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| ID | Type | Description | Link |
|---|---|---|---|
| 2011-31 | Other Identifier | CCRRC | |
| JT 1795 | Other Identifier | JeffTrial Number |
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This phase II trial studies how well reduced intensity donor stem cell transplant works in treating patients with hematologic malignancies. Giving chemotherapy and total-body irradiation before a donor peripheral blood stem cell transplant helps stop the growth of cells in the bone marrow, including normal blood-forming cells (stem cells) and cancer cells. It may also stop the patient's immune system from rejecting the donor's stem cells. When the healthy stem cells from a donor are infused into the patient they may help the patient's bone marrow make stem cells, red blood cells, white blood cells, and platelets. The donated stem cells may also replace the patient's immune cells and help destroy any remaining cancer cells. Sometimes the transplanted cells from a donor can make an immune response against the body's normal cells (called graft-versus-host disease). Giving tacrolimus and mycophenolate mofetil after the transplant may stop this from happening. Once the donated stem cells begin working, the patient's immune system may see the remaining cancer cells as not belonging in the patient's body and destroy them. Giving an infusion of the donor's white blood cells (donor lymphocyte infusion) may boost this effect.
PRIMARY OBJECTIVES:
I. To compare the overall survival (OS) rate at 2 years post treatment using the Jefferson 2 step reduced intensity conditioning (RIC) approach in patients with haploidentical family donors with hematological malignancies in morphological or radiographic remission or with chemosensitive, indolent diseases to historical OS rates in similar populations after RIC matched donor HSCT as reported in the literature.
SECONDARY OBJECTIVES:
I. To compare the treatment-related mortality (TRM) rate at 2 years for patients treated on this study to the historical TRM rates of patients undergoing RIC matched-sibling HSCT as reported in the literature.
II. To compare the 2 year relapse rates and relapse related mortality of patients with myeloid diseases to that of patients with lymphoid diseases who are treated on this Thomas Jefferson University (TJU) RIC 2 step approach.
III. To determine the incidence and severity of graft-versus-host disease (GVHD) in patients undergoing treated on the TJU RIC 2 step approach.
IV. To evaluate engraftment rates and lymphoid reconstitution in patients treated on the TJU RIC 2 step approach.
V. To evaluate the incidence of TRM at 100 days in patients treated on the TJU RIC 2 step approach.
OUTLINE:
REDUCED INTENSITY CONDITIONING: Patients receive fludarabine phosphate intravenously (IV) over 60 minutes on days -11 to -8 and bulsufan IV over 3 hours on days -10 to -9. Patients undergo total body irradiation (TBI) on day -6. Patients also receive cyclophosphamide IV over 2 hours on days -3 and -2.
TRANSPLANTATION: Patients undergo donor lymphocyte infusion (DLI) on day -6 and cluster of differentiation (CD)-34+ allogeneic peripheral blood stem cell transplantation (PBSCT) on day 0.
GVHD PROPHYLAXIS: Beginning on day -1, patients receive tacrolimus IV or orally (PO) with taper beginning on day 42. Patients also receive mycophenolate mofetil IV twice daily (BID) on days -1 to 28.
After completion of study treatment, patients are followed up periodically for 2 years.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Treatment (Allogeneic PBSCT) | Experimental | REDUCED INTENSITY CONDITIONING: Patients receive fludarabine phosphate IV over 60 minutes on days -11 to -8 and busulfan IV over 3 hours on days -10 to -9. Patients undergo TBI on day -6. Patients also receive cyclophosphamide IV over 2 hours on days -3 and -2. TRANSPLANTATION: Patients undergo DLI on day -6 and CD-34+ allogeneic PBSCT on day 0. GVHD PROPHYLAXIS: Beginning on day -1, patients receive tacrolimus IV or PO with taper beginning on day 42. Patients also receive mycophenolate mofetil IV BID on days -1 to 28. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Fludarabine | Drug | Given IV |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| Overall Survival (OS) in Patients With Haploidentical Family Donors With Hematological Malignancies in Morphological or Radiographic Remission or With Chemosensitive, Indolent Diseases | The primary null hypothesis is that 2 year OS rate is at most 35%. This hypothesis will be rejected if the 95% confidence interval for year OS rate computed from the estimated Kaplan-Meier survival curves will be entirely above 0.35. | At 2 years |
| Measure | Description | Time Frame |
|---|---|---|
| Treatment Related Mortality (TRM) | To compare the treatment related mortality rate (TRM) for patients treated on this study to the historical TRM rates of patients undergoing reduced intensity conditioning (RIC) matched-sibling hematopoietic stem cell transplant (HSCT) as reported in the literature | At 2 years |
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Inclusion Criteria:
Any patient with hematologic or oncologic diagnosis in which allogeneic HSCT is thought to be beneficial, and in whom front-line therapy has already been applied. Patients treated on this protocol will be without morphological evidence of disease (complete remission or "CR"), or if the patient has evidence of disease, the patient must have had at least a good partial response (PR) to the most recent therapy and the disease must be chemoresponsive.
Patients treated on this study will have:
Patients must have a related donor who is HLA mismatched at 2, 3, or 4 antigens at the HLA-A; B; C; DR loci in the GVHD direction. (Patients with related donors who are HLA identical or are a 1-antigen mismatch may be treated on this therapeutic approach, but will have their outcomes will not be part of the statistical aims of the study (see Summary section).
Patients must adequate organ function:
Performance status ≥ 80% (TJU Karnofsky) for patients ≥ 60 years old or ≥70% for patients < 60 years old.
HCT-CI Score ≤ 4 points for patients ≥ 60 years old or ≤ 5 points for patients < 60 years old.
• Patients must have adequate Karnofsky performance status (KPS) and hematopoietic cell transplantation comorbidity index (HCT-CI) scores:
Patients must be willing to use contraception if they have childbearing potential
Able to give informed consent
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Usama Gergis, MD | Sidney Kimmel Comprehensive Cancer Center at Thomas Jefferson University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Thomas Jefferson University | Philadelphia | Pennsylvania | 19107 | United States |
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| Label | URL |
|---|---|
| Kimmel Cancer Center at Thomas Jefferson University, an NCI-Designated Cancer Center | View source |
| Thomas Jefferson University Hospitals | View source |
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| ID | Title | Description |
|---|---|---|
| FG000 | Treatment (Allogeneic PBSCT) | REDUCED INTENSITY CONDITIONING: Patients receive fludarabine phosphate IV over 60 minutes on days -11 to -8 and busulfan IV over 3 hours on days -10 to -9. Patients undergo TBI on day -6. Patients also receive cyclophosphamide IV over 2 hours on days -3 and -2. TRANSPLANTATION: Patients undergo DLI on day -6 and CD-34+ allogeneic PBSCT on day 0. GVHD PROPHYLAXIS: Beginning on day -1, patients receive tacrolimus IV or PO with taper beginning on day 42. Patients also receive mycophenolate mofetil IV BID on days -1 to 28. Fludarabine: Given IV Busulfan: Given IV Total Body Irradiation (TBI): 2 Gy administered as part of the conditioning regimen Donor Lymphocyte Infusion (DLI): Undergo DLI Cyclophosphamide (CY): Given IV Tacrolimus: Given IV or PO Mycophenolate mofetil: Given IV Allogeneic hematopoietic stem cell transplantation: Undergo CD34+ allogeneic PBSCT Peripheral blood stem cell transplantation (PBSCT): Undergo CD34+ allogeneic PBSCT |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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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 | Jun 17, 2022 |
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| Busulfan | Drug | Given IV |
|
|
| Total Body Irradiation (TBI) | Radiation | 2 Gy administered as part of the conditioning regimen |
|
|
| Donor Lymphocyte Infusion (DLI) | Biological | Undergo DLI |
|
|
| Cyclophosphamide (CY) | Drug | Given IV |
|
|
| Tacrolimus | Drug | Given IV or PO |
|
|
| Mycophenolate mofetil | Drug | Given IV |
|
|
| Allogeneic hematopoietic stem cell transplantation | Device | Undergo CD34+ allogeneic PBSCT |
|
|
| Peripheral blood stem cell transplantation (PBSCT) | Procedure | Undergo CD34+ allogeneic PBSCT |
|
|
| Number of Participants With Acute G2-4 and/or Chronic Moderate or Severe GVHD |
The estimates of incidence rates will be presented with corresponding 95% confidence intervals using the exact method |
| Assessed up to 2 years |
| Relapse Rate | Evaluated by estimating Kaplan-Meier survival curves. From these curves, the 95% confidence interval for 2 year rates will be computed. | At 2 years |
| Engraftment Rates | Hematopoietic engraftment will be defined as:
| 44 weeks |
| Incidence of Treatment Related Mortality (TRM) | The estimates of incidence rates will be presented with corresponding 95% confidence intervals using the exact method. | At 100 days |
| Relapse Related Mortality | Evaluated by estimating Kaplan-Meier survival curves. From these curves, the 95% confidence interval for 2 year rates will be computed. | At 2 years |
| Lymphoid Reconstitution | To evaluate lymphoid reconstitution in patients treated on the Two Step approach | 100 days post-transplant |
| COMPLETED |
|
| NOT COMPLETED |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Treatment (Allogeneic PBSCT) | REDUCED INTENSITY CONDITIONING: Patients receive fludarabine phosphate IV over 60 minutes on days -11 to -8 and busulfan IV over 3 hours on days -10 to -9. Patients undergo TBI on day -6. Patients also receive cyclophosphamide IV over 2 hours on days -3 and -2. TRANSPLANTATION: Patients undergo DLI on day -6 and CD-34+ allogeneic PBSCT on day 0. GVHD PROPHYLAXIS: Beginning on day -1, patients receive tacrolimus IV or PO with taper beginning on day 42. Patients also receive mycophenolate mofetil IV BID on days -1 to 28. Fludarabine: Given IV Busulfan: Given IV Total Body Irradiation (TBI): 2 Gy administered as part of the conditioning regimen Donor Lymphocyte Infusion (DLI): Undergo DLI Cyclophosphamide (CY): Given IV Tacrolimus: Given IV or PO Mycophenolate mofetil: Given IV Allogeneic hematopoietic stem cell transplantation: Undergo CD34+ allogeneic PBSCT Peripheral blood stem cell transplantation (PBSCT): Undergo CD34+ allogeneic PBSCT |
| 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 | Participants |
| ||||||||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||||||
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||||||
| Race (NIH/OMB) | Count of Participants | 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 | Overall Survival (OS) in Patients With Haploidentical Family Donors With Hematological Malignancies in Morphological or Radiographic Remission or With Chemosensitive, Indolent Diseases | The primary null hypothesis is that 2 year OS rate is at most 35%. This hypothesis will be rejected if the 95% confidence interval for year OS rate computed from the estimated Kaplan-Meier survival curves will be entirely above 0.35. | Posted | Count of Participants | Participants | At 2 years |
|
|
| |||||||||||||||||||||||||||||
| Secondary | Treatment Related Mortality (TRM) | To compare the treatment related mortality rate (TRM) for patients treated on this study to the historical TRM rates of patients undergoing reduced intensity conditioning (RIC) matched-sibling hematopoietic stem cell transplant (HSCT) as reported in the literature | Posted | Number | 95% Confidence Interval | percentage of participants | At 2 years |
|
| |||||||||||||||||||||||||||||
| Secondary | Number of Participants With Acute G2-4 and/or Chronic Moderate or Severe GVHD | The estimates of incidence rates will be presented with corresponding 95% confidence intervals using the exact method | Posted | Number | 95% Confidence Interval | percentage of participants | Assessed up to 2 years |
|
| |||||||||||||||||||||||||||||
| Secondary | Relapse Rate | Evaluated by estimating Kaplan-Meier survival curves. From these curves, the 95% confidence interval for 2 year rates will be computed. | Posted | Number | 95% Confidence Interval | percentage of participants | At 2 years |
|
| |||||||||||||||||||||||||||||
| Secondary | Engraftment Rates | Hematopoietic engraftment will be defined as:
| Posted | Median | Full Range | days | 44 weeks |
|
| |||||||||||||||||||||||||||||
| Secondary | Incidence of Treatment Related Mortality (TRM) | The estimates of incidence rates will be presented with corresponding 95% confidence intervals using the exact method. | Posted | Number | 95% Confidence Interval | percentage of participants | At 100 days |
|
| |||||||||||||||||||||||||||||
| Secondary | Relapse Related Mortality | Evaluated by estimating Kaplan-Meier survival curves. From these curves, the 95% confidence interval for 2 year rates will be computed. | Posted | Number | 95% Confidence Interval | percentage of participants | At 2 years |
|
| |||||||||||||||||||||||||||||
| Secondary | Lymphoid Reconstitution | To evaluate lymphoid reconstitution in patients treated on the Two Step approach | This outcome measure was prespecified in the protocol; however, no data were collected because the required assessments were not implemented during study conduct due to logistical and operational constraints. As these assessments were not performed at any time during the study, no data exist and none will become available in the future. Therefore, this outcome cannot be analyzed or reported. | Posted | 100 days post-transplant |
|
All patients will be followed for adverse experiences (AEs) (serious and nonserious), regardless of relationships to study treatment, from the time of enrollment until d +100 after transplant. All-Cause Mortality was assessed up to 2 years; from the time of enrollment until 100 days after transplant
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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 | Treatment (Allogeneic PBSCT) | REDUCED INTENSITY CONDITIONING: Patients receive fludarabine phosphate IV over 60 minutes on days -11 to -8 and busulfan IV over 3 hours on days -10 to -9. Patients undergo TBI on day -6. Patients also receive cyclophosphamide IV over 2 hours on days -3 and -2. TRANSPLANTATION: Patients undergo DLI on day -6 and CD-34+ allogeneic PBSCT on day 0. GVHD PROPHYLAXIS: Beginning on day -1, patients receive tacrolimus IV or PO with taper beginning on day 42. Patients also receive mycophenolate mofetil IV BID on days -1 to 28. Fludarabine: Given IV Busulfan: Given IV Total Body Irradiation (TBI): 2 Gy administered as part of the conditioning regimen Donor Lymphocyte Infusion (DLI): Undergo DLI Cyclophosphamide (CY): Given IV Tacrolimus: Given IV or PO Mycophenolate mofetil: Given IV Allogeneic hematopoietic stem cell transplantation: Undergo CD34+ allogeneic PBSCT Peripheral blood stem cell transplantation (PBSCT): Undergo CD34+ allogeneic PBSCT | 14 | 40 | 29 | 40 | 40 | 40 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Abdominal Pain - Grade 3 | Gastrointestinal disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Acute kidney injury - Grade 2 | Renal and urinary disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Acute kidney injury - Grade 3 | Renal and urinary disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Acute kidney injury - Grade 4 | Renal and urinary disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Acute Renal Failure - Grade 3 | Renal and urinary disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Acute Renal Insufficiency - Grade 2 | Renal and urinary disorders | CTCAE (4.0) | Systematic Assessment |
| |
| AKI - Grade 3 | Renal and urinary disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Alanine aminotransferase increased - Grade 4 | Investigations | CTCAE (4.0) | Systematic Assessment |
| |
| Aspiration - Grade 4 | Respiratory, thoracic and mediastinal disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Atrial Fibrillation - Grade 3 | Cardiac disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Back Pain - Grade 3 | Musculoskeletal and connective tissue disorders | CTCAE (4.0) | Systematic Assessment |
| |
| BK viremia/viuria (BK cystitis) - Grade 3 | Infections and infestations | CTCAE (4.0) | Systematic Assessment |
| |
| Blood and lymphatic disorders- other - Decreasing t cell chimerism worrisome for rejection - Grade 3 | Blood and lymphatic system disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Blood & Lymphatic system disorders - Grade 3 | Blood and lymphatic system disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Blood and lymphatic disorders- other (Lack of 100% t cell engraftment) - Grade 3 | Blood and lymphatic system disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Blood and lymphatic disorders- other (GVHD) - Grade 3 | Blood and lymphatic system disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Blood and lymphatic disorders- other (GVHD) - Grade 5 | Blood and lymphatic system disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Blood and lymphatic disorders- other (Infection, HHV-6) - Grade 2 | Blood and lymphatic system disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Blood and Lymphatic system disorders - mixed chimerisms - Grade 3 | Blood and lymphatic system disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Blood bilirubin increased - Grade 3 | Investigations | CTCAE (4.0) | Systematic Assessment |
| |
| Blood bilirubin increased - Grade 4 | Investigations | CTCAE (4.0) | Systematic Assessment |
| |
| Blood/Bone Marrow- other (BK cystitis) - Grade 4 | Blood and lymphatic system disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Blood/Bone Marrow- other (rash with history of GVHD) - Grade 2 | Blood and lymphatic system disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Blood/Bone Marrow- other (respiratory distress after platelet transfusion) - Grade 4 | Blood and lymphatic system disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Cardiac disorders- other (Vasovagal episode) - Grade 3 | Cardiac disorders | CTCAE (4.0) | Systematic Assessment |
| |
| CMV Reactivation - Grade 2 | Infections and infestations | CTCAE (4.0) | Systematic Assessment |
| |
| Constitutional symptoms- other (compound fractures in L1 and L2 with an extradural hematoma) - Grd 2 | General disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Cystitis noninfective - Grade 2 | Renal and urinary disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Death - Grade 5 | General disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Decrease EF - Grade 3 | Investigations | CTCAE (4.0) | Systematic Assessment |
| |
| Dehydration - Grade 3 | Metabolism and nutrition disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Diarrhea - Grade 2 | Gastrointestinal disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Dysphagia - Grade 3 | Gastrointestinal disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Dyspnea - Grade 3 | Respiratory, thoracic and mediastinal disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Ejection fraction decreased - Grade 3 | Investigations | CTCAE (4.0) | Systematic Assessment |
| |
| Endocrine- other (diabetes) - Grade 3 | Metabolism and nutrition disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Esophagitis - Grade 3 | Gastrointestinal disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Febrile neutropenia - Grade 3 | Blood and lymphatic system disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Fevers - Grade 2 | General disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Hematuria - Grade 3 | Renal and urinary disorders | CTCAE (4.0) | Systematic Assessment |
| |
| HHV6 Reactivation - Grade 2 | Infections and infestations | CTCAE (4.0) | Systematic Assessment |
| |
| HSV - Grade 3 | Infections and infestations | CTCAE (4.0) | Systematic Assessment |
| |
| Hyperbilirubinemia/ Increased LFTs - Grade 3 | Investigations | CTCAE (4.0) | Systematic Assessment |
| |
| Hyperglycemia - Grade 4 | Metabolism and nutrition disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Hyperkalemia - Grade 3 | Metabolism and nutrition disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Hypotension - Grade 4 | Vascular disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Hypoxia - Grade 2 | Respiratory, thoracic and mediastinal disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Hypoxia - Grade 3 | Respiratory, thoracic and mediastinal disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Hypoxia - Grade 4 | Respiratory, thoracic and mediastinal disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Increased bilirubin - Grade 3 | Investigations | CTCAE (4.0) | Systematic Assessment |
| |
| Increased bilirubin - Grade 4 | Investigations | CTCAE (4.0) | Systematic Assessment |
| |
| Infection - Other - Grade 2 | Infections and infestations | CTCAE (4.0) | Systematic Assessment |
| |
| Infection - Other - Grade 3 | Infections and infestations | CTCAE (4.0) | Systematic Assessment |
| |
| Infections and infestations- other (Presumed sepsis) - Grade 4 | Infections and infestations | CTCAE (4.0) | Systematic Assessment |
| |
| Infusion Related Reaction - Grade 4 | General disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Left ventricular systolic dysfunction - Grade 2 | Cardiac disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Left ventricular systolic dysfunction - Grade 5 | Cardiac disorders | CTCAE (4.0) | Systematic Assessment |
| |
| LV Failure - Grade 3 | Cardiac disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Mucositis - Grade 3 | Gastrointestinal disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Nausea - Grade 3 | Gastrointestinal disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Cardiac Disorders, Other - Pericardial Effusion - Grade 3 | Cardiac disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Non-cardiac chest pain - Grade 3 | General disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Opportunistic infection - Grade 2 | Infections and infestations | CTCAE (4.0) | Systematic Assessment |
| |
| Opportunistic infection - Grade 3 | Infections and infestations | CTCAE (4.0) | Systematic Assessment |
| |
| Orthostatic hypotension - Grade 3 | Vascular disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Pancytopenia - Grade 3 | Blood and lymphatic system disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Pericardial effusion - Grade 3 | Cardiac disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Pericardial tamponade - Grade 4 | Cardiac disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Pneumonia - Grade 3 | Infections and infestations | CTCAE (4.0) | Systematic Assessment |
| |
| Pneumonitis - Grade 4 | Respiratory, thoracic and mediastinal disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Pneumonitis/Pulmonary infiltrates - Grade 4 | Respiratory, thoracic and mediastinal disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Pulmonary edema - Grade 3 | Respiratory, thoracic and mediastinal disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Rash - Grade 2 | Skin and subcutaneous tissue disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Rash maculopapular - Grade 3 | Skin and subcutaneous tissue disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Renal Failure - Grade 3 | Renal and urinary disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Renal Failure - Grade 4 | Renal and urinary disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Renal/Genitourinary- other (increased creatinine) - Grade 1 | Renal and urinary disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Respiratory, thoracic and mediastinal disorders- other - Grade 3 | Respiratory, thoracic and mediastinal disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Syncope - Grade 3 | Nervous system disorders | CTCAE (4.0) | Systematic Assessment |
| |
| White Blood Cell Decreased | Investigations | CTCAE (4.0) | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| A Fib - grade 2 | Cardiac disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Abdominal Cramping - Grade 1 | Gastrointestinal disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Abdominal cramps - Grade 1 | Gastrointestinal disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Abdominal discomfort - Grade 1 | Gastrointestinal disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Abdominal distension - Grade 1 | Gastrointestinal disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Abdominal distenstion - Grade 3 | Gastrointestinal disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Abdominal distention - Grade 1 | Gastrointestinal disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Abdominal muscle pain - Grade 1 | Gastrointestinal disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Abdominal pain - Grade 1 | Gastrointestinal disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Abdominal pain - Grade 2 | Gastrointestinal disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Abdominal tenderness - Grade 1 | Gastrointestinal disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Abnormal LFTs - Grade 2 | Investigations | CTCAE (4.0) | Systematic Assessment |
| |
| Achiness - Grade 1 | Musculoskeletal and connective tissue disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Acid Reflux - Grade 1 | Gastrointestinal disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Acid Reflux - Grade 2 | Gastrointestinal disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Acidosis- Grade 4 | Metabolism and nutrition disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Acute kidney injury - Grade 1 | Renal and urinary disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Acute kidney injury - Grade 2 | Renal and urinary disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Acute kidney injury - Grade 3 | Renal and urinary disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Acute renal insufficiency - Grade 3 | Renal and urinary disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Acute thrombus - Grade 2 | Vascular disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Adenopathy - Grade 1 | Blood and lymphatic system disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Agitation - Grade 1 | Psychiatric disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Agitation - Grade 2 | Psychiatric disorders | CTCAE (4.0) | Systematic Assessment |
| |
| AKI - Grade 1 | Renal and urinary disorders | CTCAE (4.0) | Systematic Assessment |
| |
| ALK Phosphate increase - Grade 3 | Investigations | CTCAE (4.0) | Systematic Assessment |
| |
| Alopecia - Grade 1 | Skin and subcutaneous tissue disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Altered mental status - Grade 3 | Psychiatric disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Anemic - Grade 2 | Blood and lymphatic system disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Ankle pain - Grade 1 | Musculoskeletal and connective tissue disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Anorexia - Grade 1 | Musculoskeletal and connective tissue disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Anorexia - Grade 3 | Musculoskeletal and connective tissue disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Anxiety - Grade 1 | Psychiatric disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Anxiety - Grade 2 | Psychiatric disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Anxious - Grade 1 | Psychiatric disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Anxious - Grade 2 | Psychiatric disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Arthralgias - Grade 1 | Musculoskeletal and connective tissue disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Aspiration - Grade 2 | Respiratory, thoracic and mediastinal disorders | CTCAE (4.0) | Systematic Assessment |
| |
| AST increased - Grade 2 | Investigations | CTCAE (4.0) | Systematic Assessment |
| |
| Atrial fibrillation - Grade 2 | Cardiac disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Atrial fibrillation/ A Flutter - Grade 2 | Cardiac disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Awakening at night urinate - Grade 1 | Renal and urinary disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Awakening to urinate - Grade 1 | Renal and urinary disorders | CTCAE (4.0) | Systematic Assessment |
| |
| B/L Legs- cramping/discomfort - Grade 2 | Musculoskeletal and connective tissue disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Back pain - Grade 1 | Musculoskeletal and connective tissue disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Back pain - Grade 2 | Musculoskeletal and connective tissue disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Back/Hip Pain - Grade 1 | Musculoskeletal and connective tissue disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Back/Hip Pain - Grade 2 | Musculoskeletal and connective tissue disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Bacteremia - Grade 1 | Infections and infestations | CTCAE (4.0) | Systematic Assessment |
| |
| Bacteremia - Grade 2 | Infections and infestations | CTCAE (4.0) | Systematic Assessment |
| |
| Bacteremia - Grade 3 | Infections and infestations | CTCAE (4.0) | Systematic Assessment |
| |
| Basilic vein thrombosis - Grade 1 | Vascular disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Bilateral edema - Grade 1 | General disorders | CTCAE (4.0) | Systematic Assessment |
| |
| BK Infection - Grade 2 | Infections and infestations | CTCAE (4.0) | Systematic Assessment |
| |
| BK viruria - Grade 1 | Infections and infestations | CTCAE (4.0) | Systematic Assessment |
| |
| Back/Flank pain - Grade 1 | Musculoskeletal and connective tissue disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Bladder spasms - Grade 1 | Renal and urinary disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Blisters/Wound - Grade 2 | Skin and subcutaneous tissue disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Bloating - Grade 1 | Gastrointestinal disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Bloating/Gas - Grade 1 | Gastrointestinal disorders | CTCAE (4.0) | Systematic Assessment |
| |
| blood and lymphatic system disorder, other - Grade 1 | Blood and lymphatic system disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Blood in stool - Grade 1 | Gastrointestinal disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Bloodshot/pink eyes - Grade 1 | Eye disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Blurred vision - Grade 1 | Eye disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Blurry vision - Grade 1 | Eye disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Bradycardia - Grade 1 | Cardiac disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Bradycardia - Grade 2 | Cardiac disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Bruises on abdomen - Grade 1 | Injury, poisoning and procedural complications | CTCAE (4.0) | Systematic Assessment |
| |
| C. difficile - Grade 2 | Infections and infestations | CTCAE (4.0) | Systematic Assessment |
| |
| Cardiac disorders-other-Murmur - Grade 1 | Cardiac disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Cdiff - Grade 2 | Infections and infestations | CTCAE (4.0) | Systematic Assessment |
| |
| C-diff - Grade 1 | Infections and infestations | CTCAE (4.0) | Systematic Assessment |
| |
| Cellulitis - Grade 2 | Infections and infestations | CTCAE (4.0) | Systematic Assessment |
| |
| Change in vision - Grade 1 | Eye disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Chapped lower lip - Grade 1 | Gastrointestinal disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Chest discomfort - Grade 2 | General disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Chest pain - Grade 1 | General disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Chest pain - Grade 2 | General disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Chest/rib pain | General disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Chills - Grade 1 | General disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Chills - Grade 2 | General disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Chills/rigors - Grade 2 | General disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Clostridium Difficile - Grade 2 | Infections and infestations | CTCAE (4.0) | Systematic Assessment |
| |
| CMV Activation - Grade 1 | Infections and infestations | CTCAE (4.0) | Systematic Assessment |
| |
| CMV reactivation - Grade 1 | Infections and infestations | CTCAE (4.0) | Systematic Assessment |
| |
| CMV reactivation - Grade 2 | Infections and infestations | CTCAE (4.0) | Systematic Assessment |
| |
| CMV reactivation - Grade 3 | Infections and infestations | CTCAE (4.0) | Systematic Assessment |
| |
| Colitis - Grade 2 | Gastrointestinal disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Concentration impairment - Grade 1 | Nervous system disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Confusion - Grade 1 | Psychiatric disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Confusion - Grade 2 | Psychiatric disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Constipation - Grade 1 | Gastrointestinal disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Constipation - Grade 2 | Gastrointestinal disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Cough - Grade 1 | Respiratory, thoracic and mediastinal disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Cough - Grade 2 | Respiratory, thoracic and mediastinal disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Decreased appetite - Grade 1 | Metabolism and nutrition disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Decreased appetite - Grade 2 | Metabolism and nutrition disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Decreased urine output - Grade 1 | Investigations | CTCAE (4.0) | Systematic Assessment |
| |
| Decreased Urine Output - Grade 2 | Investigations | CTCAE (4.0) | Systematic Assessment |
| |
| Dehydration - Grade 1 | Metabolism and nutrition disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Dehydration - Grade 2 | Metabolism and nutrition disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Dehydration - Grade 3 | Metabolism and nutrition disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Delirium - Grade 3 | Psychiatric disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Depression - Grade 1 | Psychiatric disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Depression - Grade 2 | Psychiatric disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Diabetes - Grade 1 | Metabolism and nutrition disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Diaphoresis - Grade 1 | Skin and subcutaneous tissue disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Diarrhea - Grade 1 | Gastrointestinal disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Diarrhea - Grade 2 | Gastrointestinal disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Diarrhea - Grade 3 | Gastrointestinal disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Diarrhea/loose stools - Grade 2 | Gastrointestinal disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Difficulty sleeping - Grade 2 | Psychiatric disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Difficulty urinating - Grade 1 | Renal and urinary disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Difficulty urination - Grade 1 | Renal and urinary disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Difficulty with balance - Grade 1 | Nervous system disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Discomfort at Picc site - Grade 1 | Injury, poisoning and procedural complications | CTCAE (4.0) | Systematic Assessment |
| |
| Disoriented - Grade 1 | Psychiatric disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Diverticulitis - Grade 1 | Gastrointestinal disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Dizziness - Grade 1 | Nervous system disorders | CTCAE (4.0) | Systematic Assessment |
| |
| DOE - Grade 1 | Respiratory, thoracic and mediastinal disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Dry eyes - Grade 1 | Eye disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Dry eyes - Grade 2 | Eye disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Dry heaves - Grade 1 | Gastrointestinal disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Dry mouth - Grade 1 | Gastrointestinal disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Dry mouth - grade 2 | Gastrointestinal disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Dry skin - Grade 1 | Skin and subcutaneous tissue disorders | CTCAE (4.0) | Systematic Assessment |
| |
| DVT - Grade 2 | Vascular disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Dyspepsia - Grade 1 | Gastrointestinal disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Dysphagia - Grade 1 | Gastrointestinal disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Dyspnea - Grade 1 | Respiratory, thoracic and mediastinal disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Dyspnea - Grade 2 | Respiratory, thoracic and mediastinal disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Dyspnea - Grade 3 | Respiratory, thoracic and mediastinal disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Dyspnea on exertion/SOB - Grade 2 | Respiratory, thoracic and mediastinal disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Dsypnea/SOB - Grade 1 | Respiratory, thoracic and mediastinal disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Dysuria - Grade 1 | Renal and urinary disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Dysuria - Grade 2 | Renal and urinary disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Left lateral ear suspected deep tissue injury (secondary to pressure) - Grade 1 | Ear and labyrinth disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Edema - Grade 1 | General disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Edema - Grade 2 | General disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Edema-arm - Grade 1 | General disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Ejection fraction decreased - Grade 2 | Investigations | CTCAE (4.0) | Systematic Assessment |
| |
| Electrolyte imbalance - Grade 1 | Metabolism and nutrition disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Electrolyte imbalance - Grade 2 | Metabolism and nutrition disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Electrolyte imbalance - Grade 3 | Metabolism and nutrition disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Elevated LFTS/ hyperbilirubinemia - Grade 1 | Investigations | CTCAE (4.0) | Systematic Assessment |
| |
| Elevated liver enzymes - Grade 1 | Investigations | CTCAE (4.0) | Systematic Assessment |
| |
| Elevated transaminases/ ALK Phos - Grade 1 | Investigations | CTCAE (4.0) | Systematic Assessment |
| |
| Emesis - Grade 1 | Gastrointestinal disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Epigastric/chest pain - Grade 1 | Gastrointestinal disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Epigastric pain - Grade 1 | Gastrointestinal disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Epistaxis - Grade 1 | Respiratory, thoracic and mediastinal disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Erectile dysfunction - Grade 1 | Reproductive system and breast disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Erythema - Grade 1 | Skin and subcutaneous tissue disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Erythema - right groin - Grade 1 | Skin and subcutaneous tissue disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Erythema/rash - Grade 2 | Skin and subcutaneous tissue disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Esophagitis - Grade 1 | Gastrointestinal disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Esophagitis - Grade 2 | Gastrointestinal disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Extremity weakness - Grade 1 | Musculoskeletal and connective tissue disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Facial swelling - Grade 1 | General disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Fatigue - Grade 1 | General disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Fatigue - Grade 2 | General disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Fatigue/Lethargy - Grade 2 | General disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Feet pain - Grade 2 | Musculoskeletal and connective tissue disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Fever - Grade 1 | General disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Fever - Grade 2 | General disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Fever - Grade 3 | General disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Fevers - Grade 1 | General disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Fevers - Grade 2 | General disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Fevers - Grade 3 | General disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Flatulence - Grade 1 | Gastrointestinal disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Floaters - Grade 1 | Eye disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Fluid Overload - Grade 1 | Metabolism and nutrition disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Fluid overload - Grade 2 | Metabolism and nutrition disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Fluid overload - Grade 3 | Metabolism and nutrition disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Flushing - Grade 2 | Vascular disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Foot pain - Grade 1 | Musculoskeletal and connective tissue disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Frustration - Grade 1 | Psychiatric disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Fungal rash - Grade 1 | Infections and infestations | CTCAE (4.0) | Systematic Assessment |
| |
| Gastritis - Grade 2 | Gastrointestinal disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Gastroesophageal reflux disease - Grade 1 | Gastrointestinal disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Fogginess - Grade 1 | General disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Generalized discomfort - Grade 2 | General disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Generalized itching - Grade 2 | Skin and subcutaneous tissue disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Generalized joint/bone pain - Grade 2 | Musculoskeletal and connective tissue disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Generalized Pain/ Discomfort - Grade 2 | General disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Generalized rash - Grade 2 | Skin and subcutaneous tissue disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Generalized weakness/activity changes - Grade 1 | Musculoskeletal and connective tissue disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Genital edema - Grade 1 | Reproductive system and breast disorders | CTCAE (4.0) | Systematic Assessment |
| |
| GERD - Grade 1 | Gastrointestinal disorders | CTCAE (4.0) | Systematic Assessment |
| |
| GERD - Grade 2 | Gastrointestinal disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Groin rash - Grade 1 | Skin and subcutaneous tissue disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Hallucination - Grade 1 | Psychiatric disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Hallucinations - Grade 1 | Psychiatric disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Hallucinations - Grade 2 | Psychiatric disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Head pain - Grade 1 | Nervous system disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Headache - Grade 1 | Nervous system disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Headache - Grade 2 | Nervous system disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Headaches - Grade 2 | Nervous system disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Heartburn - Grade 1 | Gastrointestinal disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Heartburn - Grade 2 | Gastrointestinal disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Hematuria - Grade 1 | Renal and urinary disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Hematuria - Grade 2 | Renal and urinary disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Hematuria - Grade 3 | Renal and urinary disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Hemolysis - Grade 3 | Blood and lymphatic system disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Hemorrhoid pain - Grade 2 | Gastrointestinal disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Hemorrhoids - Grade 1 | Gastrointestinal disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Hemorrhoids - Grade 2 | Gastrointestinal disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Hernia - Grade 1 | Musculoskeletal and connective tissue disorders | CTCAE (4.0) | Systematic Assessment |
| |
| HHV-6 - Grade 2 | Infections and infestations | CTCAE (4.0) | Systematic Assessment |
| |
| HHV6 activation - Grade 1 | Infections and infestations | CTCAE (4.0) | Systematic Assessment |
| |
| HHV6 infection - Grade 2 | Infections and infestations | CTCAE (4.0) | Systematic Assessment |
| |
| HHV-6 positive - Grade 1 | Infections and infestations | CTCAE (4.0) | Systematic Assessment |
| |
| HHV6 Reactivation - Grade 1 | Infections and infestations | CTCAE (4.0) | Systematic Assessment |
| |
| HHV-6 Viremia - Grade 2 | Infections and infestations | CTCAE (4.0) | Systematic Assessment |
| |
| Hiccups - Grade 1 | Respiratory, thoracic and mediastinal disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Hiccups - Grade 2 | Respiratory, thoracic and mediastinal disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Hip pain - Grade 2 | Musculoskeletal and connective tissue disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Hot flashes - Grade 1 | Vascular disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Hyperbilirubin - Grade 1 | Investigations | CTCAE (4.0) | Systematic Assessment |
| |
| Hyperbilirubin - Grade 2 | Investigations | CTCAE (4.0) | Systematic Assessment |
| |
| Hyperbilirubinemia - Grade 1 | Investigations | CTCAE (4.0) | Systematic Assessment |
| |
| Hyperbilirubinemia - Grade 2 | Investigations | CTCAE (4.0) | Systematic Assessment |
| |
| Hyperglycemia - Grade 2 | Metabolism and nutrition disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Hyperhidrosis - Grade 1 | Skin and subcutaneous tissue disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Hyperkalemia - Grade 1 | Metabolism and nutrition disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Hyperkalemia - Grade 2 | Metabolism and nutrition disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Hypernatremia - Grade 1 | Metabolism and nutrition disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Hypernatremia - Grade 2 | Metabolism and nutrition disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Hyperphosphatemia - Grade 1 | Metabolism and nutrition disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Hyperpigmentation - Grade 1 | Skin and subcutaneous tissue disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Hypertension - Grade 1 | Vascular disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Hypertension - Grade 2 | Vascular disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Hypertension - Grade 3 | Vascular disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Hypocalcemia - Grade 1 | Metabolism and nutrition disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Hypocalcemia - Grade 2 | Metabolism and nutrition disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Hypokalemia - Grade 1 | Metabolism and nutrition disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Hypokalemia - Grade 2 | Metabolism and nutrition disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Hypokalemia - Grade 3 | Metabolism and nutrition disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Hypokalemia - Grade 4 | Metabolism and nutrition disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Hypokalemia/hyponatremic - Grade 2 | Metabolism and nutrition disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Hypomagnesemia - Grade 2 | Metabolism and nutrition disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Hyponatremia - Grade 1 | Metabolism and nutrition disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Hyponatremia - Grade 3 | Metabolism and nutrition disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Hypophosphatemia - Grade 3 | Metabolism and nutrition disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Hypotension - Grade 1 | Vascular disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Hypotension - Grade 2 | Vascular disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Hypotensive - GRade 1 | Vascular disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Hypotensive - Grade 2 | Vascular disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Hypothermia - Grade 2 | Gastrointestinal disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Hypovolemic - Grade 1 | Blood and lymphatic system disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Hypoxia - Grade 2 | Respiratory, thoracic and mediastinal disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Hypoxia - Grade 3 | Respiratory, thoracic and mediastinal disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Hypoxia (infusion reaction) - Grade 2 | General disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Infections and infestations-Other - Grade 4 | Infections and infestations | CTCAE (4.0) | Systematic Assessment |
| |
| Infusion reaction - Grade 2 | General disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Infusion reaction - Headache - Grade 1 | General disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Infusion reaction - Hives - Grade 2 | General disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Infusion related reaction - Grade 2 | General disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Infusion related reaction - Chills/ Nausea - Grade 2 | General disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Infusion related reaction - Cough - Grade 1 | General disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Infusion related reaction - Itchy/Hives - Grade 2 | General disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Infusion related reaction - Mild Rigors - Grade 2 | General disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Infusion related reaction - Mouth - Grade 1 | General disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Infusion related reaction - tachycardia - Grade 1 | General disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Insomnia - Grade 1 | Psychiatric disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Irritable - Grade 2 | General disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Irritable/ Agitated - Grade 1 | General disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Irritable/ Anxiety - Grade 1 | General disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Irritation - PICC site - Grade 1 | Skin and subcutaneous tissue disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Itching - Grade 1 | Skin and subcutaneous tissue disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Itchy skin - Grade 1 | Skin and subcutaneous tissue disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Joint pain/Swelling - Grade 1 | Musculoskeletal and connective tissue disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Knee pain - Grade 1 | Musculoskeletal and connective tissue disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Left arm swelling - Grade 1 | General disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Left extremity pain - Grade 1 | Musculoskeletal and connective tissue disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Left Shoulder/Neck Pain - Grade 1 | Musculoskeletal and connective tissue disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Left upper extremity swelling - Grade 1 | General disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Leg pain - Grade 1 | Musculoskeletal and connective tissue disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Leg pain - Grade 2 | Musculoskeletal and connective tissue disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Lethargic - Grade 1 | Nervous system disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Lethargic - Grade 2 | Nervous system disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Lethargic/fatigue - Grade 1 | General disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Lethargy - Grade 1 | Nervous system disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Lethargy/ Fatigue - Grade 2 | General disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Lightheadedness - Grade 1 | Nervous system disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Lower L Back Pain - Grade 1 | Musculoskeletal and connective tissue disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Maculopapular rash - Grade 3 | Skin and subcutaneous tissue disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Maculopapular/erythematous rash - Grade 3 | Skin and subcutaneous tissue disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Malaise - Grade 1 | General disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Memory Change - Grade 1 | Nervous system disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Memory Change - Grade 2 | Nervous system disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Memory impairment/Confusion - Grade 1 | Nervous system disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Mental confusion - Grade 1 | Psychiatric disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Metabolic acidosis - Grade 1 | Metabolism and nutrition disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Metabolic and nutrition disorders- other (low sodium, calcium, phosphate, and albumin) - Grade 2 | Metabolism and nutrition disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Metabolic disorder- other (electrolyte imbalance) - Grade 2 | Metabolism and nutrition disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Metabolism disorder - Grade 1 | Metabolism and nutrition disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Metabolism disorder; other - Grade 1 | Metabolism and nutrition disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Metabolism disorder; other - Grade 2 | Metabolism and nutrition disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Metabolism disorder; other - Grade 3 | Metabolism and nutrition disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Migraine - Grade 1 | Nervous system disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Mild Rash - Grade 1 | Skin and subcutaneous tissue disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Mild Resting Tremor - Grade 1 | Nervous system disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Mouth Numbness - Grade 1 | Gastrointestinal disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Mouth Sores - Grade 1 | Gastrointestinal disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Mouth Sores/Dry Mouth - Grade 2 | Gastrointestinal disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Mucositis - Grade 1 | Gastrointestinal disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Mucositis - Grade 2 | Gastrointestinal disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Mucositis - Grade 3 | Gastrointestinal disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Myalgias - Grade 1 | Musculoskeletal and connective tissue disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Myalgias - Grade 3 | Musculoskeletal and connective tissue disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Muscle Ache/Pain - Grade 1 | Musculoskeletal and connective tissue disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Muscle Aches - Grade 1 | Musculoskeletal and connective tissue disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Muscle/Joint pain - Grade 1 | Musculoskeletal and connective tissue disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Nasal Congestion - Grade 1 | Respiratory, thoracic and mediastinal disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Nasal Congestion - Grade 2 | Respiratory, thoracic and mediastinal disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Nausea - Grade 1 | Gastrointestinal disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Nausea - Grade 2 | Gastrointestinal disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Nausea - Grade 3 | Gastrointestinal disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Nausea and vomiting - Grade 2 | Gastrointestinal disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Neck Pain - Grade 1 | Musculoskeletal and connective tissue disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Neuropathy - Grade 1 | Nervous system disorders | CTCAE (4.0) | Systematic Assessment |
| |
| New pancreatic neoplasm - Grade 1 | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | CTCAE (4.0) | Systematic Assessment |
| |
| New Rash - Grade 2 | Skin and subcutaneous tissue disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Night Sweats - Grade 1 | Skin and subcutaneous tissue disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Nocturia - Grade 1 | Renal and urinary disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Nocturia/Urinary frequency - Grade 2 | Renal and urinary disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Non-cardiac chest pain - Grade 1 | General disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Numbness/Tingling - Legs - Grade 1 | Nervous system disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Nystagmus - Grade 2 | Nervous system disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Oliguria - Grade 2 | Investigations | CTCAE (4.0) | Systematic Assessment |
| |
| Oliguria - Grade 3 | Investigations | CTCAE (4.0) | Systematic Assessment |
| |
| Orthostatic hypotension - Grade 1 | Vascular disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Orthostatic hypotension - Grade 2 | Vascular disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Pain - Grade 1 | General disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Pain - Grade 2 | General disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Pain - Crawling Skin - Grade 2 | General disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Pain - Bx Site - Grade 1 | Injury, poisoning and procedural complications | CTCAE (4.0) | Systematic Assessment |
| |
| Pain - PEG site - Grade 1 | Injury, poisoning and procedural complications | CTCAE (4.0) | Systematic Assessment |
| |
| Pain - R and L flank - Grade 2 | Musculoskeletal and connective tissue disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Pain - Right arm around PICC - Grade 2 | Injury, poisoning and procedural complications | CTCAE (4.0) | Systematic Assessment |
| |
| Pain - Shoulder/ Neck/ Back - Grade 2 | Musculoskeletal and connective tissue disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Pain - Soles and Palms - Grade 1 | Skin and subcutaneous tissue disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Pain in buttocks region - Grade 1 | Musculoskeletal and connective tissue disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Pain in extremities when becomes cold - Grade 1 | Musculoskeletal and connective tissue disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Pain in skin/arms - Grade 1 | Musculoskeletal and connective tissue disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Pain- right lower anterior chest wall - Grade 3 | Musculoskeletal and connective tissue disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Pain, other - Grade 1 | General disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Painful swallowing/ Mucositis - Grade 3 | Gastrointestinal disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Painful/difficulty urination - Grade 1 | Renal and urinary disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Pain - Jaw - Grade 1 | Gastrointestinal disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Palpitations - Grade 1 | Cardiac disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Palpitations - Grade 2 | Cardiac disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Pancytopenia - Grade 1 | Blood and lymphatic system disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Pancytopenia - Grade 3 | Blood and lymphatic system disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Papules - Grade 1 | Skin and subcutaneous tissue disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Paresthesia - Grade 1 | Nervous system disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Paresthesia - Grade 2 | Nervous system disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Perianal discomfort/Hemorrhoids - Grade 2 | Gastrointestinal disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Pericardial effusion - Grade 1 | Cardiac disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Pericardial effusion - Grade 2 | Cardiac disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Pericatheter thrombus - Grade 2 | Vascular disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Perineum pain - Grade 1 | Reproductive system and breast disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Peripheral edema - Grade 1 | General disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Petechiae - Grade 1 | Blood and lymphatic system disorders | CTCAE (4.0) | Systematic Assessment |
| |
| PICC Site soreness-Pain - Grade 1 | Injury, poisoning and procedural complications | CTCAE (4.0) | Systematic Assessment |
| |
| Platelet transfusion reaction - Grade 2 | Blood and lymphatic system disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Pleural effusions - Grade 1 | Respiratory, thoracic and mediastinal disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Pleural effusions - Grade 2 | Respiratory, thoracic and mediastinal disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Pneumonia - Grade 1 | Infections and infestations | CTCAE (4.0) | Systematic Assessment |
| |
| Pneumonia - Grade 2 | Infections and infestations | CTCAE (4.0) | Systematic Assessment |
| |
| Pneumonitis - Grade 2 | Respiratory, thoracic and mediastinal disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Polyuria - Grade 2 | Renal and urinary disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Poor Oral Intake - Grade 1 | Metabolism and nutrition disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Presyncope - Grade 2 | Nervous system disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Problems with Balance - Grade 1 | Nervous system disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Prolonged QT interval - Grade 2 | Investigations | CTCAE (4.0) | Systematic Assessment |
| |
| Proteinuria - Grade 1 | Renal and urinary disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Proteinuria - Grade 2 | Renal and urinary disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Pruritis - Grade 1 | Skin and subcutaneous tissue disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Pruritis - Grade 2 | Skin and subcutaneous tissue disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Psychiatric disorders-Other-Distress - Grade 1 | Psychiatric disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Pulmonary edema - Grade 2 | Respiratory, thoracic and mediastinal disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Pulmonary edema - Grade 3 | Respiratory, thoracic and mediastinal disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Purulent drainage - Grade 2 | Infections and infestations | CTCAE (4.0) | Systematic Assessment |
| |
| Rash - Grade 1 | Skin and subcutaneous tissue disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Rash - Grade 2 | Skin and subcutaneous tissue disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Rash - Grade 3 | Skin and subcutaneous tissue disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Rectal Pain - Grade 1 | Gastrointestinal disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Rectal Pain - Grade 3 | Gastrointestinal disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Renal and urinary disorders-Other-Dysuria - Grade 1 | Renal and urinary disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Renal and urinary disorders-Other-Urinary Changes - Grade 1 | Renal and urinary disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Respiratory Distress - Grade 3 | Respiratory, thoracic and mediastinal disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Respiratory, thorasic, and mediastinal disorders-Other-Chronic Sinusitis - Grade 2 | Respiratory, thoracic and mediastinal disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Restless Legs - Grade 1 | Nervous system disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Rhinitis - Grade 1 | Respiratory, thoracic and mediastinal disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Rhinitis - Grade 2 | Respiratory, thoracic and mediastinal disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Rhinorrhea - Grade 1 | Respiratory, thoracic and mediastinal disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Rhinovirus - Grade 1 | Infections and infestations | CTCAE (4.0) | Systematic Assessment |
| |
| Rhonchi - Grade 1 | Respiratory, thoracic and mediastinal disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Rib Pain - Grade 1 | Musculoskeletal and connective tissue disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Right Hip Discomfort - Grade 1 | Musculoskeletal and connective tissue disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Right plueral effusion - Grade 1 | Respiratory, thoracic and mediastinal disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Right subconjunctival hemorrhage - Grade 1 | Eye disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Rigors - Grade 1 | General disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Rigors - Grade 2 | General disorders | CTCAE (4.0) | Systematic Assessment |
| |
| RUE Pain - Grade 2 | Musculoskeletal and connective tissue disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Sensitive Fingers - Grade 1 | Skin and subcutaneous tissue disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Sepsis - Grade 3 | Infections and infestations | CTCAE (4.0) | Systematic Assessment |
| |
| Shortness of Breath - Grade 1 | Respiratory, thoracic and mediastinal disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Shortness of Breath - Grade 2 | Respiratory, thoracic and mediastinal disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Shoulder Pain - Grade 1 | Musculoskeletal and connective tissue disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Shoulder Pain - Grade 2 | Musculoskeletal and connective tissue disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Sinus congestion - Grade 1 | Respiratory, thoracic and mediastinal disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Sinus pain/congestion - Grade 2 | Respiratory, thoracic and mediastinal disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Sinus tachycardia - Grade 2 | Cardiac disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Skin and subcutaneous tissue disorders-Other-Bump on head - Grade 1 | Skin and subcutaneous tissue disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Skin and subcutaneous tissue disorders-Other-Hot flashes - Grade 1 | Skin and subcutaneous tissue disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Skin and subcutaneous tissue disorders-Other-Toe abrasion - Grade 1 | Skin and subcutaneous tissue disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Skin discoloration - Grade 1 | Skin and subcutaneous tissue disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Skin hyperpigmentation - Grade 1 | Skin and subcutaneous tissue disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Skin Rash - Papules - Grade 1 | Skin and subcutaneous tissue disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Skin Tear - Grade 1 | Skin and subcutaneous tissue disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Skin ulceration - Grade 1 | Skin and subcutaneous tissue disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Small intestinal Obstruction - Grade 2 | Gastrointestinal disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Somnolence - Grade 3 | Nervous system disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Sore throat - Grade 1 | Respiratory, thoracic and mediastinal disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Sore throat - Grade 2 | Respiratory, thoracic and mediastinal disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Soreness - Buttocks - Grade 1 | Musculoskeletal and connective tissue disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Soreness at PICC site - Grade 1 | Injury, poisoning and procedural complications | CTCAE (4.0) | Systematic Assessment |
| |
| Stomach Pain - Grade 1 | Gastrointestinal disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Sweats - Grade 1 | Skin and subcutaneous tissue disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Sweats - Grade 2 | Skin and subcutaneous tissue disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Swollen Ankles - Grade 1 | General disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Tachycardia - Grade 1 | Cardiac disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Tachycardia - Grade 2 | Cardiac disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Tachycardic - Grade 1 | Cardiac disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Tachypnea - Grade 1 | Respiratory, thoracic and mediastinal disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Tachypnea - Grade 2 | Respiratory, thoracic and mediastinal disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Taste alterations - Grade 1 | Nervous system disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Testicular/Scrotal pain - Grade 3 | Reproductive system and breast disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Thromboembolic event - Grade 2 | Vascular disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Tightness in Mouth - Grade 1 | Gastrointestinal disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Thrombolytic event - Grade 2 | Vascular disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Tingling - Lips - Grade 1 | Gastrointestinal disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Tooth Infection | Infections and infestations | CTCAE (4.0) | Systematic Assessment |
| |
| Total Body Pain - Grade 1 | General disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Transaminitis - Grade 1 | Investigations | CTCAE (4.0) | Systematic Assessment |
| |
| Tremors - Grade 1 | Nervous system disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Tremors - Grade 2 | Nervous system disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Trouble Sleeping - Grade 1 | Psychiatric disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Typhlitis - Grade 3 | Gastrointestinal disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Upper respiratory infection - Grade 2 | Infections and infestations | CTCAE (4.0) | Systematic Assessment |
| |
| Urinary frequency - Grade 1 | Renal and urinary disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Urinary frequency - Grade 2 | Renal and urinary disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Urinary incontinence - Grade 2 | Renal and urinary disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Urinary incontinence - Grade 3 | Renal and urinary disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Urinary retention - Grade 2 | Renal and urinary disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Urinary tract infection - Grade 1 | Infections and infestations | CTCAE (4.0) | Systematic Assessment |
| |
| Urinary tract infection - Grade 2 | Infections and infestations | CTCAE (4.0) | Systematic Assessment |
| |
| Urinary tract pain - Grade 1 | Renal and urinary disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Urinary urgency - Grade 1 | Renal and urinary disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Urine incontinence - Grade 1 | Renal and urinary disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Urine output decreased - Grade 2 | Investigations | CTCAE (4.0) | Systematic Assessment |
| |
| Vaginal bleeding/spotting - Grade 2 | Reproductive system and breast disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Vaginal dryness - Grade 1 | Reproductive system and breast disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Ventricular arrhythmia - Grade 2 | Cardiac disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Visual hallucinations - Grade 1 | Psychiatric disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Volume Overload - Grade 1 | Metabolism and nutrition disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Volume Overload - Grade 2 | Metabolism and nutrition disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Vomiting - Grade 1 | Gastrointestinal disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Vomiting - Grade 2 | Gastrointestinal disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Weakness - Grade 1 | Musculoskeletal and connective tissue disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Weakness - LE - Grade 2 | Musculoskeletal and connective tissue disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Weight Increase - Grade 1 | Investigations | CTCAE (4.0) | Systematic Assessment |
| |
| Weight Loss - Grade 1 | Investigations | CTCAE (4.0) | Systematic Assessment |
| |
| Weight Loss - Grade 3 | Investigations | CTCAE (4.0) | Systematic Assessment |
| |
| Wheezing - Grade 1 | Respiratory, thoracic and mediastinal disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Wound - B/L Upper Buttocks - Grade 2 | Injury, poisoning and procedural complications | CTCAE (4.0) | Systematic Assessment |
|
Not provided
Not provided
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dolores Grosso | Tevogen Bio | 848-256-5751 | dolores.grosso@tevogen.com |
| Jul 7, 2023 |
| Prot_SAP_000.pdf |
| ID | Term |
|---|---|
| D000013 | Congenital Abnormalities |
| D054391 | Lymphoma, Extranodal NK-T-Cell |
| D000741 | Anemia, Aplastic |
| C580364 | Pdgfra-Associated Chronic Eosinophilic Leukemia |
| D015477 | Leukemia, Myelomonocytic, Chronic |
| D015467 | Leukemia, Neutrophilic, Chronic |
| D013920 | Thrombocythemia, Essential |
| D054429 | Leukemia, Myelomonocytic, Juvenile |
| D008415 | Mastocytosis |
| D009196 | Myeloproliferative Disorders |
| D018442 | Lymphoma, B-Cell, Marginal Zone |
| D011087 | Polycythemia Vera |
| D055728 | Primary Myelofibrosis |
| D054198 | Precursor Cell Lymphoblastic Leukemia-Lymphoma |
| D015470 | Leukemia, Myeloid, Acute |
| D008228 | Lymphoma, Non-Hodgkin |
| D006689 | Hodgkin Disease |
| D016410 | Lymphoma, T-Cell, Cutaneous |
| D008224 | Lymphoma, Follicular |
| D009182 | Mycosis Fungoides |
| D012751 | Sezary Syndrome |
| D015451 | Leukemia, Lymphocytic, Chronic, B-Cell |
| D012008 | Recurrence |
| D000753 | Anemia, Refractory |
| D007943 | Leukemia, Hairy Cell |
| D009101 | Multiple Myeloma |
| D054066 | Leukemia, Large Granular Lymphocytic |
| D008258 | Waldenstrom Macroglobulinemia |
| ID | Term |
|---|---|
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D016399 | Lymphoma, T-Cell |
| D008223 | Lymphoma |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D000740 | Anemia |
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D000080983 | Bone Marrow Failure Disorders |
| D001855 | Bone Marrow Diseases |
| D007951 | Leukemia, Myeloid |
| D007938 | Leukemia |
| D054437 | Myelodysplastic-Myeloproliferative Diseases |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D001778 | Blood Coagulation Disorders |
| D013922 | Thrombocytosis |
| D001791 | Blood Platelet Disorders |
| D006474 | Hemorrhagic Disorders |
| D009372 | Neoplasms, Connective Tissue |
| D018204 | Neoplasms, Connective and Soft Tissue |
| D000090362 | Mast Cell Activation Disorders |
| D007154 | Immune System Diseases |
| D016393 | Lymphoma, B-Cell |
| D008232 | Lymphoproliferative Disorders |
| D008206 | Lymphatic Diseases |
| D007160 | Immunoproliferative Disorders |
| D019046 | Bone Marrow Neoplasms |
| D019337 | Hematologic Neoplasms |
| D009371 | Neoplasms by Site |
| D007945 | Leukemia, Lymphoid |
| D015448 | Leukemia, B-Cell |
| D009190 | Myelodysplastic Syndromes |
| D054219 | Neoplasms, Plasma Cell |
| D020141 | Hemostatic Disorders |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D010265 | Paraproteinemias |
| D001796 | Blood Protein Disorders |
| D015458 | Leukemia, T-Cell |
Not provided
Not provided
| ID | Term |
|---|---|
| C024352 | fludarabine |
| C042382 | fludarabine phosphate |
| D002066 | Busulfan |
| D014916 | Whole-Body Irradiation |
| D011878 | Radiotherapy |
| D003520 | Cyclophosphamide |
| D016559 | Tacrolimus |
| D009173 | Mycophenolic Acid |
| D036102 | Peripheral Blood Stem Cell Transplantation |
| D014180 | Transplantation |
| ID | Term |
|---|---|
| D002072 | Butylene Glycols |
| D006018 | Glycols |
| D000438 | Alcohols |
| D009930 | Organic Chemicals |
| D008698 | Mesylates |
| D000476 | Alkanesulfonates |
| D017738 | Alkanesulfonic Acids |
| D000473 | Alkanes |
| D006839 | Hydrocarbons, Acyclic |
| D006838 | Hydrocarbons |
| D013451 | Sulfonic Acids |
| D013456 | Sulfur Acids |
| D013457 | Sulfur Compounds |
| D013812 | Therapeutics |
| D008919 | Investigative Techniques |
| D010752 | Phosphoramide Mustards |
| D009588 | Nitrogen Mustard Compounds |
| D009150 | Mustard Compounds |
| D006846 | Hydrocarbons, Halogenated |
| D063088 | Phosphoramides |
| D009943 | Organophosphorus Compounds |
| D018942 | Macrolides |
| D007783 | Lactones |
| D002208 | Caproates |
| D000144 | Acids, Acyclic |
| D002264 | Carboxylic Acids |
| D005227 | Fatty Acids |
| D008055 | Lipids |
| D018380 | Hematopoietic Stem Cell Transplantation |
| D033581 | Stem Cell Transplantation |
| D017690 | Cell Transplantation |
| D064987 | Cell- and Tissue-Based Therapy |
| D001691 | Biological Therapy |
| D013514 | Surgical Procedures, Operative |
Not provided
Not provided
| Unknown or Not Reported |
|
| Native Hawaiian or Other Pacific Islander |
|
| Black or African American |
|
| White |
|
| More than one race |
|
| Unknown or Not Reported |
|
|
|
|
|
|
|
|
| Units | Counts |
|---|
| Participants |
|