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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| General Education DVD | Experimental | 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. |
|
| Bone Pain Education DVD | Experimental | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| General Education DVD | Other | A general chemotherapy side effects education DVD |
| |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Days 1 to 5 during cycle 1. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Days 1-5 for each treatment cycle |
Not provided
Inclusion Criteria
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
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| Name | Affiliation | Role |
|---|---|---|
| MD | Amgen | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Research Site | Fountain Valley | California | 92708 | United States | ||
| Research Site |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 29935909 | Background | Guinigundo AS, Maxwell CL, Vanni L, Morrow PK, Reiner M, Shih A, Klippel Z, Blanchard E. A Randomized, Single-Blind Study Evaluating the Effect of a Bone Pain Education Video on Reported Bone Pain in Patients with Breast Cancer Receiving Chemotherapy and Pegfilgrastim. Pain Manag Nurs. 2018 Dec;19(6):693-706. doi: 10.1016/j.pmn.2018.04.002. Epub 2018 Jun 21. |
| Label | URL |
|---|---|
| AmgenTrials clinical trials website | View source |
Not provided
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.
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.
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
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| Bone Pain Education DVD |
| Other |
|
| 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. | Days 1-5 for 4 treatment cycles |
| 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. | Days 1-5 for 4 treatment cycles |
| 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. | From randomization until 30 days after the last dose of pegfilgrastim, up to approximately 20 weeks |
| 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. | From randomization until 30 days after the last dose of pegfilgrastim, up to approximatley 20 weeks. |
| 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. | From Day 1 of Cycle 2 until 30 days after the last dose of pegfilgrastim, up to approximately 16 weeks. |
| Mission Hills |
| California |
| 91345 |
| United States |
| Research Site | Santa Rosa | California | 95403 | United States |
| Research Site | Vallejo | California | 94589 | United States |
| Research Site | Whittier | California | 90603 | United States |
| Research Site | Danbury | Connecticut | 06810 | United States |
| Research Site | Greenwich | Connecticut | 06830 | United States |
| Research Site | Fort Lauderdale | Florida | 33308 | United States |
| Research Site | Chicago | Illinois | 60616 | United States |
| Research Site | Elk Grove Village | Illinois | 60007 | United States |
| Research Site | Naperville | Illinois | 60540 | United States |
| Research Site | Peoria | Illinois | 61615 | United States |
| Research Site | Cedar Rapids | Iowa | 52403 | United States |
| Research Site | Mason City | Iowa | 50401 | United States |
| Research Site | Mount Sterling | Kentucky | 40353 | United States |
| Research Site | Lewiston | Maine | 04240 | United States |
| Research Site | Boston | Massachusetts | 02135 | United States |
| Research Site | Fairhaven | Massachusetts | 02719 | United States |
| Research Site | Lansing | Michigan | 48912 | United States |
| Research Site | Robbinsdale | Minnesota | 55422 | United States |
| Research Site | Saint Louis Park | Minnesota | 55426 | United States |
| Research Site | Jefferson City | Missouri | 65109 | United States |
| Research Site | St Louis | Missouri | 63136 | United States |
| Research Site | Omaha | Nebraska | 68106 | United States |
| Research Site | Portsmouth | New Hampshire | 03801 | United States |
| Research Site | Englewood | New Jersey | 07631 | United States |
| Research Site | Hamilton | New Jersey | 08650 | United States |
| Research Site | Morristown | New Jersey | 07960 | United States |
| Research Site | Vineland | New Jersey | 08360 | United States |
| Research Site | Albuquerque | New Mexico | 87109-4397 | United States |
| Research Site | Cooperstown | New York | 13326 | United States |
| Research Site | Glens Falls | New York | 12801 | United States |
| Research Site | Poughkeepsie | New York | 12601 | United States |
| Research Site | Suffern | New York | 10901 | United States |
| Research Site | Asheboro | North Carolina | 27203 | United States |
| Research Site | Charlotte | North Carolina | 28204 | United States |
| Research Site | Fayetteville | North Carolina | 28304 | United States |
| Research Site | Goldsboro | North Carolina | 27534 | United States |
| Research Site | Hendersonville | North Carolina | 28791 | United States |
| Research Site | Canton | Ohio | 44708 | United States |
| Research Site | Massillon | Ohio | 44646 | United States |
| Research Site | Middletown | Ohio | 45042 | United States |
| Research Site | Bend | Oregon | 97701 | United States |
| Research Site | Gettysburg | Pennsylvania | 17325 | United States |
| Research Site | Langhorne | Pennsylvania | 19047 | United States |
| Research Site | Aberdeen | South Dakota | 57401 | United States |
| Research Site | Sioux Falls | South Dakota | 57105 | United States |
| Research Site | Bristol | Tennessee | 37620 | United States |
| Research Site | El Paso | Texas | 79905 | United States |
| Research Site | Danville | Virginia | 24541 | United States |
| Research Site | Burien | Washington | 98166 | United States |
| FG001 |
| 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. |
| Received Pegfilgrastim |
|
| COMPLETED |
|
| NOT COMPLETED |
|
|
The full analysis set included all randomized participants who received primary prophylaxis (cycle 1 administration) with pegfilgrastim.
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| BG001 | 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. |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
| |||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||
| Race/Ethnicity, Customized | Number | participants |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | Full analysis set with imputation | Posted | Mean | Standard Error | units on a scale | Days 1 to 5 during cycle 1. |
|
|
|
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| 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. | Full analysis set with imputation | Posted | Mean | Standard Deviation | units on a scale | Days 1-5 for each treatment cycle |
|
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| 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. | Full analysis set with imputation | Posted | Mean | Standard Error | units on a scale | Days 1-5 for 4 treatment cycles |
|
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| 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. | Full analysis set with imputation | Posted | Mean | Standard Error | units on a scale * days | Days 1-5 for 4 treatment cycles |
|
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| 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. | Full analysis set | Posted | Number | percentage of participants | From randomization until 30 days after the last dose of pegfilgrastim, up to approximately 20 weeks |
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| 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. | Full analysis set | Posted | Number | percentage of participants | From randomization until 30 days after the last dose of pegfilgrastim, up to approximatley 20 weeks. |
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| 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. | Full analysis set | Posted | Number | percentage of participants | From Day 1 of Cycle 2 until 30 days after the last dose of pegfilgrastim, up to approximately 16 weeks. |
|
|
From randomization until 30 days after the last dose of pegfilgrastim, up to approximately 20 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
All sparticipants included in the analysis received at least one dose of pegfilgrastim.
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | General Chemotherapy 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. | 16 | 149 | 138 | 149 | ||
| EG001 | 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. | 20 | 151 | 144 | 151 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | MedDRA 17.1 | Systematic Assessment |
| |
| Febrile neutropenia | Blood and lymphatic system disorders | MedDRA 17.1 | Systematic Assessment |
| |
| Neutropenia | Blood and lymphatic system disorders | MedDRA 17.1 | Systematic Assessment |
| |
| Pancytopenia | Blood and lymphatic system disorders | MedDRA 17.1 | Systematic Assessment |
| |
| Atrial fibrillation | Cardiac disorders | MedDRA 17.1 | Systematic Assessment |
| |
| Cardiac failure congestive | Cardiac disorders | MedDRA 17.1 | Systematic Assessment |
| |
| Abdominal pain | Gastrointestinal disorders | MedDRA 17.1 | Systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA 17.1 | Systematic Assessment |
| |
| Dyspepsia | Gastrointestinal disorders | MedDRA 17.1 | Systematic Assessment |
| |
| Gastritis haemorrhagic | Gastrointestinal disorders | MedDRA 17.1 | Systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA 17.1 | Systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA 17.1 | Systematic Assessment |
| |
| Asthenia | General disorders | MedDRA 17.1 | Systematic Assessment |
| |
| Pain | General disorders | MedDRA 17.1 | Systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA 17.1 | Systematic Assessment |
| |
| Bacteraemia | Infections and infestations | MedDRA 17.1 | Systematic Assessment |
| |
| Clostridium difficile colitis | Infections and infestations | MedDRA 17.1 | Systematic Assessment |
| |
| Colonic abscess | Infections and infestations | MedDRA 17.1 | Systematic Assessment |
| |
| Diarrhoea infectious | Infections and infestations | MedDRA 17.1 | Systematic Assessment |
| |
| Diverticulitis | Infections and infestations | MedDRA 17.1 | Systematic Assessment |
| |
| Gastroenteritis | Infections and infestations | MedDRA 17.1 | Systematic Assessment |
| |
| Influenza | Infections and infestations | MedDRA 17.1 | Systematic Assessment |
| |
| Localised infection | Infections and infestations | MedDRA 17.1 | Systematic Assessment |
| |
| Pharyngitis | Infections and infestations | MedDRA 17.1 | Systematic Assessment |
| |
| Pneumonia | Infections and infestations | MedDRA 17.1 | Systematic Assessment |
| |
| Rectal abscess | Infections and infestations | MedDRA 17.1 | Systematic Assessment |
| |
| Sepsis | Infections and infestations | MedDRA 17.1 | Systematic Assessment |
| |
| Sepsis syndrome | Infections and infestations | MedDRA 17.1 | Systematic Assessment |
| |
| Sinusitis | Infections and infestations | MedDRA 17.1 | Systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | MedDRA 17.1 | Systematic Assessment |
| |
| Urinary tract infection bacterial | Infections and infestations | MedDRA 17.1 | Systematic Assessment |
| |
| Dehydration | Metabolism and nutrition disorders | MedDRA 17.1 | Systematic Assessment |
| |
| Lactic acidosis | Metabolism and nutrition disorders | MedDRA 17.1 | Systematic Assessment |
| |
| Bone pain | Musculoskeletal and connective tissue disorders | MedDRA 17.1 | Systematic Assessment |
| |
| Musculoskeletal chest pain | Musculoskeletal and connective tissue disorders | MedDRA 17.1 | Systematic Assessment |
| |
| Myalgia | Musculoskeletal and connective tissue disorders | MedDRA 17.1 | Systematic Assessment |
| |
| Sinus headache | Nervous system disorders | MedDRA 17.1 | Systematic Assessment |
| |
| Dyspnoea exertional | Respiratory, thoracic and mediastinal disorders | MedDRA 17.1 | Systematic Assessment |
| |
| Hypoxia | Respiratory, thoracic and mediastinal disorders | MedDRA 17.1 | Systematic Assessment |
| |
| Pulmonary embolism | Respiratory, thoracic and mediastinal disorders | MedDRA 17.1 | Systematic Assessment |
| |
| Pulmonary oedema | Respiratory, thoracic and mediastinal disorders | MedDRA 17.1 | Systematic Assessment |
| |
| Respiratory failure | Respiratory, thoracic and mediastinal disorders | MedDRA 17.1 | Systematic Assessment |
| |
| Decubitus ulcer | Skin and subcutaneous tissue disorders | MedDRA 17.1 | Systematic Assessment |
| |
| Rash | Skin and subcutaneous tissue disorders | MedDRA 17.1 | Systematic Assessment |
| |
| Stevens-Johnson syndrome | Skin and subcutaneous tissue disorders | MedDRA 17.1 | Systematic Assessment |
| |
| Hysterectomy | Surgical and medical procedures | MedDRA 17.1 | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | MedDRA 17.1 | Systematic Assessment |
| |
| Leukocytosis | Blood and lymphatic system disorders | MedDRA 17.1 | Systematic Assessment |
| |
| Neutropenia | Blood and lymphatic system disorders | MedDRA 17.1 | Systematic Assessment |
| |
| Palpitations | Cardiac disorders | MedDRA 17.1 | Systematic Assessment |
| |
| Lacrimation increased | Eye disorders | MedDRA 17.1 | Systematic Assessment |
| |
| Constipation | Gastrointestinal disorders | MedDRA 17.1 | Systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA 17.1 | Systematic Assessment |
| |
| Dyspepsia | Gastrointestinal disorders | MedDRA 17.1 | Systematic Assessment |
| |
| Gastrooesophageal reflux disease | Gastrointestinal disorders | MedDRA 17.1 | Systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA 17.1 | Systematic Assessment |
| |
| Oral pain | Gastrointestinal disorders | MedDRA 17.1 | Systematic Assessment |
| |
| Stomatitis | Gastrointestinal disorders | MedDRA 17.1 | Systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA 17.1 | Systematic Assessment |
