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 @ 9:34 PM
Ignite Modification Date:
2025-12-25 @ 7:18 PM
NCT ID:
NCT02177032
Description:
Solicited local,systemic AEs \& associated medications will be recorded on diary cards for 3,4, 7 \& 7 days post vaccination on Visits 1,2,3 \& 5,respectively.Unsolicited AEs \& associated vaccinations will be collected in diary cards from D1-29 for Groups A1 \& A2 \& from D1-50 for Groups B1 \& B2.After D29/50, until D366 only SAEs \& AEs leading to withdrawal \& associated vaccinations will be recorded.Number of exposed set participants analyzed for safety is different from the PPS for immunogenicity.
Frequency Threshold:
5
Time Frame:
Day 1 to day 366 (Study Groups: A1- 4-sites, 1-week" (4-4-4-0-0) ID PEP regimen without HRIG, A2- 4-sites, 1-week" (4-4-4-0-0) ID PEP regimen with HRIG, B1- 2-sites TRC" (2-2-2-0-2) ID PEP regimen without HRIG, B2- 2-sites TRC" (2-2-2-0-2) ID PEP regimen with HRIG).
Study:
NCT02177032
Study Brief:
Safety and Immunogenicity of Two Intradermal Rabies Vaccine Regimens Administered With and Without Human Rabies Immunoglobulin in Subjects ≥ 1 Years of Age
Event Groups(If Any):
Event Groups
| Title | Description | Deaths # Affected | Deaths # At Risk | Serious # Affected | Serious # At Risk | Other # Affected | Other # At Risk | View |
|---|---|---|---|---|---|---|---|---|
| 4-sites, 1-week WITHOUT HRIG | 12 doses of the PCEC rabies vaccine, administered ID (0.1mL for each injection) according to the "4-sites, 1-week" regimen | None | None | 5 | 356 | 292 | 356 | View |
| 4-sites, 1-week WITH HRIG | 12 doses of the PCEC rabies vaccine, administered ID (0.1mL for each injection) to adults only, according to the "4-sites, 1-week" regimen HRIG administered on day 1 (before the first dose of the vaccine) in a dose of 20 IU/kg body weight | None | None | 1 | 85 | 78 | 85 | View |
| 2-sites, TRC WITHOUT HRIG | 8 doses of the PCEC rabies vaccine, administered ID (0.1ml for each injection) according to the "2-sites, TRC", updated Thai Red Cross regimen. | None | None | 4 | 353 | 298 | 353 | View |
| 2-sites, TRC WITH HRIG | 8 doses of the PCEC rabies vaccine, administered ID (0.1ml for each injection) to adults only, according to the "2-sites, TRC", updated Thai Red Cross regimen. HRIG administered on day 1 (before the first dose of the vaccine) in a dose of 20 IU/kg body weight intramuscularly | None | None | 2 | 89 | 82 | 89 | View |
Serious Events(If Any):
Serious Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Anaemia | NON_SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | MedDRA (17.0) | View |
| Angina Unstable | NON_SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA (17.0) | View |
| Gastritis | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (17.0) | View |
| Irritable Bowel Syndrome | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (17.0) | View |
| Pyrexia | NON_SYSTEMATIC_ASSESSMENT | General disorders | MedDRA (17.0) | View |
| Appendiceal Abscess | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (17.0) | View |
| Appendicitis Perforated | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (17.0) | View |
| Dengue Fever | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (17.0) | View |
| Gastroenteritis | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (17.0) | View |
| HIV Infection | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (17.0) | View |
| Hand-Foot-And-Mouth Disease | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (17.0) | View |
| Influenza | NON_SYSTEMATIC_ASSESSMENT | Immune system disorders | MedDRA (17.0) | View |
| Pneumonia | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (17.0) | View |
| Pseudomonal Sepsis | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (17.0) | View |
| Tonsillitis | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (17.0) | View |
| Urinary Tract Infection | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (17.0) | View |
| Animal Bite | NON_SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA (17.0) | View |
| Animal Scratch | NON_SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA (17.0) | View |
| Joint Dislocation | NON_SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA (17.0) | View |
| Road Traffic Accident | NON_SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA (17.0) | View |
| Dysfunctional Uterine Bleeding | NON_SYSTEMATIC_ASSESSMENT | Reproductive system and breast disorders | MedDRA (17.0) | View |
| Pneumothorax | NON_SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA (17.0) | View |
Other Events(If Any):
Other Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| VACCINATION SITE INDURATION | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA (17.0) | View |
| NASOPHARYNGITIS | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (17.0) | View |
| DECREASED APPETITE | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA (17.0) | View |
| MYALGIA | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA (17.0) | View |
| DIARRHOEA | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (17.0) | View |
| NAUSEA | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (17.0) | View |
| VOMITING | 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 INDURATION | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA (17.0) | View |
| INJECTION SITE PAIN | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA (17.0) | View |
| INJECTION SITE SWELLING | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA (17.0) | View |
| PYREXIA | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA (17.0) | View |
| VACCINATION SITE ERYTHEMA | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA (17.0) | View |
| VACCINATION SITE SWELLING | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA (17.0) | View |
| UPPER RESPIRATORY TRACT INFECTION | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (17.0) | View |
| ARTHRALGIA | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA (17.0) | View |
| HEADACHE | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA (17.0) | View |
| RASH | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA (17.0) | View |