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| ID | Type | Description | Link |
|---|---|---|---|
| I1Y-MC-JFBF | Other Identifier | Eli Lilly and Company |
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The purpose of the study is to estimate the rate of response for patients with ovarian, non-small cell lung, prostate, colorectal, gastroesophageal, and head and neck cancers who are administered LY2523355.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| LY2523355 | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| LY2523355 | Drug | Dose determined by participant body surface area: 5 milligrams/square meter(mg/m²) or 6 mg/m², administered intravenously as a 1-hour infusion on Days 1, 2 and 3 of a 21 day cycle; for up to 2 cycles (4 cycles for prostate cancer patients). Additional cycles administered based on patient response assessment. |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants With a Complete Response (CR) or Partial Response (PR) | The percentage of participants who achieved a best response of either CR or PR, as determined by Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 guidelines. CR was defined as the disappearance of all target and non-target lesions and any pathological lymph nodes (whether target or non-target) must have reduction in short axis to <10 millimeter (mm) and normalization of tumor marker level of non-target lesions. PR was defined as at least a 30% decrease in sum of longest diameter of target lesions and for prostate cancer PR was defined as a ≥50% decrease in baseline prostate-specific antigen (PSA) value that was confirmed with a second value ≥3 weeks later. Progressive Disease (PD) was defined as at least 20% increase in sum of longest diameter of target lesions and minimum 5 mm increase over nadir. Percentage is calculated as a total number of participants with CR or PR divided by the total number of participants treated multiplied by 100. | Baseline until progressive disease up to 36 weeks post-baseline |
| Measure | Description | Time Frame |
|---|---|---|
| Progression Free Survival (PFS) | PFS defined as the time from date of first dose to the first observation of disease progression or death due to any cause. Progressive Disease (PD) was defined as at least 20% increase in sum of longest diameter of target lesions and minimum 5 millimeter (mm) increase over nadir. For participants who were not known to have died or to have progressed as of the data inclusion cutoff date, PFS were censored at the date of the last objective progression-free disease assessment prior to the date of any subsequent systemic anticancer therapy. |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants Who Died Due to Unknown Causes During the 30-Day Post-Study Treatment Follow-Up | End of study treatment up to 30-days post-study treatment discontinuation |
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 to 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. | Jonesboro | Arkansas | 72401 |
Anonymized individual patient level data will be provided in a secure access environment upon approval of a research proposal and a signed data sharing agreement.
Data are available 6 months after the primary publication and approval of the indication studied in the US and EU, whichever is later. Data will be indefinitely available for requesting.
A research proposal must be approved by an independent review panel and researchers must sign a data sharing agreement.
All participants who received at least one dose of study drug in both Cycle 1 and Cycle 2 or to have progressed or died on or before study Day 42 were considered to be completed.
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| ID | Title | Description |
|---|---|---|
| FG000 | LY2523355 | LY2523355: Dose determined by participant's body surface area: 5 milligrams/square meter(mg/m²) or 6 mg/m², administered intravenously as a 1-hour infusion on Days 1, 2 and 3 of a 21-day cycle for up to 2 cycles (4 cycles for prostate cancer participants). Additional cycles administered based on participant response assessment. Pegfilgrastim: 6 milligrams (mg), administered subcutaneously approximately 24 hours after third dose of LY2523355 on Day 4 of each 21-day cycle, for up to 2 cycles of LY2523355 administration (4 cycles for prostate cancer participants). Additional cycles of LY2523355 administered based on participant response assessment. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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|
| pegfilgrastim | Drug | 6 milligrams (mg), administered subcutaneously approximately 24 hours after third dose of LY2523355 on Day 4 of each 21-day cycle, for up to 2 cycles of LY2523355 administration (4 cycles for prostate cancer patients). Additional cycles of LY2523355 administered based on patient response assessment. |
|
| Date of enrollment to progressive disease or death due to any cause up to 36 weeks post-enrollment |
| Percentage of Participants Who Achieved a Best Response of Complete Response (CR), Partial Response (PR) or Stable Disease (SD) | Response using Response Evaluation Criteria In Solid Tumors (RECIST) v1.1 criteria. CR was defined as the disappearance of all target and non-target lesions and any pathological lymph nodes (whether target or non-target) must have reduction in short axis to <10 millimeter (mm) and normalization of tumor marker level of non-target lesions. PR was defined as at least a 30% decrease in sum of longest diameter of target lesions and for prostate cancer PR was defined as a ≥50% decrease in baseline prostate-specific antigen (PSA) value that was confirmed with a second value ≥3 weeks later. Progressive Disease (PD) was defined as at least 20% increase in sum of longest diameter of target lesions and minimum 5 mm increase over nadir. SD was defined as small changes that did not meet above criteria. | Baseline until progressive disease up to 36 weeks post-baseline |
| Tumor Marker Values as Relevant to Specific Tumor Types at Baseline | The number of participants with colorectal cancer (CRC), gastroesophageal cancer (GE), non-small cell lung cancer (NSCLC), ovarian cancer, prostate cancer or squamous cell carcinoma of head and neck (SCCHN) who had marker/molecular diagnostics performed prior to study entry to determine the mutation status of cancer genes: APC, BRAF, BRCA1, BRCA2, HRAS and KRAS and the presence of Human Papillovirus (HPV) and Epstein Barr viruses (EBV). Mutation/virus status was defined as: positive (mutation/virus present), negative (mutation/virus not present), unknown (mutation/virus status unknown), or not done (mutation/virus status was not done). | Baseline |
| Change in Tumor Size at Smallest Size (Best Response) | The percent change in tumor size at its smallest size. The sum of diameters of target lesions was determined at each tumor assessment. The percent change is the smallest post-baseline sum divided by the baseline (pre-treatment) sum, multiplied by 100. | Baseline until cycle with maximum change from baseline up to 36 weeks |
| Pharmacokinetics, Maximum Plasma Concentration (Cmax) of LY2523355 and Metabolite LSN2546307 | Plasma Cmax following daily doses of LY2523355 on Days 1, 2, and 3 of Cycle 1 (21-day cycle). | Day 3 of Cycle 1 (21-day cycle) |
| Pharmacokinetics, Intracycle Accumulation Ratio (Ra) of LY2523355 | Intracycle Ra of LY2523355 is the ratio of LY2523355 maximum plasma concentration (Cmax) on Day 3 of Cycle 1 to the Cmax of LY2523355 on Day 1 of Cycle 1 following daily doses of LY2523355 on Days 1, 2 and 3 of Cycle 1 (21-day cycle) at each dose level. | Day 1 and Day 3 of Cycle 1 (21-day cycle) |
| 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. | Jacksonville | Florida | 32256 | 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. | Macon | Georgia | 31201 | 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. | Marietta | Georgia | 30060 | 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. | Valdosta | Georgia | 31602 | 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. | Post Falls | Idaho | 83854 | 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. | Westwood | Kansas | 66205 | 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. | Wichita | Kansas | 67214 | 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. | Baton Rouge | Louisiana | 70809 | 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. | Bethesda | Maryland | 20817 | 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. | Billings | Montana | 59102 | 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. | Columbus | Ohio | 43219 | 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. | Oklahoma City | Oklahoma | 73120 | 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. | Charleston | South Carolina | 29425 | 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. | Germantown | Tennessee | 38138 | 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. | Memphis | Tennessee | 38120 | 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. | Corpus Christi | Texas | 78404 | 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. | Morgantown | West Virginia | 26506 | United States |
| Received at Least 1 Dose of Study Drug |
|
| COMPLETED |
|
| NOT COMPLETED |
|
|
All enrolled participants.
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | LY2523355 | LY2523355: Dose determined by participant body surface area: 5 milligrams/square meter(mg/m²) or 6 mg/m², administered intravenously as a one hour infusion on Days 1, 2 and 3 of a 21 day cycle for up to 2 cycles (4 cycles for prostate cancer participants). Additional cycles administered based on participant response assessment. Pegfilgrastim: 6 milligrams (mg), administered subcutaneously approximately 24 hours after third dose of LY2523355 on Day 4 of each 21-day cycle, for up to 2 cycles of LY2523355 administration (4 cycles for prostate cancer participants). Additional cycles of LY2523355 administered based on participant response assessment. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | |||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | 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 | Count of Participants | Participants |
| |||||||||||||||||||||||
| Tumor Type | Number | participants |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Percentage of Participants With a Complete Response (CR) or Partial Response (PR) | The percentage of participants who achieved a best response of either CR or PR, as determined by Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 guidelines. CR was defined as the disappearance of all target and non-target lesions and any pathological lymph nodes (whether target or non-target) must have reduction in short axis to <10 millimeter (mm) and normalization of tumor marker level of non-target lesions. PR was defined as at least a 30% decrease in sum of longest diameter of target lesions and for prostate cancer PR was defined as a ≥50% decrease in baseline prostate-specific antigen (PSA) value that was confirmed with a second value ≥3 weeks later. Progressive Disease (PD) was defined as at least 20% increase in sum of longest diameter of target lesions and minimum 5 mm increase over nadir. Percentage 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 | 90% Confidence Interval | percentage of participants | Baseline until progressive disease up to 36 weeks post-baseline |
|
|
| |||||||||||||||||||||||||||
| Secondary | Progression Free Survival (PFS) | PFS defined as the time from date of first dose to the first observation of disease progression or death due to any cause. Progressive Disease (PD) was defined as at least 20% increase in sum of longest diameter of target lesions and minimum 5 millimeter (mm) increase over nadir. For participants who were not known to have died or to have progressed as of the data inclusion cutoff date, PFS were censored at the date of the last objective progression-free disease assessment prior to the date of any subsequent systemic anticancer therapy. | All enrolled participants who received at least 1 dose of study drug. Percentage (%) of participants censored were colorectal cancer 5.9%; gastroesophageal cancer 0.0%, non-small cell lung cancer 3.4%, ovarian cancer 15.4%, prostate cancer 16.7%, and squamous cell carcinoma of the head and neck 15.4%. | Posted | Median | 90% Confidence Interval | months | Date of enrollment to progressive disease or death due to any cause up to 36 weeks post-enrollment |
| |||||||||||||||||||||||||||||
| Secondary | Percentage of Participants Who Achieved a Best Response of Complete Response (CR), Partial Response (PR) or Stable Disease (SD) | Response using Response Evaluation Criteria In Solid Tumors (RECIST) v1.1 criteria. CR was defined as the disappearance of all target and non-target lesions and any pathological lymph nodes (whether target or non-target) must have reduction in short axis to <10 millimeter (mm) and normalization of tumor marker level of non-target lesions. PR was defined as at least a 30% decrease in sum of longest diameter of target lesions and for prostate cancer PR was defined as a ≥50% decrease in baseline prostate-specific antigen (PSA) value that was confirmed with a second value ≥3 weeks later. Progressive Disease (PD) was defined as at least 20% increase in sum of longest diameter of target lesions and minimum 5 mm increase over nadir. SD was defined as small changes that did not meet above criteria. | All enrolled participants who received at least 1 dose of study drug. | Posted | Number | 90% Confidence Interval | percentage of participants | Baseline until progressive disease up to 36 weeks post-baseline |
| |||||||||||||||||||||||||||||
| Secondary | Tumor Marker Values as Relevant to Specific Tumor Types at Baseline | The number of participants with colorectal cancer (CRC), gastroesophageal cancer (GE), non-small cell lung cancer (NSCLC), ovarian cancer, prostate cancer or squamous cell carcinoma of head and neck (SCCHN) who had marker/molecular diagnostics performed prior to study entry to determine the mutation status of cancer genes: APC, BRAF, BRCA1, BRCA2, HRAS and KRAS and the presence of Human Papillovirus (HPV) and Epstein Barr viruses (EBV). Mutation/virus status was defined as: positive (mutation/virus present), negative (mutation/virus not present), unknown (mutation/virus status unknown), or not done (mutation/virus status was not done). | All enrolled participants who received at least 1 dose of study drug. | Posted | Count of Participants | Participants | No | Baseline |
| |||||||||||||||||||||||||||||
| Secondary | Change in Tumor Size at Smallest Size (Best Response) | The percent change in tumor size at its smallest size. The sum of diameters of target lesions was determined at each tumor assessment. The percent change is the smallest post-baseline sum divided by the baseline (pre-treatment) sum, multiplied by 100. | All enrolled participants who received at least 1 dose of study drug with results at baseline and at time of best response. | Posted | Mean | Standard Deviation | percentage of change | Baseline until cycle with maximum change from baseline up to 36 weeks |
|
| ||||||||||||||||||||||||||||
| Secondary | Pharmacokinetics, Maximum Plasma Concentration (Cmax) of LY2523355 and Metabolite LSN2546307 | Plasma Cmax following daily doses of LY2523355 on Days 1, 2, and 3 of Cycle 1 (21-day cycle). | All enrolled participants who received at least 1 dose of study drug with Cmax measure. | Posted | Geometric Mean | Geometric Coefficient of Variation | nanograms per milliliter (ng/mL) | Day 3 of Cycle 1 (21-day cycle) |
|
| ||||||||||||||||||||||||||||
| Secondary | Pharmacokinetics, Intracycle Accumulation Ratio (Ra) of LY2523355 | Intracycle Ra of LY2523355 is the ratio of LY2523355 maximum plasma concentration (Cmax) on Day 3 of Cycle 1 to the Cmax of LY2523355 on Day 1 of Cycle 1 following daily doses of LY2523355 on Days 1, 2 and 3 of Cycle 1 (21-day cycle) at each dose level. | All enrolled participants who received at least 1 dose of study drug with Ra measure. | Posted | Geometric Mean | Geometric Coefficient of Variation | ratio | Day 1 and Day 3 of Cycle 1 (21-day cycle) |
|
| ||||||||||||||||||||||||||||
| Other Pre-specified | Number of Participants Who Died Due to Unknown Causes During the 30-Day Post-Study Treatment Follow-Up | All enrolled participants who received at least 1 dose of study drug. | Posted | Count of Participants | Participants | No | End of study treatment up to 30-days post-study treatment discontinuation |
|
|
Not provided
Deaths due to (d/t) PD not considered AEs and reported in Participant Flow for those who died during study treatment. Deaths d/t unknown cause in the 30-day post-study treatment follow-up (PSTF) reported in Other Pre-Specified Outcome Measure. One death (unknown cause) in PSTF recorded by investigator as an SAE included in SAE summary as "Death".
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 | LY2523355 | LY2523355: Dose determined by participant's body surface area: 5 milligrams/meter squared (mg/m²) or 6 mg/m², administered intravenously on days 1, 2, 3 of a 21 day cycle; for up to 2 cycles (4 cycles for prostate cancer participants). Additional cycles administered based on participant response assessment. Pegfilgrastim: 6 milligrams (mg), administered subcutaneously 24 hours after third dose of LY2523355 on day 4 of each 21-day cycle, for up to 2 cycles of LY2523355 administration (4 cycles for prostate cancer participants). Additional cycles of LY2523355 administered based on participant response assessment. | 39 | 103 | 102 | 103 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | MedDRA 15.1 | Systematic Assessment |
| |
| Febrile neutropenia | Blood and lymphatic system disorders | MedDRA 15.1 | Systematic Assessment |
| |
| Pericardial effusion | Cardiac disorders | MedDRA 15.1 | Systematic Assessment |
| |
| Anal fistula | Gastrointestinal disorders | MedDRA 15.1 | Systematic Assessment |
| |
| Ascites | Gastrointestinal disorders | MedDRA 15.1 | Systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA 15.1 | Systematic Assessment |
| |
| Dysphagia | Gastrointestinal disorders | MedDRA 15.1 | Systematic Assessment |
| |
| Enterovesical fistula | Gastrointestinal disorders | MedDRA 15.1 | Systematic Assessment |
| |
| Gastrointestinal haemorrhage | Gastrointestinal disorders | MedDRA 15.1 | Systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA 15.1 | Systematic Assessment |
| |
| Stomatitis | Gastrointestinal disorders | MedDRA 15.1 | Systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA 15.1 | Systematic Assessment |
| |
| Death | General disorders | MedDRA 15.1 | Systematic Assessment |
| |
| Fatigue | General disorders | MedDRA 15.1 | Systematic Assessment |
| |
| Mucosal inflammation | General disorders | MedDRA 15.1 | Systematic Assessment |
| |
| Non-cardiac chest pain | General disorders | MedDRA 15.1 | Systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA 15.1 | Systematic Assessment |
| |
| Cellulitis | Infections and infestations | MedDRA 15.1 | Systematic Assessment |
| |
| Clostridium difficile colitis | Infections and infestations | MedDRA 15.1 | Systematic Assessment |
| |
| Diverticulitis | Infections and infestations | MedDRA 15.1 | Systematic Assessment |
| |
| Gastroenteritis | Infections and infestations | MedDRA 15.1 | Systematic Assessment |
| |
| Neutropenic sepsis | Infections and infestations | MedDRA 15.1 | Systematic Assessment |
| |
| Oral herpes | Infections and infestations | MedDRA 15.1 | Systematic Assessment |
| |
| Pneumonia | Infections and infestations | MedDRA 15.1 | Systematic Assessment |
| |
| Rectal abscess | Infections and infestations | MedDRA 15.1 | Systematic Assessment |
| |
| Sepsis | Infections and infestations | MedDRA 15.1 | Systematic Assessment | 1 event resulted in death |
|
| Staphylococcal sepsis | Infections and infestations | MedDRA 15.1 | Systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | MedDRA 15.1 | Systematic Assessment |
| |
| Blood creatinine increased | Investigations | MedDRA 15.1 | Systematic Assessment |
| |
| Lymphocyte count decreased | Investigations | MedDRA 15.1 | Systematic Assessment |
| |
| Neutrophil count decreased | Investigations | MedDRA 15.1 | Systematic Assessment |
| |
| White blood cell count decreased | Investigations | MedDRA 15.1 | Systematic Assessment |
| |
| Dehydration | Metabolism and nutrition disorders | MedDRA 15.1 | Systematic Assessment |
| |
| Hyperuricaemia | Metabolism and nutrition disorders | MedDRA 15.1 | Systematic Assessment |
| |
| Malnutrition | Metabolism and nutrition disorders | MedDRA 15.1 | Systematic Assessment |
| |
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA 15.1 | Systematic Assessment |
| |
| Bone pain | Musculoskeletal and connective tissue disorders | MedDRA 15.1 | Systematic Assessment |
| |
| Malignant ascites | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 15.1 | Systematic Assessment |
| |
| Non-small cell lung cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 15.1 | Systematic Assessment |
| |
| Ischaemic stroke | Nervous system disorders | MedDRA 15.1 | Systematic Assessment |
| |
| Completed suicide | Psychiatric disorders | MedDRA 15.1 | Systematic Assessment | Event resulted in death |
|
| Mental status changes | Psychiatric disorders | MedDRA 15.1 | Systematic Assessment |
| |
| Haematuria | Renal and urinary disorders | MedDRA 15.1 | Systematic Assessment |
| |
| Urinary retention | Renal and urinary disorders | MedDRA 15.1 | Systematic Assessment |
| |
| Acute respiratory distress syndrome | Respiratory, thoracic and mediastinal disorders | MedDRA 15.1 | Systematic Assessment |
| |
| Aspiration | Respiratory, thoracic and mediastinal disorders | MedDRA 15.1 | Systematic Assessment |
| |
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA 15.1 | Systematic Assessment |
| |
| Hypoxia | Respiratory, thoracic and mediastinal disorders | MedDRA 15.1 | Systematic Assessment |
| |
| Pneumonia aspiration | Respiratory, thoracic and mediastinal disorders | MedDRA 15.1 | Systematic Assessment | 1 event resulted in death |
|
| Pulmonary embolism | Respiratory, thoracic and mediastinal disorders | MedDRA 15.1 | Systematic Assessment |
| |
| Deep vein thrombosis | Vascular disorders | MedDRA 15.1 | Systematic Assessment |
| |
| Jugular vein thrombosis | Vascular 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 |
| |
| Neutropenia | Blood and lymphatic system disorders | MedDRA 15.1 | Systematic Assessment |
| |
| Thrombocytopenia | Blood and lymphatic system disorders | MedDRA 15.1 | Systematic Assessment |
| |
| Abdominal pain | Gastrointestinal disorders | MedDRA 15.1 | Systematic Assessment |
| |
| Constipation | Gastrointestinal disorders | MedDRA 15.1 | Systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA 15.1 | Systematic Assessment |
| |
| Dysphagia | Gastrointestinal disorders | MedDRA 15.1 | Systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA 15.1 | Systematic Assessment |
| |
| Oral pain | Gastrointestinal disorders | MedDRA 15.1 | Systematic Assessment |
| |
| Stomatitis | Gastrointestinal disorders | MedDRA 15.1 | Systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA 15.1 | Systematic Assessment |
| |
| Asthenia | General disorders | MedDRA 15.1 | Systematic Assessment |
| |
| Fatigue | General disorders | MedDRA 15.1 | Systematic Assessment |
| |
| Mucosal inflammation | General disorders | MedDRA 15.1 | Systematic Assessment |
| |
| Oedema peripheral | General disorders | MedDRA 15.1 | Systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA 15.1 | Systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | MedDRA 15.1 | Systematic Assessment |
| |
| Blood alkaline phosphatase increased | Investigations | MedDRA 15.1 | Systematic Assessment |
| |
| Blood creatinine increased | Investigations | MedDRA 15.1 | Systematic Assessment |
| |
| Weight 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 |
| |
| Dehydration | Metabolism and nutrition disorders | MedDRA 15.1 | Systematic Assessment |
| |
| Hypocalcaemia | Metabolism and nutrition disorders | MedDRA 15.1 | Systematic Assessment |
| |
| Hypokalaemia | Metabolism and nutrition disorders | MedDRA 15.1 | Systematic Assessment |
| |
| Hypomagnesaemia | Metabolism and nutrition disorders | MedDRA 15.1 | Systematic Assessment |
| |
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA 15.1 | Systematic Assessment |
| |
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA 15.1 | Systematic Assessment |
| |
| Bone pain | Musculoskeletal and connective tissue disorders | MedDRA 15.1 | Systematic Assessment |
| |
| Pain in extremity | Musculoskeletal and connective tissue disorders | MedDRA 15.1 | Systematic Assessment |
| |
| Dizziness | Nervous system disorders | MedDRA 15.1 | Systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA 15.1 | Systematic Assessment |
| |
| Anxiety | Psychiatric 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 |
| |
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA 15.1 | Systematic Assessment |
| |
| Alopecia | Skin and subcutaneous tissue disorders | MedDRA 15.1 | Systematic Assessment |
| |
| Hypotension | Vascular disorders | MedDRA 15.1 | Systematic Assessment |
|
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Chief Medical Officer | Eli Lilly and Company | 800-545-5979 |
| ID | Term |
|---|---|
| D010051 | Ovarian Neoplasms |
| D002289 | Carcinoma, Non-Small-Cell Lung |
| D011471 | Prostatic Neoplasms |
| D015179 | Colorectal Neoplasms |
| D013274 | Stomach Neoplasms |
| D004938 | Esophageal Neoplasms |
| D006258 | Head and Neck Neoplasms |
| ID | Term |
|---|---|
| D004701 | Endocrine Gland Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D010049 | Ovarian Diseases |
| D000291 | Adnexal Diseases |
| D005831 | Genital Diseases, Female |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D005833 | Genital Neoplasms, Female |
| D014565 | Urogenital Neoplasms |
| D000091662 | Genital Diseases |
| D004700 | Endocrine System Diseases |
| D006058 | Gonadal Disorders |
| D002283 | Carcinoma, Bronchogenic |
| D001984 | Bronchial Neoplasms |
| D008175 | Lung Neoplasms |
| D012142 | Respiratory Tract Neoplasms |
| D013899 | Thoracic Neoplasms |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D005834 | Genital Neoplasms, Male |
| D005832 | Genital Diseases, Male |
| D011469 | Prostatic Diseases |
| D052801 | Male Urogenital Diseases |
| D007414 | Intestinal Neoplasms |
| D005770 | Gastrointestinal Neoplasms |
| D004067 | Digestive System Neoplasms |
| D004066 | Digestive System Diseases |
| D005767 | Gastrointestinal Diseases |
| D003108 | Colonic Diseases |
| D007410 | Intestinal Diseases |
| D012002 | Rectal Diseases |
| D013272 | Stomach Diseases |
| D004935 | Esophageal Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| C000591843 | litronesib |
| C455861 | pegfilgrastim |
Not provided
Not provided
Not provided
| Unknown or Not Reported |
|
| Native Hawaiian or Other Pacific Islander |
|
| Black or African American |
|
| White |
|
| More than one race |
|
| Unknown or Not Reported |
|
| Non-Small Cell Lung Cancer |
|
| Ovarian Cancer |
|
| Prostate Cancer |
|
| Squamous Cell Carcinoma of the Head and Neck |
|
|
| Non-Small Cell Lung Cancer |
|
|
| Ovarian Cancer |
|
|
| Prostate Cancer |
|
|
| Squamous Cell Carcinoma of Head and Neck |
|
|
|
|
|
|
| Units | Counts |
|---|
| Participants |
|
|
|
|
|
|