| |
| Asthenia | General disorders | MedDRA 17.1 | Systematic Assessment |
| |
| Fatigue | General disorders | MedDRA 17.1 | Systematic Assessment |
| |
| Mucosal inflammation | General disorders | MedDRA 17.1 | Systematic Assessment |
| |
| Oedema peripheral | General disorders | MedDRA 17.1 | Systematic Assessment |
| |
| Pain | General disorders | MedDRA 17.1 | Systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA 17.1 | Systematic Assessment |
| |
| Cellulitis | Infections and infestations | MedDRA 17.1 | Systematic Assessment |
| |
| Upper respiratory tract infection | Infections and infestations | MedDRA 17.1 | Systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | MedDRA 17.1 | Systematic Assessment |
| |
| Decreased appetite | Metabolism and nutrition disorders | MedDRA 17.1 | Systematic Assessment |
| |
| Dehydration | Metabolism and nutrition disorders | MedDRA 17.1 | Systematic Assessment |
| |
| Hypokalaemia | Metabolism and nutrition disorders | MedDRA 17.1 | Systematic Assessment |
| |
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA 17.1 | Systematic Assessment |
| |
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA 17.1 | Systematic Assessment |
| |
| Bone pain | Musculoskeletal and connective tissue disorders | MedDRA 17.1 | Systematic Assessment |
| |
| Myalgia | Musculoskeletal and connective tissue disorders | MedDRA 17.1 | Systematic Assessment |
| |
| Pain in extremity | Musculoskeletal and connective tissue disorders | MedDRA 17.1 | Systematic Assessment |
| |
| Dizziness | Nervous system disorders | MedDRA 17.1 | Systematic Assessment |
| |
| Dysgeusia | Nervous system disorders | MedDRA 17.1 | Systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA 17.1 | Systematic Assessment |
| |
| Neuropathy peripheral | Nervous system disorders | MedDRA 17.1 | Systematic Assessment |
| |
| Anxiety | Psychiatric disorders | MedDRA 17.1 | Systematic Assessment |
| |
| Insomnia | Psychiatric disorders | MedDRA 17.1 | Systematic Assessment |
| |
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA 17.1 | Systematic Assessment |
| |
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA 17.1 | Systematic Assessment |
| |
| Oropharyngeal pain | Respiratory, thoracic and mediastinal disorders | MedDRA 17.1 | Systematic Assessment |
| |
| Alopecia | Skin and subcutaneous tissue disorders | MedDRA 17.1 | Systematic Assessment |
| |
| Rash | Skin and subcutaneous tissue disorders | MedDRA 17.1 | Systematic Assessment |
| |
| Flushing | Vascular disorders | MedDRA 17.1 | Systematic Assessment |
| |
| Hot flush | Vascular disorders | MedDRA 17.1 | Systematic Assessment |
|
The Clinical Trial Agreement generally does not restrict an investigator's discussion of trial results after completion. The Agreement permits Amgen a limited period of time to review material discussing trial results (typically up to 45 days and possible extension). Amgen may remove confidential information, but authors have final control and approval of publication content. For multicenter studies, the investigator agrees not to publish any results before the first multi-center publication.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Study Director | Amgen Inc. | 866-572-6436 |
| ID | Term |
|---|---|
| D001943 | Breast Neoplasms |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
Not provided
Not provided
| Male |
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| Black (or African American) |
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| White |
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| Other |
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| Participants |
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| Participants |
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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. |
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