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 @ 11:48 AM
Ignite Modification Date:
2025-12-26 @ 10:20 AM
NCT ID:
NCT05736861
Description:
Participants were asked to complete daily assessments and report adverse events via the study portal through day 14, then at other intervals through day 28, and at the final study visit at day 90.
Adverse event tables were updated on 5/16/2023 to reflect data cleaning and data monitoring efforts by contributing sites. Some sites determined that some previously reported events should not have been reported per the criteria noted in the protocol.
Frequency Threshold:
0
Time Frame:
Up to 90 days
Study:
NCT05736861
Study Brief:
ACTIV-6: COVID-19 Study of Repurposed Medications - Arm A (Ivermectin 400)
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 - Ivermectin 400 | Ivermectin - 7-mg tablets Participant will be instructed to take a pre-specified number of tablets for 3 consecutive days based on their weight for a daily dose of approximately 300-400 µg/kg. Ivermectin: Each participant will receive a sufficient quantity of 7-mg tablets to be taken as directed based on their weight. The tablets are white, round, biconvex tablets with "123" over the scoring on one side. All packaging will be labeled to indicate that the product is for investigational use. | 1 | None | 13 | 817 | 16 | 817 | View |
| Arm A - Placebo | Placebo - appearance and size matched to active study drug. Participant will be instructed to take a pre-specified number of tablets for 3 consecutive days based on their weight, matched to active study drug dosing. Placebo: Each study arm will contain a placebo comparator. Placebo will look similar to study drug and will be administered via the same route of administration and dose. However, placebo will be an inactive substance, containing no study drug. | 0 | None | 17 | 774 | 13 | 774 | View |
Serious Events(If Any):
Serious Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| COVID-19 pneumonia | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA | View |
| COVID-19 pneumonia aggravated | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA | View |
| Bacteremia, with signs and symptoms | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA | View |
| Pneumonia due to Staphylococcus | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA | View |
| Pneumonia due to Streptococcus, group b | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA | View |
| Pulmonary embolism | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA | View |
| Viral bronchopneumonia | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA | View |
| Venous thromboembolism | SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDRA | View |
| Diplopia | SYSTEMATIC_ASSESSMENT | Eye disorders | MedDRA | View |
| Acute kidney injury | SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | MedDRA | View |
| Acute Cholecystitis | SYSTEMATIC_ASSESSMENT | Hepatobiliary disorders | MedDRA | View |
| Coronary vasospasm | SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDRA | View |
| COVID-19 pneumonia worsening | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA | View |
| Death due to COVID-19 | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA | View |
| Pneumonia due to COVID-19 virus | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA | View |
| Upper GI bleed | SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDRA | View |
| Worsening of covid-19 pneumonia | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA | View |
| Opthalmic migraine | SYSTEMATIC_ASSESSMENT | Eye disorders | MedDRA | View |
Other Events(If Any):
Other Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Accelerated hair loss | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA | View |
| Bladder infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA | View |
| Blood pressure raised | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA | View |
| Chest tightness | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA | View |
| Confusion | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA | View |
| COVID-19 pneumonia | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA | View |
| Dizziness | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA | View |
| Dyspnea | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA | View |
| Hair loss | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA | View |
| Heartburn | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA | View |
| Hepatic steatosis | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA | View |
| Hypoxia | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA | View |
| Insomnia | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA | View |
| Interstitial pneumonia | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA | View |
| Migraine with aura | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA | View |
| Nausea | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA | View |
| Nausea and emesis | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA | View |
| Pain in limb | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA | View |
| Palpitations | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA | View |
| Rash | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA | View |
| Seasonal Allergies | SYSTEMATIC_ASSESSMENT | Immune system disorders | MedDRA | View |
| Shoulder dislocation | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA | View |
| Sinus bradycardia | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA | View |
| Sinus infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA | View |
| Splenomegaly | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | MedDRA | View |
| Suspected Covid-19 | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA | View |
| Tiredness | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA | View |
| Vomiting | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA | View |