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 @ 6:41 PM
Ignite Modification Date: 2025-12-25 @ 4:12 PM
NCT ID: NCT01891357
Description: Safety population for analysis of toxicities, comprised of 61 patients who were allocated to intervention and received at least one dose of study treatment.
Frequency Threshold: 0
Time Frame: AE collection from signature of ICF until end of study per patient, up to 3 years.
Study: NCT01891357
Study Brief: Phase II Trial to Validate Markers for a Response Evaluation of a Combined Therapy in Patients With HER2+ Breast Cancer
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Paclitaxel + Lapatinib + Trastuzumab Paclitaxel 80 mg/m2 weekly for 12 weeks with lapatinib 750 mg P.O. daily and trastuzumab 2 mg/kg IV (loading dose 4 mg/kg) weekly for 12 weeks, biopsy before and after three weeks of study treatment Biopsy before and after three weeks of study treatment: Core biopsies for histological analyses, to be analysed by the central pathology paclitaxel lapatinib trastuzumab None None 16 61 59 61 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Death SYSTEMATIC_ASSESSMENT Psychiatric disorders NCI-CTCAE version 4. View
anxiety SYSTEMATIC_ASSESSMENT Psychiatric disorders NCI-CTCAE version 4. View
Cholecystitis SYSTEMATIC_ASSESSMENT Gastrointestinal disorders NCI-CTCAE version 4. View
Decreased appetite SYSTEMATIC_ASSESSMENT Gastrointestinal disorders NCI-CTCAE version 4. View
Dehydration SYSTEMATIC_ASSESSMENT Renal and urinary disorders NCI-CTCAE version 4. View
Device related thrombosis SYSTEMATIC_ASSESSMENT Vascular disorders NCI-CTCAE version 4. View
Fatigue SYSTEMATIC_ASSESSMENT General disorders NCI-CTCAE version 4. View
hypokaleamia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders NCI-CTCAE version 4. View
Leukopenia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders NCI-CTCAE version 4. View
Urosepsis SYSTEMATIC_ASSESSMENT Renal and urinary disorders NCI-CTCAE version 4. View
Mucosal Inflammation SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders NCI-CTCAE version 4. View
Ophthalmic herpes simplex SYSTEMATIC_ASSESSMENT Eye disorders NCI-CTCAE version 4. View
Pneumonia SYSTEMATIC_ASSESSMENT Infections and infestations NCI-CTCAE version 4. View
septic shock SYSTEMATIC_ASSESSMENT Infections and infestations NCI-CTCAE version 4. View
Subcutaneous abscess SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders NCI-CTCAE version 4. View
Syncope SYSTEMATIC_ASSESSMENT Cardiac disorders NCI-CTCAE version 4. View
Urinary tract infection SYSTEMATIC_ASSESSMENT Renal and urinary disorders NCI-CTCAE version 4. View
diarrhoea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders NCI-CTCAE version 4. View
impaired healing SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders NCI-CTCAE version 4. View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Cardiac disorders SYSTEMATIC_ASSESSMENT Cardiac disorders NCI-CTCAE version 4. View
Ear and labyrinth disorders SYSTEMATIC_ASSESSMENT Ear and labyrinth disorders NCI-CTCAE version 4. View
Eye disorders SYSTEMATIC_ASSESSMENT Eye disorders NCI-CTCAE version 4. View
Gastrointestinal disorders SYSTEMATIC_ASSESSMENT Gastrointestinal disorders NCI-CTCAE version 4. View
Hepatobiliary disorders SYSTEMATIC_ASSESSMENT Hepatobiliary disorders NCI-CTCAE version 4. View
Immune system disorders SYSTEMATIC_ASSESSMENT Immune system disorders NCI-CTCAE version 4. View
Infections and infestations SYSTEMATIC_ASSESSMENT Infections and infestations NCI-CTCAE version 4. View
Injury, poisoning and procedural complications SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications NCI-CTCAE version 4. View
Investigations SYSTEMATIC_ASSESSMENT Investigations NCI-CTCAE version 4. View
Metabolism and nMetabolism and nutrition disordersutrition disorders SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders NCI-CTCAE version 4. View
Musculoskeletal and connective tissue disorders SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders NCI-CTCAE version 4. View
Nervous system disorders SYSTEMATIC_ASSESSMENT Nervous system disorders NCI-CTCAE version 4. View
Psychiatric disorders SYSTEMATIC_ASSESSMENT Psychiatric disorders NCI-CTCAE version 4. View
Renal and urinary disorders SYSTEMATIC_ASSESSMENT Renal and urinary disorders NCI-CTCAE version 4. View
Reproductive system and breast disorders SYSTEMATIC_ASSESSMENT Reproductive system and breast disorders NCI-CTCAE version 4. View
Respiratory, thoracic and mediastinal disorders SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders NCI-CTCAE version 4. View
Skin and subcutaneous tissue disorders SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders NCI-CTCAE version 4. View
Vascular disorders SYSTEMATIC_ASSESSMENT Vascular disorders NCI-CTCAE version 4. View
Blood and lymphatic system disorders SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders NCI-CTCAE version 4. View
General disorders and administration site conditions SYSTEMATIC_ASSESSMENT General disorders NCI-CTCAE version 4. View