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This open-label study will assess the efficacy and safety of Avastin (bevacizumab) plus Xeloda (capecitabine) in combination with standard technique radiotherapy of the pelvic region in the neo-adjuvant setting in patients with locally advanced primary rectal cancer. Patients will receive 4 courses of Avastin at a dose of 5 mg/kg intravenously (iv) every 2 weeks and for 38 days Xeloda at dose of 825 mg/kg twice daily orally, plus radiation therapy. After surgery, adjuvant treatment with 5-fluorouracil/leucovorin and, at the discretion of the investigator, with Avastin 5 mg/kg iv every 2 weeks for at least 6 months will be given.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Single Arm | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| bevacizumab [Avastin] | Drug | 5 mg/kg intravenously every 2 weeks, 4 cycles |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants With Pathological Complete Response (pCR) | pCR was defined as the absence of viable tumor cells, as determined by standard histologic procedure, in the tumor specimen (including regional lymph nodes) obtained at surgery. In order to minimize evaluation bias, tumor specimens were analyzed by both a central and local pathologist. The number of participants with pathological tumor stage 0 (pT0) and regional lymph nodes stage 0 (pN0) at surgery was determined. pCR was defined as the number of participants with pT0 and pN0 at surgery divided by the total number of participants with pathological tumor stage data collected. | 6 to 8 weeks following completion of neoadjuvant treatment |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants by Primary Tumor (T), Regional Lymph Nodes (N), and Distant Metastasis (M) Clinical Stage at Baseline and at the End of Neo-Adjuvant Treatment (NAT) | The frequencies of clinical tumor stage T (0, 1, 2, 3, 4, or X), regional lymph nodes stage N (0, 1, 2, 3, or 4), and distant metastasis clinical stage M (0, 1, or X) at baseline and at the end of NAT were assessed. The frequencies of pathological tumor stage T and regional lymph nodes stage N at surgery were evaluated. The clinical tumor and lymph node status was assessed by clinical examination, endosonography, and/or rectosigmoidoscopy, and pelvic and abdomen computerized tomography (CT) scan or magnetic resonance imaging (MRI). Response to treatment had to be assessed within 6 weeks after end of treatment by using the same techniques performed at baseline. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Clinical Trials | Hoffmann-La Roche | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Ancona | 60121 | Italy | ||||
Not provided
Not provided
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| ID | Title | Description |
|---|---|---|
| FG000 | Bevacizumab (Bv)+Capecitabine/Bv+Leucovorin+5-fluorouracil | Participants received bevacizumab 5 milligrams per kilogram (mg/kg) intravenously (IV) on Days -14, 1, 15, and 29 and capecitabine 825 milligrams per square meter (mg/m^2) orally (PO) twice daily (BID) from Days 1 to 38. Participants also received radiation therapy given at a daily fraction of 1.8 Gray (Gy) administered in 5 weekly fractions starting at Week 1 (through Week 6) for a maximum total dose of 45 Gy. Six to 8 weeks following all above treatments, participants received complete mesorectal excision surgery. After surgery, participants received bevacizumab 5 mg/kg IV on Day 1 and leucovorin 100 mg/m^2 IV (over 2 hours) followed by 5-fluorouracil (5-FU) 400 mg/m^2 IV bolus and then 5-FU 600 mg/m^2 IV (over 22 hours) on Days 1 and 2 every 2 weeks for a maximum of 12 cycles. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| capecitabine [Xeloda] |
| Drug |
825 mg/m2 twice daily orally, 38 days |
|
| Radiation therapy | Radiation | Total dose of 45 Gy over 38 days |
|
| Mesorectal excision | Procedure | 6-8 weeks after completion of neoadjuvant treatment |
|
| bevacizumab [Avastin] | Drug | Post-surgery adjuvant treatment at the discretion of the investigator: 5 mg/kg iv every 2 weeks for at least 6 months |
|
| 5-fluorouracil | Drug | Post-surgery adjuvant therapy: bolus of 400mg/m2 iv plus iv infusion of 600 mg/m2 on Days 1 and 2 of each 2-week cycle for 6 months |
|
| leucovorin | Drug | Post-surgery adjuvant treatment: 100 mg/m2 iv on Days 1 and 2 of each 2-week cycle for 6 months |
|
| Baseline (BL) and end of neoadjuvant treatment (within 6 weeks after the completion of study treatment) |
| Percentage of Participants Undergoing Sphincter-Saving Surgery by Type of Procedure | 6 to 8 weeks after completion of study treatment |
