Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| 2008-004936-19 | EudraCT Number | ||
| CP12-0709 | Other Identifier | ImClone Systems | |
| I4T-IE-JVBH | Other Identifier | Eli Lilly and Company |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
The purpose of this study is to test how long participants with colorectal cancer live without progressive disease when being treated with IMC-1121B (ramucirumab) and the modified FOLFOX-6 chemotherapy.
The purpose of this study is to evaluate the progression-free survival (PFS) in participants with metastatic colorectal cancer when treated with the monoclonal antibody IMC-1121B (ramucirumab) in combination with the modified FOLFOX-6 [folinic acid (FA) + fluorouracil (5-FU) + oxaliplatin, mFOLFOX-6] chemotherapy regimen as first-line therapy.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| IMC-1121B (ramucirumab) + mFOLFOX-6 | Experimental | This regimen will be repeated every 2 weeks until disease progression, unacceptable toxicity, or withdrawal. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| IMC-1121B (ramucirumab) | Biological | 8 milligrams/kilogram (mg/kg) IMC-1121B (ramucirumab) infusions every 2 weeks |
|
| Measure | Description | Time Frame |
|---|---|---|
| Progression-Free Survival (PFS) | PFS was defined as the time from date of first dose to the first observation of progression of disease (PD) or death due to any cause. PD was determined using Response Evaluation Criteria In Solid Tumors (RECIST) criteria version 1.0. PD is ≥20% increase in sum of longest diameter of target lesions and/or unequivocal progression of non-target lesion and/or new lesion. For participants who had no PD or death or had started new therapeutic anticancer treatment, PFS was censored at their last radiographic tumor assessment. | First dose to measured progressive disease or death due to any cause up to 28.1 months |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants With Complete Response or Partial Response [Objective Response Rate (ORR)] | ORR is the percentage of participants with a confirmed complete response (CR) + partial response (PR), as classified by the investigators according to the Response Evaluation Criteria In Solid Tumors (RECIST) criteria version 1.0. CR is disappearance of all target and non-target lesions; PR is a ≥30% decrease in sum of longest diameter of target lesions without new lesion and progression of non-target lesion. ORR is calculated as a total number of participants with CR or PR from the start of study treatment until disease progression or recurrence divided by the total number of participants treated, then multiplied by 100. |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| 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 |
|---|---|---|---|---|---|---|
| ImClone Investigational Site | Ottawa | Ontario | K1H 8L6 | Canada | ||
| ImClone Investigational Site |
Completer was defined as any participant who died due to any cause or progression of disease, or any participant who was alive and on study but off study treatment at the conclusion of the study.
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | IMC-1121B (Ramucirumab) + mFOLFOX-6 | Received IMC-1121B (ramucirumab) 8 milligrams/kilogram (mg/kg) on Day 1 administered intravenously over 60 minutes and followed by administration of the modified FOLFOX-6 [folinic acid (FA) + fluorouracil (5-FU) + oxaliplatin, mFOLFOX-6] regimen as follows: Oxaliplatin 85 milligrams/square meter (mg/m²) intravenous infusion over 2 hours on Day 1; FA 400 mg/m² intravenous infusion over 2 hours on Day 1; 5-FU 400 mg/m² intravenous bolus injection over 2 to 4 minutes, immediately following the FA infusion; 5-FU 2400 mg/m² intravenous continuous infusion over 46 hours immediately following bolus 5-FU injection on Days 1 and 2. This regimen was repeated every 2 weeks until disease progression, unacceptable toxicity, or withdrawal. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
All participants who received any amount of study drug.
