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 @ 2:13 PM
Ignite Modification Date:
2025-12-25 @ 12:52 PM
NCT ID:
NCT00659295
Description:
Full Analysis Set. This is a non-interventional study. According to the primary endpoint/outcome measure, the serious events collected in all countries are Serious Drug Reactions only, and not Serious Adverse Events and other adverse events
Frequency Threshold:
0
Time Frame:
Over 3, 6 and 12 months, respectively, depending on the participating country
Study:
NCT00659295
Study Brief:
Observational Study to Evaluate the Safety of Levemir® in Diabetes
Event Groups(If Any):
Event Groups
| Title | Description | Deaths # Affected | Deaths # At Risk | Serious # Affected | Serious # At Risk | Other # Affected | Other # At Risk | View |
|---|---|---|---|---|---|---|---|---|
| Type 1 Diabetes | Prescription of insulin detemir (Levemir®) according to local approved labelling by prescribing physician in a normal clinical practice to patients with type 1 diabetes, including newly diagnosed patients who have never received insulin or analogue treatment. | None | None | 130 | 13529 | 0 | 13529 | View |
| Type 2 Diabetes | Prescription of insulin detemir (Levemir®) according to local approved labelling by prescribing physician in a normal clinical practice to patients with type 1 diabetes, including newly diagnosed patients who have never received insulin or analogue treatment. | None | None | 80 | 37641 | 0 | 37641 | View |
Serious Events(If Any):
Serious Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Ventricular extrasystoles | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA (Unspecified) | View |
| Cardiac failure | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA (Unspecified) | View |
| Cardiac arrest | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA (Unspecified) | View |
| Cardiac failure congestive | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA (Unspecified) | View |
| Cardio-respiratory arrest | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA (Unspecified) | View |
| Diabetic retinopathy | SYSTEMATIC_ASSESSMENT | Eye disorders | MedDRA (Unspecified) | View |
| Gastric ulcer | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (Unspecified) | View |
| Nausea | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (Unspecified) | View |
| Vomiting | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (Unspecified) | View |
| Abdominal pain | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (Unspecified) | View |
| Adrenocortical insufficiency acute | SYSTEMATIC_ASSESSMENT | Endocrine disorders | MedDRA (Unspecified) | View |
| Asthenia | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA (Unspecified) | View |
| Chest pain | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA (Unspecified) | View |
| Condition aggravated | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA (Unspecified) | View |
| Death | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA (Unspecified) | View |
| Hypothermia | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA (Unspecified) | View |
| Injection site oedema | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA (Unspecified) | View |
| Injection site rash | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA (Unspecified) | View |
| Injection site erythema | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA (Unspecified) | View |
| Injection site pruritus | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA (Unspecified) | View |
| Pain | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA (Unspecified) | View |
| Injection site pain | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA (Unspecified) | View |
| Injection site reaction | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA (Unspecified) | View |
| Injection site stinging | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA (Unspecified) | View |
| Injection site warmth | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA (Unspecified) | View |
| Generalised oedema | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA (Unspecified) | View |
| Malaise | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA (Unspecified) | View |
| Pyrexia | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA (Unspecified) | View |
| Sudden death | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA (Unspecified) | View |
| Hepatitis | SYSTEMATIC_ASSESSMENT | Hepatobiliary disorders | MedDRA (Unspecified) | View |
| Hypersensitivity | SYSTEMATIC_ASSESSMENT | Immune system disorders | MedDRA (Unspecified) | View |
| Tinea capitis | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (Unspecified) | View |
| Gastroenteritis | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (Unspecified) | View |
| Pneumonia | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (Unspecified) | View |
| Cellulitis | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (Unspecified) | View |
| Accidental overdose | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA (Unspecified) | View |
| Blister | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA (Unspecified) | View |
| Contusion | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA (Unspecified) | View |
| Fall | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA (Unspecified) | View |
| Limp injury | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA (Unspecified) | View |
| Medication error | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA (Unspecified) | View |
| Blood glucose increase | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA (Unspecified) | View |
| Blood glucose fluctuation | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA (Unspecified) | View |
| Blood glucose decrease | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA (Unspecified) | View |
| Diabetes mellitus | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA (Unspecified) | View |
| Diabetes mellitus inadequate control | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA (Unspecified) | View |
| Diabetic ketoacidosis | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA (Unspecified) | View |
| Hyperglycaemia | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA (Unspecified) | View |
| Hypoglycaemia | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA (Unspecified) | View |
| Hypoglycaemia unawareness | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA (Unspecified) | View |
| Hypoglycaemic seizure | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA (Unspecified) | View |
| Hypoglycaemic unconsciousness | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA (Unspecified) | View |
| Ketoacidosis | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA (Unspecified) | View |
| Arthritis | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA (Unspecified) | View |
| Renal cell carcinoma | SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (Unspecified) | View |
| Coma acidotic | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA (Unspecified) | View |
| Convulsion | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA (Unspecified) | View |
| Depressed level of consciousness | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA (Unspecified) | View |
| Dizziness | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA (Unspecified) | View |
| Encephalopathy | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA (Unspecified) | View |
| Hypoglycaemic coma | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA (Unspecified) | View |
| Hypoglycaemic encephalopathy | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA (Unspecified) | View |
| Loss of consciousness | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA (Unspecified) | View |
| Anxiety | SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MedDRA (Unspecified) | View |
| Dyspnoea | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA (Unspecified) | View |
| Pneumonitis | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA (Unspecified) | View |
| Drug eruption | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA (Unspecified) | View |
| Erythema | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA (Unspecified) | View |
| Pityriasis rubra pilaris | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA (Unspecified) | View |
| Prurigo | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA (Unspecified) | View |
| Pruritus | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA (Unspecified) | View |
| Pruritus generalised | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA (Unspecified) | View |
| Rash | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA (Unspecified) | View |
| Transmyocardial revascularisation | SYSTEMATIC_ASSESSMENT | Surgical and medical procedures | MedDRA (Unspecified) | View |
| Hyperaemia | SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDRA (Unspecified) | View |
| Hypertension | SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDRA (Unspecified) | View |
Other Events(If Any):