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:
2025-12-25 @ 3:10 AM
Ignite Modification Date:
2025-12-26 @ 1:49 AM
NCT ID:
NCT01371305
Description:
The "Safety" population consisted of all participants who received at least one dose of BG00011 or placebo.
The "Other Adverse Events" section includes counts from the "Serious Adverse Events" section.
Frequency Threshold:
5
Time Frame:
Up to Week 19
Study:
NCT01371305
Study Brief:
STX-100 in Patients With Idiopathic Pulmonary Fibrosis (IPF)
Event Groups(If Any):
Event Groups
| Title | Description | Deaths # Affected | Deaths # At Risk | Serious # Affected | Serious # At Risk | Other # Affected | Other # At Risk | View |
|---|---|---|---|---|---|---|---|---|
| BG00011 0.1 mg | Participants with IPF received SC injection of 0.1 mg/kg BG00011 once weekly for 8 doses. | 0 | None | 0 | 6 | 5 | 6 | View |
| BG00011 0.3 mg | Participants with IPF received SC injection of 0.3 mg/kg BG00011 once weekly for 8 doses. | 0 | None | 0 | 6 | 6 | 6 | View |
| BG00011 1.0 mg | Participants with IPF received SC injection of 1.0 mg/kg BG00011 once weekly for 8 doses. | 1 | None | 2 | 7 | 4 | 7 | View |
| Matching Placebo | Participants with IPF received SC injection of BG00011 matching placebo once weekly for 8 doses. | 0 | None | 0 | 10 | 10 | 10 | View |
| BG00011 0.015 mg | Participants with idiopathic pulmonary fibrosis (IPF) received subcutaneous (SC) injection of 0.015 milligram per kilogram (mg/kg) BG00011 once weekly for 8 doses. | 0 | None | 1 | 6 | 6 | 6 | View |
| BG00011 3.0 mg | Participants with IPF received SC injection of 3.0 mg/kg BG00011 once weekly for 8 doses. | 0 | None | 1 | 6 | 6 | 6 | View |
Serious Events(If Any):
Serious Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Hypoxia | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA Version 20.0 | View |
| Idiopathic Pulmonary Fibrosis Exacerbation | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA Version 20.0 | View |
| Type II Second-Degree Atrioventricular Block | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA Version 20.0 | View |
| Syncope | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA Version 20.0 | View |
| Jaw fracture | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA Version 20.0 | View |
| Respiratory Failure | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA Version 20.0 | View |
| Atrioventricular Block Complete | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA Version 20.0 | View |
Other Events(If Any):
Other Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Injection Site Pain | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA Version 20.0 | View |
| Viral Infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA Version 20.0 | View |
| Hepatic Enzyme Increased | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA Version 20.0 | View |
| Dizziness | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA Version 20.0 | View |
| Idiopathic Pulmonary Fibrosis | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA Version 20.0 | View |
| Onychoclasis | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA Version 20.0 | View |
| Thrombocytopenia | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | MedDRA Version 20.0 | View |
| Phlebitis Superficial | SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDRA Version 20.0 | View |
| Cough | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA Version 20.0 | View |
| Dyspnoea | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA Version 20.0 | View |
| Hypoxia | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA Version 20.0 | View |
| Viral Upper Respiratory Tract Infection | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA Version 20.0 | View |
| Oropharyngeal Pain | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA Version 20.0 | View |
| Productive Cough | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA Version 20.0 | View |
| Rhinitis Allergic | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA Version 20.0 | View |
| Rhinorrhoea | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA Version 20.0 | View |
| Upper-Airway Cough Syndrome | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA Version 20.0 | View |
| Haemoptysis | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA Version 20.0 | View |
| Increased Bronchial Secretion | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA Version 20.0 | View |
| Lung Disorder | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA Version 20.0 | View |
| Nasal Discharge Discoloration | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA Version 20.0 | View |
| Respiratory Failure | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA Version 20.0 | View |
| Sinus Congestion | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA Version 20.0 | View |
| Sleep Apnoea Syndrome | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA Version 20.0 | View |
| Sputum Discolored | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA Version 20.0 | View |
| Fatigue | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA Version 20.0 | View |
| Chest Discomfort | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA Version 20.0 | View |
| Chills | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA Version 20.0 | View |
| Chest Pain | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA Version 20.0 | View |
| Infusion Site Bruising | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA Version 20.0 | View |
| Injection Site Erythema | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA Version 20.0 | View |
| Injection Site Paraesthesia | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA Version 20.0 | View |
| Non-Cardiac Chest Pain | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA Version 20.0 | View |
| Oedema Peripheral | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA Version 20.0 | View |
| Pyrexia | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA Version 20.0 | View |
| Vessel Puncture Site Pain | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA Version 20.0 | View |
| Upper Respiratory Tract Infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA Version 20.0 | View |
