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 @ 7:50 PM
Ignite Modification Date:
2025-12-25 @ 5:26 PM
NCT ID:
NCT00310804
Description:
Postinjection solicited AE were collected from Day1-7. Other AE's and SAEs were collected through out the study period (Day 1 to 6 months).
Overall, 1200 subjects were enrolled from 2 sites. AE event summary are based on retrospective analysis which excluded data from site 2, and include 700 subjects: 600 cTIV, 100 TIV.
In cTIV group, 599/600 subjects were included in safety dataset as one subject did not receive the vaccination and withdrew on Day 1.
Frequency Threshold:
5
Time Frame:
Through out the study period
Study:
NCT00310804
Study Brief:
Safety and Immunogenicity of 3 Lots of Cell-derived Subunit Influenza Vaccine as Compared to 1 Lot to Egg-derived Subunit Influenza Vaccine in Healthy Adults (>=18 to <=60)
Event Groups(If Any):
Event Groups
| Title | Description | Deaths # Affected | Deaths # At Risk | Serious # Affected | Serious # At Risk | Other # Affected | Other # At Risk | View |
|---|---|---|---|---|---|---|---|---|
| cTIV (Combined) | Subjects in this group received one dose of Cell Derived Trivalent Subunit Influenza Vaccine from one of three vaccine Lots (Lot1, Lot2 or Lot3). | None | None | 16 | 599 | 237 | 599 | View |
| TIV Group | Subjects in this group received one dose of Egg Derived Trivalent Subunit Influenza Vaccine (TIV). | None | None | 2 | 100 | 35 | 100 | View |
Serious Events(If Any):
Serious Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Vestibular disorder | NON_SYSTEMATIC_ASSESSMENT | Ear and labyrinth disorders | MedDRA (Unspecified) | View |
| Diarrhoea | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (Unspecified) | View |
| Cholelithiasis | NON_SYSTEMATIC_ASSESSMENT | Hepatobiliary disorders | MedDRA (Unspecified) | View |
| Influenza | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (Unspecified) | View |
| Rhinitis | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (Unspecified) | View |
| Injury Asphyxiation | NON_SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA (Unspecified) | View |
| Lower Limb Fracture | NON_SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA (Unspecified) | View |
| Spinal Compression Fracture | NON_SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA (Unspecified) | View |
| Breast Cancer | NON_SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (Unspecified) | View |
| Vertebrobasilar Insufficiency | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA (Unspecified) | View |
| Schizoaffective disorder | NON_SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MedDRA (Unspecified) | View |
| Schizoid Personality Disorder | NON_SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MedDRA (Unspecified) | View |
| Uterine Polyp | NON_SYSTEMATIC_ASSESSMENT | Reproductive system and breast disorders | MedDRA (Unspecified) | View |
| Essential Hypertension | NON_SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDRA (Unspecified) | View |
| Varicose Vein | NON_SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDRA (Unspecified) | View |
Other Events(If Any):
Other Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Chills | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA (Unspecified) | View |
| Fatigue | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA (Unspecified) | View |
| Injection Site Erythema | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA (Unspecified) | View |
| Injection Site Induration | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA (Unspecified) | View |
| Injection Site Pain | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA (Unspecified) | View |
| Malaise | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA (Unspecified) | View |
| Myalgia | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA (Unspecified) | View |
| Headache | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA (Unspecified) | View |
| Rhinitis | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (Unspecified) | View |
| Hyperhidrosis | NON_SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA (Unspecified) | View |