelet count recovery; Hematologic Improvement (HI) means the disease has not gotten worse and there is at least a 20% decrease in the leukemic blasts in the bone marrow and/or a decrease in leukemia symptoms. Response = CR, PR, or HI.
Outcome measures
| Measure |
Arm A (Veliparib, Topotecan Hydrochloride, Carboplatin)
n=16 Participants
Patients receive veliparib PO BID on days 1-21 and topotecan hydrochloride IV continuously over 24 hours and carboplatin IV continuously over 24 hours on days 3-7. Treatment repeats every 28-63 days for up to 4 cycles in the absence of disease progression or unacceptable toxicity.
|
Arm B (Topotecan Hydrochloride, Carboplatin)
n=9 Participants
Patients receive topotecan hydrochloride IV continuously over 24 hours and carboplatin IV continuously over 24 hours on days 1-5. Treatment repeats every 28-63 days for up to 4 cycles in the absence of disease progression or unacceptable toxicity.
|
|---|---|---|
|
Number of Participants With a Response
Participants with a response
|
5 Participants
|
4 Participants
|
|
Number of Participants With a Response
Participants who did not have a response
|
11 Participants
|
5 Participants
|
SECONDARY outcome
Timeframe: Up to 7 monthsAdverse events were graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events version 5.0.
Outcome measures
| Measure |
Arm A (Veliparib, Topotecan Hydrochloride, Carboplatin)
n=16 Participants
Patients receive veliparib PO BID on days 1-21 and topotecan hydrochloride IV continuously over 24 hours and carboplatin IV continuously over 24 hours on days 3-7. Treatment repeats every 28-63 days for up to 4 cycles in the absence of disease progression or unacceptable toxicity.
|
Arm B (Topotecan Hydrochloride, Carboplatin)
n=9 Participants
Patients receive topotecan hydrochloride IV continuously over 24 hours and carboplatin IV continuously over 24 hours on days 1-5. Treatment repeats every 28-63 days for up to 4 cycles in the absence of disease progression or unacceptable toxicity.
|
|---|---|---|
|
The Highest Grade Adverse Event Experienced
Grade 5 Adverse Events
|
0 Participants
|
1 Participants
|
|
The Highest Grade Adverse Event Experienced
Grade 4 Adverse Events
|
14 Participants
|
8 Participants
|
|
The Highest Grade Adverse Event Experienced
Grade 3 Adverse Events
|
2 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Up to 7 monthsStudy completion was either death or completion of all protocol-specified activities, whichever came first. Participants who came off study due to disease-related death were counted as having disease.
Outcome measures
| Measure |
Arm A (Veliparib, Topotecan Hydrochloride, Carboplatin)
n=16 Participants
Patients receive veliparib PO BID on days 1-21 and topotecan hydrochloride IV continuously over 24 hours and carboplatin IV continuously over 24 hours on days 3-7. Treatment repeats every 28-63 days for up to 4 cycles in the absence of disease progression or unacceptable toxicity.
|
Arm B (Topotecan Hydrochloride, Carboplatin)
n=9 Participants
Patients receive topotecan hydrochloride IV continuously over 24 hours and carboplatin IV continuously over 24 hours on days 1-5. Treatment repeats every 28-63 days for up to 4 cycles in the absence of disease progression or unacceptable toxicity.
|
|---|---|---|
|
Number of Participants Without Disease at Study Completion
|
3 Participants
|
3 Participants
|
SECONDARY outcome
Timeframe: Up to 7 monthsDisease-free survival is defined as participants who are still alive and without disease at study completion. Study completion was either death or completion of all protocol-specified activities, whichever came first.
Outcome measures
| Measure |
Arm A (Veliparib, Topotecan Hydrochloride, Carboplatin)
n=16 Participants
Patients receive veliparib PO BID on days 1-21 and topotecan hydrochloride IV continuously over 24 hours and carboplatin IV continuously over 24 hours on days 3-7. Treatment repeats every 28-63 days for up to 4 cycles in the absence of disease progression or unacceptable toxicity.
|
Arm B (Topotecan Hydrochloride, Carboplatin)
n=9 Participants
Patients receive topotecan hydrochloride IV continuously over 24 hours and carboplatin IV continuously over 24 hours on days 1-5. Treatment repeats every 28-63 days for up to 4 cycles in the absence of disease progression or unacceptable toxicity.
|
|---|---|---|
|
Duration of Disease-free Survival
|
120 days
Interval 37.0 to 137.0
|
89 days
Interval 27.0 to 137.0
|
SECONDARY outcome
Timeframe: Up to 7 monthsStudy completion was either death or completion of all protocol-specified activities, whichever came first.
Outcome measures
| Measure |
Arm A (Veliparib, Topotecan Hydrochloride, Carboplatin)
n=16 Participants
Patients receive veliparib PO BID on days 1-21 and topotecan hydrochloride IV continuously over 24 hours and carboplatin IV continuously over 24 hours on days 3-7. Treatment repeats every 28-63 days for up to 4 cycles in the absence of disease progression or unacceptable toxicity.
|
Arm B (Topotecan Hydrochloride, Carboplatin)
n=9 Participants
Patients receive topotecan hydrochloride IV continuously over 24 hours and carboplatin IV continuously over 24 hours on days 1-5. Treatment repeats every 28-63 days for up to 4 cycles in the absence of disease progression or unacceptable toxicity.
|
|---|---|---|
|
Number of Participants Still Alive at Study Completion
|
5 Participants
|
5 Participants
|
SECONDARY outcome
Timeframe: Up to 7 monthsStudy completion was either death or completion of all protocol-specified activities, whichever came first. Duration was measured from the date of registration to the participant's study completion date.
