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To monitor the safety profile and efficacy of GIOTRIF® (afatinib dimaleate, q.d) in Korean patients with locally advanced or metastatic non-small cell lung cancer (NSCLC)
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| GIOTRIF |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| GIOTRIF 20mg | Drug | NSCLC with GIOTRIF 20mg |
| |
| GIOTRIF 40mg |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants With Adverse Drug Reactions (ADRs) | Percentage of participants with Adverse Drug Reactions (ADRs). | From baseline (Visit 1) until last visit (the last follow-up visit a patient actually attended during the study), up to 1051 days. |
| Measure | Description | Time Frame |
|---|---|---|
| Progression-Free Survival (PFS) Rate at 48 Weeks | Progression-Free Survival (PFS) rate, defined as the percentage of patients who were alive and without disease progression at the 48-week tumour assessment. Progression was assessed by the investigator according to local standard pattern of care for non-small cell lung cancer (NSCLC). If a patient is known to have progressed, but the date of progression is not attainable, the last date when the patient was assessed will be used as date of progression. PFS rate at 48 weeks was estimated using Kaplan-Meier estimates on the PFS curve. |
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Inclusion criteria:
Exclusion criteria:
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NSCLC in Korea
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| Name | Affiliation | Role |
|---|---|---|
| Boehringer Ingelheim | Boehringer Ingelheim | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Multiple Locations | South Korea |
Not provided
| Label | URL |
|---|---|
| Related Info | View source |
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All subjects were screened for eligibility prior to participation in the trial. Subjects were not to be allocated to a treatment group if any of the entry criteria were violated.
This is an observational prospective, non-interventional, open-label, multi-centre national study in Korean patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) with Epidermal Growth Factor Receptor (EGFR) mutations or patients with locally advanced or metastatic NSCLC of squamous histology progressing on or after platinum-based chemotherapy
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| ID | Title | Description |
|---|---|---|
| FG000 | GIOTRIF® | GIOTRIF® was prescribed according to the local label and at the discretion of the treating physician. The physicians indicated doses and timing based on the current authorized label in Korea. Possible dosage were 20 milligram (mg), 30 mg and 40 mg administered orally, once daily, at least 1 hour before a meal or at least 3 hours after a meal, taken without food and swallowed whole with water. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
All Participants whose case report forms (CRFs) were retrieved during the re-examination period (29 Jan 2014 - 28 Jan 2020) and who did not violate the inclusion/exclusion criteria. 1 subject was excluded from the set based on disease indication.
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | GIOTRIF® | GIOTRIF® was prescribed according to the local label and at the discretion of the treating physician. The physicians indicated doses and timing based on the current authorized label in Korea. Possible dosage were 20 milligram (mg), 30 mg and 40 mg administered orally, once daily, at least 1 hour before a meal or at least 3 hours after a meal, taken without food and swallowed whole with water. |
| 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 | Percentage of Participants With Adverse Drug Reactions (ADRs) | Percentage of participants with Adverse Drug Reactions (ADRs). | All Participants whose case report forms (CRFs) were retrieved during the re-examination period (29 Jan 2014 - 28 Jan 2020) and who did not violate the inclusion/exclusion criteria. 1 subject was excluded from the set based on disease indication. | Posted | Number | Percentage of participants | From baseline (Visit 1) until last visit (the last follow-up visit a patient actually attended during the study), up to 1051 days. |
|
From baseline (Visit 1) until last visit (the last follow-up visit a patient actually attended during the study), up to 1051 days.
For this non interventional study, all 1272 participants whose case report forms (CRFs) were retrieved during the re-examination period (29 Jan 2014 - 28 Jan 2020) and who did not violate the inclusion/exclusion criteria were included. Among these, 6 participants were deemed not eligible retrospectively and were additionally excluded.
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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 | GIOTRIF® | GIOTRIF® was prescribed according to the local label and at the discretion of the treating physician. The physicians indicated doses and timing based on the current authorized label in Korea. Possible dosage were 20 milligram (mg), 30 mg and 40 mg administered orally, once daily, at least 1 hour before a meal or at least 3 hours after a meal, taken without food and swallowed whole with water. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | 23.1 | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Diarrhoea | Gastrointestinal disorders | 23.1 | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Boehringer Ingelheim, Call Center | Boehringer Ingelheim | 1-800-243-0127 | clintriage.rdg@boehringer-ingelheim.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 18, 2020 | Dec 21, 2020 | Prot_SAP_000.pdf |
| 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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| Drug |
NSCLC with GIOTRIF 40mg |
|
| GIOTRIF 30mg | Drug | NSCLC with GIOTRIF 30mg |
|
| From week 0 until week 48. Up to 48 weeks. |
| Percentage of Participants With Best Response | Best response is defined as the best response observed in individual subject from the date of the first administration of the study medication until the earliest recording of Progressive disease (PD), death, or end of treatment (as long as no additional anti-cancer therapy was implemented). Disease Assessment will be based on the assessment of cancer related symptoms and, if available, radiologic assessments as per standard of care at the site. Tumour response according to investigator's assessment Each patient will be assigned to one of the following categories:
| Tumour assessments performed at week 0, 8±2, 24±2 and 48±2. Up to 50 weeks. |
| Overall Survival (OS) | Overall Survival (OS), defined as time from the date of the first administration of afatinib to the date of death. Kaplan-Meier estimates and 95% confidence intervals for the 25th, median, and 75th percentiles of the survival distribution will be calculated for OS. For patients with known date of death: OS [days] = date of death - (date of start of treatment) + 1 For patients known not death case: OS (censored) [days] = date of last contact showing no death - (date of start of treatment) + 1. | From baseline (Visit 1) until last visit (the last follow-up visit a patient actually attended during the study), up to 1051 days. |
| Consented prior to the contract date |
|
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
|
|
|
| Secondary | Progression-Free Survival (PFS) Rate at 48 Weeks | Progression-Free Survival (PFS) rate, defined as the percentage of patients who were alive and without disease progression at the 48-week tumour assessment. Progression was assessed by the investigator according to local standard pattern of care for non-small cell lung cancer (NSCLC). If a patient is known to have progressed, but the date of progression is not attainable, the last date when the patient was assessed will be used as date of progression. PFS rate at 48 weeks was estimated using Kaplan-Meier estimates on the PFS curve. | Effectiveness assessment set: all participants whose case report forms (CRFs) were retrieved during the re-examination period (29 Jan 2014 - 28 Jan 2020) and who did not violate the inclusion/exclusion criteria. 221 subjects were excluded due to missing effectiveness assessments. | Posted | Number | 95% Confidence Interval | Percentage of participants | From week 0 until week 48. Up to 48 weeks. |
|
|
|
| Secondary | Percentage of Participants With Best Response | Best response is defined as the best response observed in individual subject from the date of the first administration of the study medication until the earliest recording of Progressive disease (PD), death, or end of treatment (as long as no additional anti-cancer therapy was implemented). Disease Assessment will be based on the assessment of cancer related symptoms and, if available, radiologic assessments as per standard of care at the site. Tumour response according to investigator's assessment Each patient will be assigned to one of the following categories:
| Effectiveness assessment set: all participants whose case report forms (CRFs) were retrieved during the re-examination period (29 Jan 2014 - 28 Jan 2020) and who did not violate the inclusion/exclusion criteria. 221 subjects were excluded due to missing effectiveness assessments, an additional 36 subjects were excluded for not completing the assessment at the last visit. | Posted | Number | Percentage of participants | Tumour assessments performed at week 0, 8±2, 24±2 and 48±2. Up to 50 weeks. |
|
|
|
| Secondary | Overall Survival (OS) | Overall Survival (OS), defined as time from the date of the first administration of afatinib to the date of death. Kaplan-Meier estimates and 95% confidence intervals for the 25th, median, and 75th percentiles of the survival distribution will be calculated for OS. For patients with known date of death: OS [days] = date of death - (date of start of treatment) + 1 For patients known not death case: OS (censored) [days] = date of last contact showing no death - (date of start of treatment) + 1. | Effectiveness assessment set: all participants whose case report forms (CRFs) were retrieved during the re-examination period (29 Jan 2014 - 28 Jan 2020) and who did not violate the inclusion/exclusion criteria. 221 subjects were excluded due to missing effectiveness assessments. | Posted | Median | 95% Confidence Interval | Days | From baseline (Visit 1) until last visit (the last follow-up visit a patient actually attended during the study), up to 1051 days. |
|
|
|
| 52 |
| 1,266 |
| 442 |
| 1,266 |
| 1,076 |
| 1,266 |
| Neutropenia | Blood and lymphatic system disorders | 23.1 | Systematic Assessment |
|
| Pancytopenia | Blood and lymphatic system disorders | 23.1 | Systematic Assessment |
|
| Acute myocardial infarction | Cardiac disorders | 23.1 | Systematic Assessment |
|
| Atrial flutter | Cardiac disorders | 23.1 | Systematic Assessment |
|
| Cardiac tamponade | Cardiac disorders | 23.1 | Systematic Assessment |
|
| Pericardial effusion | Cardiac disorders | 23.1 | Systematic Assessment |
|
| Otolithiasis | Ear and labyrinth disorders | 23.1 | Systematic Assessment |
|
| Vertigo positional | Ear and labyrinth disorders | 23.1 | Systematic Assessment |
|
| Thyroid mass | Endocrine disorders | 23.1 | Systematic Assessment |
|
| Glaucoma | Eye disorders | 23.1 | Systematic Assessment |
|
| Retinal detachment | Eye disorders | 23.1 | Systematic Assessment |
|
| Abdominal pain | Gastrointestinal disorders | 23.1 | Systematic Assessment |
|
| Colitis | Gastrointestinal disorders | 23.1 | Systematic Assessment |
|
| Diarrhoea | Gastrointestinal disorders | 23.1 | Systematic Assessment |
|
| Dysphagia | Gastrointestinal disorders | 23.1 | Systematic Assessment |
|
| Enteritis | Gastrointestinal disorders | 23.1 | Systematic Assessment |
|
| Enterocolitis | Gastrointestinal disorders | 23.1 | Systematic Assessment |
|
| Gastric ulcer | Gastrointestinal disorders | 23.1 | Systematic Assessment |
|
| Gastrooesophageal reflux disease | Gastrointestinal disorders | 23.1 | Systematic Assessment |
|
| Haematochezia | Gastrointestinal disorders | 23.1 | Systematic Assessment |
|
| Haemorrhoids | Gastrointestinal disorders | 23.1 | Systematic Assessment |
|
| Ileus paralytic | Gastrointestinal disorders | 23.1 | Systematic Assessment |
|
| Mechanical ileus | Gastrointestinal disorders | 23.1 | Systematic Assessment |
|
| Melaena | Gastrointestinal disorders | 23.1 | Systematic Assessment |
|
| Mouth ulceration | Gastrointestinal disorders | 23.1 | Systematic Assessment |
|
| Nausea | Gastrointestinal disorders | 23.1 | Systematic Assessment |
|
| Stomatitis | Gastrointestinal disorders | 23.1 | Systematic Assessment |
|
| Vomiting | Gastrointestinal disorders | 23.1 | Systematic Assessment |
|
| Asthenia | General disorders | 23.1 | Systematic Assessment |
|
| Chest pain | General disorders | 23.1 | Systematic Assessment |
|
| Death | General disorders | 23.1 | Systematic Assessment |
|
| Disease progression | General disorders | 23.1 | Systematic Assessment |
|
| Fatigue | General disorders | 23.1 | Systematic Assessment |
|
| Gait disturbance | General disorders | 23.1 | Systematic Assessment |
|
| Mucosal inflammation | General disorders | 23.1 | Systematic Assessment |
|
| Pyrexia | General disorders | 23.1 | Systematic Assessment |
|
| Cholelithiasis | Hepatobiliary disorders | 23.1 | Systematic Assessment |
|
| Drug-induced liver injury | Hepatobiliary disorders | 23.1 | Systematic Assessment |
|
| Hepatic cirrhosis | Hepatobiliary disorders | 23.1 | Systematic Assessment |
|
| Hepatitis toxic | Hepatobiliary disorders | 23.1 | Systematic Assessment |
|
| Hepatotoxicity | Hepatobiliary disorders | 23.1 | Systematic Assessment |
|
| Atypical pneumonia | Infections and infestations | 23.1 | Systematic Assessment |
|
| Bacteraemia | Infections and infestations | 23.1 | Systematic Assessment |
|
| Bronchiolitis | Infections and infestations | 23.1 | Systematic Assessment |
|
| Bronchitis | Infections and infestations | 23.1 | Systematic Assessment |
|
| Cellulitis | Infections and infestations | 23.1 | Systematic Assessment |
|
| Chest wall abscess | Infections and infestations | 23.1 | Systematic Assessment |
|
| Clostridium difficile colitis | Infections and infestations | 23.1 | Systematic Assessment |
|
| Clostridium difficile infection | Infections and infestations | 23.1 | Systematic Assessment |
|
| Eczema herpeticum | Infections and infestations | 23.1 | Systematic Assessment |
|
| Folliculitis | Infections and infestations | 23.1 | Systematic Assessment |
|
| Gastroenteritis | Infections and infestations | 23.1 | Systematic Assessment |
|
| Infectious pleural effusion | Infections and infestations | 23.1 | Systematic Assessment |
|
| Onychomycosis | Infections and infestations | 23.1 | Systematic Assessment |
|
| Paronychia | Infections and infestations | 23.1 | Systematic Assessment |
|
| Pharyngitis | Infections and infestations | 23.1 | Systematic Assessment |
|
| Pneumonia | Infections and infestations | 23.1 | Systematic Assessment |
|
| Pneumonia bacterial | Infections and infestations | 23.1 | Systematic Assessment |
|
| Pneumonia viral | Infections and infestations | 23.1 | Systematic Assessment |
|
| Pseudomembranous colitis | Infections and infestations | 23.1 | Systematic Assessment |
|
| Pyelonephritis acute | Infections and infestations | 23.1 | Systematic Assessment |
|
| Renal abscess | Infections and infestations | 23.1 | Systematic Assessment |
|
| Septic shock | Infections and infestations | 23.1 | Systematic Assessment |
|
| Subcutaneous abscess | Infections and infestations | 23.1 | Systematic Assessment |
|
| Upper respiratory tract infection | Infections and infestations | 23.1 | Systematic Assessment |
|
| Compression fracture | Injury, poisoning and procedural complications | 23.1 | Systematic Assessment |
|
| Fall | Injury, poisoning and procedural complications | 23.1 | Systematic Assessment |
|
| Fractured sacrum | Injury, poisoning and procedural complications | 23.1 | Systematic Assessment |
|
| Lumbar vertebral fracture | Injury, poisoning and procedural complications | 23.1 | Systematic Assessment |
|
| Meniscus injury | Injury, poisoning and procedural complications | 23.1 | Systematic Assessment |
|
| Radiation pneumonitis | Injury, poisoning and procedural complications | 23.1 | Systematic Assessment |
|
| Rib fracture | Injury, poisoning and procedural complications | 23.1 | Systematic Assessment |
|
| Spinal compression fracture | Injury, poisoning and procedural complications | 23.1 | Systematic Assessment |
|
| Subcutaneous haematoma | Injury, poisoning and procedural complications | 23.1 | Systematic Assessment |
|
| Subdural haemorrhage | Injury, poisoning and procedural complications | 23.1 | Systematic Assessment |
|
| Thoracic vertebral fracture | Injury, poisoning and procedural complications | 23.1 | Systematic Assessment |
|
| Alanine aminotransferase increased | Investigations | 23.1 | Systematic Assessment |
|
| Aspartate aminotransferase increased | Investigations | 23.1 | Systematic Assessment |
|
| Liver function test increased | Investigations | 23.1 | Systematic Assessment |
|
| Decreased appetite | Metabolism and nutrition disorders | 23.1 | Systematic Assessment |
|
| Dehydration | Metabolism and nutrition disorders | 23.1 | Systematic Assessment |
|
| Diabetes mellitus | Metabolism and nutrition disorders | 23.1 | Systematic Assessment |
|
| Hyperglycaemia | Metabolism and nutrition disorders | 23.1 | Systematic Assessment |
|
| Hyperkalaemia | Metabolism and nutrition disorders | 23.1 | Systematic Assessment |
|
| Hypoglycaemia | Metabolism and nutrition disorders | 23.1 | Systematic Assessment |
|
| Hyponatraemia | Metabolism and nutrition disorders | 23.1 | Systematic Assessment |
|
| Hypophagia | Metabolism and nutrition disorders | 23.1 | Systematic Assessment |
|
| Lactic acidosis | Metabolism and nutrition disorders | 23.1 | Systematic Assessment |
|
| Malnutrition | Metabolism and nutrition disorders | 23.1 | Systematic Assessment |
|
| Metabolic acidosis | Metabolism and nutrition disorders | 23.1 | Systematic Assessment |
|
| Tumour lysis syndrome | Metabolism and nutrition disorders | 23.1 | Systematic Assessment |
|
| Arthralgia | Musculoskeletal and connective tissue disorders | 23.1 | Systematic Assessment |
|
| Back pain | Musculoskeletal and connective tissue disorders | 23.1 | Systematic Assessment |
|
| Flank pain | Musculoskeletal and connective tissue disorders | 23.1 | Systematic Assessment |
|
| Muscular weakness | Musculoskeletal and connective tissue disorders | 23.1 | Systematic Assessment |
|
| Neck pain | Musculoskeletal and connective tissue disorders | 23.1 | Systematic Assessment |
|
| Pain in extremity | Musculoskeletal and connective tissue disorders | 23.1 | Systematic Assessment |
|
| Spinal stenosis | Musculoskeletal and connective tissue disorders | 23.1 | Systematic Assessment |
|
| Spondylolisthesis | Musculoskeletal and connective tissue disorders | 23.1 | Systematic Assessment |
|
| Adenocarcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | 23.1 | Systematic Assessment |
|
| Adrenal gland cancer metastatic | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | 23.1 | Systematic Assessment |
|
| Brain neoplasm | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | 23.1 | Systematic Assessment |
|
| Breast cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | 23.1 | Systematic Assessment |
|
| Gastric cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | 23.1 | Systematic Assessment |
|
| Lung neoplasm malignant | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | 23.1 | Systematic Assessment |
|
| Malignant neoplasm progression | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | 23.1 | Systematic Assessment |
|
| Meningioma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | 23.1 | Systematic Assessment |
|
| Metastases to bone | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | 23.1 | Systematic Assessment |
|
| Metastases to central nervous system | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | 23.1 | Systematic Assessment |
|
| Metastases to meninges | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | 23.1 | Systematic Assessment |
|
| Myelodysplastic syndrome | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | 23.1 | Systematic Assessment |
|
| Ovarian cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | 23.1 | Systematic Assessment |
|
| Pericardial effusion malignant | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | 23.1 | Systematic Assessment |
|
| Peritumoural oedema | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | 23.1 | Systematic Assessment |
|
| Renal cell carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | 23.1 | Systematic Assessment |
|
| Small intestine carcinoma metastatic | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | 23.1 | Systematic Assessment |
|
| Aphasia | Nervous system disorders | 23.1 | Systematic Assessment |
|
| Cerebral infarction | Nervous system disorders | 23.1 | Systematic Assessment |
|
| Dizziness | Nervous system disorders | 23.1 | Systematic Assessment |
|
| Embolic cerebral infarction | Nervous system disorders | 23.1 | Systematic Assessment |
|
| Epilepsy | Nervous system disorders | 23.1 | Systematic Assessment |
|
| Headache | Nervous system disorders | 23.1 | Systematic Assessment |
|
| Hemiparesis | Nervous system disorders | 23.1 | Systematic Assessment |
|
| Hydrocephalus | Nervous system disorders | 23.1 | Systematic Assessment |
|
| Hypoaesthesia | Nervous system disorders | 23.1 | Systematic Assessment |
|
| Intracranial aneurysm | Nervous system disorders | 23.1 | Systematic Assessment |
|
| Myelopathy | Nervous system disorders | 23.1 | Systematic Assessment |
|
| Normal pressure hydrocephalus | Nervous system disorders | 23.1 | Systematic Assessment |
|
| Seizure | Nervous system disorders | 23.1 | Systematic Assessment |
|
| Syncope | Nervous system disorders | 23.1 | Systematic Assessment |
|
| Bipolar disorder | Psychiatric disorders | 23.1 | Systematic Assessment |
|
| Confusional state | Psychiatric disorders | 23.1 | Systematic Assessment |
|
| Delirium | Psychiatric disorders | 23.1 | Systematic Assessment |
|
| Disorientation | Psychiatric disorders | 23.1 | Systematic Assessment |
|
| Mental status changes | Psychiatric disorders | 23.1 | Systematic Assessment |
|
| Acute kidney injury | Renal and urinary disorders | 23.1 | Systematic Assessment |
|
| Azotaemia | Renal and urinary disorders | 23.1 | Systematic Assessment |
|
| Calculus urinary | Renal and urinary disorders | 23.1 | Systematic Assessment |
|
| Chronic kidney disease | Renal and urinary disorders | 23.1 | Systematic Assessment |
|
| Dysuria | Renal and urinary disorders | 23.1 | Systematic Assessment |
|
| Acute respiratory distress syndrome | Respiratory, thoracic and mediastinal disorders | 23.1 | Systematic Assessment |
|
| Asphyxia | Respiratory, thoracic and mediastinal disorders | 23.1 | Systematic Assessment |
|
| Asthma | Respiratory, thoracic and mediastinal disorders | 23.1 | Systematic Assessment |
|
| Cough | Respiratory, thoracic and mediastinal disorders | 23.1 | Systematic Assessment |
|
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | 23.1 | Systematic Assessment |
|
| Epistaxis | Respiratory, thoracic and mediastinal disorders | 23.1 | Systematic Assessment |
|
| Haemoptysis | Respiratory, thoracic and mediastinal disorders | 23.1 | Systematic Assessment |
|
| Idiopathic pulmonary fibrosis | Respiratory, thoracic and mediastinal disorders | 23.1 | Systematic Assessment |
|
| Interstitial lung disease | Respiratory, thoracic and mediastinal disorders | 23.1 | Systematic Assessment |
|
| Laryngeal oedema | Respiratory, thoracic and mediastinal disorders | 23.1 | Systematic Assessment |
|
| Orthopnoea | Respiratory, thoracic and mediastinal disorders | 23.1 | Systematic Assessment |
|
| Pleural effusion | Respiratory, thoracic and mediastinal disorders | 23.1 | Systematic Assessment |
|
| Pleuritic pain | Respiratory, thoracic and mediastinal disorders | 23.1 | Systematic Assessment |
|
| Pneumonia aspiration | Respiratory, thoracic and mediastinal disorders | 23.1 | Systematic Assessment |
|
| Pneumonitis | Respiratory, thoracic and mediastinal disorders | 23.1 | Systematic Assessment |
|
| Pneumothorax | Respiratory, thoracic and mediastinal disorders | 23.1 | Systematic Assessment |
|
| Productive cough | Respiratory, thoracic and mediastinal disorders | 23.1 | Systematic Assessment |
|
| Pulmonary embolism | Respiratory, thoracic and mediastinal disorders | 23.1 | Systematic Assessment |
|
| Pulmonary fibrosis | Respiratory, thoracic and mediastinal disorders | 23.1 | Systematic Assessment |
|
| Pulmonary thrombosis | Respiratory, thoracic and mediastinal disorders | 23.1 | Systematic Assessment |
|
| Wheezing | Respiratory, thoracic and mediastinal disorders | 23.1 | Systematic Assessment |
|
| Drug eruption | Skin and subcutaneous tissue disorders | 23.1 | Systematic Assessment |
|
| Pain of skin | Skin and subcutaneous tissue disorders | 23.1 | Systematic Assessment |
|
| Pruritus | Skin and subcutaneous tissue disorders | 23.1 | Systematic Assessment |
|
| Rash | Skin and subcutaneous tissue disorders | 23.1 | Systematic Assessment |
|
| Rash maculo-papular | Skin and subcutaneous tissue disorders | 23.1 | Systematic Assessment |
|
| Seborrhoeic dermatitis | Skin and subcutaneous tissue disorders | 23.1 | Systematic Assessment |
|
| Deep vein thrombosis | Vascular disorders | 23.1 | Systematic Assessment |
|
| Hypovolaemic shock | Vascular disorders | 23.1 | Systematic Assessment |
|
| Orthostatic hypotension | Vascular disorders | 23.1 | Systematic Assessment |
|
| Pelvic venous thrombosis | Vascular disorders | 23.1 | Systematic Assessment |
|
| Nausea | Gastrointestinal disorders | 23.1 | Systematic Assessment |
|
| Stomatitis | Gastrointestinal disorders | 23.1 | Systematic Assessment |
|
| Paronychia | Infections and infestations | 23.1 | Systematic Assessment |
|
| Decreased appetite | Metabolism and nutrition disorders | 23.1 | Systematic Assessment |
|
| Pruritus | Skin and subcutaneous tissue disorders | 23.1 | Systematic Assessment |
|
| Rash | Skin and subcutaneous tissue disorders | 23.1 | Systematic Assessment |
|
Not provided
Not provided
Not provided
| D013899 |
| Thoracic Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| Title | Measurements |
|---|---|
|
| Progressive Disease |
|
| Not Evaluable |
|