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 @ 12:38 PM
Ignite Modification Date:
2025-12-25 @ 12:12 PM
NCT ID:
NCT02839161
Description:
None
Frequency Threshold:
0
Time Frame:
The participants were followed for 9 months after the final injection. This equates to 380 days for those receiving vaccinations according to a 0,2,4-month schedule. This equates to 448 days for those receiving vaccinations according to a 0,2,6-month schedule.
Study:
NCT02839161
Study Brief:
Study of Co-administered Na-APR-1 (M74) and Na-GST-1 in Gabonese Children
Event Groups(If Any):
Event Groups
| Title | Description | Deaths # Affected | Deaths # At Risk | Serious # Affected | Serious # At Risk | Other # Affected | Other # At Risk | View |
|---|---|---|---|---|---|---|---|---|
| Low-dose (0,2,4 Months) | 10 µg Na-APR-1 (M74) plus 5 µg GLA-AF delivered by IM injection in the deltoid muscle, with 10 µg Na-GST-1 administered IM in the alternate arm. Injections at 0, 2, and 4 months. Na-GST-1/Alhydrogel Na-APR-1 (M74)/Alhydrogel | 0 | None | 0 | 8 | 8 | 8 | View |
| Medium-dose (0,2,6 Months) | 30 µg Na-APR-1 (M74) plus 5 µg GLA-AF delivered by IM injection in the deltoid muscle, with 30 µg Na-GST-1 administered IM in the alternate arm. Injections at 0, 2, and 6 months. Na-GST-1/Alhydrogel Na-APR-1 (M74)/Alhydrogel | 0 | None | 0 | 8 | 8 | 8 | View |
| High-dose (0,2,6 Months) | 100 µg Na-APR-1 (M74) plus 5 µg GLA-AF delivered by IM injection in the deltoid muscle, with 100 µg Na-GST-1 administered IM in the alternate arm. Injections at 0, 2, and 6 months. Na-GST-1/Alhydrogel Na-APR-1 (M74)/Alhydrogel | 0 | None | 0 | 8 | 8 | 8 | View |
| Comparator (0,2,6 Months) | Hepatitis B vaccine delivered by IM injection in the deltoid muscle, with sterile saline solution administered IM in the alternate arm. Injections at 0, 2, and 6 months. Hepatitis B Vaccine | 0 | None | 0 | 6 | 6 | 6 | View |
| Low-dose (0,2,6 Months) | 10 µg Na-APR-1 (M74) plus 5 µg GLA-AF delivered by IM injection in the deltoid muscle, with 10 µg Na-GST-1 administered IM in the alternate arm. Injections at 0, 2, and 6 months. Na-GST-1/Alhydrogel Na-APR-1 (M74)/Alhydrogel | 0 | None | 0 | 8 | 8 | 8 | View |
| Medium-dose (0,2,4 Months) | 30 µg Na-APR-1 (M74) plus 5 µg GLA-AF delivered by IM injection in the deltoid muscle, with 30 µg Na-GST-1 administered IM in the alternate arm. Injections at 0, 2, and 4 months. Na-GST-1/Alhydrogel Na-APR-1 (M74)/Alhydrogel | 0 | None | 1 | 8 | 8 | 8 | View |
| High-dose (0,2,4 Months) | 100 µg Na-APR-1 (M74) plus 5 µg GLA-AF delivered by IM injection in the deltoid muscle, with 100 µg Na-GST-1 administered IM in the alternate arm. Injections at 0, 2, and 4 months. Na-GST-1/Alhydrogel Na-APR-1 (M74)/Alhydrogel | 0 | None | 0 | 8 | 8 | 8 | View |
| Comparator (0,2,4 Months) | Hepatitis B vaccine delivered by IM injection in the deltoid muscle, with sterile saline solution administered IM in the alternate arm. Injections at 0, 2, and 4 months. Hepatitis B Vaccine | 0 | None | 0 | 6 | 4 | 6 | View |
Serious Events(If Any):
Serious Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Inguinal hernia | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | None | View |
Other Events(If Any):
Other Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Injection Site Pain | SYSTEMATIC_ASSESSMENT | General disorders | None | View |
| Injection site swelling | SYSTEMATIC_ASSESSMENT | General disorders | None | View |
| Injection site tenderness | SYSTEMATIC_ASSESSMENT | General disorders | None | View |
| Pyrexia | SYSTEMATIC_ASSESSMENT | General disorders | None | View |
| Vomiting | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | None | View |
| Nausea | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | None | View |
| Diarrhoea | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | None | View |
| Inguinal hernia | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | None | View |
| Dental Caries | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | None | View |
| Abdominal Pain | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | None | View |
| Hypokinesia | SYSTEMATIC_ASSESSMENT | Nervous system disorders | None | View |
| Headache | SYSTEMATIC_ASSESSMENT | Nervous system disorders | None | View |
| Splenomegaly | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | None | View |
| Bradycardia | SYSTEMATIC_ASSESSMENT | Cardiac disorders | None | View |
| Tachycardia | SYSTEMATIC_ASSESSMENT | Cardiac disorders | None | View |
| Abscess | SYSTEMATIC_ASSESSMENT | Infections and infestations | None | View |
| Ascariasis | SYSTEMATIC_ASSESSMENT | Infections and infestations | None | View |
| Body tinea | SYSTEMATIC_ASSESSMENT | Infections and infestations | None | View |
| Bronchitis | SYSTEMATIC_ASSESSMENT | Infections and infestations | None | View |
| Ear infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | None | View |
| Eczema infected | SYSTEMATIC_ASSESSMENT | Infections and infestations | None | View |
| Enterobiasis | SYSTEMATIC_ASSESSMENT | Infections and infestations | None | View |
| Influenza | SYSTEMATIC_ASSESSMENT | Infections and infestations | None | View |
| Malaria | SYSTEMATIC_ASSESSMENT | Infections and infestations | None | View |
| Measles | SYSTEMATIC_ASSESSMENT | Infections and infestations | None | View |
| Nasopharyngitis | SYSTEMATIC_ASSESSMENT | Infections and infestations | None | View |
| Plasmodium falciparum infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | None | View |
| Rhinitis | SYSTEMATIC_ASSESSMENT | Infections and infestations | None | View |
| Skin infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | None | View |
| Subcutaneous abscess | SYSTEMATIC_ASSESSMENT | Infections and infestations | None | View |
| Tinea capitis | SYSTEMATIC_ASSESSMENT | Infections and infestations | None | View |
| Trichuriasis | SYSTEMATIC_ASSESSMENT | Infections and infestations | None | View |
| Wound infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | None | View |
| Ear injury | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | None | View |
| Limb injury | SYSTEMATIC_ASSESSMENT | Infections and infestations | None | View |
| Alanine aminotransferase increased | SYSTEMATIC_ASSESSMENT | Investigations | None | View |
| Blood pressure diastolic increased | SYSTEMATIC_ASSESSMENT | Investigations | None | View |
| Haemoglobin decreased | SYSTEMATIC_ASSESSMENT | Investigations | None | View |
| Neutrophil count decreased | SYSTEMATIC_ASSESSMENT | Investigations | None | View |
| Platelet count decreased | SYSTEMATIC_ASSESSMENT | Investigations | None | View |
| White blood cell count decreased | SYSTEMATIC_ASSESSMENT | Investigations | None | View |
| White blood cell count increased | SYSTEMATIC_ASSESSMENT | Investigations | None | View |
| Joint swelling | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | None | View |
| Myalgia | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | None | View |
| Pain in extremity | SYSTEMATIC_ASSESSMENT | Investigations | None | View |
| Anthralgia | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | None | View |
| Vaginal discharge | SYSTEMATIC_ASSESSMENT | Reproductive system and breast disorders | None | View |
| Cough | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | None | View |
| Rhinorrhoea | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | None | View |
| Eczema | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | None | View |
| Pruritus generalised | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | None | View |
| Rash | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | None | View |