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 @ 11:14 PM
Ignite Modification Date: 2025-12-25 @ 8:49 PM
NCT ID: NCT00803569
Description: AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 3.0), seriousness, study drug action taken, treatment, and outcome. In summaries, treatment-related AEs included those with a "possible", "probable", or "definite" relationship to study drug; preferred terms were counted only once per patient at the maximum reported grade.
Frequency Threshold: 0
Time Frame: All adverse events (AEs) occurring between the signing of informed consent and the off-study date were documented, regardless of the causal relationship to study drug. AEs occurring after the first dose of study drug were considered treatment emergent (i.e., TEAEs). The AE reporting period for this study was up to 26 weeks.
Study: NCT00803569
Study Brief: Vaccine Therapy in Stage II, III, or IV Epithelial Ovarian, Fallopian Tube, or Primary Peritoneal Cancers
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
ALVAC(2)-NY-ESO-1(M)/TRICOM + GM-CSF Patients received SC injections with ALVAC(2)-NY-ESO-1(M)/TRICOM (0.5 mL) on Day 1 and the GM-CSF sargramostim (100 μg) on Days 1 through 4 in continuous 28-day cycles for up to 6 cycles. 0 None 0 13 12 13 View
Serious Events(If Any):
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Injection site pain SYSTEMATIC_ASSESSMENT General disorders MedDRA 13.1 View
Injection site erythema SYSTEMATIC_ASSESSMENT General disorders MedDRA 13.1 View
Injection site reaction SYSTEMATIC_ASSESSMENT General disorders MedDRA 13.1 View
Fatigue SYSTEMATIC_ASSESSMENT General disorders MedDRA 13.1 View
Injection site induration SYSTEMATIC_ASSESSMENT General disorders MedDRA 13.1 View
Injection site pruritus SYSTEMATIC_ASSESSMENT General disorders MedDRA 13.1 View
Injection site rash SYSTEMATIC_ASSESSMENT General disorders MedDRA 13.1 View
Chills SYSTEMATIC_ASSESSMENT General disorders MedDRA 13.1 View
Hypothermia SYSTEMATIC_ASSESSMENT General disorders MedDRA 13.1 View
Influenza-like illness SYSTEMATIC_ASSESSMENT General disorders MedDRA 13.1 View
Injection site nodule SYSTEMATIC_ASSESSMENT General disorders MedDRA 13.1 View
Injection site swelling 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
Headache SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 13.1 View
Dizziness SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 13.1 View
Pruritus SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 13.1 View
Ecchymosis SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 13.1 View
Erythema SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 13.1 View
Rash SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 13.1 View
Rash pruritic SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 13.1 View
Vaginal infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 13.1 View
Acute sinusitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 13.1 View
Nasopharyngitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 13.1 View
Rhinitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 13.1 View
Myalgia SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 13.1 View
Back pain SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 13.1 View
Arthralgia SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 13.1 View
Oropharyngeal pain SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 13.1 View
Cough SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 13.1 View
Nasal congestion SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 13.1 View
Abdominal pain SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 13.1 View
Flatulence 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
Palpitations SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 13.1 View
Contusion SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 13.1 View
Skin test positive SYSTEMATIC_ASSESSMENT Investigations MedDRA 13.1 View
Anorexia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 13.1 View
Vulvovaginal pruritus SYSTEMATIC_ASSESSMENT Reproductive system and breast disorders MedDRA 13.1 View
Flushing SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA 13.1 View