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:
2025-12-26 @ 10:19 PM
Ignite Modification Date:
2025-12-26 @ 10:19 PM
NCT ID:
NCT02497612
Description:
Reported AEs were TEAEs, defined as AEs that developed/worsened or became serious during on-treatment phase - defined as the time from the start of the first dose of double-blind drug administration up to Day 63. Analysis was performed on safety population.
Frequency Threshold:
5
Time Frame:
From Baseline up to Day 63
Study:
NCT02497612
Study Brief:
To Evaluate the Efficacy, Safety, Tolerability and Pharmacokinetics of a Single Dose Regimen of Ferroquine and Artefenomel in Adults and Children With Uncomplicated Plasmodium Falciparum 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 |
|---|---|---|---|---|---|---|---|---|
| Ferroquine (up to 400 mg) + Artefenomel (up to 800 mg) | On Day 0, based on the BW, participants received orally a single dose of FQ capsules or oral suspension (along with matching placebo, as applicable to maintain blinding) and a single dose of OZ439 (maximum dose up to 800 mg oral suspension as follows: BW \>= 35 kg: FQ 400 mg + OZ439 800 mg; BW \>=24 kg to \<35 kg: FQ 300 mg + OZ439 600 mg; BW \>=15 kg to \<24 kg: FQ 200 mg + OZ439 400 mg; BW \>=10 kg to \<15 kg: FQ 150 mg + OZ439 300 mg; BW \>=7 kg to \<10 kg: FQ 100 mg + OZ439 200 mg; \>=5 kg to \<7kg: FQ 75 mg + OZ439 150 mg. | 0 | None | 0 | 92 | 77 | 92 | View |
| Ferroquine (up to 600 mg) + Artefenomel (up to 800 mg) | On Day 0, based on the BW, participants received orally a single dose of FQ capsules or oral suspension (along with matching placebo, as applicable to maintain blinding) and a single dose of OZ439 (maximum dose up to 800 mg) oral suspension as follows: BW \>= 35 kg: FQ 600 mg + OZ439 800 mg; BW \>=24 kg to \<35 kg: FQ 450 mg + OZ439 600 mg; BW \>=15 kg to \<24 kg: FQ 300 mg + OZ439 400 mg; BW \>=10 kg to \<15 kg: FQ 225 mg + OZ439 300 mg; BW \>=7 kg to \<10 kg: FQ 150 mg + OZ439 200 mg; \>=5 kg to \<7kg: FQ 115 mg + OZ439 150 mg. | 0 | None | 2 | 94 | 79 | 94 | View |
| Ferroquine (up to 900 mg) + Artefenomel (up to 800 mg) | On Day 0, based on the BW, participants received orally a single dose of FQ capsules or oral suspension (along with matching placebo, as applicable to maintain blinding) and a single dose of OZ439 (maximum dose up to 800 mg) oral suspension as follows: BW \>= 35 kg: FQ 900 mg + OZ439 800 mg; BW \>=24 kg to \<35 kg: FQ 675 mg + OZ439 600 mg; BW \>=15 kg to \<24 kg: FQ 450 mg + OZ439 400 mg; BW \>=10 kg to \<15 kg: FQ 335 mg + OZ439 300 mg; BW \>=7 kg to \<10 kg: FQ 225 mg + OZ439 200 mg; \>=5 kg to \<7kg: FQ 170 mg + OZ439 150 mg. | 0 | None | 4 | 96 | 77 | 96 | View |
| Ferroquine (up to 1200 mg) + Artefenomel (up to 800 mg) | On Day 0, based on the BW, participants received orally a single dose of FQ capsules or oral suspension (along with matching placebo, as applicable to maintain blinding) and a single dose of OZ439 (maximum dose up to 800 mg) oral suspension as follows: BW \>= 35 kg: FQ 1200 mg + OZ439 800 mg; BW \>=24 kg to \<35 kg: FQ 900 mg + OZ439 600 mg; BW \>=15 kg to \<24 kg: FQ 600 mg + OZ439 400 mg; BW \>=10 kg to \<15 kg: FQ 450 mg + OZ439 300 mg; BW \>=7 kg to \<10 kg: FQ 300 mg + OZ439 200 mg; \>=5 kg to \<7kg: FQ 225 mg + OZ439 150 mg. | 0 | None | 2 | 91 | 74 | 91 | View |
Serious Events(If Any):
Serious Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Malaria | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 22.1 | View |
| Hepatitis A | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 22.1 | View |
| Pharyngitis | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 22.1 | View |
| Pneumonia Aspiration | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA 22.1 | View |
| Drug-Induced Liver Injury | SYSTEMATIC_ASSESSMENT | Hepatobiliary disorders | MedDRA 22.1 | View |
| Alanine Aminotransferase Increased | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA 22.1 | View |
Other Events(If Any):
Other Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Malaria | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 22.1 | View |
| Upper Respiratory Tract Infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 22.1 | View |
| Bronchitis | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 22.1 | View |
| Rhinitis | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 22.1 | View |
| Decreased Appetite | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA 22.1 | View |
| Headache | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA 22.1 | View |
| Cough | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA 22.1 | View |
| Vomiting | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 22.1 | View |
| Diarrhoea | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 22.1 | View |
| Abdominal Pain | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 22.1 | View |
| Pyrexia | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA 22.1 | View |
| Electrocardiogram Qt Prolonged | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA 22.1 | View |