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 @ 2:19 PM
Ignite Modification Date: 2025-12-25 @ 12:56 PM
NCT ID: NCT01716195
Description: None
Frequency Threshold: 5
Time Frame: 5 years
Study: NCT01716195
Study Brief: Induction Chemotherapy Followed by Chemoradiotherapy for Head and Neck 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
Response Adapted Chemoradiation Paclitaxel 175 mg/m2 + Carboplatin area under curve (AUC) 6 followed by response adapted Radiation Therapy (5 - 6 weeks) + Paclitaxel Induction Chemotherapy followed by Response Adapted Chemoradiation: All patients receive induction chemotherapy with 2 cycles of paclitaxel and carboplatin followed by response adapted, de-escalated chemoradiation. Patients with a complete or partial response will receive 54 Gy with concurrent paclitaxel and patients with stable disease will receive 60 Gy with concurrent paclitaxel. 1 None 2 18 13 18 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Anorexia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders None View
Nausea SYSTEMATIC_ASSESSMENT General disorders None View
Dysphagia SYSTEMATIC_ASSESSMENT General disorders None View
Sore throat SYSTEMATIC_ASSESSMENT General disorders None View
Skin Infection SYSTEMATIC_ASSESSMENT Infections and infestations None View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Fatigue NON_SYSTEMATIC_ASSESSMENT General disorders None View
Arthralgia NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Anemia NON_SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders None View
Lymphocyte count decreased NON_SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders None View
Hypercalcemia NON_SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders None View
Alanine aminotransferase increased NON_SYSTEMATIC_ASSESSMENT Hepatobiliary disorders None View
Aspartate aminotransferase increased NON_SYSTEMATIC_ASSESSMENT Hepatobiliary disorders None View
Erythema Multiforme NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
Mucositis oral NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
White blood cell decreased NON_SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders None View
Hyponatremia NON_SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders None View
Cough NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Tinnitus NON_SYSTEMATIC_ASSESSMENT Ear and labyrinth disorders None View
Dysphagia NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Dysgeusia NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Sore throat NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Dermatitis radiation NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
Diarrhea NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Constipation NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Vomiting NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Oral Pain NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Alkaline phosphatese increased NON_SYSTEMATIC_ASSESSMENT Hepatobiliary disorders None View
Neutrophil count decreased NON_SYSTEMATIC_ASSESSMENT Immune system disorders None View
Dry Mouth NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Peripheral Sensory Neuropathy NON_SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Rash acneiform NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
Nausea NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Myalgia NON_SYSTEMATIC_ASSESSMENT General disorders None View
Ear Pain NON_SYSTEMATIC_ASSESSMENT Ear and labyrinth disorders None View
Alopecia NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
Anorexia NON_SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders None View
Anxiety NON_SYSTEMATIC_ASSESSMENT Psychiatric disorders None View
Weight loss NON_SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders None View
Sinus bradycardia NON_SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Hoarseness NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Hiccups NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Gastroesophageal reflux disorder NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View