Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| Other | Other Grant/Funding Number | program income on C06 CA059267 |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Brigham and Women's Hospital | OTHER |
| Boston Children's Hospital | OTHER |
| Dana-Farber Cancer Institute | OTHER |
| National Institutes of Health (NIH) |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
The main purpose of this study is to assess the short term and the long term side effects of proton beam radiation for pediatric bone and non-rhabdomyosarcoma soft tissue sarcomas.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Proton Beam Radiation | Experimental | Proton Beam Radiation |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Proton Beam Radiation | Radiation | Once per day, 5 days a week for a total of 4 to 6 weeks. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Cumulative Incidence (Estimated Percentage of Participants) Who Developed Toxicities Following Radiation Treatment | Cumulative incidence (percent of participants and 95% confidence intervals) who experienced a grade 3, 4, or 5 late toxicity. Late complications are defined as the delayed effects attributable to radiation which occur > 90 days following completion of radiation. | 5 years from the completion of radiation treatment |
| Local Control | Rates of local control using proton radiotherapy. Local control is the lack of tumor recurrence in and or near the area where the primary tumor occurred. | 5 years from the start of radiation treatment |
| Measure | Description | Time Frame |
|---|---|---|
| Dosimetric Comparison | Comparison of Dose distribution to tumor and surrounding normal structures using Dose-Volume Histograms (DVH) generated from the proton plan used to treat the patient and the photon plan generated for comparison purposes. | 5 years |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Torunn Yock, MD | Massachusetts General Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Massachusetts General Hospital | Boston | Massachusetts | 02114 | United States | ||
| Dana-Farber Cancer Institute |
Not provided
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Proton Beam Radiation | Proton Beam Radiation Proton Beam Radiation: Once per day, 5 days a week for a total of 4 to 6 weeks. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Proton Beam Radiation | Proton Beam Radiation Proton Beam Radiation: Once per day, 5 days a week for a total of 4 to 6 weeks. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Median |
| 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 | Cumulative Incidence (Estimated Percentage of Participants) Who Developed Toxicities Following Radiation Treatment | Cumulative incidence (percent of participants and 95% confidence intervals) who experienced a grade 3, 4, or 5 late toxicity. Late complications are defined as the delayed effects attributable to radiation which occur > 90 days following completion of radiation. | Posted | Number | 95% Confidence Interval | percentage of participants | 5 years from the completion of radiation treatment |
|
|
Up to 5 years following the completion of treatment, mean of 9.1 years
Acute toxicity will be scored at weekly status check visits by the radiation oncology nurse or doctor. In addition, acute toxicity will be scored at least one time within the 3 months following completion of radiation therapy. Version 3.0. Late toxicity is to be scored on a yearly follow-up basis for at least five years. Toxicities and will be graded according to the Common Terminology Criteria for Adverse Events (CTCAE), Version 3.0.
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 | Proton Beam Radiation | Proton Beam Radiation Proton Beam Radiation: Once per day, 5 days a week for a total of 4 to 6 weeks. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Myelodysplastic Syndrome (MDS) | Blood and lymphatic system disorders | CTCAE (3.0) | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Allergic rhinitis | Respiratory, thoracic and mediastinal disorders | CTCAE (3.0) | Systematic Assessment |
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Torunn Yock, MD | Massachusetts General, Hospital | 6177262000 | tyock@mgh.harvard.edu |
Not provided
| ID | Term |
|---|---|
| D012509 | Sarcoma |
| D001859 | Bone Neoplasms |
| ID | Term |
|---|---|
| D018204 | Neoplasms, Connective and Soft Tissue |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D009371 | Neoplasms by Site |
Not provided
Not provided
| ID | Term |
|---|---|
| D061766 | Proton Therapy |
| ID | Term |
|---|---|
| D063193 | Heavy Ion Radiotherapy |
| D011878 | Radiotherapy |
| D013812 | Therapeutics |
Not provided
Not provided
| NIH |
Not provided
Not provided
Not provided
Not provided
Not provided
| Boston |
| Massachusetts |
| 02115 |
| United States |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Participants |
|
|
|
| Primary | Local Control | Rates of local control using proton radiotherapy. Local control is the lack of tumor recurrence in and or near the area where the primary tumor occurred. | Posted | Number | 95% Confidence Interval | percentage of participants | 5 years from the start of radiation treatment |
|
|
|
|
| Secondary | Dosimetric Comparison | Comparison of Dose distribution to tumor and surrounding normal structures using Dose-Volume Histograms (DVH) generated from the proton plan used to treat the patient and the photon plan generated for comparison purposes. | Data were not collected and this outcome was not analyzed. DVH's were not generated for these patients. Data will not be collected in the future. The decision not to generate photon/proton contours DVH's was at the discretion of the dosimetrist/treating physician. | Posted | 5 years |
|
|
| 17 |
| 69 |
| 8 |
| 69 |
| 69 |
| 69 |
| Venoocclusive disease | Hepatobiliary disorders | CTCAE (3.0) | Systematic Assessment |
|
| Staphylocaccus bacteremia | Infections and infestations | CTCAE (3.0) | Systematic Assessment |
|
| Leukemia (AML) | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | CTCAE (3.0) | Systematic Assessment |
|
| Small Bowel Obstruction | Gastrointestinal disorders | CTCAE (3.0) | Systematic Assessment |
|
| Anorexia | Metabolism and nutrition disorders | CTCAE (3.0) | Systematic Assessment |
|
| Leukopenia | Blood and lymphatic system disorders | CTCAE (3.0) | Systematic Assessment |
|
| Neutropenia | Blood and lymphatic system disorders | CTCAE (3.0) | Systematic Assessment |
|
| Lymphopenia | Blood and lymphatic system disorders | CTCAE (3.0) | Systematic Assessment |
|
| Platelet count decreased | Investigations | CTCAE (3.0) | Systematic Assessment |
|
| Subglottic stenosis, tracheotomy | Respiratory, thoracic and mediastinal disorders | CTCAE (3.0) | Systematic Assessment |
|
| Febrile Neutropenia | Blood and lymphatic system disorders | CTCAE (3.0) | Systematic Assessment |
|
| Dehydration | Metabolism and nutrition disorders | CTCAE (3.0) | Systematic Assessment |
|
| Hearing w/o audiogr not in monitor prg | Ear and labyrinth disorders | CTCAE (3.0) | Systematic Assessment |
|
