Trial Outcomes & Findings for Topical Cryotherapy in Reducing Pain in Patients With Chemotherapy Induced Peripheral Neuropathy or Paclitaxel Induced Acute Pain Syndrome (NCT NCT02640053)
NCT ID: NCT02640053
Last Updated: 2019-09-30
Results Overview
Average Area Under the Curve per assessment (aAUCpa) of EORTC Chemotherapy-Induced Peripheral Neuropathy Module (EORTC QLQ-CIPN20) Sensory Neuropathy Subscale adjusting for baseline. The EORTC CIPN20 scoring algorithm was used for the sensory (items 31-36, 39, 40 and 48) subscale scores on a 0-100 scale, with higher scores represent fewer symptoms (better QOL). The aAUCpa for the subscale is calculated as the average of each AUC between each sequential assessment from pre-treatment-initiation to the week-12 assessment then subtract the corresponding baseline Sensory Neuropathy subscale score, with positive scores represent symptoms has improved from baseline and negative scores represent symptoms has worsen from baseline.
COMPLETED
NA
46 participants
Up to 12 weeks
2019-09-30
Participant Flow
Forty-six (46) participants were enrolled from 13 academic and community practice institutions in the United States between 12/24/2015 and June 16, 2017.
There were three patients who withdrew consent (1 cryotherapy, 2 control) and one patient on the cryotherapy arm who was found to be ineligible. All of these 4 participants were excluded from all analyses.
Participant milestones
| Measure |
Arm I (Cryotherapy)
Patients receive topical cryotherapy for 15 minutes prior to each paclitaxel dose, during paclitaxel infusion and for 15 minutes following paclitaxel completion. Therapy repeats every week for a planned course of 12 weeks of adjuvant paclitaxel.
|
Arm II (Control)
Patients receive the standard of care only (paclitaxel at a dose of 80 mg/m2 IV) every week for a planned course of 12 weeks.
|
|---|---|---|
|
Overall Study
STARTED
|
21
|
21
|
|
Overall Study
COMPLETED
|
17
|
17
|
|
Overall Study
NOT COMPLETED
|
4
|
4
|
Reasons for withdrawal
| Measure |
Arm I (Cryotherapy)
Patients receive topical cryotherapy for 15 minutes prior to each paclitaxel dose, during paclitaxel infusion and for 15 minutes following paclitaxel completion. Therapy repeats every week for a planned course of 12 weeks of adjuvant paclitaxel.
|
Arm II (Control)
Patients receive the standard of care only (paclitaxel at a dose of 80 mg/m2 IV) every week for a planned course of 12 weeks.
|
|---|---|---|
|
Overall Study
Withdrawal by Subject
|
2
|
1
|
|
Overall Study
Adverse Event
|
1
|
1
|
|
Overall Study
Alternative Therapy
|
1
|
1
|
|
Overall Study
Chemo regimen changed after 1st Rx
|
0
|
1
|
Baseline Characteristics
Topical Cryotherapy in Reducing Pain in Patients With Chemotherapy Induced Peripheral Neuropathy or Paclitaxel Induced Acute Pain Syndrome
Baseline characteristics by cohort
| Measure |
Arm I (Cryotherapy)
n=21 Participants
Patients receive topical cryotherapy for 15 minutes prior to each paclitaxel dose, during paclitaxel infusion and for 15 minutes following paclitaxel completion. Therapy repeats every week for a planned course of 12 weeks of adjuvant paclitaxel.
|
Arm II (Control)
n=21 Participants
Patients receive the standard of care only (paclitaxel at a dose of 80 mg/m2 IV) every week for a planned course of 12 weeks.
|
Total
n=42 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
53.0 years
n=5 Participants
|
55.0 years
n=7 Participants
|
53.0 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
20 Participants
n=5 Participants
|
21 Participants
n=7 Participants
|
41 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 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
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
21 Participants
n=5 Participants
|
21 Participants
n=7 Participants
|
42 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
21 Participants
n=5 Participants
|
21 Participants
n=7 Participants
|
42 Participants
n=5 Participants
|
|
ECOG Performance Status
0
|
18 Participants
n=5 Participants
|
18 Participants
n=7 Participants
|
36 Participants
n=5 Participants
|
|
ECOG Performance Status
1
|
3 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Up to 12 weeksPopulation: Patients who completed the EORTC QLQ-CIPN20 at pre-treatment-initiation and at least once post-treatment initiation.
Average Area Under the Curve per assessment (aAUCpa) of EORTC Chemotherapy-Induced Peripheral Neuropathy Module (EORTC QLQ-CIPN20) Sensory Neuropathy Subscale adjusting for baseline. The EORTC CIPN20 scoring algorithm was used for the sensory (items 31-36, 39, 40 and 48) subscale scores on a 0-100 scale, with higher scores represent fewer symptoms (better QOL). The aAUCpa for the subscale is calculated as the average of each AUC between each sequential assessment from pre-treatment-initiation to the week-12 assessment then subtract the corresponding baseline Sensory Neuropathy subscale score, with positive scores represent symptoms has improved from baseline and negative scores represent symptoms has worsen from baseline.
Outcome measures
| Measure |
Arm I (Cryotherapy)
n=19 Participants
Patients receive topical cryotherapy for 15 minutes prior to each paclitaxel dose, during paclitaxel infusion and for 15 minutes following paclitaxel completion. Therapy repeats every week for a planned course of 12 weeks of adjuvant paclitaxel.
|
Arm II (Control)
n=20 Participants
Patients receive the standard of care only (paclitaxel at a dose of 80 mg/m2 IV) every week for a planned course of 12 weeks.
|
|---|---|---|
|
Area Under the Curve (AUC) EORTC CIPN20 Sensory Neuropathy Subscale Adjusting for Baseline
|
-1.4 Average(subscale value*assessment)
Interval -11.7 to 6.8
|
-4.4 Average(subscale value*assessment)
Interval -57.1 to 16.2
|
PRIMARY outcome
Timeframe: Up to 12 weeksPopulation: Patients who completed the EORTC QLQ-CIPN20 at pre-treatment-initiation and at least once post-treatment initiation.
Average Area Under the Curve per assessment (aAUCpa) of EORTC Chemotherapy-Induced Peripheral Neuropathy Module (EORTC QLQ-CIPN20) Tingling Fingers or Hands over 12 weeks adjusting for baseline (item 1; "During the past week, did you have tingling fingers or hands?"; 1=Not at all, 2=A little, 3=Quite a bit; and 4=Very much). The reported score was transform into 0-100 scale, with higher scores represent fewer symptoms (better QOL). The aAUCpa for the individual item is calculated as the average of each AUC between each sequential assessment from pre-treatment-initiation to the week-12 assessment then subtract the corresponding baseline score, with positive scores represent symptoms has improved from baseline and negative scores represent symptoms has worsen from baseline.
Outcome measures
| Measure |
Arm I (Cryotherapy)
n=19 Participants
Patients receive topical cryotherapy for 15 minutes prior to each paclitaxel dose, during paclitaxel infusion and for 15 minutes following paclitaxel completion. Therapy repeats every week for a planned course of 12 weeks of adjuvant paclitaxel.
|
Arm II (Control)
n=20 Participants
Patients receive the standard of care only (paclitaxel at a dose of 80 mg/m2 IV) every week for a planned course of 12 weeks.
|
|---|---|---|
|
Area Under the Curve (AUC) EORTC CIPN20 Tingling Fingers or Hands Item Adjusting for Baseline
|
0.0 Average(subscale value*assessment)
Interval -43.9 to 30.6
|
-2.1 Average(subscale value*assessment)
Interval -68.1 to 63.9
|
PRIMARY outcome
Timeframe: Up to 12 weeksPopulation: Patients who completed the EORTC QLQ-CIPN20 at pre-treatment-initiation and at least once post-treatment initiation.
Average Area Under the Curve per assessment (aAUCpa) of EORTC Chemotherapy-Induced Peripheral Neuropathy Module (EORTC QLQ-CIPN20) Tingling Toes or Feet over 12 weeks adjusting for baseline (item 1; "During the past week, did you have tingling toes or feet?"; 1=Not at all, 2=A little, 3=Quite a bit; and 4=Very much). The reported score was transform into 0-100 scale, with higher scores represent fewer symptoms (better QOL). The aAUCpa for the individual item is calculated as the average of each AUC between each sequential assessment from pre-treatment-initiation to the week-12 assessment then subtract the corresponding baseline score, with positive scores represent symptoms has improved from baseline and negative scores represent symptoms has worsen from baseline.
Outcome measures
| Measure |
Arm I (Cryotherapy)
n=19 Participants
Patients receive topical cryotherapy for 15 minutes prior to each paclitaxel dose, during paclitaxel infusion and for 15 minutes following paclitaxel completion. Therapy repeats every week for a planned course of 12 weeks of adjuvant paclitaxel.
|
Arm II (Control)
n=20 Participants
Patients receive the standard of care only (paclitaxel at a dose of 80 mg/m2 IV) every week for a planned course of 12 weeks.
|
|---|---|---|
|
Area Under the Curve (AUC) EORTC CIPN20 Tingling Toes or Feet Item Adjusting for Baseline
|
-1.7 Average(subscale value*assessment)
Interval -29.2 to 19.4
|
-4.9 Average(subscale value*assessment)
Interval -87.5 to 63.9
|
PRIMARY outcome
Timeframe: Up to 12 weeksPopulation: Patients who completed the EORTC QLQ-CIPN20 at pre-treatment-initiation and at least once post-treatment initiation.
Average Area Under the Curve per assessment (aAUCpa) of EORTC Chemotherapy-Induced Peripheral Neuropathy Module (EORTC QLQ-CIPN20) Numbness Fingers or Hands over 12 weeks adjusting for baseline (item 1; "During the past week, did you have numbness in your fingers or hands?"; 1=Not at all, 2=A little, 3=Quite a bit; and 4=Very much). The reported score was transform into 0-100 scale, with higher scores represent fewer symptoms (better QOL). The aAUCpa for the individual item is calculated as the average of each AUC between each sequential assessment from pre-treatment-initiation to the week-12 assessment then subtract the corresponding baseline score, with positive scores represent symptoms has improved from baseline and negative scores represent symptoms has worsen from baseline.
Outcome measures
| Measure |
Arm I (Cryotherapy)
n=19 Participants
Patients receive topical cryotherapy for 15 minutes prior to each paclitaxel dose, during paclitaxel infusion and for 15 minutes following paclitaxel completion. Therapy repeats every week for a planned course of 12 weeks of adjuvant paclitaxel.
|
Arm II (Control)
n=20 Participants
Patients receive the standard of care only (paclitaxel at a dose of 80 mg/m2 IV) every week for a planned course of 12 weeks.
|
|---|---|---|
|
Area Under the Curve (AUC) EORTC CIPN20 Numbness Fingers or Hands Item Adjusting for Baseline
|
-5.6 Average(subscale value*assessment)
Interval -36.4 to 61.1
|
-4.9 Average(subscale value*assessment)
Interval -59.7 to 0.0
|
PRIMARY outcome
Timeframe: Up to 12 weeksPopulation: Patients who completed the EORTC QLQ-CIPN20 at pre-treatment-initiation and at least once post-treatment initiation.
Average Area Under the Curve per assessment (aAUCpa) of EORTC Chemotherapy-Induced Peripheral Neuropathy Module (EORTC QLQ-CIPN20) Numbness Toes or Feet over 12 weeks adjusting for baseline (item 1; "During the past week, did you have numbness in your toes or feet?"; 1=Not at all, 2=A little, 3=Quite a bit; and 4=Very much). The reported score was transform into 0-100 scale, with higher scores represent fewer symptoms (better QOL). The aAUCpa for the individual item is calculated as the average of each AUC between each sequential assessment from pre-treatment-initiation to the week-12 assessment then subtract the corresponding baseline score, with positive scores represent symptoms has improved from baseline and negative scores represent symptoms has worsen from baseline.
Outcome measures
| Measure |
Arm I (Cryotherapy)
n=19 Participants
Patients receive topical cryotherapy for 15 minutes prior to each paclitaxel dose, during paclitaxel infusion and for 15 minutes following paclitaxel completion. Therapy repeats every week for a planned course of 12 weeks of adjuvant paclitaxel.
|
Arm II (Control)
n=20 Participants
Patients receive the standard of care only (paclitaxel at a dose of 80 mg/m2 IV) every week for a planned course of 12 weeks.
|
|---|---|---|
|
Area Under the Curve (AUC) EORTC CIPN20 Numbness Toes or Feet Item Adjusting for Baseline
|
0.0 Average(subscale value*assessment)
Interval -20.8 to 13.9
|
-3.2 Average(subscale value*assessment)
Interval -58.3 to 23.6
|
PRIMARY outcome
Timeframe: Up to 12 weeksPopulation: Patients who completed the EORTC QLQ-CIPN20 at pre-treatment-initiation and at least once post-treatment initiation.
Average Area Under the Curve per assessment (aAUCpa) of EORTC Chemotherapy-Induced Peripheral Neuropathy Module (EORTC QLQ-CIPN20) Shooting/Burning Pain in Fingers or Hands over 12 weeks adjusting for baseline (item 1; "During the past week, did you have shooting or burning pain in your fingers or hands?"; 1=Not at all, 2=A little, 3=Quite a bit; and 4=Very much). The reported score was transform into 0-100 scale, with higher scores represent fewer symptoms (better QOL). The aAUCpa for the individual item is calculated as the average of each AUC between each sequential assessment from pre-treatment-initiation to the week-12 assessment then subtract the corresponding baseline score, with positive scores represent symptoms has improved from baseline and negative scores represent symptoms has worsen from baseline.
Outcome measures
| Measure |
Arm I (Cryotherapy)
n=19 Participants
Patients receive topical cryotherapy for 15 minutes prior to each paclitaxel dose, during paclitaxel infusion and for 15 minutes following paclitaxel completion. Therapy repeats every week for a planned course of 12 weeks of adjuvant paclitaxel.
|
Arm II (Control)
n=20 Participants
Patients receive the standard of care only (paclitaxel at a dose of 80 mg/m2 IV) every week for a planned course of 12 weeks.
|
|---|---|---|
|
Area Under the Curve (AUC) EORTC CIPN20 Shooting/Burning Pain in Fingers or Hands Item Adjusting for Baseline
|
0.0 Average(subscale value*assessment)
Interval -26.4 to 0.0
|
0.0 Average(subscale value*assessment)
Interval -54.2 to 0.0
|
PRIMARY outcome
Timeframe: Up to 12 weeksPopulation: Patients who completed the EORTC QLQ-CIPN20 at pre-treatment-initiation and at least once post-treatment initiation.
Average Area Under the Curve per assessment (aAUCpa) of EORTC Chemotherapy-Induced Peripheral Neuropathy Module (EORTC QLQ-CIPN20) Shooting/Burning Pain in Toes or Feet over 12 weeks adjusting for baseline (item 1; "During the past week, did you have shooting or burning pain in your Toes or Feet?"; 1=Not at all, 2=A little, 3=Quite a bit; and 4=Very much). The reported score was transform into 0-100 scale, with higher scores represent fewer symptoms (better QOL). The aAUCpa for the individual item is calculated as the average of each AUC between each sequential assessment from pre-treatment-initiation to the week-12 assessment then subtract the corresponding baseline score, with positive scores represent symptoms has improved from baseline and negative scores represent symptoms has worsen from baseline.
Outcome measures
| Measure |
Arm I (Cryotherapy)
n=19 Participants
Patients receive topical cryotherapy for 15 minutes prior to each paclitaxel dose, during paclitaxel infusion and for 15 minutes following paclitaxel completion. Therapy repeats every week for a planned course of 12 weeks of adjuvant paclitaxel.
|
Arm II (Control)
n=20 Participants
Patients receive the standard of care only (paclitaxel at a dose of 80 mg/m2 IV) every week for a planned course of 12 weeks.
|
|---|---|---|
|
Area Under the Curve (AUC) EORTC CIPN20 Shooting/Burning Pain in Toes or Feet Item Adjusting for Baseline
|
0.0 Average(subscale value*assessment)
Interval -37.5 to 36.4
|
0.0 Average(subscale value*assessment)
Interval -73.6 to 0.0
|
SECONDARY outcome
Timeframe: 1 weekPopulation: Patients who completed the Daily Post-Paclitaxel Questionnaire over the first week of paclitaxel were included in this analysis.
Average Area Under the Curve (AUC) per assessment (aAUCpa) of worst pain (item 1 on the Daily Post-Paclitaxel Questionnaire; "Please rate any aches/pain that are new since your last dose of paclitaxel, and that you think might be related to your chemotherapy treatment, by circling ONE number that best describes your aches/pain at its WORST in the last 24 hours.") over 1 week. Scores are reported on a 0-100 scale, where 100=better outcome quality of life (QOL). The aAUCpa is the average of each AUC between each sequential assessment from day 2 through 7 following paclitaxel.
Outcome measures
| Measure |
Arm I (Cryotherapy)
n=19 Participants
Patients receive topical cryotherapy for 15 minutes prior to each paclitaxel dose, during paclitaxel infusion and for 15 minutes following paclitaxel completion. Therapy repeats every week for a planned course of 12 weeks of adjuvant paclitaxel.
|
Arm II (Control)
n=19 Participants
Patients receive the standard of care only (paclitaxel at a dose of 80 mg/m2 IV) every week for a planned course of 12 weeks.
|
|---|---|---|
|
Area Under the Curve (AUC) Per Assessment (aAUCpa) of Worst Pain (Item 1 on the Daily Post-Paclitaxel Questionnaire)
|
95.0 Average(subscale value*assessment)
Interval 57.0 to 100.0
|
96.0 Average(subscale value*assessment)
Interval 27.5 to 100.0
|
Adverse Events
Arm I (Cryotherapy)
Arm II (Control)
Serious adverse events
| Measure |
Arm I (Cryotherapy)
n=21 participants at risk
Patients receive topical cryotherapy for 15 minutes prior to each paclitaxel dose, during paclitaxel infusion and for 15 minutes following paclitaxel completion. Therapy repeats every week for a planned course of 12 weeks of adjuvant paclitaxel.
|
Arm II (Control)
n=21 participants at risk
Patients receive the standard of care only (paclitaxel at a dose of 80 mg/m2 IV) every week for a planned course of 12 weeks.
|
|---|---|---|
|
Infections and infestations
Lung infection
|
0.00%
0/21 • Up to 12 weeks
The descriptions \& grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for AE reporting. Each CTCAE term in the current version is a unique representation of a specific event used for medical documentation \& scientific analysis \& is a single MedDRA Lowest Level Term (LLT).
|
4.8%
1/21 • Number of events 1 • Up to 12 weeks
The descriptions \& grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for AE reporting. Each CTCAE term in the current version is a unique representation of a specific event used for medical documentation \& scientific analysis \& is a single MedDRA Lowest Level Term (LLT).
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure
|
0.00%
0/21 • Up to 12 weeks
The descriptions \& grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for AE reporting. Each CTCAE term in the current version is a unique representation of a specific event used for medical documentation \& scientific analysis \& is a single MedDRA Lowest Level Term (LLT).
|
4.8%
1/21 • Number of events 1 • Up to 12 weeks
The descriptions \& grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for AE reporting. Each CTCAE term in the current version is a unique representation of a specific event used for medical documentation \& scientific analysis \& is a single MedDRA Lowest Level Term (LLT).
|
Other adverse events
| Measure |
Arm I (Cryotherapy)
n=21 participants at risk
Patients receive topical cryotherapy for 15 minutes prior to each paclitaxel dose, during paclitaxel infusion and for 15 minutes following paclitaxel completion. Therapy repeats every week for a planned course of 12 weeks of adjuvant paclitaxel.
|
Arm II (Control)
n=21 participants at risk
Patients receive the standard of care only (paclitaxel at a dose of 80 mg/m2 IV) every week for a planned course of 12 weeks.
|
|---|---|---|
|
Cardiac disorders
Cardiac disorders - Other, specify
|
4.8%
1/21 • Number of events 1 • Up to 12 weeks
The descriptions \& grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for AE reporting. Each CTCAE term in the current version is a unique representation of a specific event used for medical documentation \& scientific analysis \& is a single MedDRA Lowest Level Term (LLT).
|
0.00%
0/21 • Up to 12 weeks
The descriptions \& grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for AE reporting. Each CTCAE term in the current version is a unique representation of a specific event used for medical documentation \& scientific analysis \& is a single MedDRA Lowest Level Term (LLT).
|
|
Cardiac disorders
Supraventricular tachycardia
|
0.00%
0/21 • Up to 12 weeks
The descriptions \& grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for AE reporting. Each CTCAE term in the current version is a unique representation of a specific event used for medical documentation \& scientific analysis \& is a single MedDRA Lowest Level Term (LLT).
|
4.8%
1/21 • Number of events 1 • Up to 12 weeks
The descriptions \& grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for AE reporting. Each CTCAE term in the current version is a unique representation of a specific event used for medical documentation \& scientific analysis \& is a single MedDRA Lowest Level Term (LLT).
|
|
Gastrointestinal disorders
Constipation
|
0.00%
0/21 • Up to 12 weeks
The descriptions \& grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for AE reporting. Each CTCAE term in the current version is a unique representation of a specific event used for medical documentation \& scientific analysis \& is a single MedDRA Lowest Level Term (LLT).
|
4.8%
1/21 • Number of events 4 • Up to 12 weeks
The descriptions \& grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for AE reporting. Each CTCAE term in the current version is a unique representation of a specific event used for medical documentation \& scientific analysis \& is a single MedDRA Lowest Level Term (LLT).
|
|
Gastrointestinal disorders
Diarrhea
|
0.00%
0/21 • Up to 12 weeks
The descriptions \& grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for AE reporting. Each CTCAE term in the current version is a unique representation of a specific event used for medical documentation \& scientific analysis \& is a single MedDRA Lowest Level Term (LLT).
|
9.5%
2/21 • Number of events 4 • Up to 12 weeks
The descriptions \& grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for AE reporting. Each CTCAE term in the current version is a unique representation of a specific event used for medical documentation \& scientific analysis \& is a single MedDRA Lowest Level Term (LLT).
|
|
General disorders
Fatigue
|
0.00%
0/21 • Up to 12 weeks
The descriptions \& grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for AE reporting. Each CTCAE term in the current version is a unique representation of a specific event used for medical documentation \& scientific analysis \& is a single MedDRA Lowest Level Term (LLT).
|
14.3%
3/21 • Number of events 8 • Up to 12 weeks
The descriptions \& grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for AE reporting. Each CTCAE term in the current version is a unique representation of a specific event used for medical documentation \& scientific analysis \& is a single MedDRA Lowest Level Term (LLT).
|
|
Investigations
Alanine aminotransferase increased
|
0.00%
0/21 • Up to 12 weeks
The descriptions \& grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for AE reporting. Each CTCAE term in the current version is a unique representation of a specific event used for medical documentation \& scientific analysis \& is a single MedDRA Lowest Level Term (LLT).
|
4.8%
1/21 • Number of events 2 • Up to 12 weeks
The descriptions \& grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for AE reporting. Each CTCAE term in the current version is a unique representation of a specific event used for medical documentation \& scientific analysis \& is a single MedDRA Lowest Level Term (LLT).
|
|
Investigations
Lymphocyte count decreased
|
14.3%
3/21 • Number of events 4 • Up to 12 weeks
The descriptions \& grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for AE reporting. Each CTCAE term in the current version is a unique representation of a specific event used for medical documentation \& scientific analysis \& is a single MedDRA Lowest Level Term (LLT).
|
9.5%
2/21 • Number of events 12 • Up to 12 weeks
The descriptions \& grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for AE reporting. Each CTCAE term in the current version is a unique representation of a specific event used for medical documentation \& scientific analysis \& is a single MedDRA Lowest Level Term (LLT).
|
|
Investigations
Neutrophil count decreased
|
0.00%
0/21 • Up to 12 weeks
The descriptions \& grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for AE reporting. Each CTCAE term in the current version is a unique representation of a specific event used for medical documentation \& scientific analysis \& is a single MedDRA Lowest Level Term (LLT).
|
9.5%
2/21 • Number of events 2 • Up to 12 weeks
The descriptions \& grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for AE reporting. Each CTCAE term in the current version is a unique representation of a specific event used for medical documentation \& scientific analysis \& is a single MedDRA Lowest Level Term (LLT).
|
|
Investigations
White blood cell decreased
|
0.00%
0/21 • Up to 12 weeks
The descriptions \& grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for AE reporting. Each CTCAE term in the current version is a unique representation of a specific event used for medical documentation \& scientific analysis \& is a single MedDRA Lowest Level Term (LLT).
|
4.8%
1/21 • Number of events 1 • Up to 12 weeks
The descriptions \& grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for AE reporting. Each CTCAE term in the current version is a unique representation of a specific event used for medical documentation \& scientific analysis \& is a single MedDRA Lowest Level Term (LLT).
