Trial Outcomes & Findings for Trial of Mesna to Prevent Doxorubicin-induced Plasma Protein Oxidation and Tumor Necrosis Factor Alpha (TNF-α) Release (NCT NCT01205503)
NCT ID: NCT01205503
Last Updated: 2016-02-24
Results Overview
Continuous Measure of TNF-alpha at the 4 time points outlined in the protocol for each group.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
32 participants
Primary outcome timeframe
prior to and 3 hours post doxorubicin and between cycles 1 and 2
Results posted on
2016-02-24
Participant Flow
Patients were recruited at the University of Kentucky Markey Cancer Center in Lexington, Kentucky, USA between October 2010 and May 2012.
Participant milestones
| Measure |
Cycle 1 Saline; Cycle 2 Mesna
Saline infused over 15 minutes administered prior to and 3 hours post doxorubicin infusion (over 15 minutes) during 1st cycle, then Mesna administered (infused over 15 minutes, 360 mg/m2) prior to and 3 hours post doxorubicin infusion during 2nd cycle
Mesna: Mesna: 360 mg/m2 in 50 mL normal saline (NS) on cycle 2, day 1. Infused over 15 minutes
|
Cycle 1 Mesna; Cycle 2 Saline
Mesna administered (infused over 15 minutes, 360 mg/m2) prior to and 3 hours post doxorubicin infusion during 1st cycle, then Saline administered prior to and 3 hours post doxorubicin infusion (over 15 minutes) during 2nd cycle
Mesna: Mesna: 360 mg/m2 in 50 mL normal saline (NS) on cycle 1, day 1. Infused over 15 minutes
|
|---|---|---|
|
First Intervention (1st Cycle)
STARTED
|
16
|
16
|
|
First Intervention (1st Cycle)
COMPLETED
|
16
|
16
|
|
First Intervention (1st Cycle)
NOT COMPLETED
|
0
|
0
|
|
Second Intervention (2nd Cycle)
STARTED
|
16
|
16
|
|
Second Intervention (2nd Cycle)
COMPLETED
|
16
|
16
|
|
Second Intervention (2nd Cycle)
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Trial of Mesna to Prevent Doxorubicin-induced Plasma Protein Oxidation and Tumor Necrosis Factor Alpha (TNF-α) Release
Baseline characteristics by cohort
| Measure |
Cycle 1 Saline; Cycle 2 Mesna
n=16 Participants
Saline infused over 15 minutes administered prior to and 3 hours post doxorubicin infusion (over 15 minutes) during 1st cycle, then Mesna administered (infused over 15 minutes, 360 mg/m2) prior to and 3 hours post doxorubicin infusion during 2nd cycle
Mesna: Mesna: 360 mg/m2 in 50 mL normal saline (NS) on cycle 2, day 1. Infused over 15 minutes
|
Cycle 1 Mesna; Cycle 2 Saline
n=16 Participants
Mesna administered (infused over 15 minutes, 360 mg/m2) prior to and 3 hours post doxorubicin infusion during 1st cycle, then Saline administered prior to and 3 hours post doxorubicin infusion (over 15 minutes) during 2nd cycle
Mesna: Mesna: 360 mg/m2 in 50 mL normal saline (NS) on cycle 1, day 1. Infused over 15 minutes
|
Total
n=32 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
57.81 years
STANDARD_DEVIATION 11.70 • n=99 Participants
|
51.75 years
STANDARD_DEVIATION 15.51 • n=107 Participants
|
54.78 years
STANDARD_DEVIATION 1.97 • n=206 Participants
|
|
Sex: Female, Male
Female
|
12 Participants
n=99 Participants
|
7 Participants
n=107 Participants
|
19 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
4 Participants
n=99 Participants
|
9 Participants
n=107 Participants
|
13 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
16 Participants
n=99 Participants
|
16 Participants
n=107 Participants
|
32 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Black or African American
|
2 Participants
n=99 Participants
|
3 Participants
n=107 Participants
|
5 Participants
n=206 Participants
|
|
Race (NIH/OMB)
White
|
14 Participants
n=99 Participants
|
13 Participants
n=107 Participants
|
27 Participants
n=206 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Region of Enrollment
United States
|
16 participants
n=99 Participants
|
16 participants
n=107 Participants
|
32 participants
n=206 Participants
|
|
Treatment Type
Doxorubicin and cyclophosphamide (AC)
|
6 participants
n=99 Participants
|
5 participants
n=107 Participants
|
11 participants
n=206 Participants
|
|
Treatment Type
AC, vincristine, and prednisone (CHOP)
|
9 participants
n=99 Participants
|
10 participants
n=107 Participants
|
19 participants
n=206 Participants
|
|
Treatment Type
Doxorubicin, cyclophosphamide and docetaxel (TAC)
|
1 participants
n=99 Participants
|
1 participants
n=107 Participants
|
2 participants
n=206 Participants
|
|
Eastern Cooperative Oncology Group (ECOG) Performance Status
0- Fully Active
|
10 participants
n=99 Participants
|
8 participants
n=107 Participants
|
18 participants
n=206 Participants
|
|
Eastern Cooperative Oncology Group (ECOG) Performance Status
1- Restricted
|
6 participants
n=99 Participants
|
8 participants
n=107 Participants
|
14 participants
n=206 Participants
|
|
Cancer Diagnosis
Breast
|
7 participants
n=99 Participants
|
6 participants
n=107 Participants
|
13 participants
n=206 Participants
|
|
Cancer Diagnosis
Lymphoma
|
9 participants
n=99 Participants
|
10 participants
n=107 Participants
|
19 participants
n=206 Participants
|
|
Body Surface Area (BSA)
|
2.01 m^2
STANDARD_DEVIATION 0.23 • n=99 Participants
|
1.93 m^2
STANDARD_DEVIATION 0.26 • n=107 Participants
|
1.97 m^2
STANDARD_DEVIATION 0.25 • n=206 Participants
|
|
log TNF Alpha
|
1.27 log(pg/ml)
STANDARD_DEVIATION 1.11 • n=99 Participants
|
1.30 log(pg/ml)
STANDARD_DEVIATION 1.16 • n=107 Participants
|
1.28 log(pg/ml)
STANDARD_DEVIATION 1.12 • n=206 Participants
|
|
log TNF receptor 1
|
7.29 log(pg/ml)
STANDARD_DEVIATION 0.44 • n=99 Participants
|
7.04 log(pg/ml)
STANDARD_DEVIATION 0.46 • n=107 Participants
|
7.17 log(pg/ml)
STANDARD_DEVIATION 0.46 • n=206 Participants
|
|
Log interleukin (IL)-18
|
6.06 log(pg/ml)
STANDARD_DEVIATION 0.93 • n=99 Participants
|
6.16 log(pg/ml)
STANDARD_DEVIATION 0.76 • n=107 Participants
|
6.11 log(pg/ml)
STANDARD_DEVIATION 0.84 • n=206 Participants
|
|
Log Protein Carbonyl (PC)
|
4.39 log(nmol/mg protein)
STANDARD_DEVIATION 0.34 • n=99 Participants
|
4.33 log(nmol/mg protein)
STANDARD_DEVIATION 0.38 • n=107 Participants
|
4.36 log(nmol/mg protein)
STANDARD_DEVIATION 0.36 • n=206 Participants
|
|
Log Plasma 4-hydroxynonenal (HNE)
|
-0.31 log(pmol/mg)
STANDARD_DEVIATION 0.22 • n=99 Participants
|
-0.28 log(pmol/mg)
STANDARD_DEVIATION 0.20 • n=107 Participants
|
-0.29 log(pmol/mg)
STANDARD_DEVIATION 0.21 • n=206 Participants
|
|
Log 3-nitrotyrosine (3NT)
|
-0.11 log(ng/mg protein)
STANDARD_DEVIATION 0.26 • n=99 Participants
|
-0.05 log(ng/mg protein)
STANDARD_DEVIATION 0.16 • n=107 Participants
|
-0.08 log(ng/mg protein)
STANDARD_DEVIATION 0.21 • n=206 Participants
|
|
Log TNF Receptor 2
|
8.31 log(pg/ml)
STANDARD_DEVIATION 0.68 • n=99 Participants
|
8.15 log(pg/ml)
STANDARD_DEVIATION 0.74 • n=107 Participants
|
8.23 log(pg/ml)
STANDARD_DEVIATION 0.71 • n=206 Participants
|
PRIMARY outcome
Timeframe: prior to and 3 hours post doxorubicin and between cycles 1 and 2Continuous Measure of TNF-alpha at the 4 time points outlined in the protocol for each group.
