Adverse Events Module
For researchers submitting trial data to ClinicalTrials.gov, the Adverse Events module is one of four mandatory results sections. It requires reporting in three primary categories: All-Cause Mortality: A table tracking all deaths that occurred during the study, regardless of cause. Serious Adverse Events (SAEs): A tabular summary of events resulting in death, life-threatening conditions, hospitalization, or significant disability. Other Adverse Events: A table for non-serious events that exceed a specific frequency threshold, such as 5% within any study arm.
Adverse Events Module path is as follows:
Study -> Results Section -> Adverse Events Module -> Event Groups
Study -> Results Section -> Adverse Events Module -> Serious Events
Study -> Results Section -> Adverse Events Module -> Other Events
Adverse Events Module
Ignite Creation Date:
2025-12-24 @ 12:18 PM
Ignite Modification Date:
2025-12-25 @ 12:02 PM
NCT ID:
NCT04418661
Description:
Analysis was performed on safety population.
Frequency Threshold:
5
Time Frame:
Adverse events data was collected from first dose of IMP up to 30 days after the last dose, approximately 27 weeks (Part 1), approximately 111 weeks (Part 2), approximately 7 weeks (Part 3A), and approximately 50 weeks (Part 4). All-cause mortality (death) was collected from first dose of IMP up to end of follow-up, approximately 58 weeks (Part 1), 126 weeks (Part 2), 16 weeks (Part 3A), and 61 weeks (Part 4).
Study:
NCT04418661
Study Brief:
Safety and Efficacy Study of Vociprotafib (SAR442720) in Combination With Other Agents in Advanced Malignancies
Event Groups(If Any):
Event Groups
| Title | Description | Deaths # Affected | Deaths # At Risk | Serious # Affected | Serious # At Risk | Other # Affected | Other # At Risk | View |
|---|---|---|---|---|---|---|---|---|
| Part 1- SAR442720 140mg BIW + Pembrolizumab | Participants were administered SAR442720 140 mg orally BIW on Days 1 and 4 along with pembrolizumab 200 mg via IV infusion Q3W in 21-day cycles until disease progression, unacceptable AEs, or the participant's or investigator's decision to stop the treatment. | 1 | None | 0 | 4 | 4 | 4 | View |
| Part 1- SAR442720 200mg BIW + Pembrolizumab | Participants were administered SAR442720 200 mg orally BIW on Days 1 and 2 along with pembrolizumab 200 mg via IV infusion Q3W in 21-day cycles until disease progression, unacceptable AEs, or the participant's or investigator's decision to stop the treatment. | 6 | None | 7 | 13 | 13 | 13 | View |
| Part 2- SAR442720 200mg + Pembrolizumab - Cohort A1 (PDL1 TPS >=50%) | Participants with PD-L1 TPS\>=50% NSCLC were administered SAR442720 200 mg orally BIW on Days 1 and 2 in 21-day cycles along with an IV infusion of pembrolizumab 200 mg on Q3W (21 days cycle) or 400 mg Q6W (42 days cycle) until disease progression, unacceptable AEs, consent withdrawal, or the participant's or investigator's decision to stop the treatment. | 5 | None | 9 | 13 | 12 | 13 | View |
| Part 2- SAR442720 200mg + Pembrolizumab - Cohort A2 (PDL1 TPS 1% - 49%) | Participants with PDL1 TPS 1% - 49% NSCLC were administered SAR442720 200 mg orally BIW on Days 1 and 2 in 21-day cycles along with an IV infusion of pembrolizumab 200 mg on Q3W (21 days cycle) or 400 mg Q6W (42 days cycle) until disease progression, unacceptable AEs, consent withdrawal, or the participant's or investigator's decision to stop the treatment. | 11 | None | 11 | 19 | 16 | 19 | View |
| Part 3A- SAR442720 100mg BIW + Adagrasib | Participants were administered SAR442720 100 mg orally BIW on Days 1 and 2 along with adagrasib 400 mg BID in 21-day cycles until disease progression, unacceptable AEs, consent withdrawal, or the participant's or investigator's decision to stop the treatment. | 0 | None | 0 | 1 | 1 | 1 | View |
| Part 4- SAR442720 200mg + Pembrolizumab | Participants were administered SAR442720 200 mg orally BIW on Days 1 and 2 in 21-day cycles (as tablet during the first cycle and as capsule from Cycle 2) along with an IV infusion of pembrolizumab 200 mg Q3W (21-day cycle)or 400 mg Q6W (42-day cycle) until disease progression, unacceptable AEs, consent withdrawal, or the participant's or investigator's decision to stop the treatment. | 7 | None | 7 | 15 | 14 | 15 | View |
Serious Events(If Any):
Serious Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Thrombocytopenia | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | MedDra 26.1 | View |
