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 @ 11:10 PM
Ignite Modification Date:
2025-12-25 @ 8:43 PM
NCT ID:
NCT05737069
Description:
An adverse event (AE) was defined as any untoward medical occurrence in a clinical study participant, temporally associated with the use of a study product including any washout or lead-in product (or medical device), whether or not considered related to the study product, including any washout or lead-in product (or medical device). A Serious Adverse Event (SAE) is a particular category of an AE where the adverse outcome is serious. AEs were presented treatment wise.
Frequency Threshold:
0
Time Frame:
From signing of informed consent form until 30 days after the last administration of the investigational product (Up to 42 days)
Study:
NCT05737069
Study Brief:
A Bioequivalence Study of Two Ibuprofen Arginine Granules 400 mg Formulations Under Fasting and Fed Conditions in Chinese Healthy Adult Subjects
Event Groups(If Any):
Event Groups
| Title | Description | Deaths # Affected | Deaths # At Risk | Serious # Affected | Serious # At Risk | Other # Affected | Other # At Risk | View |
|---|---|---|---|---|---|---|---|---|
| Fasted Cohort: Ibuprofen Arginine Granules 400 mg (Spedifen) (Reference) | Participants received one sachet of ibuprofen arginine granules 400 mg (Spedifen) (reference product), orally, once on Day 1 of Period 1 or Period 2 as per randomization schedule under fasting conditions. Participants were instructed to take the study product after an overnight fast of at least 10 hours by dissolving it in 240 mL of warm water. | 0 | None | 0 | 34 | 5 | 34 | View |
| Fasted Cohort: Ibuprofen Arginine Granules 400 mg (Test) | Participants received one sachet of ibuprofen arginine granules 400 mg (test product), orally, once on Day 1 of Period 1 or Period 2 as per randomization schedule under fasting conditions. Participants were instructed to take the study product after an overnight fast of at least 10 hours by dissolving it in 240 mL of warm water. | 0 | None | 0 | 34 | 6 | 34 | View |
| Fed Cohort: Ibuprofen Arginine Granules 400 mg (Test) | Participants received one sachet of ibuprofen arginine granules 400 mg (test product), orally, once on Day 1 of Period 1 or Period 2 as per randomization schedule under fed conditions. Participants were instructed to take the study product after a high-fat/high-calorie meal by dissolving it in 240 mL of warm water. | 0 | None | 0 | 50 | 11 | 50 | View |
| Fed Cohort: Ibuprofen Arginine Granules 400 mg (Spedifen) (Reference) | Participants received one sachet of ibuprofen arginine granules 400 mg (Spedifen) (reference product), orally, once on Day 1 of Period 1 or Period 2 as per randomization schedule under fed conditions. Participants were instructed to take the study product after a high-fat/high-calorie meal by dissolving it in 240 mL of warm water. | 0 | None | 0 | 50 | 10 | 50 | View |
Serious Events(If Any):
Other Events(If Any):
Other Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| White blood cells urine positive | SYSTEMATIC_ASSESSMENT | Investigations | None | View |
| Blood pressure decreased | SYSTEMATIC_ASSESSMENT | Investigations | None | View |
| Blood uric acid increased | SYSTEMATIC_ASSESSMENT | Investigations | None | View |
| Eosinophil percentage increased | SYSTEMATIC_ASSESSMENT | Investigations | None | View |
| Heart rate decreased | SYSTEMATIC_ASSESSMENT | Investigations | None | View |
| Heart rate increased | SYSTEMATIC_ASSESSMENT | Investigations | None | View |
| Low density lipoprotein increased | SYSTEMATIC_ASSESSMENT | Investigations | None | View |
| Neutrophil count decreased | SYSTEMATIC_ASSESSMENT | Investigations | None | View |
| Respiratory rate increased | SYSTEMATIC_ASSESSMENT | Investigations | None | View |
| Alanine aminotransferase increased | SYSTEMATIC_ASSESSMENT | Investigations | None | View |
| Urinary occult blood positive | SYSTEMATIC_ASSESSMENT | Investigations | None | View |
| Aspartate aminotransferase increased | SYSTEMATIC_ASSESSMENT | Investigations | None | View |
| Blood glucose increased | SYSTEMATIC_ASSESSMENT | Investigations | None | View |
| Red blood cells urine positive | SYSTEMATIC_ASSESSMENT | Investigations | None | View |
| Rash | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | None | View |