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 @ 2:27 AM
Ignite Modification Date:
2025-12-26 @ 1:00 AM
NCT ID:
NCT03135834
Description:
Same event may appear as both AE and SAE, but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety population for Stage 1: participants who received at least 1 dose of investigational product during Stage 1 and for whom safety data were available. Safety population for Stage 2: participants who received booster vaccination and for whom safety data were available.
Frequency Threshold:
1
Time Frame:
Systematic assessment: Local reactions and systemic events recorded within 7 days of each vaccination; Non-systematic collection: SAEs recorded from Month 0 to 6 months after Vaccination 2 (up to Month 12) and 6 months after Booster Vaccination (Booster Vaccination was at Month 54); Non-SAEs recorded from Month 0 to 1 month after Vaccination 2 ( up to Month 7); within 48 hours of blood draw at Month 18, 30 and 42; and 1 month after Booster Vaccination
Study:
NCT03135834
Study Brief:
A Trial to Describe the Immunogenicity and Safety of 2 Doses of Bivalent rLP2086 (Trumenba) and a Pentavalent Meningococcal Vaccine in Healthy Subjects >=10 to <26 Years of Age.
Event Groups(If Any):
Event Groups
| Title | Description | Deaths # Affected | Deaths # At Risk | Serious # Affected | Serious # At Risk | Other # Affected | Other # At Risk | View |
|---|---|---|---|---|---|---|---|---|
| Stage 1: Group 2: Bivalent rLP2086 + MenACWY-CRM (ACWY-Naive) | Stage 1: ACWY-naive participants were randomized to receive an intramuscular injection of 0.5 mL bivalent recombinant lipoprotein 2086 (rLP2086) vaccine and 0.5 mL of meningococcal group A, C, W-135, and Y conjugate vaccine (MenACWY-CRM) at Month 0. Participants received 0.5 mL of bivalent rLP2086 vaccine at Month 6. Stage 1 was followed by Stage 2. Stage 2: Participants received intramuscularly injection of 0.5 mL of bivalent rLP2086 vaccine and 0.5 mL of MenACWY-CRM vaccine (booster vaccination) at Month 54. | 0 | None | 6 | 534 | 508 | 534 | View |
| Stage 1: Group 3: MenABCWY + Saline (ACWY-Experienced) | Stage 1: ACWY-experienced participants were randomized to receive an intramuscular injection of 0.5 milliliter (mL) of Neisseria meningitidis groups A, B, C, W, and Y vaccine (MenABCWY) and 0.5 mL of saline at Month 0, participants received 0.5 mL of MenABCWY vaccine intramuscularly at Month 6. Stage 1 was followed by Stage 2. Stage 2: Participants received 0.5 mL of MenABCWY vaccine (booster vaccination) intramuscularly at Month 54. | 0 | None | 6 | 271 | 259 | 271 | View |
| Stage 1: Group 4: Bivalent rLP2086 + MenACWY-CRM (ACWY-Experienced) | Stage 1: ACWY-experienced participants were randomized to receive an intramuscular injection of 0.5 mL bivalent recombinant lipoprotein 2086 (rLP2086) vaccine and 0.5 mL of meningococcal group A, C, W-135, and Y conjugate vaccine (MenACWY-CRM) at Month 0. Participants received 0.5 mL of bivalent rLP2086 vaccine at Month 6. Stage 1 was followed by Stage 2. Stage 2: Participants received intramuscularly injection of 0.5 mL of bivalent rLP2086 vaccine and 0.5 mL of MenACWY-CRM vaccine (booster vaccination) at Month 54. | 0 | None | 9 | 523 | 502 | 523 | View |
| Stage 2: Group 2: Bivalent rLP2086 + MenACWY-CRM (ACWY-Naive) | Stage 1: ACWY-naive participants were randomized to receive an intramuscular injection of 0.5 mL bivalent recombinant lipoprotein 2086 (rLP2086) vaccine and 0.5 mL of meningococcal group A, C, W-135, and Y conjugate vaccine (MenACWY-CRM) at Month 0. Participants received 0.5 mL of bivalent rLP2086 vaccine at Month 6. Stage 1 was followed by Stage 2. Stage 2: Participants received intramuscularly injection of 0.5 mL of bivalent rLP2086 vaccine and 0.5 mL of MenACWY-CRM vaccine (booster vaccination) at Month 54. | 0 | None | 1 | 65 | 37 | 65 | View |
| Stage 2: Group 3: MenABCWY + Saline (ACWY-Experienced) | Stage 1: ACWY-experienced participants were randomized to receive an intramuscular injection of 0.5 milliliter (mL) of Neisseria meningitidis groups A, B, C, W, and Y vaccine (MenABCWY) and 0.5 mL of saline at Month 0, participants received 0.5 mL of MenABCWY vaccine intramuscularly at Month 6. Stage 1 was followed by Stage 2. Stage 2: Participants received 0.5 mL of MenABCWY vaccine (booster vaccination) intramuscularly at Month 54. | 0 | None | 3 | 101 | 72 | 101 | View |
| Stage 2: Group 4: Bivalent rLP2086 + MenACWY-CRM (ACWY-Experienced) | Stage 1: ACWY-experienced participants were randomized to receive an intramuscular injection of 0.5 mL bivalent recombinant lipoprotein 2086 (rLP2086) vaccine and 0.5 mL of meningococcal group A, C, W-135, and Y conjugate vaccine (MenACWY-CRM) at Month 0. Participants received 0.5 mL of bivalent rLP2086 vaccine at Month 6. Stage 1 was followed by Stage 2. Stage 2: Participants received intramuscularly injection of 0.5 mL of bivalent rLP2086 vaccine and 0.5 mL of MenACWY-CRM vaccine (booster vaccination) at Month 54. | 0 | None | 2 | 73 | 57 | 73 | View |
| Stage 1: Group 1: MenABCWY + Saline (ACWY-Naive) | Stage 1: ACWY-naive participants were randomized to receive an intramuscular injection of 0.5 milliliter (mL) of Neisseria meningitidis groups A, B, C, W, and Y vaccine (MenABCWY) and 0.5 mL of saline at Month 0, participants received 0.5 mL of MenABCWY vaccine intramuscularly at Month 6. Stage 1 was followed by Stage 2. Stage 2: Participants received 0.5 mL of MenABCWY vaccine (booster vaccination) intramuscularly at Month 54. | 1 | None | 5 | 272 | 267 | 272 | View |
| Stage 2: Group 1: MenABCWY + Saline (ACWY-Naive) | Stage 1: ACWY-naive participants were randomized to receive an intramuscular injection of 0.5 milliliter (mL) of Neisseria meningitidis groups A, B, C, W, and Y vaccine (MenABCWY) and 0.5 mL of saline at Month 0, participants received 0.5 mL of MenABCWY vaccine intramuscularly at Month 6. Stage 1 was followed by Stage 2. Stage 2: participants received 0.5 mL of MenABCWY vaccine (booster vaccination) intramuscularly at Month 54. | 0 | None | 1 | 114 | 54 | 114 | View |
Serious Events(If Any):
Serious Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Cardiac failure chronic | NON_SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA v25.1 | View |
| Cardiopulmonary failure | NON_SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA v25.1 | View |
| Myocarditis | NON_SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA v25.1 | View |
| Colitis ulcerative | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA v25.1 | View |
| Faecaloma | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA v25.1 | View |
| Cyst | NON_SYSTEMATIC_ASSESSMENT | General disorders | MedDRA v25.1 | View |
| Cholelithiasis | NON_SYSTEMATIC_ASSESSMENT | Hepatobiliary disorders | MedDRA v25.1 | View |
| Meningitis viral | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA v25.1 | View |
| Pharyngitis | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA v25.1 | View |
| Pneumonia | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA v25.1 | View |
| Overdose | NON_SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA v25.1 | View |
| Road traffic accident | NON_SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA v25.1 | View |
| Tendon injury | NON_SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA v25.1 | View |
| Muscular weakness | NON_SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA v25.1 | View |
| Glioma | NON_SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA v25.1 | View |
| Dyskinesia | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA v25.1 | View |
| Epilepsy | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA v25.1 | View |
| Migraine with aura | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA v25.1 | View |
| Abortion spontaneous | NON_SYSTEMATIC_ASSESSMENT | Pregnancy, puerperium and perinatal conditions | MedDRA v25.1 | View |
| Aggression | NON_SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MedDRA v25.1 | View |
| Conversion disorder | NON_SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MedDRA v25.1 | View |
| Depression | NON_SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MedDRA v25.1 | View |
| Depression suicidal | NON_SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MedDRA v25.1 | View |
| Major depression | NON_SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MedDRA v25.1 | View |
| Oppositional defiant disorder | NON_SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MedDRA v25.1 | View |
| Suicidal ideation | NON_SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MedDRA v25.1 | View |
| Suicide attempt | NON_SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MedDRA v25.1 | View |
| Ovarian cyst | NON_SYSTEMATIC_ASSESSMENT | Reproductive system and breast disorders | MedDRA v25.1 | View |
| Pulmonary embolism | NON_SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA v25.1 | View |
| Femur fracture | NON_SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA v25.1 | View |
| Psychotic disorder | NON_SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MedDRA v25.1 | View |
| Hyperglycaemic hyperosmolar nonketotic syndrome | NON_SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA v25.1 | View |
Other Events(If Any):
Other Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Tachycardia | NON_SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA v25.1 | View |
| Pectus excavatum | NON_SYSTEMATIC_ASSESSMENT | Congenital, familial and genetic disorders | MedDRA v25.1 | View |
| Abdominal pain | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA v25.1 | View |
| Constipation | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA v25.1 | View |
| Diarrhoea | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA v25.1 | View |
| Gastrooesophageal reflux disease | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA v25.1 | View |
| Nausea | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA v25.1 | View |
| Vomiting | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA v25.1 | View |
| Influenza like illness | NON_SYSTEMATIC_ASSESSMENT | General disorders | MedDRA v25.1 | View |
| Seasonal allergy | NON_SYSTEMATIC_ASSESSMENT | Immune system disorders | MedDRA v25.1 | View |
| Acute sinusitis | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA v25.1 | View |
| Bacterial vaginosis | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA v25.1 | View |
| Bronchitis | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA v25.1 | View |
