Trial Outcomes & Findings for Duloxetine in Treating Peripheral Neuropathy Caused by Chemotherapy in Patients With Cancer (NCT NCT00489411)

Last Updated: 2017-04-26

Results Overview

Change in average pain from Week 1 to Week 5, measured on day 1 of Weeks 1 and 6 by the Brief Pain Inventory Short Form (BPI-SF) was calculated as value at Day 1 of Week 1 minus value at Day 1 of Week 6 to yield positive improvement values. The BPI-SF contains 4 items assessing average, worst, least, and intermediate pain severity in the last 24 hours. Pain severity items are scored using an 11-point numeric rating scale (0, no pain; 10, pain as bad as you can imagine). Average pain severity was chosen as the primary outcome based on recommendations from the Initiative on Methods, Measurements, and Pain Assessment in Clinical Trials (IMMPACT). Patients completed the BPI-SF when thinking only about pain from peripheral neuropathy. The Cronbach's alpha reliability for the BPI ranges between 0.77 and 0.91. The comparison of interest was the difference between the 2 treatment groups in pain change during the initial treatment period.

Recruitment status

COMPLETED

Study phase

PHASE3

Target enrollment

231 participants

Primary outcome timeframe

Day 1 of Week 1 to Day 1 of Week 6

Results posted on

2017-04-26

Participant Flow

The number of screened and the number offered participation but declined was not captured.

Participant milestones

Participant milestones
Measure	Arm I/Group A (Duloxetine Then Placebo) Patients will take one capsule of 30 mg duloxetine orally daily for 7 days (week 1), and then increase to two capsules of duloxetine (60 mg duloxetine) orally daily for 28 days (weeks 2-5). Duloxetine will be tapered during week 6 (one capsule daily for 7 days), and will be discontinued during week 7 (no capsules for 7 days). Patients will then cross over to receive the alternative treatment (placebo), and the sequence will be repeated. Patients will take one capsule of placebo daily for 7 days (week 8), two capsules of placebo daily for 28 days (weeks 9-12), one capsule of placebo daily for 7 days (week 13), and then no capsules for 7 days (week 14).	Arm II/Group B (Placebo Then Duloxetine) Patients will take one capsule of placebo orally daily for 7 days (week 1), and then increase to two capsules of placebo orally daily for 28 days (weeks 2-5). Placebo will be tapered during week 6 (one capsule daily for 7 days), and will be discontinued during week 7 (no capsules for 7 days). Patients will then cross over to receive the alternative treatment (duloxetine), and the sequence will be repeated. Patients will take one capsule of duloxetine daily for 7 days (week 8), two capsules of duloxetine daily for 28 days (weeks 9-12), one capsule of duloxetine daily for 7 days (week 13), and then no capsules for 7 days (week 14).
Initial Treatment Period (Weeks 1-5) STARTED	115	116
Initial Treatment Period (Weeks 1-5) COMPLETED	87	94
Initial Treatment Period (Weeks 1-5) NOT COMPLETED	28	22
Washout Period (Weeks 6-7) STARTED	87	94
Washout Period (Weeks 6-7) COMPLETED	85	93
Washout Period (Weeks 6-7) NOT COMPLETED	2	1
Crossover Treatment Period (Weeks 8-12) STARTED	85	93
Crossover Treatment Period (Weeks 8-12) COMPLETED	67	74
Crossover Treatment Period (Weeks 8-12) NOT COMPLETED	18	19

