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| ID | Type | Description | Link |
|---|---|---|---|
| H6Q-US-S004 | Other Identifier | Eli Lilly and Company |
Not provided
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The purposes of this study are to determine:
The safety of enzastaurin plus pemetrexed with carboplatin, pemetrexed with carboplatin, or docetaxel with carboplatin and any side effects that might be associated with the combination of these drugs.
Whether the combination of enzastaurin plus pemetrexed and carboplatin or pemetrexed and carboplatin can help participants with non-small cell lung cancer (NSCLC) live longer, compared with the combination of docetaxel and carboplatin.
Whether the combination of enzastaurin plus pemetrexed and carboplatin or pemetrexed and carboplatin can make your tumor smaller or disappear, and for how long, compared with the combination of docetaxel and carboplatin.
The effects of enzastaurin plus pemetrexed with carboplatin, pemetrexed with carboplatin or docetaxel with carboplatin have on your disease related symptoms.
The relation of smoking history and hormone replacement therapy (for women only) may have to your lung cancer treatment results.
The effects of certain genes and proteins in samples of your blood and tumor tissue in order to learn more about NSCLC and how enzastaurin works in the body.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Enzastaurin/Pemetrexed/Carboplatin | Experimental |
| |
| Pemetrexed/Carboplatin | Experimental |
| |
| Docetaxel/Carboplatin | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| enzastaurin | Drug | 1125-1200 milligrams (mg) loading dose then 500 mg, oral, daily, until disease progression |
|
| Measure | Description | Time Frame |
|---|---|---|
| Time to Disease Progression | Time to disease progression was defined as the time from randomization to the first date of documented disease progression or death if the participant dies due to disease progression. Response was defined using Response Evaluation Criteria In Solid Tumors (RECIST, version 1.0) criteria. Progressive disease (PD) was defined as having at least a 20% increase in sum of the longest diameter of target lesions. For participants who have not had documented disease progression, time to disease progression was censored at the date of death or date of last visit. For participants who received other anti-tumor therapy prior to disease progression, time to disease progression was censored at the first available date of other anti-tumor therapy. | Baseline to measured PD up to 22.3 months |
| Measure | Description | Time Frame |
|---|---|---|
| Tumor Biomarkers Associated With Clinical Outcomes | As specified in the protocol, tumor biomarker samples were collected from participants on the pemetrexed arms only but were not intended to be analyzed at the individual study level. | Baseline, Cycle 1, Cycle 2 (21-day cycle each), and 30-day post study treatment follow-up |
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Inclusion Criteria:
Exclusion Criteria:
Not provided
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| Name | Affiliation | Role |
|---|---|---|
| Call 1-877-CTLILLY (1-877-285-4559) or 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. | Burlington | North Carolina | 27215 |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 21102260 | Derived | Socinski MA, Raju RN, Stinchcombe T, Kocs DM, Couch LS, Barrera D, Rousey SR, Choksi JK, Jotte R, Patt DA, Periman PO, Schlossberg HR, Weissman CH, Wang Y, Asmar L, Pritchard S, Bromund J, Peng G, Treat J, Obasaju CK. Randomized, phase II trial of pemetrexed and carboplatin with or without enzastaurin versus docetaxel and carboplatin as first-line treatment of patients with stage IIIB/IV non-small cell lung cancer. J Thorac Oncol. 2010 Dec;5(12):1963-9. doi: 10.1097/JTO.0b013e3181fd42eb. |
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Presented in the participant flow are the reasons participants discontinued from study treatment.
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| ID | Title | Description |
|---|---|---|
| FG000 | Enzastaurin/Pemetrexed/Carboplatin | Enzastaurin loading dose of 1125 milligrams (mg) or 1200 mg orally on Day -7 (pre-chemotherapy) followed by 500 mg administered orally once daily starting from Day -6 until disease progression. Pemetrexed 500 milligrams per square meter (mg/m^2) and carboplatin [area under the curve (AUC)] 6 milligrams*minutes per milliliter (mg*min/mL) as an intravenous infusion on Day 1 every 21 days for a maximum of 6 cycles (21-day cycle) or disease progression whichever came first. |
| FG001 | Pemetrexed/Carboplatin | Pemetrexed 500 mg/m^2 and carboplatin AUC 6 mg*min/mL as an intravenous infusion on Day 1 every 21 days for a maximum of 6 cycles (21-day cycle) or disease progression whichever came first. |
| FG002 | Docetaxel/Carboplatin | Docetaxel 75 mg/m^2 and carboplatin AUC 6 mg*min/mL as an intravenous infusion on Day 1 every 21 days for a maximum of 6 cycles (21-day cycle) or disease progression whichever came first. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
All randomized participants.