| COVID-19 | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA v25.1 | View |
| Ear infection | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA v25.1 | View |
| Gastroenteritis | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA v25.1 | View |
| Gastroenteritis viral | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA v25.1 | View |
| Impetigo | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA v25.1 | View |
| Influenza | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA v25.1 | View |
| Nasopharyngitis | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA v25.1 | View |
| Otitis externa | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA v25.1 | View |
| Otitis media | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA v25.1 | View |
| Otitis media acute | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA v25.1 | View |
| Pharyngitis | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA v25.1 | View |
| Pharyngitis streptococcal | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA v25.1 | View |
| Sinusitis | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA v25.1 | View |
| Tonsillitis | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA v25.1 | View |
| Upper respiratory tract infection | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA v25.1 | View |
| Urinary tract infection | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA v25.1 | View |
| Viral pharyngitis | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA v25.1 | View |
| Viral upper respiratory tract infection | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA v25.1 | View |
| Contusion | NON_SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA v25.1 | View |
| Eye injury | NON_SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA v25.1 | View |
| Ligament sprain | NON_SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA v25.1 | View |
| Skin laceration | NON_SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA v25.1 | View |
| SARS-CoV-2 test positive | NON_SYSTEMATIC_ASSESSMENT | Investigations | MedDRA v25.1 | View |
| Hypercholesterolaemia | NON_SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA v25.1 | View |
| Arthralgia | NON_SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA v25.1 | View |
| Back pain | NON_SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA v25.1 | View |
| Pain in extremity | NON_SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA v25.1 | View |
| Dizziness | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA v25.1 | View |
| Headache | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA v25.1 | View |
| Migraine | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA v25.1 | View |
| Syncope | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA v25.1 | View |
| Anxiety | NON_SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MedDRA v25.1 | View |
| Depression | NON_SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MedDRA v25.1 | View |
| Insomnia | NON_SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MedDRA v25.1 | View |
| Dysmenorrhoea | NON_SYSTEMATIC_ASSESSMENT | Reproductive system and breast disorders | MedDRA v25.1 | View |
| Cough | NON_SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA v25.1 | View |
| Oropharyngeal pain | NON_SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA v25.1 | View |
| Rhinitis allergic | NON_SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA v25.1 | View |
| Sinus congestion | NON_SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA v25.1 | View |
| Dermatitis contact | NON_SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA v25.1 | View |
| Eczema | NON_SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA v25.1 | View |
| Urticaria | NON_SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA v25.1 | View |
| Haematoma | NON_SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDRA v25.1 | View |
| Diarrhoea (DIARRHEA) | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA v25.1 | View |
| Chills | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA v25.1 | View |
| Fatigue | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA v25.1 | View |
| Injection site pain (PAIN AT INJECTION SITE) | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA v25.1 | View |
| Pyrexia (FEVER) | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA v25.1 | View |
| Swelling | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA v25.1 | View |
| Arthralgia (JOINT PAIN) | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA v25.1 | View |
| Myalgia (MUSCLE PAIN) | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA v25.1 | View |
| Erythema (REDNESS) | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA v25.1 | View |
| Muscle strain | NON_SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA v25.1 | View |
| Scoliosis | NON_SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA v25.1 | View |
| Psychophysiologic insomnia | NON_SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MedDRA v25.1 | View |
| Vomiting | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA v25.1 | View |
| Headache | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA v25.1 | View |
| Pain | NON_SYSTEMATIC_ASSESSMENT | General disorders | MedDRA v25.1 | View |