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This study will evaluate the efficacy of Octreotide LAR in preventing chemotherapy-induced diarrhea (with regimens that contain 5 fluorouracil, irinotecan and capecitabine)in patients with colorectal cancer.
Eligible patients will have a diagnosis of colorectal cancer, and will be candidates to adjuvant chemotherapy or first-line chemotherapy for metastatic disease with a regimen containing fluorouracil, capecitabine and/or irinotecan. Eligible chemotherapy regimens include Irinotecan, Leucovorin (folinic acid), and Fluorouracil(IFL), Leucovorin, Fluorouracil, and Irinotecan (FOLFIRI), combinations of Irinotecan and Capecitabine, the Roswell Park regimen and the Mayo Clinic regimen, all of them without or with Oxaliplatin, Bevacizumab or Cetuximab. Patients receiving Erlotinib, or other Tyrosine-kinase, Epidermal Growth Factor Receptor (EGFR)-inhibitors, will not be eligible.
The acute treatment for diarrhea will be left to physician's discretion in both groups. Patients in the control arm will be treated without Octreotide LAR. Patients in the experimental arm will receive the first dose of Octreotide LAR (30 mg) at chemotherapy initiation, in addition to a minimum of two more identical monthly doses of Octreotide LAR (with an interval of 28 days between them), until chemotherapy is discontinued or for a maximum of six doses of Octreotide LAR, whichever occurs first. Patient evaluation will be done at each cycle for efficacy and toxicity.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Octreotide Long Acting Release | Experimental | Prevention of Chemotherapy Induced Diarrhea (CID) |
|
| Standard Treatment | Other | Physician treatment of choice for chemotherapy induced diarrhea other than Octreotide LAR. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Octreotide Long Acting Release | Drug | Patients will receive the first dose of Octreotide LAR (30 mg) at chemotherapy initiation, in addition to a minimum of two more identical monthly doses of Octreotide LAR (with an interval of 28 days between them), until first-line chemotherapy is discontinued or for a maximum of six doses of Octreotide LAR, whichever occurs first. |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants Developing Diarrhea (Grade 1 to 4) | The percentage of patients developing diarrhea (incidence of grade 1 to 4) during treatment, considering only the worst grade of diarrhea for each patient. Diarrhea was graded according to Common Toxicity Criteria where Grade 0=None, 1 = Increase of <4 stools/day over pretreatment, Grade 2 = Increase of 4-6 stools/day, or nocturnal stools, Grade 3 = Increase of ≥7 stools/day or incontinence; or need for parenteral support for dehydration and Grade 4= Physiologic consequences requiring intensive care; or hemodynamic collapse. | 6 month overall |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Episodes of Diarrhea by Patient | Number of episodes of diarrhea is evaluated by patient diaries recorded on a daily basis. | 6 months overall |
| Number of Episodes of Diarrhea by Patient by Cycle |
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Inclusion criteria:
Exclusion criteria:
Other protocol-defined inclusion/exclusion criteria may apply.
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| Name | Affiliation | Role |
|---|---|---|
| Novartis Pharmaceuticals | Novartis Pharmaceuticals | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Biocâncer | Belo Horizonte | Brazil | ||||
| CEPON-Centro de Pesquisas Oncologicas |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 24516038 | Derived | Hoff PM, Saragiotto DF, Barrios CH, del Giglio A, Coutinho AK, Andrade AC, Dutra C, Forones NM, Correa M, Portella Mdo S, Passos VQ, Chinen RN, van Eyll B. Randomized phase III trial exploring the use of long-acting release octreotide in the prevention of chemotherapy-induced diarrhea in patients with colorectal cancer: the LARCID trial. J Clin Oncol. 2014 Apr 1;32(10):1006-11. doi: 10.1200/JCO.2013.50.8077. Epub 2014 Feb 10. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Octreotide Long Acting Release | Octreotide LAR 30 mg, for intramuscular injection every 28 days for 6 months beginning with the first course of chemotherapy. |
| FG001 | Standard Treatment | Physician treatment of choice for chemotherapy induced diarrhea other than Octreotide LAR. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Octreotide Long Acting Release | Octreotide LAR 30 mg, for intramuscular injection every 28 days for 6 months beginning with the first course of chemotherapy. |
| BG001 | Standard Treatment |
| 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 Developing Diarrhea (Grade 1 to 4) | The percentage of patients developing diarrhea (incidence of grade 1 to 4) during treatment, considering only the worst grade of diarrhea for each patient. Diarrhea was graded according to Common Toxicity Criteria where Grade 0=None, 1 = Increase of <4 stools/day over pretreatment, Grade 2 = Increase of 4-6 stools/day, or nocturnal stools, Grade 3 = Increase of ≥7 stools/day or incontinence; or need for parenteral support for dehydration and Grade 4= Physiologic consequences requiring intensive care; or hemodynamic collapse. | ITT population includes all registered patients. Also considered in the intent to treat population are patients withdrawn prematurely from the study due to treatment interruption for a period of 28 consecutive days or longer. 1 patient from the "Octreotide Long Acting Release" Arm discontinued due to exclusion criteria after visit 1. | Posted | Number | 95% Confidence Interval | Percentage of Participants | 6 month overall |
|
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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 | Octreotide LAR |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | MedDRA | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | MedDRA | Systematic Assessment |
Limitations were the small number of patients who received irinotecan and small proportion of patients with grade III and IV diarrhea. It is not possible to generalize our results for these populations. Study wasn't blinded or placebo-controlled.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Study Director | Novartis | 1-800-778-8300 |
| ID | Term |
|---|---|
| D015179 | Colorectal Neoplasms |
| D003967 | Diarrhea |
| ID | Term |
|---|---|
| D007414 | Intestinal Neoplasms |
| D005770 | Gastrointestinal Neoplasms |
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
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|
|
| Standard Treatment | Other | Physician treatment of choice for chemotherapy induced diarrhea other than Octreotide LAR. |
|
Mean number of episodes of diarrhea is evaluated by patient diaries recorded by cycle. (cycle 1 to cycle 7.)
| at each cycle (28 days per cycle) |
| Percentage of Patients by Grade of Diarrhea | Grade (severity) of episodes of diarrhea is evaluated by patient diaries recorded on a daily basis by considering only worse grade of diarrhea for each patient. Diarrhea was graded according to Common Toxicity Criteria where Grade 0 = None, 1 = Increase of <4 stools/day over pretreatment, Grade 2 = Increase of 4-6 stools/day, or nocturnal stools, Grade 3 = Increase of ≥7 stools/day or incontinence; or need for parenteral support for dehydration and Grade 4= Physiologic consequences requiring intensive care; or hemodynamic collapse. | 6 months overall |