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Enzastaurin/Pemetrexed/Carboplatin | Enzastaurin loading dose of 1125 mg or 1200 mg orally on Day -7 (pre-chemotherapy) followed by 500 mg administered orally once daily starting from Day -6 until disease progression. Pemetrexed 500 mg/m^2 and carboplatin AUC 6 mg*min/mL as an intravenous infusion on Day 1 every 21 days for a maximum of 6 cycles (21-day cycle) or disease progression whichever came first. |
| 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 Disease Progression | Time to disease progression was defined as the time from randomization to the first date of documented disease progression or death if the participant dies due to disease progression. Response was defined using Response Evaluation Criteria In Solid Tumors (RECIST, version 1.0) criteria. Progressive disease (PD) was defined as having at least a 20% increase in sum of the longest diameter of target lesions. For participants who have not had documented disease progression, time to disease progression was censored at the date of death or date of last visit. For participants who received other anti-tumor therapy prior to disease progression, time to disease progression was censored at the first available date of other anti-tumor therapy. | All randomized participants. Twenty (20) participants in Enzastaurin/Pemetrexed/Carboplatin group, 15 participants in Pemetrexed/Carboplatin group, and 17 participants in Docetaxel/Carboplatin group were censored for analysis. | Posted | Median | 95% Confidence Interval | months | Baseline to measured PD up to 22.3 months |
|
Not provided
Study-specific clinical outcomes due to PD were not considered to be a SAE unless the investigator deemed it related to the use of the study drug.
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 | Enzastaurin/Pemetrexed/Carboplatin | Enzastaurin loading dose of 1125 mg or 1200 mg on Day -7 (pre-chemotherapy) followed by 500 mg administered once daily starting from Day -6 until disease progression. Pemetrexed 500 mg/m^2 and carboplatin AUC 6 mg*min/mL as an intravenous infusion on Day 1 every 21 days for a maximum of 6 cycles (21-day cycle) or disease progression whichever came first. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Febrile neutropenia | Blood and lymphatic system disorders | 16.0 | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Lymphopenia | Blood and lymphatic system disorders | 16.0 | Systematic Assessment |
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Chief Medical Officer | Eli Lilly and Company | 800-545-5979 | ClinicalTrials.gov@lilly.com |
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 |
|---|---|
| C504878 | enzastaurin |
| D000068437 | Pemetrexed |
| D000077143 | Docetaxel |
| D016190 | Carboplatin |
| ID | Term |
|---|---|
| D006147 | Guanine |
| D007042 | Hypoxanthines |
| D011688 | Purinones |
| D011687 | Purines |
| D006574 |
Not provided
Not provided
Not provided
Not provided
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| pemetrexed | Drug | 500 milligrams per square meter (mg/m^2), intravenous (IV), once every (q) 21 days, six 21 day cycles or progressive disease |
|
|
| docetaxel | Drug | 75 mg/m^2, IV, q 21 days, six 21 day cycles or progressive disease |
|
| carboplatin | Drug | Area under the curve (AUC) 6, IV, q 21 days, six 21 day cycles or progressive disease |
|
| Assessment of Smoking History (All Participants) and Hormone Replacement Therapy (Female Participants Only) Associated With Clinical Outcomes |
Data for smoking history and hormone replacement therapy were collected but were not intended to be analyzed at the individual study level. |
| Baseline |
| Number of Participants With Adverse Events (AEs) or Deaths | Data presented are the number of participants who experienced 1 or more AEs or any serious AEs (SAEs) regardless of causality, or deaths during the study including 30 days after treatment discontinuation. A summary of SAEs and other non-serious AEs is located in the Reported Adverse Events section of this report. | Baseline through study completion up to 6 cycles (21-day cycle each) and 30-day safety follow-up |
