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 @ 2:02 PM
Ignite Modification Date:
2025-12-25 @ 12:46 PM
NCT ID:
NCT04988295
Description:
SAEs \& Other AEs:safety set-randomized participants who had at least 1 dose of study drug. All-cause mortality:FAS-all randomized participants, classified per assigned drug regardless of actual drug received. As per statistical analysis, Arm A AE planned to be collected and analyzed as single arm regardless of regimen LACP/ACP-L received. Since extension cohort is ongoing and its data collection and analysis was not planned for primary analysis, AE data will be reported after study completion.
Frequency Threshold:
5
Time Frame:
From Cycle 1 Day 1 up to 1 year 7 months
Study:
NCT04988295
Study Brief:
A Study of Amivantamab and Lazertinib in Combination With Platinum-Based Chemotherapy Compared With Platinum-Based Chemotherapy in Patients With Epidermal Growth Factor Receptor (EGFR)-Mutated Locally Advanced or Metastatic Non- Small Cell Lung Cancer After Osimertinib Failure
Event Groups(If Any):
Event Groups
| Title | Description | Deaths # Affected | Deaths # At Risk | Serious # Affected | Serious # At Risk | Other # Affected | Other # At Risk | View |
|---|---|---|---|---|---|---|---|---|
| Main Study: Arm A: Lazertinib + Amivantamab + Carboplatin + Pemetrexed (LACP/ACP-L) | LACP dosing (study start until 6 November 2022): Participants received Lazertinib 240 milligrams (mg) orally on Day 1 of each subsequent cycle, starting with Cycle 3, along with Amivantamab 1400 mg (1750 mg if body weight greater than or equal to \[\>=80\] kilograms \[kg\]) on Cycle 1 Days 1, 2, 8, and 15, and Cycle 2 Day 1 and 1750 mg (2100 mg if body weight \>=80 kg). Participant also received Pemetrexed 500 mg per square meter (mg/m\^2) on Day 1 21-day cycle, in combination with carboplatin 750 mg as IV infusion starting on Cycle 1 Day 1 for 4 cycles. From cycle 5 onwards, participants received Amivantamab, Pemetrexed and Lazertinib IV infusions at same dose, as maintenance until disease progression. ACP-L dosing (from 7 November 2022 until study completion): Participants received Amivantamab 1400 mg (1750 mg if body weight \>=80\] kg) on Cycle 1 Days 1,2, 8, and 15, and Cycle 2 Day 1 and 1750 mg (2100 mg if body weight \>=80 kg). Participant also received Pemetrexed 500 mg/m\^2 on Day 1 of each 21-day cycle, in combination with carboplatin 750 mg as IV infusion starting on Cycle 1 Day 1 for 4 cycles. Lazertinib 240 mg in ACP-L started on Cycle 5 Day 1 or sooner if carboplatin is discontinued before cycle 4. From cycle 5 onwards, participants received Amivantamab, Pemetrexed and Lazertinib IV infusions at same dose, as maintenance until disease progression. Each cycle consists of 21 days. | 69 | None | 137 | 263 | 261 | 263 | View |
| Main Study: Arm B: Carboplatin + Pemetrexed (CP) | Participants received Pemetrexed 500 mg/m\^2 IV infusion and carboplatin 750 mg IV infusion from Day 1 of Cycle 1 to 4. From cycle 5 onwards, participants received Pemetrexed 500 mg/m\^2 IV infusion, as maintenance until disease progression. Each cycle consists of 21 days. | 65 | None | 49 | 243 | 222 | 243 | View |
| Main Study: Arm C: Amivantamab + Carboplatin + Pemetrexed (ACP) | Participants received Amivantamab 1400 mg (1750 mg if body weight \>=80 kg) on Cycle 1 Days 1,2, 8, and 15, and Cycle 2 Day 1 and 1750 mg (2100 mg if body weight \>=80 kg) on Day 1 of each cycle, starting with Cycle 3. Participants also received Pemetrexed 500 mg/m\^2 on Day 1 of each 21-day cycle, in combination with carboplatin 750 mg as IV infusion starting on Cycle 1 Day 1 for 4 cycles. From cycle 5 onwards, participants received Amivantamab and Pemetrexed IV infusions at same dose, as maintenance until disease progression. Each cycle consists of 21 days. | 27 | None | 42 | 130 | 129 | 130 | View |
Serious Events(If Any):
Serious Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Sepsis | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA Version 25.0 | View |
| Covid-19 | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA Version 25.0 | View |
| Skin Infection | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA Version 25.0 | View |
| Gastroenteritis | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA Version 25.0 | View |
| Gastrointestinal Infection | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA Version 25.0 | View |
| Herpes Virus Infection | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA Version 25.0 | View |
| Infectious Pleural Effusion | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA Version 25.0 | View |
| Neutropenic Sepsis | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA Version 25.0 | View |
| Pneumonia Viral | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA Version 25.0 | View |
| Soft Tissue Infection | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA Version 25.0 | View |
| Bacteraemia | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA Version 25.0 | View |
| Bacterial Infection | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA Version 25.0 | View |
| Cellulitis | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA Version 25.0 | View |
| Conjunctivitis | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA Version 25.0 | View |
| Coronavirus Pneumonia | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA Version 25.0 | View |
| Covid-19 Pneumonia | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA Version 25.0 | View |
| Enterocolitis Infectious | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA Version 25.0 | View |
| Erysipelas | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA Version 25.0 | View |
| Folliculitis | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA Version 25.0 | View |
| Infection | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA Version 25.0 | View |
| Influenza | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA Version 25.0 | View |
| Meningitis | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA Version 25.0 | View |
| Paronychia | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA Version 25.0 | View |
| Pneumonia | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA Version 25.0 | View |
| Pneumonia Pneumococcal | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA Version 25.0 | View |
| Pyelonephritis | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA Version 25.0 | View |
| Respiratory Tract Infection | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA Version 25.0 | View |
| Septic Shock | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA Version 25.0 | View |
| Upper Respiratory Tract Infection | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA Version 25.0 | View |
| Urinary Tract Infection | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA Version 25.0 | View |
| Urosepsis | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA Version 25.0 | View |
| Dyspnoea | NON_SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA Version 25.0 | View |
| Pulmonary Embolism | NON_SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA Version 25.0 | View |
| Dyspnoea Exertional | NON_SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA Version 25.0 | View |
| Hydrothorax | NON_SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA Version 25.0 | View |
| Interstitial Lung Disease | NON_SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA Version 25.0 | View |
| Pleural Effusion | NON_SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA Version 25.0 | View |
| Pneumonitis | NON_SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA Version 25.0 | View |
| Pneumothorax | NON_SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA Version 25.0 | View |
| Respiratory Failure | NON_SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA Version 25.0 | View |
| Acute Respiratory Distress Syndrome | NON_SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA Version 25.0 | View |
| Acute Respiratory Failure | NON_SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA Version 25.0 | View |
| Epistaxis | NON_SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA Version 25.0 | View |
| Respiratory Acidosis | NON_SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA Version 25.0 | View |
| Thrombocytopenia | NON_SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | MedDRA Version 25.0 | View |
| Anaemia | NON_SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | MedDRA Version 25.0 | View |
| Febrile Neutropenia | NON_SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | MedDRA Version 25.0 | View |
| Myelosuppression | NON_SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | MedDRA Version 25.0 | View |
| Neutropenia | NON_SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | MedDRA Version 25.0 | View |
| Leukopenia | NON_SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | MedDRA Version 25.0 | View |
| Pancytopenia | NON_SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | MedDRA Version 25.0 | View |
| Colitis | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA Version 25.0 | View |
| Diarrhoea | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA Version 25.0 | View |
| Nausea | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA Version 25.0 | View |
| Stomatitis | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA Version 25.0 | View |
| Vomiting | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA Version 25.0 | View |
| Abdominal Pain | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA Version 25.0 | View |
| Ascites | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA Version 25.0 | View |
| Constipation | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA Version 25.0 | View |
| Dysphagia | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA Version 25.0 | View |
| Enteritis | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA Version 25.0 | View |
| Gastric Ulcer Haemorrhage | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA Version 25.0 | View |
| Gastrointestinal Haemorrhage | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA Version 25.0 | View |
| Gastrointestinal Ulcer | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA Version 25.0 | View |
| Haematemesis | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA Version 25.0 | View |
| Pancreatitis | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA Version 25.0 | View |
| Pyrexia | NON_SYSTEMATIC_ASSESSMENT | General disorders | MedDRA Version 25.0 | View |
| Fatigue | NON_SYSTEMATIC_ASSESSMENT | General disorders | MedDRA Version 25.0 | View |
| Oedema Peripheral | NON_SYSTEMATIC_ASSESSMENT | General disorders | MedDRA Version 25.0 | View |
| Asthenia | NON_SYSTEMATIC_ASSESSMENT | General disorders | MedDRA Version 25.0 | View |
| General Physical Health Deterioration | NON_SYSTEMATIC_ASSESSMENT | General disorders | MedDRA Version 25.0 | View |
| Localised Oedema | NON_SYSTEMATIC_ASSESSMENT | General disorders | MedDRA Version 25.0 | View |
| Malaise | NON_SYSTEMATIC_ASSESSMENT | General disorders | MedDRA Version 25.0 | View |
| Non-Cardiac Chest Pain | NON_SYSTEMATIC_ASSESSMENT | General disorders | MedDRA Version 25.0 | View |
| Pain | NON_SYSTEMATIC_ASSESSMENT | General disorders | MedDRA Version 25.0 | View |
| Sudden Death | NON_SYSTEMATIC_ASSESSMENT | General disorders | MedDRA Version 25.0 | View |
| Supraventricular Tachycardia | NON_SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA Version 25.0 | View |
| Ventricular Fibrillation | NON_SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA Version 25.0 | View |
| Acute Myocardial Infarction | NON_SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA Version 25.0 | View |
| Atrial Fibrillation | NON_SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA Version 25.0 | View |
| Cardiac Arrest | NON_SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA Version 25.0 | View |
| Cardiac Failure | NON_SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA Version 25.0 | View |
| Myocardial Infarction | NON_SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA Version 25.0 | View |
| Infusion Related Reaction | NON_SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA Version 25.0 | View |
| Ankle Fracture | NON_SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA Version 25.0 | View |
| Craniocerebral Injury | NON_SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA Version 25.0 | View |
| Fall | NON_SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA Version 25.0 | View |
| Femoral Neck Fracture | NON_SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA Version 25.0 | View |
| Femur Fracture | NON_SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA Version 25.0 | View |
| Fibula Fracture | NON_SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA Version 25.0 | View |
| Gastrointestinal Injury | NON_SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA Version 25.0 | View |
| Procedural Pain | NON_SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA Version 25.0 | View |
| Spinal Compression Fracture | NON_SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA Version 25.0 | View |
| Deep Vein Thrombosis | NON_SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDRA Version 25.0 | View |
| Embolism | NON_SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDRA Version 25.0 | View |
| Hypotension | NON_SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDRA Version 25.0 | View |
| Thrombophlebitis | NON_SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDRA Version 25.0 | View |
| Venous Thrombosis | NON_SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDRA Version 25.0 | View |
| Cholecystitis Acute | NON_SYSTEMATIC_ASSESSMENT | Hepatobiliary disorders | MedDRA Version 25.0 | View |
| Drug-Induced Liver Injury | NON_SYSTEMATIC_ASSESSMENT | Hepatobiliary disorders | MedDRA Version 25.0 | View |
| Hepatic Cytolysis | NON_SYSTEMATIC_ASSESSMENT | Hepatobiliary disorders | MedDRA Version 25.0 | View |
| Hepatic Function Abnormal | NON_SYSTEMATIC_ASSESSMENT | Hepatobiliary disorders | MedDRA Version 25.0 | View |
| Blood Creatinine Increased | NON_SYSTEMATIC_ASSESSMENT | Investigations | MedDRA Version 25.0 | View |
| Alanine Aminotransferase Increased | NON_SYSTEMATIC_ASSESSMENT | Investigations | MedDRA Version 25.0 | View |
| Aspartate Aminotransferase Increased | NON_SYSTEMATIC_ASSESSMENT | Investigations | MedDRA Version 25.0 | View |
| C-Reactive Protein Increased | NON_SYSTEMATIC_ASSESSMENT | Investigations | MedDRA Version 25.0 | View |
| Gamma-Glutamyltransferase Increased | NON_SYSTEMATIC_ASSESSMENT | Investigations | MedDRA Version 25.0 | View |
| General Physical Condition Abnormal | NON_SYSTEMATIC_ASSESSMENT | Investigations | MedDRA Version 25.0 | View |
| International Normalised Ratio Increased | NON_SYSTEMATIC_ASSESSMENT | Investigations | MedDRA Version 25.0 | View |
| Troponin I Increased | NON_SYSTEMATIC_ASSESSMENT | Investigations | MedDRA Version 25.0 | View |
| Hypokalaemia | NON_SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA Version 25.0 | View |
| Decreased Appetite | NON_SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA Version 25.0 | View |
| Dehydration | NON_SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA Version 25.0 | View |
| Diabetes Mellitus | NON_SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA Version 25.0 | View |
| Electrolyte Imbalance | NON_SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA Version 25.0 | View |
| Hypercalcaemia | NON_SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA Version 25.0 | View |
| Hypoalbuminaemia | NON_SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA Version 25.0 | View |
| Hyponatraemia | NON_SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA Version 25.0 | View |
| Back Pain | NON_SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA Version 25.0 | View |
| Myositis | NON_SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA Version 25.0 | View |
| Pain in Extremity | NON_SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA Version 25.0 | View |
| Cerebral Infarction | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA Version 25.0 | View |
| Optic Neuritis | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA Version 25.0 | View |
| Cerebrovascular Accident | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA Version 25.0 | View |
| Depressed Level of Consciousness | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA Version 25.0 | View |
| Dizziness | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA Version 25.0 | View |
| Dysarthria | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA Version 25.0 | View |
| Dyskinesia | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA Version 25.0 | View |
| Epilepsy | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA Version 25.0 | View |
| Headache | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA Version 25.0 | View |
| Hypersomnia | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA Version 25.0 | View |
| Seizure | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA Version 25.0 | View |
| Subarachnoid Haemorrhage | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA Version 25.0 | View |
| Subdural Hygroma | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA Version 25.0 | View |
| Syncope | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA Version 25.0 | View |
| Transient Ischaemic Attack | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA Version 25.0 | View |
| Renal Impairment | NON_SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | MedDRA Version 25.0 | View |
| Acute Kidney Injury | NON_SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | MedDRA Version 25.0 | View |
| Bladder Dilatation | NON_SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | MedDRA Version 25.0 | View |
| Rash | NON_SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA Version 25.0 | View |
| Aseptic Pustule | NON_SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA Version 25.0 | View |
| Dermatitis Acneiform | NON_SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA Version 25.0 | View |
| Panniculitis | NON_SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA Version 25.0 | View |
| Skin Toxicity | NON_SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA Version 25.0 | View |
| Confusional State | NON_SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MedDRA Version 25.0 | View |
| Delirium | NON_SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MedDRA Version 25.0 | View |
| Disorientation | NON_SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MedDRA Version 25.0 | View |
Other Events(If Any):
Other Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Lymphopenia | NON_SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | MedDRA Version 25.0 | View |
| Rash | NON_SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA Version 25.0 | View |
| Dermatitis Acneiform | NON_SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA Version 25.0 | View |
| Pruritus | NON_SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA Version 25.0 | View |
| Dry Skin | NON_SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA Version 25.0 | View |
| Alopecia | NON_SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA Version 25.0 | View |
| Rash Maculo-Papular | NON_SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA Version 25.0 | View |
| Skin Ulcer | NON_SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA Version 25.0 | View |
| Oedema Peripheral | NON_SYSTEMATIC_ASSESSMENT | General disorders | MedDRA Version 25.0 | View |
| Fatigue | NON_SYSTEMATIC_ASSESSMENT | General disorders | MedDRA Version 25.0 | View |
| Asthenia | NON_SYSTEMATIC_ASSESSMENT | General disorders | MedDRA Version 25.0 | View |
| Pyrexia | NON_SYSTEMATIC_ASSESSMENT | General disorders | MedDRA Version 25.0 | View |
| Malaise | NON_SYSTEMATIC_ASSESSMENT | General disorders | MedDRA Version 25.0 | View |
| Infusion Related Reaction | NON_SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA Version 25.0 | View |
| Decreased Appetite | NON_SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA Version 25.0 | View |
| Hypoalbuminaemia | NON_SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA Version 25.0 | View |
| Hypokalaemia | NON_SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA Version 25.0 | View |
| Hyperglycaemia | NON_SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA Version 25.0 | View |
| Hypocalcaemia | NON_SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA Version 25.0 | View |
| Hypomagnesaemia | NON_SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA Version 25.0 | View |
| Hyponatraemia | NON_SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA Version 25.0 | View |
| Paronychia | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA Version 25.0 | View |
| Covid-19 | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA Version 25.0 | View |
| Conjunctivitis | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA Version 25.0 | View |
| Folliculitis | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA Version 25.0 | View |
| Upper Respiratory Tract Infection | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA Version 25.0 | View |
| Urinary Tract Infection | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA Version 25.0 | View |
| Alanine Aminotransferase Increased | NON_SYSTEMATIC_ASSESSMENT | Investigations | MedDRA Version 25.0 | View |
| Aspartate Aminotransferase Increased | NON_SYSTEMATIC_ASSESSMENT | Investigations | MedDRA Version 25.0 | View |
| Weight Decreased | NON_SYSTEMATIC_ASSESSMENT | Investigations | MedDRA Version 25.0 | View |
| Blood Alkaline Phosphatase Increased | NON_SYSTEMATIC_ASSESSMENT | Investigations | MedDRA Version 25.0 | View |
| Gamma-Glutamyltransferase Increased | NON_SYSTEMATIC_ASSESSMENT | Investigations | MedDRA Version 25.0 | View |
| Blood Creatinine Increased | NON_SYSTEMATIC_ASSESSMENT | Investigations | MedDRA Version 25.0 | View |
| Cough | NON_SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA Version 25.0 | View |
| Dyspnoea | NON_SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA Version 25.0 | View |
| Epistaxis | NON_SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA Version 25.0 | View |
| Productive Cough | NON_SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA Version 25.0 | View |
| Pulmonary Embolism | NON_SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA Version 25.0 | View |
| Back Pain | NON_SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA Version 25.0 | View |
| Pain in Extremity | NON_SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA Version 25.0 | View |
| Arthralgia | NON_SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA Version 25.0 | View |
| Muscular Weakness | NON_SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA Version 25.0 | View |
| Headache | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA Version 25.0 | View |
| Dizziness | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA Version 25.0 | View |
| Peripheral Sensory Neuropathy | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA Version 25.0 | View |
| Dysgeusia | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA Version 25.0 | View |
| Paraesthesia | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA Version 25.0 | View |
| Deep Vein Thrombosis | NON_SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDRA Version 25.0 | View |
| Hypotension | NON_SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDRA Version 25.0 | View |
| Insomnia | NON_SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MedDRA Version 25.0 | View |
| Dry Eye | NON_SYSTEMATIC_ASSESSMENT | Eye disorders | MedDRA Version 25.0 | View |
| Hyperbilirubinaemia | NON_SYSTEMATIC_ASSESSMENT | Hepatobiliary disorders | MedDRA Version 25.0 | View |
| Nausea | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA Version 25.0 | View |
| Constipation | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA Version 25.0 | View |
| Stomatitis | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA Version 25.0 | View |
| Vomiting | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA Version 25.0 | View |
| Diarrhoea | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA Version 25.0 | View |
| Abdominal Pain | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA Version 25.0 | View |
| Dry Mouth | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA Version 25.0 | View |
| Haemorrhoids | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA Version 25.0 | View |
| Neutropenia | NON_SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | MedDRA Version 25.0 | View |
| Thrombocytopenia | NON_SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | MedDRA Version 25.0 | View |
| Anaemia | NON_SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | MedDRA Version 25.0 | View |
| Leukopenia | NON_SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | MedDRA Version 25.0 | View |