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 @ 4:36 PM
Ignite Modification Date: 2025-12-25 @ 2:27 PM
NCT ID: NCT01213966
Description: None
Frequency Threshold: 5
Time Frame: Adverse events reported from pre-dose to end of study visit. An SAE was to be monitored until resolution. Patients experiencing AEs were monitored for up to 30 days after the end of the study or resolution of the event, whichever was the earlier.
Study: NCT01213966
Study Brief: Efficacy, Tolerability, PK of OZ439 in Adults With Acute, Uncomplicated P.Falciparum or Vivax Malaria Mono-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
Cohort 1 - OZ439 800mg 800 mg OZ439 po single dose None None 0 20 4 20 View
Cohort 2 - OZ439 400mg 400 mg OZ439 p.o. single dose None None 0 20 6 20 View
Cohort 3 - OZ439 200mg 200mg OZ439 p.o. single dose None None 1 20 10 20 View
Cohort 4 - OZ439 1200mg 1200 mg OZ439 po single dose None None 1 21 8 21 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Pyelonephritis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA View
Malaria relapse SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Anemia None Blood and lymphatic system disorders MedDRA View
Bundle branch block right None Cardiac disorders MedDRA View
Diarrhea None Gastrointestinal disorders MedDRA View
Blood Creatine PK Increased None Investigations MedDRA View
Hyperglycemia None Metabolism and nutrition disorders MedDRA View
Headache None Nervous system disorders MedDRA View
Rash Maculopapular None Skin and subcutaneous tissue disorders MedDRA View
Eosinophilia None Blood and lymphatic system disorders MedDRA View
Neutropenia None Blood and lymphatic system disorders MedDRA View
Palpitations None Cardiac disorders MedDRA View
Vomiting None Gastrointestinal disorders MedDRA View
ALAT Increased None Investigations MedDRA View
ASAT Increased None Investigations MedDRA View
ECG QT Prolonged None Investigations MedDRA View
ECG T Wave Abnormal None Investigations MedDRA View
Heamoglobin decreased None Investigations MedDRA View
Dizziness None Nervous system disorders MedDRA View
Syncope None Nervous system disorders MedDRA View