Outcome measures
| Measure |
Cycle 1 Saline; Cycle 2 Mesna
n=16 Participants
Saline infused over 15 minutes administered prior to and 3 hours post doxorubicin infusion (over 15 minutes) during 1st cycle, then Mesna administered (infused over 15 minutes, 360 mg/m2) prior to and 3 hours post doxorubicin infusion during 2nd cycle
Mesna: Mesna: 360 mg/m2 in 50 mL normal saline (NS) either on cycle 2 or cycle 1, day 1. Infused over 15 minutes
Saline: Saline (used as a placebo) infused over the same time as mesna intervention
|
Cycle 1 Mesna; Cycle 2 Saline
n=16 Participants
Mesna administered (infused over 15 minutes, 360 mg/m2) prior to and 3 hours post doxorubicin infusion during 1st cycle, then Saline administered prior to and 3 hours post doxorubicin infusion (over 15 minutes) during 2nd cycle
Mesna: Mesna: 360 mg/m2 in 50 mL normal saline (NS) either on cycle 2 or cycle 1, day 1. Infused over 15 minutes
Saline: Saline (used as a placebo) infused over the same time as mesna intervention
|
|---|---|---|
|
TNF-alpha Levels in Patients Receiving Doxorubicin Containing Chemotherapy
Cycle 1 Pre
|
3.55 log(pg/ml)
Interval 1.96 to 6.42
|
3.68 log(pg/ml)
Interval 1.98 to 6.81
|
|
TNF-alpha Levels in Patients Receiving Doxorubicin Containing Chemotherapy
Cycle 1 Post
|
2.95 log(pg/ml)
Interval 1.54 to 5.64
|
3.18 log(pg/ml)
Interval 1.79 to 5.64
|
|
TNF-alpha Levels in Patients Receiving Doxorubicin Containing Chemotherapy
Cycle 2 Pre
|
2.26 log(pg/ml)
Interval 1.37 to 3.73
|
1.67 log(pg/ml)
Interval 1.35 to 2.07
|
|
TNF-alpha Levels in Patients Receiving Doxorubicin Containing Chemotherapy
Cycle 2 Post
|
1.78 log(pg/ml)
Interval 1.05 to 3.03
|
1.29 log(pg/ml)
Interval 1.01 to 1.65
|
SECONDARY outcome
Timeframe: prior to and 3 hours post doxorubicin and between cycles 1 and 2Continuous Measure of percent changes from baseline of Protein Carbonyl at the 4 time points outlined in the protocol for each group. All measurements after naive baseline were adjusted as percent change from each individual's baseline measure.
Outcome measures
| Measure |
Cycle 1 Saline; Cycle 2 Mesna
n=16 Participants
Saline infused over 15 minutes administered prior to and 3 hours post doxorubicin infusion (over 15 minutes) during 1st cycle, then Mesna administered (infused over 15 minutes, 360 mg/m2) prior to and 3 hours post doxorubicin infusion during 2nd cycle
Mesna: Mesna: 360 mg/m2 in 50 mL normal saline (NS) either on cycle 2 or cycle 1, day 1. Infused over 15 minutes
Saline: Saline (used as a placebo) infused over the same time as mesna intervention
|
Cycle 1 Mesna; Cycle 2 Saline
n=16 Participants
Mesna administered (infused over 15 minutes, 360 mg/m2) prior to and 3 hours post doxorubicin infusion during 1st cycle, then Saline administered prior to and 3 hours post doxorubicin infusion (over 15 minutes) during 2nd cycle
Mesna: Mesna: 360 mg/m2 in 50 mL normal saline (NS) either on cycle 2 or cycle 1, day 1. Infused over 15 minutes
Saline: Saline (used as a placebo) infused over the same time as mesna intervention
|
|---|---|---|
|
Protein Carbonyl Percent Changes From Baseline in Patients Receiving Doxorubicin Containing Chemotherapy
Cycle 2 Post
|
87.91 Percent Change from Baseline
Interval 62.7 to 96.99
|
75.71 Percent Change from Baseline
Interval 49.81 to 115.08
|
|
Protein Carbonyl Percent Changes From Baseline in Patients Receiving Doxorubicin Containing Chemotherapy
Cycle 1 Post
|
108.82 Percent Change from Baseline
Interval 88.2 to 134.26
|
73.54 Percent Change from Baseline
Interval 48.09 to 112.42
|
|
Protein Carbonyl Percent Changes From Baseline in Patients Receiving Doxorubicin Containing Chemotherapy
Cycle 2 Pre
|
100.52 Percent Change from Baseline
Interval 79.52 to 127.07
|
97.00 Percent Change from Baseline
Interval 79.32 to 118.61
|
SECONDARY outcome
Timeframe: prior to and 3 hours post doxorubicin and between cycles 1 and 2Continuous Measure of the percent change from baseline of Plasma HNE at the 4 time points outlined in the protocol for each group. All measurements after naive baseline were adjusted as percent change from each individual's baseline measure.
Outcome measures
| Measure |
Cycle 1 Saline; Cycle 2 Mesna
n=16 Participants
Saline infused over 15 minutes administered prior to and 3 hours post doxorubicin infusion (over 15 minutes) during 1st cycle, then Mesna administered (infused over 15 minutes, 360 mg/m2) prior to and 3 hours post doxorubicin infusion during 2nd cycle
Mesna: Mesna: 360 mg/m2 in 50 mL normal saline (NS) either on cycle 2 or cycle 1, day 1. Infused over 15 minutes
Saline: Saline (used as a placebo) infused over the same time as mesna intervention
|
Cycle 1 Mesna; Cycle 2 Saline
n=16 Participants
Mesna administered (infused over 15 minutes, 360 mg/m2) prior to and 3 hours post doxorubicin infusion during 1st cycle, then Saline administered prior to and 3 hours post doxorubicin infusion (over 15 minutes) during 2nd cycle
Mesna: Mesna: 360 mg/m2 in 50 mL normal saline (NS) either on cycle 2 or cycle 1, day 1. Infused over 15 minutes
Saline: Saline (used as a placebo) infused over the same time as mesna intervention
|
|---|---|---|
|
Plasma HNE Percent Changes From Baseline in Patients Receiving Doxorubicin Containing Chemotherapy
Cycle 1 Post
|
98.95 Percent Change from Baseline
Interval 89.06 to 109.94
|
102.63 Percent Change from Baseline
Interval 94.74 to 111.17
|
|
Plasma HNE Percent Changes From Baseline in Patients Receiving Doxorubicin Containing Chemotherapy
Cycle 2 Pre
|
100.52 Percent Change from Baseline
Interval 79.52 to 127.07
|
97.00 Percent Change from Baseline
Interval 79.32 to 118.61
|
|
Plasma HNE Percent Changes From Baseline in Patients Receiving Doxorubicin Containing Chemotherapy
Cycle 2 Post
|
87.91 Percent Change from Baseline
Interval 62.7 to 123.26
|
75.71 Percent Change from Baseline
Interval 49.81 to 115.08
|
SECONDARY outcome
Timeframe: prior to and 3 hours post doxorubicin and between cycles 1 and 2Continuous Measure of troponin at the 4 time points outlined in the protocol for each group.
Outcome measures
| Measure |
Cycle 1 Saline; Cycle 2 Mesna
n=16 Participants
Saline infused over 15 minutes administered prior to and 3 hours post doxorubicin infusion (over 15 minutes) during 1st cycle, then Mesna administered (infused over 15 minutes, 360 mg/m2) prior to and 3 hours post doxorubicin infusion during 2nd cycle
Mesna: Mesna: 360 mg/m2 in 50 mL normal saline (NS) either on cycle 2 or cycle 1, day 1. Infused over 15 minutes
Saline: Saline (used as a placebo) infused over the same time as mesna intervention
|
Cycle 1 Mesna; Cycle 2 Saline
n=16 Participants
Mesna administered (infused over 15 minutes, 360 mg/m2) prior to and 3 hours post doxorubicin infusion during 1st cycle, then Saline administered prior to and 3 hours post doxorubicin infusion (over 15 minutes) during 2nd cycle
Mesna: Mesna: 360 mg/m2 in 50 mL normal saline (NS) either on cycle 2 or cycle 1, day 1. Infused over 15 minutes
Saline: Saline (used as a placebo) infused over the same time as mesna intervention
|
|---|---|---|
|
Troponin Levels in Patients Receiving Doxorubicin Containing Chemotherapy
Cycle 1 Pre
|
0.015 ng/ml
Interval 0.011 to 0.021
|
0.017 ng/ml
Interval 0.013 to 0.021
|
|
Troponin Levels in Patients Receiving Doxorubicin Containing Chemotherapy
Cycle 1 Post
|
0.014 ng/ml
Interval 0.01 to 0.019
|
0.012 ng/ml
Interval 0.01 to 0.015
|
|
Troponin Levels in Patients Receiving Doxorubicin Containing Chemotherapy
Cycle 2 Pre
|
0.020 ng/ml
Interval 0.014 to 0.029
|
0.016 ng/ml
Interval 0.012 to 0.021
|
|
Troponin Levels in Patients Receiving Doxorubicin Containing Chemotherapy
Cycle 2 Post
|
0.021 ng/ml
Interval 0.014 to 0.03
|
0.019 ng/ml
Interval 0.014 to 0.026
|
SECONDARY outcome
Timeframe: prior to and 3 hours post doxorubicin and between cycles 1 and 2Continuous Measure of BNP at the 4 time points outlined in protocol for each of the groups. This is a 32-amino acid polypeptide secreted by heart ventricles in response to excessive stretching of cardiomyocytes.
Outcome measures
| Measure |
Cycle 1 Saline; Cycle 2 Mesna
n=16 Participants
Saline infused over 15 minutes administered prior to and 3 hours post doxorubicin infusion (over 15 minutes) during 1st cycle, then Mesna administered (infused over 15 minutes, 360 mg/m2) prior to and 3 hours post doxorubicin infusion during 2nd cycle
Mesna: Mesna: 360 mg/m2 in 50 mL normal saline (NS) either on cycle 2 or cycle 1, day 1. Infused over 15 minutes
Saline: Saline (used as a placebo) infused over the same time as mesna intervention
|
Cycle 1 Mesna; Cycle 2 Saline
n=16 Participants
Mesna administered (infused over 15 minutes, 360 mg/m2) prior to and 3 hours post doxorubicin infusion during 1st cycle, then Saline administered prior to and 3 hours post doxorubicin infusion (over 15 minutes) during 2nd cycle
Mesna: Mesna: 360 mg/m2 in 50 mL normal saline (NS) either on cycle 2 or cycle 1, day 1. Infused over 15 minutes
Saline: Saline (used as a placebo) infused over the same time as mesna intervention
|
|---|---|---|
|
B-type Natriuretic Peptide (BNP) Blood Levels in Patients Receiving Doxorubicin Containing Chemotherapy
Cycle 1 Pre
|
46.36 pg/ml
Interval 32.23 to 66.69
|
49.24 pg/ml
Interval 33.0 to 73.48
|
|
B-type Natriuretic Peptide (BNP) Blood Levels in Patients Receiving Doxorubicin Containing Chemotherapy
Cycle 1 Post
|
50.73 pg/ml
Interval 34.16 to 75.35
|
47.17 pg/ml
Interval 31.3 to 71.07
|
|
B-type Natriuretic Peptide (BNP) Blood Levels in Patients Receiving Doxorubicin Containing Chemotherapy
Cycle 2 Pre
|
45.85 pg/ml
Interval 36.19 to 58.08
|
46.30 pg/ml
Interval 31.15 to 68.82
|
|
B-type Natriuretic Peptide (BNP) Blood Levels in Patients Receiving Doxorubicin Containing Chemotherapy
Cycle 2 Post
|
54.33 pg/ml
Interval 41.72 to 70.73
|
46.66 pg/ml
Interval 32.03 to 67.97
|
Adverse Events
Mesna
Serious events: 1 serious events
Other events: 29 other events
Deaths: 0 deaths
Saline
Serious events: 1 serious events
Other events: 30 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Mesna
n=32 participants at risk
Mesna administered (infused over 15 minutes, 360 mg/m2) prior to and 3 hours post doxorubicin infusion during cycle assigned by randomization
Mesna: Mesna: 360 mg/m2 in 50 mL normal saline (NS) on cycle 2, day 1. Infused over 15 minutes
|
Saline
n=32 participants at risk
Saline administered prior to and 3 hours post doxorubicin infusion (over 15 minutes) during cycle assigned by randomization
Infused over 15 minutes
|
|---|---|---|
|
General disorders
Non-cardiac chest pain
|
3.1%
1/32 • Number of events 1 • All participants were followed clinically during first 2 cycles of therapy, for up to 24 weeks, and adverse events were assessed and classified using the Common Terminology Criteria for Adverse Events version 4.
|
0.00%
0/32 • All participants were followed clinically during first 2 cycles of therapy, for up to 24 weeks, and adverse events were assessed and classified using the Common Terminology Criteria for Adverse Events version 4.
|
|
Infections and infestations
MRSA positive infection in toe
|
0.00%
0/32 • All participants were followed clinically during first 2 cycles of therapy, for up to 24 weeks, and adverse events were assessed and classified using the Common Terminology Criteria for Adverse Events version 4.
|
3.1%
1/32 • Number of events 1 • All participants were followed clinically during first 2 cycles of therapy, for up to 24 weeks, and adverse events were assessed and classified using the Common Terminology Criteria for Adverse Events version 4.
|
|
Infections and infestations
Lung Infection
|
0.00%
0/32 • All participants were followed clinically during first 2 cycles of therapy, for up to 24 weeks, and adverse events were assessed and classified using the Common Terminology Criteria for Adverse Events version 4.
|
3.1%
1/32 • Number of events 1 • All participants were followed clinically during first 2 cycles of therapy, for up to 24 weeks, and adverse events were assessed and classified using the Common Terminology Criteria for Adverse Events version 4.
|
|
Investigations
Blood bilirubin increased
|
0.00%
0/32 • All participants were followed clinically during first 2 cycles of therapy, for up to 24 weeks, and adverse events were assessed and classified using the Common Terminology Criteria for Adverse Events version 4.
|
3.1%
1/32 • Number of events 1 • All participants were followed clinically during first 2 cycles of therapy, for up to 24 weeks, and adverse events were assessed and classified using the Common Terminology Criteria for Adverse Events version 4.
|
|
Investigations
White blood cell decreased
|
0.00%
0/32 • All participants were followed clinically during first 2 cycles of therapy, for up to 24 weeks, and adverse events were assessed and classified using the Common Terminology Criteria for Adverse Events version 4.
|
3.1%
1/32 • Number of events 1 • All participants were followed clinically during first 2 cycles of therapy, for up to 24 weeks, and adverse events were assessed and classified using the Common Terminology Criteria for Adverse Events version 4.
|
Other adverse events
| Measure |
Mesna
n=32 participants at risk
Mesna administered (infused over 15 minutes, 360 mg/m2) prior to and 3 hours post doxorubicin infusion during cycle assigned by randomization
Mesna: Mesna: 360 mg/m2 in 50 mL normal saline (NS) on cycle 2, day 1. Infused over 15 minutes
|
Saline
n=32 participants at risk
Saline administered prior to and 3 hours post doxorubicin infusion (over 15 minutes) during cycle assigned by randomization
Infused over 15 minutes
|
|---|---|---|
|
Investigations
Alanine aminotransferase increased
|
12.5%
4/32 • Number of events 4 • All participants were followed clinically during first 2 cycles of therapy, for up to 24 weeks, and adverse events were assessed and classified using the Common Terminology Criteria for Adverse Events version 4.
|
9.4%
3/32 • Number of events 3 • All participants were followed clinically during first 2 cycles of therapy, for up to 24 weeks, and adverse events were assessed and classified using the Common Terminology Criteria for Adverse Events version 4.
|
|
Investigations
Alkaline phosphatase increased
|
3.1%
1/32 • Number of events 1 • All participants were followed clinically during first 2 cycles of therapy, for up to 24 weeks, and adverse events were assessed and classified using the Common Terminology Criteria for Adverse Events version 4.
|
3.1%
1/32 • Number of events 1 • All participants were followed clinically during first 2 cycles of therapy, for up to 24 weeks, and adverse events were assessed and classified using the Common Terminology Criteria for Adverse Events version 4.
|
|
Respiratory, thoracic and mediastinal disorders
Allergic rhinitis
|
3.1%
1/32 • Number of events 1 • All participants were followed clinically during first 2 cycles of therapy, for up to 24 weeks, and adverse events were assessed and classified using the Common Terminology Criteria for Adverse Events version 4.
|
3.1%
1/32 • Number of events 1 • All participants were followed clinically during first 2 cycles of therapy, for up to 24 weeks, and adverse events were assessed and classified using the Common Terminology Criteria for Adverse Events version 4.
|
|
Blood and lymphatic system disorders
Anemia
|
28.1%
9/32 • Number of events 9 • All participants were followed clinically during first 2 cycles of therapy, for up to 24 weeks, and adverse events were assessed and classified using the Common Terminology Criteria for Adverse Events version 4.
|
46.9%
15/32 • Number of events 15 • All participants were followed clinically during first 2 cycles of therapy, for up to 24 weeks, and adverse events were assessed and classified using the Common Terminology Criteria for Adverse Events version 4.
|
|
Metabolism and nutrition disorders
Anorexia
|
0.00%
0/32 • All participants were followed clinically during first 2 cycles of therapy, for up to 24 weeks, and adverse events were assessed and classified using the Common Terminology Criteria for Adverse Events version 4.
|
3.1%
1/32 • Number of events 1 • All participants were followed clinically during first 2 cycles of therapy, for up to 24 weeks, and adverse events were assessed and classified using the Common Terminology Criteria for Adverse Events version 4.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
3.1%
1/32 • Number of events 1 • All participants were followed clinically during first 2 cycles of therapy, for up to 24 weeks, and adverse events were assessed and classified using the Common Terminology Criteria for Adverse Events version 4.
|
3.1%
1/32 • Number of events 1 • All participants were followed clinically during first 2 cycles of therapy, for up to 24 weeks, and adverse events were assessed and classified using the Common Terminology Criteria for Adverse Events version 4.
|
|
Investigations
Aspartate aminotransferase increased
|
3.1%
1/32 • Number of events 1 • All participants were followed clinically during first 2 cycles of therapy, for up to 24 weeks, and adverse events were assessed and classified using the Common Terminology Criteria for Adverse Events version 4.
|
0.00%
0/32 • All participants were followed clinically during first 2 cycles of therapy, for up to 24 weeks, and adverse events were assessed and classified using the Common Terminology Criteria for Adverse Events version 4.
