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 @ 2:30 AM
Ignite Modification Date:
2025-12-26 @ 1:05 AM
NCT ID:
NCT03610334
Description:
Safety was the primary endpoint of this Phase 1 study Number of participants with TEAE are reported in the primary endpoint section. As this section is more appropriate to describe TEAE, it was decided to further describe the primary endpoint in this section.
Frequency Threshold:
1
Time Frame:
18 months
Study:
NCT03610334
Study Brief:
A Combined SAD and MAD Study to Investigate the Safety, Tolerability and Pharmacokinetic Profile of IFB-088
Event Groups(If Any):
Event Groups
| Title | Description | Deaths # Affected | Deaths # At Risk | Serious # Affected | Serious # At Risk | Other # Affected | Other # At Risk | View |
|---|---|---|---|---|---|---|---|---|
| SAD IFB-088 2.5mg | cohort 1: single daily dose of 2.5mg IFB-088 oral capsule, administered in the morning (8:00am), in one intake | 0 | None | 0 | 6 | 1 | 6 | View |
| SAD IFB-088 20.0mg | cohort 4: single daily dose of 20.0mg IFB-088 oral capsule, administered in two intakes of 10.0mg, 12 hours apart, in the morning (8:00am), and in the evening (8:00pm) | 0 | None | 0 | 6 | 2 | 6 | View |
| SAD IFB-088 60.0mg | cohort 6: single daily dose of 60.0mg IFB-088 oral capsule, administered in two intakes of 30.0mg, 12 hours apart, in the morning (8:00am), and in the evening (8:00pm) | 0 | None | 0 | 6 | 3 | 6 | View |
| SAD Placebo | (cohort 1 to 6): single daily dose of placebo oral capsule, administered in two intakes (except for the first SAD dose that is administered in one intake), at 12h intervals, in the morning (8:00am) and in the evening (8:00pm) | 0 | None | 0 | 12 | 2 | 12 | View |
| MAD IFB-088 50.0mg | cohort 9: subject taking 50.0mg of IFB-088 oral capsule divided in two dose of 25.0mg, at an interval of 12h, in the morning (8:00am), and in the evening (8:00pm), for 14 days. | 0 | None | 0 | 6 | 4 | 6 | View |
| SAD IFB-088 5.0mg | cohort 2: single daily dose of 5.0mg IFB-088 oral capsule, administered in two intakes of 2.5mg, 12 hours apart, in the morning (8:00am), and in the evening (8:00pm) | 0 | None | 0 | 6 | 1 | 6 | View |
| SAD IFB-088 10.0mg | cohort 3: single daily dose of 10.0mg IFB-088 oral capsule, administered in two intakes of 5.0mg, 12 hours apart, in the morning (8:00am), and in the evening (8:00pm) | 0 | None | 0 | 6 | 2 | 6 | View |
| SAD IFB-088 40.0mg | cohort 5: single daily dose of 40.0mg IFB-088 oral capsule, administered in two intakes of 20.0mg, 12 hours apart, in the morning (8:00am), and in the evening (8:00pm) | 0 | None | 0 | 6 | 2 | 6 | View |
| MAD IFB-088 15.0mg | cohort 7: subject taking 15.0mg of IFB-088 oral capsule divided in two dose of 7.5mg, at an interval of 12h, in the morning (8:00am), and in the evening (8:00pm), for 14 days. | 0 | None | 0 | 6 | 4 | 6 | View |
| MAD IFB-088 30.0mg | cohort 8: subject taking 30.0mg of IFB-088 oral capsule divided in two dose of 15.0mg, at an interval of 12h, in the morning (8:00am), and in the evening (8:00pm), for 14 days. | 0 | None | 0 | 6 | 1 | 6 | View |
| MAD Placebo | (cohort 7 to 9): subject taking placebo oral capsule divided in two doses, at an interval of 12h, in the morning (8:00am), and in the evning (8:00pm), for 14 days. | 0 | None | 0 | 6 | 2 | 6 | View |
Serious Events(If Any):
Other Events(If Any):
Other Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| headache | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA (21.0) | View |
| pyrexia | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA (21.0) | View |
| catheter site related reaction | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA (21.0) | View |
| hypertriglyceridemia | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA (21.0) | View |
| influenza like illness | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA (21.0) | View |
| nasopharyngitis | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (21.0) | View |
| toothache | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (21.0) | View |
| joint injury | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA (21.0) | View |
| diarrhoea | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (21.0) | View |
| rhinitis allergic | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA (21.0) | View |
| ear pain | SYSTEMATIC_ASSESSMENT | Ear and labyrinth disorders | MedDRA (21.0) | View |
| orthostatic hypotension | SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDRA (21.0) | View |
| nephrolithiasis | SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | MedDRA (21.0) | View |
| haematuria | SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | MedDRA (21.0) | View |
| pollakyuria | SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | MedDRA (21.0) | View |
| nausea | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (21.0) | View |
| paraesthesia | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA (21.0) | View |
| abdominal pain | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (21.0) | View |
| presyncope | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA (21.0) | View |