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 @ 3:53 PM
Ignite Modification Date: 2025-12-25 @ 1:58 PM
NCT ID: NCT04709692
Description: A standard physical examination was performed as per the study schedule and included: general appearance, head and eyes, ears, nose and throat, chest and lungs, cardiovascular, abdomen, neurological, lymphatic, and musculoskeletal. Vital signs, body temperature, and ECGs were taken per the study schedule. Participants were given contact information to self-report AEs between study visits. Signs and symptoms of malaria were not recorded as adverse events.
Frequency Threshold: 0
Time Frame: AE data was collected for the 42 days that a participant was enrolled.
Study: NCT04709692
Study Brief: Efficacy of SJ733 in Adults With Uncomplicated Plasmodium Falciparum or Vivax Malaria
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 1 B (Cohort 1) Combination of 600 mg SJ733 with 150 mg Cobicistat administered orally once every day for three consecutive days for patients with P.vivax (+)-SJ000557733 (SJ733): Anti-Malarial 0 None 1 10 2 10 View
Arm 2 B (Cohort 2) 600 mg SJ733 administered orally once every day for three consecutive days for patients with P.vivax (+)-SJ000557733 (SJ733): Anti-Malarial 0 None 1 12 3 12 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Febrile syndrome of probable viral etiology SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA v2022AA View
Severe Malaria Grade 4 SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA v2022AA View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Food Poisoning SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA v2022AA View
Hepatosplenomegaly SYSTEMATIC_ASSESSMENT General disorders MedDRA v2022AA View
Bilateral nephromegaly SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA v2022AA View
Alkaline Phosphatase Increase SYSTEMATIC_ASSESSMENT Hepatobiliary disorders MedDRA v2022AA View
Acute pharyngitis SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA v2022AA View
Increased Glucose SYSTEMATIC_ASSESSMENT Endocrine disorders MedDRA v2022AA View
Herpetic gingivostomatitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA v2022AA View