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 @ 12:20 AM
Ignite Modification Date:
2025-12-25 @ 10:24 PM
NCT ID:
NCT01367158
Description:
The analyses for serious unsolicited adverse events (SAEs) and adverse events (AEs) were done on the safety population. One subject initially randomized to group 3ABCWYqOMV and supposed to receive rMenB+1/4OMV+ACWY as the third vaccination, actually received Tdap as the third vaccination and was included in 2ABCWYqOMV group for the safety analysis.
Frequency Threshold:
5
Time Frame:
Safety was assessed up to 6 months after vaccination. Solicited local AEs and systemic AEs were collected daily for 7 days (day 1 through day 7) after vaccination. All unsolicited AEs including SAEs were collected for 7 days after the vaccination.
Study:
NCT01367158
Study Brief:
Safety, Tolerability and Immunogenicity of a Third Dose of One of Four Different Formulations of rMenB + MenACWY Combination Vaccine in Adolescents Who Previously Received the Same Study Vaccines
Event Groups(If Any):
Event Groups
| Title | Description | Deaths # Affected | Deaths # At Risk | Serious # Affected | Serious # At Risk | Other # Affected | Other # At Risk | View |
|---|---|---|---|---|---|---|---|---|
| 3ABCWY+OMV | Two doses Meningococcal (groups A, C, W, and Y) oligosaccharide diphtheria CRM-197 conjugate combined with meningococcal (group B) multicomponent recombinant vaccine plus outer membrane vesicles (OMV) in previous study and one dose of the same in current study | None | None | 0 | 25 | 23 | 25 | View |
| 3 B | Two doses of Meningococcal (group B) multicomponent recombinant adsorbed vaccine in previous study and one dose of the same in current study | None | None | 0 | 23 | 19 | 23 | View |
| 3ABCWY | Two doses of Meningococcal (group B) multicomponent recombinant adsorbed vaccine plus one dose of Meningococcal (groups A, C, W, and Y) oligosaccharide diphtheria CRM-197 conjugate vaccine in previous study and one dose of the same in current study | None | None | 0 | 24 | 20 | 24 | View |
| 3ABx2CWY | Two doses of Meningococcal (group B) multicomponent recombinant adsorbed vaccine plus Meningococcal (groups A, C, W, and Y) oligosaccharide diphtheria CRM-197 conjugate vaccine in previous study and one dose of the same in current study | None | None | 1 | 24 | 20 | 24 | View |
| 2ABx2CWY | Two doses of Meningococcal (group B) multicomponent recombinant adsorbed vaccine plus one dose of Meningococcal (groups A, C, W, and Y) oligosaccharide diphtheria CRM-197 conjugate vaccine in previous study and one dose of Tdap in current study | None | None | 1 | 49 | 36 | 49 | View |
| 2ABCWY+OMV | Two doses Meningococcal (groups A, C, W, and Y) oligosaccharide diphtheria CRM-197 conjugate combined with meningococcal (group B) multicomponent recombinant vaccine plus outer membrane vesicles (OMV) in previous study and one dose of Tdap in current study | None | None | 0 | 48 | 37 | 48 | View |
| 3ABCWYqOMV | Two doses of Meningococcal (groups A, C, W, and Y) oligosaccharide diphtheria CRM-197 conjugate combined with meningococcal (group B) multicomponent recombinant vaccine plus one quarter dose of outer membrane vesicles (qOMV) in previous study and one dose of the same in current study | None | None | 1 | 24 | 22 | 24 | View |
| 2ABCWYqOMV | Two doses of Meningococcal (groups A, C, W, and Y) oligosaccharide diphtheria CRM-197 conjugate combined with meningococcal (group B) multicomponent recombinant vaccine plus one quarter dose of outer membrane vesicles (qOMV) in previous study and one dose of Tdap in current study | None | None | 1 | 50 | 38 | 50 | View |
| 2 B | Two doses of Meningococcal (group B) multicomponent recombinant adsorbed vaccine in previous study and one dose of Tdap in current study | None | None | 1 | 50 | 40 | 50 | View |
| 1ACWY | One dose of Meningococcal (groups A, C, W, and Y) oligosaccharide diphtheria CRM-197 conjugate vaccine followed by one dose of placebo and one dose of Tdap in current study | None | None | 0 | 73 | 56 | 73 | View |
| 2ABCWY | Two doses of Meningococcal (group B) multicomponent recombinant adsorbed vaccine plus one dose of Meningococcal (groups A, C, W, and Y) oligosaccharide diphtheria CRM-197 conjugate vaccine in previous study and one dose of Tdap in current study | None | None | 0 | 49 | 38 | 49 | View |
Serious Events(If Any):
Serious Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Appendiceal Abscess | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (10.0) | View |
| Gastroenteritis | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (10.0) | View |
| Peritonsillar Abscess | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (10.0) | View |
| Burns Second Degree | NON_SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA (10.0) | View |
| Vaccination Complication | NON_SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA (10.0) | View |
Other Events(If Any):
Other Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Nausea | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (10.0) | View |
| Chills | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA (10.0) | View |
| Fatigue | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA (10.0) | View |
| Injection Site Erythema | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA (10.0) | View |
| Injection Site Induration | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA (10.0) | View |
| Injection Site Pain | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA (10.0) | View |
| Injection Site Swelling | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA (10.0) | View |
| Malaise | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA (10.0) | View |
| Pyrexia | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA (10.0) | View |
| Nasopharyngitis | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (10.0) | View |
| Athralgia | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA (10.0) | View |
| Myalgia | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA (10.0) | View |
| Headache | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA (10.0) | View |
| Rash | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA (10.0) | View |