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 @ 6:49 PM
Ignite Modification Date:
2025-12-25 @ 4:21 PM
NCT ID:
NCT01436357
Description:
For events solicited on the memory aid, a participant was considered to have 1 event if it was reported as experienced at any time in the 8 day period after a vaccination. Participants are analyzed as treated, one participant randomized to placebo received vaccine.
Frequency Threshold:
5
Time Frame:
Solicited reactogenicity symptoms were collected before vaccination, and then daily for 8 days post-vaccination (Day 0-7) after each vaccination on a memory aid. Unsolicited adverse events were collected through Day 90. At visits following Day 90 up to Day 140, only SAE's were collected.
Study:
NCT01436357
Study Brief:
Staged Phase I/II Hepatitis C Prophylactic Vaccine
Event Groups(If Any):
Event Groups
| Title | Description | Deaths # Affected | Deaths # At Risk | Serious # Affected | Serious # At Risk | Other # Affected | Other # At Risk | View |
|---|---|---|---|---|---|---|---|---|
| Sodium Chloride Placebo | Two doses of sodium chloride placebo intramuscularly, 1 at day 0 and 1 at day 56. | 2 | None | 25 | 272 | 172 | 272 | View |
| AdCh3NSmut1 and MVA-NSmut | One dose of AdCh3NSmut1 at 2.5 x 10\^10 total virus particles (vp)/dose at day 0 followed by 1 dose of MVA-NSmut intramuscularly 56 days later at the dosage 1.8 x10\^8 plaque forming units (pfu). | 5 | None | 40 | 274 | 229 | 274 | View |
Serious Events(If Any):
Serious Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Colitis | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (20.1) | View |
| Pancreatitis | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (20.1) | View |
| Cholecystitis Acute | NON_SYSTEMATIC_ASSESSMENT | Hepatobiliary disorders | MedDRA (20.1) | View |
| Hepatitis | NON_SYSTEMATIC_ASSESSMENT | Hepatobiliary disorders | MedDRA (20.1) | View |
| Liver Injury | NON_SYSTEMATIC_ASSESSMENT | Hepatobiliary disorders | MedDRA (20.1) | View |
| Abscess | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (20.1) | View |
| Abscess Limb | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (20.1) | View |
| Abscess Neck | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (20.1) | View |
| Arthritis Bacterial | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (20.1) | View |
| Bursitis Infective | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (20.1) | View |
| Cellulitis | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (20.1) | View |
| Clostridium Difficile Colitis | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (20.1) | View |
| Endocarditis | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (20.1) | View |
| Gangrene | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (20.1) | View |
| HIV Infection | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (20.1) | View |
| Osteomyelitis | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (20.1) | View |
| Pneumonia | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (20.1) | View |
| Psoas Abscess | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (20.1) | View |
| Staphylococcal Bacteraemia | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (20.1) | View |
| Subcutaneous Abscess | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (20.1) | View |
| Tooth Abscess | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (20.1) | View |
| Urosepsis | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (20.1) | View |
| Facial Bones Fracture | NON_SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA (20.1) | View |
| Head Injury | NON_SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA (20.1) | View |
| Hip Fracture | NON_SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA (20.1) | View |
| Injury | NON_SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA (20.1) | View |
| Lower Limb Fracture | NON_SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA (20.1) | View |
| Multiple Fractures | NON_SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA (20.1) | View |
| Overdose | NON_SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA (20.1) | View |
| Subdural Haematoma | NON_SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA (20.1) | View |
| Toxicity To Various Agents | NON_SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA (20.1) | View |
| Traumatic Liver Injury | NON_SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA (20.1) | View |
| Uterine Rupture | NON_SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA (20.1) | View |
| Foetal Monitoring | NON_SYSTEMATIC_ASSESSMENT | Investigations | MedDRA (20.1) | View |
| Type 1 Diabetes Mellitus | NON_SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA (20.1) | View |
| Compartment Syndrome | NON_SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA (20.1) | View |
| Transitional Cell Carcinoma | NON_SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (20.1) | View |
| Hypoxic-Ischaemic Encephalopathy | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA (20.1) | View |
| Seizure | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA (20.1) | View |
| Foetal Death | NON_SYSTEMATIC_ASSESSMENT | Pregnancy, puerperium and perinatal conditions | MedDRA (20.1) | View |
| Affective Disorder | NON_SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MedDRA (20.1) | View |
| Completed Suicide | NON_SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MedDRA (20.1) | View |
| Depression | NON_SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MedDRA (20.1) | View |
| Mental Status Changes | NON_SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MedDRA (20.1) | View |
| Psychotic Disorder | NON_SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MedDRA (20.1) | View |
| Schizoaffective Disorder | NON_SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MedDRA (20.1) | View |
| Suicidal Ideation | NON_SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MedDRA (20.1) | View |
| Suicide Attempt | NON_SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MedDRA (20.1) | View |
| Asthma | NON_SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA (20.1) | View |
| Pulmonary Embolism | NON_SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA (20.1) | View |
Other Events(If Any):
Other Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Injection site pain | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA (20.1) | View |
| Injection site warmth | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA (20.1) | View |
| Injection site erythema | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA (20.1) | View |
| Injection site induration | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA (20.1) | View |
| Headache | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA (20.1) | View |
| Malaise | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA (20.1) | View |
| Myalgia | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA (20.1) | View |
| Nausea | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (20.1) | View |
| Chills | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA (20.1) | View |
| Abdominal pain | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (20.1) | View |
| Arthralgia | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA (20.1) | View |
| Blood alkaline phosphatase increased | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA (20.1) | View |
| Injection site pain | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA (20.1) | View |
| Body temperature increase | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA (20.1) | View |
| Vomiting | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (20.1) | View |
| Aspartate aminotransferase increased | NON_SYSTEMATIC_ASSESSMENT | Investigations | MedDRA (20.1) | View |