| Change From Baseline in Total Functional Assessment of Cancer Therapy-Lung (FACT-L) Scale | The FACT-L version 4 scale is used to assess health-related quality of life (HRQoL) in participants with lung cancer. The FACT-L has 5 subscales: Physical Well-Being (PWB), Social and Family Well-Being (SFWB) and Functional Well-Being (FWB) subscales which include 7 items each, Emotional Well-Being (EWB) subscale which includes 6 items, and a Lung-Cancer Specific (LCS) subscale which include 7 items. Total FACT-L is the sum of all 5 subscales. Each item is scored from 0 to 4 giving a total overall score from 0 equal to "worst quality of life" to 136 equal to "best quality of life". The Least Square (LS) mean was calculated using an analysis of covariance (ANCOVA) model adjusted for change scores and baseline scores. | Baseline, Cycle 1 (Week 3), Cycle 2 (Week 6), Cycle 3 (Week 9), Cycle 4 (Week 12), Cycle 5 (Week 15) and Cycle 6 (Week 18) [21-day cycle each] |
| Change From Baseline in Total Functional Assessment of Cancer Therapy -Taxane (FACT-Taxane) Scale | The FACT-Taxane version 4 scale is used to assess HRQoL in participants receiving taxane chemotherapy. The FACT-taxane has 5 subscales: PWB, SFWB, and FWB subscales which include 7 items each, EWB subscale which includes 6 items, and a taxane subscale which include 16 items and has two domains (neurotoxicity and taxane). Total FACT-Taxane is the sum of all the 5 subscales. Each item is scored from 0 to 4 giving a total overall score from 0 "worst quality of life" to 172 "best quality of life". The LS mean was calculated using an ANCOVA model adjusted for change scores and baseline scores. | Baseline, Cycle 1 (Week 3), Cycle 2 (Week 6), Cycle 3 (Week 9), Cycle 4 (Week 12), Cycle 5 (Week 15) and Cycle 6 (Week 18) [21-day cycle each] |
| Overall Survival (OS) | OS was the duration from the date of randomization to the date of death from any cause. For participants who were alive, OS was censored at the date of last follow-up visit or at the date of last contact. | Baseline to date of death from any cause up to 35 months |
| Number of Participants With Complete Response (CR) or Partial Response (PR) [Tumor Response] | Response was defined using RECIST, version 1.0 criteria. Participants with a best response of CR or PR were considered to have had a tumor response. 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. | Baseline to measured PD up to 22.3 months |
| Duration of CR or PR (Duration of Response) | The duration of a CR or PR was defined as the time from first objective status assessment of CR or PR to the first time of progression or death due to any cause. Response was defined using RECIST, version 1.0 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. | Date of first response to the date of progression or death due to any cause up to 22.3 months |
| Time-to-Treatment Failure (TTF) | TTF was defined as the time from randomization to the first observation of PD, death due to any cause, or early discontinuation of treatment. Response was defined using RECIST, version 1.0 criteria. PD was defined as having at least a 20% increase in sum of longest diameter of target lesions. TTF was censored at the date of the last follow-up visit for participants who did not discontinue early, who were still alive, and who have not progressed. | Baseline to stopping treatment up to 14.1 months |
| United States |
| 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. | Chapel Hill | North Carolina | 27599 | United States |
| 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. | Columbia | South Carolina | 29210 | United States |
| 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. | Houston | Texas | 77060 | United States |
| Physician Decision |
|
| Sponsor Decision |
|
| Disease Progression |
|
| Unrelated Complication |
|
| Death |
|
| Protocol Violation |
|
| New Primary Disease Identified |
|
| BG001 | Pemetrexed/Carboplatin | Pemetrexed 500 mg/m^2 and carboplatin AUC 6 mg*min/mL as an intravenous infusion on Day 1 every 21 days for a maximum of 6 cycles (21-day cycle) or disease progression whichever came first. |
| BG002 | Docetaxel/Carboplatin | Docetaxel 75 mg/m^2 and carboplatin AUC 6 mg*min/mL as an intravenous infusion on Day 1 every 21 days for a maximum of 6 cycles (21-day cycle) or disease progression whichever came first. |
| BG003 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants | No |
|
| Race/Ethnicity, Customized | Count of Participants | Participants | No |
|
| Region of Enrollment | Count of Participants | Participants | No |
|
| Disease Stage at Study Entry | Disease stage describes how big the tumor is and how far it has spread from the site of origin. Stages range from Stage I to Stage IV. Stage III is further separated into Stage IIIA and IIIB. Stage IIIB (cancer spread to distant lymph nodes and invaded other organs like heart, esophagus etc). Stage IV (cancer spread throughout the body). | Count of Participants | Participants | No |
|
| OG000 | Enzastaurin/Pemetrexed/Carboplatin | Enzastaurin loading dose of 1125 mg or 1200 mg orally on Day -7 (pre-chemotherapy) followed by 500 mg administered orally once daily starting from Day -6 until disease progression. Pemetrexed 500 mg/m^2 and carboplatin AUC 6 mg*min/mL as an intravenous infusion on Day 1 every 21 days for a maximum of 6 cycles (21-day cycle) or disease progression whichever came first. |
| OG001 | Pemetrexed/Carboplatin | Pemetrexed 500 mg/m^2 and carboplatin AUC 6 mg*min/mL as an intravenous infusion on Day 1 every 21 days for a maximum of 6 cycles (21-day cycle) or disease progression whichever came first. |
| OG002 | Docetaxel/Carboplatin | Docetaxel 75 mg/m^2 and carboplatin AUC 6 mg*min/mL as an intravenous infusion on Day 1 every 21 days for a maximum of 6 cycles (21-day cycle) or disease progression whichever came first. |
|
|
|
| Secondary | Tumor Biomarkers Associated With Clinical Outcomes | As specified in the protocol, tumor biomarker samples were collected from participants on the pemetrexed arms only but were not intended to be analyzed at the individual study level. | Zero participants were analyzed due to insufficient samples being collected. | Posted | Baseline, Cycle 1, Cycle 2 (21-day cycle each), and 30-day post study treatment follow-up |
|
|
| Secondary | Assessment of Smoking History (All Participants) and Hormone Replacement Therapy (Female Participants Only) Associated With Clinical Outcomes | Data for smoking history and hormone replacement therapy were collected but were not intended to be analyzed at the individual study level. | Zero participants were analyzed due to insufficient samples being collected. | Posted | Baseline |
|
|
| Secondary | Number of Participants With Adverse Events (AEs) or Deaths | Data presented are the number of participants who experienced 1 or more AEs or any serious AEs (SAEs) regardless of causality, or deaths during the study including 30 days after treatment discontinuation. A summary of SAEs and other non-serious AEs is located in the Reported Adverse Events section of this report. | Randomized participants who received at least 1 dose of study drug. | Posted | Count of Participants | Participants | No | Baseline through study completion up to 6 cycles (21-day cycle each) and 30-day safety follow-up |
|
|
|
| Secondary | Change From Baseline in Total Functional Assessment of Cancer Therapy-Lung (FACT-L) Scale | The FACT-L version 4 scale is used to assess health-related quality of life (HRQoL) in participants with lung cancer. The FACT-L has 5 subscales: Physical Well-Being (PWB), Social and Family Well-Being (SFWB) and Functional Well-Being (FWB) subscales which include 7 items each, Emotional Well-Being (EWB) subscale which includes 6 items, and a Lung-Cancer Specific (LCS) subscale which include 7 items. Total FACT-L is the sum of all 5 subscales. Each item is scored from 0 to 4 giving a total overall score from 0 equal to "worst quality of life" to 136 equal to "best quality of life". The Least Square (LS) mean was calculated using an analysis of covariance (ANCOVA) model adjusted for change scores and baseline scores. | Randomized participants with non-missing FACT-L data both at baseline and at the specified cycle. | Posted | Least Squares Mean | Standard Error | units on a scale | Baseline, Cycle 1 (Week 3), Cycle 2 (Week 6), Cycle 3 (Week 9), Cycle 4 (Week 12), Cycle 5 (Week 15) and Cycle 6 (Week 18) [21-day cycle each] |
|
|
|
|
| Secondary | Change From Baseline in Total Functional Assessment of Cancer Therapy -Taxane (FACT-Taxane) Scale | The FACT-Taxane version 4 scale is used to assess HRQoL in participants receiving taxane chemotherapy. The FACT-taxane has 5 subscales: PWB, SFWB, and FWB subscales which include 7 items each, EWB subscale which includes 6 items, and a taxane subscale which include 16 items and has two domains (neurotoxicity and taxane). Total FACT-Taxane is the sum of all the 5 subscales. Each item is scored from 0 to 4 giving a total overall score from 0 "worst quality of life" to 172 "best quality of life". The LS mean was calculated using an ANCOVA model adjusted for change scores and baseline scores. | Randomized participants with non-missing FACT-Taxane data both at baseline and at the specified cycle. | Posted | Least Squares Mean | Standard Error | units on a scale | Baseline, Cycle 1 (Week 3), Cycle 2 (Week 6), Cycle 3 (Week 9), Cycle 4 (Week 12), Cycle 5 (Week 15) and Cycle 6 (Week 18) [21-day cycle each] |
|
|
|
|
| Secondary | Overall Survival (OS) | OS was the duration from the date of randomization to the date of death from any cause. For participants who were alive, OS was censored at the date of last follow-up visit or at the date of last contact. | All randomized participants. Sixteen (16) participants in Enzastaurin/Pemetrexed/Carboplatin group, 20 participants in Pemetrexed/Carboplatin group, and 19 participants in Docetaxel/Carboplatin group were censored for analysis. | Posted | Median | 95% Confidence Interval | months | Baseline to date of death from any cause up to 35 months |
|
|
|
|
| Secondary | Number of Participants With Complete Response (CR) or Partial Response (PR) [Tumor Response] | Response was defined using RECIST, version 1.0 criteria. Participants with a best response of CR or PR were considered to have had a tumor response. 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. | All randomized participants. | Posted | Count of Participants | Participants | No | Baseline to measured PD up to 22.3 months |
|
|
|
| Secondary | Duration of CR or PR (Duration of Response) | The duration of a CR or PR was defined as the time from first objective status assessment of CR or PR to the first time of progression or death due to any cause. Response was defined using RECIST, version 1.0 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. | All randomized participants. 63 participants in Enzastaurin/Pemetrexed/Carboplatin group, 58 participants in Pemetrexed/Carboplatin group, and 53 participants in Docetaxel/Carboplatin group were censored for analysis. | Posted | Median | 95% Confidence Interval | months | Date of first response to the date of progression or death due to any cause up to 22.3 months |
|
|
|
| Secondary | Time-to-Treatment Failure (TTF) | TTF was defined as the time from randomization to the first observation of PD, death due to any cause, or early discontinuation of treatment. Response was defined using RECIST, version 1.0 criteria. PD was defined as having at least a 20% increase in sum of longest diameter of target lesions. TTF was censored at the date of the last follow-up visit for participants who did not discontinue early, who were still alive, and who have not progressed. | All randomized participants. Thirty four (34) participants in Pemetrexed/Carboplatin group and 23 participants in Docetaxel/Carboplatin group were censored for analysis. No participants were censored in Enzastaurin/Pemetrexed/Carboplatin group. | Posted | Median | 95% Confidence Interval | months | Baseline to stopping treatment up to 14.1 months |
|
|
|
|
| 35 |
| 67 |
| 63 |
| 67 |
| EG001 | Pemetrexed/Carboplatin | Pemetrexed 500 mg/m^2 and carboplatin AUC 6 mg*min/mL as an intravenous infusion on Day 1 every 21 days for a maximum of 6 cycles (21-day cycle) or disease progression whichever came first. | 20 | 72 | 70 | 72 |
| EG002 | Docetaxel/Carboplatin | Docetaxel 75 mg/m^2 and carboplatin AUC 6 mg*min/mL as an intravenous infusion on Day 1 every 21 days for a maximum of 6 cycles (21-day cycle) or disease progression whichever came first. | 26 | 70 | 69 | 70 |
| Arrhythmia | Cardiac disorders | 16.0 | Systematic Assessment |
|
| Cardio-respiratory arrest | Cardiac disorders | 16.0 | Systematic Assessment |
|
| Myocardial infarction | Cardiac disorders | 16.0 | Systematic Assessment |
|
| Pericardial effusion | Cardiac disorders | 16.0 | Systematic Assessment |
|
| Abdominal pain | Gastrointestinal disorders | 16.0 | Systematic Assessment |
|
| Caecitis | Gastrointestinal disorders | 16.0 | Systematic Assessment |
|
| Diarrhoea | Gastrointestinal disorders | 16.0 | Systematic Assessment |
|
| Duodenal ulcer | Gastrointestinal disorders | 16.0 | Systematic Assessment |
|
| Dysphagia | Gastrointestinal disorders | 16.0 | Systematic Assessment |
|
| Enteritis | Gastrointestinal disorders | 16.0 | Systematic Assessment |
|
| Impaired gastric emptying | Gastrointestinal disorders | 16.0 | Systematic Assessment |
|
| Lower gastrointestinal haemorrhage | Gastrointestinal disorders | 16.0 | Systematic Assessment |
|
| Nausea | Gastrointestinal disorders | 16.0 | Systematic Assessment |
|
| Rectal haemorrhage | Gastrointestinal disorders | 16.0 | Systematic Assessment |
|
| Stomatitis | Gastrointestinal disorders | 16.0 | Systematic Assessment |
|
| Vomiting | Gastrointestinal disorders | 16.0 | Systematic Assessment |
|
| Chest pain | General disorders | 16.0 | Systematic Assessment |
|
| Disease progression | General disorders | 16.0 | Systematic Assessment |
|
| Fatigue | General disorders | 16.0 | Systematic Assessment |
|
| Localised oedema | General disorders | 16.0 | Systematic Assessment |
|
| Oedema due to cardiac disease | General disorders | 16.0 | Systematic Assessment |
|
| Pain | General disorders | 16.0 | Systematic Assessment |
|
| Pyrexia | General disorders | 16.0 | Systematic Assessment |
|
| Abdominal infection | Infections and infestations | 16.0 | Systematic Assessment |
|
| Cellulitis | Infections and infestations | 16.0 | Systematic Assessment |
|
| Pneumonia | Infections and infestations | 16.0 | Systematic Assessment |
|
| Sepsis | Infections and infestations | 16.0 | Systematic Assessment |
|
| Fall | Injury, poisoning and procedural complications | 16.0 | Systematic Assessment |
|
| Fracture | Injury, poisoning and procedural complications | 16.0 | Systematic Assessment |
|
| Aspartate aminotransferase | Investigations | 16.0 | Systematic Assessment |
|
| Blood bilirubin | Investigations | 16.0 | Systematic Assessment |
|
| Blood calcium decreased | Investigations | 16.0 | Systematic Assessment |
|
| Blood creatinine | Investigations | 16.0 | Systematic Assessment |
|
| Blood potassium decreased | Investigations | 16.0 | Systematic Assessment |
|
| Blood sodium decreased | Investigations | 16.0 | Systematic Assessment |
|
| Haemoglobin | Investigations | 16.0 | Systematic Assessment |
|
| Neutrophil count | Investigations | 16.0 | Systematic Assessment |
|
| Platelet count | Investigations | 16.0 | Systematic Assessment |
|
| White blood cell count | Investigations | 16.0 | Systematic Assessment |
|
| Decreased appetite | Metabolism and nutrition disorders | 16.0 | Systematic Assessment |
|
| Dehydration | Metabolism and nutrition disorders | 16.0 | Systematic Assessment |
|
| Electrolyte imbalance | Metabolism and nutrition disorders | 16.0 | Systematic Assessment |
|
| Hyperglycaemia | Metabolism and nutrition disorders | 16.0 | Systematic Assessment |
|
| Bone pain | Musculoskeletal and connective tissue disorders | 16.0 | Systematic Assessment |
|
| Muscular weakness | Musculoskeletal and connective tissue disorders | 16.0 | Systematic Assessment |
|
| Myalgia | Musculoskeletal and connective tissue disorders | 16.0 | Systematic Assessment |
|
| Pain in extremity | Musculoskeletal and connective tissue disorders | 16.0 | Systematic Assessment |
|
| Gastric cancer recurrent | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | 16.0 | Systematic Assessment |
|
| Cerebral ischaemia | Nervous system disorders | 16.0 | Systematic Assessment |
|
| Convulsion | Nervous system disorders | 16.0 | Systematic Assessment |
|
| Dizziness | Nervous system disorders | 16.0 | Systematic Assessment |
|
| Syncope | Nervous system disorders | 16.0 | Systematic Assessment |
|
| Confusional state | Psychiatric disorders | 16.0 | Systematic Assessment |
|
| Mental status changes | Psychiatric disorders | 16.0 | Systematic Assessment |
|
| Renal failure | Renal and urinary disorders | 16.0 | Systematic Assessment |
|
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | 16.0 | Systematic Assessment |
|
| Hypoxia | Respiratory, thoracic and mediastinal disorders | 16.0 | Systematic Assessment |
|
| Lung infiltration | Respiratory, thoracic and mediastinal disorders | 16.0 | Systematic Assessment |
|
| Orthopnoea | Respiratory, thoracic and mediastinal disorders | 16.0 | Systematic Assessment |
|
| Pleural effusion | Respiratory, thoracic and mediastinal disorders | 16.0 | Systematic Assessment |
|
| Pneumothorax | Respiratory, thoracic and mediastinal disorders | 16.0 | Systematic Assessment |
|
| Pulmonary embolism | Respiratory, thoracic and mediastinal disorders | 16.0 | Systematic Assessment |
|
| Pulmonary fibrosis | Respiratory, thoracic and mediastinal disorders | 16.0 | Systematic Assessment |
|
| Respiratory failure | Respiratory, thoracic and mediastinal disorders | 16.0 | Systematic Assessment |
|
| Respiratory tract haemorrhage | Respiratory, thoracic and mediastinal disorders | 16.0 | Systematic Assessment |
|
| Hyperhidrosis | Skin and subcutaneous tissue disorders | 16.0 | Systematic Assessment |
|
| Aortic thrombosis | Vascular disorders | 16.0 | Systematic Assessment |
|
| Deep vein thrombosis | Vascular disorders | 16.0 | Systematic Assessment |
|
| Embolism | Vascular disorders | 16.0 | Systematic Assessment |
|
| Haematoma | Vascular disorders | 16.0 | Systematic Assessment |
|
| Haemorrhage | Vascular disorders | 16.0 | Systematic Assessment |
|
| Hypotension | Vascular disorders | 16.0 | Systematic Assessment |
|
| Thrombosis | Vascular disorders | 16.0 | Systematic Assessment |
|
| Arrhythmia | Cardiac disorders | 16.0 | Systematic Assessment |
|
| Dry eye | Eye disorders | 16.0 | Systematic Assessment |
|
| Lacrimation increased | Eye disorders | 16.0 | Systematic Assessment |
|
| Abdominal pain | Gastrointestinal disorders | 16.0 | Systematic Assessment |
|
| Constipation | Gastrointestinal disorders | 16.0 | Systematic Assessment |
|
| Diarrhoea | Gastrointestinal disorders | 16.0 | Systematic Assessment |
|
| Dyspepsia | Gastrointestinal disorders | 16.0 | Systematic Assessment |
|
| Nausea | Gastrointestinal disorders | 16.0 | Systematic Assessment |
|
| Stomatitis | Gastrointestinal disorders | 16.0 | Systematic Assessment |
|
| Vomiting | Gastrointestinal disorders | 16.0 | Systematic Assessment |
|
| Chest pain | General disorders | 16.0 | Systematic Assessment |
|
| Fatigue | General disorders | 16.0 | Systematic Assessment |
|
| Localised oedema | General disorders | 16.0 | Systematic Assessment |
|
| Oedema peripheral | General disorders | 16.0 | Systematic Assessment |
|
| Pyrexia | General disorders | 16.0 | Systematic Assessment |
|
| Hypersensitivity | Immune system disorders | 16.0 | Systematic Assessment |
|
| Rhinitis | Infections and infestations | 16.0 | Systematic Assessment |
|
| Vaginal infection | Infections and infestations | 16.0 | Systematic Assessment |
|
| Alanine aminotransferase | Investigations | 16.0 | Systematic Assessment |
|
| Aspartate aminotransferase | Investigations | 16.0 | Systematic Assessment |
|
| Blood albumin decreased | Investigations | 16.0 | Systematic Assessment |
|
| Blood alkaline phosphatase | Investigations | 16.0 | Systematic Assessment |
|
| Blood creatinine | Investigations | 16.0 | Systematic Assessment |
|
| Blood magnesium decreased | Investigations | 16.0 | Systematic Assessment |
|
| Blood potassium decreased | Investigations | 16.0 | Systematic Assessment |
|
| Blood potassium increased | Investigations | 16.0 | Systematic Assessment |
|
| Blood sodium decreased | Investigations | 16.0 | Systematic Assessment |
|
| Haemoglobin | Investigations | 16.0 | Systematic Assessment |
|
| Neutrophil count | Investigations | 16.0 | Systematic Assessment |
|
| Platelet count | Investigations | 16.0 | Systematic Assessment |
|
| Weight decreased | Investigations | 16.0 | Systematic Assessment |
|
| White blood cell count | Investigations | 16.0 | Systematic Assessment |
|
| Decreased appetite | Metabolism and nutrition disorders | 16.0 | Systematic Assessment |
|
| Dehydration | Metabolism and nutrition disorders | 16.0 | Systematic Assessment |
|
| Hyperglycaemia | Metabolism and nutrition disorders | 16.0 | Systematic Assessment |
|
| Arthralgia | Musculoskeletal and connective tissue disorders | 16.0 | Systematic Assessment |
|
| Back pain | Musculoskeletal and connective tissue disorders | 16.0 | Systematic Assessment |
|
| Muscular weakness | Musculoskeletal and connective tissue disorders | 16.0 | Systematic Assessment |
|
| Myalgia | Musculoskeletal and connective tissue disorders | 16.0 | Systematic Assessment |
|
| Pain in extremity | Musculoskeletal and connective tissue disorders | 16.0 | Systematic Assessment |
|
| Dizziness | Nervous system disorders | 16.0 | Systematic Assessment |
|
| Dysgeusia | Nervous system disorders | 16.0 | Systematic Assessment |
|
| Headache | Nervous system disorders | 16.0 | Systematic Assessment |
|
| Peripheral sensory neuropathy | Nervous system disorders | 16.0 | Systematic Assessment |
|
| Syncope | Nervous system disorders | 16.0 | Systematic Assessment |
|
| Anxiety | Psychiatric disorders | 16.0 | Systematic Assessment |
|
| Depressed mood | Psychiatric disorders | 16.0 | Systematic Assessment |
|
| Insomnia | Psychiatric disorders | 16.0 | Systematic Assessment |
|
| Pollakiuria | Renal and urinary disorders | 16.0 | Systematic Assessment |
|
| Erectile dysfunction | Reproductive system and breast disorders | 16.0 | Systematic Assessment |
|
| Cough | Respiratory, thoracic and mediastinal disorders | 16.0 | Systematic Assessment |
|
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | 16.0 | Systematic Assessment |
|
| Oropharyngeal pain | Respiratory, thoracic and mediastinal disorders | 16.0 | Systematic Assessment |
|
| Respiratory tract haemorrhage | Respiratory, thoracic and mediastinal disorders | 16.0 | Systematic Assessment |
|
| Alopecia | Skin and subcutaneous tissue disorders | 16.0 | Systematic Assessment |
|
| Dry skin | Skin and subcutaneous tissue disorders | 16.0 | Systematic Assessment |
|
| Exfoliative rash | Skin and subcutaneous tissue disorders | 16.0 | Systematic Assessment |
|
| Pruritus | Skin and subcutaneous tissue disorders | 16.0 | Systematic Assessment |
|
| Hypotension | Vascular disorders | 16.0 | 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 |
| D043823 | Taxoids |
| D043822 | Cyclodecanes |
| D003516 | Cycloparaffins |
| D006840 | Hydrocarbons, Alicyclic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D004224 | Diterpenes |
| D013729 | Terpenes |
| D056831 | Coordination Complexes |
| Title | Measurements |
|---|---|
|
| Deaths Due to AEs |
|
| Cycle 2 (Week 6) |
|
|
| Cycle 3 (Week 9) |
|
|
| Cycle 4 (Week 12) |
|
|
| Cycle 5 (Week 15) |
|
|
| Cycle 6 (Week 18) |
|
|
P-value is for the change in Total FACT-L at Cycle 1 (Week 3). |
| Superiority or Other (legacy) |
| ANCOVA | 0.92 | P-value is for the change in Total FACT-L at Cycle 2 (Week 6). | Superiority or Other (legacy) |
| ANCOVA | 0.97 | P-value is for the change in Total FACT-L at Cycle 2 (Week 6). | Superiority or Other (legacy) |
| ANCOVA | 0.71 | P-value is for the change in Total FACT-L at Cycle 3 (Week 9). | Superiority or Other (legacy) |
| ANCOVA | 0.66 | P-value is for the change in Total FACT-L at Cycle 3 (Week 9). | Superiority or Other (legacy) |
| ANCOVA | 0.93 | P-value is for the change in Total FACT-L at Cycle 4 (Week 12). | Superiority or Other (legacy) |
| ANCOVA | 0.33 | P-value is for the change in Total FACT-L at Cycle 4 (Week 12). | Superiority or Other (legacy) |
| ANCOVA | 0.19 | P-value is for the change in Total FACT-L at Cycle 5 (Week 15). | Superiority or Other (legacy) |
| ANCOVA | 0.40 | P-value is for the change in Total FACT-L at Cycle 5 (Week 15). | Superiority or Other (legacy) |
| ANCOVA | 0.63 | P-value is for the change in Total FACT-L at Cycle 6 (Week 18). | Superiority or Other (legacy) |
| ANCOVA | 0.55 | P-value is for the change in Total FACT-L at Cycle 6 (Week 18). | Superiority or Other (legacy) |
| Cycle 2 (Week 6) |
|
|
| Cycle 3 (Week 9) |
|
|
| Cycle 4 (Week 12) |
|
|
| Cycle 5 (Week 15) |
|
|
| Cycle 6 (Week 18) |
|
|
P-value is for the change in Total FACT-Taxane at Cycle 1 (Week 3). |
| Superiority or Other (legacy) |
| ANCOVA | 0.69 | P-value is for the change in Total FACT-Taxane at Cycle 2 (Week 6). | Superiority or Other (legacy) |
| ANCOVA | 0.77 | P-value is for the change in Total FACT-Taxane at Cycle 2 (Week 6). | Superiority or Other (legacy) |
| ANCOVA | 0.83 | P-value is for the change in Total FACT-Taxane at Cycle 3 (Week 9). | Superiority or Other (legacy) |
| ANCOVA | 0.78 | P-value is for the change in Total FACT-Taxane at Cycle 3 (Week 9). | Superiority or Other (legacy) |
| ANCOVA | 1.00 | P-value is for the change in Total FACT-Taxane at Cycle 4 (Week 12). | Superiority or Other (legacy) |
| ANCOVA | 0.91 | P-value is for the change in Total FACT-Taxane at Cycle 4 (Week 12). | Superiority or Other (legacy) |
| ANCOVA | 0.49 | P-value is for the change in Total FACT-Taxane at Cycle 5 (Week 15). | Superiority or Other (legacy) |
| ANCOVA | 0.53 | P-value is for the change in Total FACT-Taxane at Cycle 5 (Week 15). | Superiority or Other (legacy) |
| ANCOVA | 0.80 | P-value is for the change in Total FACT-Taxane at Cycle 6 (Week 18). | Superiority or Other (legacy) |
| ANCOVA | 0.85 | P-value is for the change in Total FACT-Taxane at Cycle 6 (Week 18). | Superiority or Other (legacy) |
| Superiority or Other (legacy) |
| Superiority or Other (legacy) |