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 @ 2:49 PM
Ignite Modification Date: 2025-12-25 @ 1:16 PM
NCT ID: NCT04520659
Description: From day 0-28, all SAEs, solicited AEs, and unsolicited AEs, with the exception of the following if not treated with prescription medication or over the counter medications with antipyretic properties: diaper rashes, teething pain, and spitting up. SAEs and LRIs were reported according to Sections 7 \& 8 in the Protocol Document. From day 29-56, SAEs were collected. After day 56, from November 1 - March 31 of the following year, medically attended fever, LRI, URI and otitis media were collected.
Frequency Threshold: 0
Time Frame: From study entry to end of study. The duration of follow-up for a given participant was between 6 and 13 months for both Groups 1 & 2 depending on time of enrollment.
Study: NCT04520659
Study Brief: Evaluating the Infectivity, Safety and Immunogenicity of a Recombinant Live-Attenuated Respiratory Syncytial Virus Vaccine, LID/ΔM2-2/1030s, in RSV-Seronegative Infants and Children 6 to 24 Months of Age
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Group 1: Placebo Participants will receive a single dose of placebo at study entry (Day 0). Placebo: Administered as nose drops 0 None 0 7 4 7 View
Group 1: RSV LID/ΔM2-2/1030s Participants will receive a single dose of RSV LID/ΔM2-2/1030s vaccine at study entry (Day 0). RSV LID/ΔM2-2/1030s: 10\^5 plaque-forming units (PFU); administered as nose drops 0 None 1 14 11 14 View
Group 2: RSV LID/ΔM2-2/1030s Participants will receive a single dose of RSV LID/ΔM2-2/1030s vaccine at study entry (Day 0). RSV LID/ΔM2-2/1030s: 10\^5 plaque-forming units (PFU); administered as nose drops 0 None 0 60 29 40 View
Group 2: Placebo Participants will receive a single dose of placebo at study entry (Day 0). Placebo: Administered as nose drops 0 None 0 20 14 20 View
Groups 1 and 2 Combined: RSV LID/ΔM2-2/1030s Participants will receive a single dose of RSV LID/ΔM2-2/1030s vaccine at study entry (Day 0). RSV LID/ΔM2-2/1030s: 10\^5 plaque-forming units (PFU); administered as nose drops 0 None 1 74 40 54 View
Groups 1 and 2 Combined: Placebo Participants will receive a single dose of placebo at study entry (Day 0). Placebo: Administered as nose drops 0 None 0 27 18 27 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Wheezing SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA (Unspecified) View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Rhinorrhea SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA (Unspecified) View
Rash SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA (Unspecified) View
Diarrhea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA (Unspecified) View
Vomiting SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA (Unspecified) View
Fever SYSTEMATIC_ASSESSMENT General disorders MedDRA (Unspecified) View
Pain SYSTEMATIC_ASSESSMENT General disorders MedDRA (Unspecified) View
Conjunctivitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA (Unspecified) View
Otitis media SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA (Unspecified) View
Urinary Tract Infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA (Unspecified) View
Cough SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA (Unspecified) View
Croup SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA (Unspecified) View
Nasal congestion SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA (Unspecified) View