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 @ 11:48 AM
Ignite Modification Date:
2025-12-26 @ 10:20 AM
NCT ID:
NCT00214461
Description:
None
Frequency Threshold:
5
Time Frame:
Adverse event data were collected from the day of vaccination (Day 0) for up to 1 year post-vaccination
Study:
NCT00214461
Study Brief:
Safety, Tolerability, and Immunogenicity of a Clostridium Difficile Toxoid Vaccine in Healthy Elderly Volunteers
Event Groups(If Any):
Event Groups
| Title | Description | Deaths # Affected | Deaths # At Risk | Serious # Affected | Serious # At Risk | Other # Affected | Other # At Risk | View |
|---|---|---|---|---|---|---|---|---|
| Placebo Vaccine Group | Participants who received a dose of placebo, on Days 0, 28, and 56, respectively. | None | None | 0 | 12 | 10 | 12 | View |
| Low-dose C. Difficile Vaccine Group | Participants who received a dose of vaccine containing 2 µg C. difficile toxoid on Days 0, 28, and 56, respectively. | None | None | 0 | 12 | 12 | 12 | View |
| Medium-dose C. Difficile Vaccine Group | Participants who received a dose of vaccine containing 10 µg C. difficile toxoid on Days 0, 28, and 56, respectively. | None | None | 2 | 12 | 11 | 12 | View |
| High-dose C. Difficile Vaccine Group | Participants who received a dose of vaccine containing 50 µg, C. difficile vaccine on Days 0, 28, and 56, respectively. | None | None | 0 | 12 | 12 | 12 | View |
Serious Events(If Any):
Serious Events
Other Events(If Any):
Other Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Injection site reaction | NON_SYSTEMATIC_ASSESSMENT | General disorders | MedDRA 8.0 | View |
| Injection site warmth | NON_SYSTEMATIC_ASSESSMENT | General disorders | MedDRA 8.0 | View |
| Malaise | NON_SYSTEMATIC_ASSESSMENT | General disorders | MedDRA 8.0 | View |
| Pyrexia | NON_SYSTEMATIC_ASSESSMENT | General disorders | MedDRA 8.0 | View |
| Nasopharyngitis | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 8.0 | View |
| Upper respiratory tract infection | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 8.0 | View |
| Urinary tract infection | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 8.0 | View |
| Muscle strain | NON_SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA 8.0 | View |
| Blood creatinine increased | NON_SYSTEMATIC_ASSESSMENT | Investigations | MedDRA 8.0 | View |
| Blood potassium decreased | NON_SYSTEMATIC_ASSESSMENT | Investigations | MedDRA 8.0 | View |
| Blood potassium increased | NON_SYSTEMATIC_ASSESSMENT | Investigations | MedDRA 8.0 | View |
| Electrocardiogram ST T Change | NON_SYSTEMATIC_ASSESSMENT | Investigations | MedDRA 8.0 | View |
| Eosinophil count increased | NON_SYSTEMATIC_ASSESSMENT | Investigations | MedDRA 8.0 | View |
| Haemoglobin decreased | NON_SYSTEMATIC_ASSESSMENT | Investigations | MedDRA 8.0 | View |
| Platelet count decreased | NON_SYSTEMATIC_ASSESSMENT | Investigations | MedDRA 8.0 | View |
| Platelet count increased | NON_SYSTEMATIC_ASSESSMENT | Investigations | MedDRA 8.0 | View |
| Prostate examination abnormal | NON_SYSTEMATIC_ASSESSMENT | Investigations | MedDRA 8.0 | View |
| Red blood cells urine positive | NON_SYSTEMATIC_ASSESSMENT | Investigations | MedDRA 8.0 | View |
| White blood cell count decreased | NON_SYSTEMATIC_ASSESSMENT | Investigations | MedDRA 8.0 | View |
| Anorexia | NON_SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA 8.0 | View |
| Arthralgia | NON_SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA 8.0 | View |
| Back pain | NON_SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA 8.0 | View |
| Neck pain | NON_SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA 8.0 | View |
| Pain in extremity | NON_SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA 8.0 | View |
| Dizziness | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA 8.0 | View |
| Insomnia | NON_SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MedDRA 8.0 | View |
| Prostatitis | NON_SYSTEMATIC_ASSESSMENT | Reproductive system and breast disorders | MedDRA 8.0 | View |
| Cough | NON_SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA 8.0 | View |
| Postnasal drip | NON_SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA 8.0 | View |
| Rhinorrhoea | NON_SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA 8.0 | View |
| Sinus congestion | NON_SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA 8.0 | View |
| Thermal burn | NON_SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA 8.0 | View |
| Alanine aminotransferase increased | NON_SYSTEMATIC_ASSESSMENT | Investigations | MedDRA 8.0 | View |
| Blood bilirubin increased | NON_SYSTEMATIC_ASSESSMENT | Investigations | MedDRA 8.0 | View |
| Blood pressure increased | NON_SYSTEMATIC_ASSESSMENT | Investigations | MedDRA 8.0 | View |
| Blood urea decreased | NON_SYSTEMATIC_ASSESSMENT | Investigations | MedDRA 8.0 | View |
| Blood urea increased | NON_SYSTEMATIC_ASSESSMENT | Investigations | MedDRA 8.0 | View |
| Glucose urine | NON_SYSTEMATIC_ASSESSMENT | Investigations | MedDRA 8.0 | View |
| Haematocrit decreased | NON_SYSTEMATIC_ASSESSMENT | Investigations | MedDRA 8.0 | View |
| Protein urine present | NON_SYSTEMATIC_ASSESSMENT | Investigations | MedDRA 8.0 | View |
| Red blood cell count decreased | NON_SYSTEMATIC_ASSESSMENT | Investigations | MedDRA 8.0 | View |
| Red blood cell count increased | NON_SYSTEMATIC_ASSESSMENT | Investigations | MedDRA 8.0 | View |
| White blood cell count increased | NON_SYSTEMATIC_ASSESSMENT | Investigations | MedDRA 8.0 | View |
| White blood cells urine positive | NON_SYSTEMATIC_ASSESSMENT | Investigations | MedDRA 8.0 | View |
| Muscle spasms | NON_SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA 8.0 | View |
| Myalgia | NON_SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA 8.0 | View |
| Headache | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA 8.0 | View |
| Sinus headache | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA 8.0 | View |
| Dry throat | NON_SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA 8.0 | View |
| Pharyngolarygeal pain | NON_SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA 8.0 | View |
| Hyperchlorhydria | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 8.0 | View |
| Asthenia | NON_SYSTEMATIC_ASSESSMENT | General disorders | MedDRA 8.0 | View |
| Injection site bruising | NON_SYSTEMATIC_ASSESSMENT | General disorders | MedDRA 8.0 | View |
| Pneumonia | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 8.0 | View |
| Cardiomyopathy | NON_SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA 8.0 | View |
| Vomiting | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 8.0 | View |
| Fatigue | NON_SYSTEMATIC_ASSESSMENT | General disorders | MedDRA 8.0 | View |
| Coronary artery disease | NON_SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA 8.0 | View |
| Conjunctivitis | NON_SYSTEMATIC_ASSESSMENT | Eye disorders | MedDRA 8.0 | View |
| Vitreous detachment | NON_SYSTEMATIC_ASSESSMENT | Eye disorders | MedDRA 8.0 | View |
| Abdominal pain | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 8.0 | View |
| Constipation | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 8.0 | View |
| Diarrhoea | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 8.0 | View |
| Diverticulitis intestinal haemorrhagic | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 8.0 | View |
| Gastrooesophageal reflux disease | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 8.0 | View |
| Nausea | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 8.0 | View |
| Induration | NON_SYSTEMATIC_ASSESSMENT | General disorders | MedDRA 8.0 | View |
| Injection site erythema | NON_SYSTEMATIC_ASSESSMENT | General disorders | MedDRA 8.0 | View |
| Injection site haemorrhage | NON_SYSTEMATIC_ASSESSMENT | General disorders | MedDRA 8.0 | View |
| Injection site induration | NON_SYSTEMATIC_ASSESSMENT | General disorders | MedDRA 8.0 | View |
| Injection site nodule | NON_SYSTEMATIC_ASSESSMENT | General disorders | MedDRA 8.0 | View |
| Injection site oedema | NON_SYSTEMATIC_ASSESSMENT | General disorders | MedDRA 8.0 | View |
| Injection site pain | NON_SYSTEMATIC_ASSESSMENT | General disorders | MedDRA 8.0 | View |
| Injection site pruritus | NON_SYSTEMATIC_ASSESSMENT | General disorders | MedDRA 8.0 | View |
| Injection site swelling | NON_SYSTEMATIC_ASSESSMENT | General disorders | MedDRA 8.0 | View |
| Pain | NON_SYSTEMATIC_ASSESSMENT | General disorders | MedDRA 8.0 | View |