Breast Cancer
Conditions
Keywords
Breast cancer, Chemotherapy, Pegfilgrastim, Neulasta, Bone Pain, Education
Brief summary
The purpose of this study is to determine if patient education can affect patient reported bone pain in breast cancer patients receiving chemotherapy and pegfilgrastim.
Detailed description
In this study, the effect of patient education on reported bone pain in breast cancer patients receiving adjuvant or neoadjuvant chemotherapy and pegfilgrastim will be investigated. Each patient will receive adjuvant or neoadjuvant chemotherapy with pegfilgrastim prophylaxis, beginning in the first cycle and continuing throughout the study period. The study period for this study is the first 4 cycles of chemotherapy. participants can be planning to receive regimens with \> 4 cycles, but data will only be collected for the first 4 cycles. The choice of chemotherapy regimen (agent, dose, and schedule) is at the discretion of the treating physician. Commercially available pegfilgrastim will be administered according to US Prescribing Information and is considered background therapy.
Interventions
OTHERGeneral Education DVD
A general chemotherapy side effects education DVD
OTHERBone Pain Education DVD
Sponsors
Amgen
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
SINGLE (Investigator)
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 99 Years
Healthy volunteers
No
Inclusion criteria
* Age 18 years or over * Eastern cooperative oncology group (ECOG) performance status 0-2 * Female with newly diagnosed, not previously treated with chemotherapy, stage I-III breast cancer * Planning to receive at least 4 cycles of adjuvant or neoadjuvant chemotherapy * Medically eligible to safely receive adjuvant or neoadjuvant chemotherapy and pegfilgrastim as determined by the investigator * Planning to receive prophylaxis with pegfilgrastim starting in the first cycle and continuing throughout each chemotherapy cycle of the study period * Has provided informed consent * Able to understand the content of the DVD material, in investigator's opinion * Able to read and understand English
Exclusion criteria
* Planning to receive weekly chemotherapy * Chronic use of oral non-steroidal anti-inflammatory drugs (NSAIDs) or oral antihistamines with the following exception: \- Chronic oral aspirin use for cardiovascular-related indications * Ongoing chronic pain, or other painful conditions requiring treatment (including immediate post-operative treatment of surgical or procedural-associated pain) as determined by the investigator * Chronic oral steroid use. Premedication related to the administration of taxanes, and use of anti-emetics is allowed, per usual clinical practice. * Prior chemotherapy treatment for cancer within 5 years of current breast cancer diagnosis * Prior use of granulocyte-colony stimulating factor (G-CSF) * Currently enrolled in, or less than 30 days since ending, another clinical trial which includes language directing G-CSF (filgrastim, pegfilgrastim, other) or granulocyte-macrophage colony stimulating factor (GM-CSF) (sargramostim) use * Currently enrolled in, or less than 30 days since ending, another interventional clinical trial which includes a blinded treatment or blinded treatment arm (whether or not the subject is randomized to the blinded arm) * Currently enrolled in, or less than 30 days since ending, another interventional clinical trial which includes the use of any agent not currently considered to be standard therapy for the adjuvant or neoadjuvant treatment of stage I-III breast cancer based on National Comprehensive Cancer Network (NCCN) Clinical Practice Guidelines in Oncology for Breast Cancer * Currently enrolled in, or less than 30 days since ending, any pain intervention study
