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| ID | Type | Description | Link |
|---|---|---|---|
| 2008-004752-77 | EudraCT Number |
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This study is designed to evaluate the mechanism(s) of resistance to the anti-epidermal growth factor receptor (EGFR) antibody panitumumab given in combination with irinotecan in metastatic colorectal carcinoma (mCRC) patients with wild-type Kirsten rat sarcoma-2 virus oncogene (KRAS) tumor status at the time of initial diagnosis.
In Part 1, all participants will undergo a baseline tumor biopsy and will receive panitumumab with irinotecan. Participants who respond or have stable disease will continue to receive treatment until radiographically-confirmed disease progression. These participants will then undergo a second tumor biopsy and blood sampling and then proceed to Part 2 of the study. Participants with radiographically confirmed disease progression at the time of the first tumor measurement will undergo blood sampling and proceed directly to Part 2.
In Part 2, participants will receive panitumumab with ganitumab. In both parts of the study, panitumumab and irinotecan (Part 1) and panitumumab and ganitumab (Part 2) will be administered every 2 weeks until disease progression, intolerability, withdrawal of consent, death, or unless otherwise indicated by the study team.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Panitumumab | Experimental | Participants received panitumumab (6 mg/kg starting dose) with irinotecan (starting dose of 180 mg/m²) every 2 weeks (Q2W) during Part 1. Upon radiographically confirmed disease progression, participants proceeded to Part 2 of the study and received treatment with panitumumab (6 mg/kg starting dose) and ganitumab (12 mg/kg starting dose) Q2W. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Panitumumab | Biological | Panitumumab 6 mg/kg administered via IV infusion over 60 minutes |
|
| Measure | Description | Time Frame |
|---|---|---|
| PFS Hazard Ratio | KRAS mutation status changed from wild-type at baseline to mutant at time of second biopsy in part 1, as measured by the PFS hazard ratio. Hazard ratio is presented as wild-type: mutant | From baseline up to 152 weeks (from baseline to the time of the second biopsy prior to entering part 2) . |
| Objective Response Rate in Part 2 | Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR. | From time of randomization until confirmed complete response or partial response (part 2: up to 119 weeks) |
| Measure | Description | Time Frame |
|---|---|---|
| Objective Response Rate for Part 1 | Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Objective Response (OR) = CR + PR. | from first dose of investigational product up to 152 weeks |
Not provided
Inclusion Criteria:
Exclusion Criteria:
History of other primary cancer, unless:
Adequately treated non-melanomatous skin cancer or lentigo maligna without evidence of disease,
History of prior or concurrent central nervous system (CNS) metastases;
Prior treatment with anti-EGFR (eg, panitumumab, cetuximab or small molecule inhibitors (eg, erlotinib, gefitinib);
Prior treatment with monoclonal antibodies directed against insulin-like growth factor-1 receptor (IGF-1R) or small molecule inhibitors directed against IGF-1R;
Use of systemic chemotherapy or radiotherapy ≤ 21 days before enrollment. Subjects must have recovered from acute toxicities related to radiotherapy;
Use of any antibody therapy (eg, bevacizumab) ≤ 42 days before enrolment;
Use of anti-tumor therapies including prior experimental agents or approved anti-tumor small molecules ≤ 30 days before enrolment;
Known allergy or hypersensitivity to any component of panitumumab, irinotecan, or AMG 479;
Known uridine diphosphate glucuronosyltransferase 1A1 (UGT1A1) polymorphisms predisposing to increased irinotecan toxicity;
History of irinotecan intolerance that may interfere with planned treatment;
History of interstitial lung disease (eg, pneumonitis, pulmonary fibrosis) or evidence of interstitial lung disease on baseline chest CT scan;
Clinically significant cardiovascular disease (including myocardial infarction, unstable angina, symptomatic congestive heart failure, serious uncontrolled cardiac arrhythmia) ≤ 1 year before enrolment;
Active inflammatory bowel disease or other active bowel disease causing chronic diarrhea (defined as ≥ grade 2 per Common Terminology Criteria for Adverse Events (CTCAE) version 3.0);
Known positive test(s) for human immunodeficiency virus (HIV) infection, hepatitis C virus, acute or chronic active hepatitis B infection;
Major surgical procedure ≤ 28 days before enrollment or minor surgical procedure ≤ 14 days before enrollment. Subjects must have recovered from surgery related toxicities. Core biopsy, central venous catheter placement, fine needle aspiration, thoracentesis, or paracentesis is not considered a major or minor surgical procedure; - Other investigational procedures or drugs (ie, participation in another clinical study) ≤ 30 days before enrolment;
other criteria may apply
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| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 28945848 | Derived | Siena S, Sartore-Bianchi A, Garcia-Carbonero R, Karthaus M, Smith D, Tabernero J, Van Cutsem E, Guan X, Boedigheimer M, Ang A, Twomey B, Bach BA, Jung AS, Bardelli A. Dynamic molecular analysis and clinical correlates of tumor evolution within a phase II trial of panitumumab-based therapy in metastatic colorectal cancer. Ann Oncol. 2018 Jan 1;29(1):119-126. doi: 10.1093/annonc/mdx504. |
| Label | URL |
|---|---|
| AmgenTrials clinical trials website | View source |
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Upon radiographically confirmed disease progression per modified RECIST version 1.0, eligible subjects from part 1 proceeded to part 2 of the study to receive panitumumab plus ganitumab.
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| ID | Title | Description |
|---|---|---|
| FG000 | Overall Study | Period 1:Part 1 Panitumumab + Irinotecan Open label panitumumab 6 mg/kg every 2 weeks plus irinotecan 180 mg/m2 every 2 weeks Period 2:Part 2 Panitumumab + AMG479 Treatment with panitumumab 6 mg/kg every 2 weeks plus AMG 479 12 mg/kg every 2 weeks. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Part 1 Panitumumab + Irinotecan |
|
| ||||||||||||||||||||||||
| Part 2 Panitumumab + AMG479 |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Part 1 | Participants received panitumumab (6 mg/kg starting dose) with irinotecan (starting dose of 180 mg/m²) every 2 weeks (Q2W) during Part 1. Upon radiographically confirmed disease progression, participants proceeded to Part 2 of the study and received treatment with panitumumab (6 mg/kg starting dose) and ganitumab (12 mg/kg starting dose) Q2W. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Period 2 part 2 subjects are a subset of period 1 part 1 subjects |
| 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 | PFS Hazard Ratio | KRAS mutation status changed from wild-type at baseline to mutant at time of second biopsy in part 1, as measured by the PFS hazard ratio. Hazard ratio is presented as wild-type: mutant | Posted | Number | 95% Confidence Interval | months | From baseline up to 152 weeks (from baseline to the time of the second biopsy prior to entering part 2) . |
|
|
Part 1: All-Cause Mortality was assessed up to 152 weeks and all other adverse events were collected up to 79 weeks; Part 2: All-Cause Mortality was assessed from start of part 2 up to 119 weeks from time of randomization and all other adverse events were collected up to 41 weeks from time of randomization.
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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 Panitumumab + Irinotecan | open label panitumumab 6 mg/kg every 2 weeks plus irinotecan 180 mg/m2 every 2 weeks |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Diarrhoea | Gastrointestinal disorders | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Sandeep Bobby Reddy, Chief Medical Officer | ImmunityBio | 866-572-6436 | Bobby.Reddy@Immunitybio.com |
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| 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 | Nov 14, 2012 | Apr 8, 2024 | Prot_SAP_000.pdf |
| ID | Term |
|---|---|
| D015179 | Colorectal Neoplasms |
| ID | Term |
|---|---|
| D007414 | Intestinal Neoplasms |
| D005770 | Gastrointestinal Neoplasms |
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
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| ID | Term |
|---|---|
| D000077544 | Panitumumab |
| C545764 | ganitumab |
| D000077146 | Irinotecan |
| ID | Term |
|---|---|
| D061067 | Antibodies, Monoclonal, Humanized |
| D000911 | Antibodies, Monoclonal |
| D000906 | Antibodies |
| D007136 | Immunoglobulins |
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| Ganitumab | Biological | AMG 479 12 mg/kg adminstered by IV infusion over 60 minutes |
|
|
| Irinotecan | Drug | Irinotecan starting dose of 180 mg/m² adminstered via IV infusion |
|
| Progression-Free Survival for Part 1 | Time from the first dose of investigational product to the first date of disease progression per the modified RECIST v1.0 or death by any cause, initiating a new line of antitumor therapy, or receiving study treatment in Part 2, whichever is earlier in Part 1. Disease progression is a >= 20% increase in the sum of the longest diameter of the target lesions as compared to the smallest sum while on study per RECIST v1.0 | from first dose of investigational product up to 152 weeks |
| Progression-Free Survival for Part 2 | Time from the start of Part 2 to the first date of disease progression per the modified RECIST v1.0 or death by any cause, initiating a new line of antitumor therapy, or receiving study treatment in Part 2, whichever is earlier. Disease progression is a >= 20% increase in the sum of the longest diameter of the target lesions as compared to the smallest sum while on study per RECIST v1.0. | 119 weeks from the start of part 2, up to a maximum duration of 152 week |
| Overall Survival for Part 1 | Time from the first dose of investigational product to death from any cause in Part 1. | from first dose of investigational product up to 152 weeks |
| Overall Survival for Part 2 | Time from the start of Part 2 to death from any cause. | from the start of Part 2 up to 119 weeks |
| Time to Response for Part 1 | Time from the first dose of investigational product to the date of first confirmed objective response in Part 1. An objective response is defined as a confirmed complete response or partial response per modified RECIST v1.0 criteria during the treatment period. Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Objective Response (OR) = CR + PR. | from first dose of investigational product up to 152 weeks |
| Duration of Response for Part 1 | Time from first confirmed objective response to disease progression per modified RECIST v1.0 in Part 1. An objective response is defined as a confirmed complete response or partial response per modified RECIST v1.0 criteria during the treatment period. Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Objective Response (OR) = CR + PR; Disease progression is a >= 20% increase in the sum of the longest diameter of the target lesions as compared to the smallest sum while on study. | from first dose of investigational product up to 152 weeks |
| Part 2 Time to Response and Duration of Response | Time to response was defined as the time from study day 1 to the first observation of an objective response (confirmed complete response or partial response using modified Response Evaluation Criteria in Solid Tumors [RECIST]). Duration of response was the time from the first observation of an objective response to the subsequent time of disease progression (per modified RECIST or clinical progression, whichever came first) or death due to any cause. Objective response = a tumor response assessment of either complete response or partial response per modified Response Evaluation Criteria in Solid Tumors [RECIST]. Per 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. | From time of randomization until confirmed complete response or partial response (part 2: up to 119 weeks) |
|
| BG001 |
| Part 2 |
Participants received panitumumab (6 mg/kg starting dose) with irinotecan (starting dose of 180 mg/m²) every 2 weeks (Q2W) during Part 1. Upon radiographically confirmed disease progression, participants proceeded to Part 2 of the study and received treatment with panitumumab (6 mg/kg starting dose) and ganitumab (12 mg/kg starting dose) Q2W. |
| BG002 | Total | Total of all reporting groups |
| Mean |
| Standard Deviation |
| years |
|
| Sex: Female, Male | Period 2 part 2 subjects are a subset of period 1 part 1 subjects | Count of Participants | Participants |
|
| Race (NIH/OMB) | Period 2 part 2 subjects are a subset of period 1 part 1 subjects | Count of Participants | Participants |
|
| Subjects With Metastatic Colorectal Carcinoma Expressing Wild-type KRAS and Refractory to Oxaliplati | Count of Participants | Participants |
|
|
|
|
| Primary | Objective Response Rate in Part 2 | Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR. | Posted | Number | 95% Confidence Interval | percentage of participants | From time of randomization until confirmed complete response or partial response (part 2: up to 119 weeks) |
|
|
|
| Secondary | Objective Response Rate for Part 1 | Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Objective Response (OR) = CR + PR. | Posted | Number | 95% Confidence Interval | percentage of participants | from first dose of investigational product up to 152 weeks |
|
|
|
| Secondary | Progression-Free Survival for Part 1 | Time from the first dose of investigational product to the first date of disease progression per the modified RECIST v1.0 or death by any cause, initiating a new line of antitumor therapy, or receiving study treatment in Part 2, whichever is earlier in Part 1. Disease progression is a >= 20% increase in the sum of the longest diameter of the target lesions as compared to the smallest sum while on study per RECIST v1.0 | Posted | Median | 95% Confidence Interval | months | from first dose of investigational product up to 152 weeks |
|
|
|
| Secondary | Progression-Free Survival for Part 2 | Time from the start of Part 2 to the first date of disease progression per the modified RECIST v1.0 or death by any cause, initiating a new line of antitumor therapy, or receiving study treatment in Part 2, whichever is earlier. Disease progression is a >= 20% increase in the sum of the longest diameter of the target lesions as compared to the smallest sum while on study per RECIST v1.0. | Posted | Median | 95% Confidence Interval | months | 119 weeks from the start of part 2, up to a maximum duration of 152 week |
|
|
|
| Secondary | Overall Survival for Part 1 | Time from the first dose of investigational product to death from any cause in Part 1. | Posted | Median | 95% Confidence Interval | months | from first dose of investigational product up to 152 weeks |
|
|
|
| Secondary | Overall Survival for Part 2 | Time from the start of Part 2 to death from any cause. | Posted | Median | 95% Confidence Interval | months | from the start of Part 2 up to 119 weeks |
|
|
|
| Secondary | Time to Response for Part 1 | Time from the first dose of investigational product to the date of first confirmed objective response in Part 1. An objective response is defined as a confirmed complete response or partial response per modified RECIST v1.0 criteria during the treatment period. Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Objective Response (OR) = CR + PR. | Posted | Mean | Standard Deviation | months | from first dose of investigational product up to 152 weeks |
|
|
|
| Secondary | Duration of Response for Part 1 | Time from first confirmed objective response to disease progression per modified RECIST v1.0 in Part 1. An objective response is defined as a confirmed complete response or partial response per modified RECIST v1.0 criteria during the treatment period. Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Objective Response (OR) = CR + PR; Disease progression is a >= 20% increase in the sum of the longest diameter of the target lesions as compared to the smallest sum while on study. | Posted | Median | 95% Confidence Interval | months | from first dose of investigational product up to 152 weeks |
|
|
|
| Secondary | Part 2 Time to Response and Duration of Response | Time to response was defined as the time from study day 1 to the first observation of an objective response (confirmed complete response or partial response using modified Response Evaluation Criteria in Solid Tumors [RECIST]). Duration of response was the time from the first observation of an objective response to the subsequent time of disease progression (per modified RECIST or clinical progression, whichever came first) or death due to any cause. Objective response = a tumor response assessment of either complete response or partial response per modified Response Evaluation Criteria in Solid Tumors [RECIST]. Per 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. | Due to no subjects having complete or partial responses, these Secondary Outcomes were not summarized. | Posted | From time of randomization until confirmed complete response or partial response (part 2: up to 119 weeks) |