| Hearing w/w-o audiogr in monitor prg | Ear and labyrinth disorders | CTCAE (3.0) | Systematic Assessment |
|
| Hearing-other | Ear and labyrinth disorders | CTCAE (3.0) | Systematic Assessment |
|
| Otitis, external ear (non-infectious) | Ear and labyrinth disorders | CTCAE (3.0) | Systematic Assessment |
|
| Otitis, middle ear (non-infectious) | Ear and labyrinth disorders | CTCAE (3.0) | Systematic Assessment |
|
| Tinnitus | Ear and labyrinth disorders | CTCAE (3.0) | Systematic Assessment |
|
| Hemoglobin | Blood and lymphatic system disorders | CTCAE (3.0) | Systematic Assessment |
|
| Leukocytes | Blood and lymphatic system disorders | CTCAE (3.0) | Systematic Assessment |
|
| Lymphopenia | Blood and lymphatic system disorders | CTCAE (3.0) | Systematic Assessment |
|
| Neutrophils | Blood and lymphatic system disorders | CTCAE (3.0) | Systematic Assessment |
|
| Platelets | Blood and lymphatic system disorders | CTCAE (3.0) | Systematic Assessment |
|
| Fatigue | General disorders | CTCAE (3.0) | Systematic Assessment |
|
| Fever w/o neutropenia | General disorders | CTCAE (3.0) | Systematic Assessment |
|
| Sweating | General disorders | CTCAE (3.0) | Systematic Assessment |
|
| Alopecia | Skin and subcutaneous tissue disorders | CTCAE (3.0) | Systematic Assessment |
|
| Bruising | Skin and subcutaneous tissue disorders | CTCAE (3.0) | Systematic Assessment |
|
| Dry skin | Skin and subcutaneous tissue disorders | CTCAE (3.0) | Systematic Assessment |
|
| Erythema multiforme | Skin and subcutaneous tissue disorders | CTCAE (3.0) | Systematic Assessment |
|
| Hyperpigmentation | Skin and subcutaneous tissue disorders | CTCAE (3.0) | Systematic Assessment |
|
| Hypopigmentation | Skin and subcutaneous tissue disorders | CTCAE (3.0) | Systematic Assessment |
|
| Induration/fibrosis | Skin and subcutaneous tissue disorders | CTCAE (3.0) | Systematic Assessment |
|
| Pruritus/itching | Skin and subcutaneous tissue disorders | CTCAE (3.0) | Systematic Assessment |
|
| Radiation dermatitis | Skin and subcutaneous tissue disorders | CTCAE (3.0) | Systematic Assessment |
|
| Rash/desquamation | Skin and subcutaneous tissue disorders | CTCAE (3.0) | Systematic Assessment |
|
| Skin-other | Skin and subcutaneous tissue disorders | CTCAE (3.0) | Systematic Assessment |
|
| Telangiectasia | Skin and subcutaneous tissue disorders | CTCAE (3.0) | Systematic Assessment |
|
| Wound - non-infectious | Skin and subcutaneous tissue disorders | CTCAE (3.0) | Systematic Assessment |
|
| ACTH deficiency | Endocrine disorders | CTCAE (3.0) | Systematic Assessment |
|
| Adrenal insufficiency | Endocrine disorders | CTCAE (3.0) | Systematic Assessment |
|
| Endocrine-other | Endocrine disorders | CTCAE (3.0) | Systematic Assessment |
|
| Gonadotropin secretion abnormality | Endocrine disorders | CTCAE (3.0) | Systematic Assessment |
|
| Growth hormone secretion abnormality | Endocrine disorders | CTCAE (3.0) | Systematic Assessment |
|
| Hot flashes | Endocrine disorders | CTCAE (3.0) | Systematic Assessment |
|
| Hypothyroidism | Endocrine disorders | CTCAE (3.0) | Systematic Assessment |
|
| Anorexia | Gastrointestinal disorders | CTCAE (3.0) | Systematic Assessment |
|
| Constipation | Gastrointestinal disorders | CTCAE (3.0) | Systematic Assessment |
|
| Dehydration | Gastrointestinal disorders | CTCAE (3.0) | Systematic Assessment |
|
| Diarrhea w/o prior colostomy | Gastrointestinal disorders | CTCAE (3.0) | Systematic Assessment |
|
| Dry mouth | Gastrointestinal disorders | CTCAE (3.0) | Systematic Assessment |
|
| Dyspepsia | Gastrointestinal disorders | CTCAE (3.0) | Systematic Assessment |
|
| Dysphagia | Gastrointestinal disorders | CTCAE (3.0) | Systematic Assessment |
|
| Esophagitis | Gastrointestinal disorders | CTCAE (3.0) | Systematic Assessment |
|
| GI-other | Gastrointestinal disorders | CTCAE (3.0) | Systematic Assessment |
|
| Muco/stomatitis (symptom) pharynx | Gastrointestinal disorders | CTCAE (3.0) | Systematic Assessment |
|
| Muco/stomatitis by exam, oral cavity | Gastrointestinal disorders | CTCAE (3.0) | Systematic Assessment |
|
| Muco/stomatitis by exam, pharynx | Gastrointestinal disorders | CTCAE (3.0) | Systematic Assessment |
|
| Nausea | Gastrointestinal disorders | CTCAE (3.0) | Systematic Assessment |
|
| Obstruction, small bowel NOS | Gastrointestinal disorders | CTCAE (3.0) | Systematic Assessment |
|
| Salivary | Gastrointestinal disorders | CTCAE (3.0) | Systematic Assessment |
|
| Stenosis (incl anastomotic) pharynx | Gastrointestinal disorders | CTCAE (3.0) | Systematic Assessment |
|
| Taste disturbance | Gastrointestinal disorders | CTCAE (3.0) | Systematic Assessment |
|
| Teeth | Gastrointestinal disorders | CTCAE (3.0) | Systematic Assessment |
|
| Teeth development | Gastrointestinal disorders | CTCAE (3.0) | Systematic Assessment |
|
| Vomiting | Gastrointestinal disorders | CTCAE (3.0) | Systematic Assessment |
|
| Growth velocity reduction | General disorders | CTCAE (3.0) | Systematic Assessment |
|
| Short stature | General disorders | CTCAE (3.0) | Systematic Assessment |
|
| Spine kyphosis/lordosis | Musculoskeletal and connective tissue disorders | CTCAE (3.0) | Systematic Assessment |
|
| Hemorrhage-other | General disorders | CTCAE (3.0) | Systematic Assessment |
|
| Nose, hemorrhage | Respiratory, thoracic and mediastinal disorders | CTCAE (3.0) | Systematic Assessment |
|
| Petechiae | Skin and subcutaneous tissue disorders | CTCAE (3.0) | Systematic Assessment |
|
| Pharynx, hemorrhage | Respiratory, thoracic and mediastinal disorders | CTCAE (3.0) | Systematic Assessment |
|
| Infection w/ unk ANC sinus | Infections and infestations | CTCAE (3.0) | Systematic Assessment |
|
| Infection w/ unk ANC skin (cellulitis) | Infections and infestations | CTCAE (3.0) | Systematic Assessment |
|
| Infection-other | Infections and infestations | CTCAE (3.0) | Systematic Assessment |
|
| AST, SGOT | Metabolism and nutrition disorders | CTCAE (3.0) | Systematic Assessment |
|
| Bilirubin | Metabolism and nutrition disorders | CTCAE (3.0) | Systematic Assessment |
|
| Hyponatremia | Metabolism and nutrition disorders | CTCAE (3.0) | Systematic Assessment |
|
| Bone: spine-scoliosis | Musculoskeletal and connective tissue disorders | CTCAE (3.0) | Systematic Assessment |
|
| Cervical spine-range of motion | Musculoskeletal and connective tissue disorders | CTCAE (3.0) | Systematic Assessment |
|
| Extremity upper (function) | Musculoskeletal and connective tissue disorders | CTCAE (3.0) | Systematic Assessment |
|
| Extremity-lower (gait/walking) | Musculoskeletal and connective tissue disorders | CTCAE (3.0) | Systematic Assessment |
|
| Fibrosis-cosmesis | Musculoskeletal and connective tissue disorders | CTCAE (3.0) | Systematic Assessment |
|
| Fibrosis-deep connective tissue | Musculoskeletal and connective tissue disorders | CTCAE (3.0) | Systematic Assessment |
|
| Fracture | Musculoskeletal and connective tissue disorders | CTCAE (3.0) | Systematic Assessment |
|
| Joint-function | Musculoskeletal and connective tissue disorders | CTCAE (3.0) | Systematic Assessment |
|
| Lumbar spine-range of motion | Musculoskeletal and connective tissue disorders | CTCAE (3.0) | Systematic Assessment |
|
| Muscular/skeletal hypoplasia | Musculoskeletal and connective tissue disorders | CTCAE (3.0) | Systematic Assessment |
|
| Musculoskeletal/soft tissue-other | Musculoskeletal and connective tissue disorders | CTCAE (3.0) | Systematic Assessment |
|
| Nonneuropathic generalized weakness | Musculoskeletal and connective tissue disorders | CTCAE (3.0) | Systematic Assessment |
|
| Nonneuropathic left-side muscle weak | Musculoskeletal and connective tissue disorders | CTCAE (3.0) | Systematic Assessment |
|
| Nonneuropathic upper extr muscle weak | Musculoskeletal and connective tissue disorders | CTCAE (3.0) | Systematic Assessment |
|
| Osteonecrosis (avascular necrosis) | Musculoskeletal and connective tissue disorders | CTCAE (3.0) | Systematic Assessment |
|
| Osteoporosis | Musculoskeletal and connective tissue disorders | CTCAE (3.0) | Systematic Assessment |
|
| Trismus | Musculoskeletal and connective tissue disorders | CTCAE (3.0) | Systematic Assessment |
|
| Hypothyroidism | Endocrine disorders | CTCAE (3.0) | Systematic Assessment |
|
| Agitation | Psychiatric disorders | CTCAE (3.0) | Systematic Assessment |
|
| Cognitive disturbance | Psychiatric disorders | CTCAE (3.0) | Systematic Assessment |
|
| Depression | Psychiatric disorders | CTCAE (3.0) | Systematic Assessment |
|
| Memory impairment | Psychiatric disorders | CTCAE (3.0) | Systematic Assessment |
|
| Neurologic-other | Psychiatric disorders | CTCAE (3.0) | Systematic Assessment |
|
| Neuropathy-motor | Nervous system disorders | CTCAE (3.0) | Systematic Assessment |
|
| Neuropathy-sensory | Nervous system disorders | CTCAE (3.0) | Systematic Assessment |
|
| Speech impairment | Psychiatric disorders | CTCAE (3.0) | Systematic Assessment |
|
| Cataract | Eye disorders | CTCAE (3.0) | Systematic Assessment |
|
| Dry eye syndrome | Eye disorders | CTCAE (3.0) | Systematic Assessment |
|
| Eyelid dysfunction | Eye disorders | CTCAE (3.0) | Systematic Assessment |
|
| Glaucoma | Eye disorders | CTCAE (3.0) | Systematic Assessment |
|
| Keratitis | Eye disorders | CTCAE (3.0) | Systematic Assessment |
|
| Ocular-other | Eye disorders | CTCAE (3.0) | Systematic Assessment |
|
| Optic disc edema | Eye disorders | CTCAE (3.0) | Systematic Assessment |
|
| Tearing | Eye disorders | CTCAE (3.0) | Systematic Assessment |
|
| Vision-blurred | Eye disorders | CTCAE (3.0) | Systematic Assessment |
|
| Vision-photophobia | Eye disorders | CTCAE (3.0) | Systematic Assessment |
|
| Skin, pain | General disorders | CTCAE (3.0) | Systematic Assessment |
|
| Throat/pharynx/larynx, pain | General disorders | CTCAE (3.0) | Systematic Assessment |
|
| Aspiration | Respiratory, thoracic and mediastinal disorders | CTCAE (3.0) | Systematic Assessment |
|
| Atelectasis | Respiratory, thoracic and mediastinal disorders | CTCAE (3.0) | Systematic Assessment |
|
| Cough | Respiratory, thoracic and mediastinal disorders | CTCAE (3.0) | Systematic Assessment |
|
| Dyspnea | Respiratory, thoracic and mediastinal disorders | CTCAE (3.0) | Systematic Assessment |
|
| Edema, larynx | Respiratory, thoracic and mediastinal disorders | CTCAE (3.0) | Systematic Assessment |
|
| FEV1 | Respiratory, thoracic and mediastinal disorders | CTCAE (3.0) | Systematic Assessment |
|
| Nasal cavity/paranasal sinus reaction | Respiratory, thoracic and mediastinal disorders | CTCAE (3.0) | Systematic Assessment |
|
| Obstruction, airway-pharynx | Respiratory, thoracic and mediastinal disorders | CTCAE (3.0) | Systematic Assessment |
|
| Pulmonary/Upper Respiratory-other | Respiratory, thoracic and mediastinal disorders | CTCAE (3.0) | Systematic Assessment |
|
| Voice changes/dysarthria | Respiratory, thoracic and mediastinal disorders | CTCAE (3.0) | Systematic Assessment |
|
| Bladder spasms | Renal and urinary disorders | CTCAE (3.0) | Systematic Assessment |
|
| Cystitis | Renal and urinary disorders | CTCAE (3.0) | Systematic Assessment |
|
| Incontinence urinary | Renal and urinary disorders | CTCAE (3.0) | Systematic Assessment |
|
| Obstruction-ureteral | Renal and urinary disorders | CTCAE (3.0) | Systematic Assessment |
|
| Renal/GU-other | Renal and urinary disorders | CTCAE (3.0) | Systematic Assessment |
|
| Urinary frequency/urgency | Renal and urinary disorders | CTCAE (3.0) | Systematic Assessment |
|
| Irregular menses | Reproductive system and breast disorders | CTCAE (3.0) | Systematic Assessment |
|
| Libido | Reproductive system and breast disorders | CTCAE (3.0) | Systematic Assessment |
|
| Sexual/Reproductive function-Other | Reproductive system and breast disorders | CTCAE (3.0) | Systematic Assessment |
|
| Thrombosis/thrombus/embolism | Vascular disorders | CTCAE (3.0) | Systematic Assessment |
|
| Vascular-Other (Specify) | Vascular disorders | CTCAE (3.0) | Systematic Assessment |
|
| Edema head and neck | General disorders | CTCAE (3.0) | Systematic Assessment |
|
| Edema limb | General disorders | CTCAE (3.0) | Systematic Assessment |
|
| Lymphatics-other | General disorders | CTCAE (3.0) | Systematic Assessment |
|
| Abdomen, pain | Gastrointestinal disorders | CTCAE (3.0) | Systematic Assessment |
|
| Back, pain | Musculoskeletal and connective tissue disorders | CTCAE (3.0) | Systematic Assessment |
|
| Buttock, pain | Musculoskeletal and connective tissue disorders | CTCAE (3.0) | Systematic Assessment |
|
| Dental/teeth/peridontal, pain | Gastrointestinal disorders | CTCAE (3.0) | Systematic Assessment |
|
| External ear, pain | Ear and labyrinth disorders | CTCAE (3.0) | Systematic Assessment |
|
| Extremity-limb, pain | Musculoskeletal and connective tissue disorders | CTCAE (3.0) | Systematic Assessment |
|
| Eye, pain | Eye disorders | CTCAE (3.0) | Systematic Assessment |
|
| Face, pain | General disorders | CTCAE (3.0) | Systematic Assessment |
|
| Head/headache | Nervous system disorders | CTCAE (3.0) | Systematic Assessment |
|
| Middle ear, pain | Ear and labyrinth disorders | CTCAE (3.0) | Systematic Assessment |
|
| Neck, pain | Musculoskeletal and connective tissue disorders | CTCAE (3.0) | Systematic Assessment |
|
| Oral cavity, pain | Gastrointestinal disorders | CTCAE (3.0) | Systematic Assessment |
|
| Oral gums, pain | Gastrointestinal disorders | CTCAE (3.0) | Systematic Assessment |
|
| Pain-other | General disorders | CTCAE (3.0) | Systematic Assessment |
|
| Pelvic, pain | Reproductive system and breast disorders | CTCAE (3.0) | Systematic Assessment |
|
| Scalp, pain | Skin and subcutaneous tissue disorders | CTCAE (3.0) | Systematic Assessment |
|
| Skin, pain | Skin and subcutaneous tissue disorders | CTCAE (3.0) | Systematic Assessment |
|
| Throat/pharynx/larynx, pain | Respiratory, thoracic and mediastinal disorders | CTCAE (3.0) | Systematic Assessment |
|
Not provided
Not provided
Not provided
| D001847 | Bone Diseases |
| D009140 | Musculoskeletal Diseases |