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This phase 2 study is an open-label, multi-center study to determine the safety and tolerability of AMG 386 in combination with sunitinib in the treatment of subjects with metastatic renal cell carcinoma.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Trebananib 10 mg/kg + Sunitinib | Experimental | Trebananib 10 mg/kg intravenously (IV) once weekly (QW) plus sunitinib 50 mg orally (PO) once daily (QD) 4 weeks on/2 weeks off |
|
| Trebananib 15 mg/kg + Sunitinib | Experimental | Trebananib 15 mg/kg IV QW plus sunitinib 50 mg PO QD 4 weeks on/2 weeks off |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Sunitinib | Drug | Sunitinib will be administered 50 mg QD and is considered to be the background therapy as it is licensed for treatment of reneal cell cancer (RCC) and will be administered to all participants. |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Treatment-Emergent Adverse Events (TEAEs), Serious Adverse Events (SAEs), and Discontinuations (DCs) Due to Adverse Events (AEs) | AE: any untoward medical occurrence that does not necessarily have a causal relationship with treatment. SAE: an AE that: is fatal; is life threatening; requires in-patient hospitalization or prolongation of existing hospitalization; results in persistent or significant disability/incapacity; is a congenital anomaly/birth defect; is an other significant medical hazard. Treatment-emergent AEs (TEAEs) are those that occurred after the first administration of study drug through 30 days after the last study drug administration. Severity was graded according to Common Terminology Criteria (CTCAE) version 3.0, as grade 1 (mild), grade 2 (moderate), grade 3 (severe), grade 4 (life-threatening), grade 5 (death). | From first dose of study drug to 30 days after last dose. Median treatment duration of trebananib and sunitinib was 316 and 315 days, respectively, for Trebananib 10 mg/kg+Sunitinib, and 393 and 358 days, respectively, for Trebananib 15 mg/kg+Sunitinib. |
| Number of Participants With Dose Delays Due to Adverse Events | A trebananib dose was considered delayed if it was administered 11 or more days from the previous trebananib infusion. A sunitinib dose was considered delayed if it was administered 3 or more days from the previous dose, except during holidays. | Median treatment duration of trebananib and sunitinib was 316 and 315 days, respectively, for Trebananib 10 mg/kg+Sunitinib, and 393 and 358 days, respectively, for Trebananib 15 mg/kg+Sunitinib. |
| Number of Participants With Sunitinib Dose Modifications Within 12 Weeks of First Dose | Participants who had a sunitinib dose modification within 12 weeks from their first dose due to adverse event, laboratory toxicity, or laboratory toxicity and adverse event. | first 12 weeks of study treatment |
| Number of Participants With Worst Post-Baseline Grade 3 or Higher Toxicity in Laboratory Values |
| Measure | Description | Time Frame |
|---|---|---|
| Objective Response Rate (ORR) | ORR was defined as the percentage of participants with either a confirmed complete response (CR) or partial response (PR) per modified Response Evaluation Criteria in Solid Tumor (RECIST) criteria (responder). A confirmed CR requires 2 consecutive assessments of CR at least 28 days apart. A confirmed PR requires 2 consecutive assessments at least 28 days apart of PR or CR. All participants who did not meet the criteria for an objective response by the analysis cutoff date were considered non responders. |
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Inclusion Criteria:
Exclusion Criteria:
Disease related
Medications
General medical
Other
Other inclusion/exclusion criteria may apply, per protocol.
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| Name | Affiliation | Role |
|---|---|---|
| MD | Amgen | Study Director |
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| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 26304872 | Derived | Atkins MB, Gravis G, Drosik K, Demkow T, Tomczak P, Wong SS, Michaelson MD, Choueiri TK, Wu B, Navale L, Warner D, Ravaud A. Trebananib (AMG 386) in Combination With Sunitinib in Patients With Metastatic Renal Cell Cancer: An Open-Label, Multicenter, Phase II Study. J Clin Oncol. 2015 Oct 20;33(30):3431-8. doi: 10.1200/JCO.2014.60.6012. Epub 2015 Aug 24. |
| Label | URL |
|---|---|
| AmgenTrials clinical trials website | View source |
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De-identified individual patient data for variables necessary to address the specific research question in an approved data sharing request
Data sharing requests relating to this study will be considered beginning 18 months after the study has ended and either 1) the product and indication (or other new use) have been granted marketing authorization in both the US and Europe or 2) clinical development for the product and/or indication discontinues and the data will not be submitted to regulatory authorities. There is no end date for eligibility to submit a data sharing request for this study.
Qualified researchers may submit a request containing the research objectives, the Amgen product(s) and Amgen study/studies in scope, endpoints/outcomes of interest, statistical analysis plan, data requirements, publication plan, and qualifications of the researcher(s). In general, Amgen does not grant external requests for individual patient data for the purpose of re-evaluating safety and efficacy issues already addressed in the product labelling. Requests are reviewed by a committee of internal advisors, and if not approved, may be further arbitrated by a Data Sharing Independent Review Panel. Upon approval, information necessary to address the research question will be provided under the terms of a data sharing agreement. This may include anonymized individual patient data and/or available supporting documents, containing fragments of analysis code where provided in analysis specifications. Further details are available at the link below.
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This study was conducted at 18 sites in the United States, Australia, Belgium, France, and Poland. The first participant was enrolled on 28 May 2009. The last participant was enrolled on 29 November 2010.
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| ID | Title | Description |
|---|---|---|
| FG000 | Trebananib 10 mg/kg + Sunitinib | Trebananib 10 mg/kg intravenously (IV) once weekly (QW) plus sunitinib 50 mg orally (PO) once daily (QD) 4 weeks on/2 weeks off |
| FG001 | Trebananib 15 mg/kg + Sunitinib | Trebananib 15 mg/kg IV QW plus sunitinib 50 mg PO QD 4 weeks on/2 weeks off |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Trebananib 10 mg/kg + Sunitinib | Trebananib 10 mg/kg IV QW plus sunitinib 50 mg PO QD 4 weeks on/2 weeks off |
| BG001 | Trebananib 15 mg/kg + Sunitinib | Trebananib 15 mg/kg IV QW plus sunitinib 50 mg PO QD 4 weeks on/2 weeks off |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Customized | Number |
| 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 | Number of Participants With Treatment-Emergent Adverse Events (TEAEs), Serious Adverse Events (SAEs), and Discontinuations (DCs) Due to Adverse Events (AEs) | AE: any untoward medical occurrence that does not necessarily have a causal relationship with treatment. SAE: an AE that: is fatal; is life threatening; requires in-patient hospitalization or prolongation of existing hospitalization; results in persistent or significant disability/incapacity; is a congenital anomaly/birth defect; is an other significant medical hazard. Treatment-emergent AEs (TEAEs) are those that occurred after the first administration of study drug through 30 days after the last study drug administration. Severity was graded according to Common Terminology Criteria (CTCAE) version 3.0, as grade 1 (mild), grade 2 (moderate), grade 3 (severe), grade 4 (life-threatening), grade 5 (death). | Safety Analysis Set: all participants who received at least 1 dose of trebananib and 1 dose of sunitinib. | Posted | Number | participants | From first dose of study drug to 30 days after last dose. Median treatment duration of trebananib and sunitinib was 316 and 315 days, respectively, for Trebananib 10 mg/kg+Sunitinib, and 393 and 358 days, respectively, for Trebananib 15 mg/kg+Sunitinib. |
From first dose of study drug to 30 days after last dose. Median treatment duration of trebananib and sunitinib was 316 and 315 days, respectively, for Trebananib 10 mg/kg+Sunitinib, and 393 and 358 days, respectively, for Trebananib 15 mg/kg+Sunitinib.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. Other adverse events shows non-serious occurrences of adverse event that exceed the indicated frequency threshold.
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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 | Trebananib 10 mg/kg + Sunitinib | Trebananib 10 mg/kg IV QW plus sunitinib 50 mg PO QD 4 weeks on/2 weeks off |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | MedDRA 22.1 | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | MedDRA 22.1 | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Study Director | Amgen Inc. | 866-572-6436 | medinfo@amgen.com |
| ID | Term |
|---|---|
| D000077210 | Sunitinib |
| C551398 | trebananib |
| D020533 | Angiogenesis Inhibitors |
| ID | Term |
|---|---|
| D011758 | Pyrroles |
| D001393 | Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
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|
| Trebananib | Drug | Administered until a participant develops disease progression, clinical progression, unacceptable toxicity, withdraws consent, or death. |
|
|
Severity was graded according to Common Terminology Criteria (CTCAE) version 3.0, as grade 1 (mild), grade 2 (moderate), grade 3 (severe), grade 4 (life-threatening), grade 5 (death).
| From first dose of study drug to 30 days after last dose. Median treatment duration of trebananib and sunitinib was 316 and 315 days, respectively, for Trebananib 10 mg/kg+Sunitinib, and 393 and 358 days, respectively, for Trebananib 15 mg/kg+Sunitinib. |
| 48 months after last subject enrolled (LSE) |
| Kaplan-Meier Estimate: Duration of Response (DOR) | DOR was calculated as the time from the first confirmed objective response to first observed disease progression per modified RECIST v. 1.0 criteria or death due to any cause. DOR was calculated only for participants who had an objective response. Objective response was defined as either a confirmed CR or PR per modified RECIST criteria. A confirmed CR required 2 consecutive assessments of CR at least 28 days apart. A confirmed PR required 2 consecutive assessments at least 28 days apart of PR or CR. Participants not meeting criteria for progression by the analysis data cutoff date were censored at their last evaluable radiographical disease assessment date. | 48 months after LSE |
| Disease Control Rate (DCR) | DCR was defined as the percentage of participants with confirmed CR or PR or stable disease (SD), as defined by modified RECIST v1.0 criteria. A confirmed CR required 2 consecutive assessments of CR at least 28 days apart. A confirmed PR requires 2 consecutive assessments at least 28 days apart of PR or CR. CR or PR was confirmed at least 28 days after the criteria for response were first met. A response assessment of PR or CR that was not subsequently confirmed at least 4 weeks later were included as SD. | 48 months after LSE |
| Kaplan-Meier Estimate: Progression Free Survival (PFS) | PFS was defined as the time from enrollment date to date of disease progression (ie, radiographic progression) per modified RECIST v 1.0 criteria or death. Radiological imaging to assess disease status was performed until participants developed disease progression. Events of radiographic progression per modified RECIST 1.0 that occurred after initiation of subsequent anticancer therapy were not considered PFS events. Deaths occurring after initiation of subsequent anticancer therapy were considered PFS events. Participants not meeting criteria for progression by the analysis data cutoff date were censored at their last evaluable disease assessment date. | 48 months after LSE |
| Kaplan-Meier Estimate: Overall Survival (OS) | The time from enrollment date to date of death. Participants who had not died by the analysis data cutoff date were censored at their last contact date. | 48 months after LSE |
| Maximum Percent Reduction From Baseline in the Sum of the Longest Diameters (SLD) of Target Lesions From Baseline to Post-Baseline Nadir | Change in tumor burden was evaluated by the maximum percent reduction from baseline in the SLD of target lesions. | Baseline, 48 months after LSE |
| Pharmacokinetic Parameter: Maximum Observed Concentration (Cmax) for Trebananib Over Time | Pre-infusion and up to 10 minutes post-infusion on Weeks 1, 4, 7, 10, 13, 22, 34, 46, 58, 70, 82, 94, 106, and safety follow-up (30 ±7 days after the last dose of study drug) |
| Pharmacokinetic Parameter: Minimum Observed Concentration (Cmin) for Trebananib Over Time | Pre-infusion on Weeks 4, 7, 10, 13, 22, 34, 46, 58, 70, 82, 94, 106, and safety follow-up (30 ±7 days after the last dose of study drug) |
| Pharmacokinetic Parameter: Cmin for Sunitinib Over Time | Pre-infusion on Weeks 4, 7, 10, 16, 22, 34, 46, 58, 70, 82, 94, 106, and safety follow-up (30 ±7 days after the last dose of study drug) |
| Pharmacokinetic Parameter: Cmin for Sunitinib Metabolite Over Time | Pre-infusion on Weeks 4, 7, 10, 16, 22, 34, 46, 58, 70, 82, 94, 106, and safety follow-up (30 ±7 days after the last dose of study drug) |
| Number of Participants Binding Antibody- or Neutralizing Antibody-Positive Post-Baseline | Transient positive results were defined as a positive post-baseline result followed by a negative result at the participant's last time point tested within the study period. | 48 months after LSE |
| Full Consent Withdrawn |
|
| BG002 | Total | Total of all reporting groups |
| participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Number | participants |
|
| ID | Title | Description |
|---|---|---|
| OG000 | Trebananib 10 mg/kg + Sunitinib | Trebananib 10 mg/kg IV QW plus sunitinib 50 mg PO QD 4 weeks on/2 weeks off |
| OG001 | Trebananib 15 mg/kg + Sunitinib | Trebananib 15 mg/kg IV QW plus sunitinib 50 mg PO QD 4 weeks on/2 weeks off |
|
|
| Primary | Number of Participants With Dose Delays Due to Adverse Events | A trebananib dose was considered delayed if it was administered 11 or more days from the previous trebananib infusion. A sunitinib dose was considered delayed if it was administered 3 or more days from the previous dose, except during holidays. | Safety Analysis Set: participants who received at least 1 dose of trebananib and 1 dose of sunitinib. | Posted | Number | participants | Median treatment duration of trebananib and sunitinib was 316 and 315 days, respectively, for Trebananib 10 mg/kg+Sunitinib, and 393 and 358 days, respectively, for Trebananib 15 mg/kg+Sunitinib. |
|
|
|
| Primary | Number of Participants With Sunitinib Dose Modifications Within 12 Weeks of First Dose | Participants who had a sunitinib dose modification within 12 weeks from their first dose due to adverse event, laboratory toxicity, or laboratory toxicity and adverse event. | Safety Analysis Set: all participants who received at least 1 dose of trebananib and 1 dose of sunitinib. | Posted | Number | participants | first 12 weeks of study treatment |
|
|
|
| Primary | Number of Participants With Worst Post-Baseline Grade 3 or Higher Toxicity in Laboratory Values | Severity was graded according to Common Terminology Criteria (CTCAE) version 3.0, as grade 1 (mild), grade 2 (moderate), grade 3 (severe), grade 4 (life-threatening), grade 5 (death). | Safety Aanalysis Set: all participants who received at least 1 dose of trebananib and 1 dose of sunitinib. | Posted | Number | participants | From first dose of study drug to 30 days after last dose. Median treatment duration of trebananib and sunitinib was 316 and 315 days, respectively, for Trebananib 10 mg/kg+Sunitinib, and 393 and 358 days, respectively, for Trebananib 15 mg/kg+Sunitinib. |
|
|
|
| Secondary | Objective Response Rate (ORR) | ORR was defined as the percentage of participants with either a confirmed complete response (CR) or partial response (PR) per modified Response Evaluation Criteria in Solid Tumor (RECIST) criteria (responder). A confirmed CR requires 2 consecutive assessments of CR at least 28 days apart. A confirmed PR requires 2 consecutive assessments at least 28 days apart of PR or CR. All participants who did not meet the criteria for an objective response by the analysis cutoff date were considered non responders. | Safety Analysis Set: all participants who received at least 1 dose of trebananib and 1 dose of sunitinib. Participants with baseline measureable disease. | Posted | Number | 80% Confidence Interval | percentage of participants | 48 months after last subject enrolled (LSE) |
|
|
|
| Secondary | Kaplan-Meier Estimate: Duration of Response (DOR) | DOR was calculated as the time from the first confirmed objective response to first observed disease progression per modified RECIST v. 1.0 criteria or death due to any cause. DOR was calculated only for participants who had an objective response. Objective response was defined as either a confirmed CR or PR per modified RECIST criteria. A confirmed CR required 2 consecutive assessments of CR at least 28 days apart. A confirmed PR required 2 consecutive assessments at least 28 days apart of PR or CR. Participants not meeting criteria for progression by the analysis data cutoff date were censored at their last evaluable radiographical disease assessment date. | Safety Analysis Set: all participants who received at least 1 dose of trebananib and 1 dose of sunitinib. Participants with an objective response. | Posted | Median | 80% Confidence Interval | months | 48 months after LSE |
|
|
|
| Secondary | Disease Control Rate (DCR) | DCR was defined as the percentage of participants with confirmed CR or PR or stable disease (SD), as defined by modified RECIST v1.0 criteria. A confirmed CR required 2 consecutive assessments of CR at least 28 days apart. A confirmed PR requires 2 consecutive assessments at least 28 days apart of PR or CR. CR or PR was confirmed at least 28 days after the criteria for response were first met. A response assessment of PR or CR that was not subsequently confirmed at least 4 weeks later were included as SD. | Safety Analysis Set: all participants who received at least 1 dose of trebananib and 1 dose of sunitinib. Participants with baseline measureable disease. | Posted | Number | 80% Confidence Interval | percentage of participants | 48 months after LSE |
|
|
|
| Secondary | Kaplan-Meier Estimate: Progression Free Survival (PFS) | PFS was defined as the time from enrollment date to date of disease progression (ie, radiographic progression) per modified RECIST v 1.0 criteria or death. Radiological imaging to assess disease status was performed until participants developed disease progression. Events of radiographic progression per modified RECIST 1.0 that occurred after initiation of subsequent anticancer therapy were not considered PFS events. Deaths occurring after initiation of subsequent anticancer therapy were considered PFS events. Participants not meeting criteria for progression by the analysis data cutoff date were censored at their last evaluable disease assessment date. | Safety Analysis Set: all participants who received at least 1 dose of trebananib and 1 dose of sunitinib. | Posted | Median | 80% Confidence Interval | months | 48 months after LSE |
|
|
|
| Secondary | Kaplan-Meier Estimate: Overall Survival (OS) | The time from enrollment date to date of death. Participants who had not died by the analysis data cutoff date were censored at their last contact date. | Safety Analysis Set: all participants who received at least 1 dose of trebananib and 1 dose of sunitinib. | Posted | Median | 80% Confidence Interval | months | 48 months after LSE |
|
|
|
| Secondary | Maximum Percent Reduction From Baseline in the Sum of the Longest Diameters (SLD) of Target Lesions From Baseline to Post-Baseline Nadir | Change in tumor burden was evaluated by the maximum percent reduction from baseline in the SLD of target lesions. | Safety Analysis Set: all participants who received at least 1 dose of trebananib and 1 dose of sunitinib. Participants with baseline measureable disease and non-missing baseline and post-baseline data. | Posted | Mean | 80% Confidence Interval | percent reduction in SLD | Baseline, 48 months after LSE |
|
|
|
| Secondary | Pharmacokinetic Parameter: Maximum Observed Concentration (Cmax) for Trebananib Over Time | Pharmacokinetics Analysis Set: participants with evaluable concentration data at given time point. | Posted | Median | Full Range | µg/mL | Pre-infusion and up to 10 minutes post-infusion on Weeks 1, 4, 7, 10, 13, 22, 34, 46, 58, 70, 82, 94, 106, and safety follow-up (30 ±7 days after the last dose of study drug) |
|
|
|
| Secondary | Pharmacokinetic Parameter: Minimum Observed Concentration (Cmin) for Trebananib Over Time | Pharmacokinetics Analysis Set: participants with evaluable concentration data at given time point. | Posted | Median | Full Range | µg/mL | Pre-infusion on Weeks 4, 7, 10, 13, 22, 34, 46, 58, 70, 82, 94, 106, and safety follow-up (30 ±7 days after the last dose of study drug) |
|
|
|
| Secondary | Pharmacokinetic Parameter: Cmin for Sunitinib Over Time | Pharmacokinetics Analysis Set: participants with evaluable concentration data at given time point. Per protocol, this outcome measure evaluated a sub-group of participants at selected sites outside of Europe. | Posted | Median | Full Range | ng/mL | Pre-infusion on Weeks 4, 7, 10, 16, 22, 34, 46, 58, 70, 82, 94, 106, and safety follow-up (30 ±7 days after the last dose of study drug) |
|
|
|
| Secondary | Pharmacokinetic Parameter: Cmin for Sunitinib Metabolite Over Time | Pharmacokinetics Analysis Set: participants with evaluable concentration data at given time point. Per protocol, this outcome measure evaluated a sub-group of participants at selected sites outside of Europe. | Posted | Median | Full Range | ng/mL | Pre-infusion on Weeks 4, 7, 10, 16, 22, 34, 46, 58, 70, 82, 94, 106, and safety follow-up (30 ±7 days after the last dose of study drug) |
|
|
|
| Secondary | Number of Participants Binding Antibody- or Neutralizing Antibody-Positive Post-Baseline | Transient positive results were defined as a positive post-baseline result followed by a negative result at the participant's last time point tested within the study period. | Safety Analysis Set: all participants who received at least 1 dose of trebananib and 1 dose of sunitinib. Participants with a post-baseline result and a negative result or no result at baseline. | Posted | Number | participants | 48 months after LSE |
|
|
|
| 17 |
| 43 |
| 43 |
| 43 |
| EG001 | Trebananib 15 mg/kg + Sunitinib | Trebananib 15 mg/kg IV QW plus sunitinib 50 mg PO QD 4 weeks on/2 weeks off | 26 | 42 | 42 | 42 |
| Febrile bone marrow aplasia | Blood and lymphatic system disorders | MedDRA 22.1 | Systematic Assessment |
|
| Thrombocytopenia | Blood and lymphatic system disorders | MedDRA 22.1 | Systematic Assessment |
|
| Acute coronary syndrome | Cardiac disorders | MedDRA 22.1 | Systematic Assessment |
|
| Atrial fibrillation | Cardiac disorders | MedDRA 22.1 | Systematic Assessment |
|
| Myocardial infarction | Cardiac disorders | MedDRA 22.1 | Systematic Assessment |
|
| Hypothyroidism | Endocrine disorders | MedDRA 22.1 | Systematic Assessment |
|
| Glaucoma | Eye disorders | MedDRA 22.1 | Systematic Assessment |
|
| Papilloedema | Eye disorders | MedDRA 22.1 | Systematic Assessment |
|
| Uveitis | Eye disorders | MedDRA 22.1 | Systematic Assessment |
|
| Vision blurred | Eye disorders | MedDRA 22.1 | Systematic Assessment |
|
| Abdominal pain | Gastrointestinal disorders | MedDRA 22.1 | Systematic Assessment |
|
| Colitis | Gastrointestinal disorders | MedDRA 22.1 | Systematic Assessment |
|
| Colitis ischaemic | Gastrointestinal disorders | MedDRA 22.1 | Systematic Assessment |
|
| Diarrhoea | Gastrointestinal disorders | MedDRA 22.1 | Systematic Assessment |
|
| Duodenal ulcer | Gastrointestinal disorders | MedDRA 22.1 | Systematic Assessment |
|
| Dysphagia | Gastrointestinal disorders | MedDRA 22.1 | Systematic Assessment |
|
| Gastrooesophageal reflux disease | Gastrointestinal disorders | MedDRA 22.1 | Systematic Assessment |
|
| Ileus paralytic | Gastrointestinal disorders | MedDRA 22.1 | Systematic Assessment |
|
| Nausea | Gastrointestinal disorders | MedDRA 22.1 | Systematic Assessment |
|
| Rectourethral fistula | Gastrointestinal disorders | MedDRA 22.1 | Systematic Assessment |
|
| Small intestinal obstruction | Gastrointestinal disorders | MedDRA 22.1 | Systematic Assessment |
|
| Vomiting | Gastrointestinal disorders | MedDRA 22.1 | Systematic Assessment |
|
| Asthenia | General disorders | MedDRA 22.1 | Systematic Assessment |
|
| Chest discomfort | General disorders | MedDRA 22.1 | Systematic Assessment |
|
| Chest pain | General disorders | MedDRA 22.1 | Systematic Assessment |
|
| Fatigue | General disorders | MedDRA 22.1 | Systematic Assessment |
|
| General physical health deterioration | General disorders | MedDRA 22.1 | Systematic Assessment |
|
| Infusion site inflammation | General disorders | MedDRA 22.1 | Systematic Assessment |
|
| Malaise | General disorders | MedDRA 22.1 | Systematic Assessment |
|
| Mucosal inflammation | General disorders | MedDRA 22.1 | Systematic Assessment |
|
| Oedema | General disorders | MedDRA 22.1 | Systematic Assessment |
|
| Pyrexia | General disorders | MedDRA 22.1 | Systematic Assessment |
|
| Swelling | General disorders | MedDRA 22.1 | Systematic Assessment |
|
| Bile duct stenosis | Hepatobiliary disorders | MedDRA 22.1 | Systematic Assessment |
|
| Cholangitis | Hepatobiliary disorders | MedDRA 22.1 | Systematic Assessment |
|
| Cholecystitis | Hepatobiliary disorders | MedDRA 22.1 | Systematic Assessment |
|
| Cholecystitis acute | Hepatobiliary disorders | MedDRA 22.1 | Systematic Assessment |
|
| Cholecystitis chronic | Hepatobiliary disorders | MedDRA 22.1 | Systematic Assessment |
|
| Cholelithiasis | Hepatobiliary disorders | MedDRA 22.1 | Systematic Assessment |
|
| Hyperbilirubinaemia | Hepatobiliary disorders | MedDRA 22.1 | Systematic Assessment |
|
| Anal abscess | Infections and infestations | MedDRA 22.1 | Systematic Assessment |
|
| Escherichia sepsis | Infections and infestations | MedDRA 22.1 | Systematic Assessment |
|
| Infection | Infections and infestations | MedDRA 22.1 | Systematic Assessment |
|
| Pneumonia | Infections and infestations | MedDRA 22.1 | Systematic Assessment |
|
| Sepsis | Infections and infestations | MedDRA 22.1 | Systematic Assessment |
|
| Urinary tract infection | Infections and infestations | MedDRA 22.1 | Systematic Assessment |
|
| Humerus fracture | Injury, poisoning and procedural complications | MedDRA 22.1 | Systematic Assessment |
|
| Dehydration | Metabolism and nutrition disorders | MedDRA 22.1 | Systematic Assessment |
|
| Diabetes mellitus inadequate control | Metabolism and nutrition disorders | MedDRA 22.1 | Systematic Assessment |
|
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA 22.1 | Systematic Assessment |
|
| Bone pain | Musculoskeletal and connective tissue disorders | MedDRA 22.1 | Systematic Assessment |
|
| Muscular weakness | Musculoskeletal and connective tissue disorders | MedDRA 22.1 | Systematic Assessment |
|
| Osteonecrosis of jaw | Musculoskeletal and connective tissue disorders | MedDRA 22.1 | Systematic Assessment |
|
| Renal cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 22.1 | Systematic Assessment |
|
| Renal cell carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 22.1 | Systematic Assessment |
|
| Brain hypoxia | Nervous system disorders | MedDRA 22.1 | Systematic Assessment |
|
| Loss of consciousness | Nervous system disorders | MedDRA 22.1 | Systematic Assessment |
|
| Migraine with aura | Nervous system disorders | MedDRA 22.1 | Systematic Assessment |
|
| Monoplegia | Nervous system disorders | MedDRA 22.1 | Systematic Assessment |
|
| Presyncope | Nervous system disorders | MedDRA 22.1 | Systematic Assessment |
|
| Syncope | Nervous system disorders | MedDRA 22.1 | Systematic Assessment |
|
| Device occlusion | Product Issues | MedDRA 22.1 | Systematic Assessment |
|
| Confusional state | Psychiatric disorders | MedDRA 22.1 | Systematic Assessment |
|
| Mental status changes | Psychiatric disorders | MedDRA 22.1 | Systematic Assessment |
|
| Haematuria | Renal and urinary disorders | MedDRA 22.1 | Systematic Assessment |
|
| Renal failure | Renal and urinary disorders | MedDRA 22.1 | Systematic Assessment |
|
| Urinary retention | Renal and urinary disorders | MedDRA 22.1 | Systematic Assessment |
|
| Pelvic pain | Reproductive system and breast disorders | MedDRA 22.1 | Systematic Assessment |
|
| Acute pulmonary oedema | Respiratory, thoracic and mediastinal disorders | MedDRA 22.1 | Systematic Assessment |
|
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA 22.1 | Systematic Assessment |
|
| Hypoxia | Respiratory, thoracic and mediastinal disorders | MedDRA 22.1 | Systematic Assessment |
|
| Pleural effusion | Respiratory, thoracic and mediastinal disorders | MedDRA 22.1 | Systematic Assessment |
|
| Pneumonitis | Respiratory, thoracic and mediastinal disorders | MedDRA 22.1 | Systematic Assessment |
|
| Skin ulcer | Skin and subcutaneous tissue disorders | MedDRA 22.1 | Systematic Assessment |
|
| Deep vein thrombosis | Vascular disorders | MedDRA 22.1 | Systematic Assessment |
|
| Hypertension | Vascular disorders | MedDRA 22.1 | Systematic Assessment |
|
| Leukopenia | Blood and lymphatic system disorders | MedDRA 22.1 | Systematic Assessment |
|
| Neutropenia | Blood and lymphatic system disorders | MedDRA 22.1 | Systematic Assessment |
|
| Thrombocytopenia | Blood and lymphatic system disorders | MedDRA 22.1 | Systematic Assessment |
|
| Pericardial effusion | Cardiac disorders | MedDRA 22.1 | Systematic Assessment |
|
| Hypoacusis | Ear and labyrinth disorders | MedDRA 22.1 | Systematic Assessment |
|
| Tinnitus | Ear and labyrinth disorders | MedDRA 22.1 | Systematic Assessment |
|
| Vertigo | Ear and labyrinth disorders | MedDRA 22.1 | Systematic Assessment |
|
| Hyperthyroidism | Endocrine disorders | MedDRA 22.1 | Systematic Assessment |
|
| Hypothyroidism | Endocrine disorders | MedDRA 22.1 | Systematic Assessment |
|
| Eyelid oedema | Eye disorders | MedDRA 22.1 | Systematic Assessment |
|
| Glaucoma | Eye disorders | MedDRA 22.1 | Systematic Assessment |
|
| Lacrimation increased | Eye disorders | MedDRA 22.1 | Systematic Assessment |
|
| Periorbital oedema | Eye disorders | MedDRA 22.1 | Systematic Assessment |
|
| Visual acuity reduced | Eye disorders | MedDRA 22.1 | Systematic Assessment |
|
| Abdominal discomfort | Gastrointestinal disorders | MedDRA 22.1 | Systematic Assessment |
|
| Abdominal distension | Gastrointestinal disorders | MedDRA 22.1 | Systematic Assessment |
|
| Abdominal pain | Gastrointestinal disorders | MedDRA 22.1 | Systematic Assessment |
|
| Abdominal pain upper | Gastrointestinal disorders | MedDRA 22.1 | Systematic Assessment |
|
| Aphthous ulcer | Gastrointestinal disorders | MedDRA 22.1 | Systematic Assessment |
|
| Ascites | Gastrointestinal disorders | MedDRA 22.1 | Systematic Assessment |
|
| Constipation | Gastrointestinal disorders | MedDRA 22.1 | Systematic Assessment |
|
| Diarrhoea | Gastrointestinal disorders | MedDRA 22.1 | Systematic Assessment |
|
| Dry mouth | Gastrointestinal disorders | MedDRA 22.1 | Systematic Assessment |
|
| Dyspepsia | Gastrointestinal disorders | MedDRA 22.1 | Systematic Assessment |
|
| Dysphagia | Gastrointestinal disorders | MedDRA 22.1 | Systematic Assessment |
|
| Flatulence | Gastrointestinal disorders | MedDRA 22.1 | Systematic Assessment |
|
| Gastrooesophageal reflux disease | Gastrointestinal disorders | MedDRA 22.1 | Systematic Assessment |
|
| Gingival pain | Gastrointestinal disorders | MedDRA 22.1 | Systematic Assessment |
|
| Haemorrhoids | Gastrointestinal disorders | MedDRA 22.1 | Systematic Assessment |
|
| Nausea | Gastrointestinal disorders | MedDRA 22.1 | Systematic Assessment |
|
| Oesophagitis | Gastrointestinal disorders | MedDRA 22.1 | Systematic Assessment |
|
| Stomatitis | Gastrointestinal disorders | MedDRA 22.1 | Systematic Assessment |
|
| Vomiting | Gastrointestinal disorders | MedDRA 22.1 | Systematic Assessment |
|
| Asthenia | General disorders | MedDRA 22.1 | Systematic Assessment |
|
| Catheter site pain | General disorders | MedDRA 22.1 | Systematic Assessment |
|
| Chest pain | General disorders | MedDRA 22.1 | Systematic Assessment |
|
| Chills | General disorders | MedDRA 22.1 | Systematic Assessment |
|
| Face oedema | General disorders | MedDRA 22.1 | Systematic Assessment |
|
| Fatigue | General disorders | MedDRA 22.1 | Systematic Assessment |
|
| Generalised oedema | General disorders | MedDRA 22.1 | Systematic Assessment |
|
| Influenza like illness | General disorders | MedDRA 22.1 | Systematic Assessment |
|
| Localised oedema | General disorders | MedDRA 22.1 | Systematic Assessment |
|
| Malaise | General disorders | MedDRA 22.1 | Systematic Assessment |
|
| Mucosal dryness | General disorders | MedDRA 22.1 | Systematic Assessment |
|
| Mucosal inflammation | General disorders | MedDRA 22.1 | Systematic Assessment |
|
| Oedema peripheral | General disorders | MedDRA 22.1 | Systematic Assessment |
|
| Pyrexia | General disorders | MedDRA 22.1 | Systematic Assessment |
|
| Hyperbilirubinaemia | Hepatobiliary disorders | MedDRA 22.1 | Systematic Assessment |
|
| Bronchitis | Infections and infestations | MedDRA 22.1 | Systematic Assessment |
|
| Conjunctivitis | Infections and infestations | MedDRA 22.1 | Systematic Assessment |
|
| Cystitis | Infections and infestations | MedDRA 22.1 | Systematic Assessment |
|
| Ear infection | Infections and infestations | MedDRA 22.1 | Systematic Assessment |
|
| Gastroenteritis | Infections and infestations | MedDRA 22.1 | Systematic Assessment |
|
| Influenza | Infections and infestations | MedDRA 22.1 | Systematic Assessment |
|
| Laryngitis | Infections and infestations | MedDRA 22.1 | Systematic Assessment |
|
| Nasopharyngitis | Infections and infestations | MedDRA 22.1 | Systematic Assessment |
|
| Oral herpes | Infections and infestations | MedDRA 22.1 | Systematic Assessment |
|
| Pharyngitis | Infections and infestations | MedDRA 22.1 | Systematic Assessment |
|
| Rhinitis | Infections and infestations | MedDRA 22.1 | Systematic Assessment |
|
| Sinusitis | Infections and infestations | MedDRA 22.1 | Systematic Assessment |
|
| Tooth abscess | Infections and infestations | MedDRA 22.1 | Systematic Assessment |
|
| Upper respiratory tract infection | Infections and infestations | MedDRA 22.1 | Systematic Assessment |
|
| Urinary tract infection | Infections and infestations | MedDRA 22.1 | Systematic Assessment |
|
| Fall | Injury, poisoning and procedural complications | MedDRA 22.1 | Systematic Assessment |
|
| Alanine aminotransferase increased | Investigations | MedDRA 22.1 | Systematic Assessment |
|
| Amylase increased | Investigations | MedDRA 22.1 | Systematic Assessment |
|
| Aspartate aminotransferase increased | Investigations | MedDRA 22.1 | Systematic Assessment |
|
| Blood creatinine increased | Investigations | MedDRA 22.1 | Systematic Assessment |
|
| Lipase increased | Investigations | MedDRA 22.1 | Systematic Assessment |
|
| Weight decreased | Investigations | MedDRA 22.1 | Systematic Assessment |
|
| Weight increased | Investigations | MedDRA 22.1 | Systematic Assessment |
|
| Decreased appetite | Metabolism and nutrition disorders | MedDRA 22.1 | Systematic Assessment |
|
| Dehydration | Metabolism and nutrition disorders | MedDRA 22.1 | Systematic Assessment |
|
| Hyperglycaemia | Metabolism and nutrition disorders | MedDRA 22.1 | Systematic Assessment |
|
| Hypoalbuminaemia | Metabolism and nutrition disorders | MedDRA 22.1 | Systematic Assessment |
|
| Hypokalaemia | Metabolism and nutrition disorders | MedDRA 22.1 | Systematic Assessment |
|
| Hypophosphataemia | Metabolism and nutrition disorders | MedDRA 22.1 | Systematic Assessment |
|
| Obesity | Metabolism and nutrition disorders | MedDRA 22.1 | Systematic Assessment |
|
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA 22.1 | Systematic Assessment |
|
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA 22.1 | Systematic Assessment |
|
| Bone pain | Musculoskeletal and connective tissue disorders | MedDRA 22.1 | Systematic Assessment |
|
| Groin pain | Musculoskeletal and connective tissue disorders | MedDRA 22.1 | Systematic Assessment |
|
| Muscle spasms | Musculoskeletal and connective tissue disorders | MedDRA 22.1 | Systematic Assessment |
|
| Muscular weakness | Musculoskeletal and connective tissue disorders | MedDRA 22.1 | Systematic Assessment |
|
| Musculoskeletal pain | Musculoskeletal and connective tissue disorders | MedDRA 22.1 | Systematic Assessment |
|
| Myalgia | Musculoskeletal and connective tissue disorders | MedDRA 22.1 | Systematic Assessment |
|
| Pain in extremity | Musculoskeletal and connective tissue disorders | MedDRA 22.1 | Systematic Assessment |
|
| Spinal pain | Musculoskeletal and connective tissue disorders | MedDRA 22.1 | Systematic Assessment |
|
| Ageusia | Nervous system disorders | MedDRA 22.1 | Systematic Assessment |
|
| Dizziness | Nervous system disorders | MedDRA 22.1 | Systematic Assessment |
|
| Dysgeusia | Nervous system disorders | MedDRA 22.1 | Systematic Assessment |
|
| Formication | Nervous system disorders | MedDRA 22.1 | Systematic Assessment |
|
| Headache | Nervous system disorders | MedDRA 22.1 | Systematic Assessment |
|
| Neuropathy peripheral | Nervous system disorders | MedDRA 22.1 | Systematic Assessment |
|
| Paraesthesia | Nervous system disorders | MedDRA 22.1 | Systematic Assessment |
|
| Presyncope | Nervous system disorders | MedDRA 22.1 | Systematic Assessment |
|
| Sciatica | Nervous system disorders | MedDRA 22.1 | Systematic Assessment |
|
| Syncope | Nervous system disorders | MedDRA 22.1 | Systematic Assessment |
|
| Taste disorder | Nervous system disorders | MedDRA 22.1 | Systematic Assessment |
|
| Anxiety | Psychiatric disorders | MedDRA 22.1 | Systematic Assessment |
|
| Depression | Psychiatric disorders | MedDRA 22.1 | Systematic Assessment |
|
| Insomnia | Psychiatric disorders | MedDRA 22.1 | Systematic Assessment |
|
| Dysuria | Renal and urinary disorders | MedDRA 22.1 | Systematic Assessment |
|
| Proteinuria | Renal and urinary disorders | MedDRA 22.1 | Systematic Assessment |
|
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA 22.1 | Systematic Assessment |
|
| Dysphonia | Respiratory, thoracic and mediastinal disorders | MedDRA 22.1 | Systematic Assessment |
|
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA 22.1 | Systematic Assessment |
|
| Dyspnoea exertional | Respiratory, thoracic and mediastinal disorders | MedDRA 22.1 | Systematic Assessment |
|
| Epistaxis | Respiratory, thoracic and mediastinal disorders | MedDRA 22.1 | Systematic Assessment |
|
| Hiccups | Respiratory, thoracic and mediastinal disorders | MedDRA 22.1 | Systematic Assessment |
|
| Nasal dryness | Respiratory, thoracic and mediastinal disorders | MedDRA 22.1 | Systematic Assessment |
|
| Oropharyngeal pain | Respiratory, thoracic and mediastinal disorders | MedDRA 22.1 | Systematic Assessment |
|
| Pleural effusion | Respiratory, thoracic and mediastinal disorders | MedDRA 22.1 | Systematic Assessment |
|
| Rhinorrhoea | Respiratory, thoracic and mediastinal disorders | MedDRA 22.1 | Systematic Assessment |
|
| Dry skin | Skin and subcutaneous tissue disorders | MedDRA 22.1 | Systematic Assessment |
|
| Erythema | Skin and subcutaneous tissue disorders | MedDRA 22.1 | Systematic Assessment |
|
| Hair colour changes | Skin and subcutaneous tissue disorders | MedDRA 22.1 | Systematic Assessment |
|
| Hyperhidrosis | Skin and subcutaneous tissue disorders | MedDRA 22.1 | Systematic Assessment |
|
| Hyperkeratosis | Skin and subcutaneous tissue disorders | MedDRA 22.1 | Systematic Assessment |
|
| Nail disorder | Skin and subcutaneous tissue disorders | MedDRA 22.1 | Systematic Assessment |
|
| Palmar-plantar erythrodysaesthesia syndrome | Skin and subcutaneous tissue disorders | MedDRA 22.1 | Systematic Assessment |
|
| Pruritus | Skin and subcutaneous tissue disorders | MedDRA 22.1 | Systematic Assessment |
|
| Rash | Skin and subcutaneous tissue disorders | MedDRA 22.1 | Systematic Assessment |
|
| Skin discolouration | Skin and subcutaneous tissue disorders | MedDRA 22.1 | Systematic Assessment |
|
| Skin disorder | Skin and subcutaneous tissue disorders | MedDRA 22.1 | Systematic Assessment |
|
| Skin exfoliation | Skin and subcutaneous tissue disorders | MedDRA 22.1 | Systematic Assessment |
|
| Skin toxicity | Skin and subcutaneous tissue disorders | MedDRA 22.1 | Systematic Assessment |
|
| Yellow skin | Skin and subcutaneous tissue disorders | MedDRA 22.1 | Systematic Assessment |
|
| Hypertension | Vascular disorders | MedDRA 22.1 | Systematic Assessment |
|
| Hypotension | Vascular disorders | MedDRA 22.1 | Systematic Assessment |
|
| Pallor | Vascular disorders | MedDRA 22.1 | Systematic Assessment |
|
The Clinical Trial Agreement generally does not restrict an investigator's discussion of trial results after completion. The Agreement permits Amgen a limited period of time to review material discussing trial results (typically up to 45 days and possible extension). Amgen may remove confidential information, but authors have final control and approval of publication content. For multicenter studies, the investigator agrees not to publish any results before the first multi-center publication.
| D007211 |
| Indoles |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D043924 | Angiogenesis Modulating Agents |
| D006133 | Growth Substances |
| D045505 | Physiological Effects of Drugs |
| D020228 | Pharmacologic Actions |
| D020164 | Chemical Actions and Uses |
| D006131 | Growth Inhibitors |
| D000970 | Antineoplastic Agents |
| D045506 | Therapeutic Uses |
| DM Due to Laboratory Toxicity |
|
| DM Due to Laboratory Toxicity and Adverse Event |
|
| Alkaline Phosphatase, AN |
|
| Amylase, AN |
|
| Aspartate Aminotransferase, AN |
|
| Glucose, AN |
|
| Glucose, BN |
|
| Lipase, AN |
|
| Magnesium, BN |
|
| Phosphorus, BN |
|
| Potassium, BN |
|
| Sodium, BN |
|
| Total Bilirubin, AN |
|
| Absolute Neutrophil Count, BN |
|
| Hemoglobin, BN |
|
| Lymphocytes, BN |
|
| Partial Thromboplastin Time, AN |
|
| Platelets, BN |
|
| Total Neutrophils, BN |
|
| Week 4 |
|
|
| Week 7 |
|
|
| Week 10 |
|
|
| Week 13 |
|
|
| Week 22 |
|
|
| Week 34 |
|
|
| Week 46 |
|
|
| Week 58 |
|
|
| Week 70 |
|
|
| Week 82 |
|
|
| Week 94 |
|
|
| Week 106 |
|
|
| Safety Follow-Up |
|
|
| Week 7 |
|
|
| Week 10 |
|
|
| Week 13 |
|
|
| Week 22 |
|
|
| Week 34 |
|
|
| Week 46 |
|
|
| Week 58 |
|
|
| Week 70 |
|
|
| Week 82 |
|
|
| Week 94 |
|
|
| Week 106 |
|
|
| Safety Follow-Up |
|
|
| Week 7 |
|
|
| Week 10 |
|
|
| Week 16 |
|
|
| Week 22 |
|
|
| Week 34 |
|
|
| Week 46 |
|
|
| Week 58 |
|
|
| Week 70 |
|
|
| Week 82 |
|
|
| Week 94 |
|
|
| Week 106 |
|
|
| Safety Follow-Up |
|
|
| Week 7 |
|
|
| Week 10 |
|
|
| Week 16 |
|
|
| Week 22 |
|
|
| Week 34 |
|
|
| Week 46 |
|
|
| Week 58 |
|
|
| Week 70 |
|
|
| Week 82 |
|
|
| Week 94 |
|
|
| Week 106 |
|
|
| Safety Follow-Up |
|
|
| Neutralizing Antibody Positive PBL |
|
| Neutralizing Antibody Positive PBL, Transient |
|