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 @ 1:08 AM
Ignite Modification Date:
2025-12-25 @ 11:19 PM
NCT ID:
NCT01352793
Description:
SAEs and AEs were grouped by system organ class and summarized. AEs collected on the case report form at each visit (non-systematic assessment).
Frequency Threshold:
1
Time Frame:
AEs were recorded from Vaccination 1 to 1 month after last vaccination. SAEs, newly diagnosed chronic medical conditions and medically attended adverse events were recorded from Vaccination 1 to 6 months after the last vaccination
Study:
NCT01352793
Study Brief:
A Global Phase 3 Safety Study of 120 mcg rLP2086 Vaccine in Adolescents and Young Adults Aged 10 to 25 Years
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: rLP2086 | Randomized to receive Neisseria meningitidis serogroup B (MnB) bivalent recombinant lipoprotein 2086 (rLP2086) vaccine on a 0, 2-, 6-month schedule | None | None | 59 | 3796 | 1671 | 3796 | View |
| Group 2: HAV/Saline/HAV | Randomized to receive hepatitis A virus (HAV) vaccine (Havrix) on a 0-, 6- month schedule and normal saline on 2-month | None | None | 48 | 1908 | 640 | 1908 | View |
Serious Events(If Any):
Serious Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Neutropenia | NON_SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | MedDRA v17.0 | View |
| Autoimmune thyroiditis | NON_SYSTEMATIC_ASSESSMENT | Endocrine disorders | MedDRA v17.0 | View |
| Hyperprolactinaemia | NON_SYSTEMATIC_ASSESSMENT | Endocrine disorders | MedDRA v17.0 | View |
| Hypothalamo-pituitary disorder | NON_SYSTEMATIC_ASSESSMENT | Endocrine disorders | MedDRA v17.0 | View |
| Abdominal pain | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA v17.0 | View |
| Constipation | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA v17.0 | View |
| Duodenal perforation | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA v17.0 | View |
| Duodenal ulcer perforation | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA v17.0 | View |
| Enteritis | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA v17.0 | View |
| Biliary dyskinesia | NON_SYSTEMATIC_ASSESSMENT | Hepatobiliary disorders | MedDRA v17.0 | View |
| Allergy to arthropod sting | NON_SYSTEMATIC_ASSESSMENT | Immune system disorders | MedDRA v17.0 | View |
| Anaphylactic reaction | NON_SYSTEMATIC_ASSESSMENT | Immune system disorders | MedDRA v17.0 | View |
| Drug hypersensitivity | NON_SYSTEMATIC_ASSESSMENT | Immune system disorders | MedDRA v17.0 | View |
| Appendicitis | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA v17.0 | View |
| Gastroenteritis | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA v17.0 | View |
| Peritonsillar abscess | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA v17.0 | View |
| Meningitis viral | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA v17.0 | View |
| Abdominal abscess | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA v17.0 | View |
| Acute tonsillitis | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA v17.0 | View |
| Breast abscess | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA v17.0 | View |
| Carbuncle | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA v17.0 | View |
| Cellulitis | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA v17.0 | View |
| Cystitis | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA v17.0 | View |
| Gastrointestinal viral infection | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA v17.0 | View |
| Meningitis enterococcal | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA v17.0 | View |
| Meningitis enteroviral | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA v17.0 | View |
| Pertussis | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA v17.0 | View |
| Pilonidal cyst | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA v17.0 | View |
| Pneumonia | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA v17.0 | View |
| Postoperative wound infection | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA v17.0 | View |
| Rectal abscess | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA v17.0 | View |
| Salpingitis | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA v17.0 | View |
| Tick-borne viral encephalitis | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA v17.0 | View |
| Concussion | NON_SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA v17.0 | View |
| Intentional overdose | NON_SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA v17.0 | View |
| Cartilage injury | NON_SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA v17.0 | View |
| Clavicle fracture | NON_SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA v17.0 | View |
| Contusion | NON_SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA v17.0 | View |
| Craniocerebral injury | NON_SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA v17.0 | View |
| Fibula fracture | NON_SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA v17.0 | View |
| Forearm fracture | NON_SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA v17.0 | View |
| Gun shot wound | NON_SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA v17.0 | View |
| Head injury | NON_SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA v17.0 | View |
| Heat stroke | NON_SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA v17.0 | View |
| Jaw fracture | NON_SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA v17.0 | View |
| Lower limb fracture | NON_SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA v17.0 | View |
| Overdose | NON_SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA v17.0 | View |
| Snake bite | NON_SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA v17.0 | View |
| Spinal compression fracture | NON_SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA v17.0 | View |
| Traumatic intracranial haemorrhage | NON_SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA v17.0 | View |
