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 @ 10:09 PM
Ignite Modification Date:
2025-12-25 @ 7:45 PM
NCT ID:
NCT04048135
Description:
The Safety Analysis set included all randomized participants who received at least 1 dose of study intervention. Arm groups were based upon the actual treatment received for the purpose of safety analysis.
MedDRA version 23.0 was used for Part 1 and MedDRA version 23.1 was used for Part 2.
Frequency Threshold:
5
Time Frame:
Adverse Events were collected after dosing to end of study (up to 113 days for Part 1 and up to 162 days for Part 2).
Study:
NCT04048135
Study Brief:
A Multiple Ascending Dose Study of Pegozafermin in Participants With Biopsy Confirmed Nonalcoholic Steatohepatitis (NASH) or Nonalcoholic Fatty Liver Disease (NAFLD) and at High Risk of NASH
Event Groups(If Any):
Event Groups
| Title | Description | Deaths # Affected | Deaths # At Risk | Serious # Affected | Serious # At Risk | Other # Affected | Other # At Risk | View |
|---|---|---|---|---|---|---|---|---|
| Part 1: Pegozafermin 18 mg QW | Participants were administered 18 mg of pegozafermin QW, via SC injection, starting on Day 1 through Day 85. | 0 | None | 0 | 11 | 7 | 11 | View |
| Part 1: Pegozafermin 3 mg QW | Participants were administered 3 mg of pegozafermin QW, via SC injection, starting on Day 1 through Day 85. | 0 | None | 0 | 7 | 6 | 7 | View |
| Part 1: Pegozafermin 9 mg QW | Participants were administered 9 mg of pegozafermin QW, via SC injection, starting on Day 1 through Day 85. | 0 | None | 0 | 12 | 4 | 12 | View |
| Part 1: Pegozafermin 27 mg QW | Participants were administered 27 mg of pegozafermin QW, via SC injection, starting on Day 1 through Day 85. | 0 | None | 0 | 10 | 7 | 10 | View |
| Part 1: Pegozafermin 18 mg Q2W | Participants were administered 18 mg of pegozafermin Q2W, via SC injection, starting on Day 1 through Day 85. | 0 | None | 1 | 14 | 8 | 14 | View |
| Part 1: Pegozafermin 36 mg Q2W | Participants were administered 36 mg of pegozafermin Q2W, via SC injection, starting on Day 1 through Day 85. | 0 | None | 1 | 9 | 8 | 9 | View |
| Part 1: Placebo QW or Q2W | Participants were administered placebo matching to pegozafermin QW or Q2W, via SC injection, starting on Day 1 through Day 85. | 0 | None | 0 | 18 | 8 | 18 | View |
| Part 2: Pegozafermin 27 mg QW | Participants were administered 27 mg of pegozafermin QW, via SC injection, starting on Day 1 through Day 134. | 0 | None | 0 | 20 | 18 | 20 | View |
Serious Events(If Any):
Serious Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| COVID-19 | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA v23.1 | View |
Other Events(If Any):
Other Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Lymphadenopathy | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | MedDRA 23.0 and 23.1 | View |
| Bundle Branch Block Left | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA 23.0 and 23.1 | View |
| Thyroid Mass | SYSTEMATIC_ASSESSMENT | Endocrine disorders | MedDRA 23.0 and 23.1 | View |
| Eye Discharge | SYSTEMATIC_ASSESSMENT | Eye disorders | MedDRA 23.0 and 23.1 | View |
| Vision Blurred | SYSTEMATIC_ASSESSMENT | Eye disorders | MedDRA 23.0 and 23.1 | View |
| Abdominal Discomfort | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 23.0 and 23.1 | View |
| Abdominal Distension | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 23.0 and 23.1 | View |
| Abdominal Pain | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 23.0 and 23.1 | View |
| Abdominal Pain Lower | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 23.0 and 23.1 | View |
| Abdominal Pain Upper | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 23.0 and 23.1 | View |
| Abdominal Tenderness | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 23.0 and 23.1 | View |
| Change of Bowel Habit | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 23.0 and 23.1 | View |
| Constipation | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 23.0 and 23.1 | View |
| Diarrhoea | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 23.0 and 23.1 | View |
| Epigastric Discomfort | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 23.0 and 23.1 | View |
| Flatulence | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 23.0 and 23.1 | View |
| Frequent Bowel Movements | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 23.0 and 23.1 | View |
| Gastritis | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 23.0 and 23.1 | View |
| Gastrointestinal Sounds Abnormal | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 23.0 and 23.1 | View |
| Gastrooesophageal Reflux Disease | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 23.0 and 23.1 | View |
| Nausea | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 23.0 and 23.1 | View |
| Swollen Tongue | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 23.0 and 23.1 | View |
| Vomiting | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 23.0 and 23.1 | View |
| Chest Pain | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA 23.0 and 23.1 | View |
| Fatigue | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA 23.0 and 23.1 | View |
| Injection Site Bruising | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA 23.0 and 23.1 | View |
| Injection Site Erythema | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA 23.0 and 23.1 | View |
| Injection Site Pain | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA 23.0 and 23.1 | View |
| Injection Site Pruritus | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA 23.0 and 23.1 | View |
| Injection Site Reaction | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA 23.0 and 23.1 | View |
| Oedema Peripheral | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA 23.0 and 23.1 | View |
| Swelling Face | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA 23.0 and 23.1 | View |
| Seasonal Allergy | SYSTEMATIC_ASSESSMENT | Immune system disorders | MedDRA 23.0 and 23.1 | View |
| COVID-19 | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 23.0 and 23.1 | View |
| Gastroenteritis | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 23.0 and 23.1 | View |
| Gastroenteritis Viral | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 23.0 and 23.1 | View |
| Gastrointestinal Infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 23.0 and 23.1 | View |
| Influenza | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 23.0 and 23.1 | View |
| Oral Herpes | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 23.0 and 23.1 | View |
| Upper Respiratory Tract Infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 23.0 and 23.1 | View |
| Urinary Tract Infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 23.0 and 23.1 | View |
| Skin Abrasion | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA 23.0 and 23.1 | View |
| Thermal Burn | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA 23.0 and 23.1 | View |
| Wrist Fracture | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA 23.0 and 23.1 | View |
| Alanine Aminotransferase Increased | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA 23.0 and 23.1 | View |
| Muscle Enzyme Increased | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA 23.0 and 23.1 | View |
| Weight Increased | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA 23.0 and 23.1 | View |
| Decreased Appetite | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA 23.0 and 23.1 | View |
| Glucose Tolerance Impaired | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA 23.0 and 23.1 | View |
| Hyperglycaemia | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA 23.0 and 23.1 | View |
| Hypoglycaemia | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA 23.0 and 23.1 | View |
| Increased Appetite | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA 23.0 and 23.1 | View |
| Type 2 Diabetes Mellitus | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA 23.0 and 23.1 | View |
| Back Pain | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA 23.0 and 23.1 | View |
| Dizziness | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA 23.0 and 23.1 | View |
| Dysgeusia | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA 23.0 and 23.1 | View |
| Headache | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA 23.0 and 23.1 | View |
| Neuropathy Peripheral | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA 23.0 and 23.1 | View |
| Insomnia | SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MedDRA 23.0 and 23.1 | View |
| Polyuria | SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | MedDRA 23.0 and 23.1 | View |
| Menstrual Disorder | SYSTEMATIC_ASSESSMENT | Reproductive system and breast disorders | MedDRA 23.0 and 23.1 | View |
| Metrorrhagia | SYSTEMATIC_ASSESSMENT | Reproductive system and breast disorders | MedDRA 23.0 and 23.1 | View |
| Cough | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA 23.0 and 23.1 | View |
| Dyspnoea | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA 23.0 and 23.1 | View |
| Oropharyngeal Pain | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA 23.0 and 23.1 | View |
| Pulmonary Mass | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA 23.0 and 23.1 | View |
| Dermatitis | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA 23.0 and 23.1 | View |
| Drug Eruption | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA 23.0 and 23.1 | View |
| Erythema | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA 23.0 and 23.1 | View |
| Pruritus | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA 23.0 and 23.1 | View |
| Rash | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA 23.0 and 23.1 | View |
| Hypotension | SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDRA 23.0 and 23.1 | View |