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This is a randomized, double-blind, multicenter, phase III clinical study to compare the clinical efficacy and safety of HLX10+ Chemotherapy vs placebo+Chemotherapy in Previously Untreated Patients with Extensive Stage Small Cell Lung Cancer.
Eligible subjects in this study will be randomized to Arm A or Arm B at 2:1 ratio as follows:
Arm A (HLX10 arm): HLX10 + chemotherapy (Carboplatin-Etoposide) ; Arm B (placebo arm): Placebo + chemotherapy (Carboplatin-Etoposide); The three stratification factors for randomization include: PD-L1 expression level (negative, positive, not available), Brain metastasis (yes versus no), Age (≥ 65 years versus < 65 years)
After screening, subjects meeting the inclusion criteria and none of the exclusion criteria will be enrolled. Included subjects will be treated with HLX10 or placebo in combination with chemotherapy once every 3 weeks, until disease progression, death, intolerable toxicity, withdrawal of informed consent, or occurrence of other reasons specified in the protocol (whichever occurs first).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| A | Experimental | HLX 10+chemotherapy (Carboplatin-Etoposide) |
|
| B | Placebo Comparator | Placebo+chemotherapy (Carboplatin-Etoposide) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| HLX10 | Drug | HLX10 is an innovative monoclonal antibody targeting PD-1,developed by Shanghai Henlius Biotech, Inc. |
|
| Measure | Description | Time Frame |
|---|---|---|
| OS | Overall survival (OS) | The period from randomization through death regardless of causality (up to approximately 56 months) |
| Measure | Description | Time Frame |
|---|---|---|
| Progression Free Survival (PFS) Assessed by IRRC According to RECIST 1.1 | PFS is defined as a period from randomization initiation to the first documentation of PD or death regardless of causality (whichever occurs first). | From randomization initiation to the first documentation of PD or death regardless of causality, whichever occurs first (up to approximately 56 months). |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Institute for Personalized Medicine | Tbilisi | Georgia | ||||
| Wojew. Wielospecjalistyczne Centrum Onkologii i Traumatologi |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 42240984 | Derived | Liu J, Han L, Wu L, Chen J, Sun H, Wen G, Ji Y, Shi J, Pan Z, Shi J, Wang X, Bai Y, Pan Y, Min X, Viguro M, Li X, Zhao Y, Yang J, Makharadze T, Arkania E, Yu H, Li J, Yang X, Wang Q, Zhu J; ASTRUM-005 Study Group. First-Line Serplulimab in Extensive-Stage Small Cell Lung Cancer: Secondary Analysis of the ASTRUM-005 Phase 3 Randomized Clinical Trial. JAMA Oncol. 2026 Jun 4:e261645. doi: 10.1001/jamaoncol.2026.1645. Online ahead of print. | |
| 40932107 |
| Label | URL |
|---|---|
| Effect of First-Line Serplulimab vs Placebo Added to Chemotherapy on Survival in Patients With Extensive-Stage Small Cell Lung Cancer | View source |
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| ID | Title | Description |
|---|---|---|
| FG000 | Group A | HLX 10+chemotherapy (Carboplatin-Etoposide) HLX10: HLX10 is an innovative monoclonal antibody targeting PD-1,developed by Shanghai Henlius Biotech, Inc. carboplatin and etoposide: chemotherapeutics |
| FG001 | Group B | Placebo+chemotherapy (Carboplatin-Etoposide) carboplatin and etoposide: chemotherapeutics placebo: placebo |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Group A | HLX 10+chemotherapy (Carboplatin-Etoposide) HLX10: HLX10 is an innovative monoclonal antibody targeting PD-1,developed by Shanghai Henlius Biotech, Inc. carboplatin and etoposide: chemotherapeutics |
| BG001 | Group B |
| 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 | OS | Overall survival (OS) | Analyses of the primary efficacy endpoint is based on the ITT. The ITT Population comprises all participants to whom study intervention has been randomized. | Posted | Median | 95% Confidence Interval | month | The period from randomization through death regardless of causality (up to approximately 56 months) |
|
From ICF until 90 days after the last study treatment (up to approximately 56 months).
All AEs and treatment emergent AEs are recorded from the time of signing the ICF until 90 days after the last study treatment. If a subject starts a new antineoplastic therapy during the AE collection period, only information on AEs related to study treatment are collected after the new antineoplastic therapy.
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 | Group A | HLX 10+chemotherapy (Carboplatin-Etoposide) HLX10: HLX10 is an innovative monoclonal antibody targeting PD-1,developed by Shanghai Henlius Biotech, Inc. carboplatin and etoposide: chemotherapeutics |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| platelet count decreased | Blood and lymphatic system disorders | Non-systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | Non-systematic Assessment |
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Fan Zhang | ShanghaiHenliusBiotech | 021-33395800*6334 | Fan_Zhang2@henlius.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 | Nov 30, 2021 | Feb 26, 2025 | Prot_SAP_000.pdf |
| ID | Term |
|---|---|
| D055752 | Small Cell Lung Carcinoma |
| ID | Term |
|---|---|
| D002283 | Carcinoma, Bronchogenic |
| D001984 | Bronchial Neoplasms |
| D008175 | Lung Neoplasms |
| D012142 | Respiratory Tract Neoplasms |
Not provided
Not provided
| ID | Term |
|---|---|
| D016190 | Carboplatin |
| D005047 | Etoposide |
| ID | Term |
|---|---|
| D056831 | Coordination Complexes |
| D009930 | Organic Chemicals |
| D011034 | Podophyllotoxin |
| D013764 | Tetrahydronaphthalenes |
Not provided
Not provided
Not provided
Not provided
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| carboplatin and etoposide | Drug | chemotherapeutics |
|
| placebo | Drug | placebo |
|
| Objective Response Rate | The ORR is defined as the proportion of subjects with a best overall response of CR or PR, according to RECIST 1.1. The best overall response will be defined as the best response across all time points in the order of CR, PR, SD, PD, and not NE. | From baseline until PR or CR, whichever occurs first (up to approximately 56 months) |
| Duration of Response | DOR is defined as a period from the first documentation of response (CR or PR) through the first documentation of PD or death (whichever occurs first). | From the first documentation of response (CR or PR) through the first documentation of PD or death, whichever occurs first (up to approximately 56 months). |
| Lodz |
| Poland |
| Arkhangelsk Clinical Oncology Dispensary | Arkhangelsk | Russia |
| Medipol Mega Hospital | Istanbul | Turkey (Türkiye) |
| Komunalnyi zaklad Miska bahato | Dnipropetrovsk | Ukraine |
| Derived |
| Wang K, Shen Y, Hu C, Xu F, Wang Q, Gao Y, Zhou L. Population Pharmacokinetics and Exposure-Response Analysis of Serplulimab in Small Cell Lung Cancer Patients. Clin Transl Sci. 2025 Sep;18(9):e70322. doi: 10.1111/cts.70322. |
| 36685541 | Derived | Zhu Y, Liu K, Qin Q, Zhu H. Serplulimab plus chemotherapy as first-line treatment for extensive-stage small-cell lung cancer: A cost-effectiveness analysis. Front Immunol. 2023 Jan 4;13:1044678. doi: 10.3389/fimmu.2022.1044678. eCollection 2022. |
| 36166026 | Derived | Cheng Y, Han L, Wu L, Chen J, Sun H, Wen G, Ji Y, Dvorkin M, Shi J, Pan Z, Shi J, Wang X, Bai Y, Melkadze T, Pan Y, Min X, Viguro M, Li X, Zhao Y, Yang J, Makharadze T, Arkania E, Kang W, Wang Q, Zhu J; ASTRUM-005 Study Group. Effect of First-Line Serplulimab vs Placebo Added to Chemotherapy on Survival in Patients With Extensive-Stage Small Cell Lung Cancer: The ASTRUM-005 Randomized Clinical Trial. JAMA. 2022 Sep 27;328(12):1223-1232. doi: 10.1001/jama.2022.16464. |
| Withdrawal by Subject |
|
Placebo+chemotherapy (Carboplatin-Etoposide)
carboplatin and etoposide: chemotherapeutics
placebo: placebo
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants | No |
|
| Race/Ethnicity, Customized | Count of Participants | Participants | No |
|
| Smoking history | Count of Participants | Participants | No |
|
| Units | Counts |
|---|---|
| Participants |
|
|
|
