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| ID | Type | Description | Link |
|---|---|---|---|
| H8K-MC-JZAC | Other Identifier | Eli Lilly and Company |
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The primary objective is to estimate the time to progressive disease for patients who receive LY573636-sodium (hereafter referred to as LY573636) after two previous treatments for metastatic non-small cell lung cancer. Patients will receive an intravenous infusion of study drug once every 21 days. Computed tomography (CT)-scans will be done before the first dose and then after every other treatment.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| LY573636 | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| LY573636-sodium | Drug | A loading dose to target 420 micrograms/milliliter (µg/mL) maximum concentration (Cmax) or 380 µg/mL Cmax followed by a lower chronic dose to maintain Cmax within these target ranges, intravenous, every 21 days until disease progression. |
| Measure | Description | Time Frame |
|---|---|---|
| Time to Progression | Defined as the time from date of first dose to the first observation of progression of disease (PD) or death from study disease. PD was determined using the Response Evaluation Criteria In Solid Tumors (RECIST) criteria (version 1.0). PD is ≥20% increase in sum of longest diameter of target lesions and/or a new lesion. | First dose to measured progressive disease or death from study disease up to 10.35 months |
| Measure | Description | Time Frame |
|---|---|---|
| Progression-Free Survival | Defined as the time from date of first dose to the first observation of progression of disease (PD) or death due to any cause. PD was determined using the Response Evaluation Criteria In Solid Tumors (RECIST) criteria (version 1.0). PD is ≥20% increase in sum of longest diameter of target lesions and/or a new lesion. | First treatment dose to measured progressive disease or death from any cause up to 10.35 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST) | Eli Lilly and Company | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | Gauting | D-82131 |
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| ID | Title | Description |
|---|---|---|
| FG000 | LY573636 Target Cmax 420 µg/mL | A loading dose of LY573636 to target 420 micrograms/milliliter (µg/mL) maximum concentration (Cmax) followed by a lower chronic dose to maintain Cmax within this target range, intravenous, every 21 days until disease progression. |
| FG001 | LY573636 Target Cmax 380 µg/mL | A loading dose of LY573636 to target 380 µg/mL Cmax followed by a lower chronic dose to maintain Cmax within this target range, intravenous, every 21 days until disease progression. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | LY573636 Target Cmax 420 µg/mL | A loading dose of LY573636 to target 420 micrograms/milliliter (µg/mL) maximum concentration (Cmax) followed by a lower chronic dose to maintain Cmax within this target range, intravenous, every 21 days until disease progression. |
| BG001 | LY573636 Target Cmax 380 µg/mL |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| 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 | Time to Progression | Defined as the time from date of first dose to the first observation of progression of disease (PD) or death from study disease. PD was determined using the Response Evaluation Criteria In Solid Tumors (RECIST) criteria (version 1.0). PD is ≥20% increase in sum of longest diameter of target lesions and/or a new lesion. | All enrolled participants who received at least 1 dose of study drug. | Posted | Median | 90% Confidence Interval | months | First dose to measured progressive disease or death from study disease up to 10.35 months |
|
Not provided
Not provided
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 | LY573636 Target Cmax 420 µg/mL | A loading dose of LY573636 to target 420 micrograms/milliliter (µg/mL) maximum concentration (Cmax) followed by a lower chronic dose to maintain Cmax within this target range, intravenous, every 21 days until disease progression. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | MedDRA 10.0 | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | MedDRA 10.0 | Systematic Assessment |
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Chief Medical Officer | Eli Lilly and Company | 800-545-5979 |
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 |
|---|---|
| C534068 | N-((5-bromo-2-thienyl)sulfonyl)-2,4-dichlorobenzamide |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
|
| Percentage of Participants With Complete Response or Partial Response (Objective Response Rate) | Objective response rate is the percentage of participants with complete response (CR) + partial response (PR), as assessed according to the Response Evaluation Criteria In Solid Tumors (RECIST) guidelines (version 1.0). CR is disappearance of all target and non-target lesions; PR is ≥30% decrease in sum of longest diameter of target lesions. Objective response rate is calculated as a total number of participants with CR or PR divided by the total number of participants treated multiplied by 100. | First treatment dose to measured progressive disease or death due to any cause up to 10.35 months |
| Pharmacokinetics: Maximum Concentration (Cmax) of LY573636 | Predose up to 2 hours postdose in Cycles 1 and 2 (21 days cycle) |
| Overall Survival Time | Defined as the time from date of first dose to the date of death due to any cause. | First treatment dose to death due to any cause up to 25.23 months |
| Duration of Response | The duration of a complete response (CR) or partial response (PR) was defined as the time from first objective status assessment of CR or PR to the first time of progression of disease or death due to any cause. CR or PR is classified according to the Response Evaluation Criteria In Solid Tumors (RECIST) guidelines (version 1.0). CR is disappearance of all target and non-target lesions; PR is ≥30% decrease in sum of longest diameter of target lesions. | Time of response to progressive disease or death up to 10.35 months |
| Duration of Stable Disease | Duration of stable disease (SD) is defined from date of documented SD or better to first date of progression of disease (PD) (assessed every cycle during study therapy, or every 2 months during post-therapy until PD). SD is neither sufficient shrinkage to qualify for partial response (PR) nor sufficient increase to qualify for PD. PR is ≥30% decrease in sum of longest diameter of target lesions. PD is ≥20% increase in sum of longest diameter of target lesions and/or a new lesion. | Time from documented stable disease or better to first date of progressive disease up to 10.35 months |
| Number of Participants With Adverse Events (Safety) | Data are presented as number of participants who experienced serious adverse events or all other nonserious adverse events during the study. A summary of serious adverse events and other nonserious adverse events is located in the Reported Adverse Event section. | First treatment dose up to 25.23 months |
| Germany |
| For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | Großhansdorf | D-22927 | Germany |
| For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | Hamburg | D-21075 | Germany |
| For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | Löwenstein | 74245 | Germany |
| For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | Mannheim | 68167 | Germany |
| For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | Orbassano | 10043 | Italy |
| For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | San Sisto | 06156 | Italy |
| Disease Related Death |
|
| Not Disease Related Death |
|
| Withdrawal by Subject |
|
| Physician Decision |
|
A loading dose of LY573636 to target 380 µg/mL Cmax followed by a lower chronic dose to maintain Cmax within this target range, intravenous, every 21 days until disease progression. |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Count of Participants | Participants |
|
| Region of Enrollment | Count of Participants | Participants |
|
| Pathological Diagnosis | Count of Participants | Participants | No |
|
| OG001 | LY573636 Target Cmax 380 µg/mL | A loading dose of LY573636 to target 380 µg/mL Cmax followed by a lower chronic dose to maintain Cmax within this target range, intravenous, every 21 days until disease progression. |
|
|
| Secondary | Progression-Free Survival | Defined as the time from date of first dose to the first observation of progression of disease (PD) or death due to any cause. PD was determined using the Response Evaluation Criteria In Solid Tumors (RECIST) criteria (version 1.0). PD is ≥20% increase in sum of longest diameter of target lesions and/or a new lesion. | All enrolled participants who received at least 1 dose of study drug. | Posted | Median | 90% Confidence Interval | months | First treatment dose to measured progressive disease or death from any cause up to 10.35 months |
|
|
|
| Secondary | Percentage of Participants With Complete Response or Partial Response (Objective Response Rate) | Objective response rate is the percentage of participants with complete response (CR) + partial response (PR), as assessed according to the Response Evaluation Criteria In Solid Tumors (RECIST) guidelines (version 1.0). CR is disappearance of all target and non-target lesions; PR is ≥30% decrease in sum of longest diameter of target lesions. Objective response rate is calculated as a total number of participants with CR or PR divided by the total number of participants treated multiplied by 100. | All enrolled participants who received at least 1 dose of study drug. | Posted | Number | percentage of participants | First treatment dose to measured progressive disease or death due to any cause up to 10.35 months |
|
|
|
| Secondary | Pharmacokinetics: Maximum Concentration (Cmax) of LY573636 | Participants who received study drug and had pharmacokinetic (PK) data at the specified time points. | Posted | Geometric Mean | Geometric Coefficient of Variation | micrograms/milliliter (µg/mL) | Predose up to 2 hours postdose in Cycles 1 and 2 (21 days cycle) |
|
|
|
| Secondary | Overall Survival Time | Defined as the time from date of first dose to the date of death due to any cause. | All enrolled participants who received at least 1 dose of study drug. | Posted | Median | 90% Confidence Interval | months | First treatment dose to death due to any cause up to 25.23 months |
|
|
|
| Secondary | Duration of Response | The duration of a complete response (CR) or partial response (PR) was defined as the time from first objective status assessment of CR or PR to the first time of progression of disease or death due to any cause. CR or PR is classified according to the Response Evaluation Criteria In Solid Tumors (RECIST) guidelines (version 1.0). CR is disappearance of all target and non-target lesions; PR is ≥30% decrease in sum of longest diameter of target lesions. | Since there were zero participants with CR or PR, the duration of response could not be analyzed. | Posted | Time of response to progressive disease or death up to 10.35 months |
|
|
| Secondary | Duration of Stable Disease | Duration of stable disease (SD) is defined from date of documented SD or better to first date of progression of disease (PD) (assessed every cycle during study therapy, or every 2 months during post-therapy until PD). SD is neither sufficient shrinkage to qualify for partial response (PR) nor sufficient increase to qualify for PD. PR is ≥30% decrease in sum of longest diameter of target lesions. PD is ≥20% increase in sum of longest diameter of target lesions and/or a new lesion. | All enrolled participants who received at least 1 dose of study drug and had a best overall response of stable disease or better. | Posted | Median | 90% Confidence Interval | months | Time from documented stable disease or better to first date of progressive disease up to 10.35 months |
|
|
|
| Secondary | Number of Participants With Adverse Events (Safety) | Data are presented as number of participants who experienced serious adverse events or all other nonserious adverse events during the study. A summary of serious adverse events and other nonserious adverse events is located in the Reported Adverse Event section. | All enrolled participants who received at least 1 dose of study drug. | Posted | Count of Participants | Participants | No | First treatment dose up to 25.23 months |
|
|
|
| 17 |
| 32 |
| 30 |
| 32 |
| EG001 | LY573636 Target Cmax 380 µg/mL | A loading dose of LY573636 to target 380 µg/mL Cmax followed by a lower chronic dose to maintain Cmax within this target range, intravenous, every 21 days until disease progression. | 9 | 20 | 17 | 20 |
| Febrile Neutropenia | Blood and lymphatic system disorders | MedDRA 10.0 | Systematic Assessment |
|
| Leukopenia | Blood and lymphatic system disorders | MedDRA 10.0 | Systematic Assessment |
|
| Neutropenia | Blood and lymphatic system disorders | MedDRA 10.0 | Systematic Assessment |
|
| Thrombocytopenia | Blood and lymphatic system disorders | MedDRA 10.0 | Systematic Assessment |
|
| Angina Unstable | Cardiac disorders | MedDRA 10.0 | Systematic Assessment |
|
| Atrial Fibrillation | Cardiac disorders | MedDRA 10.0 | Systematic Assessment |
|
| Cardiac Arrest | Cardiac disorders | MedDRA 10.0 | Systematic Assessment |
|
| Cardiac Failure | Cardiac disorders | MedDRA 10.0 | Systematic Assessment |
|
| Myocardial Infarction | Cardiac disorders | MedDRA 10.0 | Systematic Assessment |
|
| Constipation | Gastrointestinal disorders | MedDRA 10.0 | Systematic Assessment |
|
| Gastrointestinal Toxicity | Gastrointestinal disorders | MedDRA 10.0 | Systematic Assessment |
|
| Nausea | Gastrointestinal disorders | MedDRA 10.0 | Systematic Assessment |
|
| Condition Aggravated | General disorders | MedDRA 10.0 | Systematic Assessment |
|
| Multi-Organ Failure | General disorders | MedDRA 10.0 | Systematic Assessment |
|
| Pyrexia | General disorders | MedDRA 10.0 | Systematic Assessment |
|
| Cholangitis | Hepatobiliary disorders | MedDRA 10.0 | Systematic Assessment |
|
| Cholestasis | Hepatobiliary disorders | MedDRA 10.0 | Systematic Assessment |
|
| Jaundice | Hepatobiliary disorders | MedDRA 10.0 | Systematic Assessment |
|
| Bronchitis Bacterial | Infections and infestations | MedDRA 10.0 | Systematic Assessment |
|
| Bronchopneumonia | Infections and infestations | MedDRA 10.0 | Systematic Assessment |
|
| Gastroenteritis Viral | Infections and infestations | MedDRA 10.0 | Systematic Assessment |
|
| Infection | Infections and infestations | MedDRA 10.0 | Systematic Assessment |
|
| Lung Infection | Infections and infestations | MedDRA 10.0 | Systematic Assessment |
|
| Pneumonia | Infections and infestations | MedDRA 10.0 | Systematic Assessment |
|
| Hip Fracture | Injury, poisoning and procedural complications | MedDRA 10.0 | Systematic Assessment |
|
| Radiation Pneumonitis | Injury, poisoning and procedural complications | MedDRA 10.0 | Systematic Assessment |
|
| Neutrophil Count Decreased | Investigations | MedDRA 10.0 | Systematic Assessment |
|
| Platelet Count Decreased | Investigations | MedDRA 10.0 | Systematic Assessment |
|
| Dehydration | Metabolism and nutrition disorders | MedDRA 10.0 | Systematic Assessment |
|
| Transient Ischaemic Attack | Nervous system disorders | MedDRA 10.0 | Systematic Assessment |
|
| Renal Failure Acute | Renal and urinary disorders | MedDRA 10.0 | Systematic Assessment |
|
| Acute Pulmonary Oedema | Respiratory, thoracic and mediastinal disorders | MedDRA 10.0 | Systematic Assessment |
|
| Alveolitis | Respiratory, thoracic and mediastinal disorders | MedDRA 10.0 | Systematic Assessment |
|
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA 10.0 | Systematic Assessment |
|
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA 10.0 | Systematic Assessment |
|
| Haemoptysis | Respiratory, thoracic and mediastinal disorders | MedDRA 10.0 | Systematic Assessment |
|
| Pleural Effusion | Respiratory, thoracic and mediastinal disorders | MedDRA 10.0 | Systematic Assessment |
|
| Pulmonary Oedema | Respiratory, thoracic and mediastinal disorders | MedDRA 10.0 | Systematic Assessment |
|
| Respiratory Failure | Respiratory, thoracic and mediastinal disorders | MedDRA 10.0 | Systematic Assessment |
|
| Circulatory Collapse | Vascular disorders | MedDRA 10.0 | Systematic Assessment |
|
| Hypertension | Vascular disorders | MedDRA 10.0 | Systematic Assessment |
|
| Hypertensive Crisis | Vascular disorders | MedDRA 10.0 | Systematic Assessment |
|
| Hypovolaemic Shock | Vascular disorders | MedDRA 10.0 | Systematic Assessment |
|
| Superior Vena Caval Occlusion | Vascular disorders | MedDRA 10.0 | Systematic Assessment |
|
| Leukopenia | Blood and lymphatic system disorders | MedDRA 10.0 | Systematic Assessment |
|
| Neutropenia | Blood and lymphatic system disorders | MedDRA 10.0 | Systematic Assessment |
|
| Thrombocytopenia | Blood and lymphatic system disorders | MedDRA 10.0 | Systematic Assessment |
|
| Myocardial Infarction | Cardiac disorders | MedDRA 10.0 | Systematic Assessment |
|
| Pericardial Effusion | Cardiac disorders | MedDRA 10.0 | Systematic Assessment |
|
| Vertigo | Ear and labyrinth disorders | MedDRA 10.0 | Systematic Assessment |
|
| Abdominal Pain Upper | Gastrointestinal disorders | MedDRA 10.0 | Systematic Assessment |
|
| Constipation | Gastrointestinal disorders | MedDRA 10.0 | Systematic Assessment |
|
| Diarrhoea | Gastrointestinal disorders | MedDRA 10.0 | Systematic Assessment |
|
| Dyspepsia | Gastrointestinal disorders | MedDRA 10.0 | Systematic Assessment |
|
| Dysphagia | Gastrointestinal disorders | MedDRA 10.0 | Systematic Assessment |
|
| Gastritis | Gastrointestinal disorders | MedDRA 10.0 | Systematic Assessment |
|
| Nausea | Gastrointestinal disorders | MedDRA 10.0 | Systematic Assessment |
|
| Oesophagitis | Gastrointestinal disorders | MedDRA 10.0 | Systematic Assessment |
|
| Rectal Haemorrhage | Gastrointestinal disorders | MedDRA 10.0 | Systematic Assessment |
|
| Stomatitis | Gastrointestinal disorders | MedDRA 10.0 | Systematic Assessment |
|
| Tooth Disorder | Gastrointestinal disorders | MedDRA 10.0 | Systematic Assessment |
|
| Vomiting | Gastrointestinal disorders | MedDRA 10.0 | Systematic Assessment |
|
| Asthenia | General disorders | MedDRA 10.0 | Systematic Assessment |
|
| Chest Pain | General disorders | MedDRA 10.0 | Systematic Assessment |
|
| Face Oedema | General disorders | MedDRA 10.0 | Systematic Assessment |
|
| Fatigue | General disorders | MedDRA 10.0 | Systematic Assessment |
|
| General Physical Health Deterioration | General disorders | MedDRA 10.0 | Systematic Assessment |
|
| Mucosal Inflammation | General disorders | MedDRA 10.0 | Systematic Assessment |
|
| Oedema Peripheral | General disorders | MedDRA 10.0 | Systematic Assessment |
|
| Pyrexia | General disorders | MedDRA 10.0 | Systematic Assessment |
|
| Bronchitis Bacterial | Infections and infestations | MedDRA 10.0 | Systematic Assessment |
|
| Herpes Zoster | Infections and infestations | MedDRA 10.0 | Systematic Assessment |
|
| Lung Infection | Infections and infestations | MedDRA 10.0 | Systematic Assessment |
|
| Nasopharyngitis | Infections and infestations | MedDRA 10.0 | Systematic Assessment |
|
| Oral Candidiasis | Infections and infestations | MedDRA 10.0 | Systematic Assessment |
|
| Sinusitis | Infections and infestations | MedDRA 10.0 | Systematic Assessment |
|
| Urinary Tract Infection | Infections and infestations | MedDRA 10.0 | Systematic Assessment |
|
| Mouth Injury | Injury, poisoning and procedural complications | MedDRA 10.0 | Systematic Assessment |
|
| Skin Laceration | Injury, poisoning and procedural complications | MedDRA 10.0 | Systematic Assessment |
|
| Blood Creatine Phosphokinase Increased | Investigations | MedDRA 10.0 | Systematic Assessment |
|
| Blood Glucose Increased | Investigations | MedDRA 10.0 | Systematic Assessment |
|
| Blood Potassium Decreased | Investigations | MedDRA 10.0 | Systematic Assessment |
|
| Forced Expiratory Volume | Investigations | MedDRA 10.0 | Systematic Assessment |
|
| Haemoglobin Decreased | Investigations | MedDRA 10.0 | Systematic Assessment |
|
| Neutrophil Count | Investigations | MedDRA 10.0 | Systematic Assessment |
|
| Neutrophil Count Decreased | Investigations | MedDRA 10.0 | Systematic Assessment |
|
| Platelet Count Decreased | Investigations | MedDRA 10.0 | Systematic Assessment |
|
| Weight Decreased | Investigations | MedDRA 10.0 | Systematic Assessment |
|
| Anorexia | Metabolism and nutrition disorders | MedDRA 10.0 | Systematic Assessment |
|
| Dehydration | Metabolism and nutrition disorders | MedDRA 10.0 | Systematic Assessment |
|
| Diabetes Mellitus | Metabolism and nutrition disorders | MedDRA 10.0 | Systematic Assessment |
|
| Hyperglycaemia | Metabolism and nutrition disorders | MedDRA 10.0 | Systematic Assessment |
|
| Hypokalaemia | Metabolism and nutrition disorders | MedDRA 10.0 | Systematic Assessment |
|
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA 10.0 | Systematic Assessment |
|
| Back Pain | Musculoskeletal and connective tissue disorders | MedDRA 10.0 | Systematic Assessment |
|
| Bone Pain | Musculoskeletal and connective tissue disorders | MedDRA 10.0 | Systematic Assessment |
|
| Muscle Spasms | Musculoskeletal and connective tissue disorders | MedDRA 10.0 | Systematic Assessment |
|
| Musculoskeletal Chest Pain | Musculoskeletal and connective tissue disorders | MedDRA 10.0 | Systematic Assessment |
|
| Osteoporosis | Musculoskeletal and connective tissue disorders | MedDRA 10.0 | Systematic Assessment |
|
| Pain In Extremity | Musculoskeletal and connective tissue disorders | MedDRA 10.0 | Systematic Assessment |
|
| Dizziness | Nervous system disorders | MedDRA 10.0 | Systematic Assessment |
|
| Dysgeusia | Nervous system disorders | MedDRA 10.0 | Systematic Assessment |
|
| Headache | Nervous system disorders | MedDRA 10.0 | Systematic Assessment |
|
| Hemiparesis | Nervous system disorders | MedDRA 10.0 | Systematic Assessment |
|
| Neuropathy | Nervous system disorders | MedDRA 10.0 | Systematic Assessment |
|
| Neuropathy Peripheral | Nervous system disorders | MedDRA 10.0 | Systematic Assessment |
|
| Syncope | Nervous system disorders | MedDRA 10.0 | Systematic Assessment |
|
| Agitation | Psychiatric disorders | MedDRA 10.0 | Systematic Assessment |
|
| Anxiety | Psychiatric disorders | MedDRA 10.0 | Systematic Assessment |
|
| Confusional State | Psychiatric disorders | MedDRA 10.0 | Systematic Assessment |
|
| Sleep Disorder | Psychiatric disorders | MedDRA 10.0 | Systematic Assessment |
|
| Incontinence | Renal and urinary disorders | MedDRA 10.0 | Systematic Assessment |
|
| Testicular Pain | Reproductive system and breast disorders | MedDRA 10.0 | Systematic Assessment |
|
| Bronchial Obstruction | Respiratory, thoracic and mediastinal disorders | MedDRA 10.0 | Systematic Assessment |
|
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA 10.0 | Systematic Assessment |
|
| Dysphonia | Respiratory, thoracic and mediastinal disorders | MedDRA 10.0 | Systematic Assessment |
|
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA 10.0 | Systematic Assessment |
|
| Epistaxis | Respiratory, thoracic and mediastinal disorders | MedDRA 10.0 | Systematic Assessment |
|
| Haemoptysis | Respiratory, thoracic and mediastinal disorders | MedDRA 10.0 | Systematic Assessment |
|
| Pharyngolaryngeal Pain | Respiratory, thoracic and mediastinal disorders | MedDRA 10.0 | Systematic Assessment |
|
| Pleural Effusion | Respiratory, thoracic and mediastinal disorders | MedDRA 10.0 | Systematic Assessment |
|
| Pleuritic Pain | Respiratory, thoracic and mediastinal disorders | MedDRA 10.0 | Systematic Assessment |
|
| Alopecia | Skin and subcutaneous tissue disorders | MedDRA 10.0 | Systematic Assessment |
|
| Dermatitis Acneiform | Skin and subcutaneous tissue disorders | MedDRA 10.0 | Systematic Assessment |
|
| Dry Skin | Skin and subcutaneous tissue disorders | MedDRA 10.0 | Systematic Assessment |
|
| Erythema | Skin and subcutaneous tissue disorders | MedDRA 10.0 | Systematic Assessment |
|
| Petechiae | Skin and subcutaneous tissue disorders | MedDRA 10.0 | Systematic Assessment |
|
| Pruritus | Skin and subcutaneous tissue disorders | MedDRA 10.0 | Systematic Assessment |
|
| Rash | Skin and subcutaneous tissue disorders | MedDRA 10.0 | Systematic Assessment |
|
| Haematoma | Vascular disorders | MedDRA 10.0 | Systematic Assessment |
|
| Hypertension | Vascular disorders | MedDRA 10.0 | Systematic Assessment |
|
| Hypotension | Vascular disorders | MedDRA 10.0 | Systematic Assessment |
|
| Peripheral Embolism | Vascular disorders | MedDRA 10.0 | Systematic Assessment |
|
| Phlebitis | Vascular disorders | MedDRA 10.0 | Systematic Assessment |
|
Not provided
| D013899 |
| Thoracic Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| Cycle 2 |
|
|