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 @ 3:46 AM
Ignite Modification Date: 2025-12-26 @ 2:33 AM
NCT ID: NCT01523002
Description: An adverse event is defined as any unfavourable and unintended sign, symptom, syndrome, or illness that developed or worsened during the period of observation in the clinical study. Clinically relevant abnormal results of diagnostic procedures including abnormal laboratory findings which are considered by the Investigator to be detrimental should be recorded as adverse events whether or not they have a causal relationship with the study drug.
Frequency Threshold: 0
Time Frame: Arm A: 140 days + follow up if necessary Arm B: 103 days + follow up if necessary
Study: NCT01523002
Study Brief: Drug Interaction Study of Pyronaridine-artesunate & Metoprolol, & Redosing Study of Pyronaridine-artesunate
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: Metoprolol DDI and Pyronaridine-artesunate 90-day Redosing Subjects will take 1 day of metoprolol followed by a 7 day wash out period; then 2 days of pyronaridine-artesunate followed by 1 day of pyronaridine-artesunate + metoprolol and then a 87 day follow-up period. Subjects will then receive pyronaridine-artesunate once daily for three days followed by a 40 day follow-up period and a study completion evaluation. 0 None 0 26 25 26 View
Arm B: Pyronaridine-artesunate 60-day Redosing Subjects will take pyronaridine-artesunate once daily for 3 days, followed by a 57 day follow-up period. Subjects will then take pyronaridine-artesunate once daily for 3 days followed by a 40 day follow-up period. 0 None 2 30 29 30 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Exanthema (rash) SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedRA View
Discus hernia (intervertebral disc protrusion) SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedRA View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Abdominal pain discomfort SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedRA View
Abdominal pain upper SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedRA View
Flatulence SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedRA View
Abdominal distension SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedRA View
Constipation SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedRA View
Alanine aminotransferase increased SYSTEMATIC_ASSESSMENT Investigations MedRA View
Aspartate aminotransferase increased SYSTEMATIC_ASSESSMENT Investigations MedRA View
Gamma-glutamyltransferase increased SYSTEMATIC_ASSESSMENT Investigations MedRA View
Neutrophil count decreased SYSTEMATIC_ASSESSMENT Investigations MedRA View
Blood alkaline phosphatase increased SYSTEMATIC_ASSESSMENT Investigations MedRA View
Blood bilirubin increased SYSTEMATIC_ASSESSMENT Investigations MedRA View
Prothrombin time prolonged SYSTEMATIC_ASSESSMENT Investigations MedRA View
White blood cell count decreased SYSTEMATIC_ASSESSMENT Investigations MedRA View
Platelet count increased SYSTEMATIC_ASSESSMENT Investigations MedRA View
Headache SYSTEMATIC_ASSESSMENT Nervous system disorders MedRA View
Dizziness SYSTEMATIC_ASSESSMENT Nervous system disorders MedRA View
Dizziness postural SYSTEMATIC_ASSESSMENT Nervous system disorders MedRA View
Paraesthesia SYSTEMATIC_ASSESSMENT Nervous system disorders MedRA View
Tremor SYSTEMATIC_ASSESSMENT Nervous system disorders MedRA View
Fatigue SYSTEMATIC_ASSESSMENT General disorders MedRA View
Chills SYSTEMATIC_ASSESSMENT General disorders MedRA View
Malaise SYSTEMATIC_ASSESSMENT General disorders MedRA View
Pyrexia SYSTEMATIC_ASSESSMENT General disorders MedRA View
Chest discomfort SYSTEMATIC_ASSESSMENT General disorders MedRA View
Feeling hot SYSTEMATIC_ASSESSMENT General disorders MedRA View
Inflammation SYSTEMATIC_ASSESSMENT General disorders MedRA View
Injection site pain SYSTEMATIC_ASSESSMENT General disorders MedRA View
Vessel puncture site SYSTEMATIC_ASSESSMENT General disorders MedRA View
Swelling SYSTEMATIC_ASSESSMENT General disorders MedRA View
Back pain SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedRA View
Pain in extremity SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedRA View
Arthralgia SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedRA View
Myalgia SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedRA View
Intervertebral disc SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedRA View
Nasopharngitis SYSTEMATIC_ASSESSMENT Infections and infestations MedRA View
Rhinitis SYSTEMATIC_ASSESSMENT Infections and infestations MedRA View
Herpes simplex SYSTEMATIC_ASSESSMENT Infections and infestations MedRA View
Cough SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedRA View
Epistaxis SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedRA View
Oropharyngeal pain SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedRA View
Hyponatraemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedRA View
Decreased appetite SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedRA View
Proteinuria SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedRA View
Pruritus SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedRA View
Rash SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedRA View
Dry skin SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedRA View
Rash papular SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedRA View
Scratch SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedRA View
Thermal burn SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedRA View
Tooth fracture SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedRA View
Hot flush SYSTEMATIC_ASSESSMENT Vascular disorders MedRA View
Surgery SYSTEMATIC_ASSESSMENT Surgical and medical procedures MedRA View
Tooth repair SYSTEMATIC_ASSESSMENT Surgical and medical procedures MedRA View
Eye irritation SYSTEMATIC_ASSESSMENT Eye disorders MedRA View
Insomnia SYSTEMATIC_ASSESSMENT Psychiatric disorders MedRA View
Metrorrhagia SYSTEMATIC_ASSESSMENT Reproductive system and breast disorders MedRA View
Diarrhoea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedRA View
Nausea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedRA View
Vomiting SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedRA View
Abdominal pain SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedRA View