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 @ 3:44 AM
Ignite Modification Date:
2025-12-26 @ 2:30 AM
NCT ID:
NCT02680002
Description:
Subjects recorded solicited local and systemic reactions to the vaccine or adjuvant, and other unsolicited symptoms or complaints, including start and stop dates, on an 8-day diary card following each of the 2 vaccinations. Diary cards captured unsolicited AEs for 21 days after each vaccination. Regular investigator assessment at each visit, except Visit 1. Abnormal laboratory test results judged clinically significant by investigator recorded as AEs or SAEs.
Frequency Threshold:
5
Time Frame:
Adverse Event (AE) data were collected from Visit 1 (Day 0) through Visit 7 (Day 42); Adverse Events of Special Interest (AESI) and Serious Adverse Events (SAEs) were assessed from Visit 1 (Day 0), until exit from the study, Visit 9 (Day 386). Data currently available to Visit 8 (Day 201).
Study:
NCT02680002
Study Brief:
Assess the Safety & Immunogenicity of Stored Inactivated Influenza H5N1 Virus Vaccine Given With & Without Stored MF59 Adjuvant
Event Groups(If Any):
Event Groups
| Title | Description | Deaths # Affected | Deaths # At Risk | Serious # Affected | Serious # At Risk | Other # Affected | Other # At Risk | View |
|---|---|---|---|---|---|---|---|---|
| 7.5 mcg H5N1 (Monobulk) Plus MF59 (Monobulk) | Two 0.5-mL doses, given at Day 0 and 21 consisting of 7.5 mcg hemagglutinin (HA) antigen stored long term as monobulk inactivated A/Vietnam/H5N1 vaccine and MF59 stored long term as bulk MF59 adjuvant | 0 | None | 0 | 70 | 44 | 70 | View |
| 15 mcg H5N1 (Monobulk) Plus MF59 (Monobulk) | Two 0.5-mL doses, given at Day 0 and 21 consisting of 15 mcg HA antigen stored long term as monobulk inactivated A/Vietnam/H5N1 vaccine and MF59 stored long term as monobulk MF59 adjuvant | 0 | None | 1 | 71 | 49 | 71 | View |
| 7.5 mcg H5N1 (Monobulk) Plus MF59 (Vials) | Two 0.5-mL doses, given at Day 0 and 21 consisting of 7.5 mcg HA antigen stored long term as monobulk inactivated A/Vietnam/H5N1 vaccine and MF59 stored short term in vials as MF59 adjuvant | 0 | None | 3 | 70 | 47 | 70 | View |
| 15 mcg H5N1 (Monobulk) Plus MF59 (Vials) | Two 0.5-mL doses, given at Day 0 and 21 consisting of 15 mcg HA antigen stored long term as monobulk inactivated A/Vietnam/H5N1 vaccine and MF59 stored short term in vials as MF59 adjuvant | 0 | None | 0 | 71 | 57 | 71 | View |
| 90 mcg H5N1 (Monobulk) Without MF59 | Two 1.0-mL doses at Day 0 and 21 consisting of 90 mcg HA antigen stored long term as monobulk inactivated A/Vietnam/H5N1 antigen formulated and filled in 2015, administered without MF59 | 0 | None | 1 | 70 | 48 | 70 | View |
| 90 mcg H5N1 (Vials) Without MF59 | Two 1.0-mL doses at Day 0 and 21 consisting of 90 mcg HA antigen stored long term in vials as inactivated A/Vietnam/H5N1 vaccine, administered without MF59 | 0 | None | 2 | 69 | 47 | 69 | View |
Serious Events(If Any):
Serious Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Pseudomeningocele | NON_SYSTEMATIC_ASSESSMENT | Surgical and medical procedures | MedDRA (19.1) | View |
| Abdominal pain | NON_SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA (19.1) | View |
| Gastrointestinal organ contusion | NON_SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA (19.1) | View |
| Acute myocardial infarction | NON_SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDRA (19.1) | View |
| Rib fracture | NON_SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA (19.1) | View |
| Flank pain | NON_SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA (19.1) | View |
| Organ failure | NON_SYSTEMATIC_ASSESSMENT | General disorders | MedDRA (19.1) | View |
| Acute respiratory distress syndrome | NON_SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA (19.1) | View |
| Appendicitis perforated | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (19.1) | View |
| Joint dislocation | NON_SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA (19.1) | View |
| Infected skin ulcer | NON_SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA (19.1) | View |
| Cellulitis | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (19.1) | View |
| Osteomyelitis | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (19.1) | View |
| Dehydration | NON_SYSTEMATIC_ASSESSMENT | General disorders | MedDRA (19.1) | View |
| Urinary tract infection | NON_SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | MedDRA (19.1) | View |
Other Events(If Any):
Other Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Injection site pain | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA (19.1) | View |
| Fatigue | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA (19.1) | View |
| Injection site induration | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA (19.1) | View |
| Injection site erythema | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA (19.1) | View |
| Headache | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA (19.1) | View |
| Myalgia | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA (19.1) | View |
| Arthralgia | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA (19.1) | View |
| Diarrhea | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (19.1) | View |
| Nausea | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (19.1) | View |