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:
2025-12-26 @ 1:19 PM
Ignite Modification Date:
2025-12-26 @ 1:19 PM
NCT ID:
NCT02919306
Description:
FAS included all participants who were randomized and who received at least 1 dose of study vaccine or placebo.
Frequency Threshold:
5
Time Frame:
Up to Week 96
Study:
NCT02919306
Study Brief:
Safety and Efficacy Study of Vaccine Schedule With Ad26.Mos.HIV and MVA-Mosaic in Human Immunodeficiency Virus (HIV)-Infected Adults
Event Groups(If Any):
Event Groups
| Title | Description | Deaths # Affected | Deaths # At Risk | Serious # Affected | Serious # At Risk | Other # Affected | Other # At Risk | View |
|---|---|---|---|---|---|---|---|---|
| Ad26.Mos.HIV Vaccine or MVA Mosaic Vaccine | Participants from study NCT03032575, NCT01397669, NCT02475915, NCT02750059, and NCT00796146 who started on antiretroviral therapy (ART) during acute human immunodeficiency virus (HIV) infection, and who were on a current stable ART for at least 4 weeks prior to screening received adenovirus serotype 26-Mosaic -Human Immunodeficiency Virus (Ad26.Mos.HIV) 0.5 milliliter (mL) injection intramuscularly (IM) (containing 5\*10\^10 viral particles \[vp\]) at Weeks 0 and 12 followed by modified Vaccinia Ankara-Mosaic (MVA mosaic) 0.5 mL injection (containing 10\^8 Plaque-forming unit \[pfu\]) at Weeks 24 and 48 (Stage 1). Participants who met immunologic response criteria (more than 50 percent \[%\] of vaccines had an increase of Interferon \[IFN\]-gamma producing cells) (36 weeks of follow-up) were verified at Week 60 (Stage 2). For eligible participants, an analytical treatment interruption (ATI) was started and all ARTs were discontinued. Participants had to reinitiate ART after ATI using the same regimen as their previous treatment (before Week 60) when Human Immunodeficiency Virus-1 (HIV-1) Ribonucleic Acid (RNA) more than (\>) 1,000 copies per milliliters (copies/mL) twice at least 1 week apart or cluster of differentiation (CD) 4+ T cell counts less than (\<) 350 per cubic millimeter (350/mm\^3) twice at least 2 weeks apart or CD4+ T cