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| ID | Type | Description | Link |
|---|---|---|---|
| 2015-003718-25 | EudraCT Number |
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The objective of this trial is to evaluate the safety and tolerability of BI 695502 in combination with leucovorin/5-fluorouracil/oxaliplatin (mFOLFOX6) and as maintenance therapy (when applicable). As well as to evaluate the following efficacy parameters: Progression-free survival (PFS), objective response rate (proportion of patients with complete response [CR] plus partial response [PR]), overall survival (OS), duration of response (DOR), time to progression (TTP).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| All patients | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| BI 695502 | Drug |
| ||
| Avastin |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Patients With Treatment-Emergent Adverse Events (TEAEs) in the Specified Categories Selected for Primary Endpoint Assessment | The primary safety endpoint of the trial was patients with any of the following selected adverse events (AEs):
| From baseline up to 18 weeks after the last dose of trial medication prior to the Switch Visit. Maximum duration of up to 32 treatment cycles + safety follow up (up to 82 weeks overall). |
| Measure | Description | Time Frame |
|---|---|---|
| Duration of Response (DOR) as Assessed by Central Imaging Review | DOR was the time from first documented Complete Response (CR) (CR is disappearance of all target lesions) or Partial Response (PR) (PR is at least a 30% decrease in the sum of diameters (SoD) of target lesions taking as reference the baseline sum diameters) until time of progression as assessed by central imaging review per Response evaluation criteria in solid tumors (RECIST) 1.1. RECIST is a set of published rules that define when tumors in cancer patients improve ("respond"), stay the same ("stabilize") or worsen ("progress") during treatment. DOR was calculated using the Kaplan-Meier technique. Confidence interval was calculated based on the Brookmeyer and Crowley method. |
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Inclusion criteria:
Exclusion criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Boehringer Ingelheim | Boehringer Ingelheim | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Mayo Clinic-Arizona | Phoenix | Arizona | 85054 | United States | ||
| Pacific Cancer Medical Center, Inc. |
All patients were screened for eligibility to participate in the trial. Patients attended specialist sites which would then ensure that they (the patient) met all strictly implemented inclusion/exclusion criteria. Patients were not to be randomised to trial treatment if any one of the specific entry criteria were violated.
This was Phase IIIb, open-label, multicenter, multinational, single-arm trial. Patients with previously untreated metastatic colorectal cancer (mCRC) were enrolled. From 21December2017, Sponsor recommended that patients should be switched from BI 695502 to the reference product Avastin® as soon as it was available at the respective clinical site.
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | BI 695502 | All patients were to receive BI 695502 (5 milligrams per kilogram [mg/kg]) solution for intravenous (i.v.) infusion in combination with mFOLFOX6 chemotherapy every 2 weeks. Patients were to continue to receive treatment during the pre-switch period until disease progression, death, unacceptable toxicity, or the end of the trial, whichever occurred earlier. Based on patient tolerability, at least 8 cycles of mFOLFOX6 were to be given to all patients. |
| Title | Milestones | Reasons Not Completed | ||||
|---|---|---|---|---|---|---|
| Pre-switch Period |
|
Not provided
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| SAP | No | Yes | No | Statistical Analysis Plan | Dec 13, 2018 | Sep 30, 2019 |
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|
| Tumor scans were performed at baseline then every ~8 weeks up to 34 weeks, then every ~12 weeks thereafter until confirmed disease progression. Analysis performed for the pre-switch period only; maximum duration of up to 32 treatment cycles (64 weeks). |
| Time to Progression (TTP) as Assessed by Central Imaging Review | TTP was defined as the time from first administration of trial medication to the date of tumor progression as assessed by central imaging review per RECIST 1.1 (RECIST is a set of published rules that define when tumors in cancer patients improve ("respond"), stay the same ("stabilize") or worsen ("progress") during treatment.). TTP was calculated using the Kaplan-Meier technique. Confidence interval was calculated based on the Brookmeyer and Crowley method. | Tumor scans were performed at baseline then every ~8 weeks up to 34 weeks, then every ~12 weeks thereafter until confirmed disease progression. Analysis performed for the pre-switch period only; maximum duration of up to 32 treatment cycles (64 weeks). |
| Objective Response (OR) Rate as Assessed by Central Imaging Review | OR rate was defined as the percentage of patients who achieved at least one visit response of CR (CR is disappearance of all target lesions) or PR (PR is at least a 30% decrease in the sum of diameters (SoD) of target lesions taking as reference the baseline sum diameters) after the start of treatment. The response criteria evaluation was carried out according to RECIST 1.1. RECIST is a set of published rules that define when tumors in cancer patients improve ("respond"), stay the same ("stabilize") or worsen ("progress") during treatment. Confidence interval was calculated using Wilson score method. The definition for OR (CR/PR) extends until disease progression/ death/ unacceptable toxicity/ end of the trial, whichever occurred earlier. However for "Duration of response" this censoring does not apply. Hence the apparent discrepancy. OR = CR + PR. | Tumor scans were performed at baseline then every ~8 weeks up to 34 weeks, then every ~12 weeks thereafter until confirmed disease progression. Analysis performed for the pre-switch period only; maximum duration of up to 32 treatment cycles (64 weeks). |
| Overall Survival (OS) Time | OS was defined as the time from first administration of trial medication until death from any cause. OS was calculated using the Kaplan-Meier technique. Confidence interval was calculated based on the Brookmeyer and Crowley method. | From date of first dose of trial medication until last date of trial medication + 18 weeks (REP), up to a maximum of 32 treatment cycles + safety follow up (up to 82 weeks overall). |
| Progression-Free Survival (PFS) Time as Assessed by Central Imaging Review | PFS was defined as the time from first administration of trial medication until disease progression as assessed by central imaging review or death due to any cause. Disease progression was assessed according to RECIST 1.1. RECIST is a set of published rules that define when tumors in cancer patients improve ("respond"), stay the same ("stabilize") or worsen ("progress") during treatment. Progression was defined as at least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study. In addition to the relative increase of 20%, the sum must also have demonstrated an absolute increase of at least 5 mm. PFS was calculated using the Kaplan-Meier technique. Confidence interval was calculated based on the Brookmeyer and Crowley method. | Tumor scans were performed at baseline then every ~8 weeks up to 34 weeks, then every ~12 weeks thereafter until confirmed disease progression. Analysis performed for the pre-switch period only; maximum duration of up to 32 treatment cycles (64 weeks). |
| Anaheim |
| California |
| 92801 |
| United States |
| The Oncology Institute of Hope and Innovation | Anaheim | California | 92801 | United States |
| Rocky Mountain Cancer Centers | Denver | Colorado | 80218 | United States |
| Ashland Bellefonte Cancer Center | Ashland | Kentucky | 41101 | United States |
| University of Michigan Health System | Ann Arbor | Michigan | 48109 | United States |
| Washington University School of Medicine | St Louis | Missouri | 63110 | United States |
| Aultman Hospital | Canton | Ohio | 44710 | United States |
| Oncology Hematology Care | Cincinnati | Ohio | 45242 | United States |
| Northwest Cancer Specialists PC | Portland | Oregon | 97225 | United States |
| Willamette Valley Cancer Institute and Research Center | Springfield | Oregon | 97477 | United States |
| Texas Oncology, P.A. | Abilene | Texas | 79606 | United States |
| Texas Oncology, PA, | Amarillo | Texas | 79106 | United States |
| Texas Oncology, P.A. | Austin | Texas | 78705 | United States |
| Texas Oncology, P.A. | Flower Mound | Texas | 75028 | United States |
| Texas Oncology, P.A. | Garland | Texas | 75042-5788 | United States |
| Oncology Consultants, P.A. | Houston | Texas | 77030 | United States |
| Texas Oncology, P.A. | McAllen | Texas | 78503-1298 | United States |
| Texas Oncology, PA | Mesquite | Texas | 75150 | United States |
| Texas Oncology-San Antonio Northeast | San Antonio | Texas | 78217 | United States |
| Texas Oncology San Antonio Medical Center | San Antonio | Texas | 78229 | United States |
| Tyler Hematology-Oncology, PA | Tyler | Texas | 75701 | United States |
| Texas Oncology, P.A. | Tyler | Texas | 75702 | United States |
| Texas Oncology, P.A., Deke Slayton Cancer Center | Webster | Texas | 77598 | United States |
| Virginia Cancer Institute | Richmond | Virginia | 23226 | United States |
