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 @ 2:34 AM
Ignite Modification Date:
2025-12-26 @ 1:11 AM
NCT ID:
NCT01366534
Description:
None
Frequency Threshold:
5
Time Frame:
Solicited local/general symptoms: during the 7-day post-vaccination period (Days 0-6). Unsolicited AEs: during the 31-day post-vaccination (Days 0-30). SAEs: during the entire study period (Day 0 - Day 236).
Study:
NCT01366534
Study Brief:
Safety, Immunogenicity and Efficacy Against of a Combined Malaria Vaccine in Healthy Malaria-naïve 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 |
|---|---|---|---|---|---|---|---|---|
| Ad35.CS.01 Group | Healthy male or non-pregnant female subjects, aged 18 to 50 years, were administered one dose of Ad35.CS.01 vaccine at Month 0, and 2 doses of GSK257049 at Months 1 and 2 intramuscularly in the deltoid of the non-dominant arm. The duration of the study was approximately 11 months for vaccinated subjects. | 0 | None | 0 | 28 | 27 | 28 | View |
| GSK257049 Group | Healthy male or non-pregnant female subjects, aged 18 to 50 years, were administered 3 doses of GSK257049 vaccine at Months 0, 1 and 2 intramuscularly in the deltoid of the non-dominant arm. The duration of the study was approximately 11 months for vaccinated subjects. | 0 | None | 0 | 27 | 27 | 27 | View |
| Control Group | Healthy male or non-pregnant female subjects, aged 18 to 50 years, were volunteers who did not receive any immunization but were subjected to the sporozoite challenge. The duration of the study was approximately 8 months for infectivity control subjects. | 0 | None | 0 | 12 | 12 | 12 | View |
Serious Events(If Any):
Other Events(If Any):
Other Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Nausea (post-vaccination) | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 15.1 | View |
| Fatigue (post-vaccination) | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA 15.1 | View |
| Malaise (post-vaccination) | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA 15.1 | View |
| Nasopharyngitis (post-vaccination) | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 15.1 | View |
| Upper respiratory tract infection (post-vaccination) | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 15.1 | View |
| Arthralgia (post-vaccination) | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA 15.1 | View |
| Back pain (post-vaccination) | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA 15.1 | View |
| Headache (post-vaccination) | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA 15.1 | View |
| Dysmenorrhoea (post-vaccination) | SYSTEMATIC_ASSESSMENT | Reproductive system and breast disorders | MedDRA 15.1 | View |
| Nasal congestion (post-vaccination) | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA 15.1 | View |
| Throat irritation | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA 15.1 | View |
| Hyperhidrosis (post-vaccination) | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA 15.1 | View |
| Pruritus (post-vaccination) | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA 15.1 | View |
| Malaria (post-challenge) | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 15.1 | View |
| Headache (post-challenge) | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA 15.1 | View |
| Oropharyngeal pain(post-challenge) | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA 15.1 | View |
| Nausea (post-challenge) | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 15.1 | View |
| Upper respiratory tract infection (post-challenge) | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 15.1 | View |
| Pruritus (post-challenge) | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA 15.1 | View |
| Pain- solicited local (post-vaccination) | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA 15.1 | View |
| Redness (post-vaccination) | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA 15.1 | View |
| Swelling (post-vaccination) | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA 15.1 | View |
| Chills (post-vaccination) | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA 15.1 | View |
| Fatigue (post-vaccination) | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA 15.1 | View |
| Gastrointestinal symptoms (post-vaccination) | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA 15.1 | View |
| Headache- solicited general (post-vaccination) | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA 15.1 | View |
| Pain (post-vaccination) | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA 15.1 | View |
| Temperature (post-vaccination) | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA 15.1 | View |