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 @ 12:32 PM
Ignite Modification Date: 2025-12-25 @ 12:10 PM
NCT ID: NCT03727061
Description: None
Frequency Threshold: 0
Time Frame: Routine visits at 10-12 weeks and until 8 months
Study: NCT03727061
Study Brief: Porfimer Sodium Interstitial Photodynamic Therapy With or Without Standard of Care Chemotherapy in Treating Patients With Locally Advanced or Recurrent 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
Arm A(Porfimer Sodium, I-PDT Patients receive porfimer sodium IV over 3-5 minutes and undergo I-PDT approximately 48 hours later. Nivolumab: Immunotherapy - Standard of care Porfimer Sodium: Given IV Interstitial Illumination Photodynamic Therapy: Undergo I-PDT Quality of Life Assessment: Ancillary Studies 3 None 3 5 5 5 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
General disorders and administration site conditions - Other, specify SYSTEMATIC_ASSESSMENT General disorders None View
Social circumstances - Other, specify SYSTEMATIC_ASSESSMENT Social circumstances None View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Photophobia SYSTEMATIC_ASSESSMENT Eye disorders None View
Vision decreased SYSTEMATIC_ASSESSMENT Eye disorders None View
Abdominal pain SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Constipation SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Dyspepsia SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Flatulence SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Gastrointestinal fistula SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Mucositis oral SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Chills SYSTEMATIC_ASSESSMENT General disorders None View
Edema face SYSTEMATIC_ASSESSMENT General disorders None View
Edema limbs SYSTEMATIC_ASSESSMENT General disorders None View
Facial pain SYSTEMATIC_ASSESSMENT General disorders None View
Fatigue SYSTEMATIC_ASSESSMENT General disorders None View
Fever SYSTEMATIC_ASSESSMENT General disorders None View
General disorders and administration site conditions - Other, specify SYSTEMATIC_ASSESSMENT General disorders None View
Localized edema SYSTEMATIC_ASSESSMENT General disorders None View
Skin infection SYSTEMATIC_ASSESSMENT Infections and infestations None View
Burn SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications None View
Injury, poisoning and procedural complications - Other, specify SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications None View
Wound complication SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications None View
Weight loss SYSTEMATIC_ASSESSMENT Investigations None View
Anorexia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders None View
Dehydration SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders None View
Amnesia SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Headache SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Paresthesia SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Vasovagal reaction SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Confusion SYSTEMATIC_ASSESSMENT Psychiatric disorders None View
Nasal congestion SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Hyperhidrosis SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
Photosensitivity SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
Pruritus SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
Skin hyperpigmentation SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View