| Chiba Cancer Center | Chiba, Chiba | 260-8717 | Japan |
| National Hospital Organization Shikoku Cancer Center | Ehime, Matsuyama | 791-0280 | Japan |
| Hokkaido University Hospital | Hokkaido, Sapporo | 060-8648 | Japan |
| Japan Organization of Occupational Health and Safety Kansai Rosai Hospital | Hyogo, Amagasaki | 660-8511 | Japan |
| Kagawa University Hospital | Kagawa, Kita-gun | 761-0793 | Japan |
| Osaka University Hospital | Osaka, Suita | 565-0871 | Japan |
| Jananese Foundation for Cancer Research | Tokyo, Koto-ku | 135-8550 | Japan |
| Hospital Vall d'Hebron | Barcelona | 08035 | Spain |
| Hospital Duran i Reynals | L'Hospitalet de Llobregat | 08907 | Spain |
| Hospital ClÃnico de Valencia | Valencia | 46010 | Spain |
| CI Chernivtsi RC Oncological Dispensary Bukovinian SMU | Chernivtsi | 58013 | Ukraine |
| Munic.Instit."City Clin.Hosp.#4" of Dnipro City Council | Dnipropetrovsk | 49102 | Ukraine |
| Regional Clinical Oncological Dispensary, Ivano-Frankivsk | Ivano-Frankivsk | 76018 | Ukraine |
| CI of PH Kharkiv CCH #2 | Kharkiv | 61037 | Ukraine |
| Treatment-Diagnostic CTR of Private Enterprise, Kirovohrad | Kirovohrad | 25006 | Ukraine |
| CI Kryvyi Rih Oncological Dispensary of DRC | Kryvyi Rih, Dnipropetrovsk | 50048 | Ukraine |
| National Institute of Cancer | Kyiv | 03022 | Ukraine |
| CI of LRC Lviv Onco.Reg.Treat.&Diag.Cent. | Lviv | 79031 | Ukraine |
| Poltava Regional Clinical Oncological Dispensary, Poltava | Poltava | 38011 | Ukraine |
| Sumy Regional Oncology Center | Sumy | 40022 | Ukraine |
| Vinnytsia Regional Clinical Oncological Dispensary | Vinnytsia | 21029 | Ukraine |
| FG001 | BI 695502 to Avastin® | At the switch visit, patients were to be switched from BI 695502 to Avastin®. Post-switch, patients were to receive Avastin® (5 mg/kg) solution for i.v. infusion in combination with mFOLFOX6 chemotherapy every 2 weeks. Patients were to continue to receive treatment until disease progression, death, unacceptable toxicity, or the end of the trial, whichever occurred earlier. |
|
| COMPLETED |
|
| NOT COMPLETED |
|
|
| Post-switch Period |
|
|
Treated set (TS): The TS contained all participants who signed informed consent and who received at least one dose of trial medication.
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | BI 695502 | All patients were to receive BI 695502 (5 milligrams per kilogram [mg/kg]) solution for intravenous (i.v.) infusion in combination with mFOLFOX6 chemotherapy every 2 weeks. Patients were to continue to receive treatment during the pre-switch period until disease progression, death, unacceptable toxicity, or the end of the trial, whichever occurred earlier. Based on patient tolerability, at least 8 cycles of mFOLFOX6 were to be given to all patients. |
| 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 |
| ||||||||||||||||||
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||||
| Race (NIH/OMB) | 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 Patients With Treatment-Emergent Adverse Events (TEAEs) in the Specified Categories Selected for Primary Endpoint Assessment | The primary safety endpoint of the trial was patients with any of the following selected adverse events (AEs):
| Treated set (TS): The TS contained all patients who signed informed consent and who received at least one dose of trial medication. | Posted | Number | 95% Confidence Interval | Percentage of participants (%) | From baseline up to 18 weeks after the last dose of trial medication prior to the Switch Visit. Maximum duration of up to 32 treatment cycles + safety follow up (up to 82 weeks overall). |
|
|
| ||||||||||||||||||||||||||||||||||
| Secondary | Duration of Response (DOR) as Assessed by Central Imaging Review | DOR was the time from first documented Complete Response (CR) (CR is disappearance of all target lesions) or Partial Response (PR) (PR is at least a 30% decrease in the sum of diameters (SoD) of target lesions taking as reference the baseline sum diameters) until time of progression as assessed by central imaging review per Response evaluation criteria in solid tumors (RECIST) 1.1. RECIST is a set of published rules that define when tumors in cancer patients improve ("respond"), stay the same ("stabilize") or worsen ("progress") during treatment. DOR was calculated using the Kaplan-Meier technique. Confidence interval was calculated based on the Brookmeyer and Crowley method. | TS: The TS contained all patients who signed informed consent and who received at least one dose of trial medication. Only patients with complete or partial objective response were included in the analysis. | Posted | Median | 95% Confidence Interval | Months | Tumor scans were performed at baseline then every ~8 weeks up to 34 weeks, then every ~12 weeks thereafter until confirmed disease progression. Analysis performed for the pre-switch period only; maximum duration of up to 32 treatment cycles (64 weeks). |
| ||||||||||||||||||||||||||||||||||||
| Secondary | Time to Progression (TTP) as Assessed by Central Imaging Review | TTP was defined as the time from first administration of trial medication to the date of tumor progression as assessed by central imaging review per RECIST 1.1 (RECIST is a set of published rules that define when tumors in cancer patients improve ("respond"), stay the same ("stabilize") or worsen ("progress") during treatment.). TTP was calculated using the Kaplan-Meier technique. Confidence interval was calculated based on the Brookmeyer and Crowley method. | TS: The TS contained all patients who signed informed consent and who received at least one dose of trial medication. | Posted | Median | 95% Confidence Interval | Months | Tumor scans were performed at baseline then every ~8 weeks up to 34 weeks, then every ~12 weeks thereafter until confirmed disease progression. Analysis performed for the pre-switch period only; maximum duration of up to 32 treatment cycles (64 weeks). |
|
| |||||||||||||||||||||||||||||||||||
| Secondary | Objective Response (OR) Rate as Assessed by Central Imaging Review | OR rate was defined as the percentage of patients who achieved at least one visit response of CR (CR is disappearance of all target lesions) or PR (PR is at least a 30% decrease in the sum of diameters (SoD) of target lesions taking as reference the baseline sum diameters) after the start of treatment. The response criteria evaluation was carried out according to RECIST 1.1. RECIST is a set of published rules that define when tumors in cancer patients improve ("respond"), stay the same ("stabilize") or worsen ("progress") during treatment. Confidence interval was calculated using Wilson score method. The definition for OR (CR/PR) extends until disease progression/ death/ unacceptable toxicity/ end of the trial, whichever occurred earlier. However for "Duration of response" this censoring does not apply. Hence the apparent discrepancy. OR = CR + PR. | TS: The TS contained all patients who signed informed consent and who received at least one dose of trial medication. | Posted | Number | 95% Confidence Interval | Percentage of participants | Tumor scans were performed at baseline then every ~8 weeks up to 34 weeks, then every ~12 weeks thereafter until confirmed disease progression. Analysis performed for the pre-switch period only; maximum duration of up to 32 treatment cycles (64 weeks). |
| ||||||||||||||||||||||||||||||||||||
| Secondary | Overall Survival (OS) Time | OS was defined as the time from first administration of trial medication until death from any cause. OS was calculated using the Kaplan-Meier technique. Confidence interval was calculated based on the Brookmeyer and Crowley method. | TS: The TS contained all patients who signed informed consent and who received at least one dose of trial medication. | Posted | Median | 95% Confidence Interval | Months | From date of first dose of trial medication until last date of trial medication + 18 weeks (REP), up to a maximum of 32 treatment cycles + safety follow up (up to 82 weeks overall). |
|
| |||||||||||||||||||||||||||||||||||
| Secondary | Progression-Free Survival (PFS) Time as Assessed by Central Imaging Review | PFS was defined as the time from first administration of trial medication until disease progression as assessed by central imaging review or death due to any cause. Disease progression was assessed according to RECIST 1.1. RECIST is a set of published rules that define when tumors in cancer patients improve ("respond"), stay the same ("stabilize") or worsen ("progress") during treatment. Progression was defined as at least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study. In addition to the relative increase of 20%, the sum must also have demonstrated an absolute increase of at least 5 mm. PFS was calculated using the Kaplan-Meier technique. Confidence interval was calculated based on the Brookmeyer and Crowley method. | TS: The TS contained all patients who signed informed consent and who received at least one dose of trial medication. | Posted | Median | 95% Confidence Interval | Months | Tumor scans were performed at baseline then every ~8 weeks up to 34 weeks, then every ~12 weeks thereafter until confirmed disease progression. Analysis performed for the pre-switch period only; maximum duration of up to 32 treatment cycles (64 weeks). |
|
From date of first dose of trial medication until last date of trial medication + 18 weeks (REP), up to a maximum of 32 treatment cycles + safety follow up (up to 82 weeks overall).
All-Cause mortality is defined as death due to any cause (including disease progression) and is reported for the overall study period, including both the pre-switch period for BI 695502 treatment and post-switch period for Avastin® treatment. Serious and other (non-serious) data is based on on-treatment adverse events.
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 | BI 695502 | All patients were to receive BI 695502 (5 milligrams per kilogram [mg/kg]) solution for intravenous (i.v.) infusion in combination with mFOLFOX6 chemotherapy every 2 weeks. Patients were to continue to receive treatment during the pre-switch period until disease progression, death, unacceptable toxicity, or the end of the trial, whichever occurred earlier. Based on patient tolerability, at least 8 cycles of mFOLFOX6 were to be given to all patients. | 41 | 123 | 33 | 123 | 118 | 123 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Sepsis | Infections and infestations | MedDRA 21.1 | Systematic Assessment |
| |
| Bacterial sepsis | Infections and infestations | MedDRA 21.1 | Systematic Assessment |
| |
| Biliary tract infection | Infections and infestations | MedDRA 21.1 | Systematic Assessment |
| |
| Device related infection | Infections and infestations | MedDRA 21.1 | Systematic Assessment |
| |
| Gastroenteritis viral | Infections and infestations | MedDRA 21.1 | Systematic Assessment |
| |
| Vulval abscess | Infections and infestations | MedDRA 21.1 | Systematic Assessment |
| |
| Colon cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 21.1 | Systematic Assessment |
| |
| Meningioma benign | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 21.1 | Systematic Assessment |
| |
| Tumour necrosis | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 21.1 | Systematic Assessment |
| |
| Febrile neutropenia | Blood and lymphatic system disorders | MedDRA 21.1 | Systematic Assessment |
| |
| Disseminated intravascular coagulation | Blood and lymphatic system disorders | MedDRA 21.1 | Systematic Assessment |
| |
| Hypersplenism | Blood and lymphatic system disorders | MedDRA 21.1 | Systematic Assessment |
| |
| Neutropenia | Blood and lymphatic system disorders | MedDRA 21.1 | Systematic Assessment |
| |
| Splenomegaly | Blood and lymphatic system disorders | MedDRA 21.1 | Systematic Assessment |
| |
| Drug hypersensitivity | Immune system disorders | MedDRA 21.1 | Systematic Assessment |
| |
| Hypersensitivity | Immune system disorders | MedDRA 21.1 | Systematic Assessment |
| |
| Dehydration | Metabolism and nutrition disorders | MedDRA 21.1 | Systematic Assessment |
| |
| Cervical radiculopathy | Nervous system disorders | MedDRA 21.1 | Systematic Assessment |
| |
| Myelopathy | Nervous system disorders | MedDRA 21.1 | Systematic Assessment |
| |
| Seizure | Nervous system disorders | MedDRA 21.1 | Systematic Assessment |
| |
| Spinal cord compression | Nervous system disorders | MedDRA 21.1 | Systematic Assessment |
| |
| Sudden hearing loss | Ear and labyrinth disorders | MedDRA 21.1 | Systematic Assessment |
| |
| Deep vein thrombosis | Vascular disorders | MedDRA 21.1 | Systematic Assessment |
| |
| Accelerated hypertension | Vascular disorders | MedDRA 21.1 | Systematic Assessment |
| |
| Brachiocephalic vein thrombosis | Vascular disorders | MedDRA 21.1 | Systematic Assessment |
| |
| Pelvic venous thrombosis | Vascular disorders | MedDRA 21.1 | Systematic Assessment |
| |
| Subclavian vein thrombosis | Vascular disorders | MedDRA 21.1 | Systematic Assessment |
| |
| Vena cava thrombosis | Vascular disorders | MedDRA 21.1 | Systematic Assessment |
| |
| Pulmonary embolism | Respiratory, thoracic and mediastinal disorders | MedDRA 21.1 | Systematic Assessment |
| |
| Chronic obstructive pulmonary disease | Respiratory, thoracic and mediastinal disorders | MedDRA 21.1 | Systematic Assessment |
| |
| Pulmonary artery thrombosis | Respiratory, thoracic and mediastinal disorders | MedDRA 21.1 | Systematic Assessment |
| |
| Ileus | Gastrointestinal disorders | MedDRA 21.1 | Systematic Assessment |
| |
| Abdominal hernia | Gastrointestinal disorders | MedDRA 21.1 | Systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA 21.1 | Systematic Assessment |
| |
| Intestinal perforation | Gastrointestinal disorders | MedDRA 21.1 | Systematic Assessment |
| |
| Intra-abdominal fluid collection | Gastrointestinal disorders | MedDRA 21.1 | Systematic Assessment |
| |
| Large intestinal stenosis | Gastrointestinal disorders | MedDRA 21.1 | Systematic Assessment |
| |
| Large intestine perforation | Gastrointestinal disorders | MedDRA 21.1 | Systematic Assessment |
| |
| Mesenteric vein thrombosis | Gastrointestinal disorders | MedDRA 21.1 | Systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA 21.1 | Systematic Assessment |
| |
| Gastrointestinal perforation | Gastrointestinal disorders | MedDRA 21.1 | Systematic Assessment |
| |
| Jaundice cholestatic | Hepatobiliary disorders | MedDRA 21.1 | Systematic Assessment |
| |
| Liver disorder | Hepatobiliary disorders | MedDRA 21.1 | Systematic Assessment |
| |
| Portal vein thrombosis | Hepatobiliary disorders | MedDRA 21.1 | Systematic Assessment |
| |
| Skin necrosis | Skin and subcutaneous tissue disorders | MedDRA 21.1 | Systematic Assessment |
| |
| Acute kidney injury | Renal and urinary disorders | MedDRA 21.1 | Systematic Assessment |
| |
| Hydronephrosis | Renal and urinary disorders | MedDRA 21.1 | Systematic Assessment |
| |
| Renal haematoma | Renal and urinary disorders | MedDRA 21.1 | Systematic Assessment |
| |
| Cervical vertebral fracture | Injury, poisoning and procedural complications | MedDRA 21.1 | Systematic Assessment |
| |
| Thoracic vertebral fracture | Injury, poisoning and procedural complications | MedDRA 21.1 | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Urinary tract infection | Infections and infestations | MedDRA 21.1 | Systematic Assessment |
| |
| Neutropenia | Blood and lymphatic system disorders | MedDRA 21.1 | Systematic Assessment |
| |
| Anaemia | Blood and lymphatic system disorders | MedDRA 21.1 | Systematic Assessment |
| |
| Thrombocytopenia | Blood and lymphatic system disorders | MedDRA 21.1 | Systematic Assessment |
| |
| Leukopenia | Blood and lymphatic system disorders | MedDRA 21.1 | Systematic Assessment |
| |
| Decreased appetite | Metabolism and nutrition disorders | MedDRA 21.1 | Systematic Assessment |
| |
| Hypokalaemia | Metabolism and nutrition disorders | MedDRA 21.1 | Systematic Assessment |
| |
| Insomnia | Psychiatric disorders | MedDRA 21.1 | Systematic Assessment |
| |
| Peripheral sensory neuropathy | Nervous system disorders | MedDRA 21.1 | Systematic Assessment |
| |
| Neuropathy peripheral | Nervous system disorders | MedDRA 21.1 | Systematic Assessment |
| |
| Dysgeusia | Nervous system disorders | MedDRA 21.1 | Systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA 21.1 | Systematic Assessment |
| |
| Dizziness | Nervous system disorders | MedDRA 21.1 | Systematic Assessment |
| |
| Neurotoxicity | Nervous system disorders | MedDRA 21.1 | Systematic Assessment |
| |
| Hypertension | Vascular disorders | MedDRA 21.1 | Systematic Assessment |
| |
| Epistaxis | Respiratory, thoracic and mediastinal disorders | MedDRA 21.1 | Systematic Assessment |
| |
| Rhinorrhoea | Respiratory, thoracic and mediastinal disorders | MedDRA 21.1 | Systematic Assessment |
| |
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA 21.1 | Systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA 21.1 | Systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA 21.1 | Systematic Assessment |
| |
| Stomatitis | Gastrointestinal disorders | MedDRA 21.1 | Systematic Assessment |
| |
| Constipation | Gastrointestinal disorders | MedDRA 21.1 | Systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA 21.1 | Systematic Assessment |
| |
| Abdominal pain | Gastrointestinal disorders | MedDRA 21.1 | Systematic Assessment |
| |
| Abdominal pain upper | Gastrointestinal disorders | MedDRA 21.1 | Systematic Assessment |
| |
| Dyspepsia | Gastrointestinal disorders | MedDRA 21.1 | Systematic Assessment |
| |
| Alopecia | Skin and subcutaneous tissue disorders | MedDRA 21.1 | Systematic Assessment |
| |
| Palmar-plantar erythrodysaesthesia syndrome | Skin and subcutaneous tissue disorders | MedDRA 21.1 | Systematic Assessment |
| |
| Skin hyperpigmentation | Skin and subcutaneous tissue disorders | MedDRA 21.1 | Systematic Assessment |
| |
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA 21.1 | Systematic Assessment |
| |
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA 21.1 | Systematic Assessment |
| |
| Pain in extremity | Musculoskeletal and connective tissue disorders | MedDRA 21.1 | Systematic Assessment |
| |
| Proteinuria | Renal and urinary disorders | MedDRA 21.1 | Systematic Assessment |
| |
| Fatigue | General disorders | MedDRA 21.1 | Systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA 21.1 | Systematic Assessment |
| |
| Malaise | General disorders | MedDRA 21.1 | Systematic Assessment |
| |
| Asthenia | General disorders | MedDRA 21.1 | Systematic Assessment |
| |
| Neutrophil count decreased | Investigations | MedDRA 21.1 | Systematic Assessment |
| |
| Platelet count decreased | Investigations | MedDRA 21.1 | Systematic Assessment |
| |
| Weight decreased | Investigations | MedDRA 21.1 | Systematic Assessment |
| |
| White blood cell count decreased | Investigations | MedDRA 21.1 | Systematic Assessment |
| |
| Gamma-glutamyltransferase increased | Investigations | MedDRA 21.1 | Systematic Assessment |
| |
| Aspartate aminotransferase increased | Investigations | MedDRA 21.1 | Systematic Assessment |
| |
| Weight increased | Investigations | MedDRA 21.1 | Systematic Assessment |
|
From 21 December 2017, the Sponsor recommended for patients to be switched from BI 695502 to Avastin®. The main analyses for reporting primary and secondary endpoints was clarified as the pre-switch period (i.e., all receiving BI 695502).
Boehringer Ingelheim (BI) acknowledges that investigators have the right to publish the study results. Investigators shall provide BI with a copy of any publication or presentation for review prior to any submission. Such review will be done with regard to proprietary information, information related to patentable inventions, medical, scientific, and statistical accuracy within 60 days. BI may request a delay of the publication in order to protect BI's intellectual property rights.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Boehringer Ingelheim, Call Centre | Boehringer Ingelheim | 1-800-243-0127 | clintriage.rdg@boehringer-ingelheim.com |
| SAP_000.pdf |
| Prot | Yes | No | No | Study Protocol | Jan 17, 2018 | Sep 30, 2019 | Prot_001.pdf |
| 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 |
| 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 |
Not provided
Not provided
| Physician Decision |
|
| Progressive disease |
|
| Other than listed |
|
| Unknown or Not Reported |
|
| Native Hawaiian or Other Pacific Islander |
|
| Black or African American |
|
| White |
|
| More than one race |
|
| Unknown or Not Reported |
|
|
| Gastrointestinal perforations |
|
| Hypertension |
|
| Proteinuria |
|
| Pulmonary Haemorrhage |
|
| Hemorrhages |
|
| Wound-healing complications |
|
| Reversible Encephalopathy Syndrome |
|
| Ovarian failure |
|
|
|
| Counts |
|---|
| Participants |
|
|
|
|
|
|
|