Adverse Events Module

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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: 2025-12-25 @ 3:26 AM
Ignite Modification Date: 2025-12-26 @ 2:06 AM
NCT ID: NCT03426605
Description: Adverse events are displayed by the dose group the participant was initially enrolled in, irrespective of intrasubject dose modifications.
Frequency Threshold: 0
Time Frame: Adverse Events were collected from the signing of informed consent through to 30 days after the final dose of study drug administration or when any ongoing drug-related AEs and/or serious adverse events (SAEs) have resolved or become stable (up to Week 48).
Study: NCT03426605
Study Brief: A Study of LAM-003 in Patients With Acute Myeloid Leukemia
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
LAM-003 750 mg QD 3 participants received 750 mg QD after intrasubject dose escalations. • Subject 006-006 received LAM-003 450 mg QD during Cycles 1, 600 mg LAM-003 in Cycle 2 and received LAM-003 750 mg QD during Cycles 3 and 4. Subject 005-011 received LAM-003 600 mg QD during Cycle 1 and received LAM-003 750 mg QD during Cycles 2 and 3. • Subject 006-007 received LAM-003 600 mg QD during Cycle 1 and received LAM-003 750 mg QD during Cycle 2. 2 None 2 3 3 3 View
LAM-003 600 mg QD 4 participants were accrued at 600 mg QD. 1 None 2 4 4 4 View
LAM-003 200 mg QD 6 participants were accrued at starting dose level of 200 mg QD. 2 None 3 6 6 6 View
LAM-003 300 mg QD 3 participants were accrued at 300 mg QD. 1 None 3 3 3 3 View
LAM-003 450 mg QD 4 participants were accrued at 450 mg QD. 2 None 3 4 4 4 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Disease Progression SYSTEMATIC_ASSESSMENT General disorders MedDRA 19.1 View
Pyrexia SYSTEMATIC_ASSESSMENT General disorders MedDRA ≥ 19.1 View
Febrile Neutropenia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA ≥ 19.1 View
Hemoglobin Decreased SYSTEMATIC_ASSESSMENT Investigations MedDRA ≥ 19.1 View
WBC Count Increased SYSTEMATIC_ASSESSMENT Investigations MedDRA ≥ 19.1 View
Cerebral Hemorrhage SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA ≥ 19.1 View
Hemorrhage Intracranial SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA ≥ 19.1 View
Diabetic ketoacidosis SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA ≥ 19.1 View
Pneumonia bacterial SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA ≥ 19.1 View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Oedma peripheral SYSTEMATIC_ASSESSMENT General disorders MedDRA ≥ 19.1 View
Pyrexia SYSTEMATIC_ASSESSMENT General disorders MedDRA ≥ 19.1 View
Fatigue SYSTEMATIC_ASSESSMENT General disorders MedDRA ≥ 19.1 View
Chills SYSTEMATIC_ASSESSMENT General disorders MedDRA ≥ 19.1 View
Disease progression SYSTEMATIC_ASSESSMENT General disorders MedDRA ≥ 19.1 View
Non-cardiac chest pain SYSTEMATIC_ASSESSMENT General disorders MedDRA ≥ 19.1 View
Pain SYSTEMATIC_ASSESSMENT General disorders MedDRA ≥ 19.1 View
Peripheral swelling SYSTEMATIC_ASSESSMENT General disorders MedDRA ≥ 19.1 View
Diarrhoea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA ≥ 19.1 View
Vomiting SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA ≥ 19.1 View
Nausea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA ≥ 19.1 View
Constipation SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA ≥ 19.1 View
Abdominal pain SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA ≥ 19.1 View
Dysphagia SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA ≥ 19.1 View
Gingival bleeding SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA ≥ 19.1 View
Gastrointestinal hemorrhage SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA ≥ 19.1 View
Gastrooesophageal reflux disease SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA ≥ 19.1 View
Rectal haemorrhage SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA ≥ 19.1 View
Retching SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA ≥ 19.1 View
Blood potassium decreased SYSTEMATIC_ASSESSMENT Investigations MedDRA ≥ 19.1 View
Platelet count decreased SYSTEMATIC_ASSESSMENT Investigations MedDRA ≥ 19.1 View
White blood cell count increased SYSTEMATIC_ASSESSMENT Investigations MedDRA ≥ 19.1 View
Alanine aminotransferase increased SYSTEMATIC_ASSESSMENT Investigations MedDRA ≥ 19.1 View
Aspartate aminotransferase increased SYSTEMATIC_ASSESSMENT Investigations MedDRA ≥ 19.1 View
Blood calcium decreased SYSTEMATIC_ASSESSMENT Investigations MedDRA ≥ 19.1 View
Blood glucose increased SYSTEMATIC_ASSESSMENT Investigations MedDRA ≥ 19.1 View
Hemoglobin decreased SYSTEMATIC_ASSESSMENT Investigations MedDRA ≥ 19.1 View
Neutrophil count decreased SYSTEMATIC_ASSESSMENT Investigations MedDRA ≥ 19.1 View
Weight decreased SYSTEMATIC_ASSESSMENT Investigations MedDRA ≥ 19.1 View
Blood bilirubin increased SYSTEMATIC_ASSESSMENT Investigations MedDRA ≥ 19.1 View
Blood magnesium decreased SYSTEMATIC_ASSESSMENT Investigations MedDRA ≥ 19.1 View
Blood phosphorus decreased SYSTEMATIC_ASSESSMENT Investigations MedDRA ≥ 19.1 View
Blood potassium increased SYSTEMATIC_ASSESSMENT Investigations MedDRA ≥ 19.1 View
Blood sodium decreased SYSTEMATIC_ASSESSMENT Investigations MedDRA ≥ 19.1 View
Ejection fraction decreased SYSTEMATIC_ASSESSMENT Investigations MedDRA ≥ 19.1 View
Tropoin T increased SYSTEMATIC_ASSESSMENT Investigations MedDRA ≥ 19.1 View
Weight increased SYSTEMATIC_ASSESSMENT Investigations MedDRA ≥ 19.1 View
Pain in extremity SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA ≥ 19.1 View
Arthralgia SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA ≥ 19.1 View
Back pain SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA ≥ 19.1 View
Muscle spasms SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA ≥ 19.1 View
Musculoskeletal chest pain SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA ≥ 19.1 View
Neck pain SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA ≥ 19.1 View
Muscular weakness SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA ≥ 19.1 View
Musculoskeletal pain SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA ≥ 19.1 View
Cough SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA ≥ 19.1 View
Epistaxis SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA ≥ 19.1 View
Dyspnoea SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA ≥ 19.1 View
Hypoxia SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA ≥ 19.1 View
Dyspnoea exertional SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA ≥ 19.1 View
Haemoptysis SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA ≥ 19.1 View
Productive cough SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA ≥ 19.1 View
Hiccups SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA ≥ 19.1 View
Nasal congestion SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA ≥ 19.1 View
Nasal ulcer SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA ≥ 19.1 View
Oropharyngeal pain SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA ≥ 19.1 View
Plural effusion SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA ≥ 19.1 View
Pneumonitis SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA ≥ 19.1 View
Pulmonary oedema SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA ≥ 19.1 View
Decreased appetitie SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA ≥ 19.1 View
Tumour lysis syndrome SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA ≥ 19.1 View
Hypovolaemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA ≥ 19.1 View
Erythema SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA ≥ 19.1 View
Petechiae SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA ≥ 19.1 View
Pruritus SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA ≥ 19.1 View
Dermatitis SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA ≥ 19.1 View
Dermatitis exfoliative SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA ≥ 19.1 View
Dry skin SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA ≥ 19.1 View
Palmar-plantar erythrodysaesthesia syndrome SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA ≥ 19.1 View
Rash SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA ≥ 19.1 View
Skin erosion SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA ≥ 19.1 View
Skin mass SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA ≥ 19.1 View
Swelling face SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA ≥ 19.1 View
Urticaria SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA ≥ 19.1 View
Headache SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA ≥ 19.1 View
Dizziness SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA ≥ 19.1 View
Neuropathy peripheral SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA ≥ 19.1 View
Syncope SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA ≥ 19.1 View
Hypoaesthesia SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA ≥ 19.1 View
Febrile neutropenia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA ≥ 19.1 View
Disseminated intravascular coagulation SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA ≥ 19.1 View
Hypotension SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA ≥ 19.1 View
Hypertension SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA ≥ 19.1 View
Haematoma SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA ≥ 19.1 View
Pallor SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA ≥ 19.1 View
Anal abcess SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA ≥ 19.1 View
Bacterial sepsis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA ≥ 19.1 View
Candida infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA ≥ 19.1 View
Clostridium difficile colitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA ≥ 19.1 View
Influenza SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA ≥ 19.1 View
Laryngitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA ≥ 19.1 View
Allergic transfusion reaction SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA ≥ 19.1 View
Contusion SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA ≥ 19.1 View
Face injury SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA ≥ 19.1 View
Hypobarism SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA ≥ 19.1 View
Procedural pain SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA ≥ 19.1 View
Tachycardia SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA ≥ 19.1 View
Sinus tachycardia SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA ≥ 19.1 View
Confusional state SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA ≥ 19.1 View
Insomnia SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA ≥ 19.1 View
Dry eye SYSTEMATIC_ASSESSMENT Eye disorders MedDRA ≥ 19.1 View
Eye irritation SYSTEMATIC_ASSESSMENT Eye disorders MedDRA ≥ 19.1 View
Eyelid pain SYSTEMATIC_ASSESSMENT Eye disorders MedDRA ≥ 19.1 View
Leukaemia cutis SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA ≥ 19.1 View
Cerumen impaction SYSTEMATIC_ASSESSMENT Ear and labyrinth disorders MedDRA ≥ 19.1 View
Haematuria SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA ≥ 19.1 View
Pollakiuria SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA ≥ 19.1 View
Scrotal irritation SYSTEMATIC_ASSESSMENT Reproductive system and breast disorders MedDRA ≥ 19.1 View
Stomatitis SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA ≥ 19.1 View