Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| IRB00127418 | Other Identifier | JHM IRB | |
| ESR-16-12244 | Other Identifier | AstraZeneca |
Not provided
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low accrual
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| Name | Class |
|---|---|
| AstraZeneca | INDUSTRY |
Not provided
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This is a pilot study of neoadjuvant 'immunoradiation' (durvalumab or durvalumab plus tremelimumab) administered every 4 weeks for 2 doses, concurrently with standard thoracic radiation (RT) (45Gy in 25 fractions), with one dose of immunotherapy alone delivered in the pre-surgical window, prior to surgical resection, for patients with stage IIIA NSCLC that is deemed resectable with a lobectomy by a thoracic surgeon. If preliminary safety of the durvalumab/thoracic RT combination is established, a second cohort investigating the combination of durvalumab/tremelimumab/thoracic RT prior to surgical resection will be opened. After surgical resection, patients may receive standard adjuvant chemotherapy, as deemed appropriate by the treating investigator.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Durvalumab with Radiation | Experimental | Drug: Durvalumab Other Names: MEDI4736 MEDI4736 1500mg via IV infusion every 4 weeks for up to 3 doses/cycles Intervention: Radiation: Thoracic Radiation 5 days per week in once daily fractionation, 1.8-2.0 Gy per fraction Intervention: Procedure/Surgery: lobectomy patients may proceed to surgery post drug and radiation intervention for lung lobectomy Intervention: Drug: Standard of care adjuvant chemotherapy patients may or may not proceed to adjuvant chemotherapy post trial drug and radiation intervention and surgery |
|
| Durvalumab and Trememlimumab with Radiation | Experimental | Drugs: Durvalumab + Tremelimumab Other Names: MEDI4736 and CP-675 MEDI4736 1500mg via IV infusion every 4 weeks for up to 3 doses/cycles + CP-675 206 75mg via IV infusion every 4 weeks up 3 doses/cycles Intervention: Radiation: Thoracic Radiation 5 days per week in once daily fractionation, 1.8-2.0 Gy per fraction Intervention: Procedure/Surgery: lobectomy patients may proceed to surgery post drug and radiation intervention for lung lobectomy Intervention: Drug: Standard of care adjuvant chemotherapy patients may or may not proceed to adjuvant chemotherapy post trial drug and radiation intervention and surgery |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Durvalumab | Drug | 1500mg via IV infusion every 4 weeks for up to 3 doses/cycles |
|
| Measure | Description | Time Frame |
|---|---|---|
| Toxicities as Measured by Number of Participants Experiencing Adverse Events | Number of participants experiencing adverse events as defined by CTCAE v4.0. | 3 months post surgery |
| Feasibility of Preoperative Immunoradiation | Number of participants with stage III resectable NSCLC who received durvalumab or durvalumab plus tremelimumab concurrently with thoracic radiation (RT) in the pre-surgical window prior to surgical resection, for whom planned surgical resection was not delayed. | Up to 3 years |
| Measure | Description | Time Frame |
|---|---|---|
| Surgical Morbidity and Mortality | Number of participants who experience post-operative death. Calculated through log-rank test and Cox proportional hazards (PH) model. The values in the table represent the number of participants who experienced post-operative death. | Up to 3 months post-surgery |
| Percentage of Participants With Pathologic Response |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Involvement in the planning and/or conduct of the study (includes AstraZeneca staff and staff at the study site)
Prior investigational therapy within 28 days/at least 5 half-lives before study drug administration
Prior chest radiation
Prior history of interstitial lung disease or pneumonitis requiring corticosteroids, or active non-infectious pneumonitis
Patients only suitable for surgical management with pneumonectomy, deemed by an attending thoracic surgeon
Prior therapy with PD-1, PD-L1, CTLA-4 or anti-cancer vaccines, including durvalumab and tremelimumab
Participation in another clinical study with an investigational product in the last 4 weeks or equivalent of 5 half-lives of the first dose of study treatment, whichever is shorter
History of another primary malignancy that requires active ongoing treatment or, in the opinion of the investigator, is likely to require treatment within 6 months of trial enrollment
Current or prior use of immunosuppressive medication within 14 days before the first dose of durvalumab or tremelimumab. The following are exceptions to this criterion:
Any unresolved toxicity (>CTCAE grade 2) from previous anti-cancer therapy
Subjects with irreversible toxicity that is not reasonably expected to be exacerbated by the investigational product may be included (e.g., hearing loss, peripherally neuropathy)
Any concurrent chemotherapy, IP, biologic, or hormonal therapy for cancer treatment. Concurrent use of hormonal therapy for non-cancer-related conditions (e.g., hormone replacement therapy) is acceptable
Radiotherapy treatment to more than 30% of the bone marrow or with a wide field of radiation within 4 weeks of the first dose of study drug.