Reasons for withdrawal

Reasons for withdrawal
Measure	Arm I/Group A (Duloxetine Then Placebo) Patients will take one capsule of 30 mg duloxetine orally daily for 7 days (week 1), and then increase to two capsules of duloxetine (60 mg duloxetine) orally daily for 28 days (weeks 2-5). Duloxetine will be tapered during week 6 (one capsule daily for 7 days), and will be discontinued during week 7 (no capsules for 7 days). Patients will then cross over to receive the alternative treatment (placebo), and the sequence will be repeated. Patients will take one capsule of placebo daily for 7 days (week 8), two capsules of placebo daily for 28 days (weeks 9-12), one capsule of placebo daily for 7 days (week 13), and then no capsules for 7 days (week 14).	Arm II/Group B (Placebo Then Duloxetine) Patients will take one capsule of placebo orally daily for 7 days (week 1), and then increase to two capsules of placebo orally daily for 28 days (weeks 2-5). Placebo will be tapered during week 6 (one capsule daily for 7 days), and will be discontinued during week 7 (no capsules for 7 days). Patients will then cross over to receive the alternative treatment (duloxetine), and the sequence will be repeated. Patients will take one capsule of duloxetine daily for 7 days (week 8), two capsules of duloxetine daily for 28 days (weeks 9-12), one capsule of duloxetine daily for 7 days (week 13), and then no capsules for 7 days (week 14).
Initial Treatment Period (Weeks 1-5) Withdrew consent prior to intervention	6	5
Initial Treatment Period (Weeks 1-5) Discontinued study drug early	21	12
Initial Treatment Period (Weeks 1-5) Incomplete data	1	5
Crossover Treatment Period (Weeks 8-12) Discontinued intervention early	11	12
Crossover Treatment Period (Weeks 8-12) Incomplete data	7	7

Baseline Characteristics

Duloxetine in Treating Peripheral Neuropathy Caused by Chemotherapy in Patients With Cancer

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Arm I/Group A (Duloxetine Then Placebo) n=109 Participants Patients will take one capsule of 30 mg duloxetine orally daily for 7 days (week 1), and then increase to two capsules of duloxetine (60 mg duloxetine) orally daily for 28 days (weeks 2-5). Duloxetine will be tapered during week 6 (one capsule daily for 7 days), and will be discontinued during week 7 (no capsules for 7 days). Patients will then cross over to receive the alternative treatment (placebo), and the sequence will be repeated. Patients will take one capsule of placebo daily for 7 days (week 8), two capsules of placebo daily for 28 days (weeks 9-12), one capsule of placebo daily for 7 days (week 13), and then no capsules for 7 days (week 14).	Arm II/Group B (Placebo Then Duloxetine) n=111 Participants Patients will take one capsule of placebo orally daily for 7 days (week 1), and then increase to two capsules of placebo orally daily for 28 days (weeks 2-5). Placebo will be tapered during week 6 (one capsule daily for 7 days), and will be discontinued during week 7 (no capsules for 7 days). Patients will then cross over to receive the alternative treatment (duloxetine), and the sequence will be repeated. Patients will take one capsule of duloxetine daily for 7 days (week 8), two capsules of duloxetine daily for 28 days (weeks 9-12), one capsule of duloxetine daily for 7 days (week 13), and then no capsules for 7 days (week 14).	Total n=220 Participants Total of all reporting groups
Age, Continuous	60.0 years STANDARD_DEVIATION 10.4 • n=5 Participants	59.0 years STANDARD_DEVIATION 10.6 • n=7 Participants	59.0 years STANDARD_DEVIATION 10.5 • n=5 Participants
Sex: Female, Male Female	71 Participants n=5 Participants	67 Participants n=7 Participants	138 Participants n=5 Participants
Sex: Female, Male Male	38 Participants n=5 Participants	44 Participants n=7 Participants	82 Participants n=5 Participants
Region of Enrollment United States	109 participants n=5 Participants	111 participants n=7 Participants	220 participants n=5 Participants

PRIMARY outcome

Timeframe: Day 1 of Week 1 to Day 1 of Week 6

Population: Patients who completed initial intervention (prior to crossing over to receive alternate study drug duloxetine or placebo) and had complete data were included in the primary analysis.

Outcome measures

Outcome measures
Measure	Arm I/Group A (Duloxetine Then Placebo) n=87 Participants Patients will take one capsule of 30 mg duloxetine orally daily for 7 days (week 1), and then increase to two capsules of duloxetine (60 mg duloxetine) orally daily for 28 days (weeks 2-5). Duloxetine will be tapered during week 6 (one capsule daily for 7 days), and will be discontinued during week 7 (no capsules for 7 days). Patients will then cross over to receive the alternative treatment (placebo), and the sequence will be repeated. Patients will take one capsule of placebo daily for 7 days (week 8), two capsules of placebo daily for 28 days (weeks 9-12), one capsule of placebo daily for 7 days (week 13), and then no capsules for 7 days (week 14).	Arm II/Group B (Placebo Then Duloxetine) n=94 Participants Patients will take one capsule of placebo orally daily for 7 days (week 1), and then increase to two capsules of placebo orally daily for 28 days (weeks 2-5). Placebo will be tapered during week 6 (one capsule daily for 7 days), and will be discontinued during week 7 (no capsules for 7 days). Patients will then cross over to receive the alternative treatment (duloxetine), and the sequence will be repeated. Patients will take one capsule of duloxetine daily for 7 days (week 8), two capsules of duloxetine daily for 28 days (weeks 9-12), one capsule of duloxetine daily for 7 days (week 13), and then no capsules for 7 days (week 14).
Change in Average Pain From Week 1 to Week 5, as Measured by the BPI-SF Average Pain Severity Item	1.06 units on a scale Interval 0.72 to 1.4	0.34 units on a scale Interval 0.01 to 0.66

SECONDARY outcome

Timeframe: Day 1 of Week 1 to Day 1 to Week 6

Population: Patients who completed initial intervention (prior to crossing over to receive alternate study drug duloxetine or placebo) and had complete data were included in the primary analysis.

Change in pain-related functional interference score during the initial treatment period (Week 1 to Week 5), as measured by the BPI-SF interference score: Using an accepted method for accessing the influence of pain on function, 7 BPI-SF items were used to quantify the degree to which pain interfered with daily activities or function (0, does not interfere; 10 completely interferes). The 7 items were summed to obtain a total interference score, which ranged from 0 to 70, with lower scores meaning less interference. The mean change in pain-related functional interference score during the initial treatment period are reported below for each treatment arm and was calculated as value at Day 1 of Week 1 minus value at Day 1 of Week 6 to yield positive improvement values.

Outcome measures

Outcome measures
Measure	Arm I/Group A (Duloxetine Then Placebo) n=87 Participants Patients will take one capsule of 30 mg duloxetine orally daily for 7 days (week 1), and then increase to two capsules of duloxetine (60 mg duloxetine) orally daily for 28 days (weeks 2-5). Duloxetine will be tapered during week 6 (one capsule daily for 7 days), and will be discontinued during week 7 (no capsules for 7 days). Patients will then cross over to receive the alternative treatment (placebo), and the sequence will be repeated. Patients will take one capsule of placebo daily for 7 days (week 8), two capsules of placebo daily for 28 days (weeks 9-12), one capsule of placebo daily for 7 days (week 13), and then no capsules for 7 days (week 14).	Arm II/Group B (Placebo Then Duloxetine) n=94 Participants Patients will take one capsule of placebo orally daily for 7 days (week 1), and then increase to two capsules of placebo orally daily for 28 days (weeks 2-5). Placebo will be tapered during week 6 (one capsule daily for 7 days), and will be discontinued during week 7 (no capsules for 7 days). Patients will then cross over to receive the alternative treatment (duloxetine), and the sequence will be repeated. Patients will take one capsule of duloxetine daily for 7 days (week 8), two capsules of duloxetine daily for 28 days (weeks 9-12), one capsule of duloxetine daily for 7 days (week 13), and then no capsules for 7 days (week 14).
Change in Pain-related Functional Interference Score From Week 1 to Week 5, as Measured by the BPI-SF Interference Score	7.9 units on a scale Interval 5.4 to 10.5	3.5 units on a scale Interval 1.1 to 5.9

SECONDARY outcome

Timeframe: Day 1 of Week 1 to Day 1 of Week 6

Population: Patients who completed initial intervention (prior to crossing over to receive alternate study drug duloxetine or placebo) and had complete data were included in the primary analysis.

Patient-reported QOL was assessed using the Functional Assessment of Cancer Treatment, Gynecologic Oncology Group Neurotoxicity (FACT/GOG-Ntx) subscale on day 1 of weeks 1, 6, 8, and 13. The instrument contains 11 questions, assessing numbness, tingling, and discomfort in the hands or feet; difficulty hearing; tinnitus; joint pain or muscle cramps; weakness; or trouble walking, buttoning buttons, or feeling small shapes when placed in the hand. Items are scored from 0 to 4 (o, not at all; 4, very much) and summed (total score range, 0-44, with higher scores indicating a worse outcome). A 2- to 3-point change is defined as a clinically meaningful improvement in QOL per published recommendations specific to similar measures. The Mean Change During Initial Treatment Period in the FACT/GOG-Ntx total score are reported for each treatment arm and was calculated as value at Day 1 of Week 1 minus value at Day 1 of Week 6 to yield positive improvement values.

