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| ID | Type | Description | Link |
|---|---|---|---|
| KL2TR001438 | U.S. NIH Grant/Contract | View source | |
| K23HL141445 | U.S. NIH Grant/Contract | View source | |
| 86-004-26 | Other Grant/Funding Number | American Cancer Society Institutional Research Grant |
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| Name | Class |
|---|---|
| National Heart, Lung, and Blood Institute (NHLBI) | NIH |
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In this study the investigators want to find out more about the addition of the antibiotic, doxycycline, to standard anti-amyloid therapy in people with amyloidosis. The investigators want to find out whether doxycycline improves the response to standard anti-amyloid therapy and whether it causes any problems (side effects).
Organ response to anti-plasma cell therapy in AL amyloidosis tends to lags behind hematologic response as chemotherapy may not clear pre-formed organ amyloid. Doxycycline has been shown to have inhibitory effects on amyloid fibril formation as well as de-fibrillogenic effects and shown to be beneficial in in vitro, murine models and other preclinical studies. The investigators will prospectively evaluate the safety and efficacy of doxycycline in AL amyloidosis patients when used in conjunction with anti-plasma cell chemotherapy.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Doxycycline | Experimental | Doxycycline will be administered at dose of 100mg orally twice daily for 1 year. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Doxycycline | Drug | Doxycycline will be continued until one of the following criteria is met:
|
| Measure | Description | Time Frame |
|---|---|---|
| Hematologic Response | This measure will record the number of subjects for each grade of response to therapy for subjects with Systematic Disease (hematologic) only. Hematologic response will be determined as follows. Complete response (CR) - Negative serum/urine immunofixation with normal Free Light Chain (FLC) ratio Very Good Partial Response (VGPR)- Difference between involved and uninvolved FLCs (dFLC) < 40 mg/L Partial Response (PR)- dFLC decrease > 50% No Response (NR)- less then PR. | 1 year |
| Measure | Description | Time Frame |
|---|---|---|
| Amyloid Organ Response | This measure is the number of subjects (systemic disease only) for each grade of response. Efficacy will be measured in heart, liver, or kidney. Heart N-terminal (NT)-proBNP response >30% and > 300 ng/L decrease in patients with baseline NT-proBNP ≥650 ng/L (Patients with progressively worsening renal function cannot be scored for NT-proBNP progression). Improvement by 2 New York Heart Association (NYHA) classes without an increase in diuretic use or in echocardiographic wall thickness ≥ 2 mm reduction in the interventricular septal thickness by echocardiogram or improvement of ejection fraction by ≥20%. Liver ≥50% decrease in an initially elevated alkaline phosphatase level, or Decrease in liver size by at least 2 cm by ultrasound. Kidney 50% reduction in 24-hour urine protein excretion (at least 0.5 g/day) without worsening of creatinine or creatinine clearance by 25% over baseline. Soft Tissue RECIST criteria will be used. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Anita D'Souza, MD | Medical College of Wisconsin | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Froedtert & Medical College of Wisconsin | Milwaukee | Wisconsin | 53226 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 32529175 | Derived | D'Souza A, Szabo A, Flynn KE, Dhakal B, Chhabra S, Pasquini MC, Weihrauch D, Hari PN. Adjuvant doxycycline to enhance anti-amyloid effects: Results from the dual phase 2 trial. EClinicalMedicine. 2020 Jun 5;23:100361. doi: 10.1016/j.eclinm.2020.100361. eCollection 2020 Jun. |
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Subjects were stratified by the type of amyloidosis. Subjects with primarily organ-based disease were classified as Localized Disease), whereas subjects with hematologic disease were classified as Systematic Disease. Each population received the same intervention but assessment of the clinical outcomes used different classification categories.
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| ID | Title | Description |
|---|---|---|
| FG000 | Doxycycline (Localized Disease) | Doxycycline will be administered at dose of 100mg orally twice daily for 1 year. Doxycycline: Doxycycline will be continued until one of the following criteria is met:
|
| FG001 | Doxacycline (Systemic Disease) | Doxycycline will be administered at dose of 100mg orally twice daily for 1 year. Doxycycline: Doxycycline will be continued until one of the following criteria is met:
|
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
Two subjects in the Localized Disease arm signed consent, but did not proceed to the treatment phase of the study. One subject withdrew consent and one subject was determined to be ineligible and was withdrawn by the investigator. Baseline demographic data were collected for these subjects.
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| ID | Title | Description |
|---|---|---|
| BG000 | Doxycycline (Localized Disease) | Doxycycline will be administered at dose of 100mg orally twice daily for 1 year. Doxycycline: Doxycycline will be continued until one of the following criteria is met:
|
| BG001 |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of 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 | Hematologic Response | This measure will record the number of subjects for each grade of response to therapy for subjects with Systematic Disease (hematologic) only. Hematologic response will be determined as follows. Complete response (CR) - Negative serum/urine immunofixation with normal Free Light Chain (FLC) ratio Very Good Partial Response (VGPR)- Difference between involved and uninvolved FLCs (dFLC) < 40 mg/L Partial Response (PR)- dFLC decrease > 50% No Response (NR)- less then PR. | Hematologic response is not relevant to subjects with localized disease. Subjects with localized disease were not included in this analysis. Five participants had expired by the 1 year time point | Posted | Count of Participants | Participants | 1 year |
|
1 year
Grade was determined using the Common Terminology Criteria for Adverse Events (CTCAE) v 4.03. Events graded as 4 or 5 were considered serious regardless of the standard criteria.
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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 | Doxycycline (Localized Disease) | Doxycycline will be administered at dose of 100mg orally twice daily for 1 year. Doxycycline: Doxycycline will be continued until one of the following criteria is met:
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Lymphocyte production decreased | Blood and lymphatic system disorders | CTCAE v4.03 | Systematic Assessment | CTCAE v4.03 Grade 4 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Fatigue | General disorders | CTCAE v4.03 | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Anita D'Souza | Medical College of Wisconsin | 414-805-0637 | dsouza@mcw.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 | Aug 19, 2016 | Sep 18, 2019 | Prot_SAP_000.pdf |
| ICF | No | No | Yes | Informed Consent Form | Sep 14, 2016 | Sep 18, 2019 | ICF_001.pdf |
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| ID | Term |
|---|---|
| D000075363 | Immunoglobulin Light-chain Amyloidosis |
| D000686 | Amyloidosis |
| ID | Term |
|---|---|
| D054219 | Neoplasms, Plasma Cell |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D057165 | Proteostasis Deficiencies |
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| ID | Term |
|---|---|
| D004318 | Doxycycline |
| ID | Term |
|---|---|
| D013754 | Tetracyclines |
| D009279 | Naphthacenes |
| D011084 | Polycyclic Aromatic Hydrocarbons |
| D006841 | Hydrocarbons, Aromatic |
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|
| 6 months and 1 year |
| Mortality | The number of living subjects will be determined at Baseline, 3 months, 6 months and 1 year | Baseline, 3 months, 6 months, 1 year |
| Patient-reported Health Quality of Life | Subjects will complete the Patient Reported Outcomes Measurement Information System Global Health instrument, a 10-item standardized patient-reported outcome measure that provides global ratings of physical function, fatigue, pain, emotional distress to report on common domains of health-related quality of life. The survey comprises a series of 5-response Likert-style questions. For each question, a low score indicates lesser or absent symptom or condition and higher indicates more severe symptom or condition (e.g., 1= None to 5=Very severe). Automated scoring produces a T-score for each domain. This measure reports the physical health score. T-scores for this domain range from 16.2 to 67.7. Higher scores indicate poorer physical health. | Baseline, 3, 6, 9 and 12 months |
| Patient-reported Mental Quality of Life | Subjects will complete the Patient Reported Outcomes Measurement Information System Global Health instrument, a 10-item standardized patient-reported outcome measure that provides global ratings of physical function, fatigue, pain, emotional distress to report on common domains of health-related quality of life. The survey comprises a series of 5-response Likert-style questions. For each question, a low score indicates lesser or absent symptom or condition and higher indicates more severe symptom or condition (e.g., 1= None to 5=Very severe). Automated scoring produces a T-score for each domain. This measure reports the mental health score. T-scores for this domain range from 21.2 to 67.6. Higher scores indicate poorer mental health. | Baseline, 3, 6, 9 and 12 months |
| Death |
|
| Doxycycline (Systemic Disease) |
Doxycycline will be administered at dose of 100mg orally twice daily for 1 year. Doxycycline: Doxycycline will be continued until one of the following criteria is met:
|
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
|
|
| Secondary | Amyloid Organ Response | This measure is the number of subjects (systemic disease only) for each grade of response. Efficacy will be measured in heart, liver, or kidney. Heart N-terminal (NT)-proBNP response >30% and > 300 ng/L decrease in patients with baseline NT-proBNP ≥650 ng/L (Patients with progressively worsening renal function cannot be scored for NT-proBNP progression). Improvement by 2 New York Heart Association (NYHA) classes without an increase in diuretic use or in echocardiographic wall thickness ≥ 2 mm reduction in the interventricular septal thickness by echocardiogram or improvement of ejection fraction by ≥20%. Liver ≥50% decrease in an initially elevated alkaline phosphatase level, or Decrease in liver size by at least 2 cm by ultrasound. Kidney 50% reduction in 24-hour urine protein excretion (at least 0.5 g/day) without worsening of creatinine or creatinine clearance by 25% over baseline. Soft Tissue RECIST criteria will be used. | Posted | Count of Participants | Participants | 6 months and 1 year |
|
|
|
| Secondary | Mortality | The number of living subjects will be determined at Baseline, 3 months, 6 months and 1 year | Posted | Count of Participants | Participants | Baseline, 3 months, 6 months, 1 year |
|
|
|
| Secondary | Patient-reported Health Quality of Life | Subjects will complete the Patient Reported Outcomes Measurement Information System Global Health instrument, a 10-item standardized patient-reported outcome measure that provides global ratings of physical function, fatigue, pain, emotional distress to report on common domains of health-related quality of life. The survey comprises a series of 5-response Likert-style questions. For each question, a low score indicates lesser or absent symptom or condition and higher indicates more severe symptom or condition (e.g., 1= None to 5=Very severe). Automated scoring produces a T-score for each domain. This measure reports the physical health score. T-scores for this domain range from 16.2 to 67.7. Higher scores indicate poorer physical health. | One subject in the Localized cohort withdrew consent prior to the 6-month visit. Five subjects in the Systemic Disease cohort expired during the course of the study; two subjects came off study; and one was lost to follow-up. | Posted | Mean | Standard Deviation | score on a scale | Baseline, 3, 6, 9 and 12 months |
|
|
|
| Secondary | Patient-reported Mental Quality of Life | Subjects will complete the Patient Reported Outcomes Measurement Information System Global Health instrument, a 10-item standardized patient-reported outcome measure that provides global ratings of physical function, fatigue, pain, emotional distress to report on common domains of health-related quality of life. The survey comprises a series of 5-response Likert-style questions. For each question, a low score indicates lesser or absent symptom or condition and higher indicates more severe symptom or condition (e.g., 1= None to 5=Very severe). Automated scoring produces a T-score for each domain. This measure reports the mental health score. T-scores for this domain range from 21.2 to 67.6. Higher scores indicate poorer mental health. | One subject in the Localized cohort withdrew consent prior to the 6-month visit. Five subjects in the Systemic Disease cohort expired during the course of the study; two subjects came off study; and one was lost to follow-up. | Posted | Mean | Standard Deviation | score on a scale | Baseline, 3, 6, 9 and 12 months |
|
|
|
| 0 |
| 5 |
| 1 |
| 5 |
| 5 |
| 5 |
| EG001 | Doxycycline (Systemic Disease) | Doxycycline will be administered at dose of 100mg orally twice daily for 1 year. Doxycycline: Doxycycline will be continued until one of the following criteria is met:
| 5 | 25 | 13 | 25 | 24 | 25 |
|
| Neutrophil Count Decreased | Blood and lymphatic system disorders | CTCAE v4.03 | Systematic Assessment | CTCAE v4.03 Grade 4 |
|
| Platelet Count Decreased | Blood and lymphatic system disorders | CTCAE v4.03 | Systematic Assessment | CTCAE v4.03 Grade 4 |
|
| White Blood Cell Count Decreased | Blood and lymphatic system disorders | CTCAE v4.03 | Systematic Assessment | CTCAE v4.03 Grade 4 |
|
| Hyperuricemia | Metabolism and nutrition disorders | CTCAE v4.03 | Systematic Assessment | CTCAE v4.03 Grade 4 |
|
| Adenovirus Infection | Infections and infestations | CTCAE v4.03 | Systematic Assessment | CTCAE v4.03 Grade 4 |
|
| Chronic Kidney Disease | Renal and urinary disorders | CTCAE v4.03 | Systematic Assessment | CTCAE v4.03 Grade 4 |
|
| Progressive cardiac amyloidosis | Cardiac disorders | CTCAE v4.03 | Systematic Assessment | CTCAE v4.03 Grade 5 |
|
| Death in Hospice | Blood and lymphatic system disorders | SNOMED | Systematic Assessment | CTCAE v4.03 Grade 5 |
|
| Natural Death | Cardiac disorders | SNOMED | Systematic Assessment | CTCAE v4.03 Grade 5 |
|
| Thrombosis of Vein of Lower Limb | Blood and lymphatic system disorders | SNOMED | Systematic Assessment | CTCAE v4.03 Grade 4 |
|
| Aspartate Aminotransferase Increased | Hepatobiliary disorders | CTCAE v4.03 | Systematic Assessment | CTCAE v4.03 Grade 4 |
|
| Alanine Aminotransferase Increased | Hepatobiliary disorders | CTCAE v4.03 | Systematic Assessment | CTCAE v4.03 Grade 4 |
|
| Bacterial Sepsis | Infections and infestations | SNOMED | Systematic Assessment | CTCAE v4.03 Grade 4 |
|
| Respiratory Failure | Respiratory, thoracic and mediastinal disorders | CTCAE v4.03 | Systematic Assessment | CTCAE v4.03 Grade 4 |
|
| Colitis | Gastrointestinal disorders | CTCAE v4.03 | Systematic Assessment | CTCA v4.03 Grade 5 |
|
| Drug-Induced Lupus | Skin and subcutaneous tissue disorders | CTCAE v4.03 | Systematic Assessment | CTCAE v4.03 Grade 3 |
|
| Hypertension | Vascular disorders | CTCAE v4.03 | Systematic Assessment |
|
| Arthralgia | Musculoskeletal and connective tissue disorders | CTCAE v4.03 | Systematic Assessment |
|
| Bruising | Injury, poisoning and procedural complications | CTCAE v4.03 | Systematic Assessment |
|
| Dyspnea | Respiratory, thoracic and mediastinal disorders | CTCAE v4.03 | Systematic Assessment |
|
| Edema, Limb | General disorders | CTCAE v4.03 | Systematic Assessment |
|
| Hypercalcemia | Investigations | CTCAE v4.03 | Systematic Assessment |
|
| Hyperglycemia | Investigations | CTCAE v4.03 | Systematic Assessment |
|
| Hyperuricemia | Metabolism and nutrition disorders | CTCAE v4.03 | Systematic Assessment |
|
| Hyponatremia | Investigations | CTCAE v4.03 | Systematic Assessment |
|
| Nausea | Gastrointestinal disorders | CTCAE v4.03 | Systematic Assessment |
|
| Pain | General disorders | CTCAE v4.03 | Systematic Assessment |
|
| Tachypnea | Respiratory, thoracic and mediastinal disorders | CTCAE v4.03 | Systematic Assessment |
|
| Upper Respiratory Infection | Infections and infestations | CTCAE v4.03 | Systematic Assessment |
|
| Anorexia | Metabolism and nutrition disorders | CTCAE v4.03 | Systematic Assessment |
|
| Anxiety | Psychiatric disorders | CTCAE v4.03 | Systematic Assessment |
|
| Bullous Dermatitis | Skin and subcutaneous tissue disorders | CTCAE v4.03 | Systematic Assessment |
|
| Cardiac Tropinin T Increased | Cardiac disorders | CTCAE v4.03 | Systematic Assessment |
|
| Contact Dermatitis | Skin and subcutaneous tissue disorders | CTCAE v4.03 | Systematic Assessment |
|
| Cough | Respiratory, thoracic and mediastinal disorders | CTCAE v4.03 | Systematic Assessment |
|
| Depression | Psychiatric disorders | CTCAE v4.03 | Systematic Assessment |
|
| Diarrhea | Gastrointestinal disorders | CTCAE v4.03 | Systematic Assessment |
|
| Dry Skin | Skin and subcutaneous tissue disorders | CTCAE v4.03 | Systematic Assessment |
|
| Fall | Injury, poisoning and procedural complications | CTCAE v4.03 | Systematic Assessment |
|
| Hearing Impaired | Ear and labyrinth disorders | CTCAE v4.03 | Systematic Assessment |
|
| Hyperkalemia | Investigations | CTCAE v4.03 | Systematic Assessment |
|
| Hypoalbuminemia | Investigations | CTCAE v4.03 | Systematic Assessment |
|
| Hypokalemia | Investigations | CTCAE v4.03 | Systematic Assessment |
|
| Laryngeal Hemorrhage | Respiratory, thoracic and mediastinal disorders | CTCAE v4.03 | Systematic Assessment |
|
| Low Vitamin D | Metabolism and nutrition disorders | CTCAE v4.03 | Systematic Assessment |
|
| Lung Crackles | Respiratory, thoracic and mediastinal disorders | CTCAE v4.03 | Systematic Assessment |
|
| Nocturia | Renal and urinary disorders | CTCAE v4.03 | Systematic Assessment |
|
| Pain in extremity | Musculoskeletal and connective tissue disorders | CTCAE v4.03 | Systematic Assessment |
|
| Paresthesia | Nervous system disorders | CTCAE v4.03 | Systematic Assessment |
|
| Rhinitis Infective | Infections and infestations | CTCAE v4.03 | Systematic Assessment |
|
| Rib Pain | General disorders | CTCAE v4.03 | Systematic Assessment |
|
| Streptococcal Test, Positive | Infections and infestations | CTCAE v4.03 | Systematic Assessment |
|
| Sunburn (Burn) | Injury, poisoning and procedural complications | CTCAE v4.03 | Systematic Assessment |
|
| Urine Output Decreased | Renal and urinary disorders | CTCAE v4.03 | Systematic Assessment |
|
| Weight Gain | Investigations | CTCAE v4.03 | Systematic Assessment |
|
| Weight Loss | Investigations | CTCAE v4.03 | Systematic Assessment |
|
| Platelet Count Decreased | Investigations | CTCAE v4.03 | Systematic Assessment |
|
| Lymphocyte Count Decreased | Investigations | CTCAE v4.03 | Systematic Assessment |
|
| White Cell Count Decreased | Investigations | CTCAE v4.03 | Systematic Assessment |
|
| Neutrophil Cound Decreased | Investigations | CTCAE v4.03 | Systematic Assessment |
|
| AST Increased | Investigations | CTCAE v4.03 | Systematic Assessment |
|
| ALT Increased | Investigations | CTCAE v4.03 | Systematic Assessment |
|
| Hyperuricemia | Metabolism and nutrition disorders | CTCAE v4.03 | Systematic Assessment |
|
| Anemia | Blood and lymphatic system disorders | CTCAE v4.03 | Systematic Assessment |
|
| Dizziness | Nervous system disorders | CTCAE v4.03 | Systematic Assessment |
|
| Dysgeusia | Nervous system disorders | CTCAE v4.03 | Systematic Assessment |
|
| Insomnia | Psychiatric disorders | CTCAE v4.03 | Systematic Assessment |
|
| Constipation | Gastrointestinal disorders | CTCAE v4.03 | Systematic Assessment |
|
| Hypotension | Vascular disorders | CTCAE v4.03 | Systematic Assessment |
|
| Abdominal Pain | Gastrointestinal disorders | CTCAE v4.03 | Systematic Assessment |
|
| Creatinine Increased | Investigations | CTCAE v4.03 | Systematic Assessment |
|
| Generalized Muscle Weakness | Musculoskeletal and connective tissue disorders | CTCAE v4.03 | Systematic Assessment |
|
| Hypocalcemia | Investigations | CTCAE v4.03 | Systematic Assessment |
|
| Tachycardia | Cardiac disorders | CTCAE v4.03 | Systematic Assessment |
|
| Back Pain | Musculoskeletal and connective tissue disorders | CTCAE v4.03 | Systematic Assessment |
|
| Fever | General disorders | CTCAE v4.03 | Systematic Assessment |
|
| Peripheral Sensory Neuropathy | Nervous system disorders | CTCAE v4.03 | Systematic Assessment |
|
| Stiffness | Musculoskeletal and connective tissue disorders | CTCAE v4.03 | Systematic Assessment |
|
| Alkaline Phosphatase Increased | Investigations | CTCAE v4.03 | Systematic Assessment |
|
| Bloating | Gastrointestinal disorders | CTCAE v4.03 | Systematic Assessment |
|
| Dry Mouth | Gastrointestinal disorders | CTCAE v4.03 | Systematic Assessment |
|
| Headache | Nervous system disorders | CTCAE v4.03 | Systematic Assessment |
|
| Hypoxia | Respiratory, thoracic and mediastinal disorders | CTCAE v4.03 | Systematic Assessment |
|
| Nasal Congestion | Respiratory, thoracic and mediastinal disorders | CTCAE v4.03 | Systematic Assessment |
|
| Noncardiac Chest Pain | General disorders | CTCAE v4.03 | Systematic Assessment |
|
| Urinary Frequency | Renal and urinary disorders | CTCAE v4.03 | Systematic Assessment |
|
| Dysphagia | Gastrointestinal disorders | CTCAE v4.03 | Systematic Assessment |
|
| Epistaxis | Respiratory, thoracic and mediastinal disorders | CTCAE v4.03 | Systematic Assessment |
|
| Hyopohosphatemia | Investigations | CTCAE v4.03 | Systematic Assessment |
|
| Sinus Tachycardia | Cardiac disorders | CTCAE v4.03 | Systematic Assessment |
|
| Sore Throat | Gastrointestinal disorders | CTCAE v4.03 | Systematic Assessment |
|
| Upper Respiratory Infection | Infections and infestations | CTCAE v4.03 | Systematic Assessment |
|
| Vomiting | Gastrointestinal disorders | CTCAE v4.03 | Systematic Assessment |
|
| Chills | General disorders | CTCAE v4.03 | Systematic Assessment |
|
| Erythema | Skin and subcutaneous tissue disorders | CTCAE v4.03 | Systematic Assessment |
|
| Hypomagnesemia | Investigations | CTCAE v4.03 | Systematic Assessment |
|
| Proteinuria | Renal and urinary disorders | CTCAE v4.03 | Systematic Assessment |
|
| Bilirubin Increased | Investigations | CTCAE v4.03 | Systematic Assessment |
|
| Hematuria | Renal and urinary disorders | CTCAE v4.03 | Systematic Assessment |
|
| Hemorrhoids | Gastrointestinal disorders | CTCAE v4.03 | Systematic Assessment |
|
| Left Atrium Enlarged | Cardiac disorders | CTCAE v4.03 | Systematic Assessment |
|
| Neck Pain | Musculoskeletal and connective tissue disorders | CTCAE v4.03 | Systematic Assessment |
|
| Palpitations | Cardiac disorders | CTCAE v4.03 | Systematic Assessment |
|
| Purpura | Skin and subcutaneous tissue disorders | CTCAE v4.03 | Systematic Assessment |
|
| Wheezing | Respiratory, thoracic and mediastinal disorders | CTCAE v4.03 | Systematic Assessment |
|
| Acute Kidney Injury | Renal and urinary disorders | CTCAE v4.03 | Systematic Assessment |
|
| Blurred Vison | Eye disorders | CTCAE v4.03 | Systematic Assessment |
|
| Chest Pain - Cardiac | Cardiac disorders | CTCAE v4.03 | Systematic Assessment |
|
| Confusion | Psychiatric disorders | CTCAE v4.03 | Systematic Assessment |
|
| Gait Disturbance, Unsteady | General disorders | CTCAE v4.03 | Systematic Assessment |
|
| Hiccups | Respiratory, thoracic and mediastinal disorders | CTCAE v4.03 | Systematic Assessment |
|
| Hypermagnesemia | Investigations | CTCAE v4.03 | Systematic Assessment |
|
| Irregular Heartbeat | Cardiac disorders | CTCAE v4.03 | Systematic Assessment |
|
| Jugular Vein Distention | Vascular disorders | CTCAE v4.03 | Systematic Assessment |
|
| Macroglossia | Gastrointestinal disorders | CTCAE v4.03 | Systematic Assessment |
|
| Mucocitis, Oral | Gastrointestinal disorders | CTCAE v4.03 | Systematic Assessment |
|
| Periorbital Edema/Puffiness | Eye disorders | CTCAE v4.03 | Systematic Assessment |
|
| Photosensitivity | Skin and subcutaneous tissue disorders | CTCAE v4.03 | Systematic Assessment |
|
| Rash | Skin and subcutaneous tissue disorders | CTCAE v4.03 | Systematic Assessment |
|
| Right Atrium Enlarged | Cardiac disorders | CTCAE v4.03 | Systematic Assessment |
|
| Urinary Tract Infection | Infections and infestations | CTCAE v4.03 | Systematic Assessment |
|
| Akathisia | Nervous system disorders | CTCAE v4.03 | Systematic Assessment |
|
| Bradycardia | Cardiac disorders | CTCAE v4.03 | Systematic Assessment |
|
| Cataract | Eye disorders | CTCAE v4.03 | Systematic Assessment |
|
| Chest Tightness | Cardiac disorders | CTCAE v4.03 | Systematic Assessment |
|
| Cyanosis | Vascular disorders | CTCAE v4.03 | Systematic Assessment |
|
| Dry Eye | Eye disorders | CTCAE v4.03 | Systematic Assessment |
|
| Edema, Tongue | General disorders | CTCAE v4.03 | Systematic Assessment |
|
| Erythematous Rash | Skin and subcutaneous tissue disorders | CTCAE v4.03 | Systematic Assessment |
|
| Eye Discharge | Eye disorders | CTCAE v4.03 | Systematic Assessment |
|
| Flatulence | Gastrointestinal disorders | CTCAE v4.03 | Systematic Assessment |
|
| Flushiing | Vascular disorders | CTCAE v4.03 | Systematic Assessment |
|
| Hypernatremia | Investigations | CTCAE v4.03 | Systematic Assessment |
|
| Hypersomnia | Nervous system disorders | CTCAE v4.03 | Systematic Assessment |
|
| Hypoglycemia | Investigations | CTCAE v4.03 | Systematic Assessment |
|
| Inguinal Hernia Repair | Injury, poisoning and procedural complications | CTCAE v4.03 | Systematic Assessment |
|
| Injury to Lip | Injury, poisoning and procedural complications | CTCAE v4.03 | Systematic Assessment |
|
| Murmur, Systolic II/IV | Cardiac disorders | CTCAE v4.03 | Systematic Assessment |
|
| Night Sweats | Reproductive system and breast disorders | CTCAE v4.03 | Systematic Assessment |
|
| Petichial Rash | Skin and subcutaneous tissue disorders | CTCAE v4.03 | Systematic Assessment |
|
| Photophobia | Eye disorders | CTCAE v4.03 | Systematic Assessment |
|
| Pleural Effusion | Respiratory, thoracic and mediastinal disorders | CTCAE v4.03 | Systematic Assessment |
|
| Rales | Respiratory, thoracic and mediastinal disorders | CTCAE v4.03 | Systematic Assessment |
|
| Sinus Bradycardia | Cardiac disorders | CTCAE v4.03 | Systematic Assessment |
|
| Skin Tear | Injury, poisoning and procedural complications | CTCAE v4.03 | Systematic Assessment |
|
| Thrush | Infections and infestations | CTCAE v4.03 | Systematic Assessment |
|
| Ulceration, Skin | Skin and subcutaneous tissue disorders | CTCAE v4.03 | Systematic Assessment |
|
| Urinary Incontinence | Renal and urinary disorders | CTCAE v4.03 | Systematic Assessment |
|
| Urinary Retention | Renal and urinary disorders | CTCAE v4.03 | Systematic Assessment |
|
| Urinary Tract Pain | Renal and urinary disorders | CTCAE v4.03 | Systematic Assessment |
|
| Urinary Urgency | Renal and urinary disorders | CTCAE v4.03 | Systematic Assessment |
|
| Vertigo | Ear and labyrinth disorders | CTCAE v4.03 | Systematic Assessment |
|
| Watering Eyes | Eye disorders | CTCAE v4.03 | Systematic Assessment |
|
Not provided
Not provided
Not provided
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D008232 | Lymphoproliferative Disorders |
| D007160 | Immunoproliferative Disorders |
| D007154 | Immune System Diseases |
| D010265 | Paraproteinemias |
| D006844 |
| Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D011083 | Polycyclic Compounds |
| Response |
|
| Expired |
|
| 6 Months |
|
| 1 Year |
|
| 3 Months |
|
|
| 6 Months |
|
|
| 9 Months |
|
|
| 12 Months |
|
|
| 3 Month |
|
|
| 6 Months |
|
|
| 9 Months |
|
|
| 12 Months |
|
|