Outcome measures
| Measure |
Arm A (Veliparib, Topotecan Hydrochloride, Carboplatin)
n=16 Participants
Patients receive veliparib PO BID on days 1-21 and topotecan hydrochloride IV continuously over 24 hours and carboplatin IV continuously over 24 hours on days 3-7. Treatment repeats every 28-63 days for up to 4 cycles in the absence of disease progression or unacceptable toxicity.
|
Arm B (Topotecan Hydrochloride, Carboplatin)
n=9 Participants
Patients receive topotecan hydrochloride IV continuously over 24 hours and carboplatin IV continuously over 24 hours on days 1-5. Treatment repeats every 28-63 days for up to 4 cycles in the absence of disease progression or unacceptable toxicity.
|
|---|---|---|
|
Duration of Overall Survival at the Time of Study Completion
|
83 Days
Interval 74.0 to 295.0
|
123 Days
Interval 82.0 to 295.0
|
SECONDARY outcome
Timeframe: Up to 7 monthsPopulation: Data was not collected.
Minimal residual disease (MRD) refers to a small number of leukemic cells that remain after treatment.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: BaselinePopulation: Data not collected.
Will be summarized using descriptive statistics. The association response will be described with appropriate tests for continuously measured biomarkers (t tests, Wilcoxon rank sum tests) and categorical biomarkers (Fisher's exact test). Descriptive analyses will be performed for the whole cohort and also separately for Arms A and B. Differential treatment outcomes for patient subgroups may be explored using appropriate tests for interactions.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: BaselinePopulation: Data not collected.
Will be reported with exact binomial 95% confidence intervals. The association response will be described with appropriate tests for continuously measured biomarkers (t tests, Wilcoxon rank sum tests) and categorical biomarkers (Fisher's exact test). Descriptive analyses will be performed for the whole cohort and also separately for Arms A and B. Differential treatment outcomes for patient subgroups may be explored using appropriate tests for interactions.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Up to 7 monthsPopulation: Data not collected.
Topotecan-induced stabilization of topoisomerase I-DNA covalent complexes from peripheral blood
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Pre-treatment, day 1, day 8, day 14, day 15, and day 22 (approximately 24 hours post last dose)Plasma trough levels will be obtained weekly through the first cycle to provide a steady-state assessment. Steady-state plasma concentrations will be calculated for each patient. Exploratory correlative studies between veliparib exposure (plasma and bone marrow) with pharmacodynamic (biological endpoints, toxicity and efficacy) will be analyzed using nonparametric statistics. Significance for comparisons will be at the p \< 0.05 level.
Outcome measures
Outcome data not reported
Adverse Events
Arm A (Veliparib, Topotecan Hydrochloride, Carboplatin)
Serious events: 4 serious events
Other events: 16 other events
Deaths: 11 deaths
Arm B (Topotecan Hydrochloride, Carboplatin)
Serious events: 4 serious events
Other events: 9 other events
Deaths: 4 deaths
Serious adverse events
| Measure |
Arm A (Veliparib, Topotecan Hydrochloride, Carboplatin)
n=16 participants at risk
Patients receive veliparib PO BID on days 1-21 and topotecan hydrochloride IV continuously over 24 hours and carboplatin IV continuously over 24 hours on days 3-7. Treatment repeats every 28-63 days for up to 4 cycles in the absence of disease progression or unacceptable toxicity.
|
Arm B (Topotecan Hydrochloride, Carboplatin)
n=9 participants at risk
Patients receive topotecan hydrochloride IV continuously over 24 hours and carboplatin IV continuously over 24 hours on days 1-5. Treatment repeats every 28-63 days for up to 4 cycles in the absence of disease progression or unacceptable toxicity.
|
|---|---|---|
|
Cardiac disorders
Atrial fibrillation
|
6.2%
1/16 • Up 7 months
|
0.00%
0/9 • Up 7 months
|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
0.00%
0/16 • Up 7 months
|
11.1%
1/9 • Up 7 months
|
|
General disorders
Fever
|
0.00%
0/16 • Up 7 months
|
11.1%
1/9 • Up 7 months
|
|
Infections and infestations
Lung infection
|
6.2%
1/16 • Up 7 months
|
0.00%
0/9 • Up 7 months
|
|
Infections and infestations
Sepsis
|
12.5%
2/16 • Up 7 months
|
11.1%
1/9 • Up 7 months
|
|
Infections and infestations
Sinusitis
|
6.2%
1/16 • Up 7 months
|
0.00%
0/9 • Up 7 months
|
|
Infections and infestations
Skin infection
|
0.00%
0/16 • Up 7 months
|
11.1%
1/9 • Up 7 months
|
|
Infections and infestations
Soft tissue infection
|
6.2%
1/16 • Up 7 months
|
0.00%
0/9 • Up 7 months
|
|
Investigations
Cardiac troponin I increased
|
6.2%
1/16 • Up 7 months
|
0.00%
0/9 • Up 7 months
|
|
Investigations
Neutrophil count decreased
|
6.2%
1/16 • Up 7 months
|
0.00%
0/9 • Up 7 months
|
|
Investigations
White blood cell count increased
|
0.00%
0/16 • Up 7 months
|
11.1%
1/9 • Up 7 months
|
|
Metabolism and nutrition disorders
Tumor lysis syndrome
|
6.2%
1/16 • Up 7 months
|
0.00%
0/9 • Up 7 months
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
0.00%
0/16 • Up 7 months
|
11.1%
1/9 • Up 7 months
|
|
Vascular disorders
Hypotension
|
0.00%
0/16 • Up 7 months
|
11.1%
1/9 • Up 7 months
|
Other adverse events
| Measure |
Arm A (Veliparib, Topotecan Hydrochloride, Carboplatin)
n=16 participants at risk
Patients receive veliparib PO BID on days 1-21 and topotecan hydrochloride IV continuously over 24 hours and carboplatin IV continuously over 24 hours on days 3-7. Treatment repeats every 28-63 days for up to 4 cycles in the absence of disease progression or unacceptable toxicity.
