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 @ 10:44 PM
Ignite Modification Date:
2025-12-25 @ 8:15 PM
NCT ID:
NCT02534935
Description:
SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment).
Frequency Threshold:
1
Time Frame:
Stage 1: SAEs:Recorded from Vaccination(Vacc) 1 through 6 months after Vacc. 3 (Month 12). Local reactions and systemic events in e-diary: 7 days after Vacc 1, 2 and 3. NSAEs: Vaccination 1 through 1 month after Vacc 3 (Month 7). Stage 2 Follow up phase: Month 24 visit (up to 30 days). Stage 2 Booster phase: SAEs: From booster vacc up to 6 months after booster vacc NSAEs: From booster vacc up to 1 month after booster vacc. Local reactions and systemic events in e-diary: 7 days after booster vacc
Study:
NCT02534935
Study Brief:
Immunogenicity, Safety and Tolerability of a Neisseria Meningitidis Serogroup B Bivalent Recominant Lipoprotein 2086 Vaccine (Bivalent rLP2086) in Healthy Toddlers.
Event Groups(If Any):
Event Groups
| Title | Description | Deaths # Affected | Deaths # At Risk | Serious # Affected | Serious # At Risk | Other # Affected | Other # At Risk | View |
|---|---|---|---|---|---|---|---|---|
| Group 1: 60- Microgram (mcg) Bivalent rLP2086 (>=12 Months to <24 Months): Stage 1 | Participants from greater than or equal to (\>=) 12 months to less than (\<) 24 months of age, received intramuscular injection of 60 mcg of bivalent rLP2086 vaccine on months 0 (visit 1, vaccination1), 2 (visit 4, vaccination 2), and 6 (visit 6, vaccination 3). | 0 | None | 4 | 44 | 43 | 44 | View |
| Group 2: 120-mcg Bivalent rLP2086 (>=12 Months to <24 Months):Stage 1 | Participants from \>=12 months to \<24 months of age, received intramuscular injection of 120 mcg of bivalent rLP2086 vaccine on months 0 (visit 1, vaccination1), 2 (visit 4, vaccination 2), and 6 (visit 6, vaccination 3). All eligible participants (who received 3 doses of bivalent rLP2086 in stage 1 at the 120 mcg dose level) received intramuscular injection of single booster dose of 120 mcg of bivalent rLP2086 after 23 months of vaccination 3 (visit 12) in stage 2. Participants were followed up approximately 6 months after the booster vaccination. | 0 | None | 19 | 220 | 209 | 220 | View |
| Group 3: HAV/Saline (>=12 Months to <24 Months): Stage 1 | Participants from \>=12 months to \<24 months of age, received intramuscular injection of saline on 2 month and HAV vaccine on a 0, 6 month schedule. | 0 | None | 8 | 132 | 113 | 132 | View |
| 120-mcg Bivalent rLP2086: Stage 2 Booster Phase | Participants who were randomly assigned to bivalent rLP2086 (irrespective of dose level) were eligible for booster vaccination. Participants received intramuscular injection of 120-mcg of bivalent rLP2086 vaccine after 23 months of visit 3. | 0 | None | 2 | 147 | 121 | 147 | View |
| Group 1: 60-mcg Bivalent rLP2086 (>=12 Months to <24 Months): Follow up | Participants from \>=12 months to \<24 months of age, received intramuscular injection of 60 µg of bivalent rLP2086 vaccine on months 0 (visit 1, vaccination1), 2 (visit 4, vaccination 2), and 6 (visit 6, vaccination 3). | 0 | None | 0 | 44 | 0 | 44 | View |
| Group 2: 120-mcg Bivalent rLP2086 (>=12 Months to <24 Months): Follow up | Participants from \>=12 months to \<24 months of age, received intramuscular injection of 120 µg of bivalent rLP2086 vaccine on months 0 (visit 1, vaccination1), 2 (visit 4, vaccination 2), and 6 (visit 6, vaccination 3). | 0 | None | 3 | 220 | 0 | 220 | View |
| Group 3: HAV/Saline (>=12 Months to <24 Months): Follow up | Participants from \>=12 months to \<24 months of age, received intramuscular injection of saline on 2- month and HAV vaccine on months 0 (visit 1, vaccination1), 2 (visit 4, vaccination 2), and 6 (visit 6, vaccination 3). | 0 | None | 0 | 132 | 0 | 132 | View |
Serious Events(If Any):
Serious Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Eyelid ptosis | NON_SYSTEMATIC_ASSESSMENT | Eye disorders | None | View |
| Enteritis | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | None | View |
| Gastrooesophageal reflux disease | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | None | View |
| Inguinal hernia | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | None | View |
| Nausea | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | None | View |
| Crying | NON_SYSTEMATIC_ASSESSMENT | General disorders | None | View |
| Pyrexia | NON_SYSTEMATIC_ASSESSMENT | General disorders | None | View |
| Bronchiolitis | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | None | View |
| Bronchitis | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | None | View |
| Croup infectious | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | None | View |
| Enterovirus infection | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | None | View |
| Gastroenteritis | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | None | View |
| Otitis media | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | None | View |
| Otitis media chronic | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | None | View |
| Pneumonia | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | None | View |
