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 @ 5:17 PM
Ignite Modification Date:
2025-12-25 @ 2:54 PM
NCT ID:
NCT00775450
Description:
None
Frequency Threshold:
5.0
Time Frame:
Adverse events data were collected from the day of vaccination to up to 6 months post-vaccination
Study:
NCT00775450
Study Brief:
Influenza Vaccine Revaccination in Ambulatory Elderly Subjects
Event Groups(If Any):
Event Groups
| Title | Description | Deaths # Affected | Deaths # At Risk | Serious # Affected | Serious # At Risk | Other # Affected | Other # At Risk | View |
|---|---|---|---|---|---|---|---|---|
| Group 1a: Fluzone ID After Fluzone ID | Participants who received a dose (0.1 mL) of Fluzone intradermal (ID) after receiving Fluzone ID in Study FID29 (NCT00551031) | None | None | 10 | 295 | 239 | 292 | View |
| Group 1b: Fluzone IM After Fluzone ID | Participants who received a dose (0.5 mL) of Fluzone intramuscular (IM) vaccine after receiving Fluzone intradermal (ID) vaccine in Study FID29 (NCT00551031) | None | None | 3 | 98 | 42 | 98 | View |
| Group 2a: Fluzone IM After Fluzone IM | Participants who received a dose (0.5 mL) Fluzone intramuscular (IM) vaccine after receiving Fluzone IM vaccine in Study FID29 NCT00551031) | None | None | 6 | 105 | 54 | 105 | View |
| Group 2b: Fluzone ID After Fluzone IM | Participants who received a dose (0.1 )Fluzone intradermal (ID) vaccine after receiving Fluzone intramuscular (IM) vaccine in Study FID29 (NCT00551031) | None | None | 3 | 108 | 86 | 107 | View |
| Group 3: Fluzone HD After Fluzone HD | Participants who received a dose (0.5 mL) of Fluzone High Dose (HD) vaccine after receiving Fluzone HD vaccine in Study FID29 (NCT00551031) | None | None | 10 | 201 | 123 | 200 | View |
Serious Events(If Any):
Serious Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Acute Myocardial Infarction | NON_SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA 11.0 | View |
| Myocardial Infarction | NON_SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA 11.0 | View |
| Retroperitoneal Haematoma | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 11.0 | View |
| Small Intestinal Obstruction | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 11.0 | View |
| Umbilical Hernia | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 11.0 | View |
| Umbilical Hernia, Obstructive | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 11.0 | View |
| Chest Pain | NON_SYSTEMATIC_ASSESSMENT | General disorders | MedDRA 11.0 | View |
| Non Cardiac Chest Pain | NON_SYSTEMATIC_ASSESSMENT | General disorders | MedDRA 11.0 | View |
| Cholecystitis Acute | NON_SYSTEMATIC_ASSESSMENT | Hepatobiliary disorders | MedDRA 11.0 | View |
| Cholelithiasis | NON_SYSTEMATIC_ASSESSMENT | Hepatobiliary disorders | MedDRA 11.0 | View |
| Bronchitis | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 11.0 | View |
| Bacterial Sepsis | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 11.0 | View |
| Gastroenteritis | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 11.0 | View |
| Infective Exacerbation of Chronic Obstructive Airways Disease | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 11.0 | View |
| Lobar Pneumonia | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 11.0 | View |
| Otitis Media Chronic | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 11.0 | View |
| Pneumonia | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 11.0 | View |
| Humerus Fracture | NON_SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA 11.0 | View |
| Pelvic Fracture | NON_SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA 11.0 | View |
| Subdural Haematoma | NON_SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA 11.0 | View |
| Tibia Fracture | NON_SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA 11.0 | View |
| Arthritis | NON_SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA 11.0 | View |
| Back Pain | NON_SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA 11.0 | View |
| Acute Myeloid Leukemia | NON_SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 11.0 | View |
| Breast Cancer | NON_SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 11.0 | View |
| Prostate Cancer | NON_SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 11.0 | View |
| Cerebral Cyst | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA 11.0 | View |
| Cerebrovascular Accident | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA 11.0 | View |
| Subarachnoid Haemorrhage | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA 11.0 | View |
| Renal Failure Acute | NON_SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | MedDRA 11.0 | View |
| Endometrial Hyperplasia | NON_SYSTEMATIC_ASSESSMENT | Reproductive system and breast disorders | MedDRA 11.0 | View |
| Asthma | NON_SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA 11.0 | View |
| Pulmonary Oedema | NON_SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA 11.0 | View |
| Cholecystectomy | NON_SYSTEMATIC_ASSESSMENT | Hepatobiliary disorders | MedDRA 11.0 | View |
| Haemorrhage | NON_SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDRA 11.0 | View |
| Hypertension | NON_SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDRA 11.0 | View |
Other Events(If Any):
Other Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Injection Site Erythema | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA 11.0 | View |
| Injection Site Swelling | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA 11.0 | View |
| Injection Site Ecchymosis | SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDRA 11.0 | View |
| Injection Site Pruritus | NON_SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA 11.0 | View |
| Shivering | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA 11.0 | View |
| Headache | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA 11.0 | View |
| Injection Site Pain | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA 11.0 | View |
| Injection Site Induration | NON_SYSTEMATIC_ASSESSMENT | General disorders | MedDRA 11.0 | View |
| Malaise | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA 11.0 | View |
| Myalgia | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA 11.0 | View |