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 @ 11:52 PM
Ignite Modification Date:
2025-12-25 @ 9:47 PM
NCT ID:
NCT01445951
Description:
Adverse Events (AE) are summarized according to how subjects were treated, not randomized. One subject that was randomized to the Technosphere Insulin-MedTone + Basal Insulin arm was treated with Insulin aspart + Basal Insulin throughout the trial.
Frequency Threshold:
2
Time Frame:
Baseline to Week 24
Study:
NCT01445951
Study Brief:
Clinical Trial Evaluating Technosphere® Insulin Versus Insulin Aspart in Subjects With Type 1 Diabetes Mellitus Over a 24-week Treatment Period
Event Groups(If Any):
Event Groups
| Title | Description | Deaths # Affected | Deaths # At Risk | Serious # Affected | Serious # At Risk | Other # Affected | Other # At Risk | View |
|---|---|---|---|---|---|---|---|---|
| Technosphere ® Insulin-Gen2 Group | Subject will receive Technosphere Insulin with Gen2 Inhaler and remain on the basal insulin they were taking prior to study entry Technosphere ®Insulin with Gen2 Inhaler: Inhalation Powder and injectable insulin | None | None | 5 | 174 | 81 | 174 | View |
| Technosphere® Insulin With MedTone C Inhaler | Subjects will receive TI with the MedToneC inhaler and remain on the basal insulin they were taking prior to study entry Technosphere® Insulin with MedTone C Inhaler: Inhalation Powder and injectable insulin | None | None | 9 | 173 | 74 | 173 | View |
| Aspart Group | Subjects will receive insulin aspart and remain on the basal insulin they were taking prior to study entry Insulin Aspart in combination with a basal insulin: Injectable insulin | None | None | 7 | 171 | 50 | 171 | View |
Serious Events(If Any):
Serious Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Cytomegalovirus Infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (15.1) | View |
| Appendicitis | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (15.1) | View |
| Joint Dislocation | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA (15.1) | View |
| Hypoglycaemia | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA (15.1) | View |
| Spinal Osteoarthritis | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA (15.1) | View |
| Hypoglycaemic Unconsciousness | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA (15.1) | View |
| Hypoglycaemic Seizure | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA (15.1) | View |
| Mental Status Changes | SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MedDRA (15.1) | View |
| Cervical Polyp | SYSTEMATIC_ASSESSMENT | Reproductive system and breast disorders | MedDRA (15.1) | View |
| Bronchial Hyperreactivity | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA (15.1) | View |
| Chest Discomfort | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA (15.1) | View |
| Drowning | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA (15.1) | View |
Other Events(If Any):
Other Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Cough | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA (15.1) | View |
| Upper Respiratory Tract Infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (15.1) | View |
| Headache | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA (15.1) | View |
| Dyspnoea | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA (15.1) | View |
| Nasopharyngitis | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (15.1) | View |
| Throat Irritation | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA (15.1) | View |
| Oropharyngeal Pain | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA (15.1) | View |
| Influenza | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (15.1) | View |
| Vomiting | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (15.1) | View |
| Nausea | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (15.1) | View |
| Blood Creatine Phosphokinase Increase | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA (15.1) | View |
| Bronchitis | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (15.1) | View |
| Diarrhoea | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (15.1) | View |
| Urinary Tract Infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (15.1) | View |