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Low accrual
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| Name | Class |
|---|---|
| Celldex Therapeutics | INDUSTRY |
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The purpose of this study is to test a new way of treating the most common form of lung cancer. The investigators are testing a combination of radiotherapy with two new forms of immunotherapy. This study is testing the safety and effectiveness of this treatment approach as compared to standard treatment options.
This is a randomized, open-label phase I/II study. Subjects will be randomized in a 1:1 ratio to receive FLT3 ligand (CDX-301), anti-CD40 antibody (CDX-1140) and SBRT (Arm 1) versus standard care (Arm 2). Subjects on either study arm with limited disease will receive SBRT to all evident sites of active disease. Subjects on Arm 1 with extensive disease will initially receive SBRT to a single site of disease but may receive additional "cycles" of FLT3 ligand (CDX-301) anti-CD40 antibody (CDX-1140), and SBRT at later time points. Subjects on Arm 2 with extensive disease are expected to receive some form of standard systemic therapy (e.g., docetaxel). Subjects on Arm 2 with limited disease may also receive standard systemic therapy following completion of SBRT to all sites of evident disease, at the discretion of the treating physicians. All subjects will be followed closely for treatment-related toxicities. Whole-body PET/CT and CT imaging will be performed prior to study entry, and restaging CT will be performed every 8 weeks thereafter.
In the phase I component of this study, subjects will be randomized between study arms until 6 subjects have been randomized to Arm 1. Study accrual will then be halted until 8 weeks after the last study subject begins treatment.
If the pre-specified safety criteria are achieved in the Phase I portion of this study, the study will proceed to phase II. The total sample size (Phase I and Phase II) will be 46 subjects. All 46 subjects will be included in efficacy analyses.
If the pre-specified safety criteria are not achieved in the Phase I portion of this study, the investigators and Celldex will review safety data from this trial as well as other trials using CDX-301 and CDX-1140 and determine if the experimental treatment regimen should be altered (e.g., by reducing the CDX-1140 dose). The study protocol would be amended accordingly, and Phase I component with the new treatment regimen would be added.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| FLT3 ligand (CDX-301), anti-CD40 antibody (CDX-1140), and SBRT | Experimental | Subjects on either study arm with limited disease will receive SBRT to all evident sites of active disease. Subjects on Arm 1 with extensive disease will initially receive SBRT to a single site of disease but may receive additional "cycles" of FLT3 ligand, anti-CD40 antibody, and SBRT at later time points. |
|
| Standard care | Active Comparator | Subjects on either study arm with limited disease will receive SBRT to all evident sites of active disease.Subjects on Arm 2 with extensive disease are expected to receive some form of standard systemic therapy (e.g., docetaxel). Subjects on Arm 2 with limited disease may also receive standard systemic therapy following completion of SBRT to all sites of evident disease, at the discretion of the treating physicians. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| FLT3 Ligand (CDX-301) | Drug | Fms-like tyrosine kinase 3 (FLT3) ligand is a potent hematopoietic growth factor that mobilizes stem cells and greatly increases the number of circulating dendritic cells (DCs) in blood and organs. |
| Measure | Description | Time Frame |
|---|---|---|
| Phase I: Dose-limiting Toxicity (DLT), Defined as Follows: | Death Any ≥ Grade 3 non-hematological toxicity, with the following exceptions: Grade 3 alopecia, vitiligo, or endocrinopathies controlled by hormone replacement therapy Grade 3 nausea that resolves to ≤ grade 2 with or without treatment within 72 hours Grade 3 vomiting and diarrhea that resolves to ≤ grade 2 with or without treatment within 72 hours Grade 3 fatigue that resolves to ≤ grade 2 within 5 days Grade 3 hypertension in the absence of maximal medical therapy Grade 3 adverse event of tumor flare (defined as local pain, irritation, or rash localized at sites of known or suspected tumor) of ≤ 7 days in duration Grade 3 amylase or lipase abnormalities that are not associated with symptoms or clinical manifestations of pancreatitis. It is recommended to consult with the Principal Investigator for grade 4 amylase or lipase abnormalities Grade 3 clinically significant laboratory abnormalities that are asymptomatic and can be reversed within 72 hours, however: Any Grade 4 | up to 8 weeks after initiation of study therapy |
| Phase II: Progression-free Survival (PFS) Duration | defined as time from study registration until disease progression (scored using iRECIST) or death, whichever comes first up to 51 weeks. |
| Measure | Description | Time Frame |
|---|---|---|
| Overall Survival (OS) Duration | Length of time that patient survives from time of study registration | From date of registration until the date of death from any cause, assessed up to 2 years |
| Radiographic Responses Using Descriptive Statistics |
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Inclusion Criteria:
Hemoglobin ≥ 9.0 g/dL Absolute neutrophil count ≥ 1.5 x 109/L Platelet count ≥ 100 x 109/L Serum creatinine ≤ 1.5 x ULN OR creatinine clearance (by Cockcroft-Gault formula) > 60 mL/min AST and ALT ≤ 2.5 x ULN Total bilirubin ≤ 2.0 x ULN (except patients with Gilbert's syndrome, who must have a total bilirubin ≤ 3.0 mg/dL)
-Negative SARS-CoV-2 (COVID-19) PCR test. COVID-19 testing may be repeated periodically based on institutional policies and must be repeated for any subject with unexplained signs (e.g., imaging findings, fever) or symptoms (e.g., anosmia) concerning for COVID-19 infection or with recent known exposure to COVID-19.
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Albert Einstein College of Medicine | The Bronx | New York | 10461 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | FLT3 Ligand (CDX-301), Anti-CD40 Antibody (CDX-1140), and SBRT | Subjects on either study arm with limited disease will receive SBRT to all evident sites of active disease. Subjects on Arm 1 with extensive disease will initially receive SBRT to a single site of disease but may receive additional "cycles" of FLT3 ligand, anti-CD40 antibody, and SBRT at later time points. FLT3 Ligand (CDX-301): Fms-like tyrosine kinase 3 (FLT3) ligand is a potent hematopoietic growth factor that mobilizes stem cells and greatly increases the number of circulating dendritic cells (DCs) in blood and organs. anti-CD40 antibody (CDX-1140): CD40 is a key molecule in the regulation of immune responses whose activity can be modulated using antibodies. CD40 is a tumor necrosis factor receptor superfamily member expressed on antigen presenting cells, including dendritic cells, as well as a host of other cell types, including a wide range of tumor cells SBRT: For subjects on Arm 1, SBRT will be delivered concurrently with FLT3 ligand during Week 1 of study therapy. If only one lesion is being treated, SBRT should be completed during week 1 (e.g., with daily treatments for a 5-fraction course of treatments every other day for a 3-fraction course). In cases where multiple lesions are being treated with SBRT (Arm 1 or Arm 2) or if treatment is interrupted due to technical issues or intercurrent illness, SBRT may extend beyond Week 1. |
| FG001 | Standard Care | Subjects on either study arm with limited disease will receive SBRT to all evident sites of active disease.Subjects on Arm 2 with extensive disease are expected to receive some form of standard systemic therapy (e.g., docetaxel). Subjects on Arm 2 with limited disease may also receive standard systemic therapy following completion of SBRT to all sites of evident disease, at the discretion of the treating physicians. SBRT: For subjects on Arm 1, SBRT will be delivered concurrently with FLT3 ligand during Week 1 of study therapy. If only one lesion is being treated, SBRT should be completed during week 1 (e.g., with daily treatments for a 5-fraction course of treatments every other day for a 3-fraction course). In cases where multiple lesions are being treated with SBRT (Arm 1 or Arm 2) or if treatment is interrupted due to technical issues or intercurrent illness, SBRT may extend beyond Week 1. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | FLT3 Ligand (CDX-301), Anti-CD40 Antibody (CDX-1140), and SBRT | Subjects on either study arm with limited disease will receive SBRT to all evident sites of active disease. Subjects on Arm 1 with extensive disease will initially receive SBRT to a single site of disease but may receive additional "cycles" of FLT3 ligand, anti-CD40 antibody, and SBRT at later time points. FLT3 Ligand (CDX-301): Fms-like tyrosine kinase 3 (FLT3) ligand is a potent hematopoietic growth factor that mobilizes stem cells and greatly increases the number of circulating dendritic cells (DCs) in blood and organs. anti-CD40 antibody (CDX-1140): CD40 is a key molecule in the regulation of immune responses whose activity can be modulated using antibodies. CD40 is a tumor necrosis factor receptor superfamily member expressed on antigen presenting cells, including dendritic cells, as well as a host of other cell types, including a wide range of tumor cells SBRT: For subjects on Arm 1, SBRT will be delivered concurrently with FLT3 ligand during Week 1 of study therapy. If only one lesion is being treated, SBRT should be completed during week 1 (e.g., with daily treatments for a 5-fraction course of treatments every other day for a 3-fraction course). In cases where multiple lesions are being treated with SBRT (Arm 1 or Arm 2) or if treatment is interrupted due to technical issues or intercurrent illness, SBRT may extend beyond Week 1. |
| 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 | Phase I: Dose-limiting Toxicity (DLT), Defined as Follows: | Death Any ≥ Grade 3 non-hematological toxicity, with the following exceptions: Grade 3 alopecia, vitiligo, or endocrinopathies controlled by hormone replacement therapy Grade 3 nausea that resolves to ≤ grade 2 with or without treatment within 72 hours Grade 3 vomiting and diarrhea that resolves to ≤ grade 2 with or without treatment within 72 hours Grade 3 fatigue that resolves to ≤ grade 2 within 5 days Grade 3 hypertension in the absence of maximal medical therapy Grade 3 adverse event of tumor flare (defined as local pain, irritation, or rash localized at sites of known or suspected tumor) of ≤ 7 days in duration Grade 3 amylase or lipase abnormalities that are not associated with symptoms or clinical manifestations of pancreatitis. It is recommended to consult with the Principal Investigator for grade 4 amylase or lipase abnormalities Grade 3 clinically significant laboratory abnormalities that are asymptomatic and can be reversed within 72 hours, however: Any Grade 4 | Data was not collected/aggregated. No analyses conducted. | Posted | up to 8 weeks after initiation of study therapy |
|
All participants enrolled in the trial were assessed through 49 weeks
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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 | FLT3 Ligand (CDX-301), Anti-CD40 Antibody (CDX-1140), and SBRT | Subjects on either study arm with limited disease will receive SBRT to all evident sites of active disease. Subjects on Arm 1 with extensive disease will initially receive SBRT to a single site of disease but may receive additional "cycles" of FLT3 ligand, anti-CD40 antibody, and SBRT at later time points. FLT3 Ligand (CDX-301): Fms-like tyrosine kinase 3 (FLT3) ligand is a potent hematopoietic growth factor that mobilizes stem cells and greatly increases the number of circulating dendritic cells (DCs) in blood and organs. anti-CD40 antibody (CDX-1140): CD40 is a key molecule in the regulation of immune responses whose activity can be modulated using antibodies. CD40 is a tumor necrosis factor receptor superfamily member expressed on antigen presenting cells, including dendritic cells, as well as a host of other cell types, including a wide range of tumor cells SBRT: For subjects on Arm 1, SBRT will be delivered concurrently with FLT3 ligand during Week 1 of study therapy. If only one lesion is being treated, SBRT should be completed during week 1 (e.g., with daily treatments for a 5-fraction course of treatments every other day for a 3-fraction course). In cases where multiple lesions are being treated with SBRT (Arm 1 or Arm 2) or if treatment is interrupted due to technical issues or intercurrent illness, SBRT may extend beyond Week 1. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Sepsis | Infections and infestations | CTCAE (5.0) | Non-systematic Assessment | Septic Shock |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anemia | Blood and lymphatic system disorders | CTCAE (5.0) | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Nitin Ohri | Albert Einstein College of Medicine | 718-405-8550 | nitin.ohri@einsteinmed.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 | May 26, 2021 | Jun 23, 2023 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D002289 | Carcinoma, Non-Small-Cell Lung |
| D008175 | Lung Neoplasms |
| ID | Term |
|---|---|
| D002283 | Carcinoma, Bronchogenic |
| D001984 | Bronchial Neoplasms |
| D012142 | Respiratory Tract Neoplasms |
| D013899 | Thoracic Neoplasms |
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| ID | Term |
|---|---|
| C084881 | flt3 ligand protein |
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This is a randomized, open-label phase I/II study. Subjects will be randomized in a 1:1 ratio to receive FLT3 ligand (CDX-301), anti-CD40 antibody (CDX-1140) and SBRT (Arm 1) versus standard care (Arm 2).
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| anti-CD40 antibody (CDX-1140) | Biological | CD40 is a key molecule in the regulation of immune responses whose activity can be modulated using antibodies. CD40 is a tumor necrosis factor receptor superfamily member expressed on antigen presenting cells, including dendritic cells, as well as a host of other cell types, including a wide range of tumor cells |
|
| SBRT | Radiation | For subjects on Arm 1, SBRT will be delivered concurrently with FLT3 ligand during Week 1 of study therapy. If only one lesion is being treated, SBRT should be completed during week 1 (e.g., with daily treatments for a 5-fraction course of treatments every other day for a 3-fraction course). In cases where multiple lesions are being treated with SBRT (Arm 1 or Arm 2) or if treatment is interrupted due to technical issues or intercurrent illness, SBRT may extend beyond Week 1. |
|
The clinical benefit rate (CBR) will be defined as the percentage of subjects who achieve best response of confirmed CR or PR, or stable disease (SD) for at least four months.
| From date of registration, assessed up to 4 months |
| Quality of Life Using EORTC QLQ-LC13 (Quality of Life Questionnaire, Lung Cancer) | Summary statistics (mean, standard deviation, median, 25th and 75th percentiles, and range) and the mean change from baseline of linear-transformed scores will be reported for all the items and subscales of the EORTC QLQ-C30 questionnaire and the QLQ-LC13, according to the EORTC scoring manual guidelines. higher scores are a better level of functioning | 1 year |
| Quality of Life Using QLQ-C30 (Quality of Life Questionnaire) | Summary statistics (mean, standard deviation, median, 25th and 75th percentiles, and range) and the mean change from baseline of linear-transformed scores will be reported for all the items and subscales of the EORTC QLQ-C30 questionnaire and the QLQ-LC13, according to the EORTC scoring manual guidelines. Most items are scored 1 to 4, higher scores are a better level of functioning. | 1 year |
| Daily Step Count Using Descriptive Statistics | Average daily step counts | 1 year |
| BG001 | Standard Care | Subjects on either study arm with limited disease will receive SBRT to all evident sites of active disease.Subjects on Arm 2 with extensive disease are expected to receive some form of standard systemic therapy (e.g., docetaxel). Subjects on Arm 2 with limited disease may also receive standard systemic therapy following completion of SBRT to all sites of evident disease, at the discretion of the treating physicians. SBRT: For subjects on Arm 1, SBRT will be delivered concurrently with FLT3 ligand during Week 1 of study therapy. If only one lesion is being treated, SBRT should be completed during week 1 (e.g., with daily treatments for a 5-fraction course of treatments every other day for a 3-fraction course). In cases where multiple lesions are being treated with SBRT (Arm 1 or Arm 2) or if treatment is interrupted due to technical issues or intercurrent illness, SBRT may extend beyond Week 1. |
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Title |
|---|
| Description |
|---|
| OG000 | FLT3 Ligand (CDX-301), Anti-CD40 Antibody (CDX-1140), and SBRT | Subjects on either study arm with limited disease will receive SBRT to all evident sites of active disease. Subjects on Arm 1 with extensive disease will initially receive SBRT to a single site of disease but may receive additional "cycles" of FLT3 ligand, anti-CD40 antibody, and SBRT at later time points. FLT3 Ligand (CDX-301): Fms-like tyrosine kinase 3 (FLT3) ligand is a potent hematopoietic growth factor that mobilizes stem cells and greatly increases the number of circulating dendritic cells (DCs) in blood and organs. anti-CD40 antibody (CDX-1140): CD40 is a key molecule in the regulation of immune responses whose activity can be modulated using antibodies. CD40 is a tumor necrosis factor receptor superfamily member expressed on antigen presenting cells, including dendritic cells, as well as a host of other cell types, including a wide range of tumor cells SBRT: For subjects on Arm 1, SBRT will be delivered concurrently with FLT3 ligand during Week 1 of study therapy. If only one lesion is being treated, SBRT should be completed during week 1 (e.g., with daily treatments for a 5-fraction course of treatments every other day for a 3-fraction course). In cases where multiple lesions are being treated with SBRT (Arm 1 or Arm 2) or if treatment is interrupted due to technical issues or intercurrent illness, SBRT may extend beyond Week 1. |
| OG001 | Standard Care | Subjects on either study arm with limited disease will receive SBRT to all evident sites of active disease.Subjects on Arm 2 with extensive disease are expected to receive some form of standard systemic therapy (e.g., docetaxel). Subjects on Arm 2 with limited disease may also receive standard systemic therapy following completion of SBRT to all sites of evident disease, at the discretion of the treating physicians. SBRT: For subjects on Arm 1, SBRT will be delivered concurrently with FLT3 ligand during Week 1 of study therapy. If only one lesion is being treated, SBRT should be completed during week 1 (e.g., with daily treatments for a 5-fraction course of treatments every other day for a 3-fraction course). In cases where multiple lesions are being treated with SBRT (Arm 1 or Arm 2) or if treatment is interrupted due to technical issues or intercurrent illness, SBRT may extend beyond Week 1. |
|
| Primary | Phase II: Progression-free Survival (PFS) Duration | Data was not collected/aggregated. No analyses conducted. | Posted | defined as time from study registration until disease progression (scored using iRECIST) or death, whichever comes first up to 51 weeks. |
|
|
| Secondary | Overall Survival (OS) Duration | Length of time that patient survives from time of study registration | Data was not collected/aggregated. No analyses conducted. | Posted | From date of registration until the date of death from any cause, assessed up to 2 years |
|
|
| Secondary | Radiographic Responses Using Descriptive Statistics | The clinical benefit rate (CBR) will be defined as the percentage of subjects who achieve best response of confirmed CR or PR, or stable disease (SD) for at least four months. | Data was not collected/aggregated. No analyses conducted. | Posted | From date of registration, assessed up to 4 months |
|
|
| Secondary | Quality of Life Using EORTC QLQ-LC13 (Quality of Life Questionnaire, Lung Cancer) | Summary statistics (mean, standard deviation, median, 25th and 75th percentiles, and range) and the mean change from baseline of linear-transformed scores will be reported for all the items and subscales of the EORTC QLQ-C30 questionnaire and the QLQ-LC13, according to the EORTC scoring manual guidelines. higher scores are a better level of functioning | Data was not collected/aggregated. No analyses conducted. | Posted | 1 year |
|
|
| Secondary | Quality of Life Using QLQ-C30 (Quality of Life Questionnaire) | Summary statistics (mean, standard deviation, median, 25th and 75th percentiles, and range) and the mean change from baseline of linear-transformed scores will be reported for all the items and subscales of the EORTC QLQ-C30 questionnaire and the QLQ-LC13, according to the EORTC scoring manual guidelines. Most items are scored 1 to 4, higher scores are a better level of functioning. | Data was not collected/aggregated. No analyses conducted. | Posted | 1 year |
|
|
| Secondary | Daily Step Count Using Descriptive Statistics | Average daily step counts | Data was not collected/aggregated. No analyses conducted. | Posted | 1 year |
|
|
| 1 |
| 2 |
| 1 |
| 2 |
| 2 |
| 2 |
| EG001 | Standard Care | Subjects on either study arm with limited disease will receive SBRT to all evident sites of active disease.Subjects on Arm 2 with extensive disease are expected to receive some form of standard systemic therapy (e.g., docetaxel). Subjects on Arm 2 with limited disease may also receive standard systemic therapy following completion of SBRT to all sites of evident disease, at the discretion of the treating physicians. SBRT: For subjects on Arm 1, SBRT will be delivered concurrently with FLT3 ligand during Week 1 of study therapy. If only one lesion is being treated, SBRT should be completed during week 1 (e.g., with daily treatments for a 5-fraction course of treatments every other day for a 3-fraction course). In cases where multiple lesions are being treated with SBRT (Arm 1 or Arm 2) or if treatment is interrupted due to technical issues or intercurrent illness, SBRT may extend beyond Week 1. | 1 | 3 | 2 | 3 | 3 | 3 |
|
| Respiratory Failure | Respiratory, thoracic and mediastinal disorders | CTCAE (5.0) | Non-systematic Assessment | Hypoxic Respiratory Failure |
|
| Pelvic Pain | Reproductive system and breast disorders | CTCAE (5.0) | Non-systematic Assessment | Recurrent hip pain leading to hospitalization |
|
| Lung Infection | Infections and infestations | CTCAE (5.0) | Non-systematic Assessment | Pneumonia |
|
| Seizure | Nervous system disorders | CTCAE (5.0) | Non-systematic Assessment |
|
| Fall | Musculoskeletal and connective tissue disorders | CTCAE (5.0) | Non-systematic Assessment | Fall |
|
| Muscle weakness left-sided | Nervous system disorders | CTCAE (5.0) | Non-systematic Assessment | Muscle weakness left-sided |
|
| Dysarthria | Nervous system disorders | CTCAE (5.0) | Non-systematic Assessment | Dysarthria |
|
| Hyponatremia | Metabolism and nutrition disorders | CTCAE (5.0) | Non-systematic Assessment |
|
| Alkaline Phosphatase Increased | Investigations | CTCAE (5.0) | Non-systematic Assessment |
|
| Aspartate Aminotransferase Increased | Investigations | CTCAE (5.0) | Non-systematic Assessment |
|
| Alanine Aminotransferase Increased | Investigations | CTCAE (5.0) | Non-systematic Assessment |
|
| Hypocalcemia | Metabolism and nutrition disorders | CTCAE (5.0) | Non-systematic Assessment |
|
| Hypoalbuminemia | Metabolism and nutrition disorders | CTCAE (5.0) | Non-systematic Assessment |
|
| Alkaline Phosphatase Increased | Investigations | CTCAE (5.0) | Non-systematic Assessment | Alkaline Phosphatase Increased |
|
| Dyspnea/Shortness of Breath | Respiratory, thoracic and mediastinal disorders | CTCAE (5.0) | Non-systematic Assessment |
|
| Fatigue/Weakness | General disorders | CTCAE (5.0) | Non-systematic Assessment |
|
| Back Pain | Musculoskeletal and connective tissue disorders | CTCAE (5.0) | Non-systematic Assessment |
|
| Nausea | Gastrointestinal disorders | CTCAE (5.0) | Non-systematic Assessment |
|
| Creatinine Increased | Investigations | CTCAE (5.0) | Non-systematic Assessment |
|
| Hypercalcemia | Metabolism and nutrition disorders | CTCAE (5.0) | Non-systematic Assessment |
|
| Hypokalemia | Metabolism and nutrition disorders | CTCAE (5.0) | Non-systematic Assessment |
|
| Lymphocyte Count Decreased | Investigations | CTCAE (5.0) | Non-systematic Assessment |
|
| Hypoglycemia | Metabolism and nutrition disorders | CTCAE (5.0) | Non-systematic Assessment |
|
| Blood Bilirubin Increased | Investigations | CTCAE (5.0) | Non-systematic Assessment |
|
| Myalgia | Musculoskeletal and connective tissue disorders | CTCAE (5.0) | Non-systematic Assessment |
|
| GGT Increased | Investigations | CTCAE (5.0) | Non-systematic Assessment |
|
| Thrombocytopenia | Blood and lymphatic system disorders | CTCAE (5.0) | Non-systematic Assessment |
|
| Hypomagnesemia | Metabolism and nutrition disorders | CTCAE (5.0) | Non-systematic Assessment |
|
| Asthma | Respiratory, thoracic and mediastinal disorders | CTCAE (5.0) | Non-systematic Assessment |
|
| Brain metastases | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | CTCAE (5.0) | Non-systematic Assessment |
|
| Slurred speech | Nervous system disorders | CTCAE (5.0) | Non-systematic Assessment | Dysarthria |
|
| Left arm weakness | Musculoskeletal and connective tissue disorders | CTCAE (5.0) | Non-systematic Assessment | Upper limb weakness |
|
| Acute kidney injury | Renal and urinary disorders | CTCAE (5.0) | Non-systematic Assessment |
|
| Glucose intolerance | Metabolism and nutrition disorders | CTCAE (5.0) | Non-systematic Assessment |
|
| Hyperphosphatemia | Metabolism and nutrition disorders | CTCAE (5.0) | Non-systematic Assessment |
|
| Platelet count decreased | Investigations | CTCAE (5.0) | Non-systematic Assessment |
|
| Hypertriglyceridemia | Metabolism and nutrition disorders | CTCAE (5.0) | Non-systematic Assessment |
|
| Cough | Respiratory, thoracic and mediastinal disorders | CTCAE (5.0) | Non-systematic Assessment |
|
| Hyperglycemia | Metabolism and nutrition disorders | CTCAE (5.0) | Non-systematic Assessment |
|
| Dermatitis Radiation | Injury, poisoning and procedural complications | CTCAE (5.0) | Non-systematic Assessment |
|
| Insomnia | Psychiatric disorders | CTCAE (5.0) | Non-systematic Assessment |
|
| Hyperkalemia | Metabolism and nutrition disorders | CTCAE (5.0) | Non-systematic Assessment |
|
| Anorexia | Metabolism and nutrition disorders | CTCAE (5.0) | Non-systematic Assessment |
|
| Phlebitis | General disorders | CTCAE (5.0) | Non-systematic Assessment | Related to gemcitabine |
|
| Anxiety | Psychiatric disorders | CTCAE (5.0) | Non-systematic Assessment |
|
Not provided
Not provided
Not provided
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |