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 @ 4:11 AM
Ignite Modification Date:
2025-12-26 @ 3:10 AM
NCT ID:
NCT02587520
Description:
A SR was an AE that was prelisted (i.e. solicited) in the eCRF and considered to be related to vaccination (ADR). An unsolicited AE was an observed AE that did not fulfill the conditions prelisted in the eCRF (i.e., solicited) in terms of symptom and/or onset post-vaccination. AEs were summarized in the safety analysis set.
Frequency Threshold:
5
Time Frame:
Non-serious AEs were collected from Day 0 to Day 7 (SRs) or Day 30 (unsolicited AEs) after vaccination. Serious AEs were collected from Day 0 up to Month 6 after vaccination.
Study:
NCT02587520
Study Brief:
Study of Tetanus Toxoid, Reduced Diphtheria Toxoid, and Acellular Pertussis Vaccine Adsorbed in Healthy Subjects
Event Groups(If Any):
Event Groups
| Title | Description | Deaths # Affected | Deaths # At Risk | Serious # Affected | Serious # At Risk | Other # Affected | Other # At Risk | View |
|---|---|---|---|---|---|---|---|---|
| Adolescents: SP0173 Formulation 1 | Healthy participants aged 10-18 years received a single dose of the SP0173 Tetanus Toxoid, Reduced Diphtheria Toxoid, and Acellular Pertussis Vaccine Adsorbed (Tdap) vaccine. | 0 | None | 0 | 79 | 71 | 79 | View |
| Adolescents: SP0173 Formulation 2 | Healthy participants aged 10-18 years received a single dose of the SP0173 Tdap vaccine. | 0 | None | 0 | 71 | 64 | 71 | View |
| Adults: SP0173 Formulation 1 | Healthy participants aged 19-64 years received a single dose of the SP0173 Tdap vaccine. | 0 | None | 1 | 76 | 52 | 76 | View |
| Adults: SP0173 Formulation 4 | Healthy participants aged 19-64 years received a single dose of the SP0173 Tdap vaccine. | 0 | None | 1 | 76 | 54 | 76 | View |
| Older Adults: SP0173 Formulation 4 | Healthy participants aged \>= 65 years received a single dose of the SP0173 Tdap vaccine. | 0 | None | 1 | 72 | 53 | 72 | View |
| Adolescents: SP0173 Formulation 3 | Healthy participants aged 10-18 years received a single dose of the SP0173 Tdap vaccine. | 0 | None | 0 | 77 | 67 | 77 | View |
| Adolescents: SP0173 Formulation 4 | Healthy participants aged 10-18 years received a single dose of the SP0173 Tdap vaccine. | 0 | None | 1 | 77 | 68 | 77 | View |
| Adolescents: Adacel® | Healthy participants aged 10-18 years received Adacel®. | 0 | None | 0 | 75 | 71 | 75 | View |
| Adolescents: Boostrix® | Healthy participants aged 10-18 years received Boostrix®. | 0 | None | 0 | 75 | 66 | 75 | View |
| Adults: SP0173 Formulation 2 | Healthy participants aged 19-64 years received a single dose of the SP0173 Tdap vaccine. | 0 | None | 1 | 73 | 53 | 73 | View |
| Adults: SP0173 Formulation 3 | Healthy participants aged 19-64 years received a single dose of the SP0173 Tdap vaccine. | 0 | None | 1 | 76 | 67 | 76 | View |
| Adults: Adacel® | Healthy participants aged 19-64 years received Adacel®. | 0 | None | 0 | 76 | 62 | 76 | View |
| Adults: Boostrix® | Healthy participants aged 19-64 years received Boostrix®. | 1 | None | 2 | 72 | 50 | 72 | View |
| Older Adults: SP0173 Formulation 1 | Healthy participants aged \>= 65 years received a single dose of the SP0173 Tdap vaccine. | 0 | None | 0 | 77 | 53 | 77 | View |
| Older Adults: SP0173 Formulation 2 | Healthy participants aged \>= 65 years received a single dose of the SP0173 Tdap vaccine. | 0 | None | 3 | 73 | 60 | 73 | View |
| Older Adults: SP0173 Formulation 3 | Healthy participants aged \>= 65 years received a single dose of the SP0173 Tdap vaccine. | 0 | None | 4 | 78 | 58 | 78 | View |
| Older Adults: Adacel® | Healthy participants aged \>= 65 years received Adacel®. | 0 | None | 2 | 76 | 49 | 76 | View |
| Older Adults: Boostrix® | Healthy participants aged \>= 65 years received Boostrix®. | 0 | None | 2 | 78 | 56 | 78 | View |
Serious Events(If Any):
Serious Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Acute Kidney Injury | SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | MedDRA 18.0 | View |
| Asthma | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA 18.0 | View |
| Chronic Obstructive Pulmonary Disease | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA 18.0 | View |
| Aortic Stenosis | SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDRA 18.0 | View |
| Cardiac Failure Congestive | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA 18.0 | View |
| Coronary Artery Disease | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA 18.0 | View |
| Post-Traumatic Stress Disorder | SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MedDRA 18.0 | View |
| Embolic Cerebral Infarction | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA 18.0 | View |
| Transient Ischaemic Attack | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA 18.0 | View |
| Ventricular Fibrillation | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA 18.0 | View |
| Device Dislocation | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA 18.0 | View |
| Drug Withdrawal Syndrome | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA 18.0 | View |
| Non-Cardiac Chest Pain | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA 18.0 | View |
| Drug Hypersensitivity | SYSTEMATIC_ASSESSMENT | Immune system disorders | MedDRA 18.0 | View |
| Appendicitis Perforated | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 18.0 | View |
| Pneumonia | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 18.0 | View |
| Humerus Fracture | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA 18.0 | View |
| Laceration | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA 18.0 | View |
| Breast Cancer Recurrent | SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 18.0 | View |
Other Events(If Any):
Other Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Pharyngitis Streptococcal | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 18.0 | View |
| Viral Pharyngitis | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 18.0 | View |
| Myalgia | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA 18.0 | View |
| Headache | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA 18.0 | View |
| Cough | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA 18.0 | View |
| Oropharyngeal Pain | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA 18.0 | View |
| Injection Site Erythema | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA 18.0 | View |
| Injection Site Pain | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA 18.0 | View |
| Injection Site Swelling | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA 18.0 | View |
| Malaise | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA 18.0 | View |
| Pharyngitis | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 18.0 | View |
| Abdominal Pain | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 18.0 | View |
| Change In Limb Circumference | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA 18.0 | View |