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: 2025-12-24 @ 6:48 PM
Ignite Modification Date: 2025-12-25 @ 4:20 PM
NCT ID: NCT00587457
Description: None
Frequency Threshold: 1
Time Frame: From start of study drug administration until 30 days after the last dose of study drug
Study: NCT00587457
Study Brief: A Phase I, Multicenter, Dose Escalation Study of CAT-8015 in Participants With Chronic 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
CAT-8015 10 Microgram Per Kilogram (mcg/kg) Participants received a single intravenous infusion of 10 mcg/kg moxetumomab pasudotox (CAT-8015) on Days 1, 3, and 5 of every 28-day cycle and continued cycles of therapy until progressive disease (PD) or until otherwise they become ineligible. None None 2 3 3 3 View
CAT-8015 20 Microgram Per Kilogram (mcg/kg) Participants received a single intravenous infusion of 20 mcg/kg moxetumomab pasudotox (CAT-8015) on Days 1, 3, and 5 of every 28-day cycle and continued cycles of therapy until progressive disease (PD) or until otherwise they become ineligible. None None 3 5 5 5 View
CAT-8015 5 Microgram Per Kilogram (mcg/kg) Participants received a single intravenous infusion of 5 mcg/kg moxetumomab pasudotox (CAT-8015) on Days 1, 3, and 5 of every 28-day cycle and continued cycles of therapy until progressive disease (PD) or until otherwise they become ineligible. None None 1 3 3 3 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Febrile neutropenia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA 13.1 View
Optic ischaemic neuropathy SYSTEMATIC_ASSESSMENT Eye disorders MedDRA 13.1 View
Acute pulmonary histoplasmosis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 13.1 View
Infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 13.1 View
Neutropenic infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 13.1 View
Pneumonia SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 13.1 View
Blood calcium increased SYSTEMATIC_ASSESSMENT Investigations MedDRA 13.1 View
Back pain SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 13.1 View
Obstructive airways disorder SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 13.1 View
Tumour lysis syndrome SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 13.1 View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Neutropenia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA 13.1 View
Sinus tachycardia SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 13.1 View
Hypothyroidism SYSTEMATIC_ASSESSMENT Endocrine disorders MedDRA 13.1 View
Vision blurred SYSTEMATIC_ASSESSMENT Eye disorders MedDRA 13.1 View
Abdominal distension SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 13.1 View
Abdominal pain SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 13.1 View
Gingival pain SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 13.1 View
Nausea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 13.1 View
Oral pain SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 13.1 View
Stomatitis SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 13.1 View
Vomiting SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 13.1 View
Chills SYSTEMATIC_ASSESSMENT General disorders MedDRA 13.1 View
Fatigue SYSTEMATIC_ASSESSMENT General disorders MedDRA 13.1 View
Localised oedema SYSTEMATIC_ASSESSMENT General disorders MedDRA 13.1 View
Oedema SYSTEMATIC_ASSESSMENT General disorders MedDRA 13.1 View
Oedema peripheral SYSTEMATIC_ASSESSMENT General disorders MedDRA 13.1 View
Pain SYSTEMATIC_ASSESSMENT General disorders MedDRA 13.1 View
Pyrexia SYSTEMATIC_ASSESSMENT General disorders MedDRA 13.1 View
Cystitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 13.1 View
Histoplasmosis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 13.1 View
Rhinitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 13.1 View
Contusion SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 13.1 View
Aspartate aminotransferase increased SYSTEMATIC_ASSESSMENT Investigations MedDRA 13.1 View
Blood albumin decreased SYSTEMATIC_ASSESSMENT Investigations MedDRA 13.1 View
Blood alkaline phosphatase increased SYSTEMATIC_ASSESSMENT Investigations MedDRA 13.1 View
Blood glucose decreased SYSTEMATIC_ASSESSMENT Investigations MedDRA 13.1 View
Blood glucose increased SYSTEMATIC_ASSESSMENT Investigations MedDRA 13.1 View
Blood magnesium decreased SYSTEMATIC_ASSESSMENT Investigations MedDRA 13.1 View
Blood magnesium increased SYSTEMATIC_ASSESSMENT Investigations MedDRA 13.1 View
Blood phosphorus decreased SYSTEMATIC_ASSESSMENT Investigations MedDRA 13.1 View
Blood potassium decreased SYSTEMATIC_ASSESSMENT Investigations MedDRA 13.1 View
Blood sodium decreased SYSTEMATIC_ASSESSMENT Investigations MedDRA 13.1 View
Blood sodium increased SYSTEMATIC_ASSESSMENT Investigations MedDRA 13.1 View
Blood triglycerides increased SYSTEMATIC_ASSESSMENT Investigations MedDRA 13.1 View
Blood uric acid increased SYSTEMATIC_ASSESSMENT Investigations MedDRA 13.1 View
Haemoglobin decreased SYSTEMATIC_ASSESSMENT Investigations MedDRA 13.1 View
Lymphocyte count decreased SYSTEMATIC_ASSESSMENT Investigations MedDRA 13.1 View
Neutrophil count decreased SYSTEMATIC_ASSESSMENT Investigations MedDRA 13.1 View
Platelet count decreased SYSTEMATIC_ASSESSMENT Investigations MedDRA 13.1 View
Protein urine present SYSTEMATIC_ASSESSMENT Investigations MedDRA 13.1 View
Urine output decreased SYSTEMATIC_ASSESSMENT Investigations MedDRA 13.1 View
White blood cell count decreased SYSTEMATIC_ASSESSMENT Investigations MedDRA 13.1 View
Hyperuricaemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 13.1 View
Arthralgia SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 13.1 View
Arthritis SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 13.1 View
Musculoskeletal chest pain SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 13.1 View
Musculoskeletal pain SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 13.1 View
Pain in extremity SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 13.1 View
Headache SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 13.1 View
Anxiety SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA 13.1 View
Confusional state SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA 13.1 View
Depression SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA 13.1 View
Haemorrhage urinary tract SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA 13.1 View
Urinary incontinence SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA 13.1 View
Urinary retention SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA 13.1 View
Bronchospasm SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 13.1 View
Cough SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 13.1 View
Dyspnoea SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 13.1 View
Angioedema SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 13.1 View
Hyperhidrosis SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 13.1 View
Petechiae SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 13.1 View
Rash SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 13.1 View
Capillary leak syndrome SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA 13.1 View
Diarrhoea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 13.1 View
Dysphagia SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 13.1 View
Decreased appetite SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 13.1 View
Lung infiltration SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 13.1 View
Oropharyngeal pain SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 13.1 View
Pleural effusion SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 13.1 View
Pulmonary congestion SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 13.1 View