| Percentage of Participants With Complete Response (CR) at the End of Neoadjuvant Treatment | Percentage of participants with CR was evaluated as the proportion of participants with complete response for the target and non-target lesions, separately, at the end of NAT according to the Response Evaluation Criteria in Solid Tumors (RECIST). CR was defined as disappearance of all target lesions or all non-target lesions and normalization of tumor marker levels. | BL and within 6 weeks after the completion of study treatment |
| Percentage of Participants With an Overall Response of CR at the End of Neoadjuvant Treatment | Percentage of participants with an overall response of CR was evaluated as the proportion of participants with CR for the target and non-target lesions plus absence of new lesions at the end of NAT according to RECIST. CR was defined as disappearance of all target lesions, all non-target lesions, and normalization of tumor marker levels. | BL and within 6 weeks after the completion of study treatment |
| Percentage of Participants With New Lesions at the Primary Tumor Site at the End of Neoadjuvant Treatment | The percentage of participants with new lesions located at the primary tumor site were evaluated at the end of NAT. | BL and within 6 weeks after the completion of study treatment |
| Percentage of Participants With Relapse During Follow-Up | The percentage of participants with local and/or regional relapse during follow-up. New lesions located at rectum or at colon or at lymph node detected at the end of NAT were evaluated as local and/or regional relapse. | BL, within 6 weeks after the completion of neoadjuvant treatment, every 2 weeks for 1 year following surgery, every 3 months thereafter until progression, up to 45 months |
| Disease-Free Survival (DFS) - Percentage of Participants With an Event | DFS was defined as the time from treatment start date to the date of first progression of disease or date of death due to any cause. | BL, within 6 weeks after the completion of neoadjuvant treatment, every 2 weeks for 1 year following surgery, every 3 months thereafter until progression, up to 45 months |
| DFS - Time to Event | The time in months from date of start-of-treatment to the date of event defined as the first documented disease progression or death due to any cause. If a participant did not have an event, the time was censored at the date of last adequate tumor assessment. DFS was estimated using the Kaplan-Meier method. | BL, within 6 weeks after the completion of neoadjuvant treatment, every 2 weeks for 1 year following surgery, every 3 months thereafter until progression, up to 45 months |
| Overall Survival (OS) - Percentage of Participants With an Event | OS was defined as the time from the date of first day of treatment until death due to any cause or the last date the participant was known to be alive. | BL, within 6 weeks after the completion of neoadjuvant treatment, every 2 weeks for 1 year following surgery, every 3 months thereafter until death, up to 45 months |
| OS - Time to Event | OS was defined as the time from the date of first day of treatment until death due to any cause or the last date the participant was known to be alive. OS was estimated using the Kaplan-Meier method. | BL, within 6 weeks after the completion of neoadjuvant treatment, every 2 weeks for 1 year following surgery, every 3 months thereafter until death, up to 45 months |
| Time to Disease Progression (TTP) - Percentage of Participants With an Event | TTP was defined as the time from date of treatment start until first documented progression of disease or death due to underlying cancer. | BL, within 6 weeks after the completion of neoadjuvant treatment, every 2 weeks for 1 year following surgery, every 3 months thereafter until death, up to 45 months |
| TTP - Time to Event | TTP was defined as the time from date of treatment start until first documented progression of disease or death due to underlying cancer. TTP was estimated using the Kaplan-Meier method. | BL, within 6 weeks after the completion of neoadjuvant treatment, every 2 weeks for 1 year following surgery, every 3 months thereafter until death, up to 45 months |
| Bologna |
| 40139 |
| Italy |
| Cuneo | 12100 | Italy |
| Genova | 16132 | Italy |
| Naples | 80131 | Italy |
| Paola | 87027 | Italy |
| Pisa | 56100 | Italy |
| Roma | 00135 | Italy |
| Siena | 53100 | Italy |
| COMPLETED |
|
| NOT COMPLETED |
|
|
Intent to treat (ITT) population: all participants who were included in the trial by signing the informed consent and were assigned to a study patient number.
