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Amgen made a business decision to discontinue AMG 160 20180273
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This study aims to evaluate the safety and tolerability of AMG 160 and to evaluate the maximum tolerated dose (MTD) or the recommended phase 2 dose (RP2D).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Part 1: Dose Exploration | Experimental | The dose exploration part of the study will estimate the MTD and/or the RP2D. |
|
| Part 2: Dose Expansion - Cohort 1 Non-squamous NSCLC | Experimental | Participants with non-squamous non-small cell lung cancer (NSCLC) will be administered the RP2D identified from the dose exploration part of the study. |
|
| Part 2: Dose Expansion - Cohort 2 Squamous NSCLC | Experimental | Participants with squamous NSCLC will be administered the RP2D identified from the dose exploration part of the study. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| AMG 160 | Drug | AMG 160 administered as an intravenous (IV) infusion |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants Who Experience One or More Dose-limiting Toxicities (DLT) | DLT were defined as any adverse event (AE) with an onset within first 28 days following first dose of AMG 160 meeting pre-specified criteria unless clearly attributable to causes other than AMG 160 treatment. | Day 1 to Day 28 |
| Number of Participants Who Experience One or More Treatment-emergent AE (TEAE) | An AE is any untoward medical occurrence in a clinical study participant irrespective of a causal relationship with the study treatment. A TEAE is any AE that occurred on or after first dose of study treatment up to 30 days after the last dose or End of Study date or start of new anti-cancer therapy, whichever is earlier. A treatment-related TEAE is any TEAE that, per investigator review, has a reasonable possibility of being caused by the study treatment. Any abnormal vital signs measurement or clinical laboratory test result, including those that worsened from Baseline, that were considered clinically significant in the medical and scientific judgement of the investigator were reported as an AE. | Median (min, max) time from first dose to 30 days after the last dose, end of study or start of new anti-cancer therapy; whichever is earlier, was 66 (52, 100) days |
| Measure | Description | Time Frame |
|---|---|---|
| Objective Response Rate (ORR) Per Modified Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 | ORR per modified RECIST v1.1 was defined as the percentage of participants who achieved a best overall response (BOR) of either complete response (CR) or partial response (PR) based on investigator assessment.
CR/PR must have been confirmed at least 4 weeks later. Exact 95% confidence interval (CI) was calculated using the Clopper-Pearson method. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| MD | Amgen | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Texas MD Anderson Cancer Center | Houston | Texas | 77030 | United States | ||
| Chris OBrien Lifehouse |
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| 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 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. If not approved, a Data Sharing Independent Review Panel will arbitrate and make the final decision. 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 URL below.
The study was terminated early due to sponsor decision after 3 participants were enrolled into Cohort 1 of Part 1 (dose exploration); no participants were screened or enrolled for additional Part 1 or Part 2 (dose expansion) cohorts.
This study was conducted at 2 centers in Australia and Austria between 31 August 2021 and 26 January 2022.
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| ID | Title | Description |
|---|---|---|
| FG000 | Part 1: AMG 160 Cohort 1 | AMG 160 was administered as a short-term intravenous (IV) infusion every 2 weeks after the target dose was reached. Treatment lasted until disease progression, up to a planned maximum of 3 years from the first dose of AMG 160. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
Safety analysis set: defined as all participants that were enrolled and receive at least 1 dose of AMG 160.
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| ID | Title | Description |
|---|---|---|
| BG000 | Part 1: AMG 160 Cohort 1 | AMG 160 was administered as a short-term IV infusion every 2 weeks after the target dose was reached. Treatment lasted until disease progression, up to a planned maximum of 3 years from the first dose of AMG 160. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Number of Participants Who Experience One or More Dose-limiting Toxicities (DLT) | DLT were defined as any adverse event (AE) with an onset within first 28 days following first dose of AMG 160 meeting pre-specified criteria unless clearly attributable to causes other than AMG 160 treatment. | DLT analysis set: defined as all participants that were enrolled and receive at least one dose of AMG 160 with an evaluable DLT endpoint. The DLT endpoint is evaluable if either: 1) the participant experienced a DLT, or 2) the participant did not experience a DLT after receiving all planned doses within the 28-day DLT window. | Posted | Count of Participants | Participants | Day 1 to Day 28 |
|
All-cause mortality: median (min, max) time from enrollment to end of study was 106 (97, 126) days. AEs: median (min, max) time from first dose to 30 days after the last dose, end of study or start of new anti-cancer therapy; whichever is earlier, was 66 (52, 100) days.
Serious AEs and other AEs are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.
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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 | Part 1: AMG 160 Cohort 1 | AMG 160 was administered as a short-term IV infusion every 2 weeks after the target dose was reached. Treatment lasted until disease progression, up to a planned maximum of 3 years from the first dose of AMG 160. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Uveitis | Eye disorders | MedDRA 25.1 | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Thrombocytopenia | Blood and lymphatic system disorders | MedDRA 25.1 | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Study Director | Amgen Inc. | 866-572-6436 | medinfo@amgen.com |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Mar 25, 2022 | Jan 16, 2024 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Oct 11, 2022 | Jan 16, 2024 | SAP_001.pdf |
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| ID | Term |
|---|---|
| D002289 | Carcinoma, Non-Small-Cell Lung |
| ID | Term |
|---|---|
| D002283 | Carcinoma, Bronchogenic |
| D001984 | Bronchial Neoplasms |
| D008175 | Lung Neoplasms |
| D012142 | Respiratory Tract Neoplasms |
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| Median (min, max) time from first dose to end of study was 100 (94, 122) days |
| Overall Survival (OS) | Overall survival (OS) was defined as the time from the date of study Day 1 until death due to any cause. OS time (months) = (date of death - study Day 1 + 1) x 12/365.25. Medians and quartiles were estimated using the Kaplan-Meier method. 95% CIs for medians and percentiles were using Greenwood's formula to estimate the standard error of the landmark estimates using the method by Kalbfleisch and Prentice (1980). | Median (min, max) time from first dose to end of study was 100 (94, 122) days |
| Radiographic Progression Free Survival (PFS) Per Modified RECIST v1.1 | Radiographic PFS per modified RECIST v1.1 was defined as the interval from study Day 1 to the earlier of a radiographic progressive disease (PD) or death from any cause, based on investigator assessment; otherwise, radiographic PFS was censored at the last evaluable tumor assessment date. - PD: Increase of 20% or greater in tumor burden compared with nadir and at least 5 mm absolute increase, or unequivocal progression of non-target lesions, or the presence of new lesions. Medians and quartiles were estimated using the Kaplan-Meier method. 95% CIs for medians and quartiles were estimated using the method by Brookmeyer and Crowley (1982). | Median (min, max) time from first dose to end of study was 100 (94, 122) days |
| Clinical PFS Per Modified RECIST v1.1 | Clinical PFS per modified RECIST v1.1 was defined as the interval from study Day 1 to the earlier of a clinical PD or death from any cause, based on investigator assessment; otherwise, clinical PFS was censored at the last evaluable tumor assessment date. - PD: Increase of 20% or greater in tumor burden compared with nadir and at least 5 mm absolute increase, or unequivocal progression of non-target lesions, or the presence of new lesions. Medians and quartiles were estimated using the Kaplan-Meier method. 95% CIs for medians and quartiles were estimated using the method by Brookmeyer and Crowley (1982). | Median (min, max) time from first dose to end of study was 100 (94, 122) days |
| Time to Response Per Modified RECIST v1.1 | Time to response per modified RECIST v1.1 was defined as the interval from study Day 1 to the either CR or PR based on investigator assessment.
CR/PR must have been confirmed at least 4 weeks later. | Median (min, max) time from first dose to end of study was 100 (94, 122) days |
| Time to Progression Per Modified RECIST v1.1 | Time to progression per modified RECIST v1.1 was defined as the interval from study Day 1 to PD, based on investigator assessment. Time to progression was censored at the last evaluable post-baseline tumor assessment prior to subsequent anti-cancer therapy; otherwise at study Day 1. - PD: Increase of 20% or greater in tumor burden compared with nadir and at least 5 mm absolute increase, or unequivocal progression of non-target lesions, or the presence of new lesions. Medians and quartiles were estimated using the Kaplan-Meier method. 95% CIs for medians and quartiles were estimated using the method by Brookmeyer and Crowley (1982). | Median (min, max) time from first dose to end of study was 100 (94, 122) days |
| Time to Clinical Progression | Time to clinical progression was defined as the interval from study Day 1 to PD. Time to clinical progression was censored at the last evaluable post-baseline tumor assessment prior to subsequent anti-cancer therapy; otherwise at study Day 1. - PD: Increase of 20% or greater in tumor burden compared with nadir and at least 5 mm absolute increase, or unequivocal progression of non-target lesions, or the presence of new lesions. Medians and quartiles were estimated using the Kaplan-Meier method. 95% CIs for medians and quartiles were estimated using the method by Brookmeyer and Crowley (1982). | Median (min, max) time from first dose to end of study was 100 (94, 122) days |
| Duration of Response (DOR) Per Modified RECIST v1.1 | DOR was defined as the time from the date of an initial objective response per modified RECIST v1.1 to the earlier of soft-tissue progression or death based on investigator assessment.
CR/PR must have been confirmed at least 4 weeks later. Participants who had not ended their response at the time of analysis had DOR censored at their last evaluable tumor assessment by CT/MRI scan. | Median (min, max) time from first dose to end of study was 100 (94, 122) days |
| Time to Subsequent Therapy | Time to subsequent therapy was defined as the time from study Day 1 to the time a participant started/received the subsequent cancer therapy/subsequent therapy; otherwise time to subsequent therapy was censored at the last known date of any of the study assessment prior to initiating the subsequent cancer therapy/subsequent therapy. Subsequent therapy was defined any anti-cancer therapies intended to treat NSCLC, or any other anti-cancer therapies started after ending study treatment and prior to End of Study. Medians and quartiles were estimated using the Kaplan-Meier method. 95% CIs for medians and quartiles were estimated using the method by Brookmeyer and Crowley (1982). | Median (min, max) time from first dose to end of study was 100 (94, 122) days |
| Camperdown |
| New South Wales |
| 2050 |
| Australia |
| Landeskrankenhaus Salzburg | Salzburg | 5020 | Austria |
| Universitaetsklinikum Allgemeines Krankenhaus Wien | Vienna | 1090 | Austria |
| Years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
|
|
| Primary | Number of Participants Who Experience One or More Treatment-emergent AE (TEAE) | An AE is any untoward medical occurrence in a clinical study participant irrespective of a causal relationship with the study treatment. A TEAE is any AE that occurred on or after first dose of study treatment up to 30 days after the last dose or End of Study date or start of new anti-cancer therapy, whichever is earlier. A treatment-related TEAE is any TEAE that, per investigator review, has a reasonable possibility of being caused by the study treatment. Any abnormal vital signs measurement or clinical laboratory test result, including those that worsened from Baseline, that were considered clinically significant in the medical and scientific judgement of the investigator were reported as an AE. | Safety analysis set: defined as all participants that were enrolled and receive at least 1 dose of AMG 160. | Posted | Count of Participants | Participants | Median (min, max) time from first dose to 30 days after the last dose, end of study or start of new anti-cancer therapy; whichever is earlier, was 66 (52, 100) days |
|
|
|
| Secondary | Objective Response Rate (ORR) Per Modified Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 | ORR per modified RECIST v1.1 was defined as the percentage of participants who achieved a best overall response (BOR) of either complete response (CR) or partial response (PR) based on investigator assessment.
CR/PR must have been confirmed at least 4 weeks later. Exact 95% confidence interval (CI) was calculated using the Clopper-Pearson method. | RECIST v1.1 evaluable analysis set: defined as all participants that are enrolled, receive at least 1 dose of AMG 160 and had measurable baseline disease per RECIST 1.1 per protocol and had the opportunity to be followed for at least 9 weeks starting from study Day 1. | Posted | Number | 95% Confidence Interval | Percentage of Participants | Median (min, max) time from first dose to end of study was 100 (94, 122) days |
|
|
|
| Secondary | Overall Survival (OS) | Overall survival (OS) was defined as the time from the date of study Day 1 until death due to any cause. OS time (months) = (date of death - study Day 1 + 1) x 12/365.25. Medians and quartiles were estimated using the Kaplan-Meier method. 95% CIs for medians and percentiles were using Greenwood's formula to estimate the standard error of the landmark estimates using the method by Kalbfleisch and Prentice (1980). | Safety analysis set: defined as all participants that were enrolled and receive at least one dose of AMG 160. | Posted | Median | 95% Confidence Interval | Months | Median (min, max) time from first dose to end of study was 100 (94, 122) days |
|
|
|
| Secondary | Radiographic Progression Free Survival (PFS) Per Modified RECIST v1.1 | Radiographic PFS per modified RECIST v1.1 was defined as the interval from study Day 1 to the earlier of a radiographic progressive disease (PD) or death from any cause, based on investigator assessment; otherwise, radiographic PFS was censored at the last evaluable tumor assessment date. - PD: Increase of 20% or greater in tumor burden compared with nadir and at least 5 mm absolute increase, or unequivocal progression of non-target lesions, or the presence of new lesions. Medians and quartiles were estimated using the Kaplan-Meier method. 95% CIs for medians and quartiles were estimated using the method by Brookmeyer and Crowley (1982). | Safety analysis set: defined as all participants that were enrolled and receive at least one dose of AMG 160. | Posted | Median | 95% Confidence Interval | Months | Median (min, max) time from first dose to end of study was 100 (94, 122) days |
|
|
|
| Secondary | Clinical PFS Per Modified RECIST v1.1 | Clinical PFS per modified RECIST v1.1 was defined as the interval from study Day 1 to the earlier of a clinical PD or death from any cause, based on investigator assessment; otherwise, clinical PFS was censored at the last evaluable tumor assessment date. - PD: Increase of 20% or greater in tumor burden compared with nadir and at least 5 mm absolute increase, or unequivocal progression of non-target lesions, or the presence of new lesions. Medians and quartiles were estimated using the Kaplan-Meier method. 95% CIs for medians and quartiles were estimated using the method by Brookmeyer and Crowley (1982). | Safety analysis set: defined as all participants that were enrolled and receive at least one dose of AMG 160. | Posted | Median | 95% Confidence Interval | Months | Median (min, max) time from first dose to end of study was 100 (94, 122) days |
|
|
|
| Secondary | Time to Response Per Modified RECIST v1.1 | Time to response per modified RECIST v1.1 was defined as the interval from study Day 1 to the either CR or PR based on investigator assessment.
CR/PR must have been confirmed at least 4 weeks later. | Safety analysis set: defined as all participants that were enrolled and receive at least one dose of AMG 160. Analyzed in participants with an objective response. | Posted | Median (min, max) time from first dose to end of study was 100 (94, 122) days |
|
|
| Secondary | Time to Progression Per Modified RECIST v1.1 | Time to progression per modified RECIST v1.1 was defined as the interval from study Day 1 to PD, based on investigator assessment. Time to progression was censored at the last evaluable post-baseline tumor assessment prior to subsequent anti-cancer therapy; otherwise at study Day 1. - PD: Increase of 20% or greater in tumor burden compared with nadir and at least 5 mm absolute increase, or unequivocal progression of non-target lesions, or the presence of new lesions. Medians and quartiles were estimated using the Kaplan-Meier method. 95% CIs for medians and quartiles were estimated using the method by Brookmeyer and Crowley (1982). | Safety analysis set: defined as all participants that were enrolled and receive at least one dose of AMG 160. | Posted | Median | 95% Confidence Interval | Months | Median (min, max) time from first dose to end of study was 100 (94, 122) days |
|
|
|
| Secondary | Time to Clinical Progression | Time to clinical progression was defined as the interval from study Day 1 to PD. Time to clinical progression was censored at the last evaluable post-baseline tumor assessment prior to subsequent anti-cancer therapy; otherwise at study Day 1. - PD: Increase of 20% or greater in tumor burden compared with nadir and at least 5 mm absolute increase, or unequivocal progression of non-target lesions, or the presence of new lesions. Medians and quartiles were estimated using the Kaplan-Meier method. 95% CIs for medians and quartiles were estimated using the method by Brookmeyer and Crowley (1982). | Safety analysis set: defined as all participants that were enrolled and receive at least one dose of AMG 160. | Posted | Median | 95% Confidence Interval | Months | Median (min, max) time from first dose to end of study was 100 (94, 122) days |
|
|
|
| Secondary | Duration of Response (DOR) Per Modified RECIST v1.1 | DOR was defined as the time from the date of an initial objective response per modified RECIST v1.1 to the earlier of soft-tissue progression or death based on investigator assessment.
CR/PR must have been confirmed at least 4 weeks later. Participants who had not ended their response at the time of analysis had DOR censored at their last evaluable tumor assessment by CT/MRI scan. | RECIST v1.1 evaluable analysis set: defined as all participants that are enrolled, receive at least 1 dose of AMG 160 and had measurable baseline disease per RECIST 1.1 per protocol and had the opportunity to be followed for at least 9 weeks starting from study Day 1. Analyzed in participants with an objective response. | Posted | Median (min, max) time from first dose to end of study was 100 (94, 122) days |
|
|
| Secondary | Time to Subsequent Therapy | Time to subsequent therapy was defined as the time from study Day 1 to the time a participant started/received the subsequent cancer therapy/subsequent therapy; otherwise time to subsequent therapy was censored at the last known date of any of the study assessment prior to initiating the subsequent cancer therapy/subsequent therapy. Subsequent therapy was defined any anti-cancer therapies intended to treat NSCLC, or any other anti-cancer therapies started after ending study treatment and prior to End of Study. Medians and quartiles were estimated using the Kaplan-Meier method. 95% CIs for medians and quartiles were estimated using the method by Brookmeyer and Crowley (1982). | Safety analysis set: defined as all participants that were enrolled and receive at least one dose of AMG 160. Analyzed in participants who received subsequent therapy. | Posted | Median (min, max) time from first dose to end of study was 100 (94, 122) days |
|
|
| 3 |
| 3 |
| 2 |
| 3 |
| 3 |
| 3 |
| Lung cancer metastatic | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 25.1 | Systematic Assessment |
|
| Respiratory arrest | Respiratory, thoracic and mediastinal disorders | MedDRA 25.1 | Systematic Assessment |
|
| Eyelid oedema | Eye disorders | MedDRA 25.1 | Systematic Assessment |
|
| Diarrhoea | Gastrointestinal disorders | MedDRA 25.1 | Systematic Assessment |
|
| Vomiting | Gastrointestinal disorders | MedDRA 25.1 | Systematic Assessment |
|
| Fatigue | General disorders | MedDRA 25.1 | Systematic Assessment |
|
| Cytokine release syndrome | Immune system disorders | MedDRA 25.1 | Systematic Assessment |
|
| Conjunctivitis | Infections and infestations | MedDRA 25.1 | Systematic Assessment |
|
| Vascular access complication | Injury, poisoning and procedural complications | MedDRA 25.1 | Systematic Assessment |
|
| Alanine aminotransferase increased | Investigations | MedDRA 25.1 | Systematic Assessment |
|
| Aspartate aminotransferase increased | Investigations | MedDRA 25.1 | Systematic Assessment |
|
| Blood alkaline phosphatase increased | Investigations | MedDRA 25.1 | Systematic Assessment |
|
| Gamma-glutamyltransferase increased | Investigations | MedDRA 25.1 | Systematic Assessment |
|
| Decreased appetite | Metabolism and nutrition disorders | MedDRA 25.1 | Systematic Assessment |
|
| Hyperglycaemia | Metabolism and nutrition disorders | MedDRA 25.1 | Systematic Assessment |
|
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA 25.1 | Systematic Assessment |
|
| Headache | Nervous system disorders | MedDRA 25.1 | Systematic Assessment |
|
| Lethargy | Nervous system disorders | MedDRA 25.1 | Systematic Assessment |
|
| Taste disorder | Nervous system disorders | MedDRA 25.1 | Systematic Assessment |
|
| Dyspnoea exertional | Respiratory, thoracic and mediastinal disorders | MedDRA 25.1 | Systematic Assessment |
|
| Eczema | Skin and subcutaneous tissue disorders | MedDRA 25.1 | Systematic Assessment |
|
| Erythema | Skin and subcutaneous tissue disorders | MedDRA 25.1 | Systematic Assessment |
|
| Rash | Skin and subcutaneous tissue disorders | MedDRA 25.1 | 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.
| D013899 |
| Thoracic Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |