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 @ 5:43 PM
Ignite Modification Date:
2025-12-25 @ 3:12 PM
NCT ID:
NCT03760068
Description:
None
Frequency Threshold:
1
Time Frame:
Adverse Event (AE)s or Serious Adverse Event (SAE)s were collected from the time the subject signed the informed consent form through the completion of the follow-up visit or 14 days after last dose of study medication.
Study:
NCT03760068
Study Brief:
Mylan Insulin Aspart 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 |
|---|---|---|---|---|---|---|---|---|
| MYL-1601D Product (100 U/mL) | MYL-1601D (100 U/mL) taken at mealtime. Product provided in a prefilled disposable pen with a 3-mL cartridge. Subjects also received during the treatment period once-daily Lantus SoloSTAR (insulin glargine injection, 100 U/mL), manufactured by Sanofi-Aventis. | 0 | None | 22 | 238 | 92 | 238 | View |
| FlexPen NovoLog® (100 U/mL) | FlexPen NovoLog®: (100 U/mL) taken at mealtime. Product provided in a prefilled disposable pen with a 3-mL cartridge. Subjects also received during the treatment period once-daily Lantus SoloSTAR (insulin glargine injection, 100 U/mL), manufactured by Sanofi-Aventis. | 1 | None | 15 | 240 | 99 | 240 | View |
Serious Events(If Any):
Serious Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Anemia | NON_SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | MedDRA Version 22.0 | View |
| Colititis | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA Version 22.0 | View |
| Chest Pain | NON_SYSTEMATIC_ASSESSMENT | General disorders | MedDRA Version 22.0 | View |
| Anal Abscess | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA Version 22.0 | View |
| Cellulitis | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA Version 22.0 | View |
| Gastroenteritis | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA Version 22.0 | View |
| Incision Site Cellulitis | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA Version 22.0 | View |
| Perineal Abscess | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA Version 22.0 | View |
| Pneumonia | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA Version 22.0 | View |
| Pyelonephritis | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA Version 22.0 | View |
| Sepsis | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA Version 22.0 | View |
| Concussion | NON_SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA Version 22.0 | View |
| Skin Laceration | NON_SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA Version 22.0 | View |
| Hypoglycemia | NON_SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA Version 22.0 | View |
| Diabetic Ketoacidosis | NON_SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA Version 22.0 | View |
| Basal Cell Carcinoma | NON_SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA Version 22.0 | View |
| Hypoglycemic Seizure | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA Version 22.0 | View |
| Suicidal Ideation | NON_SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MedDRA Version 22.0 | View |
| Acute Respiratory Failure | NON_SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA Version 22.0 | View |
| Victim of Homicide | NON_SYSTEMATIC_ASSESSMENT | Social circumstances | MedDRA Version 22.0 | View |
Other Events(If Any):
Other Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Anemia | NON_SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | MedDRA Version 22.0 | View |
| Diarrhea | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA Version 22.0 | View |
| Nausea | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA Version 22.0 | View |
| Upper Respiratory Tract Infection | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA Version 22.0 | View |
| Headache | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA Version 22.0 | View |
| Food Poisoning | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA Version 22.0 | View |
| Dyspepsia | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA Version 22.0 | View |
| Gastroesophageal Reflux Disease | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA Version 22.0 | View |
| Fatigue | NON_SYSTEMATIC_ASSESSMENT | General disorders | MedDRA Version 22.0 | View |
| Influenza Like Illness | NON_SYSTEMATIC_ASSESSMENT | General disorders | MedDRA Version 22.0 | View |
| Nasopharyngitis | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA Version 22.0 | View |
| Urinary Tract Infection | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA Version 22.0 | View |
| Sinusitis | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA Version 22.0 | View |
| Influenza | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA Version 22.0 | View |
| Gastroenteritis | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA Version 22.0 | View |
| Weight Increased | NON_SYSTEMATIC_ASSESSMENT | Investigations | MedDRA Version 22.0 | View |
| Blood Pressure Increased | NON_SYSTEMATIC_ASSESSMENT | Investigations | MedDRA Version 22.0 | View |
| Glycosylated Hemoglobin Increased | NON_SYSTEMATIC_ASSESSMENT | Investigations | MedDRA Version 22.0 | View |
| Crystal Urine Present | NON_SYSTEMATIC_ASSESSMENT | Investigations | MedDRA Version 22.0 | View |
| Hyperglycemia | NON_SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA Version 22.0 | View |
| Hyperlipidemia | NON_SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA Version 22.0 | View |
| Cough | NON_SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA Version 22.0 | View |
| Sinus Congestion | NON_SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA Version 22.0 | View |
| Orophayngeal Pain | NON_SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA Version 22.0 | View |
| Hypertension | NON_SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDRA Version 22.0 | View |