Outcome measures

Outcome measures
Measure	Arm I/Group A (Duloxetine Then Placebo) n=87 Participants Patients will take one capsule of 30 mg duloxetine orally daily for 7 days (week 1), and then increase to two capsules of duloxetine (60 mg duloxetine) orally daily for 28 days (weeks 2-5). Duloxetine will be tapered during week 6 (one capsule daily for 7 days), and will be discontinued during week 7 (no capsules for 7 days). Patients will then cross over to receive the alternative treatment (placebo), and the sequence will be repeated. Patients will take one capsule of placebo daily for 7 days (week 8), two capsules of placebo daily for 28 days (weeks 9-12), one capsule of placebo daily for 7 days (week 13), and then no capsules for 7 days (week 14).	Arm II/Group B (Placebo Then Duloxetine) n=94 Participants Patients will take one capsule of placebo orally daily for 7 days (week 1), and then increase to two capsules of placebo orally daily for 28 days (weeks 2-5). Placebo will be tapered during week 6 (one capsule daily for 7 days), and will be discontinued during week 7 (no capsules for 7 days). Patients will then cross over to receive the alternative treatment (duloxetine), and the sequence will be repeated. Patients will take one capsule of duloxetine daily for 7 days (week 8), two capsules of duloxetine daily for 28 days (weeks 9-12), one capsule of duloxetine daily for 7 days (week 13), and then no capsules for 7 days (week 14).
Change in the Total Score of the FACT/COG-NTX From Week 1 to Week 5	2.44 units on a scale Interval 0.43 to 4.45	0.87 units on a scale Interval -1.09 to 2.82

SECONDARY outcome

Timeframe: Day 1 of Week 8 to Day 1 of Week 13

Population: Patients who completed crossover intervention and had complete data were included in the analysis.

Change in average pain from Week 8 to Week 12, measured on day 1 of Weeks 8 and 13 by the Brief Pain Inventory Short Form (BPI-SF) was calculated as value at Day 1 of Week 8 minus value at Day 1 of Week 13 to yield positive improvement values. The BPI-SF contains 4 items assessing average, worst, least, and intermediate pain severity in the last 24 hours. Pain severity items are scored using an 11-point numeric rating scale (0, no pain; 10, pain as bad as you can imagine). Average pain severity was chosen as the primary outcome based on recommendations from the Initiative on Methods, Measurements, and Pain Assessment in Clinical Trials (IMMPACT). Patients completed the BPI-SF when thinking only about pain from peripheral neuropathy. The Cronbach's alpha reliability for the BPI ranges between 0.77 and 0.91. The comparison of interest was the difference between the 2 treatment groups in pain change during the crossover treatment period.

Outcome measures

Outcome measures
Measure	Arm I/Group A (Duloxetine Then Placebo) n=67 Participants Patients will take one capsule of 30 mg duloxetine orally daily for 7 days (week 1), and then increase to two capsules of duloxetine (60 mg duloxetine) orally daily for 28 days (weeks 2-5). Duloxetine will be tapered during week 6 (one capsule daily for 7 days), and will be discontinued during week 7 (no capsules for 7 days). Patients will then cross over to receive the alternative treatment (placebo), and the sequence will be repeated. Patients will take one capsule of placebo daily for 7 days (week 8), two capsules of placebo daily for 28 days (weeks 9-12), one capsule of placebo daily for 7 days (week 13), and then no capsules for 7 days (week 14).	Arm II/Group B (Placebo Then Duloxetine) n=74 Participants Patients will take one capsule of placebo orally daily for 7 days (week 1), and then increase to two capsules of placebo orally daily for 28 days (weeks 2-5). Placebo will be tapered during week 6 (one capsule daily for 7 days), and will be discontinued during week 7 (no capsules for 7 days). Patients will then cross over to receive the alternative treatment (duloxetine), and the sequence will be repeated. Patients will take one capsule of duloxetine daily for 7 days (week 8), two capsules of duloxetine daily for 28 days (weeks 9-12), one capsule of duloxetine daily for 7 days (week 13), and then no capsules for 7 days (week 14).
Change in Average Pain From Week 8 to Week 12, as Measured by the BPI-SF Average Pain Severity Item	0.41 units on a scale Interval 0.06 to 0.89	1.42 units on a scale Interval 0.97 to 1.87

Adverse Events

Arm I/Group A (Duloxetine Then Placebo)

Serious events: 1 serious events

Other events: 93 other events

Deaths: 0 deaths

Arm II/Group B (Placebo Then Duloxetine)

Serious events: 3 serious events

Other events: 91 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Arm I/Group A (Duloxetine Then Placebo) n=108 participants at risk Patients will take one capsule of 30 mg duloxetine orally daily for 7 days (week 1), and then increase to two capsules of duloxetine (60 mg duloxetine) orally daily for 28 days (weeks 2-5). Duloxetine will be tapered during week 6 (one capsule daily for 7 days), and will be discontinued during week 7 (no capsules for 7 days). Patients will then cross over to receive the alternative treatment (placebo), and the sequence will be repeated. Patients will take one capsule of placebo daily for 7 days (week 8), two capsules of placebo daily for 28 days (weeks 9-12), one capsule of placebo daily for 7 days (week 13), and then no capsules for 7 days (week 14).	Arm II/Group B (Placebo Then Duloxetine) n=107 participants at risk Patients will take one capsule of placebo orally daily for 7 days (week 1), and then increase to two capsules of placebo orally daily for 28 days (weeks 2-5). Placebo will be tapered during week 6 (one capsule daily for 7 days), and will be discontinued during week 7 (no capsules for 7 days). Patients will then cross over to receive the alternative treatment (duloxetine), and the sequence will be repeated. Patients will take one capsule of duloxetine daily for 7 days (week 8), two capsules of duloxetine daily for 28 days (weeks 9-12), one capsule of duloxetine daily for 7 days (week 13), and then no capsules for 7 days (week 14).
Gastrointestinal disorders Diarrhea	0.00% 0/108 • Adverse events are assessed during weeks 1-15 of the study. The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for AE reporting. All graded adverse events are reported. AEs are presented "per sequence" based on how they were collected in the study. The Number of Participants at Risk include subjects who received an intervention, did not have incomplete AE data during primary analysis, and did not withdraw consent prior to receiving the intervention.	1.9% 2/107 • Number of events 2 • Adverse events are assessed during weeks 1-15 of the study. The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for AE reporting. All graded adverse events are reported. AEs are presented "per sequence" based on how they were collected in the study. The Number of Participants at Risk include subjects who received an intervention, did not have incomplete AE data during primary analysis, and did not withdraw consent prior to receiving the intervention.
Gastrointestinal disorders Vomiting	0.00% 0/108 • Adverse events are assessed during weeks 1-15 of the study. The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for AE reporting. All graded adverse events are reported. AEs are presented "per sequence" based on how they were collected in the study. The Number of Participants at Risk include subjects who received an intervention, did not have incomplete AE data during primary analysis, and did not withdraw consent prior to receiving the intervention.	0.93% 1/107 • Number of events 1 • Adverse events are assessed during weeks 1-15 of the study. The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for AE reporting. All graded adverse events are reported. AEs are presented "per sequence" based on how they were collected in the study. The Number of Participants at Risk include subjects who received an intervention, did not have incomplete AE data during primary analysis, and did not withdraw consent prior to receiving the intervention.
General disorders Fatigue	0.00% 0/108 • Adverse events are assessed during weeks 1-15 of the study. The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for AE reporting. All graded adverse events are reported. AEs are presented "per sequence" based on how they were collected in the study. The Number of Participants at Risk include subjects who received an intervention, did not have incomplete AE data during primary analysis, and did not withdraw consent prior to receiving the intervention.	0.93% 1/107 • Number of events 1 • Adverse events are assessed during weeks 1-15 of the study. The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for AE reporting. All graded adverse events are reported. AEs are presented "per sequence" based on how they were collected in the study. The Number of Participants at Risk include subjects who received an intervention, did not have incomplete AE data during primary analysis, and did not withdraw consent prior to receiving the intervention.
Injury, poisoning and procedural complications Vascular access complication	0.00% 0/108 • Adverse events are assessed during weeks 1-15 of the study. The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for AE reporting. All graded adverse events are reported. AEs are presented "per sequence" based on how they were collected in the study. The Number of Participants at Risk include subjects who received an intervention, did not have incomplete AE data during primary analysis, and did not withdraw consent prior to receiving the intervention.	0.93% 1/107 • Number of events 1 • Adverse events are assessed during weeks 1-15 of the study. The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for AE reporting. All graded adverse events are reported. AEs are presented "per sequence" based on how they were collected in the study. The Number of Participants at Risk include subjects who received an intervention, did not have incomplete AE data during primary analysis, and did not withdraw consent prior to receiving the intervention.
Metabolism and nutrition disorders Anorexia	0.00% 0/108 • Adverse events are assessed during weeks 1-15 of the study. The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for AE reporting. All graded adverse events are reported. AEs are presented "per sequence" based on how they were collected in the study. The Number of Participants at Risk include subjects who received an intervention, did not have incomplete AE data during primary analysis, and did not withdraw consent prior to receiving the intervention.	0.93% 1/107 • Number of events 1 • Adverse events are assessed during weeks 1-15 of the study. The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for AE reporting. All graded adverse events are reported. AEs are presented "per sequence" based on how they were collected in the study. The Number of Participants at Risk include subjects who received an intervention, did not have incomplete AE data during primary analysis, and did not withdraw consent prior to receiving the intervention.
Nervous system disorders Dizziness	0.00% 0/108 • Adverse events are assessed during weeks 1-15 of the study. The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for AE reporting. All graded adverse events are reported. AEs are presented "per sequence" based on how they were collected in the study. The Number of Participants at Risk include subjects who received an intervention, did not have incomplete AE data during primary analysis, and did not withdraw consent prior to receiving the intervention.	0.93% 1/107 • Number of events 1 • Adverse events are assessed during weeks 1-15 of the study. The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for AE reporting. All graded adverse events are reported. AEs are presented "per sequence" based on how they were collected in the study. The Number of Participants at Risk include subjects who received an intervention, did not have incomplete AE data during primary analysis, and did not withdraw consent prior to receiving the intervention.
Nervous system disorders Headache	0.93% 1/108 • Number of events 1 • Adverse events are assessed during weeks 1-15 of the study. The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for AE reporting. All graded adverse events are reported. AEs are presented "per sequence" based on how they were collected in the study. The Number of Participants at Risk include subjects who received an intervention, did not have incomplete AE data during primary analysis, and did not withdraw consent prior to receiving the intervention.	0.93% 1/107 • Number of events 1 • Adverse events are assessed during weeks 1-15 of the study. The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for AE reporting. All graded adverse events are reported. AEs are presented "per sequence" based on how they were collected in the study. The Number of Participants at Risk include subjects who received an intervention, did not have incomplete AE data during primary analysis, and did not withdraw consent prior to receiving the intervention.
Nervous system disorders Peripheral sensory neuropathy	0.00% 0/108 • Adverse events are assessed during weeks 1-15 of the study. The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for AE reporting. All graded adverse events are reported. AEs are presented "per sequence" based on how they were collected in the study. The Number of Participants at Risk include subjects who received an intervention, did not have incomplete AE data during primary analysis, and did not withdraw consent prior to receiving the intervention.	0.93% 1/107 • Number of events 1 • Adverse events are assessed during weeks 1-15 of the study. The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for AE reporting. All graded adverse events are reported. AEs are presented "per sequence" based on how they were collected in the study. The Number of Participants at Risk include subjects who received an intervention, did not have incomplete AE data during primary analysis, and did not withdraw consent prior to receiving the intervention.
Psychiatric disorders Insomnia	0.93% 1/108 • Number of events 1 • Adverse events are assessed during weeks 1-15 of the study. The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for AE reporting. All graded adverse events are reported. AEs are presented "per sequence" based on how they were collected in the study. The Number of Participants at Risk include subjects who received an intervention, did not have incomplete AE data during primary analysis, and did not withdraw consent prior to receiving the intervention.	0.93% 1/107 • Number of events 1 • Adverse events are assessed during weeks 1-15 of the study. The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for AE reporting. All graded adverse events are reported. AEs are presented "per sequence" based on how they were collected in the study. The Number of Participants at Risk include subjects who received an intervention, did not have incomplete AE data during primary analysis, and did not withdraw consent prior to receiving the intervention.

Other adverse events

Additional Information

Ellen Lavoie Smith, PhD, APRN, AOCN, FAAN

University of Michigan School of Nursing

Phone: 734-936-1267

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place