| Pneumonia respiratory syncytial viral | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | None | View |
| Respiratory tract infection viral | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | None | View |
| Tonsillitis | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | None | View |
| Urinary tract infection | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | None | View |
| Viral tonsillitis | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | None | View |
| Viral upper respiratory tract infection | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | None | View |
| Accidental exposure to product | NON_SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | None | View |
| Head injury | NON_SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | None | View |
| Balance disorder | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | None | View |
| Cerebellar ataxia | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | None | View |
| Irritability | NON_SYSTEMATIC_ASSESSMENT | Psychiatric disorders | None | View |
| Adenoidal hypertrophy | NON_SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | None | View |
| Constipation | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | None | View |
| Rhinovirus infection | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | None | View |
| Cellulitis | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | None | View |
| Sleep apnoea syndrome | NON_SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | None | View |
| Influenza | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | None | View |
| Polydipsia psychogenic | NON_SYSTEMATIC_ASSESSMENT | Psychiatric disorders | None | View |
Other Events(If Any):
Other Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Urinary tract infection | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | None | View |
| Varicella | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | None | View |
| Viral infection | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | None | View |
| Viral pharyngitis | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | None | View |
| Viral tonsillitis | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | None | View |
| Viral upper respiratory tract infection | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | None | View |
| Arthropod bite | NON_SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | None | View |
| Arthropod sting | NON_SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | None | View |
| Concussion | NON_SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | None | View |
| Contusion | NON_SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | None | View |
| Craniocerebral injury | NON_SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | None | View |
| Excoriation | NON_SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | None | View |
| Face injury | NON_SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | None | View |
| Fall | NON_SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | None | View |
| Hand fracture | NON_SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | None | View |
| Laceration | NON_SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | None | View |
| Lip injury | NON_SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | None | View |
| Decreased appetite (loss of appetite) | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | None | View |
| Decreased appetite | NON_SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | None | View |
| Synovitis | NON_SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | None | View |
| Headache | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | None | View |
| Somnolence (drowsiness) | SYSTEMATIC_ASSESSMENT | Nervous system disorders | None | View |
| Somnolence | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | None | View |
| Irritability | NON_SYSTEMATIC_ASSESSMENT | Psychiatric disorders | None | View |
| Cough | NON_SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | None | View |
| Rhinitis allergic | NON_SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | None | View |
| Rhinorrhoea | NON_SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | None | View |
| Dermatitis allergic | NON_SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | None | View |
| Dermatitis contact | NON_SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | None | View |
| Dermatitis diaper | NON_SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | None | View |
| Eczema | NON_SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | None | View |
| Miliaria | NON_SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | None | View |
| Rash generalised | NON_SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | None | View |
| Rash | NON_SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | None | View |
| Urticaria | NON_SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | None | View |
| Irritability | SYSTEMATIC_ASSESSMENT | Psychiatric disorders | None | View |
| Dermatitis | NON_SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | None | View |
| Vomiting | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | None | View |
