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 @ 3:21 AM
Ignite Modification Date:
2025-12-26 @ 2:00 AM
NCT ID:
NCT04631705
Description:
Participants were queried about potential Adverse Events at all study visits.
Frequency Threshold:
0
Time Frame:
90 days (treatment-emergent adverse events: All adverse events after drug intake until final study visit)
Study:
NCT04631705
Study Brief:
SARS-CoV-2-Neutralizing Monoclonal COVID-19 Antibody DZIF-10c by Inhalation
Event Groups(If Any):
Event Groups
| Title | Description | Deaths # Affected | Deaths # At Risk | Serious # Affected | Serious # At Risk | Other # Affected | Other # At Risk | View |
|---|---|---|---|---|---|---|---|---|
| 2B: Infected, 100 mg Inh. | Open label, SARS-CoV-2-infected, DZIF-10c dose administered by inhalation | 0 | None | 0 | 3 | 2 | 3 | View |
| 2C: Infected, 250 mg Inh. | Open label, SARS-CoV-2-infected, DZIF-10c dose administered by inhalation | 0 | None | 0 | 3 | 2 | 3 | View |
| 2D: Infected, Placebo Inh., Placebo i.v. | Double blind and randomized, SARS-CoV-2-infected, placebo by inhalation, placebo by i.v. infusion | 0 | None | 0 | 10 | 7 | 10 | View |
| 2D: Infected, 250 mg Inh., Placebo i.v. | Double blind and randomized, SARS-CoV-2-infected, DZIF-10c by inhalation, placebo by i.v. infusion | 0 | None | 0 | 8 | 5 | 8 | View |
| 2D: Infected, 250 mg Inh., 40 mg/kg i.v. | Double blind and randomized, SARS-CoV-2-infected, DZIF-10c by inhalation, DZIF-10c by i.v. infusion | 0 | None | 0 | 9 | 4 | 9 | View |
| 1A: Healthy, 50 mg Inh. | Open label, SARS-CoV-2 negative, DZIF-10c dose administered by inhalation | 0 | None | 0 | 3 | 2 | 3 | View |
| 1B: Healthy, 100 mg Inh. | Open label, SARS-CoV-2 negative, DZIF-10c dose administered by inhalation | 0 | None | 0 | 3 | 1 | 3 | View |
| 1C: Healthy, 250 mg Inh. | Open label, SARS-CoV-2 negative, DZIF-10c dose administered by inhalation | 0 | None | 0 | 3 | 2 | 3 | View |
| 2A: Infected, 50 mg Inh. | Open label, SARS-CoV-2-infected, DZIF-10c dose administered by inhalation | 0 | None | 0 | 3 | 3 | 3 | View |
Serious Events(If Any):
Other Events(If Any):
Other Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Hypersensitivity | SYSTEMATIC_ASSESSMENT | Immune system disorders | None | View |
| Inflammation | SYSTEMATIC_ASSESSMENT | General disorders | None | View |
| Pyrexia | SYSTEMATIC_ASSESSMENT | General disorders | None | View |
| Pain | SYSTEMATIC_ASSESSMENT | General disorders | None | View |
| Fatigue | SYSTEMATIC_ASSESSMENT | General disorders | None | View |
| Chest pain | SYSTEMATIC_ASSESSMENT | General disorders | None | View |
| Aphasia | SYSTEMATIC_ASSESSMENT | Psychiatric disorders | None | View |
| Dyspnoea | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | None | View |
| Alanine aminotransferase increased | SYSTEMATIC_ASSESSMENT | Investigations | None | View |
| Lipase increased | SYSTEMATIC_ASSESSMENT | Investigations | None | View |
| Aspartate aminotransferase increased | SYSTEMATIC_ASSESSMENT | Investigations | None | View |
| Ventricular arrhythmia | SYSTEMATIC_ASSESSMENT | Cardiac disorders | None | View |
| Thrombocytopenia | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | None | View |
| Leukopenia | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | None | View |
| Neutropenia | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | None | View |
| Oropharyngeal pain | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | None | View |
| Cough | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | None | View |
| Dyspnoea exertional | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | None | View |
| Headache | SYSTEMATIC_ASSESSMENT | Nervous system disorders | None | View |
| Sciatica | SYSTEMATIC_ASSESSMENT | Nervous system disorders | None | View |
| Dysgeusia | SYSTEMATIC_ASSESSMENT | Nervous system disorders | None | View |
| Disturbance in attention | SYSTEMATIC_ASSESSMENT | Nervous system disorders | None | View |
| Parosmia | SYSTEMATIC_ASSESSMENT | Nervous system disorders | None | View |
| Diarrhoea | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | None | View |
| Gastrooesophageal reflux disease | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | None | View |
| Haematuria | SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | None | View |
| Back pain | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | None | View |
| Sinusitis | SYSTEMATIC_ASSESSMENT | Infections and infestations | None | View |
| Gastroenteritis | SYSTEMATIC_ASSESSMENT | Infections and infestations | None | View |
| Gonococcal infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | None | View |
| Herpes zoster | SYSTEMATIC_ASSESSMENT | Infections and infestations | None | View |