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 @ 3:13 AM
Ignite Modification Date:
2025-12-26 @ 1:52 AM
NCT ID:
NCT02017405
Description:
None
Frequency Threshold:
3
Time Frame:
16 Days
Study:
NCT02017405
Study Brief:
Study Evaluating the Digestibility of Serum-Derived Bovine Immunoglobulin Protein Isolate in Healthy Adults
Event Groups(If Any):
Event Groups
| Title | Description | Deaths # Affected | Deaths # At Risk | Serious # Affected | Serious # At Risk | Other # Affected | Other # At Risk | View |
|---|---|---|---|---|---|---|---|---|
| 5g Serum-derived Bovine Immunoglobulin Protein Isolate (SBI) - Crossover Phase | Subjects that received 5g SBI on either day 1 or day 2 of the crossover phase and reported AE during crossover phase. This includes groups 1A and 1B in the crossover phase. | 0 | None | 0 | 18 | 4 | 18 | View |
| 10g Serum-derived Bovine Immunoglobulin Protein Isolate (SBI) - Crossover Phase | Subjects that received 10g on either day 1 or day 2 of the crossover phase and reported AE during crossover phase. This includes groups 2A and 2B in the crossover phase. | 0 | None | 0 | 12 | 0 | 12 | View |
| 20g Serum-derived Bovine Immunoglobulin Protein Isolate (SBI) - Crossover Phase | Subjects that received 20g on either day 1 or day 2 of the crossover phase and reported AE during crossover phase. This includes groups 3A and 3B in the crossover phase. | 0 | None | 0 | 14 | 3 | 11 | View |
| Placebo - Crossover Phase | Subjects that received 5, 10, or 20g placebo dose on either day 1 or day 2 of the crossover phase and reported AE during crossover phase. This includes all subjects in the crossover phase. | 0 | None | 0 | 42 | 0 | 42 | View |
| 5g Serum-derived Bovine Immunoglobulin Protein Isolate (SBI) - Open Label Phase | Patients that took 2.5g SBI BID (5g daily) during 14 day open label phase. Reported AE during 14 day open label phase. This includes groups 1A and 1B in the open label phase. | 0 | None | 0 | 14 | 7 | 14 | View |
| 10g Serum-derived Bovine Immunoglobulin Protein Isolate (SBI) - Open Label Phase | Patients that took 5g SBI BID (10g daily) during 14 day open label phase. Reported AE during 14 day open label phase. This includes groups 2A and 2B in the open label phase. | 0 | None | 0 | 14 | 4 | 14 | View |
| 20g Serum-derived Bovine Immunoglobulin Protein Isolate (SBI) - Open Label Phase | Patients that took 10g SBI BID (20g daily) during 14 day open label phase. Reported AE during 14 day open label phase. This includes groups 3A and 3B in the open label phase. | 0 | None | 0 | 13 | 5 | 13 | View |
Serious Events(If Any):
Other Events(If Any):
Other Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Headache | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA | View |
| Abdominal pain | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA | View |
| Constipation | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA | View |
| Sinus infection | NON_SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA | View |
| Upper respiratory infection | NON_SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA | View |
| Pain in left leg | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA | View |
| Flu | NON_SYSTEMATIC_ASSESSMENT | Immune system disorders | MedDRA | View |
| Running nose | NON_SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA | View |
| Bloated Feeling | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA | View |
| Common Cold | NON_SYSTEMATIC_ASSESSMENT | General disorders | MedDRA | View |
| Flatulence | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA | View |
| Diarrhea | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA | View |
| Lightheadedness | NON_SYSTEMATIC_ASSESSMENT | General disorders | MedDRA | View |
| Knee Pain | NON_SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA | View |
| Gum Shifting | NON_SYSTEMATIC_ASSESSMENT | General disorders | MedDRA | View |
| Cramp | NON_SYSTEMATIC_ASSESSMENT | General disorders | MedDRA | View |
| Abdominal Cramp | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA | View |
| Hypoglycemia | NON_SYSTEMATIC_ASSESSMENT | General disorders | MedDRA | View |
| Bladder Irritation | NON_SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | MedDRA | View |
| Nausea | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA | View |
| Sore throat | NON_SYSTEMATIC_ASSESSMENT | General disorders | MedDRA | View |