| Bronchitis | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA Version 20.0 | View |
| Acute Sinusitis | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA Version 20.0 | View |
| Sinusitis | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA Version 20.0 | View |
| Genital Herpes | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA Version 20.0 | View |
| Headache | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA Version 20.0 | View |
| Syncope | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA Version 20.0 | View |
| Migraine | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA Version 20.0 | View |
| Blood Lactate Dehydrogenase Increased | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA Version 20.0 | View |
| Blood Pressure Increased | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA Version 20.0 | View |
| Electrocardiogram Qt Prolonged | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA Version 20.0 | View |
| Glucose Urine Present | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA Version 20.0 | View |
| Oxygen Saturation Decreased | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA Version 20.0 | View |
| Protein Urine Present | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA Version 20.0 | View |
| Total Lung Capacity Decreased | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA Version 20.0 | View |
| Urine Analysis Abnormal | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA Version 20.0 | View |
| Urine Leukocyte Esterase Positive | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA Version 20.0 | View |
| Cardiac Murmur | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA Version 20.0 | View |
| Pulmonary Function Test Decreased | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA Version 20.0 | View |
| Arthralgia | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA Version 20.0 | View |
| Musculoskeletal Chest Pain | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA Version 20.0 | View |
| Myalgia | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA Version 20.0 | View |
| Back Pain | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA Version 20.0 | View |
| Bursitis | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA Version 20.0 | View |
| Muscle Fatigue | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA Version 20.0 | View |
| Musculoskeletal Pain | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA Version 20.0 | View |
| Musculoskeletal Stiffness | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA Version 20.0 | View |
| Pain in Extremity | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA Version 20.0 | View |
| Constipation | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA Version 20.0 | View |
| Dyspepsia | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA Version 20.0 | View |
| Abdominal Pain | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA Version 20.0 | View |
| Cheilitis | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA Version 20.0 | View |
| Sensitivity of Teeth | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA Version 20.0 | View |
| Umbilical Hernia | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA Version 20.0 | View |
| Rash | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA Version 20.0 | View |
| Night Sweats | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA Version 20.0 | View |
| Acne | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA Version 20.0 | View |
| Skin Lesion | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA Version 20.0 | View |
| Contusion | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA Version 20.0 | View |
| Bone Contusion | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA Version 20.0 | View |
| Fall | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA Version 20.0 | View |
| Jaw Fracture | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA Version 20.0 | View |
| Laceration | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA Version 20.0 | View |
| Ligament Sprain | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA Version 20.0 | View |
| Limb Injury | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA Version 20.0 | View |
| Muscle Strain | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA Version 20.0 | View |
| Procedural Complication | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA Version 20.0 | View |
| Procedural Pain | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA Version 20.0 | View |
| Sunburn | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA Version 20.0 | View |
| Tooth Fracture | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA Version 20.0 | View |
| Eye Contusion | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA Version 20.0 | View |
| Insomnia | SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MedDRA Version 20.0 | View |
| Anxiety | SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MedDRA Version 20.0 | View |
| Thinking Abnormal | SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MedDRA Version 20.0 | View |
| Angina Pectoris | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA Version 20.0 | View |
| Atrioventricular Block Complete | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA Version 20.0 | View |
| Atrioventricular Block Second Degree | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA Version 20.0 | View |
| Bradycardia | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA Version 20.0 | View |
| Seasonal Allergy | SYSTEMATIC_ASSESSMENT | Immune system disorders | MedDRA Version 20.0 | View |
| Hyponatraemia | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA Version 20.0 | View |
| Anaemia | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | MedDRA Version 20.0 | View |
| Hypothyroidism | SYSTEMATIC_ASSESSMENT | Endocrine disorders | MedDRA Version 20.0 | View |
| Hypotension | SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDRA Version 20.0 | View |
| Squamous Cell Carcinoma of Skin | SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA Version 20.0 | View |