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 @ 11:33 PM
Ignite Modification Date:
2025-12-25 @ 9:22 PM
NCT ID:
NCT00500656
Description:
None
Frequency Threshold:
5
Time Frame:
An AE was assigned to the controlled phase if the start date of the event was between the first treatment of the first attack and the first treatment in the OLE phase.
Study:
NCT00500656
Study Brief:
Subcutaneous Treatment With Icatibant for Acute Attacks of Hereditary Angioedema (HAE)
Event Groups(If Any):
Event Groups
| Title | Description | Deaths # Affected | Deaths # At Risk | Serious # Affected | Serious # At Risk | Other # Affected | Other # At Risk | View |
|---|---|---|---|---|---|---|---|---|
| Controlled Phase- Icatibant (Randomized Subjects ) | Patients who were randomized to icatibant+ oral placebo in the controlled phase and experienced adverse events while participating in the controlled phase | None | None | 4 | 36 | 19 | 36 | View |
| Controlled Phase- Tranexamic Acid (Randomized Subjects) | Patients who were randomized to Tranexamic acid+ S.C. placebo in the controlled phase and experienced adverse events while participating in the controlled phase. | None | None | 1 | 38 | 16 | 38 | View |
| Controlled Phase- Icatibant (Subjects w/ Laryngeal Attack) | This represents adverse events during the controlled phase that were experienced by Patients with laryngeal symptoms at the baseline and were treated with open label icatibant during the controlled phase. | None | None | 1 | 3 | 1 | 3 | View |
| Open Label Extension Phase- Icatibant (Previously Randomized) | Patients who were randomized to either icatibant+ oral placebo or Tranexamic acid+ S.C. placebo in the controlled phase and experienced adverse events while participating in the open label extension phase. | None | None | 9 | 44 | 31 | 44 | View |
| Open Label Extension Phase (Subjects w/ Laryngeal Attack) | This represents adverse events during the open label extension phase that were experienced by Patients with laryngeal symptoms at the baseline and got treated with open label icatibant during the controlled phase and Open label extension phase. | None | None | 1 | 2 | 1 | 2 | View |
| Open Label Extension Phase(Untreated Patients at the Baseline | This represents adverse events experienced by Patients who were screened and found eligible but did not experience an angioedema attack, or had an attack that was not severe enough to merit treatment while the controlled phase was ongoing. | None | None | 0 | 8 | 4 | 8 | View |
Serious Events(If Any):
Serious Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Hereditary Angioedema | SYSTEMATIC_ASSESSMENT | Congenital, familial and genetic disorders | MedDRA version 8.1 | View |
| Aortic Value Sclerosis | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA version 8.1 | View |
| Sudden Cardiac Death | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA version 8.1 | View |
| Cholelithiasis | SYSTEMATIC_ASSESSMENT | Hepatobiliary disorders | MedDRA version 8.1 | View |
| Cystitis | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA version 8.1 | View |
| Gastroenteritis | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA version 8.1 | View |
| Hypertensive Crisis | SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDRA version 8.1 | View |
| Coronary Artery Disease | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA version 8.1 | View |
| Head Injury | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA version 8.1 | View |
| Wound | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA version 8.1 | View |
| Pancreatic Enzymes Increased | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA version 8.1 | View |
| Myalgia | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA version 8.1 | View |
| Suicide Attempt | SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MedDRA version 8.1 | View |
| Renal Failure | SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | MedDRA version 8.1 | View |
| Tooth Extraction | SYSTEMATIC_ASSESSMENT | Surgical and medical procedures | MedDRA version 8.1 | View |
| Urinary Track Infection Bacterial | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA version 8.1 | View |
| Road Traffic Accident | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA version 8.1 | View |
| Cervix Carcinoma Stage 0 | SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA version 8.1 | View |
Other Events(If Any):
Other Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Injury, poisoning and procedual complications | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | Organ system | View |
| Musculoskeletal and connective tissue disorders | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | organ system | View |
| Hereditary Angioedema | SYSTEMATIC_ASSESSMENT | Congenital, familial and genetic disorders | MedDRA version 8.1 | View |
| Injection Site Reaction | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA version 8.1 | View |
| Nasopharyngitis | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA version 8.1 | View |
| Pharyngitis | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA version 8.1 | View |
| Headache | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA version 8.1 | View |
| Urinary Track Infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA version 8.1 | View |
| Gingival Infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA version 8.1 | View |
| Dental Caries | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA version 8.1 | View |
| Respiratory Track Infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA version 8.1 | View |
| Dizziness | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA version 8.1 | View |
| Pruritus | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA version 8.1 | View |
| Dental Operation | SYSTEMATIC_ASSESSMENT | Surgical and medical procedures | MedDRA version 8.1 | View |
| Blood and Lymphatic system disorders | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | Organ system | View |