Adverse Events Module

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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 @ 7:38 PM
Ignite Modification Date: 2025-12-25 @ 5:19 PM
NCT ID: NCT03268603
Description: None
Frequency Threshold: 0
Time Frame: Adverse events were collected from the time of enrollment through the end of the follow-up period, approximately 1 year.
Study: NCT03268603
Study Brief: Intrathecal Autologous Adipose-derived Mesenchymal Stromal Cells for Amyotrophic Lateral Sclerosis (ALS)
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Mesenchymal Stromal Cells Autologous Adipose-derived Mesenchymal Stromal Cells (aaMSCs) were administered intrathecally at a single dose in a volume of 5-10 mL, all patients received 5 x 10\^7 intrathecal aaMSCs at the first injection (Visit 4). Subsequent doses may be reduced to 1 x 10\^7 or increased to 1 x 10\^8, based on Dose Modification Rules. Autologous Adipose-derived Mesenchymal Stromal Cells: The investigational product consists of autologous adipose-derived Mesenchymal Stromal Cells (MSCs), suspended in 5-10 mL Lactated Ringer's. The MSC were provided in a sterile syringe labelled with appropriate patient and product identifiers ready for intrathecal injection. 4 None 26 57 56 57 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Appendicitis SYSTEMATIC_ASSESSMENT Infections and infestations None View
Back Pain SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Disease Progression SYSTEMATIC_ASSESSMENT General disorders None View
Dysphagia SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Fall SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications None View
Feeding Tube Placement SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Fracture SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications None View
Gastrointestinal Disorders-Other SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Hematoma SYSTEMATIC_ASSESSMENT Vascular disorders None View
Infections and Infestations-Other SYSTEMATIC_ASSESSMENT Infections and infestations None View
Intracranial Hemorrhage SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Pain in Extremity SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Pneumonitis SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Respiratory Failure SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Stroke SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Superficial Thrombophlebitis SYSTEMATIC_ASSESSMENT Vascular disorders None View
Upper Respiratory Infection SYSTEMATIC_ASSESSMENT Infections and infestations None View
Weight Loss SYSTEMATIC_ASSESSMENT Investigations None View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Back Pain SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Headache SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Abdominal Pain SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Abrasion on the left side of head SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications None View
Allergic Reaction SYSTEMATIC_ASSESSMENT Immune system disorders None View
Anal Fissure SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Anemia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders None View
Anxiety SYSTEMATIC_ASSESSMENT Psychiatric disorders None View
Arachnoiditis SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Aspiration SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Bilateral Ankle Pain SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Bilateral Left Buttock Pain and Leg Pain Post Procedure SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Black Hairy Tongue SYSTEMATIC_ASSESSMENT Infections and infestations None View
Blood and Lymphatic System Disorders-Other SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders None View
Bruising SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications None View
Buttock Pain SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Chills SYSTEMATIC_ASSESSMENT General disorders None View
Confusion SYSTEMATIC_ASSESSMENT Psychiatric disorders None View
Constipation SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Cough SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Creatinine Increased SYSTEMATIC_ASSESSMENT Investigations None View
Cystitis Noninfective SYSTEMATIC_ASSESSMENT Renal and urinary disorders None View
Dehydration SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders None View
Depression SYSTEMATIC_ASSESSMENT Psychiatric disorders None View
Diarrhea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Dysarthria SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Dysphagia SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Dyspnea SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Face Edema SYSTEMATIC_ASSESSMENT General disorders None View
Limb Edema SYSTEMATIC_ASSESSMENT General disorders None View
Eye Disorder-Other SYSTEMATIC_ASSESSMENT Eye disorders None View
Eye Infection SYSTEMATIC_ASSESSMENT Infections and infestations None View
Facial Pain SYSTEMATIC_ASSESSMENT General disorders None View
Fall SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications None View
Respiratory Fatigue SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Fecal incontinence SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Feeding Tube Placement SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Fever SYSTEMATIC_ASSESSMENT General disorders None View