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Maximum Patient-reported Bone Pain in Cycle 1 | Days 1 to 5 during cycle 1. | Participants completed a brief bone pain survey once per day for 5 days beginning the day they received their pegfilgrastim injection. The bone pain survey collected the severity of pain using a 0 to 10 scale, where 0 = no pain and 10 indicates worst pain. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Mean Patient-reported Bone Pain by Cycle and Across All Cycles | Days 1-5 for 4 treatment cycles | Participants completed a brief bone pain survey once per day for 5 days beginning the day they received their pegfilgrastim injection. The bone pain survey collected the severity of pain using a 0 to 10 scale, where 0 = no pain and 10 indicates worst pain. |
| Patient-reported Bone Pain Area Under the Curve (AUC) by Cycle and Across All Cycles | Days 1-5 for 4 treatment cycles | Patient-reported bone pain AUC was calculated using the trapezoidal rule with bone pain scores from Day 1-5 for each cycle. AUC may range from 0 to 40 per cycle. |
| Maximum Patient-reported Bone Pain by Cycle and Across All Cycles | Days 1-5 for each treatment cycle | Participants completed a brief bone pain survey once per day for 5 days beginning the day they received their pegfilgrastim injection. The bone pain survey collected the severity of pain using a 0 to 10 scale, where 0 = no pain and 10 indicates worst pain. |
| Percentage of Participants With Grade 3 or 4 Bone Pain Captured in Standard Adverse Event Reporting | From randomization until 30 days after the last dose of pegfilgrastim, up to approximatley 20 weeks. | Participants with grade 3 or 4 bone pain as captured during standard adverse event reporting. A pre-defined list of Medical Dictionary for Regulatory Activities (MedDRA) version 17.1 preferred terms was used to determine if a participant experienced bone pain: Arthralgia, Arthritis, Back pain, Bone pain, Chest discomfort, Groin discomfort, Limb discomfort, Musculoskeletal chest pain, Musculoskeletal discomfort, Musculoskeletal pain, Neck pain, Non-cardiac chest pain, Osteochondritis Pain, Pain in extremity, Pain in jaw, Pelvic pain, Pubic pain, Sacroiliitis, Spinal pain, Spondylitis. The severity of each AE was graded using the Common Terminology criteria for Adverse Events (CTCAE) version 3 and are based on the following: Grade 1 = Mild AE; Grade 2 = Moderate AE; Grade 3 = Severe AE; Grade 4 = Life-threatening or disabling AE; Grade 5 = Death related to AE. |
| Percentage of Participants Who Used Analgesics for the Treatment of Bone Pain by Cycle and Across Cycles | From Day 1 of Cycle 2 until 30 days after the last dose of pegfilgrastim, up to approximately 16 weeks. | Analgesic use includes both analgesic and non-steroidal anti-inflammatory drugs. |
| Percentage of Participants With Any Grade Bone Pain as Captured in Standard Adverse Event Reporting | From randomization until 30 days after the last dose of pegfilgrastim, up to approximately 20 weeks | Participants with any grade of bone pain as captured during standard adverse event (AE) reporting. A pre-defined list of Medical Dictionary for Regulatory Activities (MedDRA) version 17.1 preferred terms was used to determine if a participant experienced bone pain: Arthralgia, Arthritis, Back pain, Bone pain, Chest discomfort, Groin discomfort, Limb discomfort, Musculoskeletal chest pain, Musculoskeletal discomfort, Musculoskeletal pain, Neck pain, Non-cardiac chest pain, Osteochondritis Pain, Pain in extremity, Pain in jaw, Pelvic pain, Pubic pain, Sacroiliitis, Spinal pain, Spondylitis. |
Countries
United States
Participant flow
Recruitment details
This study was conducted at 48 centers in the United States. Patients with stage I to III breast cancer planning to receive standard neoadjuvant or adjuvant chemotherapy regimens with pegfilgrastim support for at least 4 cycles were included. The first participant enrolled on 17 January 2013 and the last participant enrolled on 04 September 2014.
Pre-assignment details
Participants were randomized in a 1:1 ratio to receive 1 of 2 educational DVDs: general chemotherapy side effects education DVD (GE-DVD) or bone pain education DVD (BP-DVD). Participants remained on study for the first 4 chemotherapy cycles. End of study occurred 30 days after administration of pegfilgrastim in the fourth cycle of chemotherapy.
