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 @ 10:22 PM
Ignite Modification Date:
2025-12-25 @ 7:54 PM
NCT ID:
NCT00439335
Description:
The solicited symptoms are reported separately after each vaccination. The occurrence of a solicited symptom on any day(s) at any severity within the 15 day period was considered one event.
Frequency Threshold:
5
Time Frame:
Subjects recorded solicited symptoms on a memory aid for 8 days (Day 0-7) following each dose. Unsolicited non-serious adverse events were collected for 28 days after each dose and serious adverse events were collected through Day 208.
Study:
NCT00439335
Study Brief:
Higher Dose Intradermal H5 Vaccine
Event Groups(If Any):
Event Groups
| Title | Description | Deaths # Affected | Deaths # At Risk | Serious # Affected | Serious # At Risk | Other # Affected | Other # At Risk | View |
|---|---|---|---|---|---|---|---|---|
| H5 HA ID | Vaccine group H5 HA ID: the subject will receive 0.1 mL of H5 HA by the ID route in one arm and 0.1 mL of saline placebo by the IM route in the other arm. | None | None | 2 | 113 | 113 | 113 | View |
| H5 HA IM | Vaccine group H5 HA IM: the subject will receive 0.1 mL of H5 HA by the IM route in one arm and 0.1 mL of saline placebo by the ID route in the other arm. | None | None | 2 | 114 | 114 | 114 | View |
Serious Events(If Any):
Serious Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Appendicitis | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (8.1) | View |
| Bipolar disorder | NON_SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MedDRA (10.1) | View |
| Hydronephrosis | NON_SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | MedDRA (10.1) | View |
| Insulin-requiring type II diabetes mellitus | NON_SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA (10.1) | View |
Other Events(If Any):
Other Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Injection site bruising | NON_SYSTEMATIC_ASSESSMENT | General disorders | MedDRA (10.1) | View |
| Injection site desquamation | NON_SYSTEMATIC_ASSESSMENT | General disorders | MedDRA (10.0) | View |
| Reactogenicity event | NON_SYSTEMATIC_ASSESSMENT | General disorders | MedDRA (9.0) | View |
| Hypersensitivity | NON_SYSTEMATIC_ASSESSMENT | Immune system disorders | MedDRA (9.0) | View |
| Gastroenteritis | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (9.0) | View |
| Upper respiratory tract infection | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (9.0) | View |
| Headache | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA (9.0) | View |
| Dysmenorrhoea | NON_SYSTEMATIC_ASSESSMENT | Reproductive system and breast disorders | MedDRA (9.0) | View |
| Injection site erythema - post dose 1 | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA (10.0) | View |
| Injection site erythema - post dose 2 | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA (10.0) | View |
| Injection site induration (size) - post dose 1 | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA (9.0) | View |
| Injection site induration (size) - post dose 2 | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA (9.0) | View |
| Injection site induration (functional grading) - post dose 1 | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA (9.0) | View |
| Injection site induration (functional grading) - post dose 2 | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA (9.0) | View |
| Injection site discolouration - post dose 1 | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA (9.0) | View |
| Injection site discolouration - post dose 2 | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA (9.0) | View |
| Injection site pruritus - post dose 1 | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA (9.0) | View |
| Headache - post dose 1 | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA (9.0) | View |
| Headache - post dose 2 | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA (9.0) | View |
| Malaise - post dose 1 | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA (9.0) | View |
| Malaise - post dose 2 | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA (9.0) | View |
| Myalgia - post dose 1 | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA (8.1) | View |
| Myalgia - post dose 2 | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA (8.1) | View |
| Nausea - post dose 1 | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (9.0) | View |
| Nausea - post dose 2 | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (9.0) | View |
| Injection site erythema, placebo arm - post dose 1 | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA (10.0) | View |
| Injection site erythema, placebo arm - post dose 2 | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA (10.0) | View |
| Injection site induration, placebo arm - (size) - post dose 1 | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA (9.0) | View |
| Injection site induration, placebo arm - (size) - post dose 2 | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA (9.0) | View |
| Injection site induration, placebo arm - (functional grading) - post dose 1 | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA (9.0) | View |
| Injection site induration, placebo arm - (functional grading) - post dose 2 | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA (9.0) | View |
| Injection site discolouration, placebo arm - post dose 1 | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA (9.0) | View |
| Injection site discolouration, placebo arm - post dose 2 | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA (9.0) | View |
| Injection site pain, placebo arm - post dose 1 | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA (9.0) | View |
| Injection site pain, placebo arm - post dose 2 | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA (9.0) | View |
| Tenderness, placebo arm - post dose 1 | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA (8.0) | View |
| Tenderness, placebo arm - post dose 2 | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA (8.0) | View |
| Injection site pruritus - post dose 2 | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA (9.0) | View |
| Injection site pain - post dose 1 | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA (9.0) | View |
| Injection site pain - post dose 2 | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA (9.0) | View |
| Tenderness - post dose 1 | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA (8.0) | View |
| Tenderness - post dose 2 | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA (8.0) | View |
| Feeling hot - post dose 1 | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA (10.0) | View |
| Feeling hot - post dose 2 | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA (10.0) | View |