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 @ 7:06 PM
Ignite Modification Date:
2025-12-25 @ 4:40 PM
NCT ID:
NCT02212457
Description:
Solicited AEs were collected by Systematic assessment; Unsolicited AEs were collected by non-systematic assessment.
Frequency Threshold:
5
Time Frame:
Solicited AEs were collected from day 1 to day 7, Unsolicited AEs were collected from day 1 to day 30, SAEs were collected throughout the entire study period.
Study:
NCT02212457
Study Brief:
Trial to Assess Immunogenicity and Safety of GlaxoSmithKline (GSK) Biologicals' Meningococcal ABCWY Vaccine as Compared to Meningococcal B Vaccine in Adolescents
Event Groups(If Any):
Event Groups
| Title | Description | Deaths # Affected | Deaths # At Risk | Serious # Affected | Serious # At Risk | Other # Affected | Other # At Risk | View |
|---|---|---|---|---|---|---|---|---|
| ABCWY_0_6 Group | Subjects received MenABCWY vaccine at Visit Month 0 and Visit Month 6, Havrix vaccine at Visit Month 1 and Visit Month 12 and saline placebo at Visit Month 2. | 0 | None | 7 | 134 | 131 | 134 | View |
| ABCWY_0_11 Group | Subjects received MenABCWY vaccine at Visit Month 1 and Visit Month 12, Havrix vaccine at Visit Month 0 and Visit Month 6 and saline placebo at Visit Month 2. | 0 | None | 2 | 151 | 151 | 151 | View |
| ABCWY_0_2_6 Group | Subjects received MenABCWY vaccine at Visit Month 0, Visit Month 2 and Visit Month 6 and Havrix vaccine at Visit Month 1 and Visit Month 12. | 0 | None | 6 | 159 | 158 | 159 | View |
| rMenB_0_2 Group | Subjects received two injections of Bexsero vaccine at Visit Month 0 and Visit Month 2, Havrix vaccine at Visit Month 6 and Visit Month 12 and saline placebo at Visit Month 1. | 0 | None | 9 | 228 | 226 | 228 | View |
| ABCWY_ 0_2 Group | Subjects received MenABCWY vaccine at Visit Month 0 and Visit Month 2, Havrix vaccine at Visit Month 6 and Visit Month 12 and saline placebo at Visit Month 1. | 0 | None | 3 | 231 | 229 | 231 | View |
| ABCWY_0_1 Group | Subjects received MenABCWY vaccine at Visit Month 0 and Visit Month 1, Havrix vaccine at Visit Month 2 and Visit Month 12 and saline placebo at Visit Month 6. | 0 | None | 8 | 155 | 153 | 155 | View |
Serious Events(If Any):
Serious Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Abdominal migraine | None | Gastrointestinal disorders | None | View |
| Abdominal pain | None | Gastrointestinal disorders | None | View |
| Abdominal pain upper | None | Gastrointestinal disorders | None | View |
| Crohn's disease | None | Gastrointestinal disorders | None | View |
| Chest pain | None | General disorders | None | View |
| Fatigue | None | General disorders | None | View |
| Appendicitis | None | Infections and infestations | None | View |
| Escherichia urinary tract infection | None | Infections and infestations | None | View |
| Gastroenteritis | None | Infections and infestations | None | View |
| Infectious mononucleosis | None | Infections and infestations | None | View |
| Nasopharyngitis | None | Infections and infestations | None | View |
| Pelvic inflammatory disease | None | Infections and infestations | None | View |
| Peritonsillar abscess | None | Infections and infestations | None | View |
| Tonsillitis | None | Infections and infestations | None | View |
| Urinary tract infection | None | Infections and infestations | None | View |
| Carbon monoxide poisoning | None | Injury, poisoning and procedural complications | None | View |
| Femur fracture | None | Injury, poisoning and procedural complications | None | View |
| Forearm fracture | None | Injury, poisoning and procedural complications | None | View |
| Lower limb fracture | None | Injury, poisoning and procedural complications | None | View |
| Failure to thrive | None | Metabolism and nutrition disorders | None | View |
| Obesity | None | Metabolism and nutrition disorders | None | View |
| Type 1 diabetes mellitus | None | Metabolism and nutrition disorders | None | View |
| Arthritis | None | Musculoskeletal and connective tissue disorders | None | View |
| Connective tissue disorder | None | Musculoskeletal and connective tissue disorders | None | View |
| Torticollis | None | Musculoskeletal and connective tissue disorders | None | View |
| Fibroadenoma of breast | None | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | None | View |
| Partial seizures | None | Nervous system disorders | None | View |
| Seizure | None | Nervous system disorders | None | View |
| Syncope | None | Nervous system disorders | None | View |
| Abortion incomplete | None | Pregnancy, puerperium and perinatal conditions | None | View |
| Depression | None | Psychiatric disorders | None | View |
| Mental disorder | None | Psychiatric disorders | None | View |
| Suicidal ideation | None | Psychiatric disorders | None | View |
| Tubulointerstitial nephritis | None | Renal and urinary disorders | None | View |
| Testicular torsion | None | Reproductive system and breast disorders | None | View |
| Tooth extraction | None | Surgical and medical procedures | None | View |
| Iron deficiency anaemia | None | Blood and lymphatic system disorders | None | View |
| Atrioventricular block second degree | None | Cardiac disorders | None | View |
| Hypothyroidism | None | Endocrine disorders | None | View |
Other Events(If Any):
Other Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Abdominal pain upper | None | Gastrointestinal disorders | None | View |
| Nausea | None | Gastrointestinal disorders | None | View |
| Chills | None | General disorders | None | View |
| Fatigue | None | General disorders | None | View |
| Injection site erythema | None | General disorders | None | View |
| Injection site induration | None | General disorders | None | View |
| Injection site pain | None | General disorders | None | View |
| Pyrexia | None | General disorders | None | View |
| Gastroenteritis | None | Infections and infestations | None | View |
| Nasopharyngitis | None | Infections and infestations | None | View |
| Pharyngitis | None | Infections and infestations | None | View |
| Respiratory tract infection | None | Injury, poisoning and procedural complications | None | View |
| Rhinitis | None | Infections and infestations | None | View |
| Tonsillitis | None | Infections and infestations | None | View |
| Upper respiratory tract infection | None | Infections and infestations | None | View |
| Decreased appetite | None | Metabolism and nutrition disorders | None | View |
| Arthralgia | None | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | None | View |
| Myalgia | None | Musculoskeletal and connective tissue disorders | None | View |
| Headache | None | Nervous system disorders | None | View |
| Cough | None | Respiratory, thoracic and mediastinal disorders | None | View |
| Oropharyngeal pain | None | Respiratory, thoracic and mediastinal disorders | None | View |