Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| 2006-003147-23 | EudraCT Number | ||
| CP11-0602 | Other Identifier | ImClone Systems | |
| I4X-IE-JFCD | Other Identifier | Eli Lilly and Company |
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The purpose of this study is to determine if IMC-11F8 in combination with chemotherapy is effective in treating colorectal cancer (CRC).
The purpose of this study is to evaluate the anti-tumor activity (best overall response) of the anti-epidermal growth factor receptor (EGFR) monoclonal antibody IMC-11F8 administered in combination with mFOLFOX-6 chemotherapy regimen in treatment-naive, locally-advanced or metastatic CRC participants.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| IMC-11F8 (necitumumab) /mFOLFOX-6 regimen | Experimental | Participants will receive IMC-11F8 (necitumumab) once every 2 weeks in combination with the mFOLFOX-6 regimen (oxaliplatin/5-FU/FA) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| IMC-11F8 (necitumumab) | Biological | IMC-11F8 800 milligrams (mg) intravenous (IV) infusion over 50 minutes on Day 1 |
|
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants With Complete Response (CR) or Partial Response (PR) (Objective Response ) | CR and PR defined using Response Evaluation Criteria In Solid Tumors (RECIST) version (v) 1.0 criteria. CR was defined as the disappearance of all target and non-target lesions and PR defined as a ≥30% decrease in the sum of the longest diameters (LD) of the target lesions, taking as reference the baseline sum of the LD. Percentage of participants was calculated as: (total number of participants with CR or PR from start of the treatment until disease progression or recurrence) / (total number of participants treated) * 100. | Up to 30 Months |
| Measure | Description | Time Frame |
|---|---|---|
| Overall Survival (OS) | OS was defined as the duration from the date of first dose to the date of death from any cause. OS was estimated by the Kaplan-Meier method. Participants who were alive at the time of the data inclusion cutoff or lost to follow-up, OS was censored at the last contact. | First dose to date of death from any cause up to 30 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST) | Eli Lilly and Company | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| ImClone Investigational Site | Brussels | 1000 | Belgium | |||
| ImClone Investigational Site |
Participants with known best overall response and off study treatment were considered to be completed.
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| ID | Title | Description |
|---|---|---|
| FG000 | IMC-11F8 (Necitumumab) + mFOLFOX-6 | On Day 1 of each 2-week cycle, each participant received IMC-11F8 (necitumumab) in combination with the mFOLFOX-6 regimen (oxaliplatin/5-FU/FA) in the order shown:
|
| Title | Milestones | Reasons Not Completed | |||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
All enrolled participants who received any quantity of study drug.
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | IMC-11F8 (Necitumumab) + mFOLFOX-6 | On Day 1 of each 2-week cycle, each participant received IMC-11F8 (necitumumab) in combination with the mFOLFOX-6 regimen (oxaliplatin/5-FU/FA) in the order shown:
|
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Percentage of Participants With Complete Response (CR) or Partial Response (PR) (Objective Response ) | CR and PR defined using Response Evaluation Criteria In Solid Tumors (RECIST) version (v) 1.0 criteria. CR was defined as the disappearance of all target and non-target lesions and PR defined as a ≥30% decrease in the sum of the longest diameters (LD) of the target lesions, taking as reference the baseline sum of the LD. Percentage of participants was calculated as: (total number of participants with CR or PR from start of the treatment until disease progression or recurrence) / (total number of participants treated) * 100. | All enrolled participants who received any quantity of study drug. | Posted | Number | 95% Confidence Interval | percentage of participants | Up to 30 Months |