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | IMC-1121B (Ramucirumab) + mFOLFOX-6 | Received IMC-1121B (ramucirumab) 8 milligrams/kilogram (mg/kg) on Day 1 administered intravenously over 60 minutes and followed by administration of the modified FOLFOX-6 [folinic acid (FA) + fluorouracil (5-FU) + oxaliplatin, mFOLFOX-6] regimen as follows: Oxaliplatin 85 milligrams/square meter (mg/m²) intravenous infusion over 2 hours on Day 1; FA 400 mg/m² intravenous infusion over 2 hours on Day 1; 5-FU 400 mg/m² intravenous bolus injection over 2 to 4 minutes, immediately following the FA infusion; 5-FU 2400 mg/m² intravenous continuous infusion over 46 hours immediately following bolus 5-FU injection on Days 1 and 2. This regimen was repeated every 2 weeks until disease progression, unacceptable toxicity, or withdrawal. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of 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 | Progression-Free Survival (PFS) | PFS was defined as the time from date of first dose to the first observation of progression of disease (PD) or death due to any cause. PD was determined using Response Evaluation Criteria In Solid Tumors (RECIST) criteria version 1.0. PD is ≥20% increase in sum of longest diameter of target lesions and/or unequivocal progression of non-target lesion and/or new lesion. For participants who had no PD or death or had started new therapeutic anticancer treatment, PFS was censored at their last radiographic tumor assessment. | All participants who received any amount of study drug. The number of participants censored was 11. | Posted | Median | 95% Confidence Interval | months | First dose to measured progressive disease or death due to any cause up to 28.1 months |
|
Not provided
Not provided
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | IMC-1121B (Ramucirumab) + mFOLFOX-6 | Received IMC-1121B (ramucirumab) 8 milligrams/kilogram (mg/kg) on Day 1 administered intravenously over 60 minutes and followed by administration of the modified FOLFOX-6 [folinic acid (FA) + fluorouracil (5-FU) + oxaliplatin, mFOLFOX-6] regimen as follows: Oxaliplatin 85 milligrams/square meter (mg/m²) intravenous infusion over 2 hours on Day 1; FA 400 mg/m² intravenous infusion over 2 hours on Day 1; 5-FU 400 mg/m² intravenous bolus injection over 2 to 4 minutes, immediately following the FA infusion; 5-FU 2400 mg/m² intravenous continuous infusion over 46 hours immediately following bolus 5-FU injection on Days 1 and 2. This regimen was repeated every 2 weeks until disease progression, unacceptable toxicity, or withdrawal. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| COAGULOPATHY | Blood and lymphatic system disorders | MedDRA 12.0 | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| ANAEMIA | Blood and lymphatic system disorders | MedDRA 12.0 | Systematic Assessment |
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Chief Medical Officer | Eli Lilly and Company | 800-545-5979 |
Not provided
| ID | Term |
|---|---|
| D015179 | Colorectal Neoplasms |
| D003110 | Colonic Neoplasms |
| ID | Term |
|---|---|
| D007414 | Intestinal Neoplasms |
| D005770 | Gastrointestinal Neoplasms |
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
Not provided
Not provided
| ID | Term |
|---|---|
| D000096662 | Ramucirumab |
| D000077150 | Oxaliplatin |
| D002955 | Leucovorin |
| D005472 | Fluorouracil |
| ID | Term |
|---|---|
| D061067 | Antibodies, Monoclonal, Humanized |
| D000911 | Antibodies, Monoclonal |
| D000906 | Antibodies |
| D007136 | Immunoglobulins |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Oxaliplatin | Drug | 85 milligrams/square meter (mg/m²) intravenous infusion over 2 hours on Day 1 |
|
| Folinic acid | Drug | 400 mg/m² intravenous infusion over 2 hours on Day 1 |
|
| 5-FU | Drug | 400 mg/m² intravenous bolus injection over 2-4 minutes, immediately following folinic acid infusion |
|
| 5-FU | Drug | 2400 mg/m² intravenous continuous infusion over 46 hours immediately following bolus 5-FU on Days 1 and 2 |
|
| First dose to date of objective progressive disease up to 23.8 months |
| Overall Survival (OS) | OS was defined as the time from first dose to the date of death due to any cause. For participants who were alive or were lost to follow-up, OS was censored on the last date the participant was known to be alive. | First dose to death due to any cause up to 28.1 months |
| Duration of Response | The duration of response was defined as the time from first objective status assessment of complete response (CR) or partial response (PR) to the first time of progression or death as a result of any cause. CR or PR is classified by the investigators according to Response Evaluation Criteria In Solid Tumors (RECIST) criteria version 1.0. CR is disappearance of all target and non-target lesions; PR is a ≥30% decrease in sum of longest diameter of target lesions without new lesion and progression of non-target lesion. | Time of response to time of measured progressive disease up to 22.2 months |
| Number of Participants With IMC-1121B (Ramucirumab)-Related Adverse Events (AEs) | Data presented are the number of participants who experienced AEs of any grade and AEs of Grade ≥3 based on National Cancer Institute Common Terminology Criteria for Adverse Events, Version 3.0 (NCI-CTCAE v 3.0), that were considered to be related to IMC-1121B (ramucirumab) by the investigators. A summary of serious AEs (SAEs) and all other non-serious AEs regardless of causality, is located in the Reported Adverse Events module. | First dose to 25.2 months |
| Number of Participants With IMC-1121B (Ramucirumab)-Related Severe Adverse Events (SAEs) | Data presented are the number of participants who experienced SAEs, adverse events (AEs) resulting in death and AEs leading to discontinuation of treatment, that were considered to be related to IMC-1121B (ramucirumab) by the investigators. A summary of SAEs and all other non-serious AEs, regardless of causality, is located in the Reported Adverse Events module. | First dose to 25.2 months |
| Maximum Concentration (Cmax) at Day 1 of Cycle 1 | Due to sparse pharmacokinetic schedule, Cmax was not calculated. | Baseline, 1, 168, and 336 hours post infusion on Day 1 (Cycle 1) |
| Area Under the Concentration (AUC) at Day 1 of Cycle 1 | Due to sparse pharmacokinetic schedule, AUC was not calculated. | Baseline, 1, 168, and 336 hours post infusion on Day 1 (Cycle 1) |
| Half-Life (t1/2) at Day 1 of Cycle 1 | Due to sparse pharmacokinetic schedule, t1/2 was not calculated. | Baseline, 1, 168, and 336 hours post infusion on Day 1 (Cycle 1) |
| Clearance (CL) at Day 1 of Cycle 1 | Due to sparse pharmacokinetic schedule, CL was not calculated. | Baseline, 1, 168, and 336 hours post infusion on Day 1 (Cycle 1) |
| Steady State Volume of Distribution (Vss) at Day 1 of Cycle 1 | Due to sparse pharmacokinetic schedule, Vss was not calculated. | Baseline, 1, 168, and 336 hours post infusion Day 1 (Cycle 1) |
| Maximum Concentration (Cmax) at Day 1 of Cycles 5, 9, 13, 17, and 21 | Due to sparse pharmacokinetic schedule, Cmax was not calculated. | Baseline and 1 hour post infusion on Day 1 (Cycles 5, 9, 13, 17, and 21) |
| Area Under the Concentration (AUC) at Day 1 of Cycles 5, 9, 13, 17, and 21 | Due to sparse pharmacokinetic schedule, AUC was not calculated. | Baseline and 1 hour post infusion on Day 1 (Cycles 5, 9, 13, 17, and 21) |
| Half-Life (t1/2) at Day 1 of Cycles 5, 9, 13, 17, and 21 | Due to sparse pharmacokinetic schedule, t1/2 was not calculated. | Baseline and 1 hour post infusion on Day 1 (Cycles 5, 9, 13, 17, and 21) |
| Clearance (CL) at Day 1 of Cycles 5, 9, 13, 17, and 21 | Due to sparse pharmacokinetic schedule, CL was not calculated. | Baseline and 1 hour post infusion on Day 1 (Cycles 5, 9, 13, 17, and 21) |
| Steady State Volume of Distribution (Vss) at Day 1 of Cycles 5, 9, 13, 17, and 21 | Due to sparse pharmacokinetic schedule, Vss was not calculated. | Baseline and 1 hour post infusion on Day 1 (Cycles 5, 9, 13, 17, and 21) |
| Serum Anti-IMC-1121B (Immunogenicity) at Day 1 | Data presented are the number of participants with treatment emergent anti-IMC-112B antibodies. | Day 1 (Cycles 1, 5, 9, and 30-day follow-up) |
| Toronto |
| Ontario |
| M5G-2M9 |
| Canada |
| ImClone Investigational Site | Montreal | Quebec | H2L 4M1 | Canada |
| ImClone Investigational Site | Barcelona | Spain |
| ImClone Investigational Site | Santander | Spain |
| ImClone Investigational Site | Seville | Spain |
| ImClone Investigational Site | Valencia | Spain |
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
|
|
| Secondary | Percentage of Participants With Complete Response or Partial Response [Objective Response Rate (ORR)] | ORR is the percentage of participants with a confirmed complete response (CR) + partial response (PR), as classified by the investigators according to the Response Evaluation Criteria In Solid Tumors (RECIST) criteria version 1.0. CR is disappearance of all target and non-target lesions; PR is a ≥30% decrease in sum of longest diameter of target lesions without new lesion and progression of non-target lesion. ORR is calculated as a total number of participants with CR or PR from the start of study treatment until disease progression or recurrence divided by the total number of participants treated, then multiplied by 100. | All participants who received any amount of study drug. | Posted | Number | 95% Confidence Interval | percentage of participants | First dose to date of objective progressive disease up to 23.8 months |
|
|
|
| Secondary | Overall Survival (OS) | OS was defined as the time from first dose to the date of death due to any cause. For participants who were alive or were lost to follow-up, OS was censored on the last date the participant was known to be alive. | All participants who received any amount of study drug. The number of participants censored was 18. | Posted | Median | 95% Confidence Interval | months | First dose to death due to any cause up to 28.1 months |
|
|
|
| Secondary | Duration of Response | The duration of response was defined as the time from first objective status assessment of complete response (CR) or partial response (PR) to the first time of progression or death as a result of any cause. CR or PR is classified by the investigators according to Response Evaluation Criteria In Solid Tumors (RECIST) criteria version 1.0. CR is disappearance of all target and non-target lesions; PR is a ≥30% decrease in sum of longest diameter of target lesions without new lesion and progression of non-target lesion. | All participants who received any amount of study drug who had CR and PR. | Posted | Median | 95% Confidence Interval | months | Time of response to time of measured progressive disease up to 22.2 months |
|
|
|
| Secondary | Number of Participants With IMC-1121B (Ramucirumab)-Related Adverse Events (AEs) | Data presented are the number of participants who experienced AEs of any grade and AEs of Grade ≥3 based on National Cancer Institute Common Terminology Criteria for Adverse Events, Version 3.0 (NCI-CTCAE v 3.0), that were considered to be related to IMC-1121B (ramucirumab) by the investigators. A summary of serious AEs (SAEs) and all other non-serious AEs regardless of causality, is located in the Reported Adverse Events module. | All participants who received at any amount of study drug. | Posted | Number | participants | First dose to 25.2 months |
|
|
|
| Secondary | Number of Participants With IMC-1121B (Ramucirumab)-Related Severe Adverse Events (SAEs) | Data presented are the number of participants who experienced SAEs, adverse events (AEs) resulting in death and AEs leading to discontinuation of treatment, that were considered to be related to IMC-1121B (ramucirumab) by the investigators. A summary of SAEs and all other non-serious AEs, regardless of causality, is located in the Reported Adverse Events module. | All participants who received any amount of study drug. | Posted | Number | participants | First dose to 25.2 months |
|
|
|