Participants by arm
| Arm | Count |
|---|---|
| General Education DVD Participants received chemotherapy and pegfilgrastim administered as a single subcutaneous injection dose of 6 mg 24 to 72 hours after chemotherapy. Participants were required to watch a general chemotherapy side effects education DVD on 2 separate visits to the clinic prior to the first administration of pegfilgrastim in cycle 1. | 149 |
| Bone Pain Education DVD Participants received chemotherapy and pegfilgrastim administered as a single subcutaneous injection dose of 6 mg 24 to 72 hours after chemotherapy. Participants were required to watch a bone pain education DVD on 2 separate visits to the clinic prior to the first administration of pegfilgrastim in cycle 1. | 151 |
| Total | 300 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Decision by Sponsor | 6 | 9 |
| Overall Study | Lost to Follow-up | 2 | 1 |
| Overall Study | Withdrawal by Subject | 4 | 10 |
Baseline characteristics
| Characteristic | General Education DVD | Bone Pain Education DVD | Total |
|---|---|---|---|
| Age, Continuous | 53.4 years STANDARD_DEVIATION 10.4 | 54.5 years STANDARD_DEVIATION 10.4 | 54.0 years STANDARD_DEVIATION 10.4 |
| Race/Ethnicity, Customized Asian | 1 participants | 5 participants | 6 participants |
| Race/Ethnicity, Customized Black (or African American) | 19 participants | 19 participants | 38 participants |
| Race/Ethnicity, Customized Other | 1 participants | 3 participants | 4 participants |
| Race/Ethnicity, Customized White | 128 participants | 124 participants | 252 participants |
| Sex: Female, Male Female | 149 Participants | 151 Participants | 300 Participants |
| Sex: Female, Male Male | 0 Participants | 0 Participants | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 138 / 149 | 144 / 151 |
| serious Total, serious adverse events | 16 / 149 | 20 / 151 |
Outcome results
Primary
Maximum Patient-reported Bone Pain in Cycle 1
Participants completed a brief bone pain survey once per day for 5 days beginning the day they received their pegfilgrastim injection. The bone pain survey collected the severity of pain using a 0 to 10 scale, where 0 = no pain and 10 indicates worst pain.
Time frame: Days 1 to 5 during cycle 1.
Population: Full analysis set with imputation
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| General Education DVD | Maximum Patient-reported Bone Pain in Cycle 1 | 3.2 units on a scale | Standard Error 0.2 |
| Bone Pain Education DVD | Maximum Patient-reported Bone Pain in Cycle 1 | 3.5 units on a scale | Standard Error 0.3 |
Comparison: There was no statistical hypothesis testing for this study. The clinical hypothesis was that a difference in mean maximum pain of 0.5 (scale 0 to 10) in favor of bone pain education would be a clinically relevant difference.p-value: 0.347995% CI: [-0.4, 1]t-test, 2 sided
Secondary
Maximum Patient-reported Bone Pain by Cycle and Across All Cycles
Participants completed a brief bone pain survey once per day for 5 days beginning the day they received their pegfilgrastim injection. The bone pain survey collected the severity of pain using a 0 to 10 scale, where 0 = no pain and 10 indicates worst pain.
Time frame: Days 1-5 for each treatment cycle
Population: Full analysis set with imputation
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| General Education DVD | Maximum Patient-reported Bone Pain by Cycle and Across All Cycles | Cycle 2 (n=145, 144) | 2.5 units on a scale | Standard Deviation 0.2 |
| General Education DVD | Maximum Patient-reported Bone Pain by Cycle and Across All Cycles | Cycle 3 (n=142, 139) | 2.7 units on a scale | Standard Deviation 0.2 |
| General Education DVD | Maximum Patient-reported Bone Pain by Cycle and Across All Cycles | Cycle 4 (n=141, 133) | 2.4 units on a scale | Standard Deviation 0.2 |
| General Education DVD | Maximum Patient-reported Bone Pain by Cycle and Across All Cycles | All Cycles (n-149, 151) | 4.1 units on a scale | Standard Deviation 0.3 |
| Bone Pain Education DVD | Maximum Patient-reported Bone Pain by Cycle and Across All Cycles | All Cycles (n-149, 151) | 4.6 units on a scale | Standard Deviation 0.3 |
| Bone Pain Education DVD | Maximum Patient-reported Bone Pain by Cycle and Across All Cycles | Cycle 2 (n=145, 144) | 2.7 units on a scale | Standard Deviation 0.3 |
| Bone Pain Education DVD | Maximum Patient-reported Bone Pain by Cycle and Across All Cycles | Cycle 4 (n=141, 133) | 2.5 units on a scale | Standard Deviation 0.3 |
| Bone Pain Education DVD | Maximum Patient-reported Bone Pain by Cycle and Across All Cycles | Cycle 3 (n=142, 139) | 2.6 units on a scale | Standard Deviation 0.2 |
Secondary
Mean Patient-reported Bone Pain by Cycle and Across All Cycles
Participants completed a brief bone pain survey once per day for 5 days beginning the day they received their pegfilgrastim injection. The bone pain survey collected the severity of pain using a 0 to 10 scale, where 0 = no pain and 10 indicates worst pain.
Time frame: Days 1-5 for 4 treatment cycles
Population: Full analysis set with imputation
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| General Education DVD | Mean Patient-reported Bone Pain by Cycle and Across All Cycles | Cycle 2 (n=145, 144) | 1.3 units on a scale | Standard Error 0.1 |
| General Education DVD | Mean Patient-reported Bone Pain by Cycle and Across All Cycles | Cycle 4 (n=141, 133) | 1.3 units on a scale | Standard Error 0.1 |
| General Education DVD | Mean Patient-reported Bone Pain by Cycle and Across All Cycles | Cycle 3 (n=142, 139) | 1.4 units on a scale | Standard Error 0.2 |
| General Education DVD | Mean Patient-reported Bone Pain by Cycle and Across All Cycles | All cycles (n=149, 151) | 1.5 units on a scale | Standard Error 0.1 |
| General Education DVD | Mean Patient-reported Bone Pain by Cycle and Across All Cycles | Cycle 1 (n=149, 151) | 1.6 units on a scale | Standard Error 0.2 |
| Bone Pain Education DVD | Mean Patient-reported Bone Pain by Cycle and Across All Cycles | All cycles (n=149, 151) | 1.6 units on a scale | Standard Error 0.1 |
| Bone Pain Education DVD | Mean Patient-reported Bone Pain by Cycle and Across All Cycles | Cycle 1 (n=149, 151) | 1.8 units on a scale | Standard Error 0.2 |
| Bone Pain Education DVD | Mean Patient-reported Bone Pain by Cycle and Across All Cycles | Cycle 2 (n=145, 144) | 1.5 units on a scale | Standard Error 0.2 |
| Bone Pain Education DVD | Mean Patient-reported Bone Pain by Cycle and Across All Cycles | Cycle 3 (n=142, 139) | 1.4 units on a scale | Standard Error 0.2 |
| Bone Pain Education DVD | Mean Patient-reported Bone Pain by Cycle and Across All Cycles | Cycle 4 (n=141, 133) | 1.5 units on a scale | Standard Error 0.2 |
Secondary
Patient-reported Bone Pain Area Under the Curve (AUC) by Cycle and Across All Cycles
Patient-reported bone pain AUC was calculated using the trapezoidal rule with bone pain scores from Day 1-5 for each cycle. AUC may range from 0 to 40 per cycle.
Time frame: Days 1-5 for 4 treatment cycles
Population: Full analysis set with imputation
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| General Education DVD | Patient-reported Bone Pain Area Under the Curve (AUC) by Cycle and Across All Cycles | Cycle 4 (n=141, 133) | 5.6 units on a scale * days | Standard Error 0.6 |
| General Education DVD | Patient-reported Bone Pain Area Under the Curve (AUC) by Cycle and Across All Cycles | Cycle 1 (n=149, 151) | 6.7 units on a scale * days | Standard Error 0.6 |
| General Education DVD | Patient-reported Bone Pain Area Under the Curve (AUC) by Cycle and Across All Cycles | Cycle 2 (n=145, 144) | 5.4 units on a scale * days | Standard Error 0.6 |
| General Education DVD | Patient-reported Bone Pain Area Under the Curve (AUC) by Cycle and Across All Cycles | Cycle 3 (n=142, 139) | 6.2 units on a scale * days | Standard Error 0.6 |
| General Education DVD | Patient-reported Bone Pain Area Under the Curve (AUC) by Cycle and Across All Cycles | All Cycles (n=149, 151) | 6.3 units on a scale * days | Standard Error 0.6 |
| Bone Pain Education DVD | Patient-reported Bone Pain Area Under the Curve (AUC) by Cycle and Across All Cycles | All Cycles (n=149, 151) | 6.6 units on a scale * days | Standard Error 0.6 |
| Bone Pain Education DVD | Patient-reported Bone Pain Area Under the Curve (AUC) by Cycle and Across All Cycles | Cycle 3 (n=142, 139) | 6.1 units on a scale * days | Standard Error 0.7 |
| Bone Pain Education DVD | Patient-reported Bone Pain Area Under the Curve (AUC) by Cycle and Across All Cycles | Cycle 1 (n=149, 151) | 7.6 units on a scale * days | Standard Error 0.7 |
| Bone Pain Education DVD | Patient-reported Bone Pain Area Under the Curve (AUC) by Cycle and Across All Cycles | Cycle 4 (n=141, 133) | 6.2 units on a scale * days | Standard Error 0.7 |
| Bone Pain Education DVD | Patient-reported Bone Pain Area Under the Curve (AUC) by Cycle and Across All Cycles | Cycle 2 (n=145, 144) | 6.3 units on a scale * days | Standard Error 0.7 |
Secondary
Percentage of Participants Who Used Analgesics for the Treatment of Bone Pain by Cycle and Across Cycles
Analgesic use includes both analgesic and non-steroidal anti-inflammatory drugs.
Time frame: From Day 1 of Cycle 2 until 30 days after the last dose of pegfilgrastim, up to approximately 16 weeks.
Population: Full analysis set
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| General Education DVD | Percentage of Participants Who Used Analgesics for the Treatment of Bone Pain by Cycle and Across Cycles | Cycle 2 (n=145, 144) | 69.0 percentage of participants |
| General Education DVD | Percentage of Participants Who Used Analgesics for the Treatment of Bone Pain by Cycle and Across Cycles | Cycle 4 (n=141, 143) | 68.8 percentage of participants |
| General Education DVD | Percentage of Participants Who Used Analgesics for the Treatment of Bone Pain by Cycle and Across Cycles | Cycle 3 (n=142, 139) | 65.5 percentage of participants |
| General Education DVD | Percentage of Participants Who Used Analgesics for the Treatment of Bone Pain by Cycle and Across Cycles | All cycles (n=149, 151) | 85.2 percentage of participants |
| General Education DVD | Percentage of Participants Who Used Analgesics for the Treatment of Bone Pain by Cycle and Across Cycles | Cycle 1 (n=149, 151) | 74.5 percentage of participants |
| Bone Pain Education DVD | Percentage of Participants Who Used Analgesics for the Treatment of Bone Pain by Cycle and Across Cycles | All cycles (n=149, 151) | 80.1 percentage of participants |
| Bone Pain Education DVD | Percentage of Participants Who Used Analgesics for the Treatment of Bone Pain by Cycle and Across Cycles | Cycle 1 (n=149, 151) | 73.5 percentage of participants |
| Bone Pain Education DVD | Percentage of Participants Who Used Analgesics for the Treatment of Bone Pain by Cycle and Across Cycles | Cycle 2 (n=145, 144) | 65.3 percentage of participants |
| Bone Pain Education DVD | Percentage of Participants Who Used Analgesics for the Treatment of Bone Pain by Cycle and Across Cycles | Cycle 3 (n=142, 139) | 66.2 percentage of participants |
| Bone Pain Education DVD | Percentage of Participants Who Used Analgesics for the Treatment of Bone Pain by Cycle and Across Cycles | Cycle 4 (n=141, 143) | 69.2 percentage of participants |
Secondary
Percentage of Participants With Any Grade Bone Pain as Captured in Standard Adverse Event Reporting
Participants with any grade of bone pain as captured during standard adverse event (AE) reporting. A pre-defined list of Medical Dictionary for Regulatory Activities (MedDRA) version 17.1 preferred terms was used to determine if a participant experienced bone pain: Arthralgia, Arthritis, Back pain, Bone pain, Chest discomfort, Groin discomfort, Limb discomfort, Musculoskeletal chest pain, Musculoskeletal discomfort, Musculoskeletal pain, Neck pain, Non-cardiac chest pain, Osteochondritis Pain, Pain in extremity, Pain in jaw, Pelvic pain, Pubic pain, Sacroiliitis, Spinal pain, Spondylitis.
Time frame: From randomization until 30 days after the last dose of pegfilgrastim, up to approximately 20 weeks
Population: Full analysis set
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| General Education DVD | Percentage of Participants With Any Grade Bone Pain as Captured in Standard Adverse Event Reporting | Cycle 2 (n=145, 144) | 37.2 percentage of participants |
| General Education DVD | Percentage of Participants With Any Grade Bone Pain as Captured in Standard Adverse Event Reporting | Cycle 4 (n= 141, 133) | 38.3 percentage of participants |
| General Education DVD | Percentage of Participants With Any Grade Bone Pain as Captured in Standard Adverse Event Reporting | Cycle 3 (n=142, 139) | 37.3 percentage of participants |
| General Education DVD | Percentage of Participants With Any Grade Bone Pain as Captured in Standard Adverse Event Reporting | All cycles (n=149, 151) | 58.4 percentage of participants |
| General Education DVD | Percentage of Participants With Any Grade Bone Pain as Captured in Standard Adverse Event Reporting | Cycle 1 (n=149, 151) | 43.0 percentage of participants |
| Bone Pain Education DVD | Percentage of Participants With Any Grade Bone Pain as Captured in Standard Adverse Event Reporting | All cycles (n=149, 151) | 56.3 percentage of participants |
| Bone Pain Education DVD | Percentage of Participants With Any Grade Bone Pain as Captured in Standard Adverse Event Reporting | Cycle 1 (n=149, 151) | 40.4 percentage of participants |
| Bone Pain Education DVD | Percentage of Participants With Any Grade Bone Pain as Captured in Standard Adverse Event Reporting | Cycle 2 (n=145, 144) | 35.4 percentage of participants |
| Bone Pain Education DVD | Percentage of Participants With Any Grade Bone Pain as Captured in Standard Adverse Event Reporting | Cycle 3 (n=142, 139) | 35.3 percentage of participants |
| Bone Pain Education DVD | Percentage of Participants With Any Grade Bone Pain as Captured in Standard Adverse Event Reporting | Cycle 4 (n= 141, 133) | 37.6 percentage of participants |
Secondary
Percentage of Participants With Grade 3 or 4 Bone Pain Captured in Standard Adverse Event Reporting
Participants with grade 3 or 4 bone pain as captured during standard adverse event reporting. A pre-defined list of Medical Dictionary for Regulatory Activities (MedDRA) version 17.1 preferred terms was used to determine if a participant experienced bone pain: Arthralgia, Arthritis, Back pain, Bone pain, Chest discomfort, Groin discomfort, Limb discomfort, Musculoskeletal chest pain, Musculoskeletal discomfort, Musculoskeletal pain, Neck pain, Non-cardiac chest pain, Osteochondritis Pain, Pain in extremity, Pain in jaw, Pelvic pain, Pubic pain, Sacroiliitis, Spinal pain, Spondylitis. The severity of each AE was graded using the Common Terminology criteria for Adverse Events (CTCAE) version 3 and are based on the following: Grade 1 = Mild AE; Grade 2 = Moderate AE; Grade 3 = Severe AE; Grade 4 = Life-threatening or disabling AE; Grade 5 = Death related to AE.
Time frame: From randomization until 30 days after the last dose of pegfilgrastim, up to approximatley 20 weeks.
Population: Full analysis set
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| General Education DVD | Percentage of Participants With Grade 3 or 4 Bone Pain Captured in Standard Adverse Event Reporting | Cycle 2 (n=145, 144) | 0.0 percentage of participants |
| General Education DVD | Percentage of Participants With Grade 3 or 4 Bone Pain Captured in Standard Adverse Event Reporting | Cycle 4 (n=141, 133) | 2.8 percentage of participants |
| General Education DVD | Percentage of Participants With Grade 3 or 4 Bone Pain Captured in Standard Adverse Event Reporting | Cycle 3 (n=142, 139) | 0.0 percentage of participants |
| General Education DVD | Percentage of Participants With Grade 3 or 4 Bone Pain Captured in Standard Adverse Event Reporting | All cycles (n=149, 151) | 4.7 percentage of participants |
| General Education DVD | Percentage of Participants With Grade 3 or 4 Bone Pain Captured in Standard Adverse Event Reporting | Cycle 1 (n=149, 151) | 2.0 percentage of participants |
| Bone Pain Education DVD | Percentage of Participants With Grade 3 or 4 Bone Pain Captured in Standard Adverse Event Reporting | All cycles (n=149, 151) | 6.6 percentage of participants |
| Bone Pain Education DVD | Percentage of Participants With Grade 3 or 4 Bone Pain Captured in Standard Adverse Event Reporting | Cycle 1 (n=149, 151) | 5.3 percentage of participants |
| Bone Pain Education DVD | Percentage of Participants With Grade 3 or 4 Bone Pain Captured in Standard Adverse Event Reporting | Cycle 2 (n=145, 144) | 2.1 percentage of participants |
| Bone Pain Education DVD | Percentage of Participants With Grade 3 or 4 Bone Pain Captured in Standard Adverse Event Reporting | Cycle 3 (n=142, 139) | 2.2 percentage of participants |
| Bone Pain Education DVD | Percentage of Participants With Grade 3 or 4 Bone Pain Captured in Standard Adverse Event Reporting | Cycle 4 (n=141, 133) | 3.8 percentage of participants |