Food Poisoning SYSTEMATIC_ASSESSMENT General disorders None View
Forehead Abrasion SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications None View
Fracture SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications None View
Gait Disturbance SYSTEMATIC_ASSESSMENT General disorders None View
Gastroesophageal Reflux Disease SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
General Disorders and Administration Site Conditions-Other SYSTEMATIC_ASSESSMENT General disorders None View
Hamstring Stiffness SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Hangover Feeling SYSTEMATIC_ASSESSMENT General disorders None View
Head Cold SYSTEMATIC_ASSESSMENT Infections and infestations None View
Head Laceration SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications None View
Hematoma SYSTEMATIC_ASSESSMENT Vascular disorders None View
Hemorrhoids SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Hyperlipidemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders None View
Hypokalemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders None View
Hypotension SYSTEMATIC_ASSESSMENT Vascular disorders None View
Infections and Infestations-Other SYSTEMATIC_ASSESSMENT Infections and infestations None View
Influenza B SYSTEMATIC_ASSESSMENT Infections and infestations None View
Ingrown Toe Nails SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
Injection Site Soreness SYSTEMATIC_ASSESSMENT General disorders None View
Injury, Poisoning and Procedural Complications-Other SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications None View
Laryngeal Inflammation SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Left Shoulder Abrasion SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications None View
Leg Pain SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Low Back and Left Leg Pain SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Low Back Pain Tailbone SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Low Back Pain and Upper Thigh Pain SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Lower Back Soreness SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Lower Back Stiffness SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Lung Infection SYSTEMATIC_ASSESSMENT Infections and infestations None View
Muscle Cramp SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Muscle Weakness Lower Limb SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Musculoskeletal and Connective Tissue Disorder-Other SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Nasal Congestion SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Nausea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Neck Pain SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Neoplasms Benign, Malignant and Unspecified (including cysts and polyps)-Other SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) None View
Norovirus Vomiting SYSTEMATIC_ASSESSMENT Infections and infestations None View
Oral Thrush SYSTEMATIC_ASSESSMENT Infections and infestations None View
Pain SYSTEMATIC_ASSESSMENT General disorders None View
Pain in Extremity SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Pain of Skin SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
Palpitations SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Paresthesia SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Post Injection Low Back and Left Leg Pain SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications None View
Postnasal Drip SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Productive Cough SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Restlessness SYSTEMATIC_ASSESSMENT Psychiatric disorders None View
Scabs on Face from Walking into a Cable SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications None View
Scalp Pain SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
Sinus Infection SYSTEMATIC_ASSESSMENT Infections and infestations None View
Sinus Tachycardia SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Sinusitis SYSTEMATIC_ASSESSMENT Infections and infestations None View
Skin Ulceration SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
Sore Throat SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Sore, Achy Hamstrings and Calves-Bilateral SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Supraventricular Tachycardia SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Surgical and Medical Procedures-Other SYSTEMATIC_ASSESSMENT Surgical and medical procedures None View
Swollen Feet SYSTEMATIC_ASSESSMENT General disorders None View
Tailbone Pain SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Tinnitus SYSTEMATIC_ASSESSMENT Ear and labyrinth disorders None View
Upper Respiratory Infection SYSTEMATIC_ASSESSMENT Infections and infestations None View
Urinary Frequency SYSTEMATIC_ASSESSMENT Renal and urinary disorders None View
Urinary Retention SYSTEMATIC_ASSESSMENT Renal and urinary disorders None View
Urinary Tract Infection SYSTEMATIC_ASSESSMENT Infections and infestations None View
Urinary Urgency SYSTEMATIC_ASSESSMENT Renal and urinary disorders None View
Vascular Access Complication SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications None View
Vertigo SYSTEMATIC_ASSESSMENT Ear and labyrinth disorders None View
Vomiting SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Wrist Fracture SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications None View