| Percentage of Episodes by Grade | Grade (severity)of episodes of diarrhea is evaluated by patient diaries recorded on a daily basis by considering only worse grade of diarrhea for each patient. Diarrhea was graded according to Common Toxicity Criteria where Grade 1 = Increase of <4 stools/day over pretreatment, Grade 2 = Increase of 4-6 stools/day, or nocturnal stools, Grade 3 = Increase of ≥7 stools/day or incontinence;or need for parenteral support for dehydration and Grade 4= Physiologic consequences requiring intensive care; or hemodynamic collapse. | 6 months overall |
| Percentage of Participants Who Need Chemotherapy Dose Reduction Due to Diarrhea | For patient, chemotherapy dose reduction due to diarrhea as counted each time it occurred. Chemotherapy dose reduction because of other adverse events related to chemotherapy was not considered. | 6 months overall |
| Percentage of Participants Who Need Opioids for Control of Diarrhea | 6 months overall |
| Percentage of Patients Hospitalized Due to Diarrhea | 6 months overall |
| Percentage of Participants Who Need Intravenous Hydration for Control of Diarrhea | 6 months overall |
| Percentage of Participants With Complete or Partial Response at Response Evaluation Criteria in Solid Tumors (RECIST) | Lesions that can be accurately measured in at least one dimension (longest diameter (LD) to be recorded) as > 20 mm with conventional techniques (CT, MRI) or as > 10 mm with spiral CT scan. All measurable lesions up to maximum of 5 lesions per organ and 10 lesions in total representative of all involved organs should be identified as target lesions and recorded and measured at baseline. Complete Response is defined as Disappearance of all target lesions. Partial Response is defined at least a 30% decrease in the sum of LD of target lesions taking as reference the baseline sum LD. | Day 56, Day 84, Day 112, Day 140, Day 168 |
| Change From Baseline in Quality of Life Measured by the Functional Assessment of Chronic Illness Therapy-Diarrhea (FACIT-D) | Quality of life (QoL) is evaluated using FACIT-D scale. FACIT-D is composed of 38 items, whose responses range from 0 to 4. The total FACIT-D score may range from 0 to 152. The 38 items compose five subscales, each evaluating a different component of the (QOL). For calculating the subscale score, some items are computed in a reverse fashion, so that higher FACIT-D scores indicate a better (QoL). Descriptive statistics (mean, standard deviation, median, minimum and maximum) are used to summarize FACIT-D scores (total and subscales) by study group at each time point. | Baseline to Day 168 |
| Florianópolis |
| Brazil |
| Hospital Sao Lucas- Faculdade de Medicina da PUCRS | Porto Alegre | Brazil |
| Clínica AMO | Salvador | Brazil |
| Nucleo de Oncologia da Bahia | Salvador | Brazil |
| Faculdade de Medicina do ABC | Santo André | Brazil |
| Hosital Alemão Oswaldo Cruz | São Paulo | Brazil |
| Hospital A C Camargo/ Fundação Antonio Prudente | São Paulo | Brazil |
| Hospital das Clínicas - FMUSP | São Paulo | Brazil |
| Instituto Arnaldo Vieira de Carvalho - IAVC | São Paulo | Brazil |
| UNIFESP | São Paulo | Brazil |
| Protocol Violation |
|
| Death |
|
| Withdrawal by Subject |
|
| Disease Progression |
|
| Use of illicit drugs |
|
Physician treatment of choice for chemotherapy induced diarrhea other than Octreotide LAR.
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Octreotide Long Acting Release |
Octreotide LAR 30 mg, for intramuscular injection every 28 days for 6 months beginning with the first course of chemotherapy. |
| OG001 | Standard Treatment | Physician treatment of choice for chemotherapy induced diarrhea other than Octreotide LAR. |
|
|
| Secondary | Number of Episodes of Diarrhea by Patient | Number of episodes of diarrhea is evaluated by patient diaries recorded on a daily basis. | ITT population includes all registered patients. Also considered in the intent to treat population are patients withdrawn prematurely from the study due to treatment interruption for a period of 28 consecutive days or longer. Patients with observations during overall treatment period were included in this analysis. | Posted | Mean | Standard Deviation | Episodes/patients/day | 6 months overall |
|
|
|
| Secondary | Number of Episodes of Diarrhea by Patient by Cycle | Mean number of episodes of diarrhea is evaluated by patient diaries recorded by cycle. (cycle 1 to cycle 7.) | ITT population includes all registered patients. Also considered in the intent to treat population are patients withdrawn prematurely from the study due to treatment interruption for a period of 28 consecutive days or longer. "n" indicates patients with observations during each cycle. | Posted | Mean | Standard Deviation | Episodes/patient/cycle | at each cycle (28 days per cycle) |
|
|
|
| Secondary | Percentage of Patients by Grade of Diarrhea | Grade (severity) of episodes of diarrhea is evaluated by patient diaries recorded on a daily basis by considering only worse grade of diarrhea for each patient. Diarrhea was graded according to Common Toxicity Criteria where Grade 0 = None, 1 = Increase of <4 stools/day over pretreatment, Grade 2 = Increase of 4-6 stools/day, or nocturnal stools, Grade 3 = Increase of ≥7 stools/day or incontinence; or need for parenteral support for dehydration and Grade 4= Physiologic consequences requiring intensive care; or hemodynamic collapse. | ITT population includes all registered patients. Also considered in the intent to treat population are patients withdrawn prematurely from the study due to treatment interruption for a period of 28 consecutive days or longer. Patients with observations during overall treatment period were included in this analysis. | Posted | Number | Percentage of Participants | 6 months overall |
|
|
|
| Secondary | Percentage of Episodes by Grade | Grade (severity)of episodes of diarrhea is evaluated by patient diaries recorded on a daily basis by considering only worse grade of diarrhea for each patient. Diarrhea was graded according to Common Toxicity Criteria where Grade 1 = Increase of <4 stools/day over pretreatment, Grade 2 = Increase of 4-6 stools/day, or nocturnal stools, Grade 3 = Increase of ≥7 stools/day or incontinence;or need for parenteral support for dehydration and Grade 4= Physiologic consequences requiring intensive care; or hemodynamic collapse. | ITT population includes all registered patients. Also considered in the intent to treat population are patients withdrawn prematurely from the study due to treatment interruption for a period of 28 consecutive days or longer. | Posted | Number | Percentage of Episodes | 6 months overall | Episodes of Diarrhea | Participants |
|
|
|
| Secondary | Percentage of Participants Who Need Chemotherapy Dose Reduction Due to Diarrhea | For patient, chemotherapy dose reduction due to diarrhea as counted each time it occurred. Chemotherapy dose reduction because of other adverse events related to chemotherapy was not considered. | ITT population includes all registered patients. Also considered in the intent to treat population are patients withdrawn prematurely from the study due to treatment interruption for a period of 28 consecutive days or longer. 1 patient discontinued from the Octreotide LAR arm due to exclusion criteria after visit 1. | Posted | Number | 95% Confidence Interval | Percentage of participants | 6 months overall |
|
|
|
| Secondary | Percentage of Participants Who Need Opioids for Control of Diarrhea | ITT population includes all registered patients. Also considered in the intent to treat population are patients withdrawn prematurely from the study due to treatment interruption for a period of 28 consecutive days or longer. 1 patient from the "Octreotide Long Acting Release" Arm discontinued due to exclusion criteria after visit 1. | Posted | Number | 95% Confidence Interval | Percentage of Participants | 6 months overall |
|
|
|
| Secondary | Percentage of Patients Hospitalized Due to Diarrhea | ITT population includes all registered patients. Also considered in the intent to treat population are patients withdrawn prematurely from the study due to treatment interruption for a period of 28 consecutive days or longer. 1 patient from the "Octreotide Long Acting Release" Arm discontinued due to exclusion criteria after visit 1. | Posted | Number | Percentage of patients | 6 months overall |
|
|
|
| Secondary | Percentage of Participants Who Need Intravenous Hydration for Control of Diarrhea | ITT population includes all registered patients. Also considered in the intent to treat population are patients withdrawn prematurely from the study due to treatment interruption for a period of 28 consecutive days or longer. 1 patient from the "Octreotide Long Acting Release" Arm discontinued due to exclusion criteria after visit 1. | Posted | Number | 95% Confidence Interval | Percentage of Participants | 6 months overall |
|
|
|
| Secondary | Percentage of Participants With Complete or Partial Response at Response Evaluation Criteria in Solid Tumors (RECIST) | Lesions that can be accurately measured in at least one dimension (longest diameter (LD) to be recorded) as > 20 mm with conventional techniques (CT, MRI) or as > 10 mm with spiral CT scan. All measurable lesions up to maximum of 5 lesions per organ and 10 lesions in total representative of all involved organs should be identified as target lesions and recorded and measured at baseline. Complete Response is defined as Disappearance of all target lesions. Partial Response is defined at least a 30% decrease in the sum of LD of target lesions taking as reference the baseline sum LD. | ITT population includes all registered patients. Also considered in the intent to treat population are patients withdrawn prematurely from the study due to treatment interruption for a period of 28 consecutive days or longer. "N" in each category indicates the number of patients analyzed with observations at that timepoint. | Posted | Number | 95% Confidence Interval | Percentage of Participants | Day 56, Day 84, Day 112, Day 140, Day 168 |
|
|
|
| Secondary | Change From Baseline in Quality of Life Measured by the Functional Assessment of Chronic Illness Therapy-Diarrhea (FACIT-D) | Quality of life (QoL) is evaluated using FACIT-D scale. FACIT-D is composed of 38 items, whose responses range from 0 to 4. The total FACIT-D score may range from 0 to 152. The 38 items compose five subscales, each evaluating a different component of the (QOL). For calculating the subscale score, some items are computed in a reverse fashion, so that higher FACIT-D scores indicate a better (QoL). Descriptive statistics (mean, standard deviation, median, minimum and maximum) are used to summarize FACIT-D scores (total and subscales) by study group at each time point. | ITT population includes all registered patients. Also considered in the intent to treat population are patients withdrawn prematurely from the study due to treatment interruption for a period of 28 consecutive days or longer. | Posted | Mean | Standard Deviation | Units on a scale | Baseline to Day 168 |
|
|
|
| 15 |
| 68 |
| 63 |
| 68 |
| EG001 | Standard Treatment | 14 | 71 | 68 | 71 |
| Cardiac failure congestiv | Cardiac disorders | MedDRA | Systematic Assessment |
|
| Diabetes mellitus | Endocrine disorders | MedDRA | Systematic Assessment |
|
| Abdominal pain | Gastrointestinal disorders | MedDRA | Systematic Assessment |
|
| Abdominal pain upper | Gastrointestinal disorders | MedDRA | Systematic Assessment |
|
| Diarrhoea | Gastrointestinal disorders | MedDRA | Systematic Assessment |
|
| Gastrointestinal obstruct | Gastrointestinal disorders | MedDRA | Systematic Assessment |
|
| Intestinal obstruction | Gastrointestinal disorders | MedDRA | Systematic Assessment |
|
| Nausea | Gastrointestinal disorders | MedDRA | Systematic Assessment |
|
| Odynophagia | Gastrointestinal disorders | MedDRA | Systematic Assessment |
|
| Oesophageal ulcer | Gastrointestinal disorders | MedDRA | Systematic Assessment |
|
| Pancreatitis | Gastrointestinal disorders | MedDRA | Systematic Assessment |
|
| Vomiting | Gastrointestinal disorders | MedDRA | Systematic Assessment |
|
| Mucosal inflammation | General disorders | MedDRA | Systematic Assessment |
|
| Gastroenteritis | Infections and infestations | MedDRA | Systematic Assessment |
|
| Pyelonephritis | Infections and infestations | MedDRA | Systematic Assessment |
|
| Blood alkaline phosphatas | Investigations | MedDRA | Systematic Assessment |
|
| International normalised | Investigations | MedDRA | Systematic Assessment |
|
| Decreased appetite | Metabolism and nutrition disorders | MedDRA | Systematic Assessment |
|
| Dehydration | Metabolism and nutrition disorders | MedDRA | Systematic Assessment |
|
| Metastasis | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA | Systematic Assessment |
|
| Bronchopneumonia | Respiratory, thoracic and mediastinal disorders | MedDRA | Systematic Assessment |
|
| Pneumonia | Respiratory, thoracic and mediastinal disorders | MedDRA | Systematic Assessment |
|
| Respiratory failure | Respiratory, thoracic and mediastinal disorders | MedDRA | Systematic Assessment |
|
| Arterial occlusive diseas | Vascular disorders | MedDRA | Systematic Assessment |
|
| Deep vein thrombosis | Vascular disorders | MedDRA | Systematic Assessment |
|
| Neutropenia | Blood and lymphatic system disorders | MedDRA | Systematic Assessment |
|
| Thrombocytopenia | Blood and lymphatic system disorders | MedDRA | Systematic Assessment |
|
| Diabetes mellitus | Endocrine disorders | MedDRA | Systematic Assessment |
|
| Hypothyroidism | Endocrine disorders | MedDRA | Systematic Assessment |
|
| Lacrimation increased | Eye disorders | MedDRA | Systematic Assessment |
|
| Abdominal distension | Gastrointestinal disorders | MedDRA | Systematic Assessment |
|
| Abdominal pain | Gastrointestinal disorders | MedDRA | Systematic Assessment |
|
| Abdominal pain upper | Gastrointestinal disorders | MedDRA | Systematic Assessment |
|
| Constipation | Gastrointestinal disorders | MedDRA | Systematic Assessment |
|
| Diarrhoea | Gastrointestinal disorders | MedDRA | Systematic Assessment |
|
| Dyspepsia | Gastrointestinal disorders | MedDRA | Systematic Assessment |
|
| Gastritis | Gastrointestinal disorders | MedDRA | Systematic Assessment |
|
| Nausea | Gastrointestinal disorders | MedDRA | Systematic Assessment |
|
| Vomiting | Gastrointestinal disorders | MedDRA | Systematic Assessment |
|
| Asthenia | General disorders | MedDRA | Systematic Assessment |
|
| Fatigue | General disorders | MedDRA | Systematic Assessment |
|
| Mucosal inflammation | General disorders | MedDRA | Systematic Assessment |
|
| Mucositis | General disorders | MedDRA | Systematic Assessment |
|
| Oedema peripheral | General disorders | MedDRA | Systematic Assessment |
|
| Pain | General disorders | MedDRA | Systematic Assessment |
|
| Pyrexia | General disorders | MedDRA | Systematic Assessment |
|
| Cholelithiasis | Hepatobiliary disorders | MedDRA | Systematic Assessment |
|
| Influenza | Infections and infestations | MedDRA | Systematic Assessment |
|
| Blood alkaline phosphatas | Investigations | MedDRA | Systematic Assessment |
|
| Gamma-glutamyltransferase | Investigations | MedDRA | Systematic Assessment |
|
| Weight decreased | Investigations | MedDRA | Systematic Assessment |
|
| Decreased appetite | Metabolism and nutrition disorders | MedDRA | Systematic Assessment |
|
| Dehydration | Metabolism and nutrition disorders | MedDRA | Systematic Assessment |
|
| Hyperglycaemia | Metabolism and nutrition disorders | MedDRA | Systematic Assessment |
|
| Hypokalaemia | Metabolism and nutrition disorders | MedDRA | Systematic Assessment |
|
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA | Systematic Assessment |
|
| Musculoskeletal pain | Musculoskeletal and connective tissue disorders | MedDRA | Systematic Assessment |
|
| Dizziness | Nervous system disorders | MedDRA | Systematic Assessment |
|
| Headache | Nervous system disorders | MedDRA | Systematic Assessment |
|
| Neuropathy peripheral | Nervous system disorders | MedDRA | Systematic Assessment |
|
| Paraesthesia | Nervous system disorders | MedDRA | Systematic Assessment |
|
| Anxiety | Psychiatric disorders | MedDRA | Systematic Assessment |
|
| Insomnia | Psychiatric disorders | MedDRA | Systematic Assessment |
|
| Dysuria | Renal and urinary disorders | MedDRA | Systematic Assessment |
|
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA | Systematic Assessment |
|
| Oropharyngeal pain | Respiratory, thoracic and mediastinal disorders | MedDRA | Systematic Assessment |
|
| Skin disorder | Skin and subcutaneous tissue disorders | MedDRA | Systematic Assessment |
|
| Hypertension | Vascular disorders | MedDRA | Systematic Assessment |
|
| Hypotension | Vascular disorders | MedDRA | Systematic Assessment |
|
The terms and conditions of Novartis' agreements with its investigators may vary. However, Novartis does not prohibit any investigator from publishing. Any publications from a single-site are postponed until the publication of the pooled data (i.e. data from all sites) in the clinical trial.
| D009369 | Neoplasms |
| D004066 | Digestive System Diseases |
| D005767 | Gastrointestinal Diseases |
| D003108 | Colonic Diseases |
| D007410 | Intestinal Diseases |
| D012002 | Rectal Diseases |
| D012817 | Signs and Symptoms, Digestive |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| Cycle 3 (n=33,39) |
|
| Cycle 4 (n=24, 27) |
|
| Cycle 5 (n=20,29) |
|
| Cycle 6 (n=22, 22) |
|
| Cycle 7 (n= 16, 20) |
|
| Grade 3 |
|
| Grade 4 |
|
| Grade 3 |
|
| Grade 4 |
|
| Day 112 (N=1,1) |
|
| Day 140 (N=9,1) |
|
| Day 168 (N=2,1) |
|