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| ID | Type | Description | Link |
|---|---|---|---|
| H3E-CR-JMIL | Other Identifier | Eli Lilly and Company |
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The purpose of this study is to compare the efficacy and safety of two different chemotherapy types in the first line treatment of advanced Non-Small Cell Lung Cancer (NSCLC).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Pemetrexed plus Cisplatin | Experimental |
| |
| Gemcitabine plus Cisplatin | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Pemetrexed | Drug | 500 milligrams/square meter (mg/m²) administered intravenously on Day 1 of each 21-day cycle, for 6 cycles |
|
| Measure | Description | Time Frame |
|---|---|---|
| Overall Survival (OS) | OS was defined as the duration from date of randomization to date of death from any cause. Participants who were alive were censored at the date of last contact. | Randomization to date of death from any cause up to 35.8 months post-randomization |
| Measure | Description | Time Frame |
|---|---|---|
| Progression Free Survival (PFS) | PFS was defined as the date of randomization to date of first observation of clinical or objective progressive disease (PD) or death due to any cause. PD assessed using Response Evaluation Criteria in Solid Tumor (RECIST v1.0) criteria and defined as at least a 20% increase in the sum of the longest diameter of target lesions, taking as reference the smallest sum longest diameter ever recorded since study treatment started, or the appearance of one or more new lesions. Participants who were not known to have died or had PD were censored at the date of last contact. |
| Measure | Description | Time Frame |
|---|---|---|
| Disease Control Rate (DCR) | DCR was the percentage of participants with Complete Response (CR), Partial Response (PR), and Stable Disease (SD). Response determined using Response Evaluation Criteria In Solid Tumors (RECIST v1.0) criteria. CR was defined as the disappearance of all target lesions; PR was defined as at least a 30% decrease in sum of longest diameter of target lesions; progressive disease (PD) was defined as at least a 20% increase in the sum of the longest diameter of target lesions, taking as reference the smallest sum longest diameter ever recorded since study treatment started, or the appearance of 1 or more new lesions; SD was defined as small changes that did not meet the above criteria. |
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. | Beijing | 100730 |
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| ID | Title | Description |
|---|---|---|
| FG000 | Pemetrexed Plus Cisplatin (PC) | Pemetrexed: 500 milligrams/square meter (mg/m²) administered intravenously on Day 1 of each 21-day cycle, for 6 cycles Cisplatin: 75 mg/m² administered intravenously on Day 1 of each 21-day cycle, for 6 cycles |
| FG001 | Gemcitabine Plus Cisplatin (GC) | Gemcitabine: 1250 mg/m² administered intravenously on Day 1 and Day 8 of each 21-day cycle, for 6 cycles Cisplatin: 75 mg/m² administered intravenously on Day 1 of each 21-day cycle, for 6 cycles |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
All randomized participants.
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| ID | Title | Description |
|---|---|---|
| BG000 | Pemetrexed Plus Cisplatin (PC) | Pemetrexed: 500 milligrams/square meter (mg/m²) administered intravenously on Day 1 of each 21-day cycle, for 6 cycles Cisplatin: 75 mg/m² administered intravenously on day 1 of each 21-day cycle, for 6 cycles |
| BG001 | Gemcitabine Plus Cisplatin (GC) |
| 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 | Overall Survival (OS) | OS was defined as the duration from date of randomization to date of death from any cause. Participants who were alive were censored at the date of last contact. | Intent-to-Treat: all participants and are analyzed according to the treatment group they were randomly assigned. Censored participants: PC=37, GC=39. | Posted | Median | 95% Confidence Interval | months | Randomization to date of death from any cause up to 35.8 months post-randomization |
|
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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 | Pemetrexed Plus Cisplatin (PC) | Pemetrexed: 500 milligrams/square meter (mg/m²) administered intravenously on Day 1 of each 21-day cycle, for 6 cycles Cisplatin: 75 mg/m² administered intravenously on day 1 of each 21-day cycle, for 6 cycles |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Bone marrow failure | Blood and lymphatic system disorders | MedDRA 15.1 | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | MedDRA 15.1 | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Chief Medical Officer | Eli Lilly and Company | 800-545-5979 |
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| ID | Term |
|---|---|
| D002289 | Carcinoma, Non-Small-Cell Lung |
| ID | Term |
|---|---|
| D002283 | Carcinoma, Bronchogenic |
| D001984 | Bronchial Neoplasms |
| D008175 | Lung Neoplasms |
| D012142 | Respiratory Tract Neoplasms |
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| ID | Term |
|---|---|
| D000068437 | Pemetrexed |
| D000093542 | Gemcitabine |
| D002945 | Cisplatin |
| ID | Term |
|---|---|
| D006147 | Guanine |
| D007042 | Hypoxanthines |
| D011688 | Purinones |
| D011687 | Purines |
| D006574 |
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| Gemcitabine | Drug | 1250 mg/m² administered intravenously on Day 1 and Day 8 of each 21-day cycle, for 6 cycles |
|
|
| Cisplatin | Drug | 75 mg/m² administered intravenously on day 1 of each 21 day cycle, for 6 cycles |
|
| Randomization to first date of Progressive Disease (PD) or death from any cause up to 33.0 months post-randomization |
| Time to Progressive Disease (TtPD) | TtPD defined as the time from study randomization to the first date of progressive disease (PD). PD assessed using Response Evaluation Criteria in Solid Tumor (RECIST v1.0) criteria and defined as at least a 20% increase in the sum of the longest diameter of target lesions, taking as reference the smallest sum longest diameter ever recorded since study treatment started, or the appearance of 1 or more new lesions. Participants who were not known to have PD or who died without PD were censored at the date of last of last tumor assessment. | Randomization to first date of PD up to 23.7 months post-randomization |
| Duration of Response (DoR) | DoR was defined as the time from first objective status assessment of complete response (CR) or partial response (PR) to the first time progressive disease (PD) or death as a result of any cause. Response using Response Evaluation Criteria in Solid Tumor (RECIST v1.0) criteria. CR was defined as the disappearance of all target lesions. PR was defined as having at least a 30% decrease in sum of longest diameter of target lesions. Participants who are not known to have died or to have PD were censored at the date of last contact. PD assessed using RECIST v1.0 and defined as at least a 20% increase in the sum of the longest diameter of target lesions, taking as reference the smallest sum longest diameter ever recorded since study treatment started, or the appearance of 1 or more new lesions | Date of first response to the date of (PD) or death from any cause up to 22.9 months post-randomization |
| Time to Treatment Failure (TtTF) | TtTF was defined as date of randomization until the date of discontinuation of study treatment due to adverse event, progressive disease (PD), or death from any cause. PD assessed using Response Evaluation Criteria in Solid Tumor (RECIST v1.0) criteria and defined as at least a 20% increase in the sum of the longest diameter of target lesions, taking as reference the smallest sum longest diameter ever recorded since study treatment started, or the appearance of 1 or more new lesions. Participants who discontinued study treatment for any other reason were censored at the date of discontinuation of study treatment. Participants still on study drug at data-inclusion cut-off date were censored at the cut-off date. | Randomization until date of discontinuation of study treatment due to adverse events, PD, or death from any cause up to 6.3 months post-randomization |
| Tumor Response Rate | Tumor response rate was the percentage of participants with confirmed best tumor response of complete response (CR) or partial response (PR) using Response Evaluation Criteria in Solid Tumor (RECIST v1.0) criteria. Complete Response (CR) was defined as the disappearance of all target lesions; Partial Response (PR) was defined as at least a 30% decrease in sum of longest diameter of target lesions. Progressive disease (PD) assessed using RECIST v1.0 criteria and defined as at least a 20% increase in the sum of the longest diameter of target lesions, taking as reference the smallest sum longest diameter ever recorded since study treatment started, or the appearance of 1 or more new lesions. | Randomization until date of objective PD or death from any cause up to 35.8 months post-randomization |
| Risk/Benefit Ratio | Risk/benefit ratio was calculated as the percentage of participants who experienced a study-drug related toxicity of Common Terminology Criteria for Adverse Events (CTCAE v3.0) Cancer Therapy Evaluation Program (CTEP) Grade 3 or higher, divided by the Kaplan-Meier estimated percentage of participants surviving one year. | Randomization to date of death from any cause up to 35.8 months post-randomization |
| Randomization to date of objective PD or death from any cause up to 35.8 months post-randomization |
| Survival Without Toxicity (SWT) | SWT was defined as the time from randomization to a study-drug related toxicity. Toxicity was defined as Common Terminology Criteria for Adverse Events (CTCAE v3.0) Grade 3 or 4 or death. Participants who do not have a CTCAE Grade 3 or higher toxicity and are alive will be censored at the date of last contact. | Randomization to date of toxicity or date of death up to 34.6 months post-randomization |
| China |
| 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. | Changchun | 130012 | China |
| 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. | Dalian | 116023 | China |
| 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. | Guangzhou | 510080 | China |
| 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. | Nanjing | 210002 | China |
| 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. | Nanning | 530000 | China |
| 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. | Shanghai | 200433 | China |
| 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. | Sichuan | 610041 | China |
| Physician Decision |
|
Gemcitabine: 1250 mg/m² administered intravenously on Day 1 and day 8 of each 21-day cycle, for 6 cycles Cisplatin: 75 mg/m² administered intravenously on day 1 of each 21 day cycle, for 6 cycles |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
Gemcitabine: 1250 mg/m² administered intravenously on Day 1 and Day 8 of each 21-day cycle, for 6 cycles Cisplatin: 75 mg/m² administered intravenously on Day 1 of each 21-day cycle, for 6 cycles |
|
|
|
| Secondary | Progression Free Survival (PFS) | PFS was defined as the date of randomization to date of first observation of clinical or objective progressive disease (PD) or death due to any cause. PD assessed using Response Evaluation Criteria in Solid Tumor (RECIST v1.0) criteria and defined as at least a 20% increase in the sum of the longest diameter of target lesions, taking as reference the smallest sum longest diameter ever recorded since study treatment started, or the appearance of one or more new lesions. Participants who were not known to have died or had PD were censored at the date of last contact. | Intent-to-Treat: all randomized participants who are analyzed according to the treatment group they were randomly assigned. Censored participants: PC=8, GC=10. | Posted | Median | 95% Confidence Interval | months | Randomization to first date of Progressive Disease (PD) or death from any cause up to 33.0 months post-randomization |
|
|
|
|
| Secondary | Time to Progressive Disease (TtPD) | TtPD defined as the time from study randomization to the first date of progressive disease (PD). PD assessed using Response Evaluation Criteria in Solid Tumor (RECIST v1.0) criteria and defined as at least a 20% increase in the sum of the longest diameter of target lesions, taking as reference the smallest sum longest diameter ever recorded since study treatment started, or the appearance of 1 or more new lesions. Participants who were not known to have PD or who died without PD were censored at the date of last of last tumor assessment. | Intent-to-Treat: all randomized participants who were analyzed according to the treatment group they were randomly assigned. Censored participants: PC=12, GC=19. | Posted | Median | 95% Confidence Interval | months | Randomization to first date of PD up to 23.7 months post-randomization |
|
|
|
|
| Secondary | Duration of Response (DoR) | DoR was defined as the time from first objective status assessment of complete response (CR) or partial response (PR) to the first time progressive disease (PD) or death as a result of any cause. Response using Response Evaluation Criteria in Solid Tumor (RECIST v1.0) criteria. CR was defined as the disappearance of all target lesions. PR was defined as having at least a 30% decrease in sum of longest diameter of target lesions. Participants who are not known to have died or to have PD were censored at the date of last contact. PD assessed using RECIST v1.0 and defined as at least a 20% increase in the sum of the longest diameter of target lesions, taking as reference the smallest sum longest diameter ever recorded since study treatment started, or the appearance of 1 or more new lesions | Intent-to-Treat: all randomized participants who were analyzed according to the treatment group they were randomly assigned and who achieved CR or PR. Censored participants: PC=1, GC=0. | Posted | Median | 95% Confidence Interval | months | Date of first response to the date of (PD) or death from any cause up to 22.9 months post-randomization |
|
|
|
|
| Secondary | Time to Treatment Failure (TtTF) | TtTF was defined as date of randomization until the date of discontinuation of study treatment due to adverse event, progressive disease (PD), or death from any cause. PD assessed using Response Evaluation Criteria in Solid Tumor (RECIST v1.0) criteria and defined as at least a 20% increase in the sum of the longest diameter of target lesions, taking as reference the smallest sum longest diameter ever recorded since study treatment started, or the appearance of 1 or more new lesions. Participants who discontinued study treatment for any other reason were censored at the date of discontinuation of study treatment. Participants still on study drug at data-inclusion cut-off date were censored at the cut-off date. | Intent-to-Treat: all randomized participants who were analyzed according to the treatment group they were randomly assigned. Censored participants: PC=85, GC=91. | Posted | Median | 95% Confidence Interval | months | Randomization until date of discontinuation of study treatment due to adverse events, PD, or death from any cause up to 6.3 months post-randomization |
|
|
|
|
| Secondary | Tumor Response Rate | Tumor response rate was the percentage of participants with confirmed best tumor response of complete response (CR) or partial response (PR) using Response Evaluation Criteria in Solid Tumor (RECIST v1.0) criteria. Complete Response (CR) was defined as the disappearance of all target lesions; Partial Response (PR) was defined as at least a 30% decrease in sum of longest diameter of target lesions. Progressive disease (PD) assessed using RECIST v1.0 criteria and defined as at least a 20% increase in the sum of the longest diameter of target lesions, taking as reference the smallest sum longest diameter ever recorded since study treatment started, or the appearance of 1 or more new lesions. | Tumor Response-Qualified Population: all randomized participants who received at least l dose of study drug, who were diagnosed with locally advanced/metastatic non-small cell lung cancer, who had at least 1 baseline and 1 post-baseline tumor measurement, and who were not on concurrent systemic chemotherapy. | Posted | Number | percentage of participants | Randomization until date of objective PD or death from any cause up to 35.8 months post-randomization |
|
|
|
|
| Secondary | Risk/Benefit Ratio | Risk/benefit ratio was calculated as the percentage of participants who experienced a study-drug related toxicity of Common Terminology Criteria for Adverse Events (CTCAE v3.0) Cancer Therapy Evaluation Program (CTEP) Grade 3 or higher, divided by the Kaplan-Meier estimated percentage of participants surviving one year. | Safety population: all randomized participants who received at least 1 dose of study drug and were analyzed according to actual treatment received in Cycle 1 of 21-day cycle. | Posted | Number | ratio | Randomization to date of death from any cause up to 35.8 months post-randomization |
|
|
|
| Other Pre-specified | Disease Control Rate (DCR) | DCR was the percentage of participants with Complete Response (CR), Partial Response (PR), and Stable Disease (SD). Response determined using Response Evaluation Criteria In Solid Tumors (RECIST v1.0) criteria. CR was defined as the disappearance of all target lesions; PR was defined as at least a 30% decrease in sum of longest diameter of target lesions; progressive disease (PD) was defined as at least a 20% increase in the sum of the longest diameter of target lesions, taking as reference the smallest sum longest diameter ever recorded since study treatment started, or the appearance of 1 or more new lesions; SD was defined as small changes that did not meet the above criteria. | Tumor Response Qualified Population: all randomized participants who received at least l dose of study drug, who were diagnosed with locally advanced/metastatic non-small cell lung cancer, who had at least 1 baseline and 1 post-baseline tumor measurement, and who are not on concurrent systemic chemotherapy. | Posted | Number | percentage of participants | Randomization to date of objective PD or death from any cause up to 35.8 months post-randomization |
|
|
|
|
| Other Pre-specified | Survival Without Toxicity (SWT) | SWT was defined as the time from randomization to a study-drug related toxicity. Toxicity was defined as Common Terminology Criteria for Adverse Events (CTCAE v3.0) Grade 3 or 4 or death. Participants who do not have a CTCAE Grade 3 or higher toxicity and are alive will be censored at the date of last contact. | Safety population: all randomized participants who received at least 1 dose of study drug and were analyzed according to actual treatment received in Cycle 1 of 21-day cycles. Censored participants: PC=22, GC=10. | Posted | Median | 95% Confidence Interval | months | Randomization to date of toxicity or date of death up to 34.6 months post-randomization |
|
|
|
| 8 |
| 125 |
| 120 |
| 125 |
| EG001 | Gemcitabine Plus Cisplatin (GC) | Gemcitabine: 1250 mg/m² administered intravenously on Day 1 and day 8 of each 21-day cycle, for 6 cycles Cisplatin: 75 mg/m² administered intravenously on day 1 of each 21 day cycle, for 6 cycles | 9 | 127 | 123 | 127 |
| Leukopenia | Blood and lymphatic system disorders | MedDRA 15.1 | Systematic Assessment |
|
| Thrombocytopenia | Blood and lymphatic system disorders | MedDRA 15.1 | Systematic Assessment |
|
| Fatigue | General disorders | MedDRA 15.1 | Systematic Assessment |
|
| Pyrexia | General disorders | MedDRA 15.1 | Systematic Assessment |
|
| Lung infection | Infections and infestations | MedDRA 15.1 | Systematic Assessment |
|
| Neutrophil count decreased | Investigations | MedDRA 15.1 | Systematic Assessment |
|
| Hyponatraemia | Metabolism and nutrition disorders | MedDRA 15.1 | Systematic Assessment |
|
| Cerebral infarction | Nervous system disorders | MedDRA 15.1 | Systematic Assessment |
|
| Ischaemic stroke | Nervous system disorders | MedDRA 15.1 | Systematic Assessment |
|
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA 15.1 | Systematic Assessment |
|
| Pleural effusion | Respiratory, thoracic and mediastinal disorders | MedDRA 15.1 | Systematic Assessment |
|
| Pulmonary embolism | Respiratory, thoracic and mediastinal disorders | MedDRA 15.1 | Systematic Assessment |
|
| Embolism venous | Vascular disorders | MedDRA 15.1 | Systematic Assessment |
|
| Superior vena cava syndrome | Vascular disorders | MedDRA 15.1 | Systematic Assessment |
|
| Thrombophlebitis | Vascular disorders | MedDRA 15.1 | Systematic Assessment |
|
| Venous thrombosis limb | Vascular disorders | MedDRA 15.1 | Systematic Assessment |
|
| Leukopenia | Blood and lymphatic system disorders | MedDRA 15.1 | Systematic Assessment |
|
| Lymphopenia | Blood and lymphatic system disorders | MedDRA 15.1 | Systematic Assessment |
|
| Neutropenia | Blood and lymphatic system disorders | MedDRA 15.1 | Systematic Assessment |
|
| Thrombocytopenia | Blood and lymphatic system disorders | MedDRA 15.1 | Systematic Assessment |
|
| Constipation | Gastrointestinal disorders | MedDRA 15.1 | Systematic Assessment |
|
| Diarrhoea | Gastrointestinal disorders | MedDRA 15.1 | Systematic Assessment |
|
| Dyspepsia | Gastrointestinal disorders | MedDRA 15.1 | Systematic Assessment |
|
| Nausea | Gastrointestinal disorders | MedDRA 15.1 | Systematic Assessment |
|
| Vomiting | Gastrointestinal disorders | MedDRA 15.1 | Systematic Assessment |
|
| Fatigue | General disorders | MedDRA 15.1 | Systematic Assessment |
|
| Pyrexia | General disorders | MedDRA 15.1 | Systematic Assessment |
|
| Alanine aminotransferase increased | Investigations | MedDRA 15.1 | Systematic Assessment |
|
| Aspartate aminotransferase increased | Investigations | MedDRA 15.1 | Systematic Assessment |
|
| Blood creatinine increased | Investigations | MedDRA 15.1 | Systematic Assessment |
|
| Blood sodium decreased | Investigations | MedDRA 15.1 | Systematic Assessment |
|
| Haemoglobin decreased | Investigations | MedDRA 15.1 | Systematic Assessment |
|
| Neutrophil count decreased | Investigations | MedDRA 15.1 | Systematic Assessment |
|
| Platelet count decreased | Investigations | MedDRA 15.1 | Systematic Assessment |
|
| Red blood cell count decreased | Investigations | MedDRA 15.1 | Systematic Assessment |
|
| White blood cell count decreased | Investigations | MedDRA 15.1 | Systematic Assessment |
|
| Decreased appetite | Metabolism and nutrition disorders | MedDRA 15.1 | Systematic Assessment |
|
| Hypokalaemia | Metabolism and nutrition disorders | MedDRA 15.1 | Systematic Assessment |
|
| Hyponatraemia | Metabolism and nutrition disorders | MedDRA 15.1 | Systematic Assessment |
|
| Dizziness | Nervous system disorders | MedDRA 15.1 | Systematic Assessment |
|
| Insomnia | Psychiatric disorders | MedDRA 15.1 | Systematic Assessment |
|
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA 15.1 | Systematic Assessment |
|
| Rash | Skin and subcutaneous tissue disorders | MedDRA 15.1 | Systematic Assessment |
|
Not provided
| D013899 |
| Thoracic Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
| D005971 | Glutamates |
| D024342 | Amino Acids, Acidic |
| D000596 | Amino Acids |
| D000602 | Amino Acids, Peptides, and Proteins |
| D000600 | Amino Acids, Dicarboxylic |
| D003841 | Deoxycytidine |
| D003562 | Cytidine |
| D011741 | Pyrimidine Nucleosides |
| D011743 | Pyrimidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D017606 | Chlorine Compounds |
| D007287 | Inorganic Chemicals |
| D017672 | Nitrogen Compounds |
| D017671 | Platinum Compounds |