Trial Outcomes & Findings for Phase II ABT-888 With Cyclophosphamide (NCT NCT01306032)
NCT ID: NCT01306032
Last Updated: 2017-04-26
Results Overview
Complete response (CR) + partial response (PR)) of the combination of ABT-888 with metronomic oral cyclophosphamide to the response rate (CR+PR) of metronomic oral cyclophosphamide in patients with deleterious BRCA mutations and refractory ovarian cancer or patients with primary peritoneal or ovarian high-grade serous carcinoma or fallopian tube cancer. CR + PR was determined by the Response Evaluation Criteria in Solid Tumors (RECIST). CR is disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to \<10 mm). Partial response is at least a 30% decrease in the sum of the diameters of target lesions, taking as reference the baseline sum diameters.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
124 participants
Primary outcome timeframe
an average of 126 days for ovarian; 71 days for TNBC; for crossover intervention, pts stayed on study for an avg of 134 days for ovarian; 50 days for TNBC.
Results posted on
2017-04-26
Participant Flow
Triple-negative breast cancer participants were enrolled but three did not start the study (two withdrew, 1 progressed).
Participant milestones
| Measure |
Triple-negative Breast Cancer: ABT-888 + Cyclophosphamide
Oral cyclophosphamide 50mg by mouth (PO) for 21 days and oral ABT-888 60mg by mouth (PO) on a continuous schedule.
|
Triple-negative Breast Cancer: Cyclophosphamide Alone
Oral cyclophosphamide 50mg by mouth (PO) for 21 days. Participants in the cyclophosphamide alone arm crossed over to the ABT-888 plus cyclophosphamide arm at time of disease progression.
|
BRCA-positive Ovarian Cancer: ABT-888 + Cyclophosphamide
Oral cyclophosphamide 50mg by mouth (PO) for 21 days and oral ABT-888 60mg by mouth (PO) on a continuous schedule.
|
BRCA-positive Ovarian Cancer: Cyclophosphamide Alone
Oral cyclophosphamide 50mg by mouth (PO) for 21 days. Participants in the cyclophosphamide alone arm crossed over to the ABT-888 plus cyclophosphamide arm at time of disease progression.
|
Non-Hodgkin's: ABT-888 + Cyclophosphamide
Oral cyclophosphamide 50mg by mouth (PO) for 21 days and oral ABT-888 60mg by mouth (PO) on a continuous schedule.
|
Non-Hodgkin's: Cyclophosphamide Alone
Oral cyclophosphamide 50mg by mouth (PO) for 21 days. Participants in the cyclophosphamide alone arm crossed over to the ABT-888 plus cyclophosphamide arm at time of disease progression.
|
|---|---|---|---|---|---|---|
|
First Intervention
STARTED
|
22
|
20
|
37
|
38
|
2
|
2
|
|
First Intervention
COMPLETED
|
21
|
18
|
35
|
37
|
0
|
0
|
|
First Intervention
NOT COMPLETED
|
1
|
2
|
2
|
1
|
2
|
2
|
|
Disease Progression/Crossover
STARTED
|
0
|
16
|
0
|
29
|
0
|
0
|
|
Disease Progression/Crossover
COMPLETED
|
0
|
14
|
0
|
26
|
0
|
0
|
|
Disease Progression/Crossover
NOT COMPLETED
|
0
|
2
|
0
|
3
|
0
|
0
|
Reasons for withdrawal
| Measure |
Triple-negative Breast Cancer: ABT-888 + Cyclophosphamide
Oral cyclophosphamide 50mg by mouth (PO) for 21 days and oral ABT-888 60mg by mouth (PO) on a continuous schedule.
|
Triple-negative Breast Cancer: Cyclophosphamide Alone
Oral cyclophosphamide 50mg by mouth (PO) for 21 days. Participants in the cyclophosphamide alone arm crossed over to the ABT-888 plus cyclophosphamide arm at time of disease progression.
|
BRCA-positive Ovarian Cancer: ABT-888 + Cyclophosphamide
Oral cyclophosphamide 50mg by mouth (PO) for 21 days and oral ABT-888 60mg by mouth (PO) on a continuous schedule.
|
BRCA-positive Ovarian Cancer: Cyclophosphamide Alone
Oral cyclophosphamide 50mg by mouth (PO) for 21 days. Participants in the cyclophosphamide alone arm crossed over to the ABT-888 plus cyclophosphamide arm at time of disease progression.
|
Non-Hodgkin's: ABT-888 + Cyclophosphamide
Oral cyclophosphamide 50mg by mouth (PO) for 21 days and oral ABT-888 60mg by mouth (PO) on a continuous schedule.
|
Non-Hodgkin's: Cyclophosphamide Alone
Oral cyclophosphamide 50mg by mouth (PO) for 21 days. Participants in the cyclophosphamide alone arm crossed over to the ABT-888 plus cyclophosphamide arm at time of disease progression.
|
|---|---|---|---|---|---|---|
|
First Intervention
Adverse Event
|
1
|
0
|
1
|
0
|
0
|
1
|
|
First Intervention
Withdrawal by Subject
|
0
|
2
|
0
|
1
|
0
|
0
|
|
First Intervention
Death
|
0
|
0
|
1
|
0
|
0
|
0
|
|
First Intervention
Ineligible
|
0
|
0
|
0
|
0
|
0
|
1
|
|
First Intervention
Progressive disease
|
0
|
0
|
0
|
0
|
2
|
0
|
|
Disease Progression/Crossover
Withdrawal by Subject
|
0
|
0
|
0
|
1
|
0
|
0
|
|
Disease Progression/Crossover
other/symptomatic progression
|
0
|
2
|
0
|
2
|
0
|
0
|
Baseline Characteristics
Phase II ABT-888 With Cyclophosphamide
Baseline characteristics by cohort
| Measure |
Triple-negative Breast Cancer: ABT-888 + Cyclophosphamide
n=25 Participants
Oral cyclophosphamide 50mg by mouth (PO) for 21 days and oral ABT-888 60mg by mouth (PO).
|
Triple-negative Breast Cancer: Cyclophosphamide Alone
n=20 Participants
Oral cyclophosphamide 50mg by mouth (PO) for 21 days.
|
BRCA-positive Ovarian Cancer: ABT-888 + Cyclophosphamide
n=37 Participants
Oral cyclophosphamide 50mg by mouth (PO) for 21 days and oral ABT-888 60mg by mouth (PO).
|
BRCA-positive Ovarian Cancer: Cyclophosphamide Alone
n=38 Participants
Oral cyclophosphamide 50mg by mouth (PO) for 21 days.
|
Non-Hodgkin's: ABT-888 + Cyclophosphamide
n=2 Participants
Oral cyclophosphamide 50mg by mouth (PO) for 21 days and oral ABT-888 60mg by mouth (PO).
|
Non-Hodgkin's: Cyclophosphamide Alone
n=2 Participants
Oral cyclophosphamide 50mg by mouth (PO) for 21 days.
|
Total
n=124 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|---|
|
Sex: Female, Male
Male
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
0 Participants
n=10 Participants
|
1 Participants
n=115 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
1 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=10 Participants
|
5 Participants
n=115 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
22 Participants
n=5 Participants
|
17 Participants
n=7 Participants
|
36 Participants
n=5 Participants
|
35 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
2 Participants
n=10 Participants
|
113 Participants
n=115 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
2 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
0 Participants
n=10 Participants
|
6 Participants
n=115 Participants
|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=115 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
20 Participants
n=5 Participants
|
16 Participants
n=7 Participants
|
28 Participants
n=5 Participants
|
29 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
2 Participants
n=10 Participants
|
96 Participants
n=115 Participants
|
|
Age, Categorical
>=65 years
|
5 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
9 Participants
n=5 Participants
|
9 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
0 Participants
n=10 Participants
|
28 Participants
n=115 Participants
|
|
Age, Continuous
|
55 years
STANDARD_DEVIATION 10 • n=5 Participants
|
53 years
STANDARD_DEVIATION 13 • n=7 Participants
|
57 years
STANDARD_DEVIATION 10 • n=5 Participants
|
58 years
STANDARD_DEVIATION 10 • n=4 Participants
|
70 years
STANDARD_DEVIATION 24 • n=21 Participants
|
56 years
STANDARD_DEVIATION 6 • n=10 Participants
|
57 years
STANDARD_DEVIATION 11 • n=115 Participants
|
|
Sex: Female, Male
Female
|
25 Participants
n=5 Participants
|
20 Participants
n=7 Participants
|
37 Participants
n=5 Participants
|
38 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
2 Participants
n=10 Participants
|
123 Participants
n=115 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=115 Participants
|
|
Race (NIH/OMB)
Asian
|
2 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=10 Participants
|
7 Participants
n=115 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=115 Participants
|
|
Race (NIH/OMB)
Black or African American
|
7 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=10 Participants
|
10 Participants
n=115 Participants
|
|
Race (NIH/OMB)
White
|
16 Participants
n=5 Participants
|
15 Participants
n=7 Participants
|
35 Participants
n=5 Participants
|
37 Participants
n=4 Participants
|
2 Participants
n=21 Participants
|
2 Participants
n=10 Participants
|
107 Participants
n=115 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=115 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=115 Participants
|
|
Region of Enrollment
United States
|
22 Participants
n=5 Participants
|
17 Participants
n=7 Participants
|
23 Participants
n=5 Participants
|
23 Participants
n=4 Participants
|
2 Participants
n=21 Participants
|
2 Participants
n=10 Participants
|
89 Participants
n=115 Participants
|
|
Region of Enrollment
Canada
|
3 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
14 Participants
n=5 Participants
|
15 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=10 Participants
|
35 Participants
n=115 Participants
|
PRIMARY outcome
Timeframe: an average of 126 days for ovarian; 71 days for TNBC; for crossover intervention, pts stayed on study for an avg of 134 days for ovarian; 50 days for TNBC.Population: Participants evaluable for response.
Complete response (CR) + partial response (PR)) of the combination of ABT-888 with metronomic oral cyclophosphamide to the response rate (CR+PR) of metronomic oral cyclophosphamide in patients with deleterious BRCA mutations and refractory ovarian cancer or patients with primary peritoneal or ovarian high-grade serous carcinoma or fallopian tube cancer. CR + PR was determined by the Response Evaluation Criteria in Solid Tumors (RECIST). CR is disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to \<10 mm). Partial response is at least a 30% decrease in the sum of the diameters of target lesions, taking as reference the baseline sum diameters.
Outcome measures
| Measure |
Triple-negative Breast Cancer: ABT-888 + Cyclophosphamide
n=21 Participants
Oral cyclophosphamide 50mg by mouth (PO) for 21 days and oral ABT-888 60mg by mouth (PO) on a continuous schedule.
|
Triple-negative Breast Cancer: Cyclophosphamide Alone
n=18 Participants
Oral cyclophosphamide 50mg by mouth (PO) for 21 days.
|
Triple-negative Breast Cancer: Crossover
n=16 Participants
Oral cyclophosphamide 50mg by mouth (PO) for 21 days and oral ABT-888 60mg by mouth (PO) on a continuous schedule.
|
BRCA-positive Ovarian Cancer: ABT-888 + Cyclophosphamide
n=34 Participants
Oral cyclophosphamide 50mg by mouth (PO) for 21 days and oral ABT-888 60mg by mouth (PO) on a continuous schedule.
|
BRCA-positive Ovarian Cancer: Cyclophosphamide Alone
n=36 Participants
Oral cyclophosphamide 50mg by mouth (PO) for 21 days.
|
BRCA-positive Ovarian Cancer: Crossover
n=29 Participants
Oral cyclophosphamide 50mg by mouth (PO) for 21 days and oral ABT-888 60mg by mouth (PO) on a continuous schedule.
|
Non-Hodgkin's: ABT-888 & Cyclophosphamide
Oral cyclophosphamide 50mg by mouth (PO) for 21 days and oral ABT-888 60mg by mouth (PO) on a continuous schedule.
|
Non-Hodgkin's: Cyclophosphamide Alone
Oral cyclophosphamide 50mg by mouth (PO) for 21 days.
|
|---|---|---|---|---|---|---|---|---|
|
Percentage of Participants With an Overall Response Rate
|
9.5 percentage of participants
|
5.6 percentage of participants
|
0 percentage of participants
|
11.8 percentage of participants
|
19.4 percentage of participants
|
3.4 percentage of participants
|
—
|
—
|
PRIMARY outcome
Timeframe: Ovarian cancer patients stayed on study for an average of 126 days and triple-negative breast cancer patients for an average of 71 days.Population: Participants evaluable for response.
Time to progression for each participant for the initial intervention.
Outcome measures
| Measure |
Triple-negative Breast Cancer: ABT-888 + Cyclophosphamide
n=21 Participants
Oral cyclophosphamide 50mg by mouth (PO) for 21 days and oral ABT-888 60mg by mouth (PO) on a continuous schedule.
|
Triple-negative Breast Cancer: Cyclophosphamide Alone
n=18 Participants
Oral cyclophosphamide 50mg by mouth (PO) for 21 days.
|
Triple-negative Breast Cancer: Crossover
n=34 Participants
Oral cyclophosphamide 50mg by mouth (PO) for 21 days and oral ABT-888 60mg by mouth (PO) on a continuous schedule.
|
BRCA-positive Ovarian Cancer: ABT-888 + Cyclophosphamide
n=36 Participants
Oral cyclophosphamide 50mg by mouth (PO) for 21 days and oral ABT-888 60mg by mouth (PO) on a continuous schedule.
|
BRCA-positive Ovarian Cancer: Cyclophosphamide Alone
Oral cyclophosphamide 50mg by mouth (PO) for 21 days.
|
BRCA-positive Ovarian Cancer: Crossover
Oral cyclophosphamide 50mg by mouth (PO) for 21 days and oral ABT-888 60mg by mouth (PO) on a continuous schedule.
|
Non-Hodgkin's: ABT-888 & Cyclophosphamide
Oral cyclophosphamide 50mg by mouth (PO) for 21 days and oral ABT-888 60mg by mouth (PO) on a continuous schedule.
|
Non-Hodgkin's: Cyclophosphamide Alone
Oral cyclophosphamide 50mg by mouth (PO) for 21 days.
|
|---|---|---|---|---|---|---|---|---|
|
Progression Free Survival
|
3 Cycles of therapy
Interval 1.0 to 3.0
|
2 Cycles of therapy
Interval 1.0 to 9.0
|
3 Cycles of therapy
Interval 1.0 to 39.0
|
3 Cycles of therapy
Interval 1.0 to 32.0
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: up to 30 days following the last dose of study drug.Here is the number of participants with adverse events. For a detailed list of adverse events, see the adverse event module.
Outcome measures
| Measure |
Triple-negative Breast Cancer: ABT-888 + Cyclophosphamide
n=37 Participants
Oral cyclophosphamide 50mg by mouth (PO) for 21 days and oral ABT-888 60mg by mouth (PO) on a continuous schedule.
|
Triple-negative Breast Cancer: Cyclophosphamide Alone
n=38 Participants
Oral cyclophosphamide 50mg by mouth (PO) for 21 days.
|
Triple-negative Breast Cancer: Crossover
n=29 Participants
Oral cyclophosphamide 50mg by mouth (PO) for 21 days and oral ABT-888 60mg by mouth (PO) on a continuous schedule.
|
BRCA-positive Ovarian Cancer: ABT-888 + Cyclophosphamide
n=21 Participants
Oral cyclophosphamide 50mg by mouth (PO) for 21 days and oral ABT-888 60mg by mouth (PO) on a continuous schedule.
|
BRCA-positive Ovarian Cancer: Cyclophosphamide Alone
n=18 Participants
Oral cyclophosphamide 50mg by mouth (PO) for 21 days.
|
BRCA-positive Ovarian Cancer: Crossover
n=16 Participants
Oral cyclophosphamide 50mg by mouth (PO) for 21 days and oral ABT-888 60mg by mouth (PO) on a continuous schedule.
|
Non-Hodgkin's: ABT-888 & Cyclophosphamide
n=2 Participants
Oral cyclophosphamide 50mg by mouth (PO) for 21 days and oral ABT-888 60mg by mouth (PO) on a continuous schedule.
|
Non-Hodgkin's: Cyclophosphamide Alone
n=1 Participants
Oral cyclophosphamide 50mg by mouth (PO) for 21 days.
|
|---|---|---|---|---|---|---|---|---|
|
Number of Participants With Adverse Events
|
28 Participants
|
24 Participants
|
29 Participants
|
14 Participants
|
4 Participants
|
6 Participants
|
0 Participants
|
1 Participants
|
SECONDARY outcome
Timeframe: At baseline (t=0h) and 4h post drug administration (t=4h)Population: Patients with PBMCs data pre- and post-drug administration, and with PAR levels above the lower limit of quantitation (LLOQ) of 23 pg/μg protein were analyzed.
PAR levels (in pg/μg protein) were assessed in peripheral blood mononuclear cells (PBMCs) by immunoassay to assess poly (ADP-ribose) polymerase (PARP) activity. Significant inhibition of PARP activity is associated with 50% or greater reduction in PAR levels.
Outcome measures
| Measure |
Triple-negative Breast Cancer: ABT-888 + Cyclophosphamide
n=10 Participants
Oral cyclophosphamide 50mg by mouth (PO) for 21 days and oral ABT-888 60mg by mouth (PO) on a continuous schedule.
|
Triple-negative Breast Cancer: Cyclophosphamide Alone
Oral cyclophosphamide 50mg by mouth (PO) for 21 days.
|
Triple-negative Breast Cancer: Crossover
n=11 Participants
Oral cyclophosphamide 50mg by mouth (PO) for 21 days and oral ABT-888 60mg by mouth (PO) on a continuous schedule.
|
BRCA-positive Ovarian Cancer: ABT-888 + Cyclophosphamide
n=4 Participants
Oral cyclophosphamide 50mg by mouth (PO) for 21 days and oral ABT-888 60mg by mouth (PO) on a continuous schedule.
|
BRCA-positive Ovarian Cancer: Cyclophosphamide Alone
Oral cyclophosphamide 50mg by mouth (PO) for 21 days.
|
BRCA-positive Ovarian Cancer: Crossover
n=2 Participants
Oral cyclophosphamide 50mg by mouth (PO) for 21 days and oral ABT-888 60mg by mouth (PO) on a continuous schedule.
|
Non-Hodgkin's: ABT-888 & Cyclophosphamide
Oral cyclophosphamide 50mg by mouth (PO) for 21 days and oral ABT-888 60mg by mouth (PO) on a continuous schedule.
|
Non-Hodgkin's: Cyclophosphamide Alone
Oral cyclophosphamide 50mg by mouth (PO) for 21 days.
|
|---|---|---|---|---|---|---|---|---|
|
Change in Poly-ADP Ribose (PAR) Concentration Levels From Baseline
|
-81 pg/μg protein
Interval -93.0 to -48.0
|
—
|
-88 pg/μg protein
Interval -97.0 to -68.0
|
-74 pg/μg protein
Interval -83.0 to -65.0
|
—
|
-85 pg/μg protein
Interval -85.0 to -85.0
|
—
|
—
|
SECONDARY outcome
Timeframe: At baseline (t=0h) and 24h post drug administration (t=24h)Population: Patients with sufficient CTC counts (defined as ≥6 total CTCs) pre- and post-drug administration were analyzed.
Number of CTCs (evaluable defined as ≥ 6 CTCs) were measured in whole blood during the course of treatment to determine drug-induced deoxyribonucleic acid damage in tumor cells.
Outcome measures
| Measure |
Triple-negative Breast Cancer: ABT-888 + Cyclophosphamide
Oral cyclophosphamide 50mg by mouth (PO) for 21 days and oral ABT-888 60mg by mouth (PO) on a continuous schedule.
|
Triple-negative Breast Cancer: Cyclophosphamide Alone
Oral cyclophosphamide 50mg by mouth (PO) for 21 days.
|
Triple-negative Breast Cancer: Crossover
n=1 Participants
Oral cyclophosphamide 50mg by mouth (PO) for 21 days and oral ABT-888 60mg by mouth (PO) on a continuous schedule.
|
BRCA-positive Ovarian Cancer: ABT-888 + Cyclophosphamide
n=1 Participants
Oral cyclophosphamide 50mg by mouth (PO) for 21 days and oral ABT-888 60mg by mouth (PO) on a continuous schedule.
|
BRCA-positive Ovarian Cancer: Cyclophosphamide Alone
Oral cyclophosphamide 50mg by mouth (PO) for 21 days.
|
BRCA-positive Ovarian Cancer: Crossover
n=2 Participants
Oral cyclophosphamide 50mg by mouth (PO) for 21 days and oral ABT-888 60mg by mouth (PO) on a continuous schedule.
|
Non-Hodgkin's: ABT-888 & Cyclophosphamide
Oral cyclophosphamide 50mg by mouth (PO) for 21 days and oral ABT-888 60mg by mouth (PO) on a continuous schedule.
|
Non-Hodgkin's: Cyclophosphamide Alone
Oral cyclophosphamide 50mg by mouth (PO) for 21 days.
|
|---|---|---|---|---|---|---|---|---|
|
Change in ϓH2AX- Positive Circulating Tumor Cells (CTCs) in Whole Blood
|
—
|
—
|
400 ϓH2AX- Positive CTCs
Interval 400.0 to 400.0
|
200 ϓH2AX- Positive CTCs
Interval 200.0 to 200.0
|
—
|
9.5 ϓH2AX- Positive CTCs
Interval -38.0 to 57.0
|
—
|
—
|
SECONDARY outcome
Timeframe: Optional tumor biopsies were performed prior to start of treatment (baseline) and 6 monthsPopulation: Patients with sufficient tumor content in archival tissue (defined as ≥70% tumor after macrodissection) were analyzed for genetic alterations in DNA repair genes by whole-exome sequencing.
Gene expression profiling was performed in archival tumor tissue for a panel of 211 genes using deoxyribonucleic acid (DNA) array to determine deleterious mutations (i.e. nonsynonymous mutations at coding regions) of genes. Sequences were mapped to human genome reference hg19. Variants were identified with VarScan, annotated with AVIA, and masked to the exonic or exonic:splicing regions of the 211 interrogated DNA repair genes, with nonsynonymous/frameshift/stop-gain/stop-loss variants that have a population frequency of 1% or less in either 1000G (2014\_04) or the ExomeSequencingProject (ESP6500si\_all) with a minimum variant frequency of 10% and at least 20 reads. Lastly, variants were manually inspected for known platform and mapping errors.
Outcome measures
| Measure |
Triple-negative Breast Cancer: ABT-888 + Cyclophosphamide
n=28 Participants
Oral cyclophosphamide 50mg by mouth (PO) for 21 days and oral ABT-888 60mg by mouth (PO) on a continuous schedule.
|
Triple-negative Breast Cancer: Cyclophosphamide Alone
Oral cyclophosphamide 50mg by mouth (PO) for 21 days.
|
Triple-negative Breast Cancer: Crossover
n=27 Participants
Oral cyclophosphamide 50mg by mouth (PO) for 21 days and oral ABT-888 60mg by mouth (PO) on a continuous schedule.
|
BRCA-positive Ovarian Cancer: ABT-888 + Cyclophosphamide
Oral cyclophosphamide 50mg by mouth (PO) for 21 days and oral ABT-888 60mg by mouth (PO) on a continuous schedule.
|
BRCA-positive Ovarian Cancer: Cyclophosphamide Alone
Oral cyclophosphamide 50mg by mouth (PO) for 21 days.
|
BRCA-positive Ovarian Cancer: Crossover
Oral cyclophosphamide 50mg by mouth (PO) for 21 days and oral ABT-888 60mg by mouth (PO) on a continuous schedule.
|
Non-Hodgkin's: ABT-888 & Cyclophosphamide
Oral cyclophosphamide 50mg by mouth (PO) for 21 days and oral ABT-888 60mg by mouth (PO) on a continuous schedule.
|
Non-Hodgkin's: Cyclophosphamide Alone
Oral cyclophosphamide 50mg by mouth (PO) for 21 days.
|
|---|---|---|---|---|---|---|---|---|
|
Number of Participants With Deleterious Mutations in DNA Repair Genes
|
28 Participants
|
—
|
27 Participants
|
—
|
—
|
—
|
—
|
—
|
Adverse Events
BRCA-positive Ovarian Cancer: ABT-888 + Cyclophosphamide
Serious events: 3 serious events
Other events: 28 other events
Deaths: 1 deaths
BRCA-positive Ovarian Cancer: Cyclophosphamide Alone
Serious events: 0 serious events
Other events: 24 other events
Deaths: 0 deaths
BRCA-positive Ovarian Cancer: Crossover
Serious events: 0 serious events
Other events: 29 other events
Deaths: 0 deaths
Triple-negative Breast Cancer: Cyclophosphamide & ABT-888
Serious events: 2 serious events
Other events: 14 other events
Deaths: 0 deaths
Triple-negative Breast Cancer: Cyclophosphamide Alone
Serious events: 0 serious events
Other events: 4 other events
Deaths: 0 deaths
Triple-negative Breast Cancer: Crossover
Serious events: 1 serious events
Other events: 6 other events
Deaths: 0 deaths
Non-Hodgkin's: ABT-888 + Cyclophosphamide
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Non-Hodgkin's: Cyclophosphamide Alone
Serious events: 1 serious events
Other events: 1 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
BRCA-positive Ovarian Cancer: ABT-888 + Cyclophosphamide
n=37 participants at risk
Oral cyclophosphamide 50mg by mouth (PO) for 21 days and oral ABT-888 60mg by mouth (PO) on a continuous schedule.
|
BRCA-positive Ovarian Cancer: Cyclophosphamide Alone
n=38 participants at risk
Oral cyclophosphamide 50mg by mouth (PO) for 21 days.
|
BRCA-positive Ovarian Cancer: Crossover
n=29 participants at risk
Oral cyclophosphamide 50mg by mouth (PO) for 21 days and oral ABT-888 60mg by mouth (PO) on a continuous schedule.
|
Triple-negative Breast Cancer: Cyclophosphamide & ABT-888
n=21 participants at risk
Oral cyclophosphamide 50mg by mouth (PO) for 21 days and oral ABT-888 60mg by mouth (PO) on a continuous schedule.
|
Triple-negative Breast Cancer: Cyclophosphamide Alone
n=18 participants at risk
Oral cyclophosphamide 50mg by mouth (PO) for 21 days.
|
Triple-negative Breast Cancer: Crossover
n=16 participants at risk
Oral cyclophosphamide 50mg by mouth (PO) for 21 days and oral ABT-888 60mg by mouth (PO) on a continuous schedule.
|
Non-Hodgkin's: ABT-888 + Cyclophosphamide
n=2 participants at risk
Oral cyclophosphamide 50mg by mouth (PO) for 21 days and oral ABT-888 60mg by mouth (PO) on a continuous schedule.
|
Non-Hodgkin's: Cyclophosphamide Alone
n=1 participants at risk
Oral cyclophosphamide 50mg by mouth (PO) for 21 days.
|
|---|---|---|---|---|---|---|---|---|
|
Investigations
Lymphopenia
|
2.7%
1/37 • Number of events 1 • up to 30 days following the last dose of study drug.
Adverse events were categorized by treatment (initial vs. crossover treatment arms) rather than indication as this was how we analyzed the data.
|
0.00%
0/38 • up to 30 days following the last dose of study drug.
Adverse events were categorized by treatment (initial vs. crossover treatment arms) rather than indication as this was how we analyzed the data.
|
0.00%
0/29 • up to 30 days following the last dose of study drug.
Adverse events were categorized by treatment (initial vs. crossover treatment arms) rather than indication as this was how we analyzed the data.
|
0.00%
0/21 • up to 30 days following the last dose of study drug.
Adverse events were categorized by treatment (initial vs. crossover treatment arms) rather than indication as this was how we analyzed the data.
|
0.00%
0/18 • up to 30 days following the last dose of study drug.
Adverse events were categorized by treatment (initial vs. crossover treatment arms) rather than indication as this was how we analyzed the data.
|
0.00%
0/16 • up to 30 days following the last dose of study drug.
Adverse events were categorized by treatment (initial vs. crossover treatment arms) rather than indication as this was how we analyzed the data.
|
0.00%
0/2 • up to 30 days following the last dose of study drug.
Adverse events were categorized by treatment (initial vs. crossover treatment arms) rather than indication as this was how we analyzed the data.
|
0.00%
0/1 • up to 30 days following the last dose of study drug.
Adverse events were categorized by treatment (initial vs. crossover treatment arms) rather than indication as this was how we analyzed the data.
|
|
Investigations
Neutropenia
|
2.7%
1/37 • Number of events 1 • up to 30 days following the last dose of study drug.
Adverse events were categorized by treatment (initial vs. crossover treatment arms) rather than indication as this was how we analyzed the data.
|
0.00%
0/38 • up to 30 days following the last dose of study drug.
Adverse events were categorized by treatment (initial vs. crossover treatment arms) rather than indication as this was how we analyzed the data.
|
0.00%
0/29 • up to 30 days following the last dose of study drug.
Adverse events were categorized by treatment (initial vs. crossover treatment arms) rather than indication as this was how we analyzed the data.
|
0.00%
0/21 • up to 30 days following the last dose of study drug.
Adverse events were categorized by treatment (initial vs. crossover treatment arms) rather than indication as this was how we analyzed the data.
|
0.00%
0/18 • up to 30 days following the last dose of study drug.
Adverse events were categorized by treatment (initial vs. crossover treatment arms) rather than indication as this was how we analyzed the data.
|
0.00%
0/16 • up to 30 days following the last dose of study drug.
Adverse events were categorized by treatment (initial vs. crossover treatment arms) rather than indication as this was how we analyzed the data.
|
0.00%
0/2 • up to 30 days following the last dose of study drug.
Adverse events were categorized by treatment (initial vs. crossover treatment arms) rather than indication as this was how we analyzed the data.
|
0.00%
0/1 • up to 30 days following the last dose of study drug.
Adverse events were categorized by treatment (initial vs. crossover treatment arms) rather than indication as this was how we analyzed the data.
|
|
Gastrointestinal disorders
Dehydration
|
2.7%
1/37 • Number of events 1 • up to 30 days following the last dose of study drug.
Adverse events were categorized by treatment (initial vs. crossover treatment arms) rather than indication as this was how we analyzed the data.
|
0.00%
0/38 • up to 30 days following the last dose of study drug.
Adverse events were categorized by treatment (initial vs. crossover treatment arms) rather than indication as this was how we analyzed the data.
|
0.00%
0/29 • up to 30 days following the last dose of study drug.
Adverse events were categorized by treatment (initial vs. crossover treatment arms) rather than indication as this was how we analyzed the data.
|
0.00%
0/21 • up to 30 days following the last dose of study drug.
Adverse events were categorized by treatment (initial vs. crossover treatment arms) rather than indication as this was how we analyzed the data.
|
0.00%
0/18 • up to 30 days following the last dose of study drug.
Adverse events were categorized by treatment (initial vs. crossover treatment arms) rather than indication as this was how we analyzed the data.
|
0.00%
0/16 • up to 30 days following the last dose of study drug.
Adverse events were categorized by treatment (initial vs. crossover treatment arms) rather than indication as this was how we analyzed the data.
|
0.00%
0/2 • up to 30 days following the last dose of study drug.
Adverse events were categorized by treatment (initial vs. crossover treatment arms) rather than indication as this was how we analyzed the data.
|
0.00%
0/1 • up to 30 days following the last dose of study drug.
Adverse events were categorized by treatment (initial vs. crossover treatment arms) rather than indication as this was how we analyzed the data.
|
|
Metabolism and nutrition disorders
Hyponatremia
|
2.7%
1/37 • Number of events 1 • up to 30 days following the last dose of study drug.
Adverse events were categorized by treatment (initial vs. crossover treatment arms) rather than indication as this was how we analyzed the data.
|
0.00%
0/38 • up to 30 days following the last dose of study drug.
Adverse events were categorized by treatment (initial vs. crossover treatment arms) rather than indication as this was how we analyzed the data.
|
0.00%
0/29 • up to 30 days following the last dose of study drug.
Adverse events were categorized by treatment (initial vs. crossover treatment arms) rather than indication as this was how we analyzed the data.
|
0.00%
0/21 • up to 30 days following the last dose of study drug.
Adverse events were categorized by treatment (initial vs. crossover treatment arms) rather than indication as this was how we analyzed the data.
|
0.00%
0/18 • up to 30 days following the last dose of study drug.
Adverse events were categorized by treatment (initial vs. crossover treatment arms) rather than indication as this was how we analyzed the data.
|
0.00%
0/16 • up to 30 days following the last dose of study drug.
Adverse events were categorized by treatment (initial vs. crossover treatment arms) rather than indication as this was how we analyzed the data.
|
0.00%
0/2 • up to 30 days following the last dose of study drug.
Adverse events were categorized by treatment (initial vs. crossover treatment arms) rather than indication as this was how we analyzed the data.
|
0.00%
0/1 • up to 30 days following the last dose of study drug.
Adverse events were categorized by treatment (initial vs. crossover treatment arms) rather than indication as this was how we analyzed the data.
|
|
Cardiac disorders
Sinus tachycardia
|
0.00%
0/37 • up to 30 days following the last dose of study drug.
Adverse events were categorized by treatment (initial vs. crossover treatment arms) rather than indication as this was how we analyzed the data.
|
0.00%
0/38 • up to 30 days following the last dose of study drug.
Adverse events were categorized by treatment (initial vs. crossover treatment arms) rather than indication as this was how we analyzed the data.
|
0.00%
0/29 • up to 30 days following the last dose of study drug.
Adverse events were categorized by treatment (initial vs. crossover treatment arms) rather than indication as this was how we analyzed the data.
|
4.8%
1/21 • Number of events 1 • up to 30 days following the last dose of study drug.
Adverse events were categorized by treatment (initial vs. crossover treatment arms) rather than indication as this was how we analyzed the data.
|
0.00%
0/18 • up to 30 days following the last dose of study drug.
Adverse events were categorized by treatment (initial vs. crossover treatment arms) rather than indication as this was how we analyzed the data.
|
0.00%
0/16 • up to 30 days following the last dose of study drug.
Adverse events were categorized by treatment (initial vs. crossover treatment arms) rather than indication as this was how we analyzed the data.
|
0.00%
0/2 • up to 30 days following the last dose of study drug.
Adverse events were categorized by treatment (initial vs. crossover treatment arms) rather than indication as this was how we analyzed the data.
|
0.00%
0/1 • up to 30 days following the last dose of study drug.
Adverse events were categorized by treatment (initial vs. crossover treatment arms) rather than indication as this was how we analyzed the data.
|
|
Investigations
Thrombocytopenia
|
0.00%
0/37 • up to 30 days following the last dose of study drug.
Adverse events were categorized by treatment (initial vs. crossover treatment arms) rather than indication as this was how we analyzed the data.
|
0.00%
0/38 • up to 30 days following the last dose of study drug.
Adverse events were categorized by treatment (initial vs. crossover treatment arms) rather than indication as this was how we analyzed the data.
|
0.00%
0/29 • up to 30 days following the last dose of study drug.
Adverse events were categorized by treatment (initial vs. crossover treatment arms) rather than indication as this was how we analyzed the data.
|
4.8%
1/21 • Number of events 2 • up to 30 days following the last dose of study drug.
Adverse events were categorized by treatment (initial vs. crossover treatment arms) rather than indication as this was how we analyzed the data.
|
0.00%
0/18 • up to 30 days following the last dose of study drug.
Adverse events were categorized by treatment (initial vs. crossover treatment arms) rather than indication as this was how we analyzed the data.
|
0.00%
0/16 • up to 30 days following the last dose of study drug.
Adverse events were categorized by treatment (initial vs. crossover treatment arms) rather than indication as this was how we analyzed the data.
|
0.00%
0/2 • up to 30 days following the last dose of study drug.
Adverse events were categorized by treatment (initial vs. crossover treatment arms) rather than indication as this was how we analyzed the data.
|
100.0%
1/1 • Number of events 1 • up to 30 days following the last dose of study drug.
Adverse events were categorized by treatment (initial vs. crossover treatment arms) rather than indication as this was how we analyzed the data.
|
|
Cardiac disorders
Heart failure
|
0.00%
0/37 • up to 30 days following the last dose of study drug.
Adverse events were categorized by treatment (initial vs. crossover treatment arms) rather than indication as this was how we analyzed the data.
|
0.00%
0/38 • up to 30 days following the last dose of study drug.
Adverse events were categorized by treatment (initial vs. crossover treatment arms) rather than indication as this was how we analyzed the data.
|
0.00%
0/29 • up to 30 days following the last dose of study drug.
Adverse events were categorized by treatment (initial vs. crossover treatment arms) rather than indication as this was how we analyzed the data.
|
4.8%
1/21 • Number of events 1 • up to 30 days following the last dose of study drug.
Adverse events were categorized by treatment (initial vs. crossover treatment arms) rather than indication as this was how we analyzed the data.
|
0.00%
0/18 • up to 30 days following the last dose of study drug.
Adverse events were categorized by treatment (initial vs. crossover treatment arms) rather than indication as this was how we analyzed the data.
|
0.00%
0/16 • up to 30 days following the last dose of study drug.
Adverse events were categorized by treatment (initial vs. crossover treatment arms) rather than indication as this was how we analyzed the data.
|
0.00%
0/2 • up to 30 days following the last dose of study drug.
Adverse events were categorized by treatment (initial vs. crossover treatment arms) rather than indication as this was how we analyzed the data.
|
0.00%
0/1 • up to 30 days following the last dose of study drug.
Adverse events were categorized by treatment (initial vs. crossover treatment arms) rather than indication as this was how we analyzed the data.
|
|
Metabolism and nutrition disorders
Weight loss
|
0.00%
0/37 • up to 30 days following the last dose of study drug.
Adverse events were categorized by treatment (initial vs. crossover treatment arms) rather than indication as this was how we analyzed the data.
|
0.00%
0/38 • up to 30 days following the last dose of study drug.
Adverse events were categorized by treatment (initial vs. crossover treatment arms) rather than indication as this was how we analyzed the data.
|
0.00%
0/29 • up to 30 days following the last dose of study drug.
Adverse events were categorized by treatment (initial vs. crossover treatment arms) rather than indication as this was how we analyzed the data.
|
0.00%
0/21 • up to 30 days following the last dose of study drug.
Adverse events were categorized by treatment (initial vs. crossover treatment arms) rather than indication as this was how we analyzed the data.
|
0.00%
0/18 • up to 30 days following the last dose of study drug.
Adverse events were categorized by treatment (initial vs. crossover treatment arms) rather than indication as this was how we analyzed the data.
|
6.2%
1/16 • Number of events 2 • up to 30 days following the last dose of study drug.
Adverse events were categorized by treatment (initial vs. crossover treatment arms) rather than indication as this was how we analyzed the data.
|
0.00%
0/2 • up to 30 days following the last dose of study drug.
Adverse events were categorized by treatment (initial vs. crossover treatment arms) rather than indication as this was how we analyzed the data.
|
0.00%
0/1 • up to 30 days following the last dose of study drug.
Adverse events were categorized by treatment (initial vs. crossover treatment arms) rather than indication as this was how we analyzed the data.
|
|
General disorders
Death Not Associated with CTCAE: Death NOS
|
2.7%
1/37 • Number of events 1 • up to 30 days following the last dose of study drug.
Adverse events were categorized by treatment (initial vs. crossover treatment arms) rather than indication as this was how we analyzed the data.
|
0.00%
0/38 • up to 30 days following the last dose of study drug.
Adverse events were categorized by treatment (initial vs. crossover treatment arms) rather than indication as this was how we analyzed the data.
|
0.00%
0/29 • up to 30 days following the last dose of study drug.
Adverse events were categorized by treatment (initial vs. crossover treatment arms) rather than indication as this was how we analyzed the data.
|
0.00%
0/21 • up to 30 days following the last dose of study drug.
Adverse events were categorized by treatment (initial vs. crossover treatment arms) rather than indication as this was how we analyzed the data.
|
0.00%
0/18 • up to 30 days following the last dose of study drug.
Adverse events were categorized by treatment (initial vs. crossover treatment arms) rather than indication as this was how we analyzed the data.
|
0.00%
0/16 • up to 30 days following the last dose of study drug.
Adverse events were categorized by treatment (initial vs. crossover treatment arms) rather than indication as this was how we analyzed the data.
|
0.00%
0/2 • up to 30 days following the last dose of study drug.
Adverse events were categorized by treatment (initial vs. crossover treatment arms) rather than indication as this was how we analyzed the data.
|
0.00%
0/1 • up to 30 days following the last dose of study drug.
Adverse events were categorized by treatment (initial vs. crossover treatment arms) rather than indication as this was how we analyzed the data.
|
Other adverse events
| Measure |
BRCA-positive Ovarian Cancer: ABT-888 + Cyclophosphamide
n=37 participants at risk
Oral cyclophosphamide 50mg by mouth (PO) for 21 days and oral ABT-888 60mg by mouth (PO) on a continuous schedule.
|
BRCA-positive Ovarian Cancer: Cyclophosphamide Alone
n=38 participants at risk
Oral cyclophosphamide 50mg by mouth (PO) for 21 days.
|
BRCA-positive Ovarian Cancer: Crossover
n=29 participants at risk
Oral cyclophosphamide 50mg by mouth (PO) for 21 days and oral ABT-888 60mg by mouth (PO) on a continuous schedule.
|
Triple-negative Breast Cancer: Cyclophosphamide & ABT-888
n=21 participants at risk
Oral cyclophosphamide 50mg by mouth (PO) for 21 days and oral ABT-888 60mg by mouth (PO) on a continuous schedule.
|
Triple-negative Breast Cancer: Cyclophosphamide Alone
n=18 participants at risk
Oral cyclophosphamide 50mg by mouth (PO) for 21 days.
|
Triple-negative Breast Cancer: Crossover
n=16 participants at risk
Oral cyclophosphamide 50mg by mouth (PO) for 21 days and oral ABT-888 60mg by mouth (PO) on a continuous schedule.
|
Non-Hodgkin's: ABT-888 + Cyclophosphamide
n=2 participants at risk
Oral cyclophosphamide 50mg by mouth (PO) for 21 days and oral ABT-888 60mg by mouth (PO) on a continuous schedule.
|
Non-Hodgkin's: Cyclophosphamide Alone
n=1 participants at risk
Oral cyclophosphamide 50mg by mouth (PO) for 21 days.
|
|---|---|---|---|---|---|---|---|---|
|
Gastrointestinal disorders
Abdominal pain
|
2.7%
1/37 • Number of events 1 • up to 30 days following the last dose of study drug.
Adverse events were categorized by treatment (initial vs. crossover treatment arms) rather than indication as this was how we analyzed the data.
|
2.6%
1/38 • Number of events 1 • up to 30 days following the last dose of study drug.
Adverse events were categorized by treatment (initial vs. crossover treatment arms) rather than indication as this was how we analyzed the data.
|
0.00%
0/29 • up to 30 days following the last dose of study drug.
Adverse events were categorized by treatment (initial vs. crossover treatment arms) rather than indication as this was how we analyzed the data.
|
0.00%
0/21 • up to 30 days following the last dose of study drug.
Adverse events were categorized by treatment (initial vs. crossover treatment arms) rather than indication as this was how we analyzed the data.
|
0.00%
0/18 • up to 30 days following the last dose of study drug.
Adverse events were categorized by treatment (initial vs. crossover treatment arms) rather than indication as this was how we analyzed the data.
|
0.00%
0/16 • up to 30 days following the last dose of study drug.
Adverse events were categorized by treatment (initial vs. crossover treatment arms) rather than indication as this was how we analyzed the data.
|
0.00%
0/2 • up to 30 days following the last dose of study drug.
Adverse events were categorized by treatment (initial vs. crossover treatment arms) rather than indication as this was how we analyzed the data.
|
0.00%
0/1 • up to 30 days following the last dose of study drug.
Adverse events were categorized by treatment (initial vs. crossover treatment arms) rather than indication as this was how we analyzed the data.
|
|
Metabolism and nutrition disorders
Anorexia
|
2.7%
1/37 • Number of events 1 • up to 30 days following the last dose of study drug.
Adverse events were categorized by treatment (initial vs. crossover treatment arms) rather than indication as this was how we analyzed the data.
|
5.3%
2/38 • Number of events 2 • up to 30 days following the last dose of study drug.
Adverse events were categorized by treatment (initial vs. crossover treatment arms) rather than indication as this was how we analyzed the data.
|
0.00%
0/29 • up to 30 days following the last dose of study drug.
Adverse events were categorized by treatment (initial vs. crossover treatment arms) rather than indication as this was how we analyzed the data.
|
0.00%
0/21 • up to 30 days following the last dose of study drug.
Adverse events were categorized by treatment (initial vs. crossover treatment arms) rather than indication as this was how we analyzed the data.
|
0.00%
0/18 • up to 30 days following the last dose of study drug.
Adverse events were categorized by treatment (initial vs. crossover treatment arms) rather than indication as this was how we analyzed the data.
|
6.2%
1/16 • Number of events 2 • up to 30 days following the last dose of study drug.
Adverse events were categorized by treatment (initial vs. crossover treatment arms) rather than indication as this was how we analyzed the data.
|
0.00%
0/2 • up to 30 days following the last dose of study drug.
Adverse events were categorized by treatment (initial vs. crossover treatment arms) rather than indication as this was how we analyzed the data.
|
0.00%
0/1 • up to 30 days following the last dose of study drug.
Adverse events were categorized by treatment (initial vs. crossover treatment arms) rather than indication as this was how we analyzed the data.
|
|
Gastrointestinal disorders
Nausea
|
2.7%
1/37 • Number of events 1 • up to 30 days following the last dose of study drug.
Adverse events were categorized by treatment (initial vs. crossover treatment arms) rather than indication as this was how we analyzed the data.
|
2.6%
1/38 • Number of events 2 • up to 30 days following the last dose of study drug.
Adverse events were categorized by treatment (initial vs. crossover treatment arms) rather than indication as this was how we analyzed the data.
|
6.9%
2/29 • Number of events 2 • up to 30 days following the last dose of study drug.
Adverse events were categorized by treatment (initial vs. crossover treatment arms) rather than indication as this was how we analyzed the data.
|
0.00%
0/21 • up to 30 days following the last dose of study drug.
Adverse events were categorized by treatment (initial vs. crossover treatment arms) rather than indication as this was how we analyzed the data.
|
0.00%
0/18 • up to 30 days following the last dose of study drug.
Adverse events were categorized by treatment (initial vs. crossover treatment arms) rather than indication as this was how we analyzed the data.
|
0.00%
0/16 • up to 30 days following the last dose of study drug.
Adverse events were categorized by treatment (initial vs. crossover treatment arms) rather than indication as this was how we analyzed the data.
|
0.00%
0/2 • up to 30 days following the last dose of study drug.
Adverse events were categorized by treatment (initial vs. crossover treatment arms) rather than indication as this was how we analyzed the data.
|
0.00%
0/1 • up to 30 days following the last dose of study drug.
Adverse events were categorized by treatment (initial vs. crossover treatment arms) rather than indication as this was how we analyzed the data.
|
|
Gastrointestinal disorders
Oral mucositis
|
0.00%
0/37 • up to 30 days following the last dose of study drug.
Adverse events were categorized by treatment (initial vs. crossover treatment arms) rather than indication as this was how we analyzed the data.
|
2.6%
1/38 • Number of events 1 • up to 30 days following the last dose of study drug.
Adverse events were categorized by treatment (initial vs. crossover treatment arms) rather than indication as this was how we analyzed the data.
|
0.00%
0/29 • up to 30 days following the last dose of study drug.
Adverse events were categorized by treatment (initial vs. crossover treatment arms) rather than indication as this was how we analyzed the data.
|
0.00%
0/21 • up to 30 days following the last dose of study drug.
Adverse events were categorized by treatment (initial vs. crossover treatment arms) rather than indication as this was how we analyzed the data.
|
5.6%
1/18 • Number of events 1 • up to 30 days following the last dose of study drug.
Adverse events were categorized by treatment (initial vs. crossover treatment arms) rather than indication as this was how we analyzed the data.
|
0.00%
0/16 • up to 30 days following the last dose of study drug.
Adverse events were categorized by treatment (initial vs. crossover treatment arms) rather than indication as this was how we analyzed the data.
|
0.00%
0/2 • up to 30 days following the last dose of study drug.
Adverse events were categorized by treatment (initial vs. crossover treatment arms) rather than indication as this was how we analyzed the data.
|
0.00%
0/1 • up to 30 days following the last dose of study drug.
Adverse events were categorized by treatment (initial vs. crossover treatment arms) rather than indication as this was how we analyzed the data.
|
|
Blood and lymphatic system disorders
Anemia
|
24.3%
9/37 • Number of events 16 • up to 30 days following the last dose of study drug.
Adverse events were categorized by treatment (initial vs. crossover treatment arms) rather than indication as this was how we analyzed the data.
|
5.3%
2/38 • Number of events 6 • up to 30 days following the last dose of study drug.
Adverse events were categorized by treatment (initial vs. crossover treatment arms) rather than indication as this was how we analyzed the data.
|
31.0%
9/29 • Number of events 9 • up to 30 days following the last dose of study drug.
Adverse events were categorized by treatment (initial vs. crossover treatment arms) rather than indication as this was how we analyzed the data.
|
14.3%
3/21 • Number of events 3 • up to 30 days following the last dose of study drug.
Adverse events were categorized by treatment (initial vs. crossover treatment arms) rather than indication as this was how we analyzed the data.
|
16.7%
3/18 • Number of events 5 • up to 30 days following the last dose of study drug.
Adverse events were categorized by treatment (initial vs. crossover treatment arms) rather than indication as this was how we analyzed the data.
|
12.5%
2/16 • Number of events 4 • up to 30 days following the last dose of study drug.
Adverse events were categorized by treatment (initial vs. crossover treatment arms) rather than indication as this was how we analyzed the data.
|
0.00%
0/2 • up to 30 days following the last dose of study drug.
Adverse events were categorized by treatment (initial vs. crossover treatment arms) rather than indication as this was how we analyzed the data.
|
0.00%
0/1 • up to 30 days following the last dose of study drug.
Adverse events were categorized by treatment (initial vs. crossover treatment arms) rather than indication as this was how we analyzed the data.
|
|
Investigations
Leucopenia
|
32.4%
12/37 • Number of events 27 • up to 30 days following the last dose of study drug.
Adverse events were categorized by treatment (initial vs. crossover treatment arms) rather than indication as this was how we analyzed the data.
|
15.8%
6/38 • Number of events 14 • up to 30 days following the last dose of study drug.
Adverse events were categorized by treatment (initial vs. crossover treatment arms) rather than indication as this was how we analyzed the data.
|
27.6%
8/29 • Number of events 9 • up to 30 days following the last dose of study drug.
Adverse events were categorized by treatment (initial vs. crossover treatment arms) rather than indication as this was how we analyzed the data.
|
19.0%
4/21 • Number of events 8 • up to 30 days following the last dose of study drug.
Adverse events were categorized by treatment (initial vs. crossover treatment arms) rather than indication as this was how we analyzed the data.
|
0.00%
0/18 • up to 30 days following the last dose of study drug.
Adverse events were categorized by treatment (initial vs. crossover treatment arms) rather than indication as this was how we analyzed the data.
|
0.00%
0/16 • up to 30 days following the last dose of study drug.
Adverse events were categorized by treatment (initial vs. crossover treatment arms) rather than indication as this was how we analyzed the data.
|
0.00%
0/2 • up to 30 days following the last dose of study drug.
Adverse events were categorized by treatment (initial vs. crossover treatment arms) rather than indication as this was how we analyzed the data.
|
0.00%
0/1 • up to 30 days following the last dose of study drug.
Adverse events were categorized by treatment (initial vs. crossover treatment arms) rather than indication as this was how we analyzed the data.
|
|
Investigations
Neutropenia
|
18.9%
7/37 • Number of events 22 • up to 30 days following the last dose of study drug.
Adverse events were categorized by treatment (initial vs. crossover treatment arms) rather than indication as this was how we analyzed the data.
|
2.6%
1/38 • Number of events 2 • up to 30 days following the last dose of study drug.
Adverse events were categorized by treatment (initial vs. crossover treatment arms) rather than indication as this was how we analyzed the data.
|
13.8%
4/29 • Number of events 4 • up to 30 days following the last dose of study drug.
Adverse events were categorized by treatment (initial vs. crossover treatment arms) rather than indication as this was how we analyzed the data.
|
4.8%
1/21 • Number of events 6 • up to 30 days following the last dose of study drug.
Adverse events were categorized by treatment (initial vs. crossover treatment arms) rather than indication as this was how we analyzed the data.
|
0.00%
0/18 • up to 30 days following the last dose of study drug.
Adverse events were categorized by treatment (initial vs. crossover treatment arms) rather than indication as this was how we analyzed the data.
|
0.00%
0/16 • up to 30 days following the last dose of study drug.
Adverse events were categorized by treatment (initial vs. crossover treatment arms) rather than indication as this was how we analyzed the data.
|
0.00%
0/2 • up to 30 days following the last dose of study drug.
Adverse events were categorized by treatment (initial vs. crossover treatment arms) rather than indication as this was how we analyzed the data.
|
100.0%
1/1 • Number of events 1 • up to 30 days following the last dose of study drug.
Adverse events were categorized by treatment (initial vs. crossover treatment arms) rather than indication as this was how we analyzed the data.
|
|
Metabolism and nutrition disorders
Hypophosphatemia
|
0.00%
0/37 • up to 30 days following the last dose of study drug.
Adverse events were categorized by treatment (initial vs. crossover treatment arms) rather than indication as this was how we analyzed the data.
|
2.6%
1/38 • Number of events 1 • up to 30 days following the last dose of study drug.
Adverse events were categorized by treatment (initial vs. crossover treatment arms) rather than indication as this was how we analyzed the data.
|
0.00%
0/29 • up to 30 days following the last dose of study drug.
Adverse events were categorized by treatment (initial vs. crossover treatment arms) rather than indication as this was how we analyzed the data.
|
9.5%
2/21 • Number of events 2 • up to 30 days following the last dose of study drug.
Adverse events were categorized by treatment (initial vs. crossover treatment arms) rather than indication as this was how we analyzed the data.
|
0.00%
0/18 • up to 30 days following the last dose of study drug.
Adverse events were categorized by treatment (initial vs. crossover treatment arms) rather than indication as this was how we analyzed the data.
|
0.00%
0/16 • up to 30 days following the last dose of study drug.
Adverse events were categorized by treatment (initial vs. crossover treatment arms) rather than indication as this was how we analyzed the data.
|
0.00%
0/2 • up to 30 days following the last dose of study drug.
Adverse events were categorized by treatment (initial vs. crossover treatment arms) rather than indication as this was how we analyzed the data.
|
0.00%
0/1 • up to 30 days following the last dose of study drug.
Adverse events were categorized by treatment (initial vs. crossover treatment arms) rather than indication as this was how we analyzed the data.
|
|
Infections and infestations
Pelvic infection
|
0.00%
0/37 • up to 30 days following the last dose of study drug.
Adverse events were categorized by treatment (initial vs. crossover treatment arms) rather than indication as this was how we analyzed the data.
|
2.6%
1/38 • Number of events 1 • up to 30 days following the last dose of study drug.
Adverse events were categorized by treatment (initial vs. crossover treatment arms) rather than indication as this was how we analyzed the data.
|
0.00%
0/29 • up to 30 days following the last dose of study drug.
Adverse events were categorized by treatment (initial vs. crossover treatment arms) rather than indication as this was how we analyzed the data.
|
0.00%
0/21 • up to 30 days following the last dose of study drug.
Adverse events were categorized by treatment (initial vs. crossover treatment arms) rather than indication as this was how we analyzed the data.
|
0.00%
0/18 • up to 30 days following the last dose of study drug.
Adverse events were categorized by treatment (initial vs. crossover treatment arms) rather than indication as this was how we analyzed the data.
|
0.00%
0/16 • up to 30 days following the last dose of study drug.
Adverse events were categorized by treatment (initial vs. crossover treatment arms) rather than indication as this was how we analyzed the data.
|
0.00%
0/2 • up to 30 days following the last dose of study drug.
Adverse events were categorized by treatment (initial vs. crossover treatment arms) rather than indication as this was how we analyzed the data.
|
0.00%
0/1 • up to 30 days following the last dose of study drug.
Adverse events were categorized by treatment (initial vs. crossover treatment arms) rather than indication as this was how we analyzed the data.
|
|
General disorders
Fatigue
|
10.8%
4/37 • Number of events 4 • up to 30 days following the last dose of study drug.
Adverse events were categorized by treatment (initial vs. crossover treatment arms) rather than indication as this was how we analyzed the data.
|
7.9%
3/38 • Number of events 3 • up to 30 days following the last dose of study drug.
Adverse events were categorized by treatment (initial vs. crossover treatment arms) rather than indication as this was how we analyzed the data.
|
17.2%
5/29 • Number of events 5 • up to 30 days following the last dose of study drug.
Adverse events were categorized by treatment (initial vs. crossover treatment arms) rather than indication as this was how we analyzed the data.
|
0.00%
0/21 • up to 30 days following the last dose of study drug.
Adverse events were categorized by treatment (initial vs. crossover treatment arms) rather than indication as this was how we analyzed the data.
|
11.1%
2/18 • Number of events 2 • up to 30 days following the last dose of study drug.
Adverse events were categorized by treatment (initial vs. crossover treatment arms) rather than indication as this was how we analyzed the data.
|
18.8%
3/16 • Number of events 3 • up to 30 days following the last dose of study drug.
Adverse events were categorized by treatment (initial vs. crossover treatment arms) rather than indication as this was how we analyzed the data.
|
0.00%
0/2 • up to 30 days following the last dose of study drug.
Adverse events were categorized by treatment (initial vs. crossover treatment arms) rather than indication as this was how we analyzed the data.
|
0.00%
0/1 • up to 30 days following the last dose of study drug.
Adverse events were categorized by treatment (initial vs. crossover treatment arms) rather than indication as this was how we analyzed the data.
|
|
Renal and urinary disorders
Hematuria
|
0.00%
0/37 • up to 30 days following the last dose of study drug.
Adverse events were categorized by treatment (initial vs. crossover treatment arms) rather than indication as this was how we analyzed the data.
|
2.6%
1/38 • Number of events 1 • up to 30 days following the last dose of study drug.
Adverse events were categorized by treatment (initial vs. crossover treatment arms) rather than indication as this was how we analyzed the data.
|
0.00%
0/29 • up to 30 days following the last dose of study drug.
Adverse events were categorized by treatment (initial vs. crossover treatment arms) rather than indication as this was how we analyzed the data.
|
0.00%
0/21 • up to 30 days following the last dose of study drug.
Adverse events were categorized by treatment (initial vs. crossover treatment arms) rather than indication as this was how we analyzed the data.
|
0.00%
0/18 • up to 30 days following the last dose of study drug.
Adverse events were categorized by treatment (initial vs. crossover treatment arms) rather than indication as this was how we analyzed the data.
|
0.00%
0/16 • up to 30 days following the last dose of study drug.
Adverse events were categorized by treatment (initial vs. crossover treatment arms) rather than indication as this was how we analyzed the data.
|
0.00%
0/2 • up to 30 days following the last dose of study drug.
Adverse events were categorized by treatment (initial vs. crossover treatment arms) rather than indication as this was how we analyzed the data.
|
0.00%
0/1 • up to 30 days following the last dose of study drug.
Adverse events were categorized by treatment (initial vs. crossover treatment arms) rather than indication as this was how we analyzed the data.
|
|
Vascular disorders
Hot flashes
|
0.00%
0/37 • up to 30 days following the last dose of study drug.
Adverse events were categorized by treatment (initial vs. crossover treatment arms) rather than indication as this was how we analyzed the data.
|
2.6%
1/38 • Number of events 1 • up to 30 days following the last dose of study drug.
Adverse events were categorized by treatment (initial vs. crossover treatment arms) rather than indication as this was how we analyzed the data.
|
0.00%
0/29 • up to 30 days following the last dose of study drug.
Adverse events were categorized by treatment (initial vs. crossover treatment arms) rather than indication as this was how we analyzed the data.
|
0.00%
0/21 • up to 30 days following the last dose of study drug.
Adverse events were categorized by treatment (initial vs. crossover treatment arms) rather than indication as this was how we analyzed the data.
|
0.00%
0/18 • up to 30 days following the last dose of study drug.
Adverse events were categorized by treatment (initial vs. crossover treatment arms) rather than indication as this was how we analyzed the data.
|
0.00%
0/16 • up to 30 days following the last dose of study drug.
Adverse events were categorized by treatment (initial vs. crossover treatment arms) rather than indication as this was how we analyzed the data.
|
0.00%
0/2 • up to 30 days following the last dose of study drug.
Adverse events were categorized by treatment (initial vs. crossover treatment arms) rather than indication as this was how we analyzed the data.
|
0.00%
0/1 • up to 30 days following the last dose of study drug.
Adverse events were categorized by treatment (initial vs. crossover treatment arms) rather than indication as this was how we analyzed the data.
|
|
Gastrointestinal disorders
Bloating
|
2.7%
1/37 • Number of events 1 • up to 30 days following the last dose of study drug.
Adverse events were categorized by treatment (initial vs. crossover treatment arms) rather than indication as this was how we analyzed the data.
|
0.00%
0/38 • up to 30 days following the last dose of study drug.
Adverse events were categorized by treatment (initial vs. crossover treatment arms) rather than indication as this was how we analyzed the data.
|
0.00%
0/29 • up to 30 days following the last dose of study drug.
Adverse events were categorized by treatment (initial vs. crossover treatment arms) rather than indication as this was how we analyzed the data.
|
0.00%
0/21 • up to 30 days following the last dose of study drug.
Adverse events were categorized by treatment (initial vs. crossover treatment arms) rather than indication as this was how we analyzed the data.
|
0.00%
0/18 • up to 30 days following the last dose of study drug.
Adverse events were categorized by treatment (initial vs. crossover treatment arms) rather than indication as this was how we analyzed the data.
|
0.00%
0/16 • up to 30 days following the last dose of study drug.
Adverse events were categorized by treatment (initial vs. crossover treatment arms) rather than indication as this was how we analyzed the data.
|
0.00%
0/2 • up to 30 days following the last dose of study drug.
Adverse events were categorized by treatment (initial vs. crossover treatment arms) rather than indication as this was how we analyzed the data.
|
0.00%
0/1 • up to 30 days following the last dose of study drug.
Adverse events were categorized by treatment (initial vs. crossover treatment arms) rather than indication as this was how we analyzed the data.
|
|
Gastrointestinal disorders
Vomiting
|
2.7%
1/37 • Number of events 1 • up to 30 days following the last dose of study drug.
Adverse events were categorized by treatment (initial vs. crossover treatment arms) rather than indication as this was how we analyzed the data.
|
0.00%
0/38 • up to 30 days following the last dose of study drug.
Adverse events were categorized by treatment (initial vs. crossover treatment arms) rather than indication as this was how we analyzed the data.
|
3.4%
1/29 • Number of events 1 • up to 30 days following the last dose of study drug.
Adverse events were categorized by treatment (initial vs. crossover treatment arms) rather than indication as this was how we analyzed the data.
|
0.00%
0/21 • up to 30 days following the last dose of study drug.
Adverse events were categorized by treatment (initial vs. crossover treatment arms) rather than indication as this was how we analyzed the data.
|
0.00%
0/18 • up to 30 days following the last dose of study drug.
Adverse events were categorized by treatment (initial vs. crossover treatment arms) rather than indication as this was how we analyzed the data.
|
6.2%
1/16 • Number of events 1 • up to 30 days following the last dose of study drug.
Adverse events were categorized by treatment (initial vs. crossover treatment arms) rather than indication as this was how we analyzed the data.
|
0.00%
0/2 • up to 30 days following the last dose of study drug.
Adverse events were categorized by treatment (initial vs. crossover treatment arms) rather than indication as this was how we analyzed the data.
|
0.00%
0/1 • up to 30 days following the last dose of study drug.
Adverse events were categorized by treatment (initial vs. crossover treatment arms) rather than indication as this was how we analyzed the data.
|
|
Metabolism and nutrition disorders
Hyperchloremia
|
2.7%
1/37 • Number of events 1 • up to 30 days following the last dose of study drug.
Adverse events were categorized by treatment (initial vs. crossover treatment arms) rather than indication as this was how we analyzed the data.
|
0.00%
0/38 • up to 30 days following the last dose of study drug.
Adverse events were categorized by treatment (initial vs. crossover treatment arms) rather than indication as this was how we analyzed the data.
|
0.00%
0/29 • up to 30 days following the last dose of study drug.
Adverse events were categorized by treatment (initial vs. crossover treatment arms) rather than indication as this was how we analyzed the data.
|
0.00%
0/21 • up to 30 days following the last dose of study drug.
Adverse events were categorized by treatment (initial vs. crossover treatment arms) rather than indication as this was how we analyzed the data.
|
0.00%
0/18 • up to 30 days following the last dose of study drug.
Adverse events were categorized by treatment (initial vs. crossover treatment arms) rather than indication as this was how we analyzed the data.
|
0.00%
0/16 • up to 30 days following the last dose of study drug.
Adverse events were categorized by treatment (initial vs. crossover treatment arms) rather than indication as this was how we analyzed the data.
|
0.00%
0/2 • up to 30 days following the last dose of study drug.
Adverse events were categorized by treatment (initial vs. crossover treatment arms) rather than indication as this was how we analyzed the data.
|
0.00%
0/1 • up to 30 days following the last dose of study drug.
Adverse events were categorized by treatment (initial vs. crossover treatment arms) rather than indication as this was how we analyzed the data.
|
|
Metabolism and nutrition disorders
Hyponatremia
|
0.00%
0/37 • up to 30 days following the last dose of study drug.
Adverse events were categorized by treatment (initial vs. crossover treatment arms) rather than indication as this was how we analyzed the data.
|
0.00%
0/38 • up to 30 days following the last dose of study drug.
Adverse events were categorized by treatment (initial vs. crossover treatment arms) rather than indication as this was how we analyzed the data.
|
0.00%
0/29 • up to 30 days following the last dose of study drug.
Adverse events were categorized by treatment (initial vs. crossover treatment arms) rather than indication as this was how we analyzed the data.
|
4.8%
1/21 • Number of events 1 • up to 30 days following the last dose of study drug.
Adverse events were categorized by treatment (initial vs. crossover treatment arms) rather than indication as this was how we analyzed the data.
|
0.00%
0/18 • up to 30 days following the last dose of study drug.
Adverse events were categorized by treatment (initial vs. crossover treatment arms) rather than indication as this was how we analyzed the data.
|
0.00%
0/16 • up to 30 days following the last dose of study drug.
Adverse events were categorized by treatment (initial vs. crossover treatment arms) rather than indication as this was how we analyzed the data.
|
0.00%
0/2 • up to 30 days following the last dose of study drug.
Adverse events were categorized by treatment (initial vs. crossover treatment arms) rather than indication as this was how we analyzed the data.
|
0.00%
0/1 • up to 30 days following the last dose of study drug.
Adverse events were categorized by treatment (initial vs. crossover treatment arms) rather than indication as this was how we analyzed the data.
|
|
Infections and infestations
Tooth infection
|
2.7%
1/37 • Number of events 1 • up to 30 days following the last dose of study drug.
Adverse events were categorized by treatment (initial vs. crossover treatment arms) rather than indication as this was how we analyzed the data.
|
0.00%
0/38 • up to 30 days following the last dose of study drug.
Adverse events were categorized by treatment (initial vs. crossover treatment arms) rather than indication as this was how we analyzed the data.
|
0.00%
0/29 • up to 30 days following the last dose of study drug.
Adverse events were categorized by treatment (initial vs. crossover treatment arms) rather than indication as this was how we analyzed the data.
|
0.00%
0/21 • up to 30 days following the last dose of study drug.
Adverse events were categorized by treatment (initial vs. crossover treatment arms) rather than indication as this was how we analyzed the data.
|
0.00%
0/18 • up to 30 days following the last dose of study drug.
Adverse events were categorized by treatment (initial vs. crossover treatment arms) rather than indication as this was how we analyzed the data.
|
0.00%
0/16 • up to 30 days following the last dose of study drug.
Adverse events were categorized by treatment (initial vs. crossover treatment arms) rather than indication as this was how we analyzed the data.
|
0.00%
0/2 • up to 30 days following the last dose of study drug.
Adverse events were categorized by treatment (initial vs. crossover treatment arms) rather than indication as this was how we analyzed the data.
|
0.00%
0/1 • up to 30 days following the last dose of study drug.
Adverse events were categorized by treatment (initial vs. crossover treatment arms) rather than indication as this was how we analyzed the data.
|
|
Metabolism and nutrition disorders
Hypoalbuminemia
|
2.7%
1/37 • Number of events 1 • up to 30 days following the last dose of study drug.
Adverse events were categorized by treatment (initial vs. crossover treatment arms) rather than indication as this was how we analyzed the data.
|
0.00%
0/38 • up to 30 days following the last dose of study drug.
Adverse events were categorized by treatment (initial vs. crossover treatment arms) rather than indication as this was how we analyzed the data.
|
0.00%
0/29 • up to 30 days following the last dose of study drug.
Adverse events were categorized by treatment (initial vs. crossover treatment arms) rather than indication as this was how we analyzed the data.
|
4.8%
1/21 • Number of events 1 • up to 30 days following the last dose of study drug.
Adverse events were categorized by treatment (initial vs. crossover treatment arms) rather than indication as this was how we analyzed the data.
|
0.00%
0/18 • up to 30 days following the last dose of study drug.
Adverse events were categorized by treatment (initial vs. crossover treatment arms) rather than indication as this was how we analyzed the data.
|
0.00%
0/16 • up to 30 days following the last dose of study drug.
Adverse events were categorized by treatment (initial vs. crossover treatment arms) rather than indication as this was how we analyzed the data.
|
0.00%
0/2 • up to 30 days following the last dose of study drug.
Adverse events were categorized by treatment (initial vs. crossover treatment arms) rather than indication as this was how we analyzed the data.
|
0.00%
0/1 • up to 30 days following the last dose of study drug.
Adverse events were categorized by treatment (initial vs. crossover treatment arms) rather than indication as this was how we analyzed the data.
|
|
Metabolism and nutrition disorders
ALT increased
|
0.00%
0/37 • up to 30 days following the last dose of study drug.
Adverse events were categorized by treatment (initial vs. crossover treatment arms) rather than indication as this was how we analyzed the data.
|
0.00%
0/38 • up to 30 days following the last dose of study drug.
Adverse events were categorized by treatment (initial vs. crossover treatment arms) rather than indication as this was how we analyzed the data.
|
3.4%
1/29 • Number of events 1 • up to 30 days following the last dose of study drug.
Adverse events were categorized by treatment (initial vs. crossover treatment arms) rather than indication as this was how we analyzed the data.
|
0.00%
0/21 • up to 30 days following the last dose of study drug.
Adverse events were categorized by treatment (initial vs. crossover treatment arms) rather than indication as this was how we analyzed the data.
|
0.00%
0/18 • up to 30 days following the last dose of study drug.
Adverse events were categorized by treatment (initial vs. crossover treatment arms) rather than indication as this was how we analyzed the data.
|
0.00%
0/16 • up to 30 days following the last dose of study drug.
Adverse events were categorized by treatment (initial vs. crossover treatment arms) rather than indication as this was how we analyzed the data.
|
0.00%
0/2 • up to 30 days following the last dose of study drug.
Adverse events were categorized by treatment (initial vs. crossover treatment arms) rather than indication as this was how we analyzed the data.
|
0.00%
0/1 • up to 30 days following the last dose of study drug.
Adverse events were categorized by treatment (initial vs. crossover treatment arms) rather than indication as this was how we analyzed the data.
|
|
Investigations
Lymphopenia
|
62.2%
23/37 • Number of events 62 • up to 30 days following the last dose of study drug.
Adverse events were categorized by treatment (initial vs. crossover treatment arms) rather than indication as this was how we analyzed the data.
|
42.1%
16/38 • Number of events 33 • up to 30 days following the last dose of study drug.
Adverse events were categorized by treatment (initial vs. crossover treatment arms) rather than indication as this was how we analyzed the data.
|
62.1%
18/29 • Number of events 36 • up to 30 days following the last dose of study drug.
Adverse events were categorized by treatment (initial vs. crossover treatment arms) rather than indication as this was how we analyzed the data.
|
42.9%
9/21 • Number of events 21 • up to 30 days following the last dose of study drug.
Adverse events were categorized by treatment (initial vs. crossover treatment arms) rather than indication as this was how we analyzed the data.
|
16.7%
3/18 • Number of events 3 • up to 30 days following the last dose of study drug.
Adverse events were categorized by treatment (initial vs. crossover treatment arms) rather than indication as this was how we analyzed the data.
|
18.8%
3/16 • Number of events 4 • up to 30 days following the last dose of study drug.
Adverse events were categorized by treatment (initial vs. crossover treatment arms) rather than indication as this was how we analyzed the data.
|
0.00%
0/2 • up to 30 days following the last dose of study drug.
Adverse events were categorized by treatment (initial vs. crossover treatment arms) rather than indication as this was how we analyzed the data.
|
0.00%
0/1 • up to 30 days following the last dose of study drug.
Adverse events were categorized by treatment (initial vs. crossover treatment arms) rather than indication as this was how we analyzed the data.
|
|
Infections and infestations
Urinary tract infection
|
0.00%
0/37 • up to 30 days following the last dose of study drug.
Adverse events were categorized by treatment (initial vs. crossover treatment arms) rather than indication as this was how we analyzed the data.
|
0.00%
0/38 • up to 30 days following the last dose of study drug.
Adverse events were categorized by treatment (initial vs. crossover treatment arms) rather than indication as this was how we analyzed the data.
|
3.4%
1/29 • Number of events 1 • up to 30 days following the last dose of study drug.
Adverse events were categorized by treatment (initial vs. crossover treatment arms) rather than indication as this was how we analyzed the data.
|
0.00%
0/21 • up to 30 days following the last dose of study drug.
Adverse events were categorized by treatment (initial vs. crossover treatment arms) rather than indication as this was how we analyzed the data.
|
0.00%
0/18 • up to 30 days following the last dose of study drug.
Adverse events were categorized by treatment (initial vs. crossover treatment arms) rather than indication as this was how we analyzed the data.
|
0.00%
0/16 • up to 30 days following the last dose of study drug.
Adverse events were categorized by treatment (initial vs. crossover treatment arms) rather than indication as this was how we analyzed the data.
|
0.00%
0/2 • up to 30 days following the last dose of study drug.
Adverse events were categorized by treatment (initial vs. crossover treatment arms) rather than indication as this was how we analyzed the data.
|
0.00%
0/1 • up to 30 days following the last dose of study drug.
Adverse events were categorized by treatment (initial vs. crossover treatment arms) rather than indication as this was how we analyzed the data.
|
|
Musculoskeletal and connective tissue disorders
Generalized muscle weakness
|
0.00%
0/37 • up to 30 days following the last dose of study drug.
Adverse events were categorized by treatment (initial vs. crossover treatment arms) rather than indication as this was how we analyzed the data.
|
0.00%
0/38 • up to 30 days following the last dose of study drug.
Adverse events were categorized by treatment (initial vs. crossover treatment arms) rather than indication as this was how we analyzed the data.
|
3.4%
1/29 • Number of events 1 • up to 30 days following the last dose of study drug.
Adverse events were categorized by treatment (initial vs. crossover treatment arms) rather than indication as this was how we analyzed the data.
|
0.00%
0/21 • up to 30 days following the last dose of study drug.
Adverse events were categorized by treatment (initial vs. crossover treatment arms) rather than indication as this was how we analyzed the data.
|
0.00%
0/18 • up to 30 days following the last dose of study drug.
Adverse events were categorized by treatment (initial vs. crossover treatment arms) rather than indication as this was how we analyzed the data.
|
0.00%
0/16 • up to 30 days following the last dose of study drug.
Adverse events were categorized by treatment (initial vs. crossover treatment arms) rather than indication as this was how we analyzed the data.
|
0.00%
0/2 • up to 30 days following the last dose of study drug.
Adverse events were categorized by treatment (initial vs. crossover treatment arms) rather than indication as this was how we analyzed the data.
|
0.00%
0/1 • up to 30 days following the last dose of study drug.
Adverse events were categorized by treatment (initial vs. crossover treatment arms) rather than indication as this was how we analyzed the data.
|
|
Psychiatric disorders
Psychiatric disorders, other (tearfulness)
|
0.00%
0/37 • up to 30 days following the last dose of study drug.
Adverse events were categorized by treatment (initial vs. crossover treatment arms) rather than indication as this was how we analyzed the data.
|
0.00%
0/38 • up to 30 days following the last dose of study drug.
Adverse events were categorized by treatment (initial vs. crossover treatment arms) rather than indication as this was how we analyzed the data.
|
3.4%
1/29 • Number of events 1 • up to 30 days following the last dose of study drug.
Adverse events were categorized by treatment (initial vs. crossover treatment arms) rather than indication as this was how we analyzed the data.
|
0.00%
0/21 • up to 30 days following the last dose of study drug.
Adverse events were categorized by treatment (initial vs. crossover treatment arms) rather than indication as this was how we analyzed the data.
|
0.00%
0/18 • up to 30 days following the last dose of study drug.
Adverse events were categorized by treatment (initial vs. crossover treatment arms) rather than indication as this was how we analyzed the data.
|
0.00%
0/16 • up to 30 days following the last dose of study drug.
Adverse events were categorized by treatment (initial vs. crossover treatment arms) rather than indication as this was how we analyzed the data.
|
0.00%
0/2 • up to 30 days following the last dose of study drug.
Adverse events were categorized by treatment (initial vs. crossover treatment arms) rather than indication as this was how we analyzed the data.
|
0.00%
0/1 • up to 30 days following the last dose of study drug.
Adverse events were categorized by treatment (initial vs. crossover treatment arms) rather than indication as this was how we analyzed the data.
|
|
Investigations
AST increased
|
0.00%
0/37 • up to 30 days following the last dose of study drug.
Adverse events were categorized by treatment (initial vs. crossover treatment arms) rather than indication as this was how we analyzed the data.
|
0.00%
0/38 • up to 30 days following the last dose of study drug.
Adverse events were categorized by treatment (initial vs. crossover treatment arms) rather than indication as this was how we analyzed the data.
|
0.00%
0/29 • up to 30 days following the last dose of study drug.
Adverse events were categorized by treatment (initial vs. crossover treatment arms) rather than indication as this was how we analyzed the data.
|
4.8%
1/21 • Number of events 1 • up to 30 days following the last dose of study drug.
Adverse events were categorized by treatment (initial vs. crossover treatment arms) rather than indication as this was how we analyzed the data.
|
0.00%
0/18 • up to 30 days following the last dose of study drug.
Adverse events were categorized by treatment (initial vs. crossover treatment arms) rather than indication as this was how we analyzed the data.
|
0.00%
0/16 • up to 30 days following the last dose of study drug.
Adverse events were categorized by treatment (initial vs. crossover treatment arms) rather than indication as this was how we analyzed the data.
|
0.00%
0/2 • up to 30 days following the last dose of study drug.
Adverse events were categorized by treatment (initial vs. crossover treatment arms) rather than indication as this was how we analyzed the data.
|
0.00%
0/1 • up to 30 days following the last dose of study drug.
Adverse events were categorized by treatment (initial vs. crossover treatment arms) rather than indication as this was how we analyzed the data.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
0.00%
0/37 • up to 30 days following the last dose of study drug.
Adverse events were categorized by treatment (initial vs. crossover treatment arms) rather than indication as this was how we analyzed the data.
|
0.00%
0/38 • up to 30 days following the last dose of study drug.
Adverse events were categorized by treatment (initial vs. crossover treatment arms) rather than indication as this was how we analyzed the data.
|
0.00%
0/29 • up to 30 days following the last dose of study drug.
Adverse events were categorized by treatment (initial vs. crossover treatment arms) rather than indication as this was how we analyzed the data.
|
4.8%
1/21 • Number of events 1 • up to 30 days following the last dose of study drug.
Adverse events were categorized by treatment (initial vs. crossover treatment arms) rather than indication as this was how we analyzed the data.
|
0.00%
0/18 • up to 30 days following the last dose of study drug.
Adverse events were categorized by treatment (initial vs. crossover treatment arms) rather than indication as this was how we analyzed the data.
|
0.00%
0/16 • up to 30 days following the last dose of study drug.
Adverse events were categorized by treatment (initial vs. crossover treatment arms) rather than indication as this was how we analyzed the data.
|
0.00%
0/2 • up to 30 days following the last dose of study drug.
Adverse events were categorized by treatment (initial vs. crossover treatment arms) rather than indication as this was how we analyzed the data.
|
0.00%
0/1 • up to 30 days following the last dose of study drug.
Adverse events were categorized by treatment (initial vs. crossover treatment arms) rather than indication as this was how we analyzed the data.
|
|
Metabolism and nutrition disorders
Hyperglycemia
|
0.00%
0/37 • up to 30 days following the last dose of study drug.
Adverse events were categorized by treatment (initial vs. crossover treatment arms) rather than indication as this was how we analyzed the data.
|
0.00%
0/38 • up to 30 days following the last dose of study drug.
Adverse events were categorized by treatment (initial vs. crossover treatment arms) rather than indication as this was how we analyzed the data.
|
0.00%
0/29 • up to 30 days following the last dose of study drug.
Adverse events were categorized by treatment (initial vs. crossover treatment arms) rather than indication as this was how we analyzed the data.
|
9.5%
2/21 • Number of events 2 • up to 30 days following the last dose of study drug.
Adverse events were categorized by treatment (initial vs. crossover treatment arms) rather than indication as this was how we analyzed the data.
|
0.00%
0/18 • up to 30 days following the last dose of study drug.
Adverse events were categorized by treatment (initial vs. crossover treatment arms) rather than indication as this was how we analyzed the data.
|
0.00%
0/16 • up to 30 days following the last dose of study drug.
Adverse events were categorized by treatment (initial vs. crossover treatment arms) rather than indication as this was how we analyzed the data.
|
0.00%
0/2 • up to 30 days following the last dose of study drug.
Adverse events were categorized by treatment (initial vs. crossover treatment arms) rather than indication as this was how we analyzed the data.
|
0.00%
0/1 • up to 30 days following the last dose of study drug.
Adverse events were categorized by treatment (initial vs. crossover treatment arms) rather than indication as this was how we analyzed the data.
|
|
Investigations
PTT prolonged
|
0.00%
0/37 • up to 30 days following the last dose of study drug.
Adverse events were categorized by treatment (initial vs. crossover treatment arms) rather than indication as this was how we analyzed the data.
|
0.00%
0/38 • up to 30 days following the last dose of study drug.
Adverse events were categorized by treatment (initial vs. crossover treatment arms) rather than indication as this was how we analyzed the data.
|
0.00%
0/29 • up to 30 days following the last dose of study drug.
Adverse events were categorized by treatment (initial vs. crossover treatment arms) rather than indication as this was how we analyzed the data.
|
4.8%
1/21 • Number of events 1 • up to 30 days following the last dose of study drug.
Adverse events were categorized by treatment (initial vs. crossover treatment arms) rather than indication as this was how we analyzed the data.
|
0.00%
0/18 • up to 30 days following the last dose of study drug.
Adverse events were categorized by treatment (initial vs. crossover treatment arms) rather than indication as this was how we analyzed the data.
|
0.00%
0/16 • up to 30 days following the last dose of study drug.
Adverse events were categorized by treatment (initial vs. crossover treatment arms) rather than indication as this was how we analyzed the data.
|
0.00%
0/2 • up to 30 days following the last dose of study drug.
Adverse events were categorized by treatment (initial vs. crossover treatment arms) rather than indication as this was how we analyzed the data.
|
0.00%
0/1 • up to 30 days following the last dose of study drug.
Adverse events were categorized by treatment (initial vs. crossover treatment arms) rather than indication as this was how we analyzed the data.
|
|
Cardiac disorders
Sinus tachycardia
|
0.00%
0/37 • up to 30 days following the last dose of study drug.
Adverse events were categorized by treatment (initial vs. crossover treatment arms) rather than indication as this was how we analyzed the data.
|
0.00%
0/38 • up to 30 days following the last dose of study drug.
Adverse events were categorized by treatment (initial vs. crossover treatment arms) rather than indication as this was how we analyzed the data.
|
0.00%
0/29 • up to 30 days following the last dose of study drug.
Adverse events were categorized by treatment (initial vs. crossover treatment arms) rather than indication as this was how we analyzed the data.
|
4.8%
1/21 • Number of events 1 • up to 30 days following the last dose of study drug.
Adverse events were categorized by treatment (initial vs. crossover treatment arms) rather than indication as this was how we analyzed the data.
|
0.00%
0/18 • up to 30 days following the last dose of study drug.
Adverse events were categorized by treatment (initial vs. crossover treatment arms) rather than indication as this was how we analyzed the data.
|
0.00%
0/16 • up to 30 days following the last dose of study drug.
Adverse events were categorized by treatment (initial vs. crossover treatment arms) rather than indication as this was how we analyzed the data.
|
0.00%
0/2 • up to 30 days following the last dose of study drug.
Adverse events were categorized by treatment (initial vs. crossover treatment arms) rather than indication as this was how we analyzed the data.
|
0.00%
0/1 • up to 30 days following the last dose of study drug.
Adverse events were categorized by treatment (initial vs. crossover treatment arms) rather than indication as this was how we analyzed the data.
|
|
Vascular disorders
Thromboembolic event
|
0.00%
0/37 • up to 30 days following the last dose of study drug.
Adverse events were categorized by treatment (initial vs. crossover treatment arms) rather than indication as this was how we analyzed the data.
|
0.00%
0/38 • up to 30 days following the last dose of study drug.
Adverse events were categorized by treatment (initial vs. crossover treatment arms) rather than indication as this was how we analyzed the data.
|
0.00%
0/29 • up to 30 days following the last dose of study drug.
Adverse events were categorized by treatment (initial vs. crossover treatment arms) rather than indication as this was how we analyzed the data.
|
4.8%
1/21 • Number of events 1 • up to 30 days following the last dose of study drug.
Adverse events were categorized by treatment (initial vs. crossover treatment arms) rather than indication as this was how we analyzed the data.
|
0.00%
0/18 • up to 30 days following the last dose of study drug.
Adverse events were categorized by treatment (initial vs. crossover treatment arms) rather than indication as this was how we analyzed the data.
|
0.00%
0/16 • up to 30 days following the last dose of study drug.
Adverse events were categorized by treatment (initial vs. crossover treatment arms) rather than indication as this was how we analyzed the data.
|
0.00%
0/2 • up to 30 days following the last dose of study drug.
Adverse events were categorized by treatment (initial vs. crossover treatment arms) rather than indication as this was how we analyzed the data.
|
0.00%
0/1 • up to 30 days following the last dose of study drug.
Adverse events were categorized by treatment (initial vs. crossover treatment arms) rather than indication as this was how we analyzed the data.
|
|
Cardiac disorders
Heart failure
|
0.00%
0/37 • up to 30 days following the last dose of study drug.
Adverse events were categorized by treatment (initial vs. crossover treatment arms) rather than indication as this was how we analyzed the data.
|
0.00%
0/38 • up to 30 days following the last dose of study drug.
Adverse events were categorized by treatment (initial vs. crossover treatment arms) rather than indication as this was how we analyzed the data.
|
0.00%
0/29 • up to 30 days following the last dose of study drug.
Adverse events were categorized by treatment (initial vs. crossover treatment arms) rather than indication as this was how we analyzed the data.
|
0.00%
0/21 • up to 30 days following the last dose of study drug.
Adverse events were categorized by treatment (initial vs. crossover treatment arms) rather than indication as this was how we analyzed the data.
|
0.00%
0/18 • up to 30 days following the last dose of study drug.
Adverse events were categorized by treatment (initial vs. crossover treatment arms) rather than indication as this was how we analyzed the data.
|
0.00%
0/16 • up to 30 days following the last dose of study drug.
Adverse events were categorized by treatment (initial vs. crossover treatment arms) rather than indication as this was how we analyzed the data.
|
0.00%
0/2 • up to 30 days following the last dose of study drug.
Adverse events were categorized by treatment (initial vs. crossover treatment arms) rather than indication as this was how we analyzed the data.
|
0.00%
0/1 • up to 30 days following the last dose of study drug.
Adverse events were categorized by treatment (initial vs. crossover treatment arms) rather than indication as this was how we analyzed the data.
|
|
Gastrointestinal disorders
Weight loss
|
0.00%
0/37 • up to 30 days following the last dose of study drug.
Adverse events were categorized by treatment (initial vs. crossover treatment arms) rather than indication as this was how we analyzed the data.
|
0.00%
0/38 • up to 30 days following the last dose of study drug.
Adverse events were categorized by treatment (initial vs. crossover treatment arms) rather than indication as this was how we analyzed the data.
|
0.00%
0/29 • up to 30 days following the last dose of study drug.
Adverse events were categorized by treatment (initial vs. crossover treatment arms) rather than indication as this was how we analyzed the data.
|
0.00%
0/21 • up to 30 days following the last dose of study drug.
Adverse events were categorized by treatment (initial vs. crossover treatment arms) rather than indication as this was how we analyzed the data.
|
0.00%
0/18 • up to 30 days following the last dose of study drug.
Adverse events were categorized by treatment (initial vs. crossover treatment arms) rather than indication as this was how we analyzed the data.
|
6.2%
1/16 • Number of events 2 • up to 30 days following the last dose of study drug.
Adverse events were categorized by treatment (initial vs. crossover treatment arms) rather than indication as this was how we analyzed the data.
|
0.00%
0/2 • up to 30 days following the last dose of study drug.
Adverse events were categorized by treatment (initial vs. crossover treatment arms) rather than indication as this was how we analyzed the data.
|
0.00%
0/1 • up to 30 days following the last dose of study drug.
Adverse events were categorized by treatment (initial vs. crossover treatment arms) rather than indication as this was how we analyzed the data.
|
|
Investigations
ALP increased
|
0.00%
0/37 • up to 30 days following the last dose of study drug.
Adverse events were categorized by treatment (initial vs. crossover treatment arms) rather than indication as this was how we analyzed the data.
|
0.00%
0/38 • up to 30 days following the last dose of study drug.
Adverse events were categorized by treatment (initial vs. crossover treatment arms) rather than indication as this was how we analyzed the data.
|
0.00%
0/29 • up to 30 days following the last dose of study drug.
Adverse events were categorized by treatment (initial vs. crossover treatment arms) rather than indication as this was how we analyzed the data.
|
4.8%
1/21 • Number of events 1 • up to 30 days following the last dose of study drug.
Adverse events were categorized by treatment (initial vs. crossover treatment arms) rather than indication as this was how we analyzed the data.
|
0.00%
0/18 • up to 30 days following the last dose of study drug.
Adverse events were categorized by treatment (initial vs. crossover treatment arms) rather than indication as this was how we analyzed the data.
|
0.00%
0/16 • up to 30 days following the last dose of study drug.
Adverse events were categorized by treatment (initial vs. crossover treatment arms) rather than indication as this was how we analyzed the data.
|
0.00%
0/2 • up to 30 days following the last dose of study drug.
Adverse events were categorized by treatment (initial vs. crossover treatment arms) rather than indication as this was how we analyzed the data.
|
0.00%
0/1 • up to 30 days following the last dose of study drug.
Adverse events were categorized by treatment (initial vs. crossover treatment arms) rather than indication as this was how we analyzed the data.
|
|
Investigations
Thrombocytopenia
|
8.1%
3/37 • Number of events 5 • up to 30 days following the last dose of study drug.
Adverse events were categorized by treatment (initial vs. crossover treatment arms) rather than indication as this was how we analyzed the data.
|
0.00%
0/38 • up to 30 days following the last dose of study drug.
Adverse events were categorized by treatment (initial vs. crossover treatment arms) rather than indication as this was how we analyzed the data.
|
6.9%
2/29 • Number of events 2 • up to 30 days following the last dose of study drug.
Adverse events were categorized by treatment (initial vs. crossover treatment arms) rather than indication as this was how we analyzed the data.
|
0.00%
0/21 • up to 30 days following the last dose of study drug.
Adverse events were categorized by treatment (initial vs. crossover treatment arms) rather than indication as this was how we analyzed the data.
|
0.00%
0/18 • up to 30 days following the last dose of study drug.
Adverse events were categorized by treatment (initial vs. crossover treatment arms) rather than indication as this was how we analyzed the data.
|
0.00%
0/16 • up to 30 days following the last dose of study drug.
Adverse events were categorized by treatment (initial vs. crossover treatment arms) rather than indication as this was how we analyzed the data.
|
0.00%
0/2 • up to 30 days following the last dose of study drug.
Adverse events were categorized by treatment (initial vs. crossover treatment arms) rather than indication as this was how we analyzed the data.
|
0.00%
0/1 • up to 30 days following the last dose of study drug.
Adverse events were categorized by treatment (initial vs. crossover treatment arms) rather than indication as this was how we analyzed the data.
|
|
Gastrointestinal disorders
Diarrhea
|
2.7%
1/37 • Number of events 2 • up to 30 days following the last dose of study drug.
Adverse events were categorized by treatment (initial vs. crossover treatment arms) rather than indication as this was how we analyzed the data.
|
0.00%
0/38 • up to 30 days following the last dose of study drug.
Adverse events were categorized by treatment (initial vs. crossover treatment arms) rather than indication as this was how we analyzed the data.
|
0.00%
0/29 • up to 30 days following the last dose of study drug.
Adverse events were categorized by treatment (initial vs. crossover treatment arms) rather than indication as this was how we analyzed the data.
|
0.00%
0/21 • up to 30 days following the last dose of study drug.
Adverse events were categorized by treatment (initial vs. crossover treatment arms) rather than indication as this was how we analyzed the data.
|
0.00%
0/18 • up to 30 days following the last dose of study drug.
Adverse events were categorized by treatment (initial vs. crossover treatment arms) rather than indication as this was how we analyzed the data.
|
0.00%
0/16 • up to 30 days following the last dose of study drug.
Adverse events were categorized by treatment (initial vs. crossover treatment arms) rather than indication as this was how we analyzed the data.
|
0.00%
0/2 • up to 30 days following the last dose of study drug.
Adverse events were categorized by treatment (initial vs. crossover treatment arms) rather than indication as this was how we analyzed the data.
|
0.00%
0/1 • up to 30 days following the last dose of study drug.
Adverse events were categorized by treatment (initial vs. crossover treatment arms) rather than indication as this was how we analyzed the data.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place