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 @ 4:23 AM
Ignite Modification Date:
2025-12-26 @ 3:25 AM
NCT ID:
NCT03682120
Description:
None
Frequency Threshold:
5
Time Frame:
Solicited events and clinical laboratory evaluations for safety were collected from the time of each study vaccination through 7 days after each study vaccination. Unsolicited non-serious AEs were collected from the time of each study vaccination through approximately 21 days after each study vaccination. SAEs and MAAEs, including NOCMCs and PIMMCs, were collected from the time of the first study vaccination through the final study visit, approximately 12 months after the last study vaccination.
Study:
NCT03682120
Study Brief:
Safety/Efficacy Study of Seqirus A/H7N9 IIV With or Without MF59(R) Adjuvant to Prevent Avian Influenza
Event Groups(If Any):
Event Groups
| Title | Description | Deaths # Affected | Deaths # At Risk | Serious # Affected | Serious # At Risk | Other # Affected | Other # At Risk | View |
|---|---|---|---|---|---|---|---|---|
| 3.75 mcg A/H7N9+MF59 | 3.75 mcg per 0.5 ml dose of 2017 A/H7N9 Inactivated Influenza Virus Vaccine (IIV) + MF59(R) adjuvant administered intramuscularly on Day 1 and Day 22. Phosphate buffered saline (PBS) diluent may be used to achieve targeted dosages. | 0 | None | 1 | 105 | 93 | 105 | View |
| 7.5 mcg A/H7N9+MF59 | 7.5 mcg per 0.5 ml dose of 2017 A/H7N9 Inactivated Influenza Virus Vaccine (IIV) + MF59(R) adjuvant administered intramuscularly on Day 1 and Day 22. Phosphate buffered saline (PBS) diluent may be used to achieve targeted dosages. | 1 | None | 6 | 105 | 95 | 105 | View |
| 15 mcg A/H7N9+MF59 | 15 mcg per 0.5 ml dose of 2017 A/H7N9 Inactivated Influenza Virus Vaccine (IIV) + MF59(R) adjuvant administered intramuscularly on Day 1 and Day 22. Phosphate buffered saline (PBS) diluent may be used to achieve targeted dosages. | 0 | None | 4 | 104 | 92 | 104 | View |
| 15 mcg A/H7N9 | 15 mcg per 0.5 ml dose of 2017 A/H7N9 Inactivated Influenza Virus Vaccine (IIV) unadjuvanted administered intramuscularly on Day 1 and Day 22. Phosphate buffered saline (PBS) diluent may be used to achieve targeted dosages. | 0 | None | 1 | 57 | 45 | 57 | View |
Serious Events(If Any):
Serious Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Vertigo | SYSTEMATIC_ASSESSMENT | Ear and labyrinth disorders | MedDRA (23.0) | View |
| Cholecystitis | SYSTEMATIC_ASSESSMENT | Hepatobiliary disorders | MedDRA (23.0) | View |
| Appendicitis | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (23.0) | View |
| Pneumonia | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (23.0) | View |
| Anastomotic Ulcer | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA (23.0) | View |
| Multiple Injuries | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA (23.0) | View |
| Cervical Spinal Stenosis | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA (23.0) | View |
| Neck Pain | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA (23.0) | View |
| Invasive Ductal Breast Carcinoma | SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (23.0) | View |
| Major Depression | SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MedDRA (23.0) | View |
| Chlamydial Infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (23.0) | View |
| Bradycardia | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA (23.0) | View |
Other Events(If Any):
Other Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Upper Respiratory Tract Infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (23.0) | View |
| Hemoglobin Decreased | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA (23.0) | View |
| Platelet Count Increased | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA (23.0) | View |
| White Blood Cell Count Decreased | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA (23.0) | View |
| Arthralgia | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA (23.0) | View |
| Myalgia | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA (23.0) | View |
| Headache | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA (23.0) | View |
| Injection Site Erythema | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA (23.0) | View |
| Injection Site Haemorrhage | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA (23.0) | View |
| Injection Site Induration | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA (23.0) | View |
| Injection Site Pain (Tenderness) | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA (23.0) | View |
| Injection Site Pruritus | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA (23.0) | View |
| Nausea | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (23.0) | View |
| Fatigue | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA (23.0) | View |
| Feeling Hot | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA (23.0) | View |
| Malaise | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA (23.0) | View |
| Skin Laceration | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA (23.0) | View |
| Tooth Fracture | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA (23.0) | View |
| Blood Bilirubin Increased | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA (23.0) | View |
| White Blood Cell Count Increased | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA (23.0) | View |
| Injection Site Pain | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA (23.0) | View |