| Secondary | Maximum Concentration (Cmax) at Day 1 of Cycle 1 | Due to sparse pharmacokinetic schedule, Cmax was not calculated. | No participants were analyzed due to sparse pharmacokinetic schedule. | Posted | Baseline, 1, 168, and 336 hours post infusion on Day 1 (Cycle 1) |
|
|
| Secondary | Area Under the Concentration (AUC) at Day 1 of Cycle 1 | Due to sparse pharmacokinetic schedule, AUC was not calculated. | No participants were analyzed due to sparse pharmacokinetic schedule. | Posted | Baseline, 1, 168, and 336 hours post infusion on Day 1 (Cycle 1) |
|
|
| Secondary | Half-Life (t1/2) at Day 1 of Cycle 1 | Due to sparse pharmacokinetic schedule, t1/2 was not calculated. | No participants were analyzed due to sparse pharmacokinetic schedule. | Posted | Baseline, 1, 168, and 336 hours post infusion on Day 1 (Cycle 1) |
|
|
| Secondary | Clearance (CL) at Day 1 of Cycle 1 | Due to sparse pharmacokinetic schedule, CL was not calculated. | No participants were analyzed due to sparse pharmacokinetic schedule. | Posted | Baseline, 1, 168, and 336 hours post infusion on Day 1 (Cycle 1) |
|
|
| Secondary | Steady State Volume of Distribution (Vss) at Day 1 of Cycle 1 | Due to sparse pharmacokinetic schedule, Vss was not calculated. | No participants were analyzed due to sparse pharmacokinetic schedule. | Posted | Baseline, 1, 168, and 336 hours post infusion Day 1 (Cycle 1) |
|
|
| Secondary | Maximum Concentration (Cmax) at Day 1 of Cycles 5, 9, 13, 17, and 21 | Due to sparse pharmacokinetic schedule, Cmax was not calculated. | No participants were analyzed due to sparse pharmacokinetic schedule. | Posted | Baseline and 1 hour post infusion on Day 1 (Cycles 5, 9, 13, 17, and 21) |
|
|
| Secondary | Area Under the Concentration (AUC) at Day 1 of Cycles 5, 9, 13, 17, and 21 | Due to sparse pharmacokinetic schedule, AUC was not calculated. | No participants were analyzed due to sparse pharmacokinetic schedule. | Posted | Baseline and 1 hour post infusion on Day 1 (Cycles 5, 9, 13, 17, and 21) |
|
|
| Secondary | Half-Life (t1/2) at Day 1 of Cycles 5, 9, 13, 17, and 21 | Due to sparse pharmacokinetic schedule, t1/2 was not calculated. | No participants were analyzed due to sparse pharmacokinetic schedule. | Posted | Baseline and 1 hour post infusion on Day 1 (Cycles 5, 9, 13, 17, and 21) |
|
|
| Secondary | Clearance (CL) at Day 1 of Cycles 5, 9, 13, 17, and 21 | Due to sparse pharmacokinetic schedule, CL was not calculated. | No participants were analyzed due to sparse pharmacokinetic schedule. | Posted | Baseline and 1 hour post infusion on Day 1 (Cycles 5, 9, 13, 17, and 21) |
|
|
| Secondary | Steady State Volume of Distribution (Vss) at Day 1 of Cycles 5, 9, 13, 17, and 21 | Due to sparse pharmacokinetic schedule, Vss was not calculated. | No participants were analyzed due to sparse pharmacokinetic schedule. | Posted | Baseline and 1 hour post infusion on Day 1 (Cycles 5, 9, 13, 17, and 21) |
|
|
| Secondary | Serum Anti-IMC-1121B (Immunogenicity) at Day 1 | Data presented are the number of participants with treatment emergent anti-IMC-112B antibodies. | All participants who received any amount of study drug and had serum Anti-IMC-1121B (ramucirumab) evaluated. | Posted | Number | participants | Day 1 (Cycles 1, 5, 9, and 30-day follow-up) |
|
|
|
| 18 |
| 48 |
| 47 |
| 48 |
| FEBRILE NEUTROPENIA | Blood and lymphatic system disorders | MedDRA 12.0 | Systematic Assessment |
|
| NEUTROPENIA | Blood and lymphatic system disorders | MedDRA 12.0 | Systematic Assessment |
|
| ACUTE MYOCARDIAL INFARCTION | Cardiac disorders | MedDRA 12.0 | Systematic Assessment | Event resulted in death and occurred within 30 days of last dose |
|
| CARDIO-RESPIRATORY ARREST | Cardiac disorders | MedDRA 12.0 | Systematic Assessment | Event resulted in death and occurred within 30 days of last dose |
|
| ABDOMINAL PAIN | Gastrointestinal disorders | MedDRA 12.0 | Systematic Assessment |
|
| DIARRHOEA | Gastrointestinal disorders | MedDRA 12.0 | Systematic Assessment |
|
| INTESTINAL OBSTRUCTION | Gastrointestinal disorders | MedDRA 12.0 | Systematic Assessment |
|
| DISEASE PROGRESSION | General disorders | MedDRA 12.0 | Systematic Assessment |
|
| PYREXIA | General disorders | MedDRA 12.0 | Systematic Assessment |
|
| ABDOMINAL ABSCESS | Infections and infestations | MedDRA 12.0 | Systematic Assessment |
|
| ANAL ABSCESS | Infections and infestations | MedDRA 12.0 | Systematic Assessment |
|
| HAEMOPHILUS INFECTION | Infections and infestations | MedDRA 12.0 | Systematic Assessment |
|
| PELVIC ABSCESS | Infections and infestations | MedDRA 12.0 | Systematic Assessment |
|
| PNEUMONIA | Infections and infestations | MedDRA 12.0 | Systematic Assessment |
|
| UROSEPSIS | Infections and infestations | MedDRA 12.0 | Systematic Assessment |
|
| HIP FRACTURE | Injury, poisoning and procedural complications | MedDRA 12.0 | Systematic Assessment |
|
| NEPHROTIC SYNDROME | Renal and urinary disorders | MedDRA 12.0 | Systematic Assessment |
|
| OVARIAN TORSION | Reproductive system and breast disorders | MedDRA 12.0 | Systematic Assessment |
|
| HYPOXIA | Respiratory, thoracic and mediastinal disorders | MedDRA 12.0 | Systematic Assessment |
|
| PULMONARY EMBOLISM | Respiratory, thoracic and mediastinal disorders | MedDRA 12.0 | Systematic Assessment |
|
| DEEP VEIN THROMBOSIS | Vascular disorders | MedDRA 12.0 | Systematic Assessment |
|
| JUGULAR VEIN THROMBOSIS | Vascular disorders | MedDRA 12.0 | Systematic Assessment |
|
| HAEMOGLOBINAEMIA | Blood and lymphatic system disorders | MedDRA 12.0 | Systematic Assessment |
|
| LEUKOPENIA | Blood and lymphatic system disorders | MedDRA 12.0 | Systematic Assessment |
|
| NEUTROPENIA | Blood and lymphatic system disorders | MedDRA 12.0 | Systematic Assessment |
|
| THROMBOCYTOPENIA | Blood and lymphatic system disorders | MedDRA 12.0 | Systematic Assessment |
|
| CONJUNCTIVITIS | Eye disorders | MedDRA 12.0 | Systematic Assessment |
|
| ABDOMINAL PAIN | Gastrointestinal disorders | MedDRA 12.0 | Systematic Assessment |
|
| CONSTIPATION | Gastrointestinal disorders | MedDRA 12.0 | Systematic Assessment |
|
| DIARRHOEA | Gastrointestinal disorders | MedDRA 12.0 | Systematic Assessment |
|
| DYSPEPSIA | Gastrointestinal disorders | MedDRA 12.0 | Systematic Assessment |
|
| FLATULENCE | Gastrointestinal disorders | MedDRA 12.0 | Systematic Assessment |
|
| HAEMORRHOIDS | Gastrointestinal disorders | MedDRA 12.0 | Systematic Assessment |
|
| NAUSEA | Gastrointestinal disorders | MedDRA 12.0 | Systematic Assessment |
|
| PROCTALGIA | Gastrointestinal disorders | MedDRA 12.0 | Systematic Assessment |
|
| RECTAL HAEMORRHAGE | Gastrointestinal disorders | MedDRA 12.0 | Systematic Assessment |
|
| STOMATITIS | Gastrointestinal disorders | MedDRA 12.0 | Systematic Assessment |
|
| VOMITING | Gastrointestinal disorders | MedDRA 12.0 | Systematic Assessment |
|
| ASTHENIA | General disorders | MedDRA 12.0 | Systematic Assessment |
|
| FATIGUE | General disorders | MedDRA 12.0 | Systematic Assessment |
|
| INFUSION RELATED REACTION | General disorders | MedDRA 12.0 | Systematic Assessment |
|
| MUCOSAL INFLAMMATION | General disorders | MedDRA 12.0 | Systematic Assessment |
|
| OEDEMA PERIPHERAL | General disorders | MedDRA 12.0 | Systematic Assessment |
|
| PYREXIA | General disorders | MedDRA 12.0 | Systematic Assessment |
|
| NASOPHARYNGITIS | Infections and infestations | MedDRA 12.0 | Systematic Assessment |
|
| RESPIRATORY TRACT INFECTION | Infections and infestations | MedDRA 12.0 | Systematic Assessment |
|
| URINARY TRACT INFECTION | Infections and infestations | MedDRA 12.0 | Systematic Assessment |
|
| ALANINE AMINOTRANSFERASE INCREASED | Investigations | MedDRA 12.0 | Systematic Assessment |
|
| ASPARTATE AMINOTRANSFERASE INCREASED | Investigations | MedDRA 12.0 | Systematic Assessment |
|
| GAMMA-GLUTAMYLTRANSFERASE INCREASED | Investigations | MedDRA 12.0 | Systematic Assessment |
|
| WEIGHT DECREASED | Investigations | MedDRA 12.0 | Systematic Assessment |
|
| ANOREXIA | Metabolism and nutrition disorders | MedDRA 12.0 | Systematic Assessment |
|
| ARTHRALGIA | Musculoskeletal and connective tissue disorders | MedDRA 12.0 | Systematic Assessment |
|
| BACK PAIN | Musculoskeletal and connective tissue disorders | MedDRA 12.0 | Systematic Assessment |
|
| PAIN IN EXTREMITY | Musculoskeletal and connective tissue disorders | MedDRA 12.0 | Systematic Assessment |
|
| DIZZINESS | Nervous system disorders | MedDRA 12.0 | Systematic Assessment |
|
| DYSAESTHESIA | Nervous system disorders | MedDRA 12.0 | Systematic Assessment |
|
| DYSGEUSIA | Nervous system disorders | MedDRA 12.0 | Systematic Assessment |
|
| HEADACHE | Nervous system disorders | MedDRA 12.0 | Systematic Assessment |
|
| HYPOAESTHESIA | Nervous system disorders | MedDRA 12.0 | Systematic Assessment |
|
| NEUROPATHY PERIPHERAL | Nervous system disorders | MedDRA 12.0 | Systematic Assessment |
|
| NEUROTOXICITY | Nervous system disorders | MedDRA 12.0 | Systematic Assessment |
|
| PARAESTHESIA | Nervous system disorders | MedDRA 12.0 | Systematic Assessment |
|
| PERIPHERAL SENSORY NEUROPATHY | Nervous system disorders | MedDRA 12.0 | Systematic Assessment |
|
| INSOMNIA | Psychiatric disorders | MedDRA 12.0 | Systematic Assessment |
|
| DYSURIA | Renal and urinary disorders | MedDRA 12.0 | Systematic Assessment |
|
| HAEMATURIA | Renal and urinary disorders | MedDRA 12.0 | Systematic Assessment |
|
| PROTEINURIA | Renal and urinary disorders | MedDRA 12.0 | Systematic Assessment |
|
| COUGH | Respiratory, thoracic and mediastinal disorders | MedDRA 12.0 | Systematic Assessment |
|
| DYSAESTHESIA PHARYNX | Respiratory, thoracic and mediastinal disorders | MedDRA 12.0 | Systematic Assessment |
|
| DYSPHONIA | Respiratory, thoracic and mediastinal disorders | MedDRA 12.0 | Systematic Assessment |
|
| DYSPNOEA | Respiratory, thoracic and mediastinal disorders | MedDRA 12.0 | Systematic Assessment |
|
| EPISTAXIS | Respiratory, thoracic and mediastinal disorders | MedDRA 12.0 | Systematic Assessment |
|
| RHINORRHOEA | Respiratory, thoracic and mediastinal disorders | MedDRA 12.0 | Systematic Assessment |
|
| ALOPECIA | Skin and subcutaneous tissue disorders | MedDRA 12.0 | Systematic Assessment |
|
| DERMATITIS ACNEIFORM | Skin and subcutaneous tissue disorders | MedDRA 12.0 | Systematic Assessment |
|
| ERYTHEMA | Skin and subcutaneous tissue disorders | MedDRA 12.0 | Systematic Assessment |
|
| PALMAR-PLANTAR ERYTHRODYSAESTHESIA SYNDROME | Skin and subcutaneous tissue disorders | MedDRA 12.0 | Systematic Assessment |
|
| HYPERTENSION | Vascular disorders | MedDRA 12.0 | Systematic Assessment |
|
Investigators agreed to delay independently publishing or disclosing data, findings or conclusions from the study except as part of a multi-center publication. Upon study publication or if the draft publication is not produced within approximately 6 months of the final report of the study results, investigators may independently publish, subject to confidential information review/redaction by sponsor. The sponsor may request publication delay up to 90 days to seek patent protection.
| D009369 | Neoplasms |
| D004066 | Digestive System Diseases |
| D005767 | Gastrointestinal Diseases |
| D003108 | Colonic Diseases |
| D007410 | Intestinal Diseases |
| D012002 | Rectal Diseases |
| D007162 |
| Immunoproteins |
| D001798 | Blood Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D012712 | Serum Globulins |
| D005916 | Globulins |
| D056831 | Coordination Complexes |
| D009930 | Organic Chemicals |
| D005575 | Formyltetrahydrofolates |
| D013763 | Tetrahydrofolates |
| D005492 | Folic Acid |
| D011622 | Pterins |
| D011621 | Pteridines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
| D003067 | Coenzymes |
| D045762 | Enzymes and Coenzymes |
| D014498 | Uracil |
| D011744 | Pyrimidinones |
| D011743 | Pyrimidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| Title | Measurements |
|---|---|
|
| Related AE leading to discontinuation |
|
| Title | Measurements |
|---|---|
|
| 30-day Follow-up (n=17) |
|