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: 2025-12-25 @ 3:55 AM
Ignite Modification Date: 2025-12-26 @ 2:46 AM
NCT ID: NCT00312702
Description: Evaluate the safety by 1) the occurrence of solicited AEs over a 7 day follow-up period (day of immunization and 6 days post-immunization); 2) the occurrence of unsolicited AEs over a 30 day follow-up period (day of immunization and 29 day follow-up period ); and 3) the occurrence of SAE's during the study period. Subjects in the Infectivity Control group were not included in this analysis and are not presented in the final clinical study report.
Frequency Threshold: 0
Time Frame: Up to 6 months
Study: NCT00312702
Study Brief: Phase I/II Trial of a Malaria Vaccine in Adults Living in the United States of America
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
10µg Dose FMP011 Falciparum Malaria Protein 11 with AS02A adjuvant Falciparum Malaria Protein 11 with AS02A adjuvant: vaccine 0 None 0 5 5 5 View
50µg Dose FMP011 Falciparum Malaria Protein 11 with AS02A adjuvant Falciparum Malaria Protein 11 with AS02A adjuvant: vaccine 0 None 0 13 13 13 View
Infecticvity Control (IC) 12 Subjects from the high dose group and 1 non immunized subject enrolled prior to challenge to serve as IC's for malaria sporozoite challenge. 1 infectivity control subject out of the 6 came from this phase 1 study, the other 5 came from the phase 2 study (WRAIR 1250, NCT00312663). Both studies were included in one final clinical study report. 0 None 0 1 0 1 View
Serious Events(If Any):
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Redness SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA View
Fever SYSTEMATIC_ASSESSMENT General disorders MedDRA View
Local SYSTEMATIC_ASSESSMENT General disorders MedDRA View
Pain SYSTEMATIC_ASSESSMENT General disorders MedDRA View
Swelling SYSTEMATIC_ASSESSMENT General disorders MedDRA View
Nausea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA View
Headache SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA View
Malaise SYSTEMATIC_ASSESSMENT General disorders MedDRA View
Myalgia SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA View
Fatigue SYSTEMATIC_ASSESSMENT General disorders MedDRA View
Local SYSTEMATIC_ASSESSMENT General disorders MedDRA View
Pain SYSTEMATIC_ASSESSMENT General disorders MedDRA View
Swelling SYSTEMATIC_ASSESSMENT General disorders MedDRA View
Redness SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA View
Fever SYSTEMATIC_ASSESSMENT General disorders MedDRA View
Myalgia SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA View
Fatigue SYSTEMATIC_ASSESSMENT General disorders MedDRA View
Local SYSTEMATIC_ASSESSMENT General disorders MedDRA View
Pain SYSTEMATIC_ASSESSMENT General disorders MedDRA View
Swelling SYSTEMATIC_ASSESSMENT General disorders MedDRA View
Redness SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA View
Fever SYSTEMATIC_ASSESSMENT General disorders MedDRA View
Nausea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA View
Headache SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA View
Malaise SYSTEMATIC_ASSESSMENT General disorders MedDRA View
Myalgia SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA View
Fatigue SYSTEMATIC_ASSESSMENT General disorders MedDRA View
Chills NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA View
Bruise at injection site NON_SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA View
Axilla lymphadenopathy NON_SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA View
Ringing in ears - bilateral NON_SYSTEMATIC_ASSESSMENT Ear and labyrinth disorders MedDRA View
Vasovagal event NON_SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA View
Ringing in ears - bilateral NON_SYSTEMATIC_ASSESSMENT Ear and labyrinth disorders MedDRA View
Bruise at injection site NON_SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA View
Axilla lymphadenopathy NON_SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA View
Vasovagal event NON_SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA View