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 @ 1:17 PM
Ignite Modification Date: 2025-12-25 @ 12:25 PM
NCT ID: NCT02071095
Description: None
Frequency Threshold: 0
Time Frame: None
Study: NCT02071095
Study Brief: Enhancement by Poly-ICLC During HIV-1 Infection
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: Poly-ICLC Poly-ICLC: Poly-ICLC (Hiltonol®, Oncovir) Administration - On days 1 and 2, patients randomized to this arm will be injected subcutaneously in the arm with 1.4 mg of Poly-ICLC (Hiltonol®, Oncovir). Each subject will receive a total of 2 SC doses of Poly-ICLC. The volume of each injection is 0.7ml. 0 None 11 12 1 12 View
Arm B: Normal Saline Normal Saline: Normal Saline - On days 1 and 2, patients randomized to this arm will be injected subcutaneously in the arm with normal saline obtained from the Rockefeller University Pharmacy. Each subject will receive a total of 2 SC doses of normal saline. The volume of each injection is 0.7ml. 0 None 3 3 0 3 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Chills None General disorders None View
erythema None Surgical and medical procedures None View
Pain None Surgical and medical procedures None View
Fatigue None General disorders None View
Fever None General disorders None View
Malaise None General disorders None View
Headache None Nervous system disorders None View
Myalgias None Musculoskeletal and connective tissue disorders None View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Low neutrophils count None Blood and lymphatic system disorders None View