| Angina Pectoris | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDra 26.1 | View |
| Cardiac Failure Congestive | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDra 26.1 | View |
| Cardio-Respiratory Arrest | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDra 26.1 | View |
| Myocardial Infarction | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDra 26.1 | View |
| Pericardial Effusion | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDra 26.1 | View |
| Tachycardia | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDra 26.1 | View |
| Visual Impairment | SYSTEMATIC_ASSESSMENT | Eye disorders | MedDra 26.1 | View |
| Abdominal Pain | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDra 26.1 | View |
| Ascites | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDra 26.1 | View |
| Diarrhoea | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDra 26.1 | View |
| Gastric Haemorrhage | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDra 26.1 | View |
| Small Intestinal Obstruction | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDra 26.1 | View |
| Disease Progression | SYSTEMATIC_ASSESSMENT | General disorders | MedDra 26.1 | View |
| Fatigue | SYSTEMATIC_ASSESSMENT | General disorders | MedDra 26.1 | View |
| Non-Cardiac Chest Pain | SYSTEMATIC_ASSESSMENT | General disorders | MedDra 26.1 | View |
| Pyrexia | SYSTEMATIC_ASSESSMENT | General disorders | MedDra 26.1 | View |
| Sudden Death | SYSTEMATIC_ASSESSMENT | General disorders | MedDra 26.1 | View |
| Bile Duct Stone | SYSTEMATIC_ASSESSMENT | Hepatobiliary disorders | MedDra 26.1 | View |
| Bronchitis | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDra 26.1 | View |
| Cytomegalovirus Colitis | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDra 26.1 | View |
| Pneumonia | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDra 26.1 | View |
| Pseudomembranous Colitis | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDra 26.1 | View |
| Alanine Aminotransferase Increased | SYSTEMATIC_ASSESSMENT | Investigations | MedDra 26.1 | View |
| Aspartate Aminotransferase Increased | SYSTEMATIC_ASSESSMENT | Investigations | MedDra 26.1 | View |
| Malignant Neoplasm Progression | SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDra 26.1 | View |
| Neoplasm Malignant | SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDra 26.1 | View |
| Central Nervous System Lesion | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDra 26.1 | View |
| Cerebral Ischaemia | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDra 26.1 | View |
| Seizure | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDra 26.1 | View |
| Transverse Sinus Thrombosis | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDra 26.1 | View |
| Dyspnoea | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDra 26.1 | View |
| Dyspnoea At Rest | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDra 26.1 | View |
| Interstitial Lung Disease | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDra 26.1 | View |
| Pleural Effusion | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDra 26.1 | View |
| Pneumonitis | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDra 26.1 | View |
| Pulmonary Embolism | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDra 26.1 | View |
| Respiratory Failure | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDra 26.1 | View |
| Angiopathy | SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDra 26.1 | View |
| Deep Vein Thrombosis | SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDra 26.1 | View |
| Hypertension | SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDra 26.1 | View |
| Hyperbilirubinaemia | SYSTEMATIC_ASSESSMENT | Hepatobiliary disorders | MedDra 26.1 | View |
| Pulmonary Tumour Thrombotic Microangiopathy | SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDra 26.1 | View |
Other Events(If Any):
Other Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Anaemia | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | MedDra 26.1 | View |
| Disseminated Intravascular Coagulation | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | MedDra 26.1 | View |
| Eosinophilia | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | MedDra 26.1 | View |
| Haemolytic Anaemia | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | MedDra 26.1 | View |
| Lymphadenopathy | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | MedDra 26.1 | View |
| Neutropenia | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | MedDra 26.1 | View |
| Thrombocytopenia | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | MedDra 26.1 | View |
| Atrial Fibrillation | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDra 26.1 | View |
| Cardiac Ventricular Thrombosis | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDra 26.1 | View |
| Sinus Tachycardia | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDra 26.1 | View |
| Vertigo | SYSTEMATIC_ASSESSMENT | Ear and labyrinth disorders | MedDra 26.1 | View |
| Hypothyroidism | SYSTEMATIC_ASSESSMENT | Endocrine disorders | MedDra 26.1 | View |
| Dry Eye | SYSTEMATIC_ASSESSMENT | Eye disorders | MedDra 26.1 | View |
| Eyelid Irritation | SYSTEMATIC_ASSESSMENT | Eye disorders | MedDra 26.1 | View |
| Lacrimation Increased | SYSTEMATIC_ASSESSMENT | Eye disorders | MedDra 26.1 | View |
| Photophobia | SYSTEMATIC_ASSESSMENT | Eye disorders | MedDra 26.1 | View |
| Vision Blurred | SYSTEMATIC_ASSESSMENT | Eye disorders | MedDra 26.1 | View |
| Visual Acuity Reduced | SYSTEMATIC_ASSESSMENT | Eye disorders | MedDra 26.1 | View |
| Abdominal Distension | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDra 26.1 | View |
| Abdominal Pain | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDra 26.1 | View |
| Abdominal Pain Lower | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDra 26.1 | View |
| Abdominal Pain Upper | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDra 26.1 | View |
| Ascites | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDra 26.1 | View |
| Constipation | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDra 26.1 | View |
| Diarrhoea | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDra 26.1 | View |
| Dyschezia | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDra 26.1 | View |
| Dyspepsia | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDra 26.1 | View |
| Dysphagia | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDra 26.1 | View |
| Flatulence | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDra 26.1 | View |
| Gastritis | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDra 26.1 | View |
| Gastrooesophageal Reflux Disease | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDra 26.1 | View |
| Glossodynia | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDra 26.1 | View |
| Nausea | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDra 26.1 | View |
| Odynophagia | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDra 26.1 | View |
| Oesophagitis | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDra 26.1 | View |
| Stomatitis | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDra 26.1 | View |
| Vomiting | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDra 26.1 | View |
| Asthenia | SYSTEMATIC_ASSESSMENT | General disorders | MedDra 26.1 | View |
| Chest Pain | SYSTEMATIC_ASSESSMENT | General disorders | MedDra 26.1 | View |
| Chills | SYSTEMATIC_ASSESSMENT | General disorders | MedDra 26.1 | View |
| Face Oedema | SYSTEMATIC_ASSESSMENT | General disorders | MedDra 26.1 | View |
| Fatigue | SYSTEMATIC_ASSESSMENT | General disorders | MedDra 26.1 | View |
| Feeling Cold | SYSTEMATIC_ASSESSMENT | General disorders | MedDra 26.1 | View |
| Generalised Oedema | SYSTEMATIC_ASSESSMENT | General disorders | MedDra 26.1 | View |
| Influenza Like Illness | SYSTEMATIC_ASSESSMENT | General disorders | MedDra 26.1 | View |
| Mucosal Inflammation | SYSTEMATIC_ASSESSMENT | General disorders | MedDra 26.1 | View |
| Multiple Organ Dysfunction Syndrome | SYSTEMATIC_ASSESSMENT | General disorders | MedDra 26.1 | View |
| Oedema | SYSTEMATIC_ASSESSMENT | General disorders | MedDra 26.1 | View |
| Oedema Peripheral | SYSTEMATIC_ASSESSMENT | General disorders | MedDra 26.1 | View |
| Pain | SYSTEMATIC_ASSESSMENT | General disorders | MedDra 26.1 | View |
| Peripheral Swelling | SYSTEMATIC_ASSESSMENT | General disorders | MedDra 26.1 | View |
| Pyrexia | SYSTEMATIC_ASSESSMENT | General disorders | MedDra 26.1 | View |
| Swelling | SYSTEMATIC_ASSESSMENT | General disorders | MedDra 26.1 | View |
| Temperature Intolerance | SYSTEMATIC_ASSESSMENT | General disorders | MedDra 26.1 | View |
| Hypertransaminasaemia | SYSTEMATIC_ASSESSMENT | Hepatobiliary disorders | MedDra 26.1 | View |
| Bacteraemia | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDra 26.1 | View |
| Bronchitis | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDra 26.1 | View |
| Covid-19 | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDra 26.1 | View |
| Cellulitis | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDra 26.1 | View |
| Herpes Zoster | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDra 26.1 | View |
| Oral Candidiasis | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDra 26.1 | View |
| Oral Herpes | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDra 26.1 | View |
| Pneumonia | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDra 26.1 | View |
| Sinusitis | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDra 26.1 | View |
| Skin Infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDra 26.1 | View |
| Tracheobronchitis | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDra 26.1 | View |
| Urinary Tract Infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDra 26.1 | View |
| Accidental Overdose | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDra 26.1 | View |
| Fall | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDra 26.1 | View |
| Head Injury | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDra 26.1 | View |
| Pelvic Fracture | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDra 26.1 | View |
| Activated Partial Thromboplastin Time Prolonged | SYSTEMATIC_ASSESSMENT | Investigations | MedDra 26.1 | View |
| Alanine Aminotransferase Increased | SYSTEMATIC_ASSESSMENT | Investigations | MedDra 26.1 | View |
| Aspartate Aminotransferase Increased | SYSTEMATIC_ASSESSMENT | Investigations | MedDra 26.1 | View |
| Blood Alkaline Phosphatase Increased | SYSTEMATIC_ASSESSMENT | Investigations | MedDra 26.1 | View |
| Blood Creatine Phosphokinase Increased | SYSTEMATIC_ASSESSMENT | Investigations | MedDra 26.1 | View |
| Blood Creatinine Increased | SYSTEMATIC_ASSESSMENT | Investigations | MedDra 26.1 | View |
| Blood Fibrinogen Decreased | SYSTEMATIC_ASSESSMENT | Investigations | MedDra 26.1 | View |
| Blood Potassium Decreased | SYSTEMATIC_ASSESSMENT | Investigations | MedDra 26.1 | View |
| Blood Sodium Decreased | SYSTEMATIC_ASSESSMENT | Investigations | MedDra 26.1 | View |
| Ejection Fraction Decreased | SYSTEMATIC_ASSESSMENT | Investigations | MedDra 26.1 | View |
| Gamma-Glutamyltransferase Increased | SYSTEMATIC_ASSESSMENT | Investigations | MedDra 26.1 | View |
| International Normalised Ratio | SYSTEMATIC_ASSESSMENT | Investigations | MedDra 26.1 | View |
| International Normalised Ratio Increased | SYSTEMATIC_ASSESSMENT | Investigations | MedDra 26.1 | View |
| Lipase Increased | SYSTEMATIC_ASSESSMENT | Investigations | MedDra 26.1 | View |
| Neutrophil Count Decreased | SYSTEMATIC_ASSESSMENT | Investigations | MedDra 26.1 | View |
| Platelet Count Decreased | SYSTEMATIC_ASSESSMENT | Investigations | MedDra 26.1 | View |
| Transaminases Increased | SYSTEMATIC_ASSESSMENT | Investigations | MedDra 26.1 | View |
| Troponin Increased | SYSTEMATIC_ASSESSMENT | Investigations | MedDra 26.1 | View |
| Weight Decreased | SYSTEMATIC_ASSESSMENT | Investigations | MedDra 26.1 | View |
| Weight Increased | SYSTEMATIC_ASSESSMENT | Investigations | MedDra 26.1 | View |
| Decreased Appetite | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDra 26.1 | View |
| Dehydration | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDra 26.1 | View |
| Hyperkalaemia | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDra 26.1 | View |
| Hypoalbuminaemia | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDra 26.1 | View |
| Hypocalcaemia | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDra 26.1 | View |
| Hypokalaemia | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDra 26.1 | View |
| Hyponatraemia | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDra 26.1 | View |
| Arthralgia | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDra 26.1 | View |
| Arthritis | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDra 26.1 | View |
| Back Pain | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDra 26.1 | View |
| Joint Swelling | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDra 26.1 | View |
| Muscular Weakness | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDra 26.1 | View |
| Musculoskeletal Chest Pain | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDra 26.1 | View |
| Musculoskeletal Stiffness | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDra 26.1 | View |
| Myalgia | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDra 26.1 | View |
| Basal Cell Carcinoma | SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDra 26.1 | View |
| Dizziness | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDra 26.1 | View |
| Dysgeusia | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDra 26.1 | View |
| Headache | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDra 26.1 | View |
| Neuropathy Peripheral | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDra 26.1 | View |
| Paraesthesia | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDra 26.1 | View |
| Syncope | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDra 26.1 | View |
| Transient Ischaemic Attack | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDra 26.1 | View |
| Tremor | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDra 26.1 | View |
| Affective Disorder | SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MedDra 26.1 | View |
| Anxiety | SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MedDra 26.1 | View |
| Confusional State | SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MedDra 26.1 | View |
| Insomnia | SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MedDra 26.1 | View |
| Haematuria | SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | MedDra 26.1 | View |
| Breast Pain | SYSTEMATIC_ASSESSMENT | Reproductive system and breast disorders | MedDra 26.1 | View |
| Prostatic Obstruction | SYSTEMATIC_ASSESSMENT | Reproductive system and breast disorders | MedDra 26.1 | View |
| Atelectasis | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDra 26.1 | View |
| Chronic Obstructive Pulmonary Disease | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDra 26.1 | View |
| Chylothorax | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDra 26.1 | View |
| Cough | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDra 26.1 | View |
| Dyspnoea | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDra 26.1 | View |
| Dyspnoea Exertional | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDra 26.1 | View |
| Epistaxis | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDra 26.1 | View |
| Haemoptysis | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDra 26.1 | View |
| Hypoxia | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDra 26.1 | View |
| Oropharyngeal Pain | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDra 26.1 | View |
| Pharyngeal Haemorrhage | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDra 26.1 | View |
| Pleural Effusion | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDra 26.1 | View |
| Pneumothorax | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDra 26.1 | View |
| Productive Cough | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDra 26.1 | View |
| Pulmonary Hypertension | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDra 26.1 | View |
| Respiratory Failure | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDra 26.1 | View |
| Alopecia | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDra 26.1 | View |
| Dermatitis | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDra 26.1 | View |
| Dermatitis Acneiform | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDra 26.1 | View |
| Erythema | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDra 26.1 | View |
| Pruritus | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDra 26.1 | View |
| Rash | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDra 26.1 | View |
| Rash Erythematous | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDra 26.1 | View |
| Rash Papular | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDra 26.1 | View |
| Skin Exfoliation | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDra 26.1 | View |
| Urticaria | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDra 26.1 | View |
| Angiopathy | SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDra 26.1 | View |
| Deep Vein Thrombosis | SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDra 26.1 | View |
| Hot Flush | SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDra 26.1 | View |
| Hypertension | SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDra 26.1 | View |
| Lymphoedema | SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDra 26.1 | View |