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 @ 1:32 AM
Ignite Modification Date:
2025-12-25 @ 11:45 PM
NCT ID:
NCT02716194
Description:
Adverse events were recorded throughout the study from screening to completion/termination visit.
Frequency Threshold:
0
Time Frame:
Throughout the study period (total study duration approximately 9 months). For each participant from screening until study termination visit (approximately 6 weeks ± 4 days after BAX 826 administration).
Study:
NCT02716194
Study Brief:
BAX 826 Dose-Escalation Safety Study
Event Groups(If Any):
Event Groups
| Title | Description | Deaths # Affected | Deaths # At Risk | Serious # Affected | Serious # At Risk | Other # Affected | Other # At Risk | View |
|---|---|---|---|---|---|---|---|---|
| Cohort 3 - High Dose BAX 826 | After the washout period following the infusion of 75±3 IU/kg ADVATE, participants received a single dose of BAX 826, equivalent to the ADVATE dose they had received, followed by a 7-day PK evaluation. | 0 | None | 0 | 13 | 5 | 13 | View |
| Cohort 1 - Low Dose BAX 826 | After the 4 day washout period following the infusion of 25±3 IU/kg ADVATE, participants received a single dose of BAX 826, equivalent to the ADVATE dose they had received, followed by a 7-day PK evaluation. | 0 | None | 0 | 10 | 6 | 10 | View |
| Cohort 2 - Medium Dose BAX 826 | After the washout period following the infusion of 50±5 IU/kg ADVATE, participants received a single dose of BAX 826, equivalent to the ADVATE dose they had received, followed by a 7-day PK evaluation. | 0 | None | 0 | 15 | 6 | 15 | View |
| Cohort 3 - High Dose ADVATE | Participants received an infusion of 75±3 IU/kg ADVATE followed by a minimum 4-day (96 hours) wash out period including a 3 day PK evaluation. | 0 | None | 0 | 13 | 4 | 13 | View |
| Cohort 1 - Low Dose ADVATE | Participants received an infusion of 25±3 IU/kg ADVATE followed by a minimum 4-day (96 hours) wash out period including a 3 day PK evaluation. | 0 | None | 0 | 11 | 3 | 11 | View |
| Cohort 2 - Medium Dose ADVATE | Participants received an infusion of 50±5 IU/kg ADVATE followed by a minimum 4-day (96 hours) wash out period including a 3 day PK evaluation. | 0 | None | 0 | 16 | 0 | 16 | View |
Serious Events(If Any):
Other Events(If Any):
Other Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Eye pruritus | NON_SYSTEMATIC_ASSESSMENT | Eye disorders | MedDRA 19.1 | View |
| Abdominal wall haemorrhage | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 19.1 | View |
| Diarrhoea | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 19.1 | View |
| Drug ineffective | NON_SYSTEMATIC_ASSESSMENT | General disorders | MedDRA 19.1 | View |
| Pyrexia | NON_SYSTEMATIC_ASSESSMENT | General disorders | MedDRA 19.1 | View |
| Hepatitis C | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 19.1 | View |
| Nasopharyngitis | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 19.1 | View |
| Oral herpes | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 19.1 | View |
| Contusion | NON_SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA 19.1 | View |
| Laceration | NON_SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA 19.1 | View |
| Muscle strain | NON_SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA 19.1 | View |
| Traumatic haemorrhage | NON_SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA 19.1 | View |
| Alanine aminotransferase increased | NON_SYSTEMATIC_ASSESSMENT | Investigations | MedDRA 19.1 | View |
| Aspartate aminotransferase increased | NON_SYSTEMATIC_ASSESSMENT | Investigations | MedDRA 19.1 | View |
| Blood urine present | NON_SYSTEMATIC_ASSESSMENT | Investigations | MedDRA 19.1 | View |
| High density lipoprotein decreased | NON_SYSTEMATIC_ASSESSMENT | Investigations | MedDRA 19.1 | View |
| Arthralgia | NON_SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA 19.1 | View |
| Back pain | NON_SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA 19.1 | View |
| Haemarthrosis | NON_SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA 19.1 | View |
| Joint range of motion decreased | NON_SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA 19.1 | View |
| Muscle haemorrhage | NON_SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA 19.1 | View |
| Myalgia | NON_SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA 19.1 | View |
| Dysuria | NON_SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | MedDRA 19.1 | View |
| Cough | NON_SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA 19.1 | View |
| Erythema | NON_SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA 19.1 | View |
| Haematoma | NON_SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDRA 19.1 | View |
| Haemorrhage | NON_SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDRA 19.1 | View |
| Ear pain | NON_SYSTEMATIC_ASSESSMENT | Ear and labyrinth disorders | MedDRA 19.1 | View |
| Dyspepsia | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 19.1 | View |
| Joint swelling | NON_SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA 19.1 | View |
| Dizziness | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA 19.1 | View |
| Headache | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA 19.1 | View |