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Bv+Capecitabine/Bv+Leucovorin+5-FU | Participants received bevacizumab 5 mg/kg IV on Days -14, 1, 15, and 29 and capecitabine 825 mg/m^2 PO BID from Days 1 to 38. Participants also received radiation therapy given at a daily fraction of 1.8 Gy administered in 5 weekly fractions starting at Week 1 (through Week 6) for a maximum total dose of 45 Gy. Six to 8 weeks following all above treatments, participants received complete mesorectal excision surgery. After surgery, participants received bevacizumab 5 mg/kg IV on Day 1 and leucovorin 100 mg/m^2 IV (over 2 hours) followed by 5-FU 400 mg/m^2 IV bolus and then 5-FU 600 mg/m^2 IV (over 22 hours) on Days 1 and 2 every 2 weeks for a maximum of 12 cycles. |
| 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 |
|
| 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 Pathological Complete Response (pCR) | pCR was defined as the absence of viable tumor cells, as determined by standard histologic procedure, in the tumor specimen (including regional lymph nodes) obtained at surgery. In order to minimize evaluation bias, tumor specimens were analyzed by both a central and local pathologist. The number of participants with pathological tumor stage 0 (pT0) and regional lymph nodes stage 0 (pN0) at surgery was determined. pCR was defined as the number of participants with pT0 and pN0 at surgery divided by the total number of participants with pathological tumor stage data collected. | ITT population; only participants who underwent surgery and had pathological tumor stage data were included in the analysis. | Posted | Number | 95% Confidence Interval | percentage of participants | 6 to 8 weeks following completion of neoadjuvant treatment |
|
|
|
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Percentage of Participants by Primary Tumor (T), Regional Lymph Nodes (N), and Distant Metastasis (M) Clinical Stage at Baseline and at the End of Neo-Adjuvant Treatment (NAT) | The frequencies of clinical tumor stage T (0, 1, 2, 3, 4, or X), regional lymph nodes stage N (0, 1, 2, 3, or 4), and distant metastasis clinical stage M (0, 1, or X) at baseline and at the end of NAT were assessed. The frequencies of pathological tumor stage T and regional lymph nodes stage N at surgery were evaluated. The clinical tumor and lymph node status was assessed by clinical examination, endosonography, and/or rectosigmoidoscopy, and pelvic and abdomen computerized tomography (CT) scan or magnetic resonance imaging (MRI). Response to treatment had to be assessed within 6 weeks after end of treatment by using the same techniques performed at baseline. | ITT population | Posted | Number | percentage of participants | Baseline (BL) and end of neoadjuvant treatment (within 6 weeks after the completion of study treatment) |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Percentage of Participants Undergoing Sphincter-Saving Surgery by Type of Procedure | ITT population; only participants who underwent surgery were included in the analysis. n (number) equals (=) number of participants assessed for the specified parameter (colostomy) | Posted | Number | percentage of participants | 6 to 8 weeks after completion of study treatment |
|
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Percentage of Participants With Complete Response (CR) at the End of Neoadjuvant Treatment | Percentage of participants with CR was evaluated as the proportion of participants with complete response for the target and non-target lesions, separately, at the end of NAT according to the Response Evaluation Criteria in Solid Tumors (RECIST). CR was defined as disappearance of all target lesions or all non-target lesions and normalization of tumor marker levels. | ITT population | Posted | Number | percentage of participants | BL and within 6 weeks after the completion of study treatment |
|
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Percentage of Participants With an Overall Response of CR at the End of Neoadjuvant Treatment | Percentage of participants with an overall response of CR was evaluated as the proportion of participants with CR for the target and non-target lesions plus absence of new lesions at the end of NAT according to RECIST. CR was defined as disappearance of all target lesions, all non-target lesions, and normalization of tumor marker levels. | ITT population | Posted | Number | percentage of participants | BL and within 6 weeks after the completion of study treatment |
|
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Percentage of Participants With New Lesions at the Primary Tumor Site at the End of Neoadjuvant Treatment | The percentage of participants with new lesions located at the primary tumor site were evaluated at the end of NAT. | ITT population | Posted | Number | percentage of participants | BL and within 6 weeks after the completion of study treatment |
|
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Percentage of Participants With Relapse During Follow-Up | The percentage of participants with local and/or regional relapse during follow-up. New lesions located at rectum or at colon or at lymph node detected at the end of NAT were evaluated as local and/or regional relapse. | ITT population; only participants who underwent radical surgery were included in the analysis | Posted | Number | percentage of participants | BL, within 6 weeks after the completion of neoadjuvant treatment, every 2 weeks for 1 year following surgery, every 3 months thereafter until progression, up to 45 months |
|
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Disease-Free Survival (DFS) - Percentage of Participants With an Event | DFS was defined as the time from treatment start date to the date of first progression of disease or date of death due to any cause. | ITT population | Posted | Number | percentage of participants | BL, within 6 weeks after the completion of neoadjuvant treatment, every 2 weeks for 1 year following surgery, every 3 months thereafter until progression, up to 45 months |
|
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | DFS - Time to Event | The time in months from date of start-of-treatment to the date of event defined as the first documented disease progression or death due to any cause. If a participant did not have an event, the time was censored at the date of last adequate tumor assessment. DFS was estimated using the Kaplan-Meier method. | ITT population | Posted | Mean | Standard Deviation | months | BL, within 6 weeks after the completion of neoadjuvant treatment, every 2 weeks for 1 year following surgery, every 3 months thereafter until progression, up to 45 months |
|
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Overall Survival (OS) - Percentage of Participants With an Event | OS was defined as the time from the date of first day of treatment until death due to any cause or the last date the participant was known to be alive. | ITT population | Posted | Number | percentage of participants | BL, within 6 weeks after the completion of neoadjuvant treatment, every 2 weeks for 1 year following surgery, every 3 months thereafter until death, up to 45 months |
|
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | OS - Time to Event | OS was defined as the time from the date of first day of treatment until death due to any cause or the last date the participant was known to be alive. OS was estimated using the Kaplan-Meier method. | ITT population | Posted | Mean | Standard Deviation | months | BL, within 6 weeks after the completion of neoadjuvant treatment, every 2 weeks for 1 year following surgery, every 3 months thereafter until death, up to 45 months |
|
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Time to Disease Progression (TTP) - Percentage of Participants With an Event | TTP was defined as the time from date of treatment start until first documented progression of disease or death due to underlying cancer. | ITT population | Posted | Number | percentage of participants | BL, within 6 weeks after the completion of neoadjuvant treatment, every 2 weeks for 1 year following surgery, every 3 months thereafter until death, up to 45 months |
|
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | TTP - Time to Event | TTP was defined as the time from date of treatment start until first documented progression of disease or death due to underlying cancer. TTP was estimated using the Kaplan-Meier method. | ITT population | Posted | Mean | Standard Deviation | months | BL, within 6 weeks after the completion of neoadjuvant treatment, every 2 weeks for 1 year following surgery, every 3 months thereafter until death, up to 45 months |
|
|
Adverse events were collected from the date of first study-drug administration until 28 days after the last dose of study drug administration.
All enrolled participants who received at least 1 dose of study medication were included in the safety population.
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 | Bv+Capecitabine/Bv+Leucovorin+5-FU | Participants received bevacizumab 5 mg/kg IV on Days -14, 1, 15, and 29 and capecitabine 825 mg/m^2 PO BID from Days 1 to 38. Participants also received radiation therapy given at a daily fraction of 1.8 Gy administered in 5 weekly fractions starting at Week 1 (through Week 6) for a maximum total dose of 45 Gy. Six to 8 weeks following all above treatments, participants received complete mesorectal excision surgery. After surgery, participants received bevacizumab 5 mg/kg IV on Day 1 and leucovorin 100 mg/m^2 IV (over 2 hours) followed by 5-FU 400 mg/m^2 IV bolus and then 5-FU 600 mg/m^2 IV (over 22 hours) on Days 1 and 2 every 2 weeks for a maximum of 12 cycles. | 8 | 42 | 39 | 42 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Diarrhoea | Gastrointestinal disorders | MedDRA 11.1 | Non-systematic Assessment |
| |
| Miocardic ischemia | Cardiac disorders | MedDRA 11.1 | Non-systematic Assessment |
| |
| Bowel perforation | Gastrointestinal disorders | MedDRA 11.1 | Non-systematic Assessment |
| |
| Cardiac ischemia | Cardiac disorders | MedDRA 11.1 | Non-systematic Assessment |
| |
| Anastomosis dehiscence | Injury, poisoning and procedural complications | MedDRA 11.1 | Non-systematic Assessment |
| |
| Intestinal occlusion | Gastrointestinal disorders | MedDRA 11.1 | Non-systematic Assessment |
| |
| Postoperative abscess | Injury, poisoning and procedural complications | MedDRA 11.1 | Non-systematic Assessment |
| |
| Ipokaliemia | Metabolism and nutrition disorders | MedDRA 11.1 | Non-systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anemia | Blood and lymphatic system disorders | MedDRA 11.1 | Non-systematic Assessment |
| |
| Leukopenia | Blood and lymphatic system disorders | MedDRA 11.1 | Non-systematic Assessment |
| |
| Neutropenia | Blood and lymphatic system disorders | MedDRA 11.1 | Non-systematic Assessment |
| |
| Abdominal pain | Gastrointestinal disorders | MedDRA 11.1 | Non-systematic Assessment |
| |
| Constipation | Gastrointestinal disorders | MedDRA 11.1 | Non-systematic Assessment |
| |
| Diarrhea | Gastrointestinal disorders | MedDRA 11.1 | Non-systematic Assessment |
| |
| Hematochezia | Gastrointestinal disorders | MedDRA 11.1 | Non-systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA 11.1 | Non-systematic Assessment |
| |
| Proctalgia | Gastrointestinal disorders | MedDRA 11.1 | Non-systematic Assessment |
| |
| Proctitis | Gastrointestinal disorders | MedDRA 11.1 | Non-systematic Assessment |
| |
| Rectal hemorrhage | Gastrointestinal disorders | MedDRA 11.1 | Non-systematic Assessment |
| |
| Rectal tenesmus | Gastrointestinal disorders | MedDRA 11.1 | Non-systematic Assessment |
| |
| Asthenia | General disorders | MedDRA 11.1 | Non-systematic Assessment |
| |
| Fatigue | General disorders | MedDRA 11.1 | Non-systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA 11.1 | Non-systematic Assessment |
| |
| Cystitis | Infections and infestations | MedDRA 11.1 | Non-systematic Assessment |
| |
| Hypokalaemia | Metabolism and nutrition disorders | MedDRA 11.1 | Non-systematic Assessment |
| |
| Dysuria | Renal and urinary disorders | MedDRA 11.1 | Non-systematic Assessment |
| |
| Hypertension | Vascular disorders | MedDRA 11.1 | Non-systematic Assessment |
| |
| Thrombocytopenia | Blood and lymphatic system disorders | MedDRA 11.1 | Non-systematic Assessment |
| |
| Tachycardia | Cardiac disorders | MedDRA 11.1 | Non-systematic Assessment |
| |
| Vertigo | Ear and labyrinth disorders | MedDRA 11.1 | Non-systematic Assessment |
| |
| Conjunctivitis | Eye disorders | MedDRA 11.1 | Non-systematic Assessment |
| |
| Anal fistula | Gastrointestinal disorders | MedDRA 11.1 | Non-systematic Assessment |
| |
| Anorectal discomfort | Gastrointestinal disorders | MedDRA 11.1 | Non-systematic Assessment |
| |
| Haemorrhoids | Gastrointestinal disorders | MedDRA 11.1 | Non-systematic Assessment |
| |
| Mucous stools | Gastrointestinal disorders | MedDRA 11.1 | Non-systematic Assessment |
| |
| Perianal erythema | Gastrointestinal disorders | MedDRA 11.1 | Non-systematic Assessment |
| |
| Stomatitis | Gastrointestinal disorders | MedDRA 11.1 | Non-systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA 11.1 | Non-systematic Assessment |
| |
| Chest pain | General disorders | MedDRA 11.1 | Non-systematic Assessment |
| |
| Mucosal inflammation | General disorders | MedDRA 11.1 | Non-systematic Assessment |
| |
| Hyperbilirubinaemia | Hepatobiliary disorders | MedDRA 11.1 | Non-systematic Assessment |
| |
| Hypertransaminasaemia | Hepatobiliary disorders | MedDRA 11.1 | Non-systematic Assessment |
| |
| Iatrogenic infection | Infections and infestations | MedDRA 11.1 | Non-systematic Assessment |
| |
| Influenza | Infections and infestations | MedDRA 11.1 | Non-systematic Assessment |
| |
| Oral herpes | Infections and infestations | MedDRA 11.1 | Non-systematic Assessment |
| |
| Gastrointestinal stoma complication | Injury, poisoning and procedural complications | MedDRA 11.1 | Non-systematic Assessment |
| |
| Blood lactate dehydrogenase increased | Investigations | MedDRA 11.1 | Non-systematic Assessment |
| |
| Transaminases abnormal | Investigations | MedDRA 11.1 | Non-systematic Assessment |
| |
| Hyperuricaemia | Metabolism and nutrition disorders | MedDRA 11.1 | Non-systematic Assessment |
| |
| Hypocalcaemia | Metabolism and nutrition disorders | MedDRA 11.1 | Non-systematic Assessment |
| |
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA 11.1 | Non-systematic Assessment |
| |
| Fistula | Musculoskeletal and connective tissue disorders | MedDRA 11.1 | Non-systematic Assessment |
| |
| Muscular weakness | Musculoskeletal and connective tissue disorders | MedDRA 11.1 | Non-systematic Assessment |
| |
| Musculoskeletal pain | Musculoskeletal and connective tissue disorders | MedDRA 11.1 | Non-systematic Assessment |
| |
| Pain in extremity | Musculoskeletal and connective tissue disorders | MedDRA 11.1 | Non-systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA 11.1 | Non-systematic Assessment |
| |
| Neurotoxicity | Nervous system disorders | MedDRA 11.1 | Non-systematic Assessment |
| |
| Paraesthesia | Nervous system disorders | MedDRA 11.1 | Non-systematic Assessment |
| |
| Anxiety | Psychiatric disorders | MedDRA 11.1 | Non-systematic Assessment |
| |
| Haematuria | Renal and urinary disorders | MedDRA 11.1 | Non-systematic Assessment |
| |
| Pollakiuria | Renal and urinary disorders | MedDRA 11.1 | Non-systematic Assessment |
| |
| Proteinuria | Renal and urinary disorders | MedDRA 11.1 | Non-systematic Assessment |
| |
| Strangury | Renal and urinary disorders | MedDRA 11.1 | Non-systematic Assessment |
| |
| Prostatitis | Reproductive system and breast disorders | MedDRA 11.1 | Non-systematic Assessment |
| |
| Vulvovaginal burning sensation | Reproductive system and breast disorders | MedDRA 11.1 | Non-systematic Assessment |
| |
| Epistaxis | Respiratory, thoracic and mediastinal disorders | MedDRA 11.1 | Non-systematic Assessment |
| |
| Hypoxia | Respiratory, thoracic and mediastinal disorders | MedDRA 11.1 | Non-systematic Assessment |
| |
| Oropharyngeal swelling | Respiratory, thoracic and mediastinal disorders | MedDRA 11.1 | Non-systematic Assessment |
| |
| Dermatitis | Skin and subcutaneous tissue disorders | MedDRA 11.1 | Non-systematic Assessment |
| |
| Dermatitis exfoliative | Skin and subcutaneous tissue disorders | MedDRA 11.1 | Non-systematic Assessment |
| |
| Palmar-plantar erythrodysaesthesia syndrome | Skin and subcutaneous tissue disorders | MedDRA 11.1 | Non-systematic Assessment |
| |
| Rash | Skin and subcutaneous tissue disorders | MedDRA 11.1 | Non-systematic Assessment |
| |
| Arterial thrombosis | Vascular disorders | MedDRA 11.1 | Non-systematic Assessment |
| |
| Hypotension | Vascular disorders | MedDRA 11.1 | Non-systematic Assessment |
|
The Study being conducted under this agreement is part of the Overall Study. Investigator is free to publish in reputable journals or to present at professional conferences the results of the Study, but only after the first publication or presentation that involves the Overall Study. The Sponsor may request the Confidential Information be deleted and/or the publication be postponed in order to protect the Sponsor's intellectual property rights.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Medical Communications | Hoffmann-LaRoche | 800-821-8590 | genentech@druginfo.com |
| ID | Term |
|---|---|
| D015179 | Colorectal Neoplasms |
| ID | Term |
|---|---|
| D007414 | Intestinal Neoplasms |
| D005770 | Gastrointestinal Neoplasms |
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D004066 | Digestive System Diseases |
| D005767 | Gastrointestinal Diseases |
| D003108 | Colonic Diseases |
| D007410 | Intestinal Diseases |
| D012002 | Rectal Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| D000068258 | Bevacizumab |
| D000069287 | Capecitabine |
| D011878 | Radiotherapy |
| D005472 | Fluorouracil |
| D002955 | Leucovorin |
| ID | Term |
|---|---|
| D061067 | Antibodies, Monoclonal, Humanized |
| D000911 | Antibodies, Monoclonal |
| D000906 | Antibodies |
| D007136 | Immunoglobulins |
| D007162 | Immunoproteins |
| D001798 | Blood Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D012712 | Serum Globulins |
| D005916 | Globulins |
| D003841 | Deoxycytidine |
| D003562 | Cytidine |
| D011741 | Pyrimidine Nucleosides |
| D011743 | Pyrimidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D014498 | Uracil |
| D011744 | Pyrimidinones |
| D003853 | Deoxyribonucleosides |
| D009705 | Nucleosides |
| D009706 | Nucleic Acids, Nucleotides, and Nucleosides |
| D013812 | Therapeutics |
| D005575 | Formyltetrahydrofolates |
| D013763 | Tetrahydrofolates |
| D005492 | Folic Acid |
| D011622 | Pterins |
| D011621 | Pteridines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D003067 | Coenzymes |
| D045762 | Enzymes and Coenzymes |
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