|
|
| 66 |
| 74 |
| 26 |
| 74 |
| 74 |
| 74 |
| EG001 | Part 2 Panitumumab + AMG479 | treatment with panitumumab 6 mg/kg every 2 weeks plus AMG 479 12 mg/kg every 2 weeks. | 30 | 36 | 8 | 36 | 35 | 36 |
| Leukopenia | Blood and lymphatic system disorders | Systematic Assessment |
|
| Neutropenia | Blood and lymphatic system disorders | Systematic Assessment |
|
| Cardiac failure | Cardiac disorders | Systematic Assessment |
|
| Abdominal pain | Gastrointestinal disorders | Systematic Assessment |
|
| Diarrhoea | Gastrointestinal disorders | Systematic Assessment |
|
| Ileus | Gastrointestinal disorders | Systematic Assessment |
|
| Intestinal obstruction | Gastrointestinal disorders | Systematic Assessment |
|
| Oesophagitis | Gastrointestinal disorders | Systematic Assessment |
|
| Rectal haemorrhage | Gastrointestinal disorders | Systematic Assessment |
|
| Stomatitis | Gastrointestinal disorders | Systematic Assessment |
|
| Vomiting | Gastrointestinal disorders | Systematic Assessment |
|
| Asthenia | General disorders | Systematic Assessment |
|
| Fatigue | General disorders | Systematic Assessment |
|
| General physical health deterioration | General disorders | Systematic Assessment |
|
| Performance status decreased | General disorders | Systematic Assessment |
|
| Cholangitis | Hepatobiliary disorders | Systematic Assessment |
|
| Cholestasis | Hepatobiliary disorders | Systematic Assessment |
|
| Hypersensitivity | Immune system disorders | Systematic Assessment |
|
| Anal abscess | Infections and infestations | Systematic Assessment |
|
| Bronchitis | Infections and infestations | Systematic Assessment |
|
| Device related infection | Infections and infestations | Systematic Assessment |
|
| Gastroenteritis | Infections and infestations | Systematic Assessment |
|
| Staphylococcal sepsis | Infections and infestations | Systematic Assessment |
|
| Urinary tract infection | Infections and infestations | Systematic Assessment |
|
| Weight decreased | Investigations | Systematic Assessment |
|
| Decreased appetite | Metabolism and nutrition disorders | Systematic Assessment |
|
| Hypokalaemia | Metabolism and nutrition disorders | Systematic Assessment |
|
| Hypomagnesaemia | Metabolism and nutrition disorders | Systematic Assessment |
|
| Arthralgia | Musculoskeletal and connective tissue disorders | Systematic Assessment |
|
| Back pain | Musculoskeletal and connective tissue disorders | Systematic Assessment |
|
| Bone pain | Musculoskeletal and connective tissue disorders | Systematic Assessment |
|
| Muscle contracture | Musculoskeletal and connective tissue disorders | Systematic Assessment |
|
| Myalgia | Musculoskeletal and connective tissue disorders | Systematic Assessment |
|
| Colorectal cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | Systematic Assessment |
|
| Metastases to peritoneum | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | Systematic Assessment |
|
| Paresis | Nervous system disorders | Systematic Assessment |
|
| Syncope | Nervous system disorders | Systematic Assessment |
|
| Confusional state | Psychiatric disorders | Systematic Assessment |
|
| Renal failure acute | Renal and urinary disorders | Systematic Assessment |
|
| Urinary retention | Renal and urinary disorders | Systematic Assessment |
|
| Atelectasis | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
|
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
|
| Pulmonary embolism | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
|
| Pyrexia | General disorders | Systematic Assessment |
|
| Asthenia | General disorders | Systematic Assessment |
|
| Rash | Skin and subcutaneous tissue disorders | Systematic Assessment |
|
| Nausea | Gastrointestinal disorders | Systematic Assessment |
|
| Decreased Appetite | Metabolism and nutrition disorders | Systematic Assessment |
|
| Vomiting | Gastrointestinal disorders | Systematic Assessment |
|
| Mucosal Inflammation | General disorders | Systematic Assessment |
|
| Dry Skin | Skin and subcutaneous tissue disorders | Systematic Assessment |
|
| Alopecia | Skin and subcutaneous tissue disorders | Systematic Assessment |
|
| Hypomagnesaemia | Metabolism and nutrition disorders | Systematic Assessment |
|
| Constipation | Gastrointestinal disorders | Systematic Assessment |
|
| Skin Fissures | Skin and subcutaneous tissue disorders | Systematic Assessment |
|
| Abdominal Pain | General disorders | Systematic Assessment |
|
| Paronychia | Psychiatric disorders | Systematic Assessment |
|
| Skin Toxicity | Skin and subcutaneous tissue disorders | Systematic Assessment |
|
| Fatigue | General disorders | Systematic Assessment |
|
| Pruritus | General disorders | Systematic Assessment |
|
| Anaemia | Blood and lymphatic system disorders | Systematic Assessment |
|
| Pyrexia | General disorders | Systematic Assessment |
|
| Acne | Skin and subcutaneous tissue disorders | Systematic Assessment |
|
| General Physical Health Deterioration | General disorders | Systematic Assessment |
|
| Back Pain | Musculoskeletal and connective tissue disorders | Systematic Assessment |
|
| Conjunctivitis | Eye disorders | Systematic Assessment |
|
| Neutropenia | Blood and lymphatic system disorders | Systematic Assessment |
|
| Weight Decreased | Investigations | Systematic Assessment |
|
| Abdominal Pain Upper | General disorders | Systematic Assessment |
|
| Cough | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
|
| Dermatitis Acneiform | Skin and subcutaneous tissue disorders | Systematic Assessment |
|
| Insomnia | Psychiatric disorders | Systematic Assessment |
|
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
|
| Hypokalaemia | Metabolism and nutrition disorders | Systematic Assessment |
|
| Xerosis | General disorders | Systematic Assessment |
|
| Dyspepsia | Gastrointestinal disorders | Systematic Assessment |
|
| Folliculitis | Skin and subcutaneous tissue disorders | Systematic Assessment |
|
| Headache | General disorders | Systematic Assessment |
|
| Musculoskeletal Pain | Musculoskeletal and connective tissue disorders | Systematic Assessment |
|
| Urinary Tract Infection | Renal and urinary disorders | Systematic Assessment |
|
| Arthralgia | Musculoskeletal and connective tissue disorders | Systematic Assessment |
|
| Dysgeusia | Renal and urinary disorders | Systematic Assessment |
|
| Erythema | General disorders | Systematic Assessment |
|
| Oedema Peripheral | Nervous system disorders | Systematic Assessment |
|
| Oropharyngeal Pain | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
|
| Paraesthesia | Nervous system disorders | Systematic Assessment |
|
| Polyneuropathy | Nervous system disorders | Systematic Assessment |
|
| Productive Cough | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
|
| Stomatitis | Gastrointestinal disorders | Systematic Assessment |
|
| Trichomegaly | Skin and subcutaneous tissue disorders | Systematic Assessment |
|
| Abdominal Distension | General disorders | Systematic Assessment |
|
| Chest Pain | General disorders | Systematic Assessment |
|
| Dry Eye | Eye disorders | Systematic Assessment |
|
| Dysphonia | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
|
| Dysuria | Renal and urinary disorders | Systematic Assessment |
|
| Haematoma | Vascular disorders | Systematic Assessment |
|
| Haemorrhoids | Vascular disorders | Systematic Assessment |
|
| Nail Toxicity | Skin and subcutaneous tissue disorders | Systematic Assessment |
|
| Nasopharyngitis | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
|
| Neurotoxicity | Nervous system disorders | Systematic Assessment |
|
| Tachycardia | Cardiac disorders | Systematic Assessment |
|
| Hypomagnesaemia | General disorders | Systematic Assessment |
|
| Epistaxis | Ear and labyrinth disorders | Systematic Assessment |
|
| Infusion Related Reaction | Investigations | Systematic Assessment |
|
| Nail Bed Inflammation | Skin and subcutaneous tissue disorders | Systematic Assessment |
|
| Palmar-Plantar Erythrodysaesthesia Syndrome | Nervous system disorders | Systematic Assessment |
|
| Colorectal Cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | Systematic Assessment |
|
| Eczema | Skin and subcutaneous tissue disorders | Systematic Assessment |
|
| Hepatic Pain | General disorders | Systematic Assessment |
|
| Hypersensitivity | General disorders | Systematic Assessment |
|
| Infection | General 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 |
| D007162 |
| Immunoproteins |
| D001798 | Blood Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D012712 | Serum Globulins |
| D005916 | Globulins |
| D002166 | Camptothecin |
| D000470 | Alkaloids |
| D006571 | Heterocyclic Compounds |
| Male |
|
| Native Hawaiian or Other Pacific Islander |
|
| Black or African American |
|
| White |
|
| More than one race |
|
| Unknown or Not Reported |
|
| Asian |
|
| Native Hawaiian or Other Pacific Islander |
|
| Black or African American |
|
| White |
|
| More than one race |
|
| Unknown or Not Reported |
|