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| ID | Type | Description | Link |
|---|---|---|---|
| I1Q-MC-JDDG | Other Identifier | Eli Lilly and Company |
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This phase 2 study is a multicenter, randomized, double-blind, placebo-controlled trial in participants with locally advanced/inoperable or metastatic pancreatic cancer, and will investigate 2 different doses of LY2495655 in combination with standard of care chemotherapy.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 300 mg LY2495655 + chemotherapy | Experimental | 300 mg LY2495655 intravenous (IV) in combination with standard of care chemotherapy (investigator's choice) |
|
| 100 mg LY2495655 + chemotherapy | Experimental | 100 mg LY2495655 intravenous (IV) in combination with standard of care chemotherapy (investigator's choice) |
|
| Placebo + chemotherapy | Placebo Comparator | Placebo in combination with standard of care chemotherapy (investigator's choice) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| LY2495655 | Drug | Intravenous (IV) treatment every 14 days while on study. Number of Cycles: until treatment options are exhausted or unacceptable toxicity develops. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Overall Survival (OS) | Overall survival (OS) duration was measured from the date of randomization to the date of death from any cause. | Baseline to Death from Any Cause (Up to 23 months) |
| Measure | Description | Time Frame |
|---|---|---|
| Progression Free Survival (PFS) | PFS was defined as the time from date of first dose to the first observation of disease progression or death from any cause. PD was determined using Response Evaluation Criteria In Solid Tumors (RECIST version 1.1) criteria. PD is ≥20% increase in sum of longest diameter of target lesions and/or a new lesion. | Baseline to Disease Progression or Death from Any Cause (Up to 16 months) |
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Inclusion:
Exclusion:
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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. | Washington D.C. | District of Columbia |
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.
The reasons for discontinuation listed in the participant flow are the reasons the participant discontinued treatment and a participant was considered to have "completed" the trial if they died due to any cause while on study or completed treatment and was known to be alive at the last scheduled follow-up.
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| ID | Title | Description |
|---|---|---|
| FG000 | 300 mg LY2495655 + Chemotherapy | 300 milligram (mg) LY2495655 intravenous (IV) in combination with standard of care chemotherapy (investigator's choice). |
| FG001 | 100 mg LY2495655 + Chemotherapy |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Placebo | Drug | Intravenous (IV) treatment every 14 days while on study. Number of Cycles: until treatment options are exhausted or unacceptable toxicity develops. |
|
| Standard of Care Chemotherapy | Drug | Standard of care, gemcitabine-based regimen (single-agent gemcitabine or gemcitabine plus erlotinib) or FOLFIRINOX (combination chemotherapy regimen including 5-fluorouracil, leucovorin, oxaliplatin, and irinotecan). The choice of gemcitabine-based regimen or FOLFIRINOX will be determined by the investigator (based on the standard of care used at the treating institution or as directed by local regulatory authorities). |
|
| Percentage of Participants With Tumor Response Rate (RR) | Response rate (RR) was defined using Response Evaluation Criteria In Solid Tumors (RECIST, version 1.1) criteria. Complete Response (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; Partial Response (PR) was defined as having at least a 30% decrease in sum of longest diameter of target lesions; Progressive Disease (PD) was defined as having at least 20% increase in sum of longest diameter of target lesions and minimum 5 mm increase above nadir; Stable Disease (SD) was defined as small changes that did not meet above criteria. | Baseline to Disease Progression (Up to 11 months) |
| Duration of Response | The duration of a complete response (CR) or partial response (PR) was defined as the time from first objective status assessment of CR or PR to the first time of progression or death as a result of any cause. Response was defined using Response Evaluation Criteria In Solid Tumors (RECIST, version 1.1) criteria. Complete Response (CR) was defined as the disappearance of all non-nodal target lesions, with the short axes of any target lymph nodes reduced to <10 millimeters (mm). Partial Response (PR) was defined as having at least a 30% decrease in the sum of the diameters of target lesions (including the short axes of any target lymph nodes), taking as reference the baseline sum diameter. | First CR or PR to Disease Progression (Up to 11 months) |
| Change in Lean Body Mass | Change in lean body mass was assessed using dual-energy x-ray absorptiometry (DXA). | Baseline, Cycles 3, 5, 7, 9 and 11; Day 1 |
| Change in Physical Performance Measures Using Hand Grip Strength | Hand grip strength (HGS) of the non-dominant hand measured using a hand dynamometer. | Baseline, Cycles 2, 4, 6, 8 and 10; Day 1 |
| Change in Physical Performance Measures Using the Time Up and Go (TUG) Test | Time Up and Go (TUG) is a timed walking test designed to measure gait performance and balance. It measures in seconds the time taken by an individual to stand up from a standard arm chair (approximate seat height of 46 cm [18in], arm height 65 cm [25.6 in]), walk a distance of 3 meters (118 inches, approximately 10 feet), turn, walk back to the chair, and sit down. | Baseline, Cycles 2, 4, 6, 8 and 10; Day 1 |
| Change in Physical Performance Measures Using the 6 Minute Walk Test | The 6 minute walk test measured the distance walked in 6 minutes, as quickly as possible, without running. | Baseline, Cycles 2, 4, 6, 8 and 10; Day 1 |
| Change in Physical Performance Measures Using Stair Climbing Time (StC) | Stair climbing time (StC) measured the ascend and descend of a flight of 12 steps (each step 18 cm high and 28 cm deep). | Baseline, Cycles 3, 5, 7, 9 and 11; Day 1 |
| Change in Patient Reported Outcomes (PRO) | Data from PRO scales are not be presented. An error in coding the scales (coded differently early and late in the study) occurred. Unable to determine which results were affected therefore analysis not completed. | Baseline, Cycles 2, 4, 6, 8 and 10; Day 1 |
| Change in Pain Scale Physical Functioning | The 36-item Short-Form Health Survey (SF-36) pain scale is a generic, health-related scale assessing participant's quality of life on 8 domains: physical functioning, social functioning, bodily pain, vitality, mental health, role-physical, role-emotional and general health and 2 summary scores (mental component summary [MCS] and physical component summary [PCS]). The PCS physical functioning domain score ranges from 0 to 100 (higher scores indicate better health status). | Baseline, Cycles 2, 4, 6, 8 and 10; Day 1 |
| Number of Participants With Anti-LY2495655 Antibodies | Cycle 1, Day 1 and Day 29 (Pre-Dose); Cycle 6 Day 1 |
| 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. | Dallas | Texas | 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. | The Woodlands | Texas | 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. | Tyler | Texas | 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. | Wenatchee | Washington | 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. | Calgary | Alberta | Canada |
| 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. | Toronto | Ontario | Canada |
| 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. | Jerusalem | Israel |
| 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. | Kfar Saba | Israel |
| 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. | Petah Tikva | Israel |
| 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. | Tel Aviv | Israel |
| 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. | Tel Litwinsky | Israel |
| 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. | Oslo | Norway |
| 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. | Trondheim | Norway |
| 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. | Cambridge | Cambridgeshire | United Kingdom |
| 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. | London | England | United Kingdom |
| 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. | Southampton | Hants | United Kingdom |
| 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. | Acton | London | United Kingdom |
| 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. | Nottingham | Nottinghamshire | United Kingdom |
| 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. | Edinburgh | Scotland | United Kingdom |
| 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. | Cardiff | South Glamorgan | United Kingdom |
100 mg LY2495655 intravenous (IV) in combination with standard of care chemotherapy (investigator's choice).
| FG002 | Placebo + Chemotherapy | Placebo in combination with standard of care chemotherapy (investigator's choice). |
| Received At Least One Dose of Study Drug |
|
| Completed One Cycle of Study Drug |
|
| COMPLETED |
|
| NOT COMPLETED |
|
|
All randomized participants.
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | 300 mg LY2495655 + Chemotherapy | 300 mg LY2495655 intravenous (IV) in combination with standard of care chemotherapy (investigator's choice). |
| BG001 | 100 mg LY2495655 + Chemotherapy | 100 mg LY2495655 intravenous (IV) in combination with standard of care chemotherapy (investigator's choice). |
| BG002 | Placebo + Chemotherapy | Placebo in combination with standard of care chemotherapy (investigator's choice). |
| BG003 | Total | Total of all reporting groups |
| 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 | No |
| |||||||||||||||
| Ethnicity (NIH/OMB) | Count of Participants | Participants | No |
| |||||||||||||||
| Race (NIH/OMB) | Count of Participants | Participants | No |
|
| 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) | Overall survival (OS) duration was measured from the date of randomization to the date of death from any cause. | All randomized participants. Participants who were alive at data cut-off for the OS analysis or lost to follow-up were censored on the last date the participant was known to be alive. Censored participants; 300 mg LY2495655 = 9,100 mg LY2495655 =13, Placebo= 16. | Posted | Median | 90% Confidence Interval | months | Baseline to Death from Any Cause (Up to 23 months) |
|
|
| |||||||||||||||||||||||||||||||
| Secondary | Progression Free Survival (PFS) | PFS was defined as the time from date of first dose to the first observation of disease progression or death from any cause. PD was determined using Response Evaluation Criteria In Solid Tumors (RECIST version 1.1) criteria. PD is ≥20% increase in sum of longest diameter of target lesions and/or a new lesion. | All randomized participants. | Posted | Median | 90% Confidence Interval | months | Baseline to Disease Progression or Death from Any Cause (Up to 16 months) |
|
| ||||||||||||||||||||||||||||||||
| Secondary | Percentage of Participants With Tumor Response Rate (RR) | Response rate (RR) was defined using Response Evaluation Criteria In Solid Tumors (RECIST, version 1.1) criteria. Complete Response (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; Partial Response (PR) was defined as having at least a 30% decrease in sum of longest diameter of target lesions; Progressive Disease (PD) was defined as having at least 20% increase in sum of longest diameter of target lesions and minimum 5 mm increase above nadir; Stable Disease (SD) was defined as small changes that did not meet above criteria. | All randomized participants. | Posted | Number | percentage of participants | Baseline to Disease Progression (Up to 11 months) |
| ||||||||||||||||||||||||||||||||||
| Secondary | Duration of Response | The duration of a complete response (CR) or partial response (PR) was defined as the time from first objective status assessment of CR or PR to the first time of progression or death as a result of any cause. Response was defined using Response Evaluation Criteria In Solid Tumors (RECIST, version 1.1) criteria. Complete Response (CR) was defined as the disappearance of all non-nodal target lesions, with the short axes of any target lymph nodes reduced to <10 millimeters (mm). Partial Response (PR) was defined as having at least a 30% decrease in the sum of the diameters of target lesions (including the short axes of any target lymph nodes), taking as reference the baseline sum diameter. | All randomized participants. | Posted | Median | 90% Confidence Interval | months | First CR or PR to Disease Progression (Up to 11 months) |
| |||||||||||||||||||||||||||||||||
| Secondary | Change in Lean Body Mass | Change in lean body mass was assessed using dual-energy x-ray absorptiometry (DXA). | All participants that received at least one dose of study drug and had evaluable post-baseline measurements. | Posted | Mean | Standard Deviation | grams (g) | Baseline, Cycles 3, 5, 7, 9 and 11; Day 1 |
|
| ||||||||||||||||||||||||||||||||
| Secondary | Change in Physical Performance Measures Using Hand Grip Strength | Hand grip strength (HGS) of the non-dominant hand measured using a hand dynamometer. | All participants that received at least one dose of study drug and had evaluable post-baseline measurements. | Posted | Mean | Standard Deviation | kilogram (kg) | Baseline, Cycles 2, 4, 6, 8 and 10; Day 1 |
|
| ||||||||||||||||||||||||||||||||
| Secondary | Change in Physical Performance Measures Using the Time Up and Go (TUG) Test | Time Up and Go (TUG) is a timed walking test designed to measure gait performance and balance. It measures in seconds the time taken by an individual to stand up from a standard arm chair (approximate seat height of 46 cm [18in], arm height 65 cm [25.6 in]), walk a distance of 3 meters (118 inches, approximately 10 feet), turn, walk back to the chair, and sit down. | All participants that received at least one dose of study drug and had evaluable post-baseline measurements. | Posted | Mean | Standard Deviation | seconds | Baseline, Cycles 2, 4, 6, 8 and 10; Day 1 |
| |||||||||||||||||||||||||||||||||
| Secondary | Change in Physical Performance Measures Using the 6 Minute Walk Test | The 6 minute walk test measured the distance walked in 6 minutes, as quickly as possible, without running. | All participants that received at least one dose of study drug and had evaluable post-baseline measurements. | Posted | Mean | Standard Deviation | meter | Baseline, Cycles 2, 4, 6, 8 and 10; Day 1 |
|
| ||||||||||||||||||||||||||||||||
| Secondary | Change in Physical Performance Measures Using Stair Climbing Time (StC) | Stair climbing time (StC) measured the ascend and descend of a flight of 12 steps (each step 18 cm high and 28 cm deep). | All participants that received at least one dose of study drug and had evaluable post-baseline measurements. | Posted | Mean | Standard Deviation | joule/second | Baseline, Cycles 3, 5, 7, 9 and 11; Day 1 |
|
| ||||||||||||||||||||||||||||||||
| Secondary | Change in Patient Reported Outcomes (PRO) | Data from PRO scales are not be presented. An error in coding the scales (coded differently early and late in the study) occurred. Unable to determine which results were affected therefore analysis not completed. | Zero participants analyzed. An error in coding the scales (coded differently early and late in the study) occurred. Unable to determine which results were affected therefore analysis not completed. | Posted | Baseline, Cycles 2, 4, 6, 8 and 10; Day 1 |
|
| |||||||||||||||||||||||||||||||||||
| Secondary | Change in Pain Scale Physical Functioning | The 36-item Short-Form Health Survey (SF-36) pain scale is a generic, health-related scale assessing participant's quality of life on 8 domains: physical functioning, social functioning, bodily pain, vitality, mental health, role-physical, role-emotional and general health and 2 summary scores (mental component summary [MCS] and physical component summary [PCS]). The PCS physical functioning domain score ranges from 0 to 100 (higher scores indicate better health status). | All randomized participants with evaluable SF-36 domain scores. | Posted | Mean | Standard Deviation | units on a scale | Baseline, Cycles 2, 4, 6, 8 and 10; Day 1 |
| |||||||||||||||||||||||||||||||||
| Secondary | Number of Participants With Anti-LY2495655 Antibodies | All randomized participants. | Posted | Count of Participants | Participants | No | Cycle 1, Day 1 and Day 29 (Pre-Dose); Cycle 6 Day 1 |
|
|
Not provided
All randomized participants who received at least one dose of 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 | 300 mg LY2495655 | 300 mg LY2495655 intravenous (IV) in combination with standard of care chemotherapy (investigator's choice). LY2495655: Intravenous (IV) treatment every 14 days while on study. | 26 | 41 | 41 | 41 | ||
| EG001 | 100 mg LY2495655 | 100 mg LY2495655 intravenous (IV) in combination with standard of care chemotherapy (investigator's choice). LY2495655: Intravenous (IV) treatment every 14 days while on study. | 30 | 42 | 41 | 42 | ||
| EG002 | Placebo | Placebo in combination with standard of care chemotherapy (investigator's choice). Placebo: Intravenous (IV) treatment every 14 days while on study. | 25 | 41 | 41 | 41 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | MedDRA 17.1 | Systematic Assessment |
| |
| Neutropenia | Blood and lymphatic system disorders | MedDRA 17.1 | Systematic Assessment |
| |
| Splenic infarction | Blood and lymphatic system disorders | MedDRA 17.1 | Systematic Assessment |
| |
| Splenic vein thrombosis | Blood and lymphatic system disorders | MedDRA 17.1 | Systematic Assessment |
| |
| Myocardial infarction | Cardiac disorders | MedDRA 17.1 | Systematic Assessment |
| |
| Inappropriate antidiuretic hormone secretion | Endocrine disorders | MedDRA 17.1 | Systematic Assessment |
| |
| Abdominal pain | Gastrointestinal disorders | MedDRA 17.1 | Systematic Assessment |
| |
| Ascites | Gastrointestinal disorders | MedDRA 17.1 | Systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA 17.1 | Systematic Assessment |
| |
| Duodenal obstruction | Gastrointestinal disorders | MedDRA 17.1 | Systematic Assessment |
| |
| Duodenal perforation | Gastrointestinal disorders | MedDRA 17.1 | Systematic Assessment |
| |
| Dysphagia | Gastrointestinal disorders | MedDRA 17.1 | Systematic Assessment |
| |
| Gastrointestinal haemorrhage | Gastrointestinal disorders | MedDRA 17.1 | Systematic Assessment |
| |
| Haematemesis | Gastrointestinal disorders | MedDRA 17.1 | Systematic Assessment |
| |
| Impaired gastric emptying | Gastrointestinal disorders | MedDRA 17.1 | Systematic Assessment |
| |
| Intestinal obstruction | Gastrointestinal disorders | MedDRA 17.1 | Systematic Assessment |
| |
| Intestinal perforation | Gastrointestinal disorders | MedDRA 17.1 | Systematic Assessment |
| |
| Intra-abdominal haemorrhage | Gastrointestinal disorders | MedDRA 17.1 | Systematic Assessment |
| |
| Large intestinal obstruction | Gastrointestinal disorders | MedDRA 17.1 | Systematic Assessment |
| |
| Lower gastrointestinal haemorrhage | Gastrointestinal disorders | MedDRA 17.1 | Systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA 17.1 | Systematic Assessment |
| |
| Obstruction gastric | Gastrointestinal disorders | MedDRA 17.1 | Systematic Assessment |
| |
| Pancreatitis | Gastrointestinal disorders | MedDRA 17.1 | Systematic Assessment |
| |
| Small intestinal obstruction | Gastrointestinal disorders | MedDRA 17.1 | Systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA 17.1 | Systematic Assessment |
| |
| Device occlusion | General disorders | MedDRA 17.1 | Systematic Assessment |
| |
| Fatigue | General disorders | MedDRA 17.1 | Systematic Assessment |
| |
| General physical health deterioration | General disorders | MedDRA 17.1 | Systematic Assessment |
| |
| Oedema peripheral | General disorders | MedDRA 17.1 | Systematic Assessment |
| |
| Pain | General disorders | MedDRA 17.1 | Systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA 17.1 | Systematic Assessment |
| |
| Bile duct obstruction | Hepatobiliary disorders | MedDRA 17.1 | Systematic Assessment |
| |
| Cholangitis | Hepatobiliary disorders | MedDRA 17.1 | Systematic Assessment |
| |
| Cholecystitis | Hepatobiliary disorders | MedDRA 17.1 | Systematic Assessment |
| |
| Hepatic failure | Hepatobiliary disorders | MedDRA 17.1 | Systematic Assessment |
| |
| Hyperbilirubinaemia | Hepatobiliary disorders | MedDRA 17.1 | Systematic Assessment |
| |
| Hypersensitivity | Immune system disorders | MedDRA 17.1 | Systematic Assessment |
| |
| Bacteraemia | Infections and infestations | MedDRA 17.1 | Systematic Assessment |
| |
| Biliary sepsis | Infections and infestations | MedDRA 17.1 | Systematic Assessment |
| |
| Biliary tract infection | Infections and infestations | MedDRA 17.1 | Systematic Assessment |
| |
| Bronchitis | Infections and infestations | MedDRA 17.1 | Systematic Assessment |
| |
| Cellulitis | Infections and infestations | MedDRA 17.1 | Systematic Assessment |
| |
| Clostridium difficile infection | Infections and infestations | MedDRA 17.1 | Systematic Assessment |
| |
| Diverticulitis | Infections and infestations | MedDRA 17.1 | Systematic Assessment |
| |
| Enterobacter infection | Infections and infestations | MedDRA 17.1 | Systematic Assessment |
| |
| Infection | Infections and infestations | MedDRA 17.1 | Systematic Assessment |
| |
| Infusion site cellulitis | Infections and infestations | MedDRA 17.1 | Systematic Assessment |
| |
| Liver abscess | Infections and infestations | MedDRA 17.1 | Systematic Assessment |
| |
| Lower respiratory tract infection | Infections and infestations | MedDRA 17.1 | Systematic Assessment |
| |
| Neutropenic sepsis | Infections and infestations | MedDRA 17.1 | Systematic Assessment |
| |
| Pneumonia | Infections and infestations | MedDRA 17.1 | Systematic Assessment |
| |
| Pneumonia streptococcal | Infections and infestations | MedDRA 17.1 | Systematic Assessment |
| |
| Sepsis | Infections and infestations | MedDRA 17.1 | Systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | MedDRA 17.1 | Systematic Assessment |
| |
| Urosepsis | Infections and infestations | MedDRA 17.1 | Systematic Assessment |
| |
| Viral labyrinthitis | Infections and infestations | MedDRA 17.1 | Systematic Assessment |
| |
| Blood bilirubin increased | Investigations | MedDRA 17.1 | Systematic Assessment |
| |
| Blood creatinine increased | Investigations | MedDRA 17.1 | Systematic Assessment |
| |
| Decreased appetite | Metabolism and nutrition disorders | MedDRA 17.1 | Systematic Assessment |
| |
| Dehydration | Metabolism and nutrition disorders | MedDRA 17.1 | Systematic Assessment |
| |
| Hypercalcaemia | Metabolism and nutrition disorders | MedDRA 17.1 | Systematic Assessment |
| |
| Hyperglycaemia | Metabolism and nutrition disorders | MedDRA 17.1 | Systematic Assessment |
| |
| Hypoglycaemia | Metabolism and nutrition disorders | MedDRA 17.1 | Systematic Assessment |
| |
| Hyponatraemia | Metabolism and nutrition disorders | MedDRA 17.1 | Systematic Assessment |
| |
| Ketoacidosis | Metabolism and nutrition disorders | MedDRA 17.1 | Systematic Assessment |
| |
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA 17.1 | Systematic Assessment |
| |
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA 17.1 | Systematic Assessment |
| |
| Malignant pleural effusion | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 17.1 | Systematic Assessment |
| |
| Tumour haemorrhage | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 17.1 | Systematic Assessment |
| |
| Tumour pain | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 17.1 | Systematic Assessment |
| |
| Cerebral haemorrhage | Nervous system disorders | MedDRA 17.1 | Systematic Assessment |
| |
| Cerebral ischaemia | Nervous system disorders | MedDRA 17.1 | Systematic Assessment |
| |
| Cerebrovascular accident | Nervous system disorders | MedDRA 17.1 | Systematic Assessment |
| |
| Syncope | Nervous system disorders | MedDRA 17.1 | Systematic Assessment |
| |
| Anxiety | Psychiatric disorders | MedDRA 17.1 | Systematic Assessment |
| |
| Confusional state | Psychiatric disorders | MedDRA 17.1 | Systematic Assessment |
| |
| Renal failure | Renal and urinary disorders | MedDRA 17.1 | Systematic Assessment |
| |
| Renal failure acute | Renal and urinary disorders | MedDRA 17.1 | Systematic Assessment |
| |
| Ovarian cyst | Reproductive system and breast disorders | MedDRA 17.1 | Systematic Assessment | This event is gender specific, only occurring in female participants. The number of participants exposed has been adjusted accordingly. |
|
| Acute respiratory failure | Respiratory, thoracic and mediastinal disorders | MedDRA 17.1 | Systematic Assessment |
| |
| Chronic obstructive pulmonary disease | Respiratory, thoracic and mediastinal disorders | MedDRA 17.1 | Systematic Assessment |
| |
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA 17.1 | Systematic Assessment |
| |
| Pleural effusion | Respiratory, thoracic and mediastinal disorders | MedDRA 17.1 | Systematic Assessment |
| |
| Pulmonary embolism | Respiratory, thoracic and mediastinal disorders | MedDRA 17.1 | Systematic Assessment |
| |
| Deep vein thrombosis | Vascular disorders | MedDRA 17.1 | Systematic Assessment |
| |
| Hypotension | Vascular disorders | MedDRA 17.1 | Systematic Assessment |
| |
| Intra-abdominal haematoma | Vascular disorders | MedDRA 17.1 | Systematic Assessment |
| |
| Phlebitis | Vascular disorders | MedDRA 17.1 | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | MedDRA 17.1 | Systematic Assessment |
| |
| Neutropenia | Blood and lymphatic system disorders | MedDRA 17.1 | Systematic Assessment |
| |
| Thrombocytopenia | Blood and lymphatic system disorders | MedDRA 17.1 | Systematic Assessment |
| |
| Abdominal distension | Gastrointestinal disorders | MedDRA 17.1 | Systematic Assessment |
| |
| Abdominal pain | Gastrointestinal disorders | MedDRA 17.1 | Systematic Assessment |
| |
| Ascites | Gastrointestinal disorders | MedDRA 17.1 | Systematic Assessment |
| |
| Constipation | Gastrointestinal disorders | MedDRA 17.1 | Systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA 17.1 | Systematic Assessment |
| |
| Dry mouth | Gastrointestinal disorders | MedDRA 17.1 | Systematic Assessment |
| |
| Dyspepsia | Gastrointestinal disorders | MedDRA 17.1 | Systematic Assessment |
| |
| Flatulence | Gastrointestinal disorders | MedDRA 17.1 | Systematic Assessment |
| |
| Mouth ulceration | Gastrointestinal disorders | MedDRA 17.1 | Systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA 17.1 | Systematic Assessment |
| |
| Stomatitis | Gastrointestinal disorders | MedDRA 17.1 | Systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA 17.1 | Systematic Assessment |
| |
| Asthenia | General disorders | MedDRA 17.1 | Systematic Assessment |
| |
| Chest pain | General disorders | MedDRA 17.1 | Systematic Assessment |
| |
| Fatigue | General disorders | MedDRA 17.1 | Systematic Assessment |
| |
| Influenza like illness | General disorders | MedDRA 17.1 | Systematic Assessment |
| |
| Mucosal inflammation | General disorders | MedDRA 17.1 | Systematic Assessment |
| |
| Oedema peripheral | General disorders | MedDRA 17.1 | Systematic Assessment |
| |
| Pain | General disorders | MedDRA 17.1 | Systematic Assessment |
| |
| Peripheral swelling | General disorders | MedDRA 17.1 | Systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA 17.1 | Systematic Assessment |
| |
| Hypersensitivity | Immune system disorders | MedDRA 17.1 | Systematic Assessment |
| |
| Device related infection | Infections and infestations | MedDRA 17.1 | Systematic Assessment |
| |
| Oral candidiasis | Infections and infestations | MedDRA 17.1 | Systematic Assessment |
| |
| Tooth infection | Infections and infestations | MedDRA 17.1 | Systematic Assessment |
| |
| Upper respiratory tract infection | Infections and infestations | MedDRA 17.1 | Systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | MedDRA 17.1 | Systematic Assessment |
| |
| Alanine aminotransferase increased | Investigations | MedDRA 17.1 | Systematic Assessment |
| |
| Aspartate aminotransferase increased | Investigations | MedDRA 17.1 | Systematic Assessment |
| |
| Blood alkaline phosphatase increased | Investigations | MedDRA 17.1 | Systematic Assessment |
| |
| Blood bilirubin increased | Investigations | MedDRA 17.1 | Systematic Assessment |
| |
| Gamma-glutamyltransferase increased | Investigations | MedDRA 17.1 | Systematic Assessment |
| |
| Neutrophil count decreased | Investigations | MedDRA 17.1 | Systematic Assessment |
| |
| Platelet count decreased | Investigations | MedDRA 17.1 | Systematic Assessment |
| |
| Weight decreased | Investigations | MedDRA 17.1 | Systematic Assessment |
| |
| White blood cell count decreased | Investigations | MedDRA 17.1 | Systematic Assessment |
| |
| Decreased appetite | Metabolism and nutrition disorders | MedDRA 17.1 | Systematic Assessment |
| |
| Dehydration | Metabolism and nutrition disorders | MedDRA 17.1 | Systematic Assessment |
| |
| Hyperglycaemia | Metabolism and nutrition disorders | MedDRA 17.1 | Systematic Assessment |
| |
| Hypoalbuminaemia | Metabolism and nutrition disorders | MedDRA 17.1 | Systematic Assessment |
| |
| Hypoglycaemia | Metabolism and nutrition disorders | MedDRA 17.1 | Systematic Assessment |
| |
| Hypokalaemia | Metabolism and nutrition disorders | MedDRA 17.1 | Systematic Assessment |
| |
| Hypomagnesaemia | Metabolism and nutrition disorders | MedDRA 17.1 | Systematic Assessment |
| |
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA 17.1 | Systematic Assessment |
| |
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA 17.1 | Systematic Assessment |
| |
| Bone pain | Musculoskeletal and connective tissue disorders | MedDRA 17.1 | Systematic Assessment |
| |
| Joint swelling | Musculoskeletal and connective tissue disorders | MedDRA 17.1 | Systematic Assessment |
| |
| Muscle spasms | Musculoskeletal and connective tissue disorders | MedDRA 17.1 | Systematic Assessment |
| |
| Muscular weakness | Musculoskeletal and connective tissue disorders | MedDRA 17.1 | Systematic Assessment |
| |
| Musculoskeletal pain | Musculoskeletal and connective tissue disorders | MedDRA 17.1 | Systematic Assessment |
| |
| Myalgia | Musculoskeletal and connective tissue disorders | MedDRA 17.1 | Systematic Assessment |
| |
| Pain in extremity | Musculoskeletal and connective tissue disorders | MedDRA 17.1 | Systematic Assessment |
| |
| Dizziness | Nervous system disorders | MedDRA 17.1 | Systematic Assessment |
| |
| Dysgeusia | Nervous system disorders | MedDRA 17.1 | Systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA 17.1 | Systematic Assessment |
| |
| Neuropathy peripheral | Nervous system disorders | MedDRA 17.1 | Systematic Assessment |
| |
| Peripheral sensory neuropathy | Nervous system disorders | MedDRA 17.1 | Systematic Assessment |
| |
| Anxiety | Psychiatric disorders | MedDRA 17.1 | Systematic Assessment |
| |
| Confusional state | Psychiatric disorders | MedDRA 17.1 | Systematic Assessment |
| |
| Depression | Psychiatric disorders | MedDRA 17.1 | Systematic Assessment |
| |
| Insomnia | Psychiatric disorders | MedDRA 17.1 | Systematic Assessment |
| |
| Vulvovaginal pruritus | Reproductive system and breast disorders | MedDRA 17.1 | Systematic Assessment | This event is gender specific, only occurring in female participants. The number of participants exposed has been adjusted accordingly. |
|
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA 17.1 | Systematic Assessment |
| |
| Dysphonia | Respiratory, thoracic and mediastinal disorders | MedDRA 17.1 | Systematic Assessment |
| |
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA 17.1 | Systematic Assessment |
| |
| Epistaxis | Respiratory, thoracic and mediastinal disorders | MedDRA 17.1 | Systematic Assessment |
| |
| Hiccups | Respiratory, thoracic and mediastinal disorders | MedDRA 17.1 | Systematic Assessment |
| |
| Oropharyngeal pain | Respiratory, thoracic and mediastinal disorders | MedDRA 17.1 | Systematic Assessment |
| |
| Pulmonary embolism | Respiratory, thoracic and mediastinal disorders | MedDRA 17.1 | Systematic Assessment |
| |
| Alopecia | Skin and subcutaneous tissue disorders | MedDRA 17.1 | Systematic Assessment |
| |
| Dermatitis acneiform | Skin and subcutaneous tissue disorders | MedDRA 17.1 | Systematic Assessment |
| |
| Dry skin | Skin and subcutaneous tissue disorders | MedDRA 17.1 | Systematic Assessment |
| |
| Pruritus | Skin and subcutaneous tissue disorders | MedDRA 17.1 | Systematic Assessment |
| |
| Rash | Skin and subcutaneous tissue disorders | MedDRA 17.1 | Systematic Assessment |
| |
| Rash maculo-papular | Skin and subcutaneous tissue disorders | MedDRA 17.1 | Systematic Assessment |
| |
| Deep vein thrombosis | Vascular disorders | MedDRA 17.1 | Systematic Assessment |
| |
| Hot flush | Vascular disorders | MedDRA 17.1 | Systematic Assessment |
| |
| Hypertension | Vascular disorders | MedDRA 17.1 | Systematic Assessment |
| |
| Hypotension | Vascular disorders | MedDRA 17.1 | Systematic Assessment |
|
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Chief Medical Officer | Eli Lilly and Company | 800-545-5979 |
| ID | Term |
|---|---|
| D010190 | Pancreatic Neoplasms |
| ID | Term |
|---|---|
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D004701 | Endocrine Gland Neoplasms |
| D004066 | Digestive System Diseases |
| D010182 | Pancreatic Diseases |
| D004700 | Endocrine System Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| C000607476 | landogrozumab |
Not provided
Not provided
Not provided
| Male |
|
| Not Hispanic or Latino |
|
| Unknown or Not Reported |
|
| Asian |
|
| Native Hawaiian or Other Pacific Islander |
|
| Black or African American |
|
| White |
|
| More than one race |
|
| Unknown or Not Reported |
|
| Counts |
|---|
| Participants |
|
|
Placebo in combination with standard of care chemotherapy (investigator's choice). |
|
|
Placebo in combination with standard of care chemotherapy (investigator's choice).
|
|
|
|
|
| Units | Counts |
|---|---|
| Participants |
|
|
|
|
|
|
| Counts |
|---|
| Participants |
|
| Units | Counts |
|---|---|
| Participants |
|
|
|