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 @ 1:46 AM
Ignite Modification Date:
2025-12-26 @ 12:05 AM
NCT ID:
NCT01992094
Description:
All the unsolicited AEs were reported by non-systematic assessment and the solicited AEs were reported by systemic assessment.
For SAEs- analysis was done on Unsolicited safety set. For Other Aes-analysis was done on overall safety set.
Frequency Threshold:
5
Time Frame:
Solicited AEs were collected from day 1to day 7 post vaccination, unsolicited AEs were collected from day 1 to day 22 post vaccination and SAEs were collected from day 1 to day 181
Study:
NCT01992094
Study Brief:
Safety and Immunogenicity of Three Influenza Vaccines Adults Ages 18 and Older
Event Groups(If Any):
Event Groups
| Title | Description | Deaths # Affected | Deaths # At Risk | Serious # Affected | Serious # At Risk | Other # Affected | Other # At Risk | View |
|---|---|---|---|---|---|---|---|---|
| QIVc (≥18 Years) | Subjects received one dose of cell derived quadrivalent influenza vaccine (QIVc) | None | None | 52 | 1324 | 681 | 1324 | View |
| TIV1c (≥ 18 Years) | Subjects received one dose of cell derived trivalent influenza vaccine TIV1c (H1N1, H3N2, B1) recommended for 2013-2014 season | None | None | 22 | 673 | 332 | 673 | View |
| TIV2c (≥18 Years) | Subjects received one dose of cell derived trivalent influenza vaccine TIV2c that contains an alternate B strain compared to what is recommended for 2013-2014 | None | None | 21 | 665 | 335 | 665 | View |
| Total | Total Number of Subjects | None | None | 95 | 2662 | 1348 | 2662 | View |
Serious Events(If Any):
Serious Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| HISTIOCYTOSIS HAEMATOPHAGIC | NON_SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | MedDRA 17.0 | View |
| IRON DEFICIENCY ANAEMIA | NON_SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | MedDRA 17.0 | View |
| ANGINA PECTORIS | NON_SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA 17.0 | View |
| ARTERIOSCLEROSIS CORONARY ARTERY | NON_SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA 17.0 | View |
| ATRIAL FIBRILLATION | NON_SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA 17.0 | View |
| CARDIAC ARREST | NON_SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA 17.0 | View |
| CARDIAC FAILURE CONGESTIVE | NON_SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA 17.0 | View |
| MITRAL VALVE INCOMPETENCE | NON_SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA 17.0 | View |
| MYOCARDIAL INFARCTION | NON_SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA 17.0 | View |
| MYOCARDIAL ISCHAEMIA | NON_SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA 17.0 | View |
| VENTRICULAR FIBRILLATION | NON_SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA 17.0 | View |
| ABDOMINAL PAIN | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 17.0 | View |
| GASTROINTESTINAL HAEMORRHAGE | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 17.0 | View |
| LOWER GASTROINTESTINAL HAEMORRHAGE | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 17.0 | View |
| SMALL INTESTINAL OBSTRUCTION | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 17.0 | View |
| CHEST DISCOMFORT | NON_SYSTEMATIC_ASSESSMENT | General disorders | MedDRA 17.0 | View |
| CHEST PAIN | NON_SYSTEMATIC_ASSESSMENT | General disorders | MedDRA 17.0 | View |
| CORONARY ARTERY RESTENOSIS | NON_SYSTEMATIC_ASSESSMENT | General disorders | MedDRA 17.0 | View |
| DEATH | NON_SYSTEMATIC_ASSESSMENT | General disorders | MedDRA 17.0 | View |
| NON-CARDIAC CHEST PAIN | NON_SYSTEMATIC_ASSESSMENT | General disorders | MedDRA 17.0 | View |
| STRANGULATED HERNIA | NON_SYSTEMATIC_ASSESSMENT | General disorders | MedDRA 17.0 | View |
| ANAPHYLACTIC REACTION | NON_SYSTEMATIC_ASSESSMENT | Immune system disorders | MedDRA 17.0 | View |
| APPENDICITIS | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 17.0 | View |
| BRONCHITIS | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 17.0 | View |
| CELLULITIS | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 17.0 | View |
| DIVERTICULITIS | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 17.0 | View |
| ESCHERICHIA SEPSIS | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 17.0 | View |
| GASTROENTERITIS | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 17.0 | View |
| GASTROENTERITIS VIRAL | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 17.0 | View |
| MENINGITIS VIRAL | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 17.0 | View |
| PNEUMONIA | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 17.0 | View |
| PNEUMONIA LEGIONELLA | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 17.0 | View |
| PYELONEPHRITIS | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 17.0 | View |
| SEPSIS | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 17.0 | View |
| URINARY TRACT INFECTION | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 17.0 | View |
| HEAD INJURY | NON_SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA 17.0 | View |
| HIP FRACTURE | NON_SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA 17.0 | View |
| LUMBAR VERTEBRAL FRACTURE | NON_SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA 17.0 | View |
| POSTOPERATIVE ILEUS | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA 17.0 | View |
| SUBDURAL HAEMATOMA | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA 17.0 | View |
| TENDON RUPTURE | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA 17.0 | View |
| DIABETES MELLITUS | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA 17.0 | View |
| HYPONATRAEMIA | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA 17.0 | View |
| HYPOVOLAEMIA | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA 17.0 | View |
| ARTHRALGIA | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA 17.0 | View |
| MUSCLE HAEMORRHAGE | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA 17.0 | View |
| MUSCULAR WEAKNESS | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA 17.0 | View |
| OSTEOARTHRITIS | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA 17.0 | View |
| PAIN IN EXTREMITY | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA 17.0 | View |
| ROTATOR CUFF SYNDROME | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA 17.0 | View |
| ACUTE MYELOID LEUKAEMIA | SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 17.0 | View |
| BASAL CELL CARCINOMA | SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 17.0 | View |
| CERVIX CARCINOMA | SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 17.0 | View |
| ENDOMETRIAL ADENOCARCINOMA | SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 17.0 | View |
| ENDOMETRIAL CANCER | SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 17.0 | View |
| METASTASES TO LUNG | SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 17.0 | View |
| OVARIAN ADENOMA | SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 17.0 | View |
| SQUAMOUS CELL CARCINOMA | SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 17.0 | View |
| TRANSITIONAL CELL CARCINOMA | SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 17.0 | View |
| AMYOTROPHIC LATERAL SCLEROSIS | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA 17.0 | View |
| DIZZINESS | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA 17.0 | View |
| GENERALISED TONIC-CLONIC SEIZURE | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA 17.0 | View |
| PRESYNCOPE | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA 17.0 | View |
| TRANSIENT ISCHAEMIC ATTACK | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA 17.0 | View |
| ALCOHOLISM | SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MedDRA 17.0 | View |
| BIPOLAR DISORDER | SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MedDRA 17.0 | View |
| DEPRESSION | SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MedDRA 17.0 | View |
| BENIGN PROSTATIC HYPERPLASIA | SYSTEMATIC_ASSESSMENT | Reproductive system and breast disorders | MedDRA 17.0 | View |
| ENDOMETRIOSIS | SYSTEMATIC_ASSESSMENT | Reproductive system and breast disorders | MedDRA 17.0 | View |
| ACUTE RESPIRATORY FAILURE | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA 17.0 | View |
| CHRONIC OBSTRUCTIVE PULMONARY DISEASE | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA 17.0 | View |
| HYPOXIA | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA 17.0 | View |
| PULMONARY EMBOLISM | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA 17.0 | View |
| RESPIRATORY FAILURE | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA 17.0 | View |
| IMPLANTABLE DEFIBRILLATOR INSERTION | SYSTEMATIC_ASSESSMENT | Surgical and medical procedures | MedDRA 17.0 | View |
| ARTERIOSCLEROSIS | SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDRA 17.0 | View |
| HYPERTENSION | SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDRA 17.0 | View |
| CARDIAC FAILURE ACUTE | NON_SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA 17.0 | View |
| CORONARY ARTERY DISEASE | NON_SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA 17.0 | View |
Other Events(If Any):
Other Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| DIARRHOEA | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 17.0 | View |
| NAUSEA | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 17.0 | View |
| CHILLS | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA 17.0 | View |
| FATIGUE | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA 17.0 | View |
| INJECTION SITE ERYTHEMA | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA 17.0 | View |
| INJECTION SITE HAEMORRHAGE | NON_SYSTEMATIC_ASSESSMENT | General disorders | MedDRA 17.0 | View |
| INJECTION SITE INDURATION | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA 17.0 | View |
| INJECTION SITE PAIN | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA 17.0 | View |
| DECREASED APPETITE | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA 17.0 | View |
| ARTHRALGIA | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA 17.0 | View |
| MYALGIA | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA 17.0 | View |
| HEADACHE | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA 17.0 | View |