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.00%
0/21 • Up to 12 weeks
The descriptions \& grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for AE reporting. Each CTCAE term in the current version is a unique representation of a specific event used for medical documentation \& scientific analysis \& is a single MedDRA Lowest Level Term (LLT).
|
4.8%
1/21 • Number of events 1 • Up to 12 weeks
The descriptions \& grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for AE reporting. Each CTCAE term in the current version is a unique representation of a specific event used for medical documentation \& scientific analysis \& is a single MedDRA Lowest Level Term (LLT).
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
4.8%
1/21 • Number of events 1 • Up to 12 weeks
The descriptions \& grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for AE reporting. Each CTCAE term in the current version is a unique representation of a specific event used for medical documentation \& scientific analysis \& is a single MedDRA Lowest Level Term (LLT).
|
0.00%
0/21 • Up to 12 weeks
The descriptions \& grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for AE reporting. Each CTCAE term in the current version is a unique representation of a specific event used for medical documentation \& scientific analysis \& is a single MedDRA Lowest Level Term (LLT).
|
|
Nervous system disorders
Peripheral motor neuropathy
|
0.00%
0/21 • Up to 12 weeks
The descriptions \& grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for AE reporting. Each CTCAE term in the current version is a unique representation of a specific event used for medical documentation \& scientific analysis \& is a single MedDRA Lowest Level Term (LLT).
|
4.8%
1/21 • Number of events 1 • Up to 12 weeks
The descriptions \& grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for AE reporting. Each CTCAE term in the current version is a unique representation of a specific event used for medical documentation \& scientific analysis \& is a single MedDRA Lowest Level Term (LLT).
|
|
Nervous system disorders
Peripheral sensory neuropathy
|
0.00%
0/21 • Up to 12 weeks
The descriptions \& grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for AE reporting. Each CTCAE term in the current version is a unique representation of a specific event used for medical documentation \& scientific analysis \& is a single MedDRA Lowest Level Term (LLT).
|
4.8%
1/21 • Number of events 1 • Up to 12 weeks
The descriptions \& grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for AE reporting. Each CTCAE term in the current version is a unique representation of a specific event used for medical documentation \& scientific analysis \& is a single MedDRA Lowest Level Term (LLT).
|
|
Nervous system disorders
Syncope
|
0.00%
0/21 • Up to 12 weeks
The descriptions \& grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for AE reporting. Each CTCAE term in the current version is a unique representation of a specific event used for medical documentation \& scientific analysis \& is a single MedDRA Lowest Level Term (LLT).
|
4.8%
1/21 • Number of events 1 • Up to 12 weeks
The descriptions \& grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for AE reporting. Each CTCAE term in the current version is a unique representation of a specific event used for medical documentation \& scientific analysis \& is a single MedDRA Lowest Level Term (LLT).
|
|
Psychiatric disorders
Insomnia
|
0.00%
0/21 • Up to 12 weeks
The descriptions \& grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for AE reporting. Each CTCAE term in the current version is a unique representation of a specific event used for medical documentation \& scientific analysis \& is a single MedDRA Lowest Level Term (LLT).
|
4.8%
1/21 • Number of events 1 • Up to 12 weeks
The descriptions \& grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for AE reporting. Each CTCAE term in the current version is a unique representation of a specific event used for medical documentation \& scientific analysis \& is a single MedDRA Lowest Level Term (LLT).
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
0.00%
0/21 • Up to 12 weeks
The descriptions \& grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for AE reporting. Each CTCAE term in the current version is a unique representation of a specific event used for medical documentation \& scientific analysis \& is a single MedDRA Lowest Level Term (LLT).
|
9.5%
2/21 • Number of events 21 • Up to 12 weeks
The descriptions \& grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for AE reporting. Each CTCAE term in the current version is a unique representation of a specific event used for medical documentation \& scientific analysis \& is a single MedDRA Lowest Level Term (LLT).
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place