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 @ 1:05 PM
Ignite Modification Date:
2025-12-25 @ 12:20 PM
NCT ID:
NCT01238861
Description:
The safety population included all participants who received any investigational product and had safety data available for analysis. One participant, randomized to the EOS- placebo group received a single dose of 100 mg benralizumab on Week 16 and was analyzed for safety in the 100 mg benralizumab group .
Frequency Threshold:
2
Time Frame:
From initiation of investigational product administration up to Week 92
Study:
NCT01238861
Study Brief:
Study to Evaluate the Efficacy and Safety of MEDI-563 in Adults With Uncontrolled Asthma
Event Groups(If Any):
Event Groups
| Title | Description | Deaths # Affected | Deaths # At Risk | Serious # Affected | Serious # At Risk | Other # Affected | Other # At Risk | View |
|---|---|---|---|---|---|---|---|---|
| EOS POS Placebo | EOS+ participants received two placebo injections subcutaneously. | None | None | 7 | 80 | 44 | 80 | View |
| EOS POS Benralizumab 2 mg | EOS+ participants received single benralizumab 2 milligram (mg) injection followed by a single placebo injection subcutaneously. | None | None | 10 | 81 | 54 | 81 | View |
| EOS POS Benralizumab 20 mg | EOS+ participants received single benralizumab 20 mg injection followed by a single placebo injection subcutaneously. | None | None | 6 | 81 | 57 | 81 | View |
| EOS POS Benralizumab 100 mg | EOS+ participants received two benralizumab 50 mg injections subcutaneously. | None | None | 6 | 82 | 68 | 82 | View |
| EOS NEG Placebo | EOS- participants received two placebo injections subcutaneously. | None | None | 16 | 141 | 94 | 141 | View |
| EOS NEG Benralizumab 100 mg | EOS- participants received two benralizumab 50 mg injections subcutaneously. | None | None | 18 | 141 | 93 | 141 | View |
Serious Events(If Any):
Serious Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Acute myocardial infarct | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA 16.0 | View |
| Atrial fibrillation | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA 16.0 | View |
| Cardiac failure acute | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA 16.0 | View |
| Myocardial ischaemia | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA 16.0 | View |
| Supraventricular tachyca | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA 16.0 | View |
| Abdominal hernia | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 16.0 | View |
| Gastrooesophageal reflux | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 16.0 | View |
| Intestinal obstruction | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 16.0 | View |
| Cholecystitis | SYSTEMATIC_ASSESSMENT | Hepatobiliary disorders | MedDRA 16.0 | View |
| Cholecystitis acute | SYSTEMATIC_ASSESSMENT | Hepatobiliary disorders | MedDRA 16.0 | View |
| Drug hypersensitivity | SYSTEMATIC_ASSESSMENT | Immune system disorders | MedDRA 16.0 | View |
| Bronchitis | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 16.0 | View |
| Cholecystitis infective | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 16.0 | View |
| Gastritis viral | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 16.0 | View |
| Herpes zoster | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 16.0 | View |
| Pneumonia | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 16.0 | View |
| Abdominal wound dehiscen | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA 16.0 | View |
| Hypercholesterolaemia | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA 16.0 | View |
| Back pain | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA 16.0 | View |
| Musculoskeletal pain | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA 16.0 | View |
| Osteochondrosis | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA 16.0 | View |
| Malignant melanoma | SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 16.0 | View |
| Thyroid neoplasm | SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 16.0 | View |
| Convulsion | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA 16.0 | View |
| Grand mal convulsion | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA 16.0 | View |
| Ischaemic stroke | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA 16.0 | View |
| Syncope | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA 16.0 | View |
| Depression | SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MedDRA 16.0 | View |
| Insomnia | SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MedDRA 16.0 | View |
| Asthma | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA 16.0 | View |
| Asthmatic crisis | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA 16.0 | View |
| Nasal polyps | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA 16.0 | View |
| Pulmonary embolism | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA 16.0 | View |
| Erythema nodosum | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA 16.0 | View |
| Urticaria | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA 16.0 | View |
| Umbilical hernia | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 16.0 | View |
| Anaphylactic reaction | SYSTEMATIC_ASSESSMENT | Immune system disorders | MedDRA 16.0 | View |
| Gastroenteritis | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 16.0 | View |
| Post procedural cellulit | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 16.0 | View |
| Postoperative wound infe | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 16.0 | View |
| Tonsillitis bacterial | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 16.0 | View |
| Ulna fracture | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA 16.0 | View |
| Uterine leiomyoma | SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 16.0 | View |
| Interstitial lung diseas | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA 16.0 | View |
| Eczema | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA 16.0 | View |
| Hypertension | SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDRA 16.0 | View |
| Polyarteritis nodosa | SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDRA 16.0 | View |
| Abdominal pain | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 16.0 | View |
| Eczema infected | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 16.0 | View |
| Enteritis infectious | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 16.0 | View |
| Spinal osteoarthritis | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA 16.0 | View |
| Fibrous histiocytoma | SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 16.0 | View |
| Lower respiratory tract | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 16.0 | View |
Other Events(If Any):
Other Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Injection site erythema | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA 16.0 | View |
| Influenza | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 16.0 | View |
| Sinusitis | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 16.0 | View |
| Nausea | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 16.0 | View |
| Injection site pain | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA 16.0 | View |
| Pyrexia | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA 16.0 | View |
| Acute sinusitis | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 16.0 | View |
| Bronchitis | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 16.0 | View |
| Nasopharyngitis | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 16.0 | View |
| Pharyngitis | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 16.0 | View |
| Rhinitis | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 16.0 | View |
| Upper respiratory tract | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 16.0 | View |
| Urinary tract infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 16.0 | View |
| Arthralgia | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA 16.0 | View |
| Back pain | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA 16.0 | View |
| Myalgia | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA 16.0 | View |
| Headache | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA 16.0 | View |
| Asthma | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA 16.0 | View |
| Rhinitis allergic | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA 16.0 | View |
| Hypertension | SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDRA 16.0 | View |