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 @ 12:37 AM
Ignite Modification Date:
2025-12-25 @ 10:46 PM
NCT ID:
NCT00707967
Description:
None
Frequency Threshold:
5
Time Frame:
Solicited local/general symptoms: during the 7-day period; Unsolicited AEs: during the 30-day period; SAEs: during the entire study period, from Day 0 up to Day 210.
Study:
NCT00707967
Study Brief:
Safety and Immunogenicity of a Candidate Tuberculosis (TB) Vaccine in HIV-positive Adults.
Event Groups(If Any):
Event Groups
| Title | Description | Deaths # Affected | Deaths # At Risk | Serious # Affected | Serious # At Risk | Other # Affected | Other # At Risk | View |
|---|---|---|---|---|---|---|---|---|
| GSK692342 Group | Subjects received 2 doses of the GSK692342 vaccine, intramuscularly into the deltoid region of the non-dominant arm, at Day 0 and into the deltoid region of the dominant arm, at Day 30. | None | None | 2 | 22 | 21 | 22 | View |
| Control Group | Subjects received 2 doses of the GSK AS01E adjuvant, intramuscularly into the deltoid region of the non-dominant arm, at Day 0 and into the deltoid region of the dominant arm, at Day 30. | None | None | 0 | 8 | 8 | 8 | View |
| Placebo Group | Subjects received 2 doses of saline solution, intramuscularly into the deltoid region of the non-dominant arm, at Day 0 and into the deltoid region of the dominant arm, at Day 30. | None | None | 0 | 7 | 6 | 7 | View |
Other Events(If Any):
Other Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Nasopharyngitis | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 12.1 | View |
| Headache | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA 12.1 | View |
| Myalgia | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA 12.1 | View |
| Migraine | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA 12.1 | View |
| Back pain | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA 12.1 | View |
| Cough | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA 12.1 | View |
| Fatigue | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA 12.1 | View |
| Feeling hot | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA 12.1 | View |
| Injection site pruritus | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA 12.1 | View |
| Pain in extremity | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA 12.1 | View |
| Pyrexia | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA 12.1 | View |
| Pterygium | SYSTEMATIC_ASSESSMENT | Eye disorders | MedDRA 12.1 | View |
| Diarrhoea | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 12.1 | View |
| Flatulence | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 12.1 | View |
| Vomiting | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 12.1 | View |
| Genital herpes | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 12.1 | View |
| Oral herpes | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 12.1 | View |
| Subcutaneous abscess | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 12.1 | View |
| Insomnia | SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MedDRA 12.1 | View |
| Dysmenorrhoea | SYSTEMATIC_ASSESSMENT | Reproductive system and breast disorders | MedDRA 12.1 | View |
| Nasal congestion | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA 12.1 | View |
| Pain | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA 12.1 | View |
| Swelling | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA 12.1 | View |
| Fatigue | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA 12.1 | View |
| Gastrointestinal | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA 12.1 | View |
| Headache | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA 12.1 | View |
| Malaise | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA 12.1 | View |
| Myalgia | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA 12.1 | View |
| Temperature (Axillary) | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA 12.1 | View |
| Cd4 lymphocytes decreased | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA 12.1 | View |
| Oropharyngeal pain | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA 12.1 | View |
| Abdominal pain upper | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 12.1 | View |
| Redness | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA 12.1 | View |