| Fatigue | SYSTEMATIC_ASSESSMENT | General disorders | None | View |
| Injection site pain | SYSTEMATIC_ASSESSMENT | General disorders | None | View |
| Arthralgia | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | None | View |
| Myalgia | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | None | View |
| Headache | SYSTEMATIC_ASSESSMENT | Nervous system disorders | None | View |
| Diarrhoea | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | None | View |
| Diarrhoea | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | None | View |
| Vomiting | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | None | View |
| Injection site erythema (redness) | SYSTEMATIC_ASSESSMENT | General disorders | None | View |
| Injection site pain (tenderness at injection site) | SYSTEMATIC_ASSESSMENT | General disorders | None | View |
| Eustachian tube disorder | NON_SYSTEMATIC_ASSESSMENT | Ear and labyrinth disorders | None | View |
| Middle ear effusion | NON_SYSTEMATIC_ASSESSMENT | Ear and labyrinth disorders | None | View |
| Anisometropia | NON_SYSTEMATIC_ASSESSMENT | Eye disorders | None | View |
| Astigmatism | NON_SYSTEMATIC_ASSESSMENT | Eye disorders | None | View |
| Conjunctivitis allergic | NON_SYSTEMATIC_ASSESSMENT | Eye disorders | None | View |
| Hypermetropia | NON_SYSTEMATIC_ASSESSMENT | Eye disorders | None | View |
| Aphthous ulcer | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | None | View |
| Enteritis | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | None | View |
| Flatulence | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | None | View |
| Teething | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | None | View |
| Chills | NON_SYSTEMATIC_ASSESSMENT | General disorders | None | View |
| Injection site erythema | NON_SYSTEMATIC_ASSESSMENT | General disorders | None | View |
| Injection site pain | NON_SYSTEMATIC_ASSESSMENT | General disorders | None | View |
| Injection site swelling (swelling) | SYSTEMATIC_ASSESSMENT | General disorders | None | View |
| Pyrexia (fever) | SYSTEMATIC_ASSESSMENT | General disorders | None | View |
| Pyrexia | NON_SYSTEMATIC_ASSESSMENT | General disorders | None | View |
| Vaccination site pain | NON_SYSTEMATIC_ASSESSMENT | General disorders | None | View |
| Vessel puncture site bruise | NON_SYSTEMATIC_ASSESSMENT | General disorders | None | View |
| Food allergy | NON_SYSTEMATIC_ASSESSMENT | Immune system disorders | None | View |
| Bronchiolitis | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | None | View |
| Bronchitis | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | None | View |
| Cellulitis | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | None | View |
| Conjunctivitis | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | None | View |
| Croup infectious | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | None | View |
| Enterobiasis | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | None | View |
| Exanthema subitum | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | None | View |
| Gastroenteritis viral | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | None | View |
| Gastroenteritis | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | None | View |
| Hand-foot-and-mouth disease | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | None | View |
| Impetigo | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | None | View |
| Infected bite | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | None | View |
| Laryngitis | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | None | View |
| Lower respiratory tract infection | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | None | View |
| Molluscum contagiosum | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | None | View |
| Nasopharyngitis | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | None | View |
| Otitis externa | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | None | View |
| Otitis media acute | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | None | View |
| Otitis media | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | None | View |
| Pharyngitis streptococcal | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | None | View |
| Pharyngitis | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | None | View |
| Pharyngotonsillitis | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | None | View |
| Pneumonia | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | None | View |
| Respiratory tract infection viral | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | None | View |
| Respiratory tract infection | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | None | View |
| Rhinitis | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | None | View |
| Skin candida | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | None | View |
| Tonsillitis | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | None | View |
| Tracheitis | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | None | View |
| Upper respiratory tract infection | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | None | View |