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 @ 10:06 PM
Ignite Modification Date:
2025-12-25 @ 7:43 PM
NCT ID:
NCT04348435
Description:
Out of 53 total subjects, 37 subjects had reported at least one adverse event (AE). A total of 139 AEs were recorded during the entire course of study, out of which 135 were mild in severity, 4 were moderate and none was severe. There were no serious adverse events (SAEs) reported during the study period.
Frequency Threshold:
0
Time Frame:
Week 0 through Week 26 (End of Study)
Study:
NCT04348435
Study Brief:
A Randomized, Double-Blind, Single Center, Efficacy and Safety Study of Allogeneic HB-adMSCs Against COVID-19.
Event Groups(If Any):
Event Groups
| Title | Description | Deaths # Affected | Deaths # At Risk | Serious # Affected | Serious # At Risk | Other # Affected | Other # At Risk | View |
|---|---|---|---|---|---|---|---|---|
| Allogeneic HB-adMSCs 200MM | Subjects assigned to this arm will receive 5 intravenous infusions of HB-adMSCs at 200 million cells/dose. HB-adMSCs: Hope Biosciences allogeneic adipose-derived mesenchymal stem cells | 0 | None | 0 | 19 | 15 | 19 | View |
| Allogeneic HB-adMSCs 100MM | Subjects assigned to this arm will receive 5 intravenous infusions of HB-adMSCs at 100 million cells/dose. HB-adMSCs: Hope Biosciences allogeneic adipose-derived mesenchymal stem cells | 0 | None | 0 | 9 | 5 | 9 | View |
| Placebo | Subjects assigned to this arm will receive 5 intravenous infusions of placebo intervention (saline). Placebos: Saline | 0 | None | 0 | 13 | 10 | 13 | View |
| Allogeneic HB-adMSCs 50MM | Subjects assigned to this arm will receive 5 intravenous infusions of HB-adMSCs at 50 million cells/dose. HB-adMSCs: Hope Biosciences allogeneic adipose-derived mesenchymal stem cells | 0 | None | 0 | 12 | 7 | 12 | View |
Serious Events(If Any):
Other Events(If Any):
Other Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Visual impairment | NON_SYSTEMATIC_ASSESSMENT | Eye disorders | None | View |
| Back injury | NON_SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | None | View |
| Muscle fatigue | NON_SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | None | View |
| Myalgia | NON_SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | None | View |
| Arthralgia | NON_SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | None | View |
| Back pain | NON_SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | None | View |
| Joint swelling | NON_SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | None | View |
| Muscle rigidity | NON_SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | None | View |
| Pain in extremity | NON_SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | None | View |
| Headache | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | None | View |
| Anosmia | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | None | View |
| Dizziness | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | None | View |
| Ageusia | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | None | View |
| Hypoaesthesia | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | None | View |
| Paresthesia | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | None | View |
| Somnolence | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | None | View |
| Influenza like illness | NON_SYSTEMATIC_ASSESSMENT | General disorders | None | View |
| Fatigue | NON_SYSTEMATIC_ASSESSMENT | General disorders | None | View |
| Pain | NON_SYSTEMATIC_ASSESSMENT | General disorders | None | View |
| Pyrexia | NON_SYSTEMATIC_ASSESSMENT | General disorders | None | View |
| Nausea | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | None | View |
| Diarrhea | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | None | View |
| Salivary hyper-secretion | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | None | View |
| Corona virus Infection | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | None | View |
| Cellulitis | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | None | View |
| Urinary tract infection | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | None | View |
| Vertigo | NON_SYSTEMATIC_ASSESSMENT | Ear and labyrinth disorders | None | View |
| Fracture | NON_SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | None | View |
| Appendicectomy | NON_SYSTEMATIC_ASSESSMENT | Surgical and medical procedures | None | View |
| Rotator cuff repair | NON_SYSTEMATIC_ASSESSMENT | Surgical and medical procedures | None | View |
| Leukocytosis | NON_SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | None | View |
| Atrial fibrillation | NON_SYSTEMATIC_ASSESSMENT | Cardiac disorders | None | View |
| Blood pressure increased | NON_SYSTEMATIC_ASSESSMENT | Investigations | None | View |
| Pollakiuria | NON_SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | None | View |
| Cough | NON_SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | None | View |
| Hypoxia | NON_SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | None | View |