|
Arm B (Topotecan Hydrochloride, Carboplatin)
n=9 participants at risk
Patients receive topotecan hydrochloride IV continuously over 24 hours and carboplatin IV continuously over 24 hours on days 1-5. Treatment repeats every 28-63 days for up to 4 cycles in the absence of disease progression or unacceptable toxicity.
|
|---|---|---|
|
Gastrointestinal disorders
Dyspepsia
|
25.0%
4/16 • Up 7 months
|
22.2%
2/9 • Up 7 months
|
|
Gastrointestinal disorders
Dysphagia
|
6.2%
1/16 • Up 7 months
|
0.00%
0/9 • Up 7 months
|
|
Gastrointestinal disorders
enteritis
|
6.2%
1/16 • Up 7 months
|
0.00%
0/9 • Up 7 months
|
|
Gastrointestinal disorders
Fecal incontinence
|
6.2%
1/16 • Up 7 months
|
0.00%
0/9 • Up 7 months
|
|
Gastrointestinal disorders
Flatulence
|
12.5%
2/16 • Up 7 months
|
22.2%
2/9 • Up 7 months
|
|
Gastrointestinal disorders
Gastroesophageal reflux disease
|
12.5%
2/16 • Up 7 months
|
0.00%
0/9 • Up 7 months
|
|
Gastrointestinal disorders
GI bleed, site unknown
|
0.00%
0/16 • Up 7 months
|
11.1%
1/9 • Up 7 months
|
|
Gastrointestinal disorders
Hemorrhoidal hemorrhage
|
6.2%
1/16 • Up 7 months
|
0.00%
0/9 • Up 7 months
|
|
Gastrointestinal disorders
Hemorrhoids
|
6.2%
1/16 • Up 7 months
|
0.00%
0/9 • Up 7 months
|
|
Gastrointestinal disorders
Ileus
|
12.5%
2/16 • Up 7 months
|
11.1%
1/9 • Up 7 months
|
|
Gastrointestinal disorders
Lower gastrointestinal hemorrhage
|
6.2%
1/16 • Up 7 months
|
0.00%
0/9 • Up 7 months
|
|
Gastrointestinal disorders
Mucositis oral
|
43.8%
7/16 • Up 7 months
|
22.2%
2/9 • Up 7 months
|
|
Gastrointestinal disorders
Nausea
|
62.5%
10/16 • Up 7 months
|
77.8%
7/9 • Up 7 months
|
|
Gastrointestinal disorders
Oral hemorrhage
|
12.5%
2/16 • Up 7 months
|
0.00%
0/9 • Up 7 months
|
|
Gastrointestinal disorders
Oral pain
|
18.8%
3/16 • Up 7 months
|
11.1%
1/9 • Up 7 months
|
|
Gastrointestinal disorders
pneumatosis
|
0.00%
0/16 • Up 7 months
|
11.1%
1/9 • Up 7 months
|
|
Gastrointestinal disorders
Rectal fissure
|
0.00%
0/16 • Up 7 months
|
11.1%
1/9 • Up 7 months
|
|
Gastrointestinal disorders
Rectal hemorrhage
|
0.00%
0/16 • Up 7 months
|
11.1%
1/9 • Up 7 months
|
|
Gastrointestinal disorders
Rectal pain
|
6.2%
1/16 • Up 7 months
|
0.00%
0/9 • Up 7 months
|
|
Gastrointestinal disorders
Small intestinal mucositis
|
0.00%
0/16 • Up 7 months
|
11.1%
1/9 • Up 7 months
|
|
Gastrointestinal disorders
Upper gastrointestinal hemorrhage
|
6.2%
1/16 • Up 7 months
|
11.1%
1/9 • Up 7 months
|
|
Gastrointestinal disorders
Vomiting
|
56.2%
9/16 • Up 7 months
|
55.6%
5/9 • Up 7 months
|
|
General disorders
Chills
|
25.0%
4/16 • Up 7 months
|
11.1%
1/9 • Up 7 months
|
|
General disorders
Edema face
|
6.2%
1/16 • Up 7 months
|
0.00%
0/9 • Up 7 months
|
|
General disorders
Edema limbs
|
31.2%
5/16 • Up 7 months
|
33.3%
3/9 • Up 7 months
|
|
General disorders
Edema trunk
|
6.2%
1/16 • Up 7 months
|
0.00%
0/9 • Up 7 months
|
|
General disorders
Facial pain
|
0.00%
0/16 • Up 7 months
|
11.1%
1/9 • Up 7 months
|
|
General disorders
Fatigue
|
50.0%
8/16 • Up 7 months
|
77.8%
7/9 • Up 7 months
|
|
General disorders
Fever
|
43.8%
7/16 • Up 7 months
|
33.3%
3/9 • Up 7 months
|
|
General disorders
Generalized edema
|
18.8%
3/16 • Up 7 months
|
11.1%
1/9 • Up 7 months
|
|
General disorders
Hypothermia
|
0.00%
0/16 • Up 7 months
|
11.1%
1/9 • Up 7 months
|
|
General disorders
Localized edema
|
6.2%
1/16 • Up 7 months
|
11.1%
1/9 • Up 7 months
|
|
General disorders
Pain
|
31.2%
5/16 • Up 7 months
|
33.3%
3/9 • Up 7 months
|
|
Hepatobiliary disorders
cholelithiasis
|
6.2%
1/16 • Up 7 months
|
0.00%
0/9 • Up 7 months
|
|
Hepatobiliary disorders
liver parenchyma disease
|
6.2%
1/16 • Up 7 months
|
0.00%
0/9 • Up 7 months
|
|
Immune system disorders
Allergic reaction
|
0.00%
0/16 • Up 7 months
|
11.1%
1/9 • Up 7 months
|
|
Immune system disorders
Anaphylaxis
|
6.2%
1/16 • Up 7 months
|
0.00%
0/9 • Up 7 months
|
|
Immune system disorders
C Reactive Protein > ULN
|
0.00%
0/16 • Up 7 months
|
11.1%
1/9 • Up 7 months
|
|
Immune system disorders
Erythrocyte Sedimentation Rate > ULN
|
0.00%
0/16 • Up 7 months
|
11.1%
1/9 • Up 7 months
|
|
Immune system disorders
Spleen Disorder
|
6.2%
1/16 • Up 7 months
|
0.00%
0/9 • Up 7 months
|
|
Infections and infestations
Bacteremia
|
6.2%
1/16 • Up 7 months
|
0.00%
0/9 • Up 7 months
|
|
Infections and infestations
Bilateral nodules
|
6.2%
1/16 • Up 7 months
|
0.00%
0/9 • Up 7 months
|
|
Infections and infestations
Bilateral pulmonary nodules
|
0.00%
0/16 • Up 7 months
|
11.1%
1/9 • Up 7 months
|
|
Infections and infestations
Bone infection
|
6.2%
1/16 • Up 7 months
|
0.00%
0/9 • Up 7 months
|
|
Infections and infestations
Catheter related infection
|
6.2%
1/16 • Up 7 months
|
11.1%
1/9 • Up 7 months
|
|
Infections and infestations
Endocarditis infective
|
6.2%
1/16 • Up 7 months
|
0.00%
0/9 • Up 7 months
|
|
Infections and infestations
Enterocolitis infectious
|
0.00%
0/16 • Up 7 months
|
11.1%
1/9 • Up 7 months
|
|
Infections and infestations
Lung infection
|
25.0%
4/16 • Up 7 months
|
22.2%
2/9 • Up 7 months
|
|
Infections and infestations
Mucosal infection
|
0.00%
0/16 • Up 7 months
|
11.1%
1/9 • Up 7 months
|
|
Infections and infestations
multi organ bacteremia
|
6.2%
1/16 • Up 7 months
|
0.00%
0/9 • Up 7 months
|
|
Infections and infestations
Paronychia
|
6.2%
1/16 • Up 7 months
|
0.00%
0/9 • Up 7 months
|
|
Infections and infestations
Salivary gland infection
|
0.00%
0/16 • Up 7 months
|
11.1%
1/9 • Up 7 months
|
|
Infections and infestations
Sepsis
|
31.2%
5/16 • Up 7 months
|
0.00%
0/9 • Up 7 months
|
|
Infections and infestations
Skin infection
|
12.5%
2/16 • Up 7 months
|
22.2%
2/9 • Up 7 months
|
|
Infections and infestations
Soft tissue infection
|
6.2%
1/16 • Up 7 months
|
0.00%
0/9 • Up 7 months
|
|
Infections and infestations
Strep salivarious infection
|
6.2%
1/16 • Up 7 months
|
0.00%
0/9 • Up 7 months
|
|
Infections and infestations
Thrush
|
6.2%
1/16 • Up 7 months
|
0.00%
0/9 • Up 7 months
|
|
Infections and infestations
Urinary tract infection
|
0.00%
0/16 • Up 7 months
|
11.1%
1/9 • Up 7 months
|
|
Injury, poisoning and procedural complications
Arterial injury
|
6.2%
1/16 • Up 7 months
|
0.00%
0/9 • Up 7 months
|
|
Injury, poisoning and procedural complications
Bruising
|
12.5%
2/16 • Up 7 months
|
33.3%
3/9 • Up 7 months
|
|
Injury, poisoning and procedural complications
Fall
|
6.2%
1/16 • Up 7 months
|
11.1%
1/9 • Up 7 months
|
|
Injury, poisoning and procedural complications
Infusion related reaction
|
6.2%
1/16 • Up 7 months
|
0.00%
0/9 • Up 7 months
|
|
Injury, poisoning and procedural complications
Vascular access complication
|
0.00%
0/16 • Up 7 months
|
11.1%
1/9 • Up 7 months
|
|
Injury, poisoning and procedural complications
Wound complication
|
0.00%
0/16 • Up 7 months
|
11.1%
1/9 • Up 7 months
|
|
Investigations
Activated partial thromboplastin time prolonged
|
12.5%
2/16 • Up 7 months
|
22.2%
2/9 • Up 7 months
|
|
Investigations
Alanine aminotransferase increased
|
50.0%
8/16 • Up 7 months
|
55.6%
5/9 • Up 7 months
|
|
Investigations
Alkaline phosphatase increased
|
68.8%