Major surgical procedure (as defined by the Investigator) within 28 days prior to the first dose of IP. Note: Local surgery of isolated lesions for palliative intent is acceptable
History of allogenic organ transplantation.
Active or prior documented autoimmune or inflammatory disorders (including inflammatory bowel disease [e.g., colitis or Crohn's disease], diverticulitis [with the exception of diverticulosis], systemic lupus erythematosus, Sarcoidosis syndrome, or Wegener syndrome [granulomatosis with polyangiitis, Graves' disease, rheumatoid arthritis, hypophysitis, uveitis, etc]). The following are exceptions to this criterion (vitiligo or alopecia; hypothyroidism (eg, following Hashimoto syndrome) stable on hormone replacement; any chronic skin condition that does not require systemic therapy; active disease in the last 5 years may be included but only after consultation with the study physician; celiac disease controlled by diet alone.)
Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, uncontrolled hypertension, unstable angina pectoris, cardiac arrhythmia, active peptic ulcer disease or gastritis, active bleeding diatheses including any subject known to have evidence of acute or chronic hepatitis B, hepatitis C or human immunodeficiency virus (HIV), or psychiatric illness/social situations that would limit compliance with study requirements or compromise the ability of the subject to give written informed consent
Active infection including tuberculosis (clinical evaluation that includes clinical history, physical examination and radiographic findings, and TB testing in line with local practice), hepatitis B (known positive HBV surface antigen (HBsAg) result), hepatitis C, or human immunodeficiency virus (positive HIV 1/2 antibodies). Subjects with a past or resolved HBV infection (defined as the presence of hepatitis B core antibody [anti-HBc] and absence of HBsAg) are eligible. Subjects positive for hepatitis C (HCV) antibody are eligible only if polymerase chain reaction is negative for HCV RNA.
Receipt of live attenuated vaccination within 30 days prior to study entry or within 30 days of receiving durvalumab or tremelimumab
Female subjects who are pregnant, breast-feeding or male or female patients of reproductive potential who are not employing an effective method of birth control.
Any condition that, in the opinion of the investigator, would interfere with evaluation of study treatment or interpretation of patient safety or study result.
Known allergy or hypersensitivity to IP or any excipient
Uncontrolled psychiatric illness/social situations that would limit compliance with study requirements or compromise the ability of the subject to give written consent
Any condition that, in the opinion of the investigator would interfere with evaluation of study treatment or interpretation of patient safety or study results.
Not provided
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| Name | Affiliation | Role |
|---|---|---|
| Patrick Forde, MD | Johns Hopkins University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Johns Hopkins Bayview Medical Center | Baltimore | Maryland | 21224 | United States | ||
| Princess Margaret Cancer Centre |
The study was terminated due to low accrual on Arm A (Durvalumab with Radiation) so no participants were assigned to Arm B (Durvalumab and Trememlimumab with Radiation).
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Durvalumab With Radiation | Drug: Durvalumab Other Names: MEDI4736 MEDI4736 1500mg via IV infusion every 4 weeks for up to 3 doses/cycles Intervention: Radiation: Thoracic Radiation 5 days per week in once daily fractionation, 1.8-2.0 Gy per fraction Intervention: Procedure/Surgery: lobectomy patients may proceed to surgery post drug and radiation intervention for lung lobectomy Intervention: Drug: Standard of care adjuvant chemotherapy patients may or may not proceed to adjuvant chemotherapy post trial drug and radiation intervention and surgery Durvalumab: 1500mg via IV infusion every 4 weeks for up to 3 doses/cycles Thoracic Radiation: 5 days per week in once daily fractionation, 1.8-2.0 Gy per fraction lobectomy: patients may proceed to surgery post drug and radiation intervention for lung lobectomy Standard of care adjuvant chemotherapy: patients may or may not proceed to adjuvant chemotherapy post trial drug and radiation intervention and surgery |
| FG001 | Durvalumab and Trememlimumab With Radiation | Drugs: Durvalumab + Tremelimumab Other Names: MEDI4736 and CP-675 MEDI4736 1500mg via IV infusion every 4 weeks for up to 3 doses/cycles + CP-675 206 75mg via IV infusion every 4 weeks up 3 doses/cycles Intervention: Radiation: Thoracic Radiation 5 days per week in once daily fractionation, 1.8-2.0 Gy per fraction Intervention: Procedure/Surgery: lobectomy patients may proceed to surgery post drug and radiation intervention for lung lobectomy Intervention: Drug: Standard of care adjuvant chemotherapy patients may or may not proceed to adjuvant chemotherapy post trial drug and radiation intervention and surgery Durvalumab: 1500mg via IV infusion every 4 weeks for up to 3 doses/cycles Tremelimumab: 75mg via IV infusion every 4 weeks Thoracic Radiation: 5 days per week in once daily fractionation, 1.8-2.0 Gy per fraction lobectomy: patients may proceed to surgery post drug and radiation intervention for lung lobectomy Standard of care adjuvant chemotherapy: patients may or may not proceed to adjuvant chemotherapy post trial drug and radiation intervention and surgery |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
The protocol planned for a second cohort for patients to be treated with durvalumab and trememlimumab with radiation, however, due to low accrual in cohort 1, there was no second cohort.
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Durvalumab With Radiation | Drug: Durvalumab Other Names: MEDI4736 MEDI4736 1500mg via IV infusion every 4 weeks for up to 3 doses/cycles Intervention: Radiation: Thoracic Radiation 5 days per week in once daily fractionation, 1.8-2.0 Gy per fraction Intervention: Procedure/Surgery: lobectomy patients may proceed to surgery post drug and radiation intervention for lung lobectomy Intervention: Drug: Standard of care adjuvant chemotherapy patients may or may not proceed to adjuvant chemotherapy post trial drug and radiation intervention and surgery Durvalumab: 1500mg via IV infusion every 4 weeks for up to 3 doses/cycles Thoracic Radiation: 5 days per week in once daily fractionation, 1.8-2.0 Gy per fraction lobectomy: patients may proceed to surgery post drug and radiation intervention for lung lobectomy Standard of care adjuvant chemotherapy: patients may or may not proceed to adjuvant chemotherapy post trial drug and radiation intervention and surgery |
| 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 | Toxicities as Measured by Number of Participants Experiencing Adverse Events | Number of participants experiencing adverse events as defined by CTCAE v4.0. | all participants who were assigned to the durvalumab with radiation arm | Posted | Count of Participants | Participants | 3 months post surgery |
|
Adverse events were assessed post-surgery, up to 3 months. Deaths were assessed for approximately 5 years.
The number of participants at risk for SAEs, AEs, and all-cause mortality is zero for the Durvalumab and Trememlimumab With Radiation arm because the study was terminated and there were no patients enrolled onto arm B, and no data was collected.
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Durvalumab With Radiation | Drug: Durvalumab Other Names: MEDI4736 MEDI4736 1500mg via IV infusion every 4 weeks for up to 3 doses/cycles Intervention: Radiation: Thoracic Radiation 5 days per week in once daily fractionation, 1.8-2.0 Gy per fraction Intervention: Procedure/Surgery: lobectomy patients may proceed to surgery post drug and radiation intervention for lung lobectomy Intervention: Drug: Standard of care adjuvant chemotherapy patients may or may not proceed to adjuvant chemotherapy post trial drug and radiation intervention and surgery Durvalumab: 1500mg via IV infusion every 4 weeks for up to 3 doses/cycles Thoracic Radiation: 5 days per week in once daily fractionation, 1.8-2.0 Gy per fraction lobectomy: patients may proceed to surgery post drug and radiation intervention for lung lobectomy Standard of care adjuvant chemotherapy: patients may or may not proceed to adjuvant chemotherapy post trial drug and radiation intervention and surgery |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| aspiration pneumonia | Respiratory, thoracic and mediastinal disorders | CTCAE (4.0) | Non-systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| fatigue | General disorders | CTCAE (4.0) | Non-systematic Assessment |
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Jasmine Brooks, Senior Research Program Coordinator | Johns Hopkins SKCCC CRO Coordinating Center | 667-306-8335 | jbrook54@jhmi.edu |
Not provided
| 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 | Mar 2, 2022 | May 26, 2023 | Prot_SAP_000.pdf |
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D002289 | Carcinoma, Non-Small-Cell Lung |
| ID | Term |
|---|---|
| D002283 | Carcinoma, Bronchogenic |
| D001984 | Bronchial Neoplasms |
| D008175 | Lung Neoplasms |
| D012142 | Respiratory Tract Neoplasms |
Not provided
Not provided
| ID | Term |
|---|---|
| C000613593 | durvalumab |
| C520704 | tremelimumab |
| D038481 | Anterior Temporal Lobectomy |
| ID | Term |
|---|---|
| D013514 | Surgical Procedures, Operative |
| D019635 | Neurosurgical Procedures |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
|
| Tremelimumab | Drug | 75mg via IV infusion every 4 weeks |
|
|
| Thoracic Radiation | Radiation | 5 days per week in once daily fractionation, 1.8-2.0 Gy per fraction |
|
| lobectomy | Procedure | patients may proceed to surgery post drug and radiation intervention for lung lobectomy |
|
| Standard of care adjuvant chemotherapy | Drug | patients may or may not proceed to adjuvant chemotherapy post trial drug and radiation intervention and surgery |
|
Percentage of participants with major pathologic response (MPR), partial response (PR) or no response (NR), where MPR is >90% reduction in tumor cells, PR = 10-90% or NR = 0-10%. The percentage of patients whose tumor samples achieve MPR, PR and NR will be tabulated. |
| Up to 3 years |
| Percentage of Participants With Radiologic Response | Percentage of participants with complete response (CR), partial response (PR), progressive disease (PD), and stable disease (SD) as defined by RECIST 1.1 and immune-related RECIST criteria when treated with preoperative immunoradiation followed by surgery. CR = disappearance of all target lesions, PR is =>30% decrease in sum of diameters of target lesions, PD is >20% increase in sum of diameters of target lesions, SD is <30% decrease or <20% increase in sum of diameters of target lesions. | Up to 3 years |
| Overall Survival | Number of months alive after treatment with preoperative immunoradiation followed by surgery. Calculated through log-rank test and Cox proportional hazards (PH) model. | Approximately 5 years |
| Toronto |
| Ontario |
| Canada |
| BG001 | Durvalumab and Trememlimumab With Radiation | Drugs: Durvalumab + Tremelimumab Other Names: MEDI4736 and CP-675 MEDI4736 1500mg via IV infusion every 4 weeks for up to 3 doses/cycles + CP-675 206 75mg via IV infusion every 4 weeks up 3 doses/cycles Intervention: Radiation: Thoracic Radiation 5 days per week in once daily fractionation, 1.8-2.0 Gy per fraction Intervention: Procedure/Surgery: lobectomy patients may proceed to surgery post drug and radiation intervention for lung lobectomy Intervention: Drug: Standard of care adjuvant chemotherapy patients may or may not proceed to adjuvant chemotherapy post trial drug and radiation intervention and surgery Durvalumab: 1500mg via IV infusion every 4 weeks for up to 3 doses/cycles Tremelimumab: 75mg via IV infusion every 4 weeks Thoracic Radiation: 5 days per week in once daily fractionation, 1.8-2.0 Gy per fraction lobectomy: patients may proceed to surgery post drug and radiation intervention for lung lobectomy Standard of care adjuvant chemotherapy: patients may or may not proceed to adjuvant chemotherapy post trial drug and radiation intervention and surgery |
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Mean | Full Range | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Count of Participants | Participants |
|
| Region of Enrollment | Count of Participants | Participants |
|
| OG001 | Durvalumab and Trememlimumab With Radiation | Drugs: Durvalumab + Tremelimumab Other Names: MEDI4736 and CP-675 MEDI4736 1500mg via IV infusion every 4 weeks for up to 3 doses/cycles + CP-675 206 75mg via IV infusion every 4 weeks up 3 doses/cycles Intervention: Radiation: Thoracic Radiation 5 days per week in once daily fractionation, 1.8-2.0 Gy per fraction Intervention: Procedure/Surgery: lobectomy patients may proceed to surgery post drug and radiation intervention for lung lobectomy Intervention: Drug: Standard of care adjuvant chemotherapy patients may or may not proceed to adjuvant chemotherapy post trial drug and radiation intervention and surgery Durvalumab: 1500mg via IV infusion every 4 weeks for up to 3 doses/cycles Tremelimumab: 75mg via IV infusion every 4 weeks Thoracic Radiation: 5 days per week in once daily fractionation, 1.8-2.0 Gy per fraction lobectomy: patients may proceed to surgery post drug and radiation intervention for lung lobectomy Standard of care adjuvant chemotherapy: patients may or may not proceed to adjuvant chemotherapy post trial drug and radiation intervention and surgery |
|
|
| Primary | Feasibility of Preoperative Immunoradiation | Number of participants with stage III resectable NSCLC who received durvalumab or durvalumab plus tremelimumab concurrently with thoracic radiation (RT) in the pre-surgical window prior to surgical resection, for whom planned surgical resection was not delayed. | The study closed early due to low accrual on Arm A Durvalumab with Radiation so no data was collected for Arm B Durvalumab and Trememlimumab with Radiation. | Posted | Count of Participants | Participants | Up to 3 years |
|
|
|
| Secondary | Surgical Morbidity and Mortality | Number of participants who experience post-operative death. Calculated through log-rank test and Cox proportional hazards (PH) model. The values in the table represent the number of participants who experienced post-operative death. | The study closed to enrollment before patients could be enrolled onto Arm B: durvalumab and trememlimumab with radiation | Posted | Count of Participants | Participants | Up to 3 months post-surgery |
|
|
|
| Secondary | Percentage of Participants With Pathologic Response | Percentage of participants with major pathologic response (MPR), partial response (PR) or no response (NR), where MPR is >90% reduction in tumor cells, PR = 10-90% or NR = 0-10%. The percentage of patients whose tumor samples achieve MPR, PR and NR will be tabulated. | The study closed to enrollment before patients could be enrolled onto Arm B: durvalumab and trememlimumab with radiation | Posted | Count of Participants | Participants | Up to 3 years |
