Not provided
Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| QUILT-3.026 | Other Identifier | NantCell, Inc. |
Not provided
Not provided
Not provided
Sponsor decision - subjects rolled over to protocol 20101116
Not provided
Not provided
This is a multi-center, 2-part phase 1b/2 study of AMG 655 in combination with AMG 479 to be conducted in the United States and Spain.
Part 1 is a dose escalation segment to identify a dose of AMG 655 in combination with AMG 479 that is safe and tolerable.
Part 2 will evaluate the safety and estimate the efficacy of AMG 655 at the dose selected in Part 1 in combination with AMG 479 for the treatment of patients with advanced NSCLC (non-squamous histology; squamous histology), CRC, pancreatic cancer, ovarian cancer, and sarcoma.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Part 1 Cohort 3 | Experimental | AMG 479 18 mg/kg IV plus AMG 655 15 mg/kg IV (day 1 of each Q3W cycle) |
|
| Part 1 Cohort 1 | Experimental | AMG 479 18 mg/kg IV plus AMG 655 1 mg/kg IV (day 1 of each Q3W cycle) |
|
| Part 1 Cohort 2 | Experimental | AMG 479 18 mg/kg IV plus AMG 655 3 mg/kg IV (day 1 of each Q3W cycle) |
|
| Part 2 | Experimental | AMG 479 18 mg/kg IV plus AMG 655 15 mg/kg Q3W, or the MTD, as determined in Part 1 of the study |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| AMG 479 | Biological | AMG 479 is an investigational, fully human, monoclonal antibody that binds with Insulin-like growth factor receptor type 1. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Dose-limiting Toxicities | Incidence of adverse events and clinical laboratory abnormalities defined as DLTs. Dose-limiting toxicities included any grade 3 or higher hematologic or nonhematologic toxicity related to conatumumab or the combination of conatumumab with ganitumab except for lymphocytopenia and anemia. | Time from first dose up to 24 months |
| Objective Response Rate | The objective response rate (ORR) is defined as confirmed complete response or partial response using modified Response Evaluation Criteria in Solid Tumors [RECIST]: a complete response is the disappearance of all target lesions; a partial response is defined as at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters. | Time from first dose up to 24 months |
| Measure | Description | Time Frame |
|---|---|---|
| Progression Free Survival | Progression-free survival is defined as the number of days from study day 1 (first dose of investigational product) to the first observation of disease progression (by modified RECIST; or clinical progression, whichever came first) or death due to any cause. Disease progression by RECIST is defined as at least a 20% increase in the sum of diameters of target lesions in reference to the smallest sum on study and an absolute increase of at least 5 mm; the appearance of any new lesions is also considered progression. |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| MD | Amgen | Study Director |
Not provided
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 24816908 | Background | Tabernero J, Chawla SP, Kindler H, Reckamp K, Chiorean EG, Azad NS, Lockhart AC, Hsu CP, Baker NF, Galimi F, Beltran P, Baselga J. Anticancer activity of the type I insulin-like growth factor receptor antagonist, ganitumab, in combination with the death receptor 5 agonist, conatumumab. Target Oncol. 2015 Mar;10(1):65-76. doi: 10.1007/s11523-014-0315-z. Epub 2014 May 11. |
| Label | URL |
|---|---|
| AmgenTrials clinical trials website | View source |
Not provided
Not provided
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Part 1 Cohort 1 | AMG 479 18 mg/kg IV plus AMG 655 1 mg/kg IV (day 1 of each Q3W cycle) AMG 479: AMG 479 is an investigational, fully human, monoclonal antibody that binds with Insulin-like growth factor receptor type 1. AMG 655: AMG 655 is an investigational, fully human, monoclonal antibody that binds with TNF-related apoptosis-inducing ligand, DR 5. |
| FG001 | Part 1 Cohort 2 | AMG 479 18 mg/kg IV plus AMG 655 3 mg/kg IV (day 1 of each Q3W cycle) AMG 479: AMG 479 is an investigational, fully human, monoclonal antibody that binds with Insulin-like growth factor receptor type 1. AMG 655: AMG 655 is an investigational, fully human, monoclonal antibody that binds with TNF-related apoptosis-inducing ligand, DR 5. |
| FG002 | Part 1 Cohort 3 | AMG 479 18 mg/kg IV plus AMG 655 15 mg/kg IV (day 1 of each Q3W cycle) AMG 479: AMG 479 is an investigational, fully human, monoclonal antibody that binds with Insulin-like growth factor receptor type 1. AMG 655: AMG 655 is an investigational, fully human, monoclonal antibody that binds with TNF-related apoptosis-inducing ligand, DR 5. |
| FG003 | Part 2 Cohort 1 | AMG 479 18 mg/kg (Q3W) with AMG 655 15 mg/kg (Q3W) Non-squamous NSCLC |
| FG004 | Part 2 Cohort 2 | AMG 479 18 mg/kg (Q3W) with AMG 655 15 mg/kg (Q3W) Squamous Non -Small Cell Lung Cancer (NSCLC) |
| FG005 | Part 2 Cohort 3 | AMG 479 18 mg/kg (Q3W) with AMG 655 15 mg/kg (Q3W) Colorectal Cancer (CRC) |
| FG006 | Part 2 Cohort 4 | AMG 479 18 mg/kg (Q3W) with AMG 655 15 mg/kg (Q3W) Pancreatic Cancer |
| FG007 | Part 2 Cohort 5 | AMG 479 18 mg/kg (Q3W) with AMG 655 15 mg/kg (Q3W) Ovarian Cancer |
| FG008 | Part 2 Cohort 6 | AMG 479 18 mg/kg (Q3W) with AMG 655 15 mg/kg (Q3W) Sarcoma |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Part 1 Cohort 1 | AMG 479 18 mg/kg IV plus AMG 655 1 mg/kg IV (day 1 of each Q3W cycle) AMG 479: AMG 479 is an investigational, fully human, monoclonal antibody that binds with Insulin-like growth factor receptor type 1. AMG 655: AMG 655 is an investigational, fully human, monoclonal antibody that binds with TNF-related apoptosis-inducing ligand, DR 5. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Part 1 and Part 2 were analyzed separately. |
| 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 Dose-limiting Toxicities | Incidence of adverse events and clinical laboratory abnormalities defined as DLTs. Dose-limiting toxicities included any grade 3 or higher hematologic or nonhematologic toxicity related to conatumumab or the combination of conatumumab with ganitumab except for lymphocytopenia and anemia. | Posted | Count of Participants | Participants | Time from first dose up to 24 months |
|
All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
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 | Part 1 Cohort 1 | AMG 479 18 mg/kg IV plus AMG 655 1 mg/kg IV (day 1 of each Q3W cycle) AMG 479: AMG 479 is an investigational, fully human, monoclonal antibody that binds with Insulin-like growth factor receptor type 1. AMG 655: AMG 655 is an investigational, fully human, monoclonal antibody that binds with TNF-related apoptosis-inducing ligand, DR 5. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | Systematic Assessment |
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Sandeep Bobby Reddy, Chief Medical Officer | ImmunityBio | 855-797-9277 | Bobby.Reddy@immunitybio.com |
Not provided
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | May 25, 2011 | Jun 18, 2024 | Prot_SAP_000.pdf |
| ID | Term |
|---|---|
| D015179 | Colorectal Neoplasms |
| D009362 | Neoplasm Metastasis |
| D002289 | Carcinoma, Non-Small-Cell Lung |
| D010051 | Ovarian Neoplasms |
| D010190 | Pancreatic Neoplasms |
| D012509 | Sarcoma |
| ID | Term |
|---|---|
| D007414 | Intestinal Neoplasms |
| D005770 | Gastrointestinal Neoplasms |
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
Not provided
Not provided
| ID | Term |
|---|---|
| C545764 | ganitumab |
| C554537 | conatumumab |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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| AMG 655 | Biological | AMG 655 is an investigational, fully human, monoclonal antibody that binds with TNF-related apoptosis-inducing ligand, DR 5. |
|
|
| Time from first dose up to 24 months |
| To Evaluate Anti-AMG 655 Antibody Formation and Anti-AMG 479 Antibody Formation | Time from first dose up to 24 months |
| To Evaluate the Concentration Level of AMG 655 | Median, minimum, and maximum concentration of AMG 655 at specified time points. | Cycle 1 Day 1 end of infusion; Cycle 3 Day 1 end of infusion (each cycle is 28 days, each infusion is up to 1 hour) |
| To Evaluate the Concentration Level of AMG 479 | Median, minimum, and maximum concentration of AMG 479 at specified time points. | Cycle 1 Day 1 end of infusion; Cycle 3 Day 1 end of infusion (each cycle is 28 days, each infusion is up to 1 hour) |
| Time to Response | Time to response is the time from study day 1 to the first observation of an objective response. Subjects without an objective response are excluded from the analysis of this endpoint. Objective response is defined as a tumor response assessment of either complete response or partial response per modified Response Evaluation Criteria in Solid Tumors (RECIST) and will be determined based on the Investigator-reported assessment only for subjects with measurable disease at baseline. Per RECIST v 1.1: a complete response is the disappearance of all target lesions; a partial response is defined as at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters. | Time from first dose up to 24 months |
| Duration of Response | Duration of response is defined as the number of days between the date of first objective response to the time of the first progressive disease (per modified Response Evaluation Criteria in Solid Tumors [RECIST] or clinical progression, whichever occurs first) or death due to any cause. Objective response is defined as a tumor response assessment of either complete response or partial response per modified RECIST where a complete response is the disappearance of all target lesions and a partial response is defined as at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters. Per RECIST v 1.1, disease progression is defined as at least a 20% increase in the sum of diameters of target lesions in reference to the smallest sum on study and an absolute increase of at least 5 mm; the appearance of any new lesions is also considered progression. | Time from objective response to 24 months |
| Related Info | View source |
| Lost to Follow-up |
|
| Death |
|
| Ineligibility determined |
|
| Adverse Event |
|
| Administrative Decision |
|
| BG001 |
| Part 1 Cohort 2 |
AMG 479 18 mg/kg IV plus AMG 655 3 mg/kg IV (day 1 of each Q3W cycle) AMG 479: AMG 479 is an investigational, fully human, monoclonal antibody that binds with Insulin-like growth factor receptor type 1. AMG 655: AMG 655 is an investigational, fully human, monoclonal antibody that binds with TNF-related apoptosis-inducing ligand, DR 5. |
| BG002 | Part 1 Cohort 3 | AMG 479 18 mg/kg IV plus AMG 655 15 mg/kg IV (day 1 of each Q3W cycle) AMG 479: AMG 479 is an investigational, fully human, monoclonal antibody that binds with Insulin-like growth factor receptor type 1. AMG 655: AMG 655 is an investigational, fully human, monoclonal antibody that binds with TNF-related apoptosis-inducing ligand, DR 5. |
| BG003 | Part 2 Cohort 1 | AMG 479 18 mg/kg (Q3W) with AMG 655 15 mg/kg (Q3W) Non-squamous NSCLC |
| BG004 | Part 2 Cohort 2 | AMG 479 18 mg/kg (Q3W) with AMG 655 15 mg/kg (Q3W) Squamous NSCLC |
| BG005 | Part 2 Cohort 3 | AMG 479 18 mg/kg (Q3W) with AMG 655 15 mg/kg (Q3W) CRC |
| BG006 | Part 2 Cohort 4 | AMG 479 18 mg/kg (Q3W) with AMG 655 15 mg/kg (Q3W) Pancreatic Cancer |
| BG007 | Part 2 Cohort 5 | AMG 479 18 mg/kg (Q3W) with AMG 655 15 mg/kg (Q3W) Ovarian Cancer |
| BG008 | Part 2 Cohort 6 | AMG 479 18 mg/kg (Q3W) with AMG 655 15 mg/kg (Q3W) Sarcoma |
| BG009 | Total | Total of all reporting groups |
| Mean |
| Standard Deviation |
| years |
|
| Sex: Female, Male | For part 2 the full analysis population was used which included only those subjects that received investigational product. | Count of Participants | Participants |
|
| Race (NIH/OMB) | For part 2 the full analysis population was used which included only those subjects that received investigational product. | Count of Participants | Participants |
|
| Part 1 Cohort 2 |
AMG 479 18 mg/kg IV plus AMG 655 3 mg/kg IV (day 1 of each Q3W cycle) AMG 479: AMG 479 is an investigational, fully human, monoclonal antibody that binds with Insulin-like growth factor receptor type 1. AMG 655: AMG 655 is an investigational, fully human, monoclonal antibody that binds with TNF-related apoptosis-inducing ligand, DR 5. |
| OG002 | Part 1 Cohort 3 | AMG 479 18 mg/kg IV plus AMG 655 15 mg/kg IV (day 1 of each Q3W cycle) AMG 479: AMG 479 is an investigational, fully human, monoclonal antibody that binds with Insulin-like growth factor receptor type 1. AMG 655: AMG 655 is an investigational, fully human, monoclonal antibody that binds with TNF-related apoptosis-inducing ligand, DR 5. |
|
|
| Primary | Objective Response Rate | The objective response rate (ORR) is defined as confirmed complete response or partial response using modified Response Evaluation Criteria in Solid Tumors [RECIST]: a complete response is the disappearance of all target lesions; a partial response is defined as at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters. | A subject was included in the analysis if they received at least one dose of study drug. | Posted | Count of Participants | Participants | Time from first dose up to 24 months |
|
|
|
| Secondary | Progression Free Survival | Progression-free survival is defined as the number of days from study day 1 (first dose of investigational product) to the first observation of disease progression (by modified RECIST; or clinical progression, whichever came first) or death due to any cause. Disease progression by RECIST is defined as at least a 20% increase in the sum of diameters of target lesions in reference to the smallest sum on study and an absolute increase of at least 5 mm; the appearance of any new lesions is also considered progression. | Posted | Median | 95% Confidence Interval | months | Time from first dose up to 24 months |
|
|
|
| Secondary | To Evaluate Anti-AMG 655 Antibody Formation and Anti-AMG 479 Antibody Formation | Antibody Population = All subjects in the full analysis set tested for antibodies during the study. | Posted | Count of Participants | Participants | Time from first dose up to 24 months |
|
|
|
| Secondary | To Evaluate the Concentration Level of AMG 655 | Median, minimum, and maximum concentration of AMG 655 at specified time points. | PK population = All subjects in the full analysis set who underwent blood sampling for PK evaluation during the study. | Posted | Median | Full Range | μg/mL | Cycle 1 Day 1 end of infusion; Cycle 3 Day 1 end of infusion (each cycle is 28 days, each infusion is up to 1 hour) |
|
|
|
| Secondary | To Evaluate the Concentration Level of AMG 479 | Median, minimum, and maximum concentration of AMG 479 at specified time points. | PK population = All subjects in the full analysis set who underwent blood sampling for PK evaluation during the study. | Posted | Median | Full Range | μg/mL | Cycle 1 Day 1 end of infusion; Cycle 3 Day 1 end of infusion (each cycle is 28 days, each infusion is up to 1 hour) |
|
|
|
| Secondary | Time to Response | Time to response is the time from study day 1 to the first observation of an objective response. Subjects without an objective response are excluded from the analysis of this endpoint. Objective response is defined as a tumor response assessment of either complete response or partial response per modified Response Evaluation Criteria in Solid Tumors (RECIST) and will be determined based on the Investigator-reported assessment only for subjects with measurable disease at baseline. Per RECIST v 1.1: a complete response is the disappearance of all target lesions; a partial response is defined as at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters. | Because no subjects in Part 2, and only one subject in Part 1, had an objective response the analyses of time to response was not calculated. | Posted | Time from first dose up to 24 months |
|
|
| Secondary | Duration of Response | Duration of response is defined as the number of days between the date of first objective response to the time of the first progressive disease (per modified Response Evaluation Criteria in Solid Tumors [RECIST] or clinical progression, whichever occurs first) or death due to any cause. Objective response is defined as a tumor response assessment of either complete response or partial response per modified RECIST where a complete response is the disappearance of all target lesions and a partial response is defined as at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters. Per RECIST v 1.1, disease progression is defined as at least a 20% increase in the sum of diameters of target lesions in reference to the smallest sum on study and an absolute increase of at least 5 mm; the appearance of any new lesions is also considered progression. | Because no subjects in Part 2, and only one subject in Part 1, had an objective response the analysis of duration of response was not calculated. | Posted | Time from objective response to 24 months |
|
|
| 1 |
| 3 |
| 2 |
| 3 |
| 3 |
| 3 |
| EG001 | Part 1 Cohort 2 | AMG 479 18 mg/kg IV plus AMG 655 3 mg/kg IV (day 1 of each Q3W cycle) AMG 479: AMG 479 is an investigational, fully human, monoclonal antibody that binds with Insulin-like growth factor receptor type 1. AMG 655: AMG 655 is an investigational, fully human, monoclonal antibody that binds with TNF-related apoptosis-inducing ligand, DR 5. | 1 | 3 | 0 | 3 | 3 | 3 |
| EG002 | Part 1 Cohort 3 | AMG 479 18 mg/kg IV plus AMG 655 15 mg/kg IV (day 1 of each Q3W cycle) AMG 479: AMG 479 is an investigational, fully human, monoclonal antibody that binds with Insulin-like growth factor receptor type 1. AMG 655: AMG 655 is an investigational, fully human, monoclonal antibody that binds with TNF-related apoptosis-inducing ligand, DR 5. | 3 | 3 | 2 | 3 | 3 | 3 |
| EG003 | Part 2 Cohort 1 | AMG 479 18 mg/kg (Q3W) with AMG 655 15 mg/kg (Q3W) Non-squamous NSCLC | 8 | 15 | 3 | 15 | 15 | 15 |
| EG004 | Part 2 Cohort 2 | AMG 479 18 mg/kg (Q3W) with AMG 655 15 mg/kg (Q3W) Squamous NSCLC | 5 | 8 | 6 | 7 | 7 | 7 |
| EG005 | Part 2 Cohort 3 | AMG 479 18 mg/kg (Q3W) with AMG 655 15 mg/kg (Q3W) CRC | 7 | 16 | 2 | 16 | 15 | 16 |
| EG006 | Part 2 Cohort 4 | AMG 479 18 mg/kg (Q3W) with AMG 655 15 mg/kg (Q3W) Pancreatic Cancer | 9 | 16 | 3 | 16 | 14 | 16 |
| EG007 | Part 2 Cohort 5 | AMG 479 18 mg/kg (Q3W) with AMG 655 15 mg/kg (Q3W) Ovarian Cancer | 4 | 9 | 3 | 9 | 9 | 9 |
| EG008 | Part 2 Cohort 6 | AMG 479 18 mg/kg (Q3W) with AMG 655 15 mg/kg (Q3W) Sarcoma | 7 | 16 | 2 | 15 | 11 | 15 |
| Pericardial Effusion | Cardiac disorders | Systematic Assessment |
|
| Ileus | Gastrointestinal disorders | Systematic Assessment |
|
| Metastases To Small Intestine | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | Systematic Assessment |
|
| Pneumonia | Infections and infestations | Systematic Assessment |
|
| Small Intestinal Obstruction | Gastrointestinal disorders | Systematic Assessment |
|
| Abdominal Pain | Gastrointestinal disorders | Systematic Assessment |
|
| Constipation | Gastrointestinal disorders | Systematic Assessment |
|
| Gastrointestinal Haemorrhage | Gastrointestinal disorders | Systematic Assessment |
|
| Intestinal Obstruction | Gastrointestinal disorders | Systematic Assessment |
|
| Nausea | Gastrointestinal disorders | Systematic Assessment |
|
| Vomiting | Gastrointestinal disorders | Systematic Assessment |
|
| Asthenia | General disorders | Systematic Assessment |
|
| Pyrexia | General disorders | Systematic Assessment |
|
| Jaundice | Hepatobiliary disorders | Systematic Assessment |
|
| Urinary Tract Infection | Infections and infestations | Systematic Assessment |
|
| Humerus Fracture | Injury, poisoning and procedural complications | Systematic Assessment |
|
| Blood Amylase Increased | Investigations | Systematic Assessment |
|
| Blood Bilirubin | Investigations | Systematic Assessment |
|
| Hyperglycaemia | Metabolism and nutrition disorders | Systematic Assessment |
|
| Malignant Neoplasm Progression | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | Systematic Assessment |
|
| Metastases To Central Nervous System | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | Systematic Assessment |
|
| Peripheral Motor Neuropathy | Nervous system disorders | Systematic Assessment |
|
| Somnolence | Nervous system disorders | Systematic Assessment |
|
| Hydronephrosis | Renal and urinary disorders | Systematic Assessment |
|
| Acute Respiratory Failure | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
|
| Chronic Respiratory Failure | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
|
| Cough | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
|
| Haemoptysis | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
|
| Pleural Effusion | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
|
| Pneumothorax | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
|
| Pulmonary Embolism | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
|
| Respiratory Distress | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
|
| Deep Vein Thrombosis | Vascular disorders | Systematic Assessment |
|
| Orthostatic Hypotension | Vascular disorders | Systematic Assessment |
|
| Thrombosis | Vascular disorders | Systematic Assessment |
|
| Neutropenia | Blood and lymphatic system disorders | Systematic Assessment |
|
| Thrombocytopenia | Blood and lymphatic system disorders | Systematic Assessment |
|
| Pericardial Effusion | Cardiac disorders | Systematic Assessment |
|
| Sinus Tachycardia | Cardiac disorders | Systematic Assessment |
|
| Abdominal Distension | Gastrointestinal disorders | Systematic Assessment |
|
| Abdominal Pain | Gastrointestinal disorders | Systematic Assessment |
|
| Abdominal Pain Upper | Gastrointestinal disorders | Systematic Assessment |
|
| Ascites | Gastrointestinal disorders | Systematic Assessment |
|
| Constipation | Gastrointestinal disorders | Systematic Assessment |
|
| Diarrhoea | Gastrointestinal disorders | Systematic Assessment |
|
| Dyspepsia | Gastrointestinal disorders | Systematic Assessment |
|
| Dysphagia | Gastrointestinal disorders | Systematic Assessment |
|
| Ileus | Gastrointestinal disorders | Systematic Assessment |
|
| Nausea | Gastrointestinal disorders | Systematic Assessment |
|
| Small Intestinal Obstruction | Gastrointestinal disorders | Systematic Assessment |
|
| Stomatitis | Gastrointestinal disorders | Systematic Assessment |
|
| Adverse Drug Reaction | General disorders | Systematic Assessment |
|
| Asthenia | General disorders | Systematic Assessment |
|
| Fatigue | General disorders | Systematic Assessment |
|
| Oedema Peripheral | General disorders | Systematic Assessment |
|
| Pain | General disorders | Systematic Assessment |
|
| Hyperbilirubinaemia | Hepatobiliary disorders | Systematic Assessment |
|
| Drug Hypersensitivity | Immune system disorders | Systematic Assessment |
|
| Escherichia Urinary Tract Infection | Infections and infestations | Systematic Assessment |
|
| Fungal Skin Infection | Infections and infestations | Systematic Assessment |
|
| Oral Herpes | Infections and infestations | Systematic Assessment |
|
| Pneumonia | Infections and infestations | Systematic Assessment |
|
| Upper Respiratory Tract Infection | Infections and infestations | Systematic Assessment |
|
| Infusion Related Reaction | Injury, poisoning and procedural complications | Systematic Assessment |
|
| Procedural Pain | Injury, poisoning and procedural complications | Systematic Assessment |
|
| Alanine Aminotransferase Abnormal | Investigations | Systematic Assessment |
|
| Alanine Aminotransferase Increased | Investigations | Systematic Assessment |
|
| Aspartate Aminotransferase Abnormal | Infections and infestations | Systematic Assessment |
|
| Blood Alkaline Phosphatase Abnormal | Investigations | Systematic Assessment |
|
| Blood Alkaline Phosphatase Increased | Investigations | Systematic Assessment |
|
| Blood Glucose Increased | Investigations | Systematic Assessment |
|
| Blood Pressure Increased | Investigations | Systematic Assessment |
|
| Ejection Fraction Decreased | Investigations | Systematic Assessment |
|
| Decreased Appetite | Metabolism and nutrition disorders | Systematic Assessment |
|
| Dehydration | Metabolism and nutrition disorders | Systematic Assessment |
|
| Hyperglycaemia | Metabolism and nutrition disorders | Systematic Assessment |
|
| Hypoalbuminaemia | Metabolism and nutrition disorders | Systematic Assessment |
|
| Hypokalaemia | Metabolism and nutrition disorders | Systematic Assessment |
|
| Hyponatraemia | Metabolism and nutrition disorders | Systematic Assessment |
|
| Hypophosphataemia | Metabolism and nutrition disorders | Systematic Assessment |
|
| Arthralgia | Musculoskeletal and connective tissue disorders | Systematic Assessment |
|
| Back Pain | Musculoskeletal and connective tissue disorders | Systematic Assessment |
|
| Muscle Spasms | Musculoskeletal and connective tissue disorders | Systematic Assessment |
|
| Myalgia | Musculoskeletal and connective tissue disorders | Systematic Assessment |
|
| Pain In Extremity | Musculoskeletal and connective tissue disorders | Systematic Assessment |
|
| Metastases To Small Intestine | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | Systematic Assessment |
|
| Headache | Nervous system disorders | Systematic Assessment |
|
| Hypoaesthesia | Nervous system disorders | Systematic Assessment |
|
| Insomnia | Psychiatric disorders | Systematic Assessment |
|
| Ketonuria | Renal and urinary disorders | Systematic Assessment |
|
| Oliguria | Renal and urinary disorders | Systematic Assessment |
|
| Proteinuria | Renal and urinary disorders | Systematic Assessment |
|
| Cough | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
|
| Dysphonia | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
|
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
|
| Pleural Effusion | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
|
| Drug Eruption | Skin and subcutaneous tissue disorders | Systematic Assessment |
|
| Night Sweats | Skin and subcutaneous tissue disorders | Systematic Assessment |
|
| Pruritus | Skin and subcutaneous tissue disorders | Systematic Assessment |
|
| Rash | Skin and subcutaneous tissue disorders | Systematic Assessment |
|
| Swelling Face | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
|
| Tachycardia | Cardiac disorders | Systematic Assessment |
|
| Ear Pain | Ear and labyrinth disorders | Systematic Assessment |
|
| Tinnitus | Ear and labyrinth disorders | Systematic Assessment |
|
| Eye Discharge | Eye disorders | Systematic Assessment |
|
| Eye Pruritus | Eye disorders | Systematic Assessment |
|
| Vision Blurred | Eye disorders | Systematic Assessment |
|
| Abdominal Discomfort | Gastrointestinal disorders | Systematic Assessment |
|
| Ascites | Gastrointestinal disorders | Systematic Assessment |
|
| Abdominal Pain Lower | Gastrointestinal disorders | Systematic Assessment |
|
| Dry Mouth | Gastrointestinal disorders | Systematic Assessment |
|
| Enteritis | Gastrointestinal disorders | Systematic Assessment |
|
| Gastrointestinal Haemorrhage | Gastrointestinal disorders | Systematic Assessment |
|
| Gastrooesophageal Reflux Disease | Gastrointestinal disorders | Systematic Assessment |
|
| Haematochezia | Gastrointestinal disorders | Systematic Assessment |
|
| Haemorrhoids | Gastrointestinal disorders | Systematic Assessment |
|
| Intestinal Obstruction | Gastrointestinal disorders | Systematic Assessment |
|
| Oral Pain | Gastrointestinal disorders | Systematic Assessment |
|
| Pancreatitis | Gastrointestinal disorders | Systematic Assessment |
|
| Rectal Haemorrhage | Gastrointestinal disorders | Systematic Assessment |
|
| Toothache | Gastrointestinal disorders | Systematic Assessment |
|
| Vomiting | Gastrointestinal disorders | Systematic Assessment |
|
| Chest Pain | General disorders | Systematic Assessment |
|
| Chills | General disorders | Systematic Assessment |
|
| Early Satiety | General disorders | Systematic Assessment |
|
| Facial Pain | General disorders | Systematic Assessment |
|
| Influenza Like Illness | General disorders | Systematic Assessment |
|
| Injection Site Reaction | General disorders | Systematic Assessment |
|
| Mucosal Inflammation | General disorders | Systematic Assessment |
|
| Mucous Membrane Disorder | General disorders | Systematic Assessment |
|
| Oedema | General disorders | Systematic Assessment |
|
| Pyrexia | General disorders | Systematic Assessment |
|
| Vessel Puncture Site Reaction | General disorders | Systematic Assessment |
|
| Hepatic Pain | Hepatobiliary disorders | Systematic Assessment |
|
| Jaundice | Hepatobiliary disorders | Systematic Assessment |
|
| Abscess | Infections and infestations | Systematic Assessment |
|
| Bronchitis | Infections and infestations | Systematic Assessment |
|
| Candidiasis | Infections and infestations | Systematic Assessment |
|
| Herpes Zoster | Infections and infestations | Systematic Assessment |
|
| Influenza | Infections and infestations | Systematic Assessment |
|
| Nasopharyngitis | Infections and infestations | Systematic Assessment |
|
| Pharyngitis | Infections and infestations | Systematic Assessment |
|
| Urinary Tract Infection | Infections and infestations | Systematic Assessment |
|
| Wound Infection | Infections and infestations | Systematic Assessment |
|
| Contusion | Injury, poisoning and procedural complications | Systematic Assessment |
|
| Humerus Fracture | Injury, poisoning and procedural complications | Systematic Assessment |
|
| Limb Injury | Injury, poisoning and procedural complications | Systematic Assessment |
|
| Alanine Aminotransferase | Investigations | Systematic Assessment |
|
| Aspartate Aminotransferase | Investigations | Systematic Assessment |
|
| Aspartate Aminotransferase Increased | Investigations | Systematic Assessment |
|
| Blood Alkaline Phosphatase Decreased | Investigations | Systematic Assessment |
|
| Blood Amylase | Investigations | Systematic Assessment |
|
| Blood Amylase Increased | Investigations | Systematic Assessment |
|
| Blood Bilirubin | Investigations | Systematic Assessment |
|
| Breath Sounds Abnormal | Investigations | Systematic Assessment |
|
| Electrocardiogram Abnormal | Investigations | Systematic Assessment |
|
| Glycosylated Haemoglobin Increased | Investigations | Systematic Assessment |
|
| Haematocrit Decreased | Investigations | Systematic Assessment |
|
| Haemoglobin | Investigations | Systematic Assessment |
|
| Haemoglobin Decreased | Investigations | Systematic Assessment |
|
| Heart Rate Increased | Investigations | Systematic Assessment |
|
| Lipase Increased | Investigations | Systematic Assessment |
|
| Neutrophil Count Decreased | Investigations | Systematic Assessment |
|
| Oxygen Saturation Decreased | Investigations | Systematic Assessment |
|
| Platelet Count Decreased | Investigations | Systematic Assessment |
|
| Red Blood Cell Count Decreased | Investigations | Systematic Assessment |
|
| Weight Decreased | Investigations | Systematic Assessment |
|
| Hypercalcaemia | Metabolism and nutrition disorders | Systematic Assessment |
|
| Hypocalcaemia | Metabolism and nutrition disorders | Systematic Assessment |
|
| Hypomagnesaemia | Metabolism and nutrition disorders | Systematic Assessment |
|
| Malnutrition | Metabolism and nutrition disorders | Systematic Assessment |
|
| Weight Fluctuation | Metabolism and nutrition disorders | Systematic Assessment |
|
| Coccydynia | Musculoskeletal and connective tissue disorders | Systematic Assessment |
|
| Flank Pain | Musculoskeletal and connective tissue disorders | Systematic Assessment |
|
| Muscular Weakness | Musculoskeletal and connective tissue disorders | Systematic Assessment |
|
| Musculoskeletal chest pain | Musculoskeletal and connective tissue disorders | Systematic Assessment |
|
| Musculoskeletal Discomfort | Musculoskeletal and connective tissue disorders | Systematic Assessment |
|
| Musculoskeletal Pain | Musculoskeletal and connective tissue disorders | Systematic Assessment |
|
| Neck Pain | Musculoskeletal and connective tissue disorders | Systematic Assessment |
|
| Pain In Jaw | Musculoskeletal and connective tissue disorders | Systematic Assessment |
|
| Malignant Neoplasm Progression | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | Systematic Assessment |
|
| Metastases To Central Nervous System | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | Systematic Assessment |
|
| Neoplasm | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | Systematic Assessment |
|
| Dizziness | Nervous system disorders | Systematic Assessment |
|
| Neuropathy Peripheral | Nervous system disorders | Systematic Assessment |
|
| Peripheral Motor Neuropathy | Nervous system disorders | Systematic Assessment |
|
| Peripheral Sensory Neuropathy | Nervous system disorders | Systematic Assessment |
|
| Somnolence | Nervous system disorders | Systematic Assessment |
|
| Tremor | Nervous system disorders | Systematic Assessment |
|
| Anxiety | Psychiatric disorders | Systematic Assessment |
|
| Depression | Psychiatric disorders | Systematic Assessment |
|
| Eating Disorder | Psychiatric disorders | Systematic Assessment |
|
| Mental Status Changes | Psychiatric disorders | Systematic Assessment |
|
| Restlessness | Psychiatric disorders | Systematic Assessment |
|
| Chromaturia | Renal and urinary disorders | Systematic Assessment |
|
| Dysuria | Renal and urinary disorders | Systematic Assessment |
|
| Haematuria | Renal and urinary disorders | Systematic Assessment |
|
| Hydronephrosis | Renal and urinary disorders | Systematic Assessment |
|
| Renal Failure Acute | Renal and urinary disorders | Systematic Assessment |
|
| Acute Respiratory Failure | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
|
| Atelectasis | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
|
| Chronic Respiratory Failure | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
|
| Dyspnoea Exertional | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
|
| Epistaxis | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
|
| Haemoptysis | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
|
| Hiccups | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
|
| Hypoxia | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
|
| Nasal Congestion | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
|
| Oropharyngeal Pain | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
|
| Paranasal Sinus Hypersecretion | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
|
| Pleural Effusion | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
|
| Pneumothorax | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
|
| Productive Cough | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
|
| Pulmonary Congestion | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
|
| Pulmonary Embolism | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
|
| Respiratory Distress | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
|
| Alopecia | Skin and subcutaneous tissue disorders | Systematic Assessment |
|
| Cold Sweat | Skin and subcutaneous tissue disorders | Systematic Assessment |
|
| Ecchymosis | Skin and subcutaneous tissue disorders | Systematic Assessment |
|
| Hyperhidrosis | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
|
| Deep Vein Thrombosis | Vascular disorders | Systematic Assessment |
|
| Hot Flush | Vascular disorders | Systematic Assessment |
|
| Hypertension | Vascular disorders | Systematic Assessment |
|
| Hypotension | Vascular disorders | Systematic Assessment |
|
| Orthostatic Hypotension | Vascular disorders | Systematic Assessment |
|
| Thrombosis | Vascular disorders | Systematic Assessment |
|
Not provided
Not provided
| D009369 | Neoplasms |
| D004066 | Digestive System Diseases |
| D005767 | Gastrointestinal Diseases |
| D003108 | Colonic Diseases |
| D007410 | Intestinal Diseases |
| D012002 | Rectal Diseases |
| D009385 | Neoplastic Processes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D002283 | Carcinoma, Bronchogenic |
| D001984 | Bronchial Neoplasms |
| D008175 | Lung Neoplasms |
| D012142 | Respiratory Tract Neoplasms |
| D013899 | Thoracic Neoplasms |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D004701 | Endocrine Gland Neoplasms |
| D010049 | Ovarian Diseases |
| D000291 | Adnexal Diseases |
| D005831 | Genital Diseases, Female |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D005833 | Genital Neoplasms, Female |
| D014565 | Urogenital Neoplasms |
| D000091662 | Genital Diseases |
| D004700 | Endocrine System Diseases |
| D006058 | Gonadal Disorders |
| D010182 | Pancreatic Diseases |
| D018204 | Neoplasms, Connective and Soft Tissue |
| D009370 | Neoplasms by Histologic Type |
|
| Male |
|
| Asian |
|
| Native Hawaiian or Other Pacific Islander |
|
| Black or African American |
|
| White |
|
| More than one race |
|
| Unknown or Not Reported |
|
| AMG 655 - Neutralizing antibody positive at any time |
|
| AMG 479 - Binding antibody positive at any time |
|
| AMG 479 - Neutralizing antibody positive at any time |
|
|
| Cycle 3-End of infusion |
|
|
|
| Cycle 3-End of Infusion |
|
|