| Secondary | Progression Free Survival (PFS) Assessed by IRRC According to RECIST 1.1 | PFS is defined as a period from randomization initiation to the first documentation of PD or death regardless of causality (whichever occurs first). | Analysis of PFS is based on ITT. | Posted | Median | 95% Confidence Interval | month | From randomization initiation to the first documentation of PD or death regardless of causality, whichever occurs first (up to approximately 56 months). |
|
|
|
|
| Secondary | Objective Response Rate | The ORR is defined as the proportion of subjects with a best overall response of CR or PR, according to RECIST 1.1. The best overall response will be defined as the best response across all time points in the order of CR, PR, SD, PD, and not NE. | ORR is analyzed based on ITT. | Posted | Count of Participants | Participants | From baseline until PR or CR, whichever occurs first (up to approximately 56 months) |
|
|
|
| Secondary | Duration of Response | DOR is defined as a period from the first documentation of response (CR or PR) through the first documentation of PD or death (whichever occurs first). | DOR is analyzed based on ITT. | Posted | Median | 95% Confidence Interval | month | From the first documentation of response (CR or PR) through the first documentation of PD or death, whichever occurs first (up to approximately 56 months). |
|
|
|
| 224 |
| 389 |
| 146 |
| 389 |
| 367 |
| 389 |
| EG001 | Group B | Placebo+chemotherapy (Carboplatin-Etoposide) carboplatin and etoposide: chemotherapeutics placebo: placebo | 140 | 196 | 71 | 196 | 187 | 196 |
| Neutrophil count decreased | Investigations | Non-systematic Assessment |
|
| Neutrophil count decreased | Investigations | Non-systematic Assessment |
|
| Alanine aminotransferase increased | Investigations | Non-systematic Assessment |
|
| Aspartate aminotransferase increased | Investigations | Non-systematic Assessment |
|
| Blood ketone body increased | Investigations | Non-systematic Assessment |
|
| Fibrin D dimer increased | Investigations | Non-systematic Assessment |
|
| Gamma-glutamyltransferase increased | Investigations | Non-systematic Assessment |
|
| Red blood cell count decreased | Investigations | Non-systematic Assessment |
|
| Disease progression | General disorders | Non-systematic Assessment |
|
| Death | Gastrointestinal disorders | Non-systematic Assessment |
|
| Pyrexia | General disorders | Non-systematic Assessment |
|
| Sudden death | General disorders | Non-systematic Assessment |
|
| Asthenia | General disorders | Non-systematic Assessment |
|
| Fatigue | General disorders | Non-systematic Assessment |
|
| Non-cardiac chest pain | General disorders | Non-systematic Assessment |
|
| Multiple organ dysfunction syndrome | General disorders | Non-systematic Assessment |
|
| General physical health deterioration | General disorders | Non-systematic Assessment |
|
| Pneumonia | Infections and infestations | Non-systematic Assessment |
|
| COVID-19 | Infections and infestations | Non-systematic Assessment |
|
| Septic shock | Infections and infestations | Non-systematic Assessment |
|
| COVID-19 pneumonia | Infections and infestations | Non-systematic Assessment |
|
| Device related infection | Infections and infestations | Non-systematic Assessment |
|
| Gastroenteritis | Infections and infestations | Non-systematic Assessment |
|
| Infection | Infections and infestations | Non-systematic Assessment |
|
| Lip infection | Infections and infestations | Non-systematic Assessment |
|
| Lung abscess | Infections and infestations | Non-systematic Assessment |
|
| Meningoencephalitis herpetic | Infections and infestations | Non-systematic Assessment |
|
| Pneumonia bacterial | Infections and infestations | Non-systematic Assessment |
|
| Sepsis | Infections and infestations | Non-systematic Assessment |
|
| Intracranial infection | Infections and infestations | Non-systematic Assessment |
|
| Pneumonia aspiration | Infections and infestations | Non-systematic Assessment |
|
| Urinary tract infection | Infections and infestations | Non-systematic Assessment |
|
| Viral infection | Infections and infestations | Non-systematic Assessment |
|
| Neutropenia | Blood and lymphatic system disorders | Non-systematic Assessment |
|
| Thrombocytopenia | Blood and lymphatic system disorders | Non-systematic Assessment |
|
| Leukopenia | Blood and lymphatic system disorders | Non-systematic Assessment |
|
| Anaemia | Blood and lymphatic system disorders | Non-systematic Assessment |
|
| Febrile neutropenia | Blood and lymphatic system disorders | Non-systematic Assessment |
|
| Myelosuppression | Blood and lymphatic system disorders | Non-systematic Assessment |
|
| Agranulocytosis | Blood and lymphatic system disorders | Non-systematic Assessment |
|
| Hyponatraemia | Metabolism and nutrition disorders | Non-systematic Assessment |
|
| Hyperglycaemia | Metabolism and nutrition disorders | Non-systematic Assessment |
|
| Decreased appetite | Metabolism and nutrition disorders | Non-systematic Assessment |
|
| Diabetic ketoacidosis | Metabolism and nutrition disorders | Non-systematic Assessment |
|
| Diabetes mellitus | Metabolism and nutrition disorders | Non-systematic Assessment |
|
| Hypoalbuminaemia | Metabolism and nutrition disorders | Non-systematic Assessment |
|
| Hypoglycaemia | Metabolism and nutrition disorders | Non-systematic Assessment |
|
| Hypokalaemia | Metabolism and nutrition disorders | Non-systematic Assessment |
|
| Immune-mediated lung disease | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
|
| Pleural effusion | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
|
| Chronic obstructive pulmonary disease | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
|
| Pneumothorax | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
|
| Haemoptysis | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
|
| Pulmonary embolism | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
|
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
|
| Respiratory failure | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
|
| Cough | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
|
| Vomiting | Gastrointestinal disorders | Non-systematic Assessment |
|
| Intestinal obstruction | Gastrointestinal disorders | Non-systematic Assessment |
|
| Anal fissure | Gastrointestinal disorders | Non-systematic Assessment |
|
| Diarrhoea | Gastrointestinal disorders | Non-systematic Assessment |
|
| Gastric haemorrhage | Gastrointestinal disorders | Non-systematic Assessment |
|
| Gastrointestinal disorder | Gastrointestinal disorders | Non-systematic Assessment |
|
| Gastrointestinal haemorrhage | Gastrointestinal disorders | Non-systematic Assessment |
|
| Immune-mediated pancreatitis | Gastrointestinal disorders | Non-systematic Assessment |
|
| Impaired gastric emptying | Gastrointestinal disorders | Non-systematic Assessment |
|
| Nausea | Gastrointestinal disorders | Non-systematic Assessment |
|
| Upper gastrointestinal haemorrhage | Gastrointestinal disorders | Non-systematic Assessment |
|
| Immune-mediated encephalitis | Nervous system disorders | Non-systematic Assessment |
|
| Cerebral infarction | Nervous system disorders | Non-systematic Assessment |
|
| Aphasia | Nervous system disorders | Non-systematic Assessment |
|
| Cognitive disorder | Nervous system disorders | Non-systematic Assessment |
|
| Diabetic hyperosmolar coma | Nervous system disorders | Non-systematic Assessment |
|
| Hypoxic-ischaemic encephalopathy | Nervous system disorders | Non-systematic Assessment |
|
| Lacunar infarction | Nervous system disorders | Non-systematic Assessment |
|
| Neuropathy peripheral | Nervous system disorders | Non-systematic Assessment |
|
| Neurotoxicity | Nervous system disorders | Non-systematic Assessment |
|
| Peripheral sensorimotor neuropathy | Nervous system disorders | Non-systematic Assessment |
|
| Headache | Nervous system disorders | Non-systematic Assessment |
|
| Acute coronary syndrome | Cardiac disorders | Non-systematic Assessment |
|
| Angina pectoris | Cardiac disorders | Non-systematic Assessment |
|
| Acute myocardial infarction | Cardiac disorders | Non-systematic Assessment |
|
| Atrial fibrillation | Cardiac disorders | Non-systematic Assessment |
|
| Cardiac failure acute | Cardiac disorders | Non-systematic Assessment |
|
| Cardiopulmonary failure | Cardiac disorders | Non-systematic Assessment |
|
| Cardiac arrest | Cardiac disorders | Non-systematic Assessment |
|
| Cardiac tamponade | Cardiac disorders | Non-systematic Assessment |
|
| Coronary artery disease | Cardiac disorders | Non-systematic Assessment |
|
| Myocardial infarction | Cardiac disorders | Non-systematic Assessment |
|
| Supraventricular extrasystoles | Cardiac disorders | Non-systematic Assessment |
|
| Drug-induced liver injury | Hepatobiliary disorders | Non-systematic Assessment |
|
| Hepatic function abnormal | Hepatobiliary disorders | Non-systematic Assessment |
|
| Immune-mediated hepatitis | Hepatobiliary disorders | Non-systematic Assessment |
|
| Cholecystitis | Hepatobiliary disorders | Non-systematic Assessment |
|
| Hepatic failure | Hepatobiliary disorders | Non-systematic Assessment |
|
| Hepatic lesion | Hepatobiliary disorders | Non-systematic Assessment |
|
| Jaundice | Hepatobiliary disorders | Non-systematic Assessment |
|
| Embolism | Vascular disorders | Non-systematic Assessment |
|
| Hypotension | Vascular disorders | Non-systematic Assessment |
|
| Venous thrombosis limb | Vascular disorders | Non-systematic Assessment |
|
| Aortic arteriosclerosis | Vascular disorders | Non-systematic Assessment |
|
| Aortic dissection rupture | Vascular disorders | Non-systematic Assessment |
|
| Deep vein thrombosis | Vascular disorders | Non-systematic Assessment |
|
| Embolism arterial | Vascular disorders | Non-systematic Assessment |
|
| Hypovolaemic shock | Vascular disorders | Non-systematic Assessment |
|
| Superior vena cava syndrome | Vascular disorders | Non-systematic Assessment |
|
| Foot fracture | Injury, poisoning and procedural complications | Non-systematic Assessment |
|
| Humerus fracture | Injury, poisoning and procedural complications | Non-systematic Assessment |
|
| Joint dislocation | Injury, poisoning and procedural complications | Non-systematic Assessment |
|
| Postoperative thrombosis | Injury, poisoning and procedural complications | Non-systematic Assessment |
|
| Upper limb fracture | Injury, poisoning and procedural complications | Non-systematic Assessment |
|
| Sternal fracture | Injury, poisoning and procedural complications | Non-systematic Assessment |
|
| Acute kidney injury | Renal and urinary disorders | Non-systematic Assessment |
|
| Ureterolithiasis | Renal and urinary disorders | Non-systematic Assessment |
|
| Renal impairment | Renal and urinary disorders | Non-systematic Assessment |
|
| Metastatic neoplasm | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | Non-systematic Assessment |
|
| Ovarian adenoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | Non-systematic Assessment |
|
| Papillary thyroid cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | Non-systematic Assessment |
|
| Anaphylactic reaction | Immune system disorders | Non-systematic Assessment |
|
| Drug hypersensitivity | Immune system disorders | Non-systematic Assessment |
|
| Hypothyroidism | Endocrine disorders | Non-systematic Assessment |
|
| Vision blurred | Eye disorders | Non-systematic Assessment |
|
| Panic disorder | Psychiatric disorders | Non-systematic Assessment |
|
| Ovarian cyst | Reproductive system and breast disorders | Non-systematic Assessment |
|
| Rash | Skin and subcutaneous tissue disorders | Non-systematic Assessment |
|
| Neutropenia | Blood and lymphatic system disorders | Non-systematic Assessment |
|
| Leukopenia | Blood and lymphatic system disorders | Non-systematic Assessment |
|
| Thrombocytopenia | Blood and lymphatic system disorders | Non-systematic Assessment |
|
| Neutrophil count decreased | Investigations | Non-systematic Assessment |
|
| White blood cell count decreased | Investigations | Non-systematic Assessment |
|
| Platelet count decreased | Investigations | Non-systematic Assessment |
|
| Alanine aminotransferase increased | Investigations | Non-systematic Assessment |
|
| Lymphocyte count decreased | Investigations | Non-systematic Assessment |
|
| Aspartate aminotransferase increased | Investigations | Non-systematic Assessment |
|
| Blood alkaline phosphatase increased | Investigations | Non-systematic Assessment |
|
| Blood lactate dehydrogenase increased | Investigations | Non-systematic Assessment |
|
| Weight decreased | Investigations | Non-systematic Assessment |
|
| Weight increased | Investigations | Non-systematic Assessment |
|
| Gamma-glutamyltransferase increased | Investigations | Non-systematic Assessment |
|
| Blood cholesterol increased | Investigations | Non-systematic Assessment |
|
| Blood bilirubin increased | Investigations | Non-systematic Assessment |
|
| Blood creatinine increased | Investigations | Non-systematic Assessment |
|
| Decreased appetite | Metabolism and nutrition disorders | Non-systematic Assessment |
|
| Hyponatraemia | Metabolism and nutrition disorders | Non-systematic Assessment |
|
| Hypoalbuminaemia | Metabolism and nutrition disorders | Non-systematic Assessment |
|
| Hypertriglyceridaemia | Metabolism and nutrition disorders | Non-systematic Assessment |
|
| Hypokalaemia | Metabolism and nutrition disorders | Non-systematic Assessment |
|
| Hyperglycaemia | Metabolism and nutrition disorders | Non-systematic Assessment |
|
| Hypercholesterolaemia | Metabolism and nutrition disorders | Non-systematic Assessment |
|
| Hyperuricaemia | Metabolism and nutrition disorders | Non-systematic Assessment |
|
| Hypocalcaemia | Metabolism and nutrition disorders | Non-systematic Assessment |
|
| Hypomagnesaemia | Metabolism and nutrition disorders | Non-systematic Assessment |
|
| Hypochloraemia | Metabolism and nutrition disorders | Non-systematic Assessment |
|
| Hypoproteinaemia | Metabolism and nutrition disorders | Non-systematic Assessment |
|
| Hyperlipidaemia | Metabolism and nutrition disorders | Non-systematic Assessment |
|
| Hypophosphataemia | Metabolism and nutrition disorders | Non-systematic Assessment |
|
| Nausea | Gastrointestinal disorders | Non-systematic Assessment |
|
| Constipation | Gastrointestinal disorders | Non-systematic Assessment |
|
| Vomiting | Gastrointestinal disorders | Non-systematic Assessment |
|
| Diarrhoea | Gastrointestinal disorders | Non-systematic Assessment |
|
| Alopecia | Skin and subcutaneous tissue disorders | Non-systematic Assessment |
|
| Rash | Skin and subcutaneous tissue disorders | Non-systematic Assessment |
|
| Pyrexia | General disorders | Non-systematic Assessment |
|
| Asthenia | General disorders | Non-systematic Assessment |
|
| Fatigue | General disorders | Non-systematic Assessment |
|
| Non-cardiac chest pain | General disorders | Non-systematic Assessment |
|
| Malaise | General disorders | Non-systematic Assessment |
|
| Chest discomfort | General disorders | Non-systematic Assessment |
|
| Cough | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
|
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
|
| Haemoptysis | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
|
| Productive cough | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
|
| Back pain | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
|
| Arthralgia | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
|
| Pain in extremity | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
|
| Hypothyroidism | Endocrine disorders | Non-systematic Assessment |
|
| Hyperthyroidism | Endocrine disorders | Non-systematic Assessment |
|
| Urinary tract infection | Infections and infestations | Non-systematic Assessment |
|
| Pneumonia | Infections and infestations | Non-systematic Assessment |
|
| Dizziness | Nervous system disorders | Non-systematic Assessment |
|
| Headache | Nervous system disorders | Non-systematic Assessment |
|
| Insomnia | Psychiatric disorders | Non-systematic Assessment |
|
| Proteinuria | Renal and urinary disorders | Non-systematic Assessment |
|
| Sinus tachycardia | Cardiac disorders | Non-systematic Assessment |
|
| Hypertension | Vascular disorders | Non-systematic Assessment |
|
| Hepatic function abnormal | Hepatobiliary disorders | Non-systematic Assessment |
|
Not provided
Not provided
| D013899 |
| Thoracic Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D009281 |
| Naphthalenes |
| D011084 | Polycyclic Aromatic Hydrocarbons |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D011083 | Polycyclic Compounds |
| D005960 | Glucosides |
| D006027 | Glycosides |
| D002241 | Carbohydrates |