|
|
|
| Secondary | Percentage of Participants With Radiologic Response | Percentage of participants with complete response (CR), partial response (PR), progressive disease (PD), and stable disease (SD) as defined by RECIST 1.1 and immune-related RECIST criteria when treated with preoperative immunoradiation followed by surgery. CR = disappearance of all target lesions, PR is =>30% decrease in sum of diameters of target lesions, PD is >20% increase in sum of diameters of target lesions, SD is <30% decrease or <20% increase in sum of diameters of target lesions. | The study closed to enrollment before patients could be enrolled onto Arm B: durvalumab and trememlimumab with radiation | Posted | Count of Participants | Participants | Up to 3 years |
|
|
|
| Secondary | Overall Survival | Number of months alive after treatment with preoperative immunoradiation followed by surgery. Calculated through log-rank test and Cox proportional hazards (PH) model. | The study closed to enrollment before patients could be enrolled onto Arm B: durvalumab and trememlimumab with radiation | Posted | Median | 95% Confidence Interval | months | Approximately 5 years |
|
|
|
| 2 |
| 9 |
| 3 |
| 9 |
| 9 |
| 9 |
| EG001 | Durvalumab and Trememlimumab With Radiation | Drugs: Durvalumab + Tremelimumab Other Names: MEDI4736 and CP-675 MEDI4736 1500mg via IV infusion every 4 weeks for up to 3 doses/cycles + CP-675 206 75mg via IV infusion every 4 weeks up 3 doses/cycles Intervention: Radiation: Thoracic Radiation 5 days per week in once daily fractionation, 1.8-2.0 Gy per fraction Intervention: Procedure/Surgery: lobectomy patients may proceed to surgery post drug and radiation intervention for lung lobectomy Intervention: Drug: Standard of care adjuvant chemotherapy patients may or may not proceed to adjuvant chemotherapy post trial drug and radiation intervention and surgery Durvalumab: 1500mg via IV infusion every 4 weeks for up to 3 doses/cycles Tremelimumab: 75mg via IV infusion every 4 weeks Thoracic Radiation: 5 days per week in once daily fractionation, 1.8-2.0 Gy per fraction lobectomy: patients may proceed to surgery post drug and radiation intervention for lung lobectomy Standard of care adjuvant chemotherapy: patients may or may not proceed to adjuvant chemotherapy post trial drug and radiation intervention and surgery | 0 | 0 | 0 | 0 | 0 | 0 |
| thromboembolic event | Vascular disorders | CTCAE (4.0) | Non-systematic Assessment | pulmonary embolism |
|
| appendicitis | Infections and infestations | CTCAE (4.0) | Non-systematic Assessment |
|
| pneumothorax | Respiratory, thoracic and mediastinal disorders | CTCAE (4.0) | Non-systematic Assessment |
|
| atrial fibrillation | Cardiac disorders | CTCAE (4.0) | Non-systematic Assessment |
|
| aspiration | Respiratory, thoracic and mediastinal disorders | CTCAE (4.0) | Non-systematic Assessment |
|
| pleural effusion | Respiratory, thoracic and mediastinal disorders | CTCAE (4.0) | Non-systematic Assessment |
|
| dry skin | Skin and subcutaneous tissue disorders | CTCAE (4.0) | Non-systematic Assessment |
|
| pruritus | Skin and subcutaneous tissue disorders | CTCAE (4.0) | Non-systematic Assessment |
|
| sore throat | Respiratory, thoracic and mediastinal disorders | CTCAE (4.0) | Non-systematic Assessment |
|
| pain of skin | Skin and subcutaneous tissue disorders | CTCAE (4.0) | Non-systematic Assessment |
|
| esophageal pain | Gastrointestinal disorders | CTCAE (4.0) | Non-systematic Assessment |
|
| superficial thrombophlebitis | Vascular disorders | CTCAE (4.0) | Non-systematic Assessment |
|
| chest wall pain | Musculoskeletal and connective tissue disorders | CTCAE (4.0) | Non-systematic Assessment |
|
| dyspnea | Respiratory, thoracic and mediastinal disorders | CTCAE (4.0) | Non-systematic Assessment |
|
| cough | Respiratory, thoracic and mediastinal disorders | CTCAE (4.0) | Non-systematic Assessment |
|
| urinary urgency | Renal and urinary disorders | CTCAE (4.0) | Non-systematic Assessment |
|
| toothache | Gastrointestinal disorders | CTCAE (4.0) | Non-systematic Assessment |
|
| facial pain | General disorders | CTCAE (4.0) | Non-systematic Assessment |
|
| peripheral sensory neuropathy | Nervous system disorders | CTCAE (4.0) | Non-systematic Assessment |
|
| bone pain | Musculoskeletal and connective tissue disorders | CTCAE (4.0) | Non-systematic Assessment |
|
| back pain | Musculoskeletal and connective tissue disorders | CTCAE (4.0) | Non-systematic Assessment |
|
| diarrhea | Gastrointestinal disorders | CTCAE (4.0) | Non-systematic Assessment |
|
| neutrophil count decreased | Investigations | CTCAE (4.0) | Non-systematic Assessment |
|
| acute kidney injury | Renal and urinary disorders | CTCAE (4.0) | Non-systematic Assessment |
|
| thrombophelbitis | Vascular disorders | CTCAE (4.0) | Non-systematic Assessment |
|
| rash maculo-papular | Skin and subcutaneous tissue disorders | CTCAE (4.0) | Non-systematic Assessment |
|
| nausea | Gastrointestinal disorders | CTCAE (4.0) | Non-systematic Assessment |
|
| constipation | Gastrointestinal disorders | CTCAE (4.0) | Non-systematic Assessment |
|
| fever | General disorders | CTCAE (4.0) | Non-systematic Assessment |
|
| chills | General disorders | CTCAE (4.0) | Non-systematic Assessment |
|
| myalgia | Musculoskeletal and connective tissue disorders | CTCAE (4.0) | Non-systematic Assessment |
|
| violaceus raticular rash - upper forearm | Skin and subcutaneous tissue disorders | CTCAE (4.0) | Non-systematic Assessment |
|
| erythematous rash - thighs and knees | Skin and subcutaneous tissue disorders | CTCAE (4.0) | Non-systematic Assessment |
|
| anterior chest rash | Skin and subcutaneous tissue disorders | CTCAE (4.0) | Non-systematic Assessment |
|
| arthralgia | Musculoskeletal and connective tissue disorders | CTCAE (4.0) | Non-systematic Assessment |
|
| polyarthritis | Musculoskeletal and connective tissue disorders | CTCAE (4.0) | Non-systematic Assessment |
|
| joint pain | Musculoskeletal and connective tissue disorders | CTCAE (4.0) | Non-systematic Assessment |
|
| sinus disorder - sinus drainage | Respiratory, thoracic and mediastinal disorders | CTCAE (4.0) | Non-systematic Assessment |
|
| productive cough | Respiratory, thoracic and mediastinal disorders | CTCAE (4.0) | Non-systematic Assessment |
|
| vomiting | Gastrointestinal disorders | CTCAE (4.0) | Non-systematic Assessment |
|
| orange-colored skin | Skin and subcutaneous tissue disorders | CTCAE (4.0) | Non-systematic Assessment |
|
| pain at thoracotomy | Respiratory, thoracic and mediastinal disorders | CTCAE (4.0) | Non-systematic Assessment |
|
| hypokalemia | Metabolism and nutrition disorders | CTCAE (4.0) | Non-systematic Assessment |
|
| hypertension | Vascular disorders | CTCAE (4.0) | Non-systematic Assessment |
|
| hypotension | Vascular disorders | CTCAE (4.0) | Non-systematic Assessment |
|
| serum amylase increased | Investigations | CTCAE (4.0) | Non-systematic Assessment |
|
| white blood cell decreased | Investigations | CTCAE (4.0) | Non-systematic Assessment |
|
| allergic rhinitis | Respiratory, thoracic and mediastinal disorders | CTCAE (4.0) | Non-systematic Assessment |
|
| rash acneiform | Skin and subcutaneous tissue disorders | CTCAE (4.0) | Non-systematic Assessment |
|
| dizziness | Nervous system disorders | CTCAE (4.0) | Non-systematic Assessment |
|
Not provided
Not provided
| D013899 |
| Thoracic Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |