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 @ 4:02 PM
Ignite Modification Date:
2025-12-25 @ 2:04 PM
NCT ID:
NCT05663866
Description:
Safety analysis set included all participants who received at least 1 administration of amivantamab and lazertinib. The study was to evaluate reduction in infusion-related reactions (IRRs) associated with amivantamab when given after prophylactic treatment with dexamethasone, montelukast, and methotrexate. Hence, safety data was collected and analyzed only for amivantamab/ amivantamab + lazertinib and is reported below.
Frequency Threshold:
5
Time Frame:
From Cycle 1 Day 1 up to 10 months (each cycle of 28 days)
Study:
NCT05663866
Study Brief:
Premedication to Reduce Amivantamab Associated Infusion Related Reactions
Event Groups(If Any):
Event Groups
| Title | Description | Deaths # Affected | Deaths # At Risk | Serious # Affected | Serious # At Risk | Other # Affected | Other # At Risk | View |
|---|---|---|---|---|---|---|---|---|
| Cohort B: Montelukast 10 mg | Participants were administered with oral montelukast 10 mg tablet as a prophylactic treatment once daily in the morning on Days - 4, -3, -2, -1, and Cycle 1 Day 1 prior to combination therapy of lazertinib 240 mg oral tablets and IV infusion of amivantamab 1050 mg (for participants \<80 kg) or 1400 mg (for participants \>=80 kg) on Cycle 1 Day 1 until disease progression or withdrawal from study. Each cycle was of 28 days. | 2 | None | 5 | 15 | 15 | 15 | View |
| Cohort C: Methotrexate 25 mg | Participants were administered with a single dose of methotrexate 25 mg subcutaneous injection as a prophylactic treatment on any day between Days -7 and Day -3 (Cycle 1) prior to combination therapy of lazertinib 240 mg oral tablets and IV infusion of amivantamab 1050 mg (for participants \<80 kg) or 1400 mg (for participants \>=80 kg) on Cycle 1 Day 1 until disease progression or withdrawal from study. Each cycle was of 28 days. | 0 | None | 2 | 6 | 6 | 6 | View |
| Cohort A2: Dexamethasone 8 mg | Participants were administered with oral dexamethasone 8 mg tablet as a prophylactic treatment twice a day (16 mg total daily dose) on Day -2 and -1 (Cycle 1) and 8 mg approximately one hour prior to IV infusion of amivantamab 1050 mg (for participants \<80 kg) or 1400 mg (for participants \>=80 kg) on Cycle 1 Day 1 until disease progression or withdrawal from study. Each cycle was of 28 days. | 4 | None | 20 | 41 | 41 | 41 | View |
| Cohort A1: Dexamethasone 4 Milligrams (mg) | Participants were administered with oral dexamethasone 4 mg tablet as a prophylactic treatment twice a day (8 mg total daily dose) on Day -1 (Cycle 1) prior to combination therapy of lazertinib 240 mg oral tablets and IV infusion of amivantamab 1050 mg (for participants less than \[\<\] 80 kilograms \[kg\]) or 1400 mg (for participants greater than or equal to \[\>=\] 80 kg) on Cycle 1 Day 1 until disease progression or withdrawal from study. Each cycle was of 28 days. | 0 | None | 2 | 6 | 6 | 6 | View |
Serious Events(If Any):
Serious Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Pneumonia | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA Version 26.1 | View |
| Cellulitis | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA Version 26.1 | View |
| Empyema | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA Version 26.1 | View |
| Pneumonia Aspiration | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA Version 26.1 | View |
| Pneumonia Bacterial | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA Version 26.1 | View |
| Respiratory Tract Infection | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA Version 26.1 | View |
| Skin Infection | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA Version 26.1 | View |
| Subcutaneous Abscess | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA Version 26.1 | View |
| Pleural Effusion | NON_SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA Version 26.1 | View |
| Dyspnoea | NON_SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA Version 26.1 | View |
| Haemoptysis | NON_SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA Version 26.1 | View |
| Pneumonitis | NON_SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA Version 26.1 | View |
| Pneumothorax | NON_SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA Version 26.1 | View |
| Pulmonary Embolism | NON_SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA Version 26.1 | View |
| Respiratory Distress | NON_SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA Version 26.1 | View |
| Respiratory Failure | NON_SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA Version 26.1 | View |
| Intestinal Obstruction | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA Version 26.1 | View |
| Abdominal Distension | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA Version 26.1 | View |
| Diarrhoea | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA Version 26.1 | View |
| Pyrexia | NON_SYSTEMATIC_ASSESSMENT | General disorders | MedDRA Version 26.1 | View |
| Fatigue | NON_SYSTEMATIC_ASSESSMENT | General disorders | MedDRA Version 26.1 | View |
| Spinal Cord Compression | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA Version 26.1 | View |
| Cerebral Infarction | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA Version 26.1 | View |
| Decreased Appetite | NON_SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA Version 26.1 | View |
| Hypokalaemia | NON_SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA Version 26.1 | View |
| Malnutrition | NON_SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA Version 26.1 | View |
| Arthralgia | NON_SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA Version 26.1 | View |
| Back Pain | NON_SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA Version 26.1 | View |
| Osteoporotic Fracture | NON_SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA Version 26.1 | View |
| Atrial Fibrillation | NON_SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA Version 26.1 | View |
| Femur Fracture | NON_SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA Version 26.1 | View |
| Abnormal Behaviour | NON_SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MedDRA Version 26.1 | View |
| Hypotension | NON_SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDRA Version 26.1 | View |
Other Events(If Any):
Other Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Myalgia | NON_SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA Version 26.1 | View |
| Back Pain | NON_SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA Version 26.1 | View |
| Arthralgia | NON_SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA Version 26.1 | View |
| Bone Pain | NON_SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA Version 26.1 | View |
| Muscular Weakness | NON_SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA Version 26.1 | View |
| Neck Pain | NON_SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA Version 26.1 | View |
| Osteoporosis | NON_SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA Version 26.1 | View |
| Hypotension | NON_SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDRA Version 26.1 | View |
| Flushing | NON_SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDRA Version 26.1 | View |
| Deep Vein Thrombosis | NON_SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDRA Version 26.1 | View |
| Hypertension | NON_SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDRA Version 26.1 | View |
| Orthostatic Hypotension | NON_SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDRA Version 26.1 | View |
| Venous Thrombosis | NON_SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDRA Version 26.1 | View |
| Alanine Aminotransferase Increased | NON_SYSTEMATIC_ASSESSMENT | Investigations | MedDRA Version 26.1 | View |
| Aspartate Aminotransferase Increased | NON_SYSTEMATIC_ASSESSMENT | Investigations | MedDRA Version 26.1 | View |
| Blood Creatine Phosphokinase Increased | NON_SYSTEMATIC_ASSESSMENT | Investigations | MedDRA Version 26.1 | View |
| Blood Alkaline Phosphatase Increased | NON_SYSTEMATIC_ASSESSMENT | Investigations | MedDRA Version 26.1 | View |
| Blood Creatinine Increased | NON_SYSTEMATIC_ASSESSMENT | Investigations | MedDRA Version 26.1 | View |
| Blood Creatine Increased | NON_SYSTEMATIC_ASSESSMENT | Investigations | MedDRA Version 26.1 | View |
| Anaemia | NON_SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | MedDRA Version 26.1 | View |
| Thrombocytopenia | NON_SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | MedDRA Version 26.1 | View |
| Dry Eye | NON_SYSTEMATIC_ASSESSMENT | Eye disorders | MedDRA Version 26.1 | View |
| Trichiasis | NON_SYSTEMATIC_ASSESSMENT | Eye disorders | MedDRA Version 26.1 | View |
| Eye Pain | NON_SYSTEMATIC_ASSESSMENT | Eye disorders | MedDRA Version 26.1 | View |
| Fall | NON_SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA Version 26.1 | View |
| Limb Injury | NON_SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA Version 26.1 | View |
| Hypertransaminasaemia | NON_SYSTEMATIC_ASSESSMENT | Hepatobiliary disorders | MedDRA Version 26.1 | View |
| Sinus Tachycardia | NON_SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA Version 26.1 | View |
| Ear Inflammation | NON_SYSTEMATIC_ASSESSMENT | Ear and labyrinth disorders | MedDRA Version 26.1 | View |
| Renal Failure | NON_SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | MedDRA Version 26.1 | View |
| Genital Rash | NON_SYSTEMATIC_ASSESSMENT | Reproductive system and breast disorders | MedDRA Version 26.1 | View |
| Acne | NON_SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA Version 26.1 | View |
| Urticaria | NON_SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA Version 26.1 | View |
| Eczema | NON_SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA Version 26.1 | View |
| Rash Pruritic | NON_SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA Version 26.1 | View |
| Seborrhoeic Dermatitis | NON_SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA Version 26.1 | View |
| Xeroderma | NON_SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA Version 26.1 | View |
| Hyperhidrosis | NON_SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA Version 26.1 | View |
| Palmar-Plantar Erythrodysaesthesia Syndrome | NON_SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA Version 26.1 | View |
| Rash Erythematous | NON_SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA Version 26.1 | View |
| Nausea | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA Version 26.1 | View |
| Stomatitis | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA Version 26.1 | View |
| Constipation | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA Version 26.1 | View |
| Diarrhoea | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA Version 26.1 | View |
| Vomiting | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA Version 26.1 | View |
| Gingival Bleeding | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA Version 26.1 | View |
| Mouth Ulceration | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA Version 26.1 | View |
| Gastrooesophageal Reflux Disease | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA Version 26.1 | View |
| Gastric Ulcer | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA Version 26.1 | View |
| Haemorrhoidal Haemorrhage | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA Version 26.1 | View |
| Haemorrhoids | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA Version 26.1 | View |
| Mouth Haemorrhage | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA Version 26.1 | View |
| Proctalgia | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA Version 26.1 | View |
| Paronychia | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA Version 26.1 | View |
| Covid-19 | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA Version 26.1 | View |
| Folliculitis | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA Version 26.1 | View |
| Conjunctivitis | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA Version 26.1 | View |
| Pneumonia | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA Version 26.1 | View |
| Nasopharyngitis | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA Version 26.1 | View |
| Sinusitis | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA Version 26.1 | View |
| Upper Respiratory Tract Infection | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA Version 26.1 | View |
| Eye Infection | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA Version 26.1 | View |
| Oedema Peripheral | NON_SYSTEMATIC_ASSESSMENT | General disorders | MedDRA Version 26.1 | View |
| Asthenia | NON_SYSTEMATIC_ASSESSMENT | General disorders | MedDRA Version 26.1 | View |
| Chills | NON_SYSTEMATIC_ASSESSMENT | General disorders | MedDRA Version 26.1 | View |
| Chest Discomfort | NON_SYSTEMATIC_ASSESSMENT | General disorders | MedDRA Version 26.1 | View |
| Fatigue | NON_SYSTEMATIC_ASSESSMENT | General disorders | MedDRA Version 26.1 | View |
| Pyrexia | NON_SYSTEMATIC_ASSESSMENT | General disorders | MedDRA Version 26.1 | View |
| Malaise | NON_SYSTEMATIC_ASSESSMENT | General disorders | MedDRA Version 26.1 | View |
| Infusion Site Extravasation | NON_SYSTEMATIC_ASSESSMENT | General disorders | MedDRA Version 26.1 | View |
| Feeling Hot | NON_SYSTEMATIC_ASSESSMENT | General disorders | MedDRA Version 26.1 | View |
| Lithiasis | NON_SYSTEMATIC_ASSESSMENT | General disorders | MedDRA Version 26.1 | View |
| Localised Oedema | NON_SYSTEMATIC_ASSESSMENT | General disorders | MedDRA Version 26.1 | View |
| Non-Cardiac Chest Pain | NON_SYSTEMATIC_ASSESSMENT | General disorders | MedDRA Version 26.1 | View |
| Temperature Regulation Disorder | NON_SYSTEMATIC_ASSESSMENT | General disorders | MedDRA Version 26.1 | View |
| Epistaxis | NON_SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA Version 26.1 | View |
| Dyspnoea | NON_SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA Version 26.1 | View |
| Cough | NON_SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA Version 26.1 | View |
| Productive Cough | NON_SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA Version 26.1 | View |
| Pulmonary Embolism | NON_SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA Version 26.1 | View |
| Rhinorrhoea | NON_SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA Version 26.1 | View |
| Hypoxia | NON_SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA Version 26.1 | View |
| Oropharyngeal Pain | NON_SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA Version 26.1 | View |
| Dysphonia | NON_SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA Version 26.1 | View |
| Dyspnoea Exertional | NON_SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA Version 26.1 | View |
| Laryngeal Haemorrhage | NON_SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA Version 26.1 | View |
| Pulmonary Fibrosis | NON_SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA Version 26.1 | View |
| Sinus Congestion | NON_SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA Version 26.1 | View |
| Throat Irritation | NON_SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA Version 26.1 | View |
| Hypoalbuminaemia | NON_SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA Version 26.1 | View |
| Decreased Appetite | NON_SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA Version 26.1 | View |
| Hypocalcaemia | NON_SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA Version 26.1 | View |
| Hypercalcaemia | NON_SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA Version 26.1 | View |
| Hypoaesthesia | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA Version 26.1 | View |
| Headache | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA Version 26.1 | View |
| Dizziness | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA Version 26.1 | View |
| Paraesthesia | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA Version 26.1 | View |
| Peripheral Sensory Neuropathy | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA Version 26.1 | View |
| Petit Mal Epilepsy | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA Version 26.1 | View |
| Tremor | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA Version 26.1 | View |
| Pain in Extremity | NON_SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA Version 26.1 | View |
| Muscle Spasms | NON_SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA Version 26.1 | View |
| Rash | NON_SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA Version 26.1 | View |
| Pruritus | NON_SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA Version 26.1 | View |
| Dermatitis Acneiform | NON_SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA Version 26.1 | View |
| Dry Skin | NON_SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA Version 26.1 | View |
| Alopecia | NON_SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA Version 26.1 | View |
| Onycholysis | NON_SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA Version 26.1 | View |
| Skin Fissures | NON_SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA Version 26.1 | View |
| Skin Necrosis | NON_SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA Version 26.1 | View |
| Abdominal Distension | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA Version 26.1 | View |
| Abdominal Pain Upper | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA Version 26.1 | View |
| Dyspepsia | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA Version 26.1 | View |
| Dysphagia | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA Version 26.1 | View |
| Gingivitis | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA Version 26.1 | View |
| Influenza | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA Version 26.1 | View |
| Rash Pustular | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA Version 26.1 | View |
| Respiratory Tract Infection | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA Version 26.1 | View |