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 @ 11:41 PM
Ignite Modification Date: 2025-12-25 @ 9:32 PM
NCT ID: NCT00415051
Description: Within 30 days post vaccination, 119 AEs (22 local and 97 systemic) were reported. Between 31 days and 1 year post vaccination, 33 systemic AEs (no local AEs) were reported. A total of 152 AEs (22 local and 130 systemic) were reported during the study.
Frequency Threshold: 0
Time Frame: 1 year
Study: NCT00415051
Study Brief: Safety/Immunogenicity/Genetic Drift of MP-12 Rift Valley Fever Vaccine
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Single Group Assignment RVF MP-12 RVF MP-12: Administer 1 ml SQ None None 0 19 19 19 View
Serious Events(If Any):
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Headache SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Fatigue SYSTEMATIC_ASSESSMENT General disorders None View
Flu-like symptoms SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Fever SYSTEMATIC_ASSESSMENT General disorders None View
Chills SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Menstrual cramps SYSTEMATIC_ASSESSMENT Reproductive system and breast disorders None View
Nasal congestion SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Rhinorrhea SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Sore throat SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Blurred vision SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Ear discomfort SYSTEMATIC_ASSESSMENT Ear and labyrinth disorders None View
Throat scratchy and sore SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Left eye itching SYSTEMATIC_ASSESSMENT Eye disorders None View
Eyelid twitching SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Nausea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Diarrhea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Vomiting SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Abdominal cramping SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Dehydration SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Cervial nodes slightly tender SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders None View
Increase in bleeding post venipuncture SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders None View
Muscle pain SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Pain SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Back pain SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Lower back discomfort SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Knee joint pain SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Dental pain SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Stiff neck SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Dizziness SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Lightheaded SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Spacey SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Cough SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Chest congestion SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Tenderness (vaccine site) SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
Induration SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
Redness (vaccine site) SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
Clammy skin (hands) SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
Bruise SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
Itching SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
Injection site warm SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
Redness (phlebotomy site) SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
Cold sore SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
Allergic reaction SYSTEMATIC_ASSESSMENT Immune system disorders None View
Insomnia SYSTEMATIC_ASSESSMENT Psychiatric disorders None View
Pain (testicle) SYSTEMATIC_ASSESSMENT Reproductive system and breast disorders None View
Heart palpitations SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Cold SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Eye twitching SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Laryngitis SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Sore throat SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Emesis SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Indigestion SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Nausea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Knee pain SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Muscle ache SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Pain SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Pain (chest and back) SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Pain (lower back) SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Pain (shoulder) SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Scar reconstruction ABD wall liposuction SYSTEMATIC_ASSESSMENT Surgical and medical procedures None View
Shin splints SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Shoulder injury SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications None View
Stiff neck SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Traumatic injury to L middle finger SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications None View
Dizziness SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Migrane SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Cough SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Pneumonia SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Conjunctivitis (OS) SYSTEMATIC_ASSESSMENT Infections and infestations None View
Ankel pain SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Nasal congestion SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View