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 @ 3:19 AM
Ignite Modification Date:
2025-12-26 @ 1:58 AM
NCT ID:
NCT00270205
Description:
None
Frequency Threshold:
5
Time Frame:
From start of study vaccination to week 61
Study:
NCT00270205
Study Brief:
Safety, Tolerability and Immune Response to LC002, an Experimental Therapeutic Vaccine, in Adults Receiving HAART
Event Groups(If Any):
Event Groups
| Title | Description | Deaths # Affected | Deaths # At Risk | Serious # Affected | Serious # At Risk | Other # Affected | Other # At Risk | View |
|---|---|---|---|---|---|---|---|---|
| A: 0.1 mg DNA/Participant Vaccination at Weeks 1, 7, 13 | Participants receiving three separate low-dose vaccinations of LC002 (0.1 mg DNA/participant, 0.8 ml total, administered over two skin sites \[on the left and right upper back\] of 80 cm\^2 each, 0.4 ml/site) at weeks 1, 7, and 13. | 0 | None | 0 | 6 | 5 | 6 | View |
| C: 0.4 mg DNA/Participant Vaccination at Weeks 1, 7, 13 | Participants receiving three separate high-dose vaccinations of LC002 (0.4 mg DNA/participant, 3.2 ml total, administered over four skin sites \[on the left and right upper back and left and right upper ventral thigh\] of 80 cm\^2 each, 0.8 ml/site) at weeks 1, 7, and 13. | 0 | None | 0 | 6 | 6 | 6 | View |
| E: 0.4 mg DNA/Participant Vaccination at Weeks 0,1,6,7,12,13 | Participants receiving six separate high-dose vaccinations of LC002 (0.4 mg DNA/participant, 3.2 ml total, administered over four skin sites \[on the left and right upper back and left and right upper ventral thigh\] of 80 cm\^2 each, 0.8 ml/site) at study entry and weeks 1, 6, 7, 12, and 13. | 0 | None | 0 | 6 | 6 | 6 | View |
| Placebo | All participants receiving vaccinations of LC002 placebo were combined together in this arm/group. This includes those participants in arms B, D and F. | 0 | None | 0 | 7 | 6 | 7 | View |
Serious Events(If Any):
Other Events(If Any):
Other Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Abdominal distension | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 14.0 | View |
| Abdominal pain | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 14.0 | View |
| Abdominal pain lower | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 14.0 | View |
| Diarrhoea | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 14.0 | View |
| Hiatus hernia | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 14.0 | View |
| Nausea | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 14.0 | View |
| Proctalgia | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 14.0 | View |
| Rectal ulcer | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 14.0 | View |
| Vomiting | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 14.0 | View |
| Chills | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA 14.0 | View |
| Fatigue | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA 14.0 | View |
| Injection site discomfort | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA 14.0 | View |
| Injection site erythema | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA 14.0 | View |
| Injection site mass | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA 14.0 | View |
| Injection site pain | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA 14.0 | View |
| Pyrexia | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA 14.0 | View |
| Vaccination site erythema | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA 14.0 | View |
| Vaccination site pain | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA 14.0 | View |
| Vaccination site reaction | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA 14.0 | View |
| Hordeolum | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 14.0 | View |
| Secondary syphilis | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 14.0 | View |
| Vaginitis bacterial | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 14.0 | View |
| Burns second degree | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA 14.0 | View |
| Alanine aminotransferase increased | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA 14.0 | View |
| Aspartate aminotransferase increased | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA 14.0 | View |
| Blood bicarbonate | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA 14.0 | View |
| Blood bilirubin increased | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA 14.0 | View |
| Blood creatine phosphokinase increased | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA 14.0 | View |
| Blood creatinine increased | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA 14.0 | View |
| Blood glucose abnormal | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA 14.0 | View |
| Blood glucose decreased | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA 14.0 | View |
| Blood phosphorus decreased | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA 14.0 | View |
| Blood sodium decreased | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA 14.0 | View |
| Weight decreased | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA 14.0 | View |
| Decreased appetite | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA 14.0 | View |
| Hypoglycaemia | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA 14.0 | View |
| Arthralgia | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA 14.0 | View |
| Back pain | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA 14.0 | View |
| Groin pain | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA 14.0 | View |
| Muscle spasms | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA 14.0 | View |
| Myalgia | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA 14.0 | View |
| Pain in extremity | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA 14.0 | View |
| Amnesia | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA 14.0 | View |
| Burning sensation | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA 14.0 | View |
| Anxiety | SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MedDRA 14.0 | View |
| Insomnia | SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MedDRA 14.0 | View |
| Cough | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA 14.0 | View |
| Nasal congestion | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA 14.0 | View |
| Oropharyngeal pain | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA 14.0 | View |
| Productive cough | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA 14.0 | View |
| Respiratory tract congestion | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA 14.0 | View |
| Alopecia areata | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA 14.0 | View |
| Erythema | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA 14.0 | View |
| Lipoatrophy | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA 14.0 | View |
| Papule | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA 14.0 | View |
| Pruritus | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA 14.0 | View |
| Rash | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA 14.0 | View |
| Rash macular | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA 14.0 | View |
| Rash papular | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA 14.0 | View |
| Lymphadenopathy | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | MedDRA 14.0 | View |
| Eye pain | SYSTEMATIC_ASSESSMENT | Eye disorders | MedDRA 14.0 | View |
| Lacrimation decreased | SYSTEMATIC_ASSESSMENT | Eye disorders | MedDRA 14.0 | View |
| Macular degeneration | SYSTEMATIC_ASSESSMENT | Eye disorders | MedDRA 14.0 | View |
| Injection site pruritus | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA 14.0 | View |
| Malaise | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA 14.0 | View |
| Oedema peripheral | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA 14.0 | View |
| Pain | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA 14.0 | View |
| Dizziness | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA 14.0 | View |
| Dysgeusia | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA 14.0 | View |
| Headache | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA 14.0 | View |
| Paraesthesia | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA 14.0 | View |
| Upper respiratory tract congestion | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA 14.0 | View |