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | IMC-11F8 (Necitumumab) + mFOLFOX-6 | On Day 1 of each 2-week cycle, each participant received IMC-11F8 (necitumumab) in combination with the mFOLFOX-6 regimen (oxaliplatin/5-FU/FA) in the order shown:
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Febrile neutropenia | Blood and lymphatic system disorders | MedDRA 13.0 | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | MedDRA 13.0 | 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 |
| ID | Term |
|---|---|
| D007414 | Intestinal Neoplasms |
| D005770 | Gastrointestinal Neoplasms |
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
Not provided
Not provided
| ID | Term |
|---|---|
| C527969 | necitumumab |
| D000077150 | Oxaliplatin |
| D002955 | Leucovorin |
| D005472 | Fluorouracil |
| ID | Term |
|---|---|
| D056831 | Coordination Complexes |
| D009930 | Organic Chemicals |
| D005575 | Formyltetrahydrofolates |
| D013763 | Tetrahydrofolates |
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| Oxaliplatin | Drug | Oxaliplatin 85 milligrams per meter square (mg/m²) IV infusion over 2 hours on Day 1 |
|
| Folinic acid (FA) | Drug | FA 400 mg/m² IV infusion bolus injection |
|
| 5-FU | Drug | 5-FU 400 mg/m² as a bolus followed by 2400 mg/m² IV continuous infusion over 46 hours |
|
| Progression-Free Survival (PFS) | PFS was 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 determined using RECIST v1.0 criteria. PD was defined as ≥20% increase in the sum of LD of target lesions, taking as reference the smallest sum of the LD recorded since treatment started or the appearance of new lesions and/or unequivocal progression of existing nontarget lesions. PFS was estimated by the Kaplan-Meier method. Participants who had no PD or death at the time of the data inclusion cutoff, PFS was censored at their last tumor assessment prior to the earliest of the following events: 2 or more missed visits, additional cancer treatment or the end of the follow-up period. | First dose to measured PD or death up to 30 months |
| Number of Participants With Adverse Events (AEs), Serious AEs (SAEs) or Death | The number of participants who experienced AEs, SAEs or death during the study and within 30 days of last dose. A summary of SAEs and other non-serious AEs, regardless of causality, is located in the Reported Adverse Events module. | First dose to end of treatment and 30-day post treatment follow-up up to 31 months |
| Duration of Response | The duration of response was defined as the time from first confirmed CR or PR to the first time of PD or death due to any cause. CR, PR and PD were defined using RECIST v1.0 criteria. CR was defined as the disappearance of all target and non-target lesions; PR was defined as a ≥30% decrease in the sum of the LD of the target lesions, taking as reference the baseline sum of the LD; PD was defined as a ≥20% increase in the sum of LD of target lesions, taking as reference the smallest sum of the LD recorded since treatment started or the appearance of new lesions and/or unequivocal progression of existing nontarget lesions. Participants with CR or PR who had no PD or death at the time of the data inclusion cutoff, the duration of response was censored at their last contact. | Time of response to time of measured PD or death up to 30 months |
| Serum Anti-IMC-11F8 Antibody Assessment (Immunogenicity) | A participant was considered to have an anti-IMC-11F8 response if there were 2 consecutive positive samples or if the final sample tested is positive. Participants with a baseline sample positive for anti-IMC-11F8 antibodies were considered unevaluable for immunogenicity. A sample was considered positive for IMC-11F8 antibodies if it exhibited a post-baseline treatment emergent antibody level that exceeded the upper 95% confidence interval of the mean determined from the normal anti-IMC 11F8 level found in healthy treatment-naïve individuals. | Baseline up to last day of treatment plus 45 days after last treatment (127 weeks) |
| Maximum Concentration (Cmax) of IMC-11F8 at Study Day 1 of Cycle 1 | Cycle 1 Day 1 predose, immediately after infusion, and 1, 2, 4, 24, 72, 96, 144, 168 and 236 hours postdose |
| Area Under the Concentration-Time Curve From Time 0 to Infinity [AUC(0-∞)] of IMC-11F8 at Study Day 1 of Cycle 1 | Cycle 1 Day 1 predose, immediately after infusion, and 1, 2, 4, 24, 72, 96, 144, 168 and 236 hours postdose |
| Half-Life (t1/2) of IMC-11F8 at Study Day 1 of Cycle 1 | The t1/2 is the time measured for the plasma concentration of the drug to decrease by one half. | Cycle 1 Day 1 predose, immediately after infusion, and 1, 2, 4, 24, 72, 96, 144, 168 and 236 hours postdose |
| Clearance (CL) of IMC-11F8 at Study Day 1 of Cycle 1 | CL is the volume of plasma (or blood) from which the drug is completely removed, or cleared, in a given time. | Cycle 1 Day 1 predose, immediately after infusion, and 1, 2, 4, 24, 72, 96, 144, 168 and 236 hours postdose |
| Volume of Distribution (Vss) of IMC-11F8 at Study Day 1 of Cycle 1 | Vss is defined as the theoretical volume in which the total amount of drug would need to be uniformly distributed to produce the desired blood concentration of a drug at steady-state. | Cycle 1 Day 1 predose, immediately after infusion, and 1, 2, 4, 24, 72, 96, 144, 168 and 236 hours postdose |
| Cmax at Study Day 1 of Cycles 2 Through 6 | Day 1 Cycles 2 through 6 predose and 1 hour postdose |
| Area Under the Curve (AUC) at Study Day 1 of Cycles 2 Through 6 | Day 1 Cycles 2 through 6 predose and 1 hour postdose |
| t1/2 at Study Day 1 of Cycles 2 Through 6 | Day 1 Cycles 2 through 6 predose and 1 hour post dose |
| CL at Study Day 1 of Cycles 2 Through 6 | Day 1 Cycles 2 through 6 predose and 1 hour postdose |
| Vss at Study Day 1 of Cycles 2 Through 6 | Day 1 Cycles 2 through 6 predose and 1 hour postdose |
| Change From Baseline in Tumor Size | Baseline, 29 Months |
| Kirsten Rat Sarcoma (KRAS) Mutation Status | Tumor tissues collected prior to study drug administration were evaluated for the presence or absence of KRAS mutations by a retrospective analysis. | Baseline |
| Haine-Saint-Paul |
| 7100 |
| Belgium |
| ImClone Investigational Site | Barcelona | 08035 | Spain |
| ImClone Investigational Site | Madrid | 28040 | Spain |
| ImClone Investigational Site | Valencia | 46010 | Spain |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
|
|
| Secondary | Overall Survival (OS) | OS was defined as the duration from the date of first dose to the date of death from any cause. OS was estimated by the Kaplan-Meier method. Participants who were alive at the time of the data inclusion cutoff or lost to follow-up, OS was censored at the last contact. | All enrolled participants who received any quantity of study drug. Participants censored =14. | Posted | Median | 95% Confidence Interval | months | First dose to date of death from any cause up to 30 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 due to any cause. Progressive disease (PD) was determined using RECIST v1.0 criteria. PD was defined as ≥20% increase in the sum of LD of target lesions, taking as reference the smallest sum of the LD recorded since treatment started or the appearance of new lesions and/or unequivocal progression of existing nontarget lesions. PFS was estimated by the Kaplan-Meier method. Participants who had no PD or death at the time of the data inclusion cutoff, PFS was censored at their last tumor assessment prior to the earliest of the following events: 2 or more missed visits, additional cancer treatment or the end of the follow-up period. | All enrolled participants who received any quantity of study drug. Participants censored =13. | Posted | Median | 95% Confidence Interval | months | First dose to measured PD or death up to 30 months |
|
|
|
| Secondary | Number of Participants With Adverse Events (AEs), Serious AEs (SAEs) or Death | The number of participants who experienced AEs, SAEs or death during the study and within 30 days of last dose. A summary of SAEs and other non-serious AEs, regardless of causality, is located in the Reported Adverse Events module. | All enrolled participants who received any quantity of study drug. | Posted | Number | participants | First dose to end of treatment and 30-day post treatment follow-up up to 31 months |
|
|
|
| Secondary | Duration of Response | The duration of response was defined as the time from first confirmed CR or PR to the first time of PD or death due to any cause. CR, PR and PD were defined using RECIST v1.0 criteria. CR was defined as the disappearance of all target and non-target lesions; PR was defined as a ≥30% decrease in the sum of the LD of the target lesions, taking as reference the baseline sum of the LD; PD was defined as a ≥20% increase in the sum of LD of target lesions, taking as reference the smallest sum of the LD recorded since treatment started or the appearance of new lesions and/or unequivocal progression of existing nontarget lesions. Participants with CR or PR who had no PD or death at the time of the data inclusion cutoff, the duration of response was censored at their last contact. | All enrolled participants who received any quantity of study drug and had confirmed CR or PR. Participants censored =2. | Posted | Median | 95% Confidence Interval | months | Time of response to time of measured PD or death up to 30 months |
|
|
|
| Secondary | Serum Anti-IMC-11F8 Antibody Assessment (Immunogenicity) | A participant was considered to have an anti-IMC-11F8 response if there were 2 consecutive positive samples or if the final sample tested is positive. Participants with a baseline sample positive for anti-IMC-11F8 antibodies were considered unevaluable for immunogenicity. A sample was considered positive for IMC-11F8 antibodies if it exhibited a post-baseline treatment emergent antibody level that exceeded the upper 95% confidence interval of the mean determined from the normal anti-IMC 11F8 level found in healthy treatment-naïve individuals. | All participants who received any amount of study drug and were IMC-11F8 antibody negative at baseline. | Posted | Number | participants | Baseline up to last day of treatment plus 45 days after last treatment (127 weeks) |
|
|
|
| Secondary | Maximum Concentration (Cmax) of IMC-11F8 at Study Day 1 of Cycle 1 | All enrolled participants who received any quantity of study drug and had pharmacokinetic (PK) data available to calculate Cmax. | Posted | Geometric Mean | Geometric Coefficient of Variation | micrograms/milliliter (µg/mL) | Cycle 1 Day 1 predose, immediately after infusion, and 1, 2, 4, 24, 72, 96, 144, 168 and 236 hours postdose |
|
|
|
| Secondary | Area Under the Concentration-Time Curve From Time 0 to Infinity [AUC(0-∞)] of IMC-11F8 at Study Day 1 of Cycle 1 | All enrolled participants who received any quantity of study drug and had PK data available to calculate AUC(0-∞). | Posted | Geometric Mean | Geometric Coefficient of Variation | micrograms*hour/milliliter (µg*h/mL)] | Cycle 1 Day 1 predose, immediately after infusion, and 1, 2, 4, 24, 72, 96, 144, 168 and 236 hours postdose |
|
|
|
| Secondary | Half-Life (t1/2) of IMC-11F8 at Study Day 1 of Cycle 1 | The t1/2 is the time measured for the plasma concentration of the drug to decrease by one half. | All enrolled participants who received any quantity of study drug and had PK data available to calculate t1/2. | Posted | Geometric Mean | Full Range | hours (h) | Cycle 1 Day 1 predose, immediately after infusion, and 1, 2, 4, 24, 72, 96, 144, 168 and 236 hours postdose |
|
|
|
| Secondary | Clearance (CL) of IMC-11F8 at Study Day 1 of Cycle 1 | CL is the volume of plasma (or blood) from which the drug is completely removed, or cleared, in a given time. | All enrolled participants who received any quantity of study drug and had PK data available to calculate CL. | Posted | Geometric Mean | Geometric Coefficient of Variation | milliliters/hour (mL/h) | Cycle 1 Day 1 predose, immediately after infusion, and 1, 2, 4, 24, 72, 96, 144, 168 and 236 hours postdose |
|
|
|
| Secondary | Volume of Distribution (Vss) of IMC-11F8 at Study Day 1 of Cycle 1 | Vss is defined as the theoretical volume in which the total amount of drug would need to be uniformly distributed to produce the desired blood concentration of a drug at steady-state. | All enrolled participants who received any quantity of study drug and had PK data available to calculate Vss. | Posted | Geometric Mean | Geometric Coefficient of Variation | milliliters (mL) | Cycle 1 Day 1 predose, immediately after infusion, and 1, 2, 4, 24, 72, 96, 144, 168 and 236 hours postdose |
|
|
|
| Secondary | Cmax at Study Day 1 of Cycles 2 Through 6 | Zero participants were analyzed, Cmax results were not collected. | Posted | Day 1 Cycles 2 through 6 predose and 1 hour postdose |
|
|
| Secondary | Area Under the Curve (AUC) at Study Day 1 of Cycles 2 Through 6 | Zero participants were analyzed, AUC results were not collected. | Posted | Day 1 Cycles 2 through 6 predose and 1 hour postdose |
|
|
| Secondary | t1/2 at Study Day 1 of Cycles 2 Through 6 | Zero participants were analyzed, t1/2 results were not collected. | Posted | Day 1 Cycles 2 through 6 predose and 1 hour post dose |
|
|
| Secondary | CL at Study Day 1 of Cycles 2 Through 6 | Zero participants were analyzed, CL results were not collected. | Posted | Day 1 Cycles 2 through 6 predose and 1 hour postdose |
|
|
| Secondary | Vss at Study Day 1 of Cycles 2 Through 6 | Zero participants were analyzed, Vss results were not collected. | Posted | Day 1 Cycles 2 through 6 predose and 1 hour postdose |
|
|
| Secondary | Change From Baseline in Tumor Size | Zero participants were analyzed, the outcome measure was registered in error. | Posted | Baseline, 29 Months |
|
|
| Secondary | Kirsten Rat Sarcoma (KRAS) Mutation Status | Tumor tissues collected prior to study drug administration were evaluated for the presence or absence of KRAS mutations by a retrospective analysis. | All enrolled participants who had assessment of tumor tissue samples at baseline. | Posted | Number | participants | Baseline |
|
|
|
| 16 |
| 44 |
| 44 |
| 44 |
| Abdominal pain | Gastrointestinal disorders | MedDRA 13.0 | Systematic Assessment |
|
| Diarrhoea | Gastrointestinal disorders | MedDRA 13.0 | Systematic Assessment |
|
| Gastrointestinal obstruction | Gastrointestinal disorders | MedDRA 13.0 | Systematic Assessment |
|
| Intestinal obstruction | Gastrointestinal disorders | MedDRA 13.0 | Systematic Assessment |
|
| Large intestine perforation | Gastrointestinal disorders | MedDRA 13.0 | Systematic Assessment |
|
| Rectal haemorrhage | Gastrointestinal disorders | MedDRA 13.0 | Systematic Assessment |
|
| Vomiting | Gastrointestinal disorders | MedDRA 13.0 | Systematic Assessment |
|
| General physical health deterioration | General disorders | MedDRA 13.0 | Systematic Assessment |
|
| Medical device complication | General disorders | MedDRA 13.0 | Systematic Assessment |
|
| Pyrexia | General disorders | MedDRA 13.0 | Systematic Assessment |
|
| Thrombosis in device | General disorders | MedDRA 13.0 | Systematic Assessment |
|
| Hypersensitivity | Immune system disorders | MedDRA 13.0 | Systematic Assessment |
|
| Sepsis | Infections and infestations | MedDRA 13.0 | Systematic Assessment |
|
| Muscular weakness | Musculoskeletal and connective tissue disorders | MedDRA 13.0 | Systematic Assessment |
|
| Confusional state | Psychiatric disorders | MedDRA 13.0 | Systematic Assessment |
|
| Organising pneumonia | Respiratory, thoracic and mediastinal disorders | MedDRA 13.0 | Systematic Assessment |
|
| Respiratory failure | Respiratory, thoracic and mediastinal disorders | MedDRA 13.0 | Systematic Assessment |
|
| Neutropenia | Blood and lymphatic system disorders | MedDRA 13.0 | Systematic Assessment |
|
| Thrombocytopenia | Blood and lymphatic system disorders | MedDRA 13.0 | Systematic Assessment |
|
| Conjunctivitis | Eye disorders | MedDRA 13.0 | Systematic Assessment |
|
| Abdominal pain | Gastrointestinal disorders | MedDRA 13.0 | Systematic Assessment |
|
| Abdominal pain upper | Gastrointestinal disorders | MedDRA 13.0 | Systematic Assessment |
|
| Constipation | Gastrointestinal disorders | MedDRA 13.0 | Systematic Assessment |
|
| Diarrhoea | Gastrointestinal disorders | MedDRA 13.0 | Systematic Assessment |
|
| Dyspepsia | Gastrointestinal disorders | MedDRA 13.0 | Systematic Assessment |
|
| Nausea | Gastrointestinal disorders | MedDRA 13.0 | Systematic Assessment |
|
| Oesophagitis | Gastrointestinal disorders | MedDRA 13.0 | Systematic Assessment |
|
| Rectal tenesmus | Gastrointestinal disorders | MedDRA 13.0 | Systematic Assessment |
|
| Stomatitis | Gastrointestinal disorders | MedDRA 13.0 | Systematic Assessment |
|
| Vomiting | Gastrointestinal disorders | MedDRA 13.0 | Systematic Assessment |
|
| Asthenia | General disorders | MedDRA 13.0 | Systematic Assessment |
|
| Fatigue | General disorders | MedDRA 13.0 | Systematic Assessment |
|
| Mucosal inflammation | General disorders | MedDRA 13.0 | Systematic Assessment |
|
| Pyrexia | General disorders | MedDRA 13.0 | Systematic Assessment |
|
| Hypersensitivity | Immune system disorders | MedDRA 13.0 | Systematic Assessment |
|
| Paronychia | Infections and infestations | MedDRA 13.0 | Systematic Assessment |
|
| Respiratory tract infection | Infections and infestations | MedDRA 13.0 | Systematic Assessment |
|
| Urinary tract infection | Infections and infestations | MedDRA 13.0 | Systematic Assessment |
|
| Weight decreased | Investigations | MedDRA 13.0 | Systematic Assessment |
|
| Weight increased | Investigations | MedDRA 13.0 | Systematic Assessment |
|
| Decreased appetite | Metabolism and nutrition disorders | MedDRA 13.0 | Systematic Assessment |
|
| Hypomagnesaemia | Metabolism and nutrition disorders | MedDRA 13.0 | Systematic Assessment |
|
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA 13.0 | Systematic Assessment |
|
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA 13.0 | Systematic Assessment |
|
| Pain in extremity | Musculoskeletal and connective tissue disorders | MedDRA 13.0 | Systematic Assessment |
|
| Dysaesthesia | Nervous system disorders | MedDRA 13.0 | Systematic Assessment |
|
| Dysgeusia | Nervous system disorders | MedDRA 13.0 | Systematic Assessment |
|
| Headache | Nervous system disorders | MedDRA 13.0 | Systematic Assessment |
|
| Neuropathy peripheral | Nervous system disorders | MedDRA 13.0 | Systematic Assessment |
|
| Neurotoxicity | Nervous system disorders | MedDRA 13.0 | Systematic Assessment |
|
| Paraesthesia | Nervous system disorders | MedDRA 13.0 | Systematic Assessment |
|
| Peripheral sensory neuropathy | Nervous system disorders | MedDRA 13.0 | Systematic Assessment |
|
| Insomnia | Psychiatric disorders | MedDRA 13.0 | Systematic Assessment |
|
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA 13.0 | Systematic Assessment |
|
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA 13.0 | Systematic Assessment |
|
| Epistaxis | Respiratory, thoracic and mediastinal disorders | MedDRA 13.0 | Systematic Assessment |
|
| Alopecia | Skin and subcutaneous tissue disorders | MedDRA 13.0 | Systematic Assessment |
|
| Dermatitis acneiform | Skin and subcutaneous tissue disorders | MedDRA 13.0 | Systematic Assessment |
|
| Dry skin | Skin and subcutaneous tissue disorders | MedDRA 13.0 | Systematic Assessment |
|
| Palmar-plantar erythrodysaesthesia syndrome | Skin and subcutaneous tissue disorders | MedDRA 13.0 | Systematic Assessment |
|
| Pruritus | Skin and subcutaneous tissue disorders | MedDRA 13.0 | Systematic Assessment |
|
| Rash | Skin and subcutaneous tissue disorders | MedDRA 13.0 | Systematic Assessment |
|
| Skin fissures | Skin and subcutaneous tissue disorders | MedDRA 13.0 | Systematic Assessment |
|
| Hypotension | Vascular disorders | MedDRA 13.0 | 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 |
| 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 |
|---|
|