11/16 • Up 7 months
|
44.4%
4/9 • Up 7 months
|
|
Investigations
Aspartate aminotransferase increased
|
62.5%
10/16 • Up 7 months
|
33.3%
3/9 • Up 7 months
|
|
Investigations
Blood bicarbonate decreased
|
0.00%
0/16 • Up 7 months
|
11.1%
1/9 • Up 7 months
|
|
Investigations
Blood bilirubin increased
|
75.0%
12/16 • Up 7 months
|
33.3%
3/9 • Up 7 months
|
|
Investigations
Blood lactate dehydrogenase increased
|
6.2%
1/16 • Up 7 months
|
33.3%
3/9 • Up 7 months
|
|
Investigations
Creatinine increased
|
37.5%
6/16 • Up 7 months
|
11.1%
1/9 • Up 7 months
|
|
Investigations
D Dimer Increased
|
6.2%
1/16 • Up 7 months
|
11.1%
1/9 • Up 7 months
|
|
Investigations
Electrocardiogram QT corrected interval prolonged
|
0.00%
0/16 • Up 7 months
|
22.2%
2/9 • Up 7 months
|
|
Investigations
Fibrinogen decreased
|
12.5%
2/16 • Up 7 months
|
0.00%
0/9 • Up 7 months
|
|
Investigations
GGT increased
|
6.2%
1/16 • Up 7 months
|
0.00%
0/9 • Up 7 months
|
|
Investigations
Haptoglobin decreased
|
0.00%
0/16 • Up 7 months
|
11.1%
1/9 • Up 7 months
|
|
Investigations
INR increased
|
12.5%
2/16 • Up 7 months
|
33.3%
3/9 • Up 7 months
|
|
Investigations
Left inguinal hernia
|
0.00%
0/16 • Up 7 months
|
11.1%
1/9 • Up 7 months
|
|
Investigations
Lipase increased
|
6.2%
1/16 • Up 7 months
|
0.00%
0/9 • Up 7 months
|
|
Investigations
Liver Abscess
|
6.2%
1/16 • Up 7 months
|
0.00%
0/9 • Up 7 months
|
|
Investigations
Lymphocyte count decreased
|
100.0%
16/16 • Up 7 months
|
88.9%
8/9 • Up 7 months
|
|
Investigations
Neutrophil count decreased
|
87.5%
14/16 • Up 7 months
|
77.8%
7/9 • Up 7 months
|
|
Investigations
Platelet count decreased
|
93.8%
15/16 • Up 7 months
|
88.9%
8/9 • Up 7 months
|
|
Investigations
Swollen scrotum
|
0.00%
0/16 • Up 7 months
|
11.1%
1/9 • Up 7 months
|
|
Investigations
Weight loss
|
18.8%
3/16 • Up 7 months
|
66.7%
6/9 • Up 7 months
|
|
Investigations
White blood cell count increased
|
6.2%
1/16 • Up 7 months
|
0.00%
0/9 • Up 7 months
|
|
Investigations
White blood cell decreased
|
100.0%
16/16 • Up 7 months
|
100.0%
9/9 • Up 7 months
|
|
Metabolism and nutrition disorders
Acidosis
|
0.00%
0/16 • Up 7 months
|
11.1%
1/9 • Up 7 months
|
|
Metabolism and nutrition disorders
Anorexia
|
56.2%
9/16 • Up 7 months
|
66.7%
6/9 • Up 7 months
|
|
Metabolism and nutrition disorders
early satiety
|
6.2%
1/16 • Up 7 months
|
0.00%
0/9 • Up 7 months
|
|
Metabolism and nutrition disorders
Hyperglycemia
|
37.5%
6/16 • Up 7 months
|
11.1%
1/9 • Up 7 months
|
|
Metabolism and nutrition disorders
Hyperkalemia
|
25.0%
4/16 • Up 7 months
|
33.3%
3/9 • Up 7 months
|
|
Metabolism and nutrition disorders
Hypermagnesemia
|
18.8%
3/16 • Up 7 months
|
11.1%
1/9 • Up 7 months
|
|
Metabolism and nutrition disorders
Hypernatremia
|
31.2%
5/16 • Up 7 months
|
0.00%
0/9 • Up 7 months
|
|
Metabolism and nutrition disorders
Hyperphosphatemia
|
50.0%
8/16 • Up 7 months
|
22.2%
2/9 • Up 7 months
|
|
Metabolism and nutrition disorders
Hypertriglyceridemia
|
0.00%
0/16 • Up 7 months
|
11.1%
1/9 • Up 7 months
|
|
Metabolism and nutrition disorders
Hyperuricemia
|
6.2%
1/16 • Up 7 months
|
11.1%
1/9 • Up 7 months
|
|
Metabolism and nutrition disorders
Hypoalbuminemia
|
93.8%
15/16 • Up 7 months
|
77.8%
7/9 • Up 7 months
|
|
Metabolism and nutrition disorders
Hypocalcemia
|
56.2%
9/16 • Up 7 months
|
55.6%
5/9 • Up 7 months
|
|
Metabolism and nutrition disorders
Hypoglycemia
|
12.5%
2/16 • Up 7 months
|
11.1%
1/9 • Up 7 months
|
|
Metabolism and nutrition disorders
Hypokalemia
|
93.8%
15/16 • Up 7 months
|
55.6%
5/9 • Up 7 months
|
|
Metabolism and nutrition disorders
Hypomagnesemia
|
62.5%
10/16 • Up 7 months
|
33.3%
3/9 • Up 7 months
|
|
Metabolism and nutrition disorders
Hyponatremia
|
62.5%
10/16 • Up 7 months
|
33.3%
3/9 • Up 7 months
|
|
Metabolism and nutrition disorders
Hypophosphatemia
|
62.5%
10/16 • Up 7 months
|
55.6%
5/9 • Up 7 months
|
|
Metabolism and nutrition disorders
post-prandial discomfort
|
6.2%
1/16 • Up 7 months
|
0.00%
0/9 • Up 7 months
|
|
Metabolism and nutrition disorders
vitamin b12 deficiency
|
6.2%
1/16 • Up 7 months
|
0.00%
0/9 • Up 7 months
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
6.2%
1/16 • Up 7 months
|
11.1%
1/9 • Up 7 months
|
|
Musculoskeletal and connective tissue disorders
Arthritis
|
0.00%
0/16 • Up 7 months
|
22.2%
2/9 • Up 7 months
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
12.5%
2/16 • Up 7 months
|
0.00%
0/9 • Up 7 months
|
|
Musculoskeletal and connective tissue disorders
Flank pain
|
6.2%
1/16 • Up 7 months
|
0.00%
0/9 • Up 7 months
|
|
Musculoskeletal and connective tissue disorders
Generalized muscle weakness
|
6.2%
1/16 • Up 7 months
|
11.1%
1/9 • Up 7 months
|
|
Musculoskeletal and connective tissue disorders
Muscle cramp
|
6.2%
1/16 • Up 7 months
|
11.1%
1/9 • Up 7 months
|
|
Musculoskeletal and connective tissue disorders
Muscle weakness lower limb
|
6.2%
1/16 • Up 7 months
|
0.00%
0/9 • Up 7 months
|
|
Musculoskeletal and connective tissue disorders
Myositis
|
6.2%
1/16 • Up 7 months
|
0.00%
0/9 • Up 7 months
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
12.5%
2/16 • Up 7 months
|
0.00%
0/9 • Up 7 months
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
31.2%
5/16 • Up 7 months
|
33.3%
3/9 • Up 7 months
|
|
Musculoskeletal and connective tissue disorders
R toenail changes
|
6.2%
1/16 • Up 7 months
|
0.00%
0/9 • Up 7 months
|
|
Musculoskeletal and connective tissue disorders
Rotator cuff injury
|
6.2%
1/16 • Up 7 months
|
0.00%
0/9 • Up 7 months
|
|
Nervous system disorders
Dizziness
|
12.5%
2/16 • Up 7 months
|
44.4%
4/9 • Up 7 months
|
|
Nervous system disorders
Dysgeusia
|
12.5%
2/16 • Up 7 months
|
33.3%
3/9 • Up 7 months
|
|
Nervous system disorders
Headache
|
25.0%
4/16 • Up 7 months
|
22.2%
2/9 • Up 7 months
|
|
Nervous system disorders
Hypersomnia
|
6.2%
1/16 • Up 7 months
|
0.00%
0/9 • Up 7 months
|
|
Nervous system disorders
Intracranial hemorrhage
|
6.2%
1/16 • Up 7 months
|
0.00%
0/9 • Up 7 months
|
|
Nervous system disorders
Lethargy
|
6.2%
1/16 • Up 7 months
|
0.00%
0/9 • Up 7 months
|
|
Nervous system disorders
Paresthesia
|
6.2%
1/16 • Up 7 months
|
22.2%
2/9 • Up 7 months
|
|
Nervous system disorders
Presyncope
|
6.2%
1/16 • Up 7 months
|
11.1%
1/9 • Up 7 months
|
|
Nervous system disorders
Somnolence
|
18.8%
3/16 • Up 7 months
|
11.1%
1/9 • Up 7 months
|
|
Nervous system disorders
Tremor
|
12.5%
2/16 • Up 7 months
|
11.1%
1/9 • Up 7 months
|
|
Psychiatric disorders
Anxiety
|
6.2%
1/16 • Up 7 months
|
11.1%
1/9 • Up 7 months
|
|
Psychiatric disorders
Confusion
|
6.2%
1/16 • Up 7 months
|
0.00%
0/9 • Up 7 months
|
|
Psychiatric disorders
Delirium
|
18.8%
3/16 • Up 7 months
|
11.1%
1/9 • Up 7 months
|
|
Psychiatric disorders
Depression
|
6.2%
1/16 • Up 7 months
|
0.00%
0/9 • Up 7 months
|
|
Psychiatric disorders
Hallucinations
|
6.2%
1/16 • Up 7 months
|
0.00%
0/9 • Up 7 months
|
|
Psychiatric disorders
Insomnia
|
0.00%
0/16 • Up 7 months
|
11.1%
1/9 • Up 7 months
|
|
Renal and urinary disorders
Bladder spasm
|
0.00%
0/16 • Up 7 months
|
11.1%
1/9 • Up 7 months
|
|
Renal and urinary disorders
Dysuria
|
0.00%
0/16 • Up 7 months
|
11.1%
1/9 • Up 7 months
|
|
Renal and urinary disorders
Glucosuria
|
12.5%
2/16 • Up 7 months
|
0.00%
0/9 • Up 7 months
|
|
Renal and urinary disorders
Hematuria
|
37.5%
6/16 • Up 7 months
|
11.1%
1/9 • Up 7 months
|
|
Renal and urinary disorders
Proteinuria
|
25.0%
4/16 • Up 7 months
|
33.3%
3/9 • Up 7 months
|
|
Renal and urinary disorders
Urinary incontinence
|
6.2%
1/16 • Up 7 months
|
0.00%
0/9 • Up 7 months
|
|
Renal and urinary disorders
Urinary retention
|
0.00%
0/16 • Up 7 months
|
11.1%
1/9 • Up 7 months
|
|
Renal and urinary disorders
Urinary tract pain
|
0.00%
0/16 • Up 7 months
|
11.1%
1/9 • Up 7 months
|
|
Reproductive system and breast disorders
Pelvic pain
|
6.2%
1/16 • Up 7 months
|
0.00%
0/9 • Up 7 months
|
|
Reproductive system and breast disorders
Scrotal pain
|
0.00%
0/16 • Up 7 months
|
11.1%
1/9 • Up 7 months
|
|
Respiratory, thoracic and mediastinal disorders
Atelectasis
|
18.8%
3/16 • Up 7 months
|
22.2%
2/9 • Up 7 months
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
31.2%
5/16 • Up 7 months
|
0.00%
0/9 • Up 7 months
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
37.5%
6/16 • Up 7 months
|
44.4%
4/9 • Up 7 months
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
50.0%
8/16 • Up 7 months
|
66.7%
6/9 • Up 7 months
|
|
Respiratory, thoracic and mediastinal disorders
Hiccups
|
0.00%
0/16 • Up 7 months
|
11.1%
1/9 • Up 7 months
|
|
Respiratory, thoracic and mediastinal disorders
Hoarseness
|
6.2%
1/16 • Up 7 months
|
0.00%
0/9 • Up 7 months
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
31.2%
5/16 • Up 7 months
|
0.00%
0/9 • Up 7 months
|
|
Respiratory, thoracic and mediastinal disorders
Laryngeal hemorrhage
|
12.5%
2/16 • Up 7 months
|
11.1%
1/9 • Up 7 months
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
18.8%
3/16 • Up 7 months
|
11.1%
1/9 • Up 7 months
|
|
Respiratory, thoracic and mediastinal disorders
Pharyngeal mucositis
|
0.00%
0/16 • Up 7 months
|
11.1%
1/9 • Up 7 months
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
18.8%
3/16 • Up 7 months
|
0.00%
0/9 • Up 7 months
|
|
Respiratory, thoracic and mediastinal disorders
Pleuritic pain
|
12.5%
2/16 • Up 7 months
|
0.00%
0/9 • Up 7 months
|
|
Respiratory, thoracic and mediastinal disorders
Postnasal drip
|
0.00%
0/16 • Up 7 months
|
11.1%
1/9 • Up 7 months
|
|
Respiratory, thoracic and mediastinal disorders
Productive cough
|
0.00%
0/16 • Up 7 months
|
11.1%
1/9 • Up 7 months
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary edema
|
12.5%
2/16 • Up 7 months
|
0.00%
0/9 • Up 7 months
|
|
Respiratory, thoracic and mediastinal disorders
Rhinorrhea
|
6.2%
1/16 • Up 7 months
|
22.2%
2/9 • Up 7 months
|
|
Respiratory, thoracic and mediastinal disorders
Sore throat
|
12.5%
2/16 • Up 7 months
|
22.2%
2/9 • Up 7 months
|
|
Respiratory, thoracic and mediastinal disorders
tachypnea
|
6.2%
1/16 • Up 7 months
|
0.00%
0/9 • Up 7 months
|
|
Respiratory, thoracic and mediastinal disorders
Wheezing
|
12.5%
2/16 • Up 7 months
|
0.00%
0/9 • Up 7 months
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
6.2%
1/16 • Up 7 months
|
11.1%
1/9 • Up 7 months
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
12.5%
2/16 • Up 7 months
|
0.00%
0/9 • Up 7 months
|
|
Skin and subcutaneous tissue disorders
Erythema multiforme
|
6.2%
1/16 • Up 7 months
|
0.00%
0/9 • Up 7 months
|
|
Skin and subcutaneous tissue disorders
Hives
|
0.00%
0/16 • Up 7 months
|
11.1%
1/9 • Up 7 months
|
|
Skin and subcutaneous tissue disorders
Hyperhidrosis
|
6.2%
1/16 • Up 7 months
|
11.1%
1/9 • Up 7 months
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
18.8%
3/16 • Up 7 months
|
22.2%
2/9 • Up 7 months
|
|
Skin and subcutaneous tissue disorders
Purpura
|
0.00%
0/16 • Up 7 months
|
22.2%
2/9 • Up 7 months
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
37.5%
6/16 • Up 7 months
|
33.3%
3/9 • Up 7 months
|
|
Skin and subcutaneous tissue disorders
Subcutaneous emphysema
|
6.2%
1/16 • Up 7 months
|
0.00%
0/9 • Up 7 months
|
|
Vascular disorders
Hematoma
|
12.5%
2/16 • Up 7 months
|
22.2%
2/9 • Up 7 months
|
|
Vascular disorders
Hypertension
|
56.2%
9/16 • Up 7 months
|
44.4%
4/9 • Up 7 months
|
|
Vascular disorders
Hypotension
|
37.5%
6/16 • Up 7 months
|
33.3%
3/9 • Up 7 months
|
|
Vascular disorders
Thromboembolic event
|
6.2%
1/16 • Up 7 months
|
11.1%
1/9 • Up 7 months
|
|
Blood and lymphatic system disorders
Anemia
|
87.5%
14/16 • Up 7 months
|
100.0%
9/9 • Up 7 months
|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
68.8%
11/16 • Up 7 months
|
55.6%
5/9 • Up 7 months
|
|
Blood and lymphatic system disorders
Hemolysis
|
6.2%
1/16 • Up 7 months
|
0.00%
0/9 • Up 7 months
|
|
Blood and lymphatic system disorders
Splenomegaly
|
6.2%
1/16 • Up 7 months
|
11.1%
1/9 • Up 7 months
|
|
Cardiac disorders
Atrial fibrillation
|
0.00%
0/16 • Up 7 months
|
33.3%
3/9 • Up 7 months
|
|
Cardiac disorders
Chest pain - cardiac
|
0.00%
0/16 • Up 7 months
|
11.1%
1/9 • Up 7 months
|
|
Cardiac disorders
Pericardial effusion
|
6.2%
1/16 • Up 7 months
|
0.00%
0/9 • Up 7 months
|
|
Cardiac disorders
Sinus bradycardia
|
18.8%
3/16 • Up 7 months
|
0.00%
0/9 • Up 7 months
|
|
Cardiac disorders
Sinus tachycardia
|
37.5%
6/16 • Up 7 months
|
33.3%
3/9 • Up 7 months
|
|
Cardiac disorders
Supraventricular tachycardia
|
6.2%
1/16 • Up 7 months
|
0.00%
0/9 • Up 7 months
|
|
Ear and labyrinth disorders
Hearing impaired
|
6.2%
1/16 • Up 7 months
|
0.00%
0/9 • Up 7 months
|
|
Ear and labyrinth disorders
mild bleeding
|
6.2%
1/16 • Up 7 months
|
0.00%
0/9 • Up 7 months
|
|
Eye disorders
Blurred vision
|
6.2%
1/16 • Up 7 months
|
11.1%
1/9 • Up 7 months
|
|
Eye disorders
mild L subconjunctival hemorrhage
|
0.00%
0/16 • Up 7 months
|
11.1%
1/9 • Up 7 months
|
|
Eye disorders
Right eye drainage
|
6.2%
1/16 • Up 7 months
|
0.00%
0/9 • Up 7 months
|
|
Eye disorders
Uveitis
|
0.00%
0/16 • Up 7 months
|
11.1%
1/9 • Up 7 months
|
|
Gastrointestinal disorders
Abdominal distension
|
0.00%
0/16 • Up 7 months
|
22.2%
2/9 • Up 7 months
|
|
Gastrointestinal disorders
Abdominal pain
|
68.8%
11/16 • Up 7 months
|
44.4%
4/9 • Up 7 months
|
|
Gastrointestinal disorders
Anal mucositis
|
0.00%
0/16 • Up 7 months
|
11.1%
1/9 • Up 7 months
|
|
Gastrointestinal disorders
Ascites
|
18.8%
3/16 • Up 7 months
|
0.00%
0/9 • Up 7 months
|
|
Gastrointestinal disorders
Belching
|
6.2%
1/16 • Up 7 months
|
0.00%
0/9 • Up 7 months
|
|
Gastrointestinal disorders
Bloating
|
6.2%
1/16 • Up 7 months
|
44.4%
4/9 • Up 7 months
|
|
Gastrointestinal disorders
Colitis
|
12.5%
2/16 • Up 7 months
|
22.2%
2/9 • Up 7 months
|
|
Gastrointestinal disorders
Constipation
|
25.0%
4/16 • Up 7 months
|
22.2%
2/9 • Up 7 months
|
|
Gastrointestinal disorders
Diarrhea
|
81.2%
13/16 • Up 7 months
|
100.0%
9/9 • Up 7 months
|
|
Gastrointestinal disorders
Diverticulitis
|
6.2%
1/16 • Up 7 months
|
0.00%
0/9 • Up 7 months
|
|
Gastrointestinal disorders
Dry mouth
|
25.0%
4/16 • Up 7 months
|
11.1%
1/9 • Up 7 months
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: LTE60