|
|
Investigations
Blood bilirubin increased
|
3.1%
1/32 • Number of events 1 • All participants were followed clinically during first 2 cycles of therapy, for up to 24 weeks, and adverse events were assessed and classified using the Common Terminology Criteria for Adverse Events version 4.
|
0.00%
0/32 • All participants were followed clinically during first 2 cycles of therapy, for up to 24 weeks, and adverse events were assessed and classified using the Common Terminology Criteria for Adverse Events version 4.
|
|
Eye disorders
Blurred Vision
|
0.00%
0/32 • All participants were followed clinically during first 2 cycles of therapy, for up to 24 weeks, and adverse events were assessed and classified using the Common Terminology Criteria for Adverse Events version 4.
|
3.1%
1/32 • Number of events 1 • All participants were followed clinically during first 2 cycles of therapy, for up to 24 weeks, and adverse events were assessed and classified using the Common Terminology Criteria for Adverse Events version 4.
|
|
Skin and subcutaneous tissue disorders
Bullous Dermatitis
|
3.1%
1/32 • Number of events 1 • All participants were followed clinically during first 2 cycles of therapy, for up to 24 weeks, and adverse events were assessed and classified using the Common Terminology Criteria for Adverse Events version 4.
|
0.00%
0/32 • All participants were followed clinically during first 2 cycles of therapy, for up to 24 weeks, and adverse events were assessed and classified using the Common Terminology Criteria for Adverse Events version 4.
|
|
General disorders
Chills
|
0.00%
0/32 • All participants were followed clinically during first 2 cycles of therapy, for up to 24 weeks, and adverse events were assessed and classified using the Common Terminology Criteria for Adverse Events version 4.
|
6.2%
2/32 • Number of events 2 • All participants were followed clinically during first 2 cycles of therapy, for up to 24 weeks, and adverse events were assessed and classified using the Common Terminology Criteria for Adverse Events version 4.
|
|
Gastrointestinal disorders
Constipation
|
3.1%
1/32 • Number of events 1 • All participants were followed clinically during first 2 cycles of therapy, for up to 24 weeks, and adverse events were assessed and classified using the Common Terminology Criteria for Adverse Events version 4.
|
12.5%
4/32 • Number of events 4 • All participants were followed clinically during first 2 cycles of therapy, for up to 24 weeks, and adverse events were assessed and classified using the Common Terminology Criteria for Adverse Events version 4.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
3.1%
1/32 • Number of events 1 • All participants were followed clinically during first 2 cycles of therapy, for up to 24 weeks, and adverse events were assessed and classified using the Common Terminology Criteria for Adverse Events version 4.
|
9.4%
3/32 • Number of events 3 • All participants were followed clinically during first 2 cycles of therapy, for up to 24 weeks, and adverse events were assessed and classified using the Common Terminology Criteria for Adverse Events version 4.
|
|
Investigations
Creatinine increased
|
3.1%
1/32 • Number of events 1 • All participants were followed clinically during first 2 cycles of therapy, for up to 24 weeks, and adverse events were assessed and classified using the Common Terminology Criteria for Adverse Events version 4.
|
3.1%
1/32 • Number of events 1 • All participants were followed clinically during first 2 cycles of therapy, for up to 24 weeks, and adverse events were assessed and classified using the Common Terminology Criteria for Adverse Events version 4.
|
|
Psychiatric disorders
Depression
|
0.00%
0/32 • All participants were followed clinically during first 2 cycles of therapy, for up to 24 weeks, and adverse events were assessed and classified using the Common Terminology Criteria for Adverse Events version 4.
|
3.1%
1/32 • Number of events 1 • All participants were followed clinically during first 2 cycles of therapy, for up to 24 weeks, and adverse events were assessed and classified using the Common Terminology Criteria for Adverse Events version 4.
|
|
Skin and subcutaneous tissue disorders
Dermatitis
|
0.00%
0/32 • All participants were followed clinically during first 2 cycles of therapy, for up to 24 weeks, and adverse events were assessed and classified using the Common Terminology Criteria for Adverse Events version 4.
|
3.1%
1/32 • Number of events 1 • All participants were followed clinically during first 2 cycles of therapy, for up to 24 weeks, and adverse events were assessed and classified using the Common Terminology Criteria for Adverse Events version 4.
|
|
Gastrointestinal disorders
Diarrhea
|
6.2%
2/32 • Number of events 2 • All participants were followed clinically during first 2 cycles of therapy, for up to 24 weeks, and adverse events were assessed and classified using the Common Terminology Criteria for Adverse Events version 4.
|
3.1%
1/32 • Number of events 1 • All participants were followed clinically during first 2 cycles of therapy, for up to 24 weeks, and adverse events were assessed and classified using the Common Terminology Criteria for Adverse Events version 4.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
3.1%
1/32 • Number of events 1 • All participants were followed clinically during first 2 cycles of therapy, for up to 24 weeks, and adverse events were assessed and classified using the Common Terminology Criteria for Adverse Events version 4.
|
6.2%
2/32 • Number of events 2 • All participants were followed clinically during first 2 cycles of therapy, for up to 24 weeks, and adverse events were assessed and classified using the Common Terminology Criteria for Adverse Events version 4.
|
|
General disorders
Edema Limbs
|
3.1%
1/32 • Number of events 1 • All participants were followed clinically during first 2 cycles of therapy, for up to 24 weeks, and adverse events were assessed and classified using the Common Terminology Criteria for Adverse Events version 4.
|
6.2%
2/32 • Number of events 2 • All participants were followed clinically during first 2 cycles of therapy, for up to 24 weeks, and adverse events were assessed and classified using the Common Terminology Criteria for Adverse Events version 4.
|
|
Respiratory, thoracic and mediastinal disorders
Esophageal Spasms
|
0.00%
0/32 • All participants were followed clinically during first 2 cycles of therapy, for up to 24 weeks, and adverse events were assessed and classified using the Common Terminology Criteria for Adverse Events version 4.
|
3.1%
1/32 • Number of events 1 • All participants were followed clinically during first 2 cycles of therapy, for up to 24 weeks, and adverse events were assessed and classified using the Common Terminology Criteria for Adverse Events version 4.
|
|
General disorders
Fatigue
|
25.0%
8/32 • Number of events 8 • All participants were followed clinically during first 2 cycles of therapy, for up to 24 weeks, and adverse events were assessed and classified using the Common Terminology Criteria for Adverse Events version 4.
|
28.1%
9/32 • Number of events 9 • All participants were followed clinically during first 2 cycles of therapy, for up to 24 weeks, and adverse events were assessed and classified using the Common Terminology Criteria for Adverse Events version 4.
|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
0.00%
0/32 • All participants were followed clinically during first 2 cycles of therapy, for up to 24 weeks, and adverse events were assessed and classified using the Common Terminology Criteria for Adverse Events version 4.
|
6.2%
2/32 • Number of events 2 • All participants were followed clinically during first 2 cycles of therapy, for up to 24 weeks, and adverse events were assessed and classified using the Common Terminology Criteria for Adverse Events version 4.
|
|
Investigations
Fibrinogen decreased
|
0.00%
0/32 • All participants were followed clinically during first 2 cycles of therapy, for up to 24 weeks, and adverse events were assessed and classified using the Common Terminology Criteria for Adverse Events version 4.
|
3.1%
1/32 • Number of events 1 • All participants were followed clinically during first 2 cycles of therapy, for up to 24 weeks, and adverse events were assessed and classified using the Common Terminology Criteria for Adverse Events version 4.
|
|
Musculoskeletal and connective tissue disorders
Flank Pain
|
0.00%
0/32 • All participants were followed clinically during first 2 cycles of therapy, for up to 24 weeks, and adverse events were assessed and classified using the Common Terminology Criteria for Adverse Events version 4.
|
6.2%
2/32 • Number of events 2 • All participants were followed clinically during first 2 cycles of therapy, for up to 24 weeks, and adverse events were assessed and classified using the Common Terminology Criteria for Adverse Events version 4.
|
|
Gastrointestinal disorders
Gastritis
|
0.00%
0/32 • All participants were followed clinically during first 2 cycles of therapy, for up to 24 weeks, and adverse events were assessed and classified using the Common Terminology Criteria for Adverse Events version 4.
|
3.1%
1/32 • Number of events 1 • All participants were followed clinically during first 2 cycles of therapy, for up to 24 weeks, and adverse events were assessed and classified using the Common Terminology Criteria for Adverse Events version 4.
|
|
Gastrointestinal disorders
Gastroparesis
|
3.1%
1/32 • Number of events 1 • All participants were followed clinically during first 2 cycles of therapy, for up to 24 weeks, and adverse events were assessed and classified using the Common Terminology Criteria for Adverse Events version 4.
|
0.00%
0/32 • All participants were followed clinically during first 2 cycles of therapy, for up to 24 weeks, and adverse events were assessed and classified using the Common Terminology Criteria for Adverse Events version 4.
|
|
Nervous system disorders
Headache
|
6.2%
2/32 • Number of events 2 • All participants were followed clinically during first 2 cycles of therapy, for up to 24 weeks, and adverse events were assessed and classified using the Common Terminology Criteria for Adverse Events version 4.
|
12.5%
4/32 • Number of events 4 • All participants were followed clinically during first 2 cycles of therapy, for up to 24 weeks, and adverse events were assessed and classified using the Common Terminology Criteria for Adverse Events version 4.
|
|
Gastrointestinal disorders
Hemorrhoids
|
0.00%
0/32 • All participants were followed clinically during first 2 cycles of therapy, for up to 24 weeks, and adverse events were assessed and classified using the Common Terminology Criteria for Adverse Events version 4.
|
3.1%
1/32 • Number of events 1 • All participants were followed clinically during first 2 cycles of therapy, for up to 24 weeks, and adverse events were assessed and classified using the Common Terminology Criteria for Adverse Events version 4.
|
|
Metabolism and nutrition disorders
Hyperglycemia
|
0.00%
0/32 • All participants were followed clinically during first 2 cycles of therapy, for up to 24 weeks, and adverse events were assessed and classified using the Common Terminology Criteria for Adverse Events version 4.
|
3.1%
1/32 • Number of events 1 • All participants were followed clinically during first 2 cycles of therapy, for up to 24 weeks, and adverse events were assessed and classified using the Common Terminology Criteria for Adverse Events version 4.
|
|
Metabolism and nutrition disorders
Hypernatremia
|
0.00%
0/32 • All participants were followed clinically during first 2 cycles of therapy, for up to 24 weeks, and adverse events were assessed and classified using the Common Terminology Criteria for Adverse Events version 4.
|
6.2%
2/32 • Number of events 2 • All participants were followed clinically during first 2 cycles of therapy, for up to 24 weeks, and adverse events were assessed and classified using the Common Terminology Criteria for Adverse Events version 4.
|
|
Metabolism and nutrition disorders
Hypoalbuminemia
|
12.5%
4/32 • Number of events 4 • All participants were followed clinically during first 2 cycles of therapy, for up to 24 weeks, and adverse events were assessed and classified using the Common Terminology Criteria for Adverse Events version 4.
|
9.4%
3/32 • Number of events 3 • All participants were followed clinically during first 2 cycles of therapy, for up to 24 weeks, and adverse events were assessed and classified using the Common Terminology Criteria for Adverse Events version 4.
|
|
Metabolism and nutrition disorders
Hypocalcemia
|
15.6%
5/32 • Number of events 5 • All participants were followed clinically during first 2 cycles of therapy, for up to 24 weeks, and adverse events were assessed and classified using the Common Terminology Criteria for Adverse Events version 4.
|
9.4%
3/32 • Number of events 3 • All participants were followed clinically during first 2 cycles of therapy, for up to 24 weeks, and adverse events were assessed and classified using the Common Terminology Criteria for Adverse Events version 4.
|
|
Metabolism and nutrition disorders
Hypoglycemia
|
3.1%
1/32 • Number of events 1 • All participants were followed clinically during first 2 cycles of therapy, for up to 24 weeks, and adverse events were assessed and classified using the Common Terminology Criteria for Adverse Events version 4.
|
0.00%
0/32 • All participants were followed clinically during first 2 cycles of therapy, for up to 24 weeks, and adverse events were assessed and classified using the Common Terminology Criteria for Adverse Events version 4.
|
|
Metabolism and nutrition disorders
Hypokalemia
|
21.9%
7/32 • Number of events 7 • All participants were followed clinically during first 2 cycles of therapy, for up to 24 weeks, and adverse events were assessed and classified using the Common Terminology Criteria for Adverse Events version 4.
|
9.4%
3/32 • Number of events 3 • All participants were followed clinically during first 2 cycles of therapy, for up to 24 weeks, and adverse events were assessed and classified using the Common Terminology Criteria for Adverse Events version 4.
|
|
Metabolism and nutrition disorders
Hypomagnesemia
|
0.00%
0/32 • All participants were followed clinically during first 2 cycles of therapy, for up to 24 weeks, and adverse events were assessed and classified using the Common Terminology Criteria for Adverse Events version 4.
|
3.1%
1/32 • Number of events 1 • All participants were followed clinically during first 2 cycles of therapy, for up to 24 weeks, and adverse events were assessed and classified using the Common Terminology Criteria for Adverse Events version 4.
|
|
Metabolism and nutrition disorders
Hypoatremia
|
9.4%
3/32 • Number of events 3 • All participants were followed clinically during first 2 cycles of therapy, for up to 24 weeks, and adverse events were assessed and classified using the Common Terminology Criteria for Adverse Events version 4.
|
12.5%
4/32 • Number of events 4 • All participants were followed clinically during first 2 cycles of therapy, for up to 24 weeks, and adverse events were assessed and classified using the Common Terminology Criteria for Adverse Events version 4.
|
|
Vascular disorders
Hypotension
|
0.00%
0/32 • All participants were followed clinically during first 2 cycles of therapy, for up to 24 weeks, and adverse events were assessed and classified using the Common Terminology Criteria for Adverse Events version 4.
|
3.1%
1/32 • Number of events 1 • All participants were followed clinically during first 2 cycles of therapy, for up to 24 weeks, and adverse events were assessed and classified using the Common Terminology Criteria for Adverse Events version 4.
|
|
Psychiatric disorders
Insomnia
|
0.00%
0/32 • All participants were followed clinically during first 2 cycles of therapy, for up to 24 weeks, and adverse events were assessed and classified using the Common Terminology Criteria for Adverse Events version 4.
|
6.2%
2/32 • Number of events 2 • All participants were followed clinically during first 2 cycles of therapy, for up to 24 weeks, and adverse events were assessed and classified using the Common Terminology Criteria for Adverse Events version 4.
|
|
Infections and infestations
Lip Infection
|
0.00%
0/32 • All participants were followed clinically during first 2 cycles of therapy, for up to 24 weeks, and adverse events were assessed and classified using the Common Terminology Criteria for Adverse Events version 4.
|
3.1%
1/32 • Number of events 1 • All participants were followed clinically during first 2 cycles of therapy, for up to 24 weeks, and adverse events were assessed and classified using the Common Terminology Criteria for Adverse Events version 4.
|
|
Investigations
Lymphocyte count decreased
|
31.2%
10/32 • Number of events 10 • All participants were followed clinically during first 2 cycles of therapy, for up to 24 weeks, and adverse events were assessed and classified using the Common Terminology Criteria for Adverse Events version 4.
|
31.2%
10/32 • Number of events 10 • All participants were followed clinically during first 2 cycles of therapy, for up to 24 weeks, and adverse events were assessed and classified using the Common Terminology Criteria for Adverse Events version 4.
|
|
Gastrointestinal disorders
Mucositis oral
|
3.1%
1/32 • Number of events 1 • All participants were followed clinically during first 2 cycles of therapy, for up to 24 weeks, and adverse events were assessed and classified using the Common Terminology Criteria for Adverse Events version 4.
|
6.2%
2/32 • Number of events 2 • All participants were followed clinically during first 2 cycles of therapy, for up to 24 weeks, and adverse events were assessed and classified using the Common Terminology Criteria for Adverse Events version 4.
|
|
Musculoskeletal and connective tissue disorders
Muscle weakness upper limb
|
0.00%
0/32 • All participants were followed clinically during first 2 cycles of therapy, for up to 24 weeks, and adverse events were assessed and classified using the Common Terminology Criteria for Adverse Events version 4.
|
3.1%
1/32 • Number of events 1 • All participants were followed clinically during first 2 cycles of therapy, for up to 24 weeks, and adverse events were assessed and classified using the Common Terminology Criteria for Adverse Events version 4.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
3.1%
1/32 • Number of events 1 • All participants were followed clinically during first 2 cycles of therapy, for up to 24 weeks, and adverse events were assessed and classified using the Common Terminology Criteria for Adverse Events version 4.
|
9.4%
3/32 • Number of events 3 • All participants were followed clinically during first 2 cycles of therapy, for up to 24 weeks, and adverse events were assessed and classified using the Common Terminology Criteria for Adverse Events version 4.
|
|
Gastrointestinal disorders
Nausea
|
37.5%
12/32 • Number of events 12 • All participants were followed clinically during first 2 cycles of therapy, for up to 24 weeks, and adverse events were assessed and classified using the Common Terminology Criteria for Adverse Events version 4.
|
40.6%
13/32 • Number of events 13 • All participants were followed clinically during first 2 cycles of therapy, for up to 24 weeks, and adverse events were assessed and classified using the Common Terminology Criteria for Adverse Events version 4.
|
|
Investigations
Neutrophil count decreased
|
31.2%
10/32 • Number of events 10 • All participants were followed clinically during first 2 cycles of therapy, for up to 24 weeks, and adverse events were assessed and classified using the Common Terminology Criteria for Adverse Events version 4.
|
28.1%
9/32 • Number of events 9 • All participants were followed clinically during first 2 cycles of therapy, for up to 24 weeks, and adverse events were assessed and classified using the Common Terminology Criteria for Adverse Events version 4.
|
|
General disorders
Non-cardiac chest pain
|
3.1%
1/32 • Number of events 1 • All participants were followed clinically during first 2 cycles of therapy, for up to 24 weeks, and adverse events were assessed and classified using the Common Terminology Criteria for Adverse Events version 4.
|
3.1%
1/32 • Number of events 1 • All participants were followed clinically during first 2 cycles of therapy, for up to 24 weeks, and adverse events were assessed and classified using the Common Terminology Criteria for Adverse Events version 4.
|
|
General disorders
Pain
|
6.2%
2/32 • Number of events 2 • All participants were followed clinically during first 2 cycles of therapy, for up to 24 weeks, and adverse events were assessed and classified using the Common Terminology Criteria for Adverse Events version 4.
|
6.2%
2/32 • Number of events 2 • All participants were followed clinically during first 2 cycles of therapy, for up to 24 weeks, and adverse events were assessed and classified using the Common Terminology Criteria for Adverse Events version 4.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
0.00%
0/32 • All participants were followed clinically during first 2 cycles of therapy, for up to 24 weeks, and adverse events were assessed and classified using the Common Terminology Criteria for Adverse Events version 4.
|
3.1%
1/32 • Number of events 1 • All participants were followed clinically during first 2 cycles of therapy, for up to 24 weeks, and adverse events were assessed and classified using the Common Terminology Criteria for Adverse Events version 4.
|
|
Cardiac disorders
Palpitations
|
0.00%
0/32 • All participants were followed clinically during first 2 cycles of therapy, for up to 24 weeks, and adverse events were assessed and classified using the Common Terminology Criteria for Adverse Events version 4.
|
3.1%
1/32 • Number of events 1 • All participants were followed clinically during first 2 cycles of therapy, for up to 24 weeks, and adverse events were assessed and classified using the Common Terminology Criteria for Adverse Events version 4.
|
|
Nervous system disorders
Paresthesia
|
15.6%
5/32 • Number of events 5 • All participants were followed clinically during first 2 cycles of therapy, for up to 24 weeks, and adverse events were assessed and classified using the Common Terminology Criteria for Adverse Events version 4.
|
12.5%
4/32 • Number of events 4 • All participants were followed clinically during first 2 cycles of therapy, for up to 24 weeks, and adverse events were assessed and classified using the Common Terminology Criteria for Adverse Events version 4.
|
|
Nervous system disorders
Peripheral sensory neuropathy
|
3.1%
1/32 • Number of events 1 • All participants were followed clinically during first 2 cycles of therapy, for up to 24 weeks, and adverse events were assessed and classified using the Common Terminology Criteria for Adverse Events version 4.
|
0.00%
0/32 • All participants were followed clinically during first 2 cycles of therapy, for up to 24 weeks, and adverse events were assessed and classified using the Common Terminology Criteria for Adverse Events version 4.
|
|
Investigations
Platelet count decreased
|
9.4%
3/32 • Number of events 3 • All participants were followed clinically during first 2 cycles of therapy, for up to 24 weeks, and adverse events were assessed and classified using the Common Terminology Criteria for Adverse Events version 4.
|
12.5%
4/32 • Number of events 4 • All participants were followed clinically during first 2 cycles of therapy, for up to 24 weeks, and adverse events were assessed and classified using the Common Terminology Criteria for Adverse Events version 4.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
6.2%
2/32 • Number of events 2 • All participants were followed clinically during first 2 cycles of therapy, for up to 24 weeks, and adverse events were assessed and classified using the Common Terminology Criteria for Adverse Events version 4.
|
3.1%
1/32 • Number of events 1 • All participants were followed clinically during first 2 cycles of therapy, for up to 24 weeks, and adverse events were assessed and classified using the Common Terminology Criteria for Adverse Events version 4.
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
0.00%
0/32 • All participants were followed clinically during first 2 cycles of therapy, for up to 24 weeks, and adverse events were assessed and classified using the Common Terminology Criteria for Adverse Events version 4.
|
3.1%
1/32 • Number of events 1 • All participants were followed clinically during first 2 cycles of therapy, for up to 24 weeks, and adverse events were assessed and classified using the Common Terminology Criteria for Adverse Events version 4.
|
|
Infections and infestations
Skin Infection
|
3.1%
1/32 • Number of events 1 • All participants were followed clinically during first 2 cycles of therapy, for up to 24 weeks, and adverse events were assessed and classified using the Common Terminology Criteria for Adverse Events version 4.
|
0.00%
0/32 • All participants were followed clinically during first 2 cycles of therapy, for up to 24 weeks, and adverse events were assessed and classified using the Common Terminology Criteria for Adverse Events version 4.
|
|
Respiratory, thoracic and mediastinal disorders
Sore Throat
|
3.1%
1/32 • Number of events 1 • All participants were followed clinically during first 2 cycles of therapy, for up to 24 weeks, and adverse events were assessed and classified using the Common Terminology Criteria for Adverse Events version 4.
|
3.1%
1/32 • Number of events 1 • All participants were followed clinically during first 2 cycles of therapy, for up to 24 weeks, and adverse events were assessed and classified using the Common Terminology Criteria for Adverse Events version 4.
|
|
Infections and infestations
Tooth Infection
|
3.1%
1/32 • Number of events 1 • All participants were followed clinically during first 2 cycles of therapy, for up to 24 weeks, and adverse events were assessed and classified using the Common Terminology Criteria for Adverse Events version 4.
|
0.00%
0/32 • All participants were followed clinically during first 2 cycles of therapy, for up to 24 weeks, and adverse events were assessed and classified using the Common Terminology Criteria for Adverse Events version 4.
|
|
Nervous system disorders
Tremor
|
3.1%
1/32 • Number of events 1 • All participants were followed clinically during first 2 cycles of therapy, for up to 24 weeks, and adverse events were assessed and classified using the Common Terminology Criteria for Adverse Events version 4.
|
0.00%
0/32 • All participants were followed clinically during first 2 cycles of therapy, for up to 24 weeks, and adverse events were assessed and classified using the Common Terminology Criteria for Adverse Events version 4.
|
|
Renal and urinary disorders
Urinary Frequency
|
0.00%
0/32 • All participants were followed clinically during first 2 cycles of therapy, for up to 24 weeks, and adverse events were assessed and classified using the Common Terminology Criteria for Adverse Events version 4.
|
3.1%
1/32 • Number of events 1 • All participants were followed clinically during first 2 cycles of therapy, for up to 24 weeks, and adverse events were assessed and classified using the Common Terminology Criteria for Adverse Events version 4.
|
|
Infections and infestations
Vaginal Infection
|
0.00%
0/32 • All participants were followed clinically during first 2 cycles of therapy, for up to 24 weeks, and adverse events were assessed and classified using the Common Terminology Criteria for Adverse Events version 4.
|
3.1%
1/32 • Number of events 1 • All participants were followed clinically during first 2 cycles of therapy, for up to 24 weeks, and adverse events were assessed and classified using the Common Terminology Criteria for Adverse Events version 4.
|
|
Gastrointestinal disorders
Vomiting
|
3.1%
1/32 • Number of events 1 • All participants were followed clinically during first 2 cycles of therapy, for up to 24 weeks, and adverse events were assessed and classified using the Common Terminology Criteria for Adverse Events version 4.
|
9.4%
3/32 • Number of events 3 • All participants were followed clinically during first 2 cycles of therapy, for up to 24 weeks, and adverse events were assessed and classified using the Common Terminology Criteria for Adverse Events version 4.
|
|
Investigations
Weight Loss
|
3.1%
1/32 • Number of events 1 • All participants were followed clinically during first 2 cycles of therapy, for up to 24 weeks, and adverse events were assessed and classified using the Common Terminology Criteria for Adverse Events version 4.
|
0.00%
0/32 • All participants were followed clinically during first 2 cycles of therapy, for up to 24 weeks, and adverse events were assessed and classified using the Common Terminology Criteria for Adverse Events version 4.
|
|
Respiratory, thoracic and mediastinal disorders
Wheezing
|
0.00%
0/32 • All participants were followed clinically during first 2 cycles of therapy, for up to 24 weeks, and adverse events were assessed and classified using the Common Terminology Criteria for Adverse Events version 4.
|
3.1%
1/32 • Number of events 1 • All participants were followed clinically during first 2 cycles of therapy, for up to 24 weeks, and adverse events were assessed and classified using the Common Terminology Criteria for Adverse Events version 4.
|
|
Investigations
White blood cell decreased
|
50.0%
16/32 • Number of events 16 • All participants were followed clinically during first 2 cycles of therapy, for up to 24 weeks, and adverse events were assessed and classified using the Common Terminology Criteria for Adverse Events version 4.
|
28.1%
9/32 • Number of events 9 • All participants were followed clinically during first 2 cycles of therapy, for up to 24 weeks, and adverse events were assessed and classified using the Common Terminology Criteria for Adverse Events version 4.
|
|
Infections and infestations
Wound Infection
|
3.1%
1/32 • Number of events 1 • All participants were followed clinically during first 2 cycles of therapy, for up to 24 weeks, and adverse events were assessed and classified using the Common Terminology Criteria for Adverse Events version 4.
|
0.00%
0/32 • All participants were followed clinically during first 2 cycles of therapy, for up to 24 weeks, and adverse events were assessed and classified using the Common Terminology Criteria for Adverse Events version 4.
|
Additional Information
Emily Dressler, PhD
Markey Cancer Center Biostatistics Shared Resource Facility
Phone: 859 323-3076
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place