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 @ 7:35 PM
Ignite Modification Date: 2025-12-25 @ 5:16 PM
NCT ID: NCT05513703
Description: All-cause mortality and adverse events: all participants who received at least 1 dose of study drug.
Frequency Threshold: 5
Time Frame: All-cause mortality and adverse event tables include events reported from the start of safety data collection (Day 1) to the end of the study. The median time on follow-up was 14.3 months.
Study: NCT05513703
Study Brief: A Study to Assess Disease Activity of Intravenously (IV) Infused Telisotuzumab Vedotin in Adult Participants With Advanced/Metastatic Non-Squamous Non-Small Cell Lung Cancer (NSCLC)
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Telisotuzumab Vedotin Participants received telisotuzumab vedotin by IV infusion every 2 weeks until they met study drug discontinuation criteria. 4 None 3 9 9 9 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
DIARRHOEA SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 27.1 View
INTESTINAL OBSTRUCTION SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 27.1 View
DISEASE PROGRESSION SYSTEMATIC_ASSESSMENT General disorders MedDRA 27.1 View
PNEUMONIA SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 27.1 View
DYSPNOEA SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 27.1 View
PNEUMONITIS SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 27.1 View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
ANAEMIA SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA 27.1 View
LEUKOCYTOSIS SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA 27.1 View
NEUTROPENIA SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA 27.1 View
HYPERTHYROIDISM SYSTEMATIC_ASSESSMENT Endocrine disorders MedDRA 27.1 View
KERATITIS SYSTEMATIC_ASSESSMENT Eye disorders MedDRA 27.1 View
ABDOMINAL PAIN SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 27.1 View
CONSTIPATION SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 27.1 View
NAUSEA SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 27.1 View
ASTHENIA SYSTEMATIC_ASSESSMENT General disorders MedDRA 27.1 View
DISEASE PROGRESSION SYSTEMATIC_ASSESSMENT General disorders MedDRA 27.1 View
FATIGUE SYSTEMATIC_ASSESSMENT General disorders MedDRA 27.1 View
MEDICAL DEVICE PAIN SYSTEMATIC_ASSESSMENT General disorders MedDRA 27.1 View
OEDEMA PERIPHERAL SYSTEMATIC_ASSESSMENT General disorders MedDRA 27.1 View
PYREXIA SYSTEMATIC_ASSESSMENT General disorders MedDRA 27.1 View
CHOLESTASIS SYSTEMATIC_ASSESSMENT Hepatobiliary disorders MedDRA 27.1 View
ORAL FUNGAL INFECTION SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 27.1 View
LIGAMENT SPRAIN SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 27.1 View
ALANINE AMINOTRANSFERASE INCREASED SYSTEMATIC_ASSESSMENT Investigations MedDRA 27.1 View
ASPARTATE AMINOTRANSFERASE INCREASED SYSTEMATIC_ASSESSMENT Investigations MedDRA 27.1 View
BLOOD ALKALINE PHOSPHATASE INCREASED SYSTEMATIC_ASSESSMENT Investigations MedDRA 27.1 View
BLOOD GLUCOSE INCREASED SYSTEMATIC_ASSESSMENT Investigations MedDRA 27.1 View
BLOOD TESTOSTERONE DECREASED SYSTEMATIC_ASSESSMENT Investigations MedDRA 27.1 View
C-REACTIVE PROTEIN INCREASED SYSTEMATIC_ASSESSMENT Investigations MedDRA 27.1 View
LYMPHOCYTE COUNT DECREASED SYSTEMATIC_ASSESSMENT Investigations MedDRA 27.1 View
NEUTROPHIL COUNT INCREASED SYSTEMATIC_ASSESSMENT Investigations MedDRA 27.1 View
WEIGHT DECREASED SYSTEMATIC_ASSESSMENT Investigations MedDRA 27.1 View
WHITE BLOOD CELL COUNT DECREASED SYSTEMATIC_ASSESSMENT Investigations MedDRA 27.1 View
DECREASED APPETITE SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 27.1 View
HYPOALBUMINAEMIA SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 27.1 View
HYPOKALAEMIA SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 27.1 View
NEUROPATHY PERIPHERAL SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 27.1 View
PERIPHERAL SENSORY NEUROPATHY SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 27.1 View
PRESYNCOPE SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 27.1 View
TASTE DISORDER SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 27.1 View
COUGH SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 27.1 View
DYSPNOEA SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 27.1 View
HAEMOPTYSIS SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 27.1 View
PNEUMONITIS SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 27.1 View
PULMONARY HAEMORRHAGE SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 27.1 View
PRURITUS SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 27.1 View
RASH SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 27.1 View