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 @ 3:15 PM
Ignite Modification Date:
2025-12-25 @ 1:37 PM
NCT ID:
NCT04976192
Description:
The safety analysis set included all randomized participants who received at least 1 dose of study drug. The transition period safety analysis set included all randomized participants who received the study drug at Week 12.
Frequency Threshold:
5
Time Frame:
Baseline up to Week 40
Study:
NCT04976192
Study Brief:
Study to Compare Efficacy and Safety of TEV-45779 With XOLAIR (Omalizumab) in Adults With Chronic Idiopathic Urticaria
Event Groups(If Any):
Event Groups
| Title | Description | Deaths # Affected | Deaths # At Risk | Serious # Affected | Serious # At Risk | Other # Affected | Other # At Risk | View |
|---|---|---|---|---|---|---|---|---|
| Main Treatment Period: TEV-45779 High Dose | Participants received TEV-45779 SC injection at a high dose level Q4W at Weeks 0, 4, and 8. | 0 | None | 1 | 201 | 30 | 201 | View |
| Main Treatment Period: TEV-45779 Low Dose | Participants received TEV-45779 SC injection at a low dose level Q4W at Weeks 0, 4, and 8. | 0 | None | 0 | 102 | 19 | 102 | View |
| Main Treatment Period: XOLAIR High Dose | Participants received XOLAIR SC injection at a high dose level Q4W at Weeks 0, 4, and 8. | 0 | None | 3 | 203 | 30 | 203 | View |
| Main Treatment Period: XOLAIR Low Dose | Participants received XOLAIR SC injection at a low dose level Q4W at Weeks 0, 4, and 8. | 0 | None | 0 | 102 | 10 | 102 | View |
| Transition Period: TEV-45779/TEV-45779 High Dose | Participants who received TEV-45779 SC injection at a high dose level in the main treatment period continued to receive TEV-45779 at the same dose level at Weeks 12, 16, and 20 in the transition period. | 0 | None | 4 | 188 | 29 | 188 | View |
| Transition Period: TEV-45779/TEV-45779 Low Dose | Participants who received TEV-45779 SC injection at a low dose level in the main treatment period continued to receive TEV-45779 at the same dose level at Weeks 12, 16, and 20 in the transition period. | 0 | None | 3 | 98 | 11 | 98 | View |
| Transition Period: XOLAIR/XOLAIR High Dose | Participants who received XOLAIR SC injection at a high dose level in the main treatment period continued to receive XOLAIR at the same dose level at Weeks 12, 16, and 20 in the transition period. | 0 | None | 4 | 97 | 16 | 97 | View |
| Transition Period: XOLAIR/TEV-45779 High Dose | Participants who received XOLAIR SC injection at a high dose level in the main treatment period, received TEV-45779 at a high dose level at Weeks 12, 16, and 20 in the transition period. | 0 | None | 1 | 97 | 10 | 97 | View |
| Transition Period: XOLAIR/TEV-45779 Low Dose | Participants who received XOLAIR SC injection at a low dose level in the main treatment period, received TEV-45779 at a low dose level at Weeks 12, 16, and 20 in the transition period. | 0 | None | 1 | 50 | 6 | 50 | View |
| Transition Period: XOLAIR/XOLAIR Low Dose | Participants who received XOLAIR SC injection at a low dose level in the main treatment period continued to receive XOLAIR at the same dose level at Weeks 12, 16, and 20 in the transition period. | 0 | None | 0 | 51 | 8 | 51 | View |
Serious Events(If Any):
Serious Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Strangulated umbilical hernia | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 24.0 | View |
| Erysipelas | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 24.0 | View |
| Lower limb fracture | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA 24.0 | View |
| Back pain | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA 24.0 | View |
| Rotator cuff syndrome | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA 24.0 | View |
| Adenomyosis | SYSTEMATIC_ASSESSMENT | Reproductive system and breast disorders | MedDRA 24.0 | View |
| Pulmonary oedema | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA 24.0 | View |
| Urticaria | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA 24.0 | View |
| Colitis | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 24.0 | View |
| Pancreatitis | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 24.0 | View |
| Pyrexia | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA 24.0 | View |
| Cholelithiasis | SYSTEMATIC_ASSESSMENT | Hepatobiliary disorders | MedDRA 24.0 | View |
| Epiglottitis | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 24.0 | View |
| Pyelonephritis chronic | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 24.0 | View |
| Urinary tract infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 24.0 | View |
| Chondromalacia | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA 24.0 | View |
Other Events(If Any):
Other Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Injection site erythema | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA 24.0 | View |
| Injection site induration | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA 24.0 | View |
| Injection site pain | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA 24.0 | View |
| Injection site swelling | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA 24.0 | View |
| COVID-19 | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 24.0 | View |
| Upper respiratory tract infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 24.0 | View |