| Diabetes mellitus inadequate control | NON_SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA v17.0 | View |
| Type 1 diabetes mellitus | NON_SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA v17.0 | View |
| Intervertebral disc protrusion | NON_SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA v17.0 | View |
| Osteochondrosis | NON_SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA v17.0 | View |
| Pain in extremity | NON_SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA v17.0 | View |
| Central Nervous System germinoma | NON_SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA v17.0 | View |
| Migraine | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA v17.0 | View |
| Multiple sclerosis | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA v17.0 | View |
| Convulsion | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA v17.0 | View |
| Demyelination | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA v17.0 | View |
| Headache | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA v17.0 | View |
| Meningism | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA v17.0 | View |
| Neuralgia | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA v17.0 | View |
| Radicular syndrome | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA v17.0 | View |
| Tension headache | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA v17.0 | View |
| Abortion spontaneous | NON_SYSTEMATIC_ASSESSMENT | Pregnancy, puerperium and perinatal conditions | MedDRA v17.0 | View |
| Abortion missed | NON_SYSTEMATIC_ASSESSMENT | Pregnancy, puerperium and perinatal conditions | MedDRA v17.0 | View |
| Ectopic pregnancy | NON_SYSTEMATIC_ASSESSMENT | Pregnancy, puerperium and perinatal conditions | MedDRA v17.0 | View |
| Suicidal ideation | NON_SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MedDRA v17.0 | View |
| Depression | NON_SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MedDRA v17.0 | View |
| Major depression | NON_SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MedDRA v17.0 | View |
| Substance abuse | NON_SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MedDRA v17.0 | View |
| Attention deficit or hyperactivity disorder | NON_SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MedDRA v17.0 | View |
| Psychotic disorder | NON_SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MedDRA v17.0 | View |
| Schizoaffective disorder | NON_SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MedDRA v17.0 | View |
| Renal tubular necrosis | NON_SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | MedDRA v17.0 | View |
| Menorrhagia | NON_SYSTEMATIC_ASSESSMENT | Reproductive system and breast disorders | MedDRA v17.0 | View |
| Testicular torsion | NON_SYSTEMATIC_ASSESSMENT | Reproductive system and breast disorders | MedDRA v17.0 | View |
| Asthma | NON_SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA v17.0 | View |
| Hyperventilation | NON_SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA v17.0 | View |
| Status asthmaticus | NON_SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA v17.0 | View |
| Ingrowing nail | NON_SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA v17.0 | View |
| Pyelonephritis | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA v17.0 | View |
Other Events(If Any):
Other Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Headache | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA v17.0 | View |
| Oropharyngeal pain | NON_SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA v17.0 | View |
| Cough | NON_SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA v17.0 | View |
| Nausea | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA v17.0 | View |
| Vomiting | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA v17.0 | View |
| Abdominal pain | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA v17.0 | View |
| Diarrhoea | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA v17.0 | View |
| Injection site pain | NON_SYSTEMATIC_ASSESSMENT | General disorders | MedDRA v17.0 | View |
| Pyrexia | NON_SYSTEMATIC_ASSESSMENT | General disorders | MedDRA v17.0 | View |
| Injection site erythema | NON_SYSTEMATIC_ASSESSMENT | General disorders | MedDRA v17.0 | View |
| Vaccination site pain | NON_SYSTEMATIC_ASSESSMENT | General disorders | MedDRA v17.0 | View |
| Fatigue | NON_SYSTEMATIC_ASSESSMENT | General disorders | MedDRA v17.0 | View |
| Injection site swelling | NON_SYSTEMATIC_ASSESSMENT | General disorders | MedDRA v17.0 | View |
| Upper respiratory tract infection | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA v17.0 | View |
| Nasopharyngitis | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA v17.0 | View |
| Pharyngitis | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA v17.0 | View |
| Gastroenteritis | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA v17.0 | View |
| Bronchitis | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA v17.0 | View |
| Sinusitis | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA v17.0 | View |
| Pharyngitis streptococcal | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA v17.0 | View |
| Tonsillitis | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA v17.0 | View |
| Viral pharyngitis | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA v17.0 | View |
| Ligament sprain | NON_SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA v17.0 | View |
| Contusion | NON_SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA v17.0 | View |
| Fall | NON_SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA v17.0 | View |
| Pain in extremity | NON_SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA v17.0 | View |
| Back pain | NON_SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA v17.0 | View |
| Arthralgia | NON_SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA v17.0 | View |
| Urinary tract infection | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA v17.0 | View |