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| Name | Class |
|---|---|
| National Cancer Institute (NCI) | NIH |
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Proton beam radiation therapy is known to spare surrounding normal tissues from radiation. Proton beam radiation delivers less radiation beyond the area of the target tissues. This may reduce side effects that patients would normally experience with standard (photon) radiation therapy which tends to unavoidably include more normal tissue along with tumor target tissue.
In this research study, the investigators are looking to determine if proton beam radiation is effective in controlling your cancer growth. The investigators are also looking to see if proton beam radiation can reduce side effects when compared to standard radiation treatment (photon radiation).
Subjects will receive proton beam radiation treatment as an outpatient at the Francis H. Burr Proton Center at Massachusetts General Hospital, 5 days per week (Mon-Fri) over 5-6 weeks depending on the type of cancer.
Tests and procedures during study treatment (weekly):
After completion of proton beam radiation treatment, subjects will be followed for 5 years. Follow-up visits will occur every 3 months for 2 years; every 4 months to year 3 and every 6 months thereafter. At each visit subjects will receive:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Proton Radiation Therapy | Other | This is a single arm study; all participants will receive proton radiation therapy. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Proton radiation therapy | Radiation | 5 days per week (Mon-Fri) for 5-6 weeks |
|
| Measure | Description | Time Frame |
|---|---|---|
| Dosimetric Comparison of Proton Beam Treatment With 3-dimensional Conformal Radiation Therapy (3DCRT) and Intensity Modulated Radiation Therapy (IMRT) | In a population of women with cancers of the cervix or endometrium with pathologically proven spread to regional lymph nodes, dose volume histograms (DVH) were compared between scanning proton beam teletherapy, 3-dimensional conformal radiation therapy (3DCRT) and intensity modulated radiation therapy (IMRT). Structure sets contoured for the proton beam therapy delivered on study were used to plan alternative 3DCRT and IMRT plans by the the same medical physics team (3DCRT and IMRT were not used on study; actual dose for proton beam was compared to the doses that would have been delivered for 3DCRT or IMRT.) Median, 25th percentile, and 75th percentile doses are listed below by tissue volume irradiated (mL) or percentage irradiated (%) for each modality. Dose is measured in grays (Gy), which is defined as the absorption of one joule of radiation energy per kilogram of matter. | 5 years |
| Acute Radiation Side Effects | Acute radiation side effects were prospectively assessed. Below are the treatment-related acute toxicities (adverse events possibly, probably, or definitely related to protocol treatment that started within 4 weeks of treatment completion) that occurred on study, along with the number of participants who experienced each event at a given severity (Grade 1/mild, Grade 2/moderate, Grade 3/severe) according to the CTCAE v 4.02 (Common terminology criteria for adverse events). | 10 weeks |
| Delayed Radiation Complications | Delayed complications from radiation were prospectively assessed. Below are the treatment-related late toxicities (adverse events possibly, probably, or definitely related to protocol treatment that started 6 months or later after treatment completion) that occurred on study, along with the number of participants who experienced each event at a given severity (Grade 1/mild, Grade 2/moderate, Grade 3/severe) according to the CTCAE v 4.02 (Common terminology criteria for adverse events). | 5 years |
| Measure | Description | Time Frame |
|---|---|---|
| Quality of Life (QOL) | The total FACT-EN/Cx scale (Functional Assessment of Cancer Therapy - Endometrial/Cervical) score was assessed at baseline and timepoints of 6 months, 1 year, 2 years, 3 years, 4 years, and 5 years to evaluate quality of life (QOL) before and after adjuvant scanning proton beam therapy. Unit = Scores on a scale. Subset scores are summed together to get a total score. Functional Assessment of Cancer Therapy - Endometrial - score range 0 - 172, with higher scores indicating a better outcome Functional Assessment of Cancer Therapy - Cervical - score range 0 - 168, with higher scores indicating a better outcome |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Andrea Russo, MD | Massachusetts General Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Massachusetts General Hospital | Boston | Massachusetts | 02114 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | Proton Radiation Therapy | This is a single arm study; all participants will receive proton radiation therapy. Proton radiation therapy: 5 days per week (Mon-Fri) for 5-6 weeks |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
22 patients enrolled, and 1 patient withdrew consent prior to study treatment. The other 21 patients were included in the final analyses.
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| ID | Title | Description |
|---|---|---|
| BG000 | Proton Radiation Therapy | This is a single arm study; all participants will receive proton radiation therapy. Proton radiation therapy: 5 days per week (Mon-Fri) for 5-6 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 | Dosimetric Comparison of Proton Beam Treatment With 3-dimensional Conformal Radiation Therapy (3DCRT) and Intensity Modulated Radiation Therapy (IMRT) | In a population of women with cancers of the cervix or endometrium with pathologically proven spread to regional lymph nodes, dose volume histograms (DVH) were compared between scanning proton beam teletherapy, 3-dimensional conformal radiation therapy (3DCRT) and intensity modulated radiation therapy (IMRT). Structure sets contoured for the proton beam therapy delivered on study were used to plan alternative 3DCRT and IMRT plans by the the same medical physics team (3DCRT and IMRT were not used on study; actual dose for proton beam was compared to the doses that would have been delivered for 3DCRT or IMRT.) Median, 25th percentile, and 75th percentile doses are listed below by tissue volume irradiated (mL) or percentage irradiated (%) for each modality. Dose is measured in grays (Gy), which is defined as the absorption of one joule of radiation energy per kilogram of matter. | 22 patients enrolled, 1 of whom withdrew consent prior to study treatment. Remaining 21 patients were included in the final analysis. | Posted | Median | Inter-Quartile Range | Gy | 5 years |
Adverse events will be collected and reported from initiation of study treatment until 60 months after the last dose of study medication/radiation treatment (5 years). This was assessed every 3 months years 1-2 post-treatment, every 4 months year 3, and every 6 months until 5 years from the end of the last dose of radiation.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Proton Radiation Therapy | This is a single arm study; all participants will receive proton radiation therapy. Proton radiation therapy: 5 days per week (Mon-Fri) for 5-6 weeks |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Abdominal distension | Gastrointestinal disorders | CTCAE (4.02) | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Andrea Russo, MD | Massachusetts General Hospital | 617-726-7941 | alrusso@mgh.harvard.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Oct 9, 2019 | Aug 25, 2024 | Prot_SAP_000.pdf |
| ICF | No | No | Yes | Informed Consent Form | Oct 28, 2019 | Aug 25, 2024 | ICF_001.pdf |
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| ID | Term |
|---|---|
| D014594 | Uterine Neoplasms |
| D002583 | Uterine Cervical Neoplasms |
| D009362 | Neoplasm Metastasis |
| ID | Term |
|---|---|
| D005833 | Genital Neoplasms, Female |
| D014565 | Urogenital Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
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| ID | Term |
|---|---|
| D011522 | Protons |
| ID | Term |
|---|---|
| D002414 | Cations, Monovalent |
| D002412 | Cations |
| D007477 | Ions |
| D004573 | Electrolytes |
| D007287 |
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| Baseline, 6 months, 1 year, 2 years, 3 years, 4 years, and 5 years |
| Progression-free Survival (PFS) | PFS is defined as the duration of time from start of treatment to time of objective disease progression at any site as detected by symptomatic recurrence or routine surveillance follow-up physical examination/imaging, or death from any cause. | 12 months, 24 months, 36 months, 48 months, and 60 months |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| ID | Title | Description |
|---|
| OG000 | Proton Radiation Therapy | This is a single arm study; all participants will receive proton radiation therapy. Proton radiation therapy: 5 days per week (Mon-Fri) for 5-6 weeks |
|
|
| Primary | Acute Radiation Side Effects | Acute radiation side effects were prospectively assessed. Below are the treatment-related acute toxicities (adverse events possibly, probably, or definitely related to protocol treatment that started within 4 weeks of treatment completion) that occurred on study, along with the number of participants who experienced each event at a given severity (Grade 1/mild, Grade 2/moderate, Grade 3/severe) according to the CTCAE v 4.02 (Common terminology criteria for adverse events). | 22 patients enrolled, 1 of whom discontinued prior to study treatment. The remaining 21 patients were analyzed. | Posted | Count of Participants | Participants | 10 weeks |
|
|
|
| Primary | Delayed Radiation Complications | Delayed complications from radiation were prospectively assessed. Below are the treatment-related late toxicities (adverse events possibly, probably, or definitely related to protocol treatment that started 6 months or later after treatment completion) that occurred on study, along with the number of participants who experienced each event at a given severity (Grade 1/mild, Grade 2/moderate, Grade 3/severe) according to the CTCAE v 4.02 (Common terminology criteria for adverse events). | 22 subjects enrolled, and 1 subject withdrew consent prior to treatment. The remaining 21 subjects were analyzed. | Posted | Count of Participants | Participants | 5 years |
|
|
|
| Secondary | Quality of Life (QOL) | The total FACT-EN/Cx scale (Functional Assessment of Cancer Therapy - Endometrial/Cervical) score was assessed at baseline and timepoints of 6 months, 1 year, 2 years, 3 years, 4 years, and 5 years to evaluate quality of life (QOL) before and after adjuvant scanning proton beam therapy. Unit = Scores on a scale. Subset scores are summed together to get a total score. Functional Assessment of Cancer Therapy - Endometrial - score range 0 - 172, with higher scores indicating a better outcome Functional Assessment of Cancer Therapy - Cervical - score range 0 - 168, with higher scores indicating a better outcome | 22 patients were enrolled, 1 of whom withdrew consent prior to study treatment. The remaining 21 subjects were analyzed. | Posted | Mean | Standard Deviation | total score on FACT-EN/Cx scale | Baseline, 6 months, 1 year, 2 years, 3 years, 4 years, and 5 years |
|
|
|
| Secondary | Progression-free Survival (PFS) | PFS is defined as the duration of time from start of treatment to time of objective disease progression at any site as detected by symptomatic recurrence or routine surveillance follow-up physical examination/imaging, or death from any cause. | 22 patients were enrolled, 1 of whom withdrew prior to study treatment. The remaining 21 patients were included in this analysis. | Posted | Number | 95% Confidence Interval | percentage of participants | 12 months, 24 months, 36 months, 48 months, and 60 months |
|
|
|
| 0 |
| 21 |
| 0 |
| 21 |
| 21 |
| 21 |
| Abdominal pain | Gastrointestinal disorders | CTCAE (4.02) | Systematic Assessment |
|
| Acute kidney injury | Renal and urinary disorders | CTCAE (4.02) | Systematic Assessment |
|
| Agitation | Psychiatric disorders | CTCAE (4.02) | Systematic Assessment |
|
| Alkaline phosphatase increased | Investigations | CTCAE (4.02) | Systematic Assessment |
|
| Allergic reaction | Immune system disorders | CTCAE (4.02) | Systematic Assessment |
|
| Alopecia | Skin and subcutaneous tissue disorders | CTCAE (4.02) | Systematic Assessment |
|
| Amnesia | Nervous system disorders | CTCAE (4.02) | Systematic Assessment |
|
| Anal hemorrhage | Gastrointestinal disorders | CTCAE (4.02) | Systematic Assessment |
|
| Anal pain | Gastrointestinal disorders | CTCAE (4.02) | Systematic Assessment |
|
| Anemia | Blood and lymphatic system disorders | CTCAE (4.02) | Systematic Assessment |
|
| Anorexia | Metabolism and nutrition disorders | CTCAE (4.02) | Systematic Assessment |
|
| Anxiety | Psychiatric disorders | CTCAE (4.02) | Systematic Assessment |
|
| Apnea | Respiratory, thoracic and mediastinal disorders | CTCAE (4.02) | Systematic Assessment |
|
| Arthralgia | Musculoskeletal and connective tissue disorders | CTCAE (4.02) | Systematic Assessment |
|
| Arthritis | Musculoskeletal and connective tissue disorders | CTCAE (4.02) | Systematic Assessment |
|
| Ascites | Gastrointestinal disorders | CTCAE (4.02) | Systematic Assessment |
|
| Atelectasis | Respiratory, thoracic and mediastinal disorders | CTCAE (4.02) | Systematic Assessment |
|
| Atrial fibrillation | Cardiac disorders | CTCAE (4.02) | Systematic Assessment |
|
| Atrial flutter | Cardiac disorders | CTCAE (4.02) | Systematic Assessment |
|
| Autoimmune disorder | Immune system disorders | CTCAE (4.02) | Systematic Assessment |
|
| Back pain | Musculoskeletal and connective tissue disorders | CTCAE (4.02) | Systematic Assessment |
|
| Bladder spasm | Renal and urinary disorders | CTCAE (4.02) | Systematic Assessment |
|
| Bloating | Gastrointestinal disorders | CTCAE (4.02) | Systematic Assessment |
|
| Blood and lymphatic system disorders - Other, specify: Iron deficiency | Blood and lymphatic system disorders | CTCAE (4.02) | Systematic Assessment |
|
| Blood and lymphatic system disorders - Other, specify: Mucosal hyperemia | Blood and lymphatic system disorders | CTCAE (4.02) | Systematic Assessment |
|
| Blood corticotrophin decreased | Investigations | CTCAE (4.02) | Systematic Assessment |
|
| Bone pain | Musculoskeletal and connective tissue disorders | CTCAE (4.02) | Systematic Assessment |
|
| Breast pain | Reproductive system and breast disorders | CTCAE (4.02) | Systematic Assessment |
|
| Bruising | Injury, poisoning and procedural complications | CTCAE (4.02) | Systematic Assessment |
|
| Buttock pain | Musculoskeletal and connective tissue disorders | CTCAE (4.02) | Systematic Assessment |
|
| Cardiac disorders - Other, specify: Carotid bruit | Cardiac disorders | CTCAE (4.02) | Systematic Assessment |
|
| Cardiac disorders - Other, specify: Abdominal aortic pulsation | Cardiac disorders | CTCAE (4.02) | Systematic Assessment |
|
| Cardiac disorders - Other, specify: Dilated cardiomyopathy | Cardiac disorders | CTCAE (4.02) | Systematic Assessment |
|
| Cardiac disorders - Other, specify: systolic murmur | Cardiac disorders | CTCAE (4.02) | Systematic Assessment |
|
| Cardiac disorders - Other, specify | Cardiac disorders | CTCAE (4.02) | Systematic Assessment |
|
| Cataract | Eye disorders | CTCAE (4.02) | Systematic Assessment |
|
| Chest pain - cardiac | Cardiac disorders | CTCAE (4.02) | Systematic Assessment |
|
| Chills | General disorders | CTCAE (4.02) | Systematic Assessment |
|
| Cholecystitis | Hepatobiliary disorders | CTCAE (4.02) | Systematic Assessment |
|
| Cholesterol high | Investigations | CTCAE (4.02) | Systematic Assessment |
|
| Colitis | Gastrointestinal disorders | CTCAE (4.02) | Systematic Assessment |
|
| Confusion | Psychiatric disorders | CTCAE (4.02) | Systematic Assessment |
|
| Constipation | Gastrointestinal disorders | CTCAE (4.02) | Systematic Assessment |
|
| Cough | Respiratory, thoracic and mediastinal disorders | CTCAE (4.02) | Systematic Assessment |
|
| Cystitis noninfective | Renal and urinary disorders | CTCAE (4.02) | Systematic Assessment |
|
| Dehydration | Metabolism and nutrition disorders | CTCAE (4.02) | Systematic Assessment |
|
| Dental caries | Gastrointestinal disorders | CTCAE (4.02) | Systematic Assessment |
|
| Depression | Psychiatric disorders | CTCAE (4.02) | Systematic Assessment |
|
| Dermatitis radiation | Injury, poisoning and procedural complications | CTCAE (4.02) | Systematic Assessment |
|
| Diarrhea | Gastrointestinal disorders | CTCAE (4.02) | Systematic Assessment |
|
| Dizziness | Nervous system disorders | CTCAE (4.02) | Systematic Assessment |
|
| Dry mouth | Gastrointestinal disorders | CTCAE (4.02) | Systematic Assessment |
|
| Dry skin | Skin and subcutaneous tissue disorders | CTCAE (4.02) | Systematic Assessment |
|
| Duodenal hemorrhage | Gastrointestinal disorders | CTCAE (4.02) | Systematic Assessment |
|
| Duodenal ulcer | Gastrointestinal disorders | CTCAE (4.02) | Systematic Assessment |
|
| Dysgeusia | Nervous system disorders | CTCAE (4.02) | Systematic Assessment |
|
| Dyspareunia | Reproductive system and breast disorders | CTCAE (4.02) | Systematic Assessment |
|
| Dyspepsia | Gastrointestinal disorders | CTCAE (4.02) | Systematic Assessment |
|
| Dyspnea | Respiratory, thoracic and mediastinal disorders | CTCAE (4.02) | Systematic Assessment |
|
| Ear pain | Ear and labyrinth disorders | CTCAE (4.02) | Systematic Assessment |
|
| Edema face | General disorders | CTCAE (4.02) | Systematic Assessment |
|
| Edema limbs | General disorders | CTCAE (4.02) | Systematic Assessment |
|
| Endocrine disorders - Other, specify: bilateral small hypoechoic nodules; benign appearance | Endocrine disorders | CTCAE (4.02) | Systematic Assessment |
|
| Endocrine disorders - Other, specify: Multinodular goiter | Endocrine disorders | CTCAE (4.02) | Systematic Assessment |
|
| Enterocolitis | Gastrointestinal disorders | CTCAE (4.02) | Systematic Assessment |
|
| Epistaxis | Respiratory, thoracic and mediastinal disorders | CTCAE (4.02) | Systematic Assessment |
|
| Erythema multiforme | Skin and subcutaneous tissue disorders | CTCAE (4.02) | Systematic Assessment |
|
| Eye disorders - Other, specify: exopthalmos | Eye disorders | CTCAE (4.02) | Systematic Assessment |
|
| Eye disorders - Other, specify: Left upper lid pain - swollen, crusty discharge | Eye disorders | CTCAE (4.02) | Systematic Assessment |
|
| Eye disorders - Other, specify: hordeolum externum of left upper eyelid | Eye disorders | CTCAE (4.02) | Systematic Assessment |
|
| Eye disorders - Other, specify: pain and swelling in Right upper eyelid | Eye disorders | CTCAE (4.02) | Systematic Assessment |
|
| Eye disorders - Other, specify: pathologic myopia | Eye disorders | CTCAE (4.02) | Systematic Assessment |
|
| Eye disorders - Other, specify: asthenopia | Eye disorders | CTCAE (4.02) | Systematic Assessment |
|
| Eye disorders - Other, specify: meibomian gland dysfunction | Eye disorders | CTCAE (4.02) | Systematic Assessment |
|
| Eye pain | Eye disorders | CTCAE (4.02) | Systematic Assessment |
|
| Fall | Injury, poisoning and procedural complications | CTCAE (4.02) | Systematic Assessment |
|
| Fatigue | General disorders | CTCAE (4.02) | Systematic Assessment |
|
| Fecal incontinence | Gastrointestinal disorders | CTCAE (4.02) | Systematic Assessment |
|
| Fever | General disorders | CTCAE (4.02) | Systematic Assessment |
|
| Flatulence | Gastrointestinal disorders | CTCAE (4.02) | Systematic Assessment |
|
| Floaters | Eye disorders | CTCAE (4.02) | Systematic Assessment |
|
| Flu like symptoms | General disorders | CTCAE (4.02) | Systematic Assessment |
|
| Flushing | Vascular disorders | CTCAE (4.02) | Systematic Assessment |
|
| Fracture | Injury, poisoning and procedural complications | CTCAE (4.02) | Systematic Assessment |
|
| Gait disturbance | General disorders | CTCAE (4.02) | Systematic Assessment |
|
| Gastritis | Gastrointestinal disorders | CTCAE (4.02) | Systematic Assessment |
|
| Gastroesophageal reflux disease | Gastrointestinal disorders | CTCAE (4.02) | Systematic Assessment |
|
| Gastrointestinal disorders - Other, specify | Gastrointestinal disorders | CTCAE (4.02) | Systematic Assessment |
|
| Gastrointestinal disorders - Other, specify: history of crohn's disease | Gastrointestinal disorders | CTCAE (4.02) | Systematic Assessment |
|
| Gastrointestinal disorders - Other, specify: small bowel obstruction | Gastrointestinal disorders | CTCAE (4.02) | Systematic Assessment |
|
| Gastrointestinal disorders - Other, specify: abdominal spasms | Gastrointestinal disorders | CTCAE (4.02) | Systematic Assessment |
|
| Gastrointestinal disorders - Other, specify: Rectal urgency | Gastrointestinal disorders | CTCAE (4.02) | Systematic Assessment |
|
| Gastrointestinal disorders - Other, specify: Diverticulosis | Gastrointestinal disorders | CTCAE (4.02) | Systematic Assessment |
|
| Gastrointestinal disorders - Other, specify: Rectal discharge | Gastrointestinal disorders | CTCAE (4.02) | Systematic Assessment |
|
| Gastrointestinal disorders - Other, specify: Abdominal discomfort secondary to oral contrast agent | Gastrointestinal disorders | CTCAE (4.02) | Systematic Assessment |
|
| Gastrointestinal disorders - Other, specify: Hiatal hernia | Gastrointestinal disorders | CTCAE (4.02) | Systematic Assessment |
|
| Gastrointestinal disorders - Other, specify: Melena | Gastrointestinal disorders | CTCAE (4.02) | Systematic Assessment |
|
| Gastrointestinal disorders - Other, specify: Hematochezia | Gastrointestinal disorders | CTCAE (4.02) | Systematic Assessment |
|
| Gastrointestinal disorders - Other, specify: Rectocele | Gastrointestinal disorders | CTCAE (4.02) | Systematic Assessment |
|
| Gastrointestinal disorders - Other, specify: Irritable bowel syndrome | Gastrointestinal disorders | CTCAE (4.02) | Systematic Assessment |
|
| Gastrointestinal disorders - Other, specify: Rectal urgency | Gastrointestinal disorders | CTCAE (4.02) | Systematic Assessment |
|
| Gastrointestinal disorders - Other, specify: Bowel urgency | Gastrointestinal disorders | CTCAE (4.02) | Systematic Assessment |
|
| Gastrointestinal disorders - Other, specify: increased frequency of bowel movements | Gastrointestinal disorders | CTCAE (4.02) | Systematic Assessment |
|
| General disorders and administration site conditions - Other, specify: Diaphoresis | General disorders | CTCAE (4.02) | Systematic Assessment |
|
| General disorders and administration site conditions - Other, specify: lesion on finger | General disorders | CTCAE (4.02) | Systematic Assessment |
|
| Generalized muscle weakness | Musculoskeletal and connective tissue disorders | CTCAE (4.02) | Systematic Assessment |
|
| Glaucoma | Eye disorders | CTCAE (4.02) | Systematic Assessment |
|
| Gum infection | Infections and infestations | CTCAE (4.02) | Systematic Assessment |
|
| Hallucinations | Psychiatric disorders | CTCAE (4.02) | Systematic Assessment |
|
| Headache | Nervous system disorders | CTCAE (4.02) | Systematic Assessment |
|
| Hearing impaired | Ear and labyrinth disorders | CTCAE (4.02) | Systematic Assessment |
|
| Heart failure | Cardiac disorders | CTCAE (4.02) | Systematic Assessment |
|
| Hematuria | Renal and urinary disorders | CTCAE (4.02) | Systematic Assessment |
|
| Hemorrhoidal hemorrhage | Gastrointestinal disorders | CTCAE (4.02) | Systematic Assessment |
|
| Hemorrhoids | Gastrointestinal disorders | CTCAE (4.02) | Systematic Assessment |
|
| Hepatobiliary disorders - Other, specify: cholelithisasis | Hepatobiliary disorders | CTCAE (4.02) | Systematic Assessment |
|
| Hirsutism | Skin and subcutaneous tissue disorders | CTCAE (4.02) | Systematic Assessment |
|
| Hoarseness | Respiratory, thoracic and mediastinal disorders | CTCAE (4.02) | Systematic Assessment |
|
| Hot flashes | Vascular disorders | CTCAE (4.02) | Systematic Assessment |
|
| Hyperglycemia | Metabolism and nutrition disorders | CTCAE (4.02) | Systematic Assessment |
|
| Hyperhidrosis | Skin and subcutaneous tissue disorders | CTCAE (4.02) | Systematic Assessment |
|
| Hyperkalemia | Metabolism and nutrition disorders | CTCAE (4.02) | Systematic Assessment |
|
| Hypertension | Vascular disorders | CTCAE (4.02) | Systematic Assessment |
|
| Hyperthyroidism | Endocrine disorders | CTCAE (4.02) | Systematic Assessment |
|
| Hypertriglyceridemia | Metabolism and nutrition disorders | CTCAE (4.02) | Systematic Assessment |
|
| Hypoalbuminemia | Metabolism and nutrition disorders | CTCAE (4.02) | Systematic Assessment |
|
| Hypocalcemia | Metabolism and nutrition disorders | CTCAE (4.02) | Systematic Assessment |
|
| Hypokalemia | Metabolism and nutrition disorders | CTCAE (4.02) | Systematic Assessment |
|
| Hypomagnesemia | Metabolism and nutrition disorders | CTCAE (4.02) | Systematic Assessment |
|
| Hyponatremia | Metabolism and nutrition disorders | CTCAE (4.02) | Systematic Assessment |
|
| Hypophosphatemia | Metabolism and nutrition disorders | CTCAE (4.02) | Systematic Assessment |
|
| Hypotension | Vascular disorders | CTCAE (4.02) | Systematic Assessment |
|
| Hypothyroidism | Endocrine disorders | CTCAE (4.02) | Systematic Assessment |
|
| Hypoxia | Respiratory, thoracic and mediastinal disorders | CTCAE (4.02) | Systematic Assessment |
|
| Infections and infestations - Other, specify: herpes simplex virus | Infections and infestations | CTCAE (4.02) | Systematic Assessment |
|
| Infections and infestations - Other, specify: tooth infection | Infections and infestations | CTCAE (4.02) | Systematic Assessment |
|
| Infections and infestations - Other, specify: yeast infection | Infections and infestations | CTCAE (4.02) | Systematic Assessment |
|
| Injury, poisoning and procedural complications - Other, specify: rotator cuff tear | Injury, poisoning and procedural complications | CTCAE (4.02) | Systematic Assessment |
|
| Injury, poisoning and procedural complications - Other, specify: port site pain | Injury, poisoning and procedural complications | CTCAE (4.02) | Systematic Assessment |
|
| INR increased | Investigations | CTCAE (4.02) | Systematic Assessment |
|
| Insomnia | Psychiatric disorders | CTCAE (4.02) | Systematic Assessment |
|
| Irritability | General disorders | CTCAE (4.02) | Systematic Assessment |
|
| Kidney infection | Infections and infestations | CTCAE (4.02) | Systematic Assessment |
|
| Libido decreased | Psychiatric disorders | CTCAE (4.02) | Systematic Assessment |
|
| Lip infection | Infections and infestations | CTCAE (4.02) | Systematic Assessment |
|
| Localized edema | General disorders | CTCAE (4.02) | Systematic Assessment |
|
| Lymphedema | Vascular disorders | CTCAE (4.02) | Systematic Assessment |
|
| Lymphocyte count decreased | Investigations | CTCAE (4.02) | Systematic Assessment |
|
| Metabolism and nutrition disorders - Other, specify: Insulin resistance | Metabolism and nutrition disorders | CTCAE (4.02) | Systematic Assessment |
|
| Metabolism and nutrition disorders - Other, specify: lactic acidosis | Metabolism and nutrition disorders | CTCAE (4.02) | Systematic Assessment |
|
| Metabolism and nutrition disorders - Other, specify: vitamin D deficiency | Metabolism and nutrition disorders | CTCAE (4.02) | Systematic Assessment |
|
| Musculoskeletal and connective tissue disorder - Other, specify: hip pain | Musculoskeletal and connective tissue disorders | CTCAE (4.02) | Systematic Assessment |
|
| Musculoskeletal and connective tissue disorder - Other, specify: knee pain | Musculoskeletal and connective tissue disorders | CTCAE (4.02) | Systematic Assessment |
|
| Musculoskeletal and connective tissue disorder - Other, specify: plantar lesion | Musculoskeletal and connective tissue disorders | CTCAE (4.02) | Systematic Assessment |
|
| Musculoskeletal and connective tissue disorder - Other, specify: Soft bulging when standing up | Musculoskeletal and connective tissue disorders | CTCAE (4.02) | Systematic Assessment |
|
| Musculoskeletal and connective tissue disorder - Other, specify: degenerative disc disease | Musculoskeletal and connective tissue disorders | CTCAE (4.02) | Systematic Assessment |
|
| Musculoskeletal and connective tissue disorder - Other, specify: finger pain | Musculoskeletal and connective tissue disorders | CTCAE (4.02) | Systematic Assessment |
|
| Musculoskeletal and connective tissue disorder - Other, specify: subacromial spur w/ tendinopathy | Musculoskeletal and connective tissue disorders | CTCAE (4.02) | Systematic Assessment |
|
| Musculoskeletal and connective tissue disorder - Other, specify: hyperreflexia | Musculoskeletal and connective tissue disorders | CTCAE (4.02) | Systematic Assessment |
|
| Musculoskeletal and connective tissue disorder - Other, specify: Sciatica | Musculoskeletal and connective tissue disorders | CTCAE (4.02) | Systematic Assessment |
|
| Musculoskeletal and connective tissue disorder - Other, specify: Fibromyalgia | Musculoskeletal and connective tissue disorders | CTCAE (4.02) | Systematic Assessment |
|
| Musculoskeletal and connective tissue disorder - Other, specify: osteitis deformans | Musculoskeletal and connective tissue disorders | CTCAE (4.02) | Systematic Assessment |
|
| Musculoskeletal and connective tissue disorder - Other, specify | Musculoskeletal and connective tissue disorders | CTCAE (4.02) | Systematic Assessment |
|
| Musculoskeletal and connective tissue disorder - Other, specify: Musculoskeletal deformity | Musculoskeletal and connective tissue disorders | CTCAE (4.02) | Systematic Assessment |
|
| Myalgia | Musculoskeletal and connective tissue disorders | CTCAE (4.02) | Systematic Assessment |
|
| Nail discoloration | Skin and subcutaneous tissue disorders | CTCAE (4.02) | Systematic Assessment |
|
| Nail infection | Infections and infestations | CTCAE (4.02) | Systematic Assessment |
|
| Nail loss | Skin and subcutaneous tissue disorders | CTCAE (4.02) | Systematic Assessment |
|
| Nasal congestion | Respiratory, thoracic and mediastinal disorders | CTCAE (4.02) | Systematic Assessment |
|
| Nausea | Gastrointestinal disorders | CTCAE (4.02) | Systematic Assessment |
|
| Neck pain | Musculoskeletal and connective tissue disorders | CTCAE (4.02) | Systematic Assessment |
|
| Neoplasms benign, malignant and unspecified (incl cysts and polyps) - Other, specify | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | CTCAE (4.02) | Systematic Assessment |
|
| Neoplasms benign, malignant and unspecified (incl cysts and polyps) - Other, specify: Vascular polyp | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | CTCAE (4.02) | Systematic Assessment |
|
| Neoplasms benign, malignant and unspecified (incl cysts and polyps) - Other, specify: Baker's cyst | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | CTCAE (4.02) | Systematic Assessment |
|
| Neoplasms benign, malignant and unspecified (incl cysts and polyps) - Other, specify: Cyst | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | CTCAE (4.02) | Systematic Assessment |
|
| Neoplasms benign, malignant and unspecified (incl cysts and polyps) - Other, specify: Ganglion cyst | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | CTCAE (4.02) | Systematic Assessment |
|
| Nervous system disorders - Other, specify: hyperreflexia | Nervous system disorders | CTCAE (4.02) | Systematic Assessment |
|
| Nervous system disorders - Other, specify | Nervous system disorders | CTCAE (4.02) | Systematic Assessment |
|
| Nervous system disorders - Other, specify: Carpal tunnel syndrome | Nervous system disorders | CTCAE (4.02) | Systematic Assessment |
|
| Neuralgia | Nervous system disorders | CTCAE (4.02) | Systematic Assessment |
|
| Neutrophil count decreased | Investigations | CTCAE (4.02) | Systematic Assessment |
|
| Non-cardiac chest pain | General disorders | CTCAE (4.02) | Systematic Assessment |
|
| Obesity | Metabolism and nutrition disorders | CTCAE (4.02) | Systematic Assessment |
|
| Oral pain | Gastrointestinal disorders | CTCAE (4.02) | Systematic Assessment |
|
| Pain | General disorders | CTCAE (4.02) | Systematic Assessment |
|
| Pain in extremity | Musculoskeletal and connective tissue disorders | CTCAE (4.02) | Systematic Assessment |
|
| Palpitations | Cardiac disorders | CTCAE (4.02) | Systematic Assessment |
|
| Paresthesia | Nervous system disorders | CTCAE (4.02) | Systematic Assessment |
|
| Pelvic pain | Reproductive system and breast disorders | CTCAE (4.02) | Systematic Assessment |
|
| Periorbital edema | Skin and subcutaneous tissue disorders | CTCAE (4.02) | Systematic Assessment |
|
| Peripheral motor neuropathy | Nervous system disorders | CTCAE (4.02) | Systematic Assessment |
|
| Peripheral sensory neuropathy | Nervous system disorders | CTCAE (4.02) | Systematic Assessment |
|
| Pharyngitis | Infections and infestations | CTCAE (4.02) | Systematic Assessment |
|
| Photosensitivity | Skin and subcutaneous tissue disorders | CTCAE (4.02) | Systematic Assessment |
|
| Platelet count decreased | Investigations | CTCAE (4.02) | Systematic Assessment |
|
| Pleuritic pain | Respiratory, thoracic and mediastinal disorders | CTCAE (4.02) | Systematic Assessment |
|
| Postnasal drip | Respiratory, thoracic and mediastinal disorders | CTCAE (4.02) | Systematic Assessment |
|
| Premature menopause | Reproductive system and breast disorders | CTCAE (4.02) | Systematic Assessment |
|
| Proctitis | Gastrointestinal disorders | CTCAE (4.02) | Systematic Assessment |
|
| Productive cough | Respiratory, thoracic and mediastinal disorders | CTCAE (4.02) | Systematic Assessment |
|
| Proteinuria | Renal and urinary disorders | CTCAE (4.02) | Systematic Assessment |
|
| Pruritus | Skin and subcutaneous tissue disorders | CTCAE (4.02) | Systematic Assessment |
|
| Psychiatric disorders - Other, specify: PTSD | Psychiatric disorders | CTCAE (4.02) | Systematic Assessment |
|
| Psychiatric disorders - Other, specify: Recent cognitive struggles, sleep disruption and sadness. | Psychiatric disorders | CTCAE (4.02) | Systematic Assessment |
|
| Psychiatric disorders - Other, specify: ADHD | Psychiatric disorders | CTCAE (4.02) | Systematic Assessment |
|
| Pulmonary edema | Respiratory, thoracic and mediastinal disorders | CTCAE (4.02) | Systematic Assessment |
|
| Rash acneiform | Skin and subcutaneous tissue disorders | CTCAE (4.02) | Systematic Assessment |
|
| Rash maculo-papular | Skin and subcutaneous tissue disorders | CTCAE (4.02) | Systematic Assessment |
|
| Rectal hemorrhage | Gastrointestinal disorders | CTCAE (4.02) | Systematic Assessment |
|
| Rectal mucositis | Gastrointestinal disorders | CTCAE (4.02) | Systematic Assessment |
|
| Rectal pain | Gastrointestinal disorders | CTCAE (4.02) | Systematic Assessment |
|
| Renal and urinary disorders - Other, specify: Dysuria | Renal and urinary disorders | CTCAE (4.02) | Systematic Assessment |
|
| Renal and urinary disorders - Other, specify: Bladder pressure and urinary frequency | Renal and urinary disorders | CTCAE (4.02) | Systematic Assessment |
|
| Renal and urinary disorders - Other, specify: Mons swelling | Renal and urinary disorders | CTCAE (4.02) | Systematic Assessment |
|
| Renal and urinary disorders - Other, specify: cytocele | Renal and urinary disorders | CTCAE (4.02) | Systematic Assessment |
|
| Renal and urinary disorders - Other, specify: Urinary leakage | Renal and urinary disorders | CTCAE (4.02) | Systematic Assessment |
|
| Renal and urinary disorders - Other, specify: Suprapubic pressure and discomfort with urination | Renal and urinary disorders | CTCAE (4.02) | Systematic Assessment |
|
| Reproductive system and breast disorders - Other, specify: changes to vaginal mucosa | Reproductive system and breast disorders | CTCAE (4.02) | Systematic Assessment |
|
| Reproductive system and breast disorders - Other, specify: Synechiae in vagina | Reproductive system and breast disorders | CTCAE (4.02) | Systematic Assessment |
|
| Reproductive system and breast disorders - Other, specify: radiation changes in vagina | Reproductive system and breast disorders | CTCAE (4.02) | Systematic Assessment |
|
| Reproductive system and breast disorders - Other, specify: Vaginal bleeding | Reproductive system and breast disorders | CTCAE (4.02) | Systematic Assessment |
|
| Reproductive system and breast disorders - Other, specify: Radiation stigmata | Reproductive system and breast disorders | CTCAE (4.02) | Systematic Assessment |
|
| Reproductive system and breast disorders - Other, specify: Yeast infection | Reproductive system and breast disorders | CTCAE (4.02) | Systematic Assessment |
|
| Reproductive system and breast disorders - Other, specify: Vaginal discharge discoloration | Reproductive system and breast disorders | CTCAE (4.02) | Systematic Assessment |
|
| Reproductive system and breast disorders - Other, specify: Vaginitis | Reproductive system and breast disorders | CTCAE (4.02) | Systematic Assessment |
|
| Reproductive system and breast disorders - Other, specify: Vaginal bleeding during intercourse | Reproductive system and breast disorders | CTCAE (4.02) | Systematic Assessment |
|
| Reproductive system and breast disorders - Other, specify: Post-coital bleeding | Reproductive system and breast disorders | CTCAE (4.02) | Systematic Assessment |
|
| Reproductive system and breast disorders - Other, specify: Perineal erythema | Reproductive system and breast disorders | CTCAE (4.02) | Systematic Assessment |
|
| Reproductive system and breast disorders - Other, specify: Vaginal atrophy | Reproductive system and breast disorders | CTCAE (4.02) | Systematic Assessment |
|
| Reproductive system and breast disorders - Other, specify: Vaginal mucosa atrophy | Reproductive system and breast disorders | CTCAE (4.02) | Systematic Assessment |
|
| Reproductive system and breast disorders - Other, specify: Mons pubis swelling, pressure, discomfort | Reproductive system and breast disorders | CTCAE (4.02) | Systematic Assessment |
|
| Reproductive system and breast disorders - Other, specify: Mild hyperemia of vagina | Reproductive system and breast disorders | CTCAE (4.02) | Systematic Assessment |
|
| Reproductive system and breast disorders - Other, specify: Radiation changes/erythema at the cuff | Reproductive system and breast disorders | CTCAE (4.02) | Systematic Assessment |
|
| Reproductive system and breast disorders - Other, specify | Reproductive system and breast disorders | CTCAE (4.02) | Systematic Assessment |
|
| Reproductive system and breast disorders - Other, specify: Vaginal burning | Reproductive system and breast disorders | CTCAE (4.02) | Systematic Assessment |
|
| Reproductive system and breast disorders - Other, specify: Radiation fibrosis of vaginal rugae | Reproductive system and breast disorders | CTCAE (4.02) | Systematic Assessment |
|
| Reproductive system and breast disorders - Other, specify: Enlarged veins R labial vulvar region | Reproductive system and breast disorders | CTCAE (4.02) | Systematic Assessment |
|
| Reproductive system and breast disorders - Other, specify: Sphincter tone decreased | Reproductive system and breast disorders | CTCAE (4.02) | Systematic Assessment |
|
| Reproductive system and breast disorders - Other, specify: vulva lesions | Reproductive system and breast disorders | CTCAE (4.02) | Systematic Assessment |
|
| Respiratory, thoracic and mediastinal disorders - Other, specify: Tachypnea | Respiratory, thoracic and mediastinal disorders | CTCAE (4.02) | Systematic Assessment |
|
| Retinal tear | Eye disorders | CTCAE (4.02) | Systematic Assessment |
|
| Sepsis | Infections and infestations | CTCAE (4.02) | Systematic Assessment |
|
| Sinus bradycardia | Cardiac disorders | CTCAE (4.02) | Systematic Assessment |
|
| Sinus pain | Nervous system disorders | CTCAE (4.02) | Systematic Assessment |
|
| Sinus tachycardia | Cardiac disorders | CTCAE (4.02) | Systematic Assessment |
|
| Skin and subcutaneous tissue disorders - Other, specify: Ingrown toenail | Skin and subcutaneous tissue disorders | CTCAE (4.02) | Systematic Assessment |
|
| Skin and subcutaneous tissue disorders - Other, specify: rash | Skin and subcutaneous tissue disorders | CTCAE (4.02) | Systematic Assessment |
|
| Skin hyperpigmentation | Skin and subcutaneous tissue disorders | CTCAE (4.02) | Systematic Assessment |
|
| Skin induration | Skin and subcutaneous tissue disorders | CTCAE (4.02) | Systematic Assessment |
|
| Skin infection | Infections and infestations | CTCAE (4.02) | Systematic Assessment |
|
| Skin/subcutaneous tissue disorders; Other, specify: Rash on inner surface of elbows | Skin and subcutaneous tissue disorders | CTCAE (4.02) | Systematic Assessment |
|
| Skin/subcutaneous tissue disorders; Other: Erythematous macular rash, venous stasis dermatitis | Skin and subcutaneous tissue disorders | CTCAE (4.02) | Systematic Assessment |
|
| Skin/subcutaneous tissue disorders; Other, specify: Seborrheic keratosis | Skin and subcutaneous tissue disorders | CTCAE (4.02) | Systematic Assessment |
|
| Skin/subcutaneous tissue disorders; Other, specify: Slight pinkness on chest | Skin and subcutaneous tissue disorders | CTCAE (4.02) | Systematic Assessment |
|
| Skin/subcutaneous tissue disorders; Other, specify: Skin tag swollen and painful left axilla | Skin and subcutaneous tissue disorders | CTCAE (4.02) | Systematic Assessment |
|
| Skin/subcutaneous tissue disorders; Other, specify: Yeast dermatitis | Skin and subcutaneous tissue disorders | CTCAE (4.02) | Systematic Assessment |
|
| Skin/subcutaneous tissue disorders; Other, specify: perineal itching | Skin and subcutaneous tissue disorders | CTCAE (4.02) | Systematic Assessment |
|
| Skin/subcutaneous tissue disorders; Other, specify: itchy rash on arms | Skin and subcutaneous tissue disorders | CTCAE (4.02) | Systematic Assessment |
|
| Skin/subcutaneous tissue disorders; Other, specify: Perineal irritation | Skin and subcutaneous tissue disorders | CTCAE (4.02) | Systematic Assessment |
|
| Skin/subcutaneous tissue disorders; Other, specify: Onychocryptosis | Skin and subcutaneous tissue disorders | CTCAE (4.02) | Systematic Assessment |
|
| Skin/subcutaneous tissue disorders; Other, specify: Erythema | Skin and subcutaneous tissue disorders | CTCAE (4.02) | Systematic Assessment |
|
| Skin/subcutaneous tissue disorders; Other, specify: lichen planus | Skin and subcutaneous tissue disorders | CTCAE (4.02) | Systematic Assessment |
|
| Skin/subcutaneous tissue disorders; Other, specify: Eczema | Skin and subcutaneous tissue disorders | CTCAE (4.02) | Systematic Assessment |
|
| Sleep apnea | Respiratory, thoracic and mediastinal disorders | CTCAE (4.02) | Systematic Assessment |
|
| Small intestinal obstruction | Gastrointestinal disorders | CTCAE (4.02) | Systematic Assessment |
|
| Sore throat | Respiratory, thoracic and mediastinal disorders | CTCAE (4.02) | Systematic Assessment |
|
| Spasticity | Nervous system disorders | CTCAE (4.02) | Systematic Assessment |
|
| Spinal fracture | Injury, poisoning and procedural complications | CTCAE (4.02) | Systematic Assessment |
|
| Stomach pain | Gastrointestinal disorders | CTCAE (4.02) | Systematic Assessment |
|
| Suicidal ideation | Psychiatric disorders | CTCAE (4.02) | Systematic Assessment |
|
| Superficial thrombophlebitis | Vascular disorders | CTCAE (4.02) | Systematic Assessment |
|
| Surgical and medical procedures - Other, specify: Laparoscopic gastric bypass surgery | Surgical and medical procedures | CTCAE (4.02) | Systematic Assessment |
|
| Syncope | Nervous system disorders | CTCAE (4.02) | Systematic Assessment |
|
| Telangiectasia | Skin and subcutaneous tissue disorders | CTCAE (4.02) | Systematic Assessment |
|
| Thromboembolic event | Vascular disorders | CTCAE (4.02) | Systematic Assessment |
|
| Tinnitus | Ear and labyrinth disorders | CTCAE (4.02) | Systematic Assessment |
|
| Tooth infection | Infections and infestations | CTCAE (4.02) | Systematic Assessment |
|
| Tremor | Nervous system disorders | CTCAE (4.02) | Systematic Assessment |
|
| Upper respiratory infection | Infections and infestations | CTCAE (4.02) | Systematic Assessment |
|
| Urinary frequency | Renal and urinary disorders | CTCAE (4.02) | Systematic Assessment |
|
| Urinary incontinence | Renal and urinary disorders | CTCAE (4.02) | Systematic Assessment |
|
| Urinary retention | Renal and urinary disorders | CTCAE (4.02) | Systematic Assessment |
|
| Urinary tract infection | Infections and infestations | CTCAE (4.02) | Systematic Assessment |
|
| Urinary tract pain | Renal and urinary disorders | CTCAE (4.02) | Systematic Assessment |
|
| Urinary urgency | Renal and urinary disorders | CTCAE (4.02) | Systematic Assessment |
|
| Vaginal discharge | Reproductive system and breast disorders | CTCAE (4.02) | Systematic Assessment |
|
| Vaginal dryness | Reproductive system and breast disorders | CTCAE (4.02) | Systematic Assessment |
|
| Vaginal hemorrhage | Reproductive system and breast disorders | CTCAE (4.02) | Systematic Assessment |
|
| Vaginal infection | Infections and infestations | CTCAE (4.02) | Systematic Assessment |
|
| Vaginal inflammation | Reproductive system and breast disorders | CTCAE (4.02) | Systematic Assessment |
|
| Vaginal obstruction | Reproductive system and breast disorders | CTCAE (4.02) | Systematic Assessment |
|
| Vaginal pain | Reproductive system and breast disorders | CTCAE (4.02) | Systematic Assessment |
|
| Vaginal stricture | Reproductive system and breast disorders | CTCAE (4.02) | Systematic Assessment |
|
| Vascular access complication | Injury, poisoning and procedural complications | CTCAE (4.02) | Systematic Assessment |
|
| Vascular disorders - Other, specify: Peripheral artery disease | Vascular disorders | CTCAE (4.02) | Systematic Assessment |
|
| Vascular disorders - Other, specify: Varicose veins | Vascular disorders | CTCAE (4.02) | Systematic Assessment |
|
| Vascular disorders - Other, specify: Venous incompetence | Vascular disorders | CTCAE (4.02) | Systematic Assessment |
|
| Vertigo | Ear and labyrinth disorders | CTCAE (4.02) | Systematic Assessment |
|
| Vomiting | Gastrointestinal disorders | CTCAE (4.02) | Systematic Assessment |
|
| Vulval infection | Infections and infestations | CTCAE (4.02) | Systematic Assessment |
|
| Weight gain | Investigations | CTCAE (4.02) | Systematic Assessment |
|
| Weight loss | Investigations | CTCAE (4.02) | Systematic Assessment |
|
| Wheezing | Respiratory, thoracic and mediastinal disorders | CTCAE (4.02) | Systematic Assessment |
|
| White blood cell decreased | Investigations | CTCAE (4.02) | Systematic Assessment |
|
| Wound infection | Infections and infestations | CTCAE (4.02) | Systematic Assessment |
|
Not provided
Not provided
Not provided
| D014591 |
| Uterine Diseases |
| D005831 | Genital Diseases, Female |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D000091662 | Genital Diseases |
| D002577 | Uterine Cervical Diseases |
| D009385 | Neoplastic Processes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| Inorganic Chemicals |
| D006859 | Hydrogen |
| D004602 | Elements |
| D005740 | Gases |
| D000071940 | Nucleons |
| D004601 | Elementary Particles |
| D055585 | Physical Phenomena |
| Grade 3-severe |
|
| Anemia |
|
| Anorexia |
|
| Bladder spasm |
|
| Bloating |
|
| Constipation |
|
| Cystitis noninfective |
|
| Dermatitis radiation |
|
| Diarrhea |
|
| Fatigue |
|
| Flatulence |
|
| Gastrointestinal disorders - Other, specify |
|
| Hematuria |
|
| Hypokalemia |
|
| Infections and infestations - Other, specify |
|
| Lymphocyte count decreased |
|
| Nausea |
|
| Neutrophil count decreased |
|
| Pain |
|
| Pelvic pain |
|
| Platelet count decreased |
|
| Proctitis |
|
| Proteinuria |
|
| Pruritis |
|
| Rectal hemorrhage |
|
| Rectal pain |
|
| Renal and urinary disorders - other, specify |
|
| Reproductive system and breast disorders - other, specify |
|
| Skin and subcutaneous tissue disorders - other, specify |
|
| Stomach pain |
|
| Superficial thrombophlebitis |
|
| Urinary frequency |
|
| urinary tract infection |
|
| Urinary tract pain |
|
| Urinary urgency |
|
| Vaginal discharge |
|
| Vaginal dryness |
|
| Vaginal inflammation |
|
| Vaginal pain |
|
| Vomiting |
|
| While blood cell decreased |
|
| Grade 3 (Severe |
|
| Abdominal pain |
|
| Anal pain |
|
| Anemia |
|
| Constipation |
|
| Cystitis noninfective |
|
| Dermatitis radiation |
|
| Diarrhea |
|
| Dry skin |
|
| Duodenal ulcer |
|
| Dyspareunia |
|
| Edema limbs |
|
| Fatigue |
|
| Fecal incontinence |
|
| Flatulence |
|
| Gastritis |
|
| Gastrointestinal disorders - other, specify |
|
| Hematuria |
|
| Hemorrhoids |
|
| Libido decreased |
|
| Lymphedema |
|
| Lymphocyte count decreased |
|
| Nausea |
|
| Paresthesia |
|
| Pelvic pain |
|
| Proctitis |
|
| Psychiatric disorders - other, specify |
|
| Rectal hemorrhage |
|
| Renal and urinary disorders - other, specify |
|
| Reproductive system and breast disorders - other, specify |
|
| Small intestinal obstruction |
|
| Telangiectasia |
|
| Urinary frequency |
|
| Urinary incontinence |
|
| Urinary retention |
|
| Urinary tract pain |
|
| Vaginal discharge |
|
| Vaginal dryness |
|
| Vaginal hemorrhage |
|
| Vaginal inflammation |
|
| Vaginal obstruction |
|
| Vaginal pain |
|
| Vaginal stricture |
|
| Vomiting |
|
| Vulval infection |
|
| Weight gain |
|
| White blood cell decreased |
|
| Title | Measurements |
|---|---|
|
| 2 years |
|
| 3 years |
|
| 4 years |
|
| 5 years |
|
|
| 48 months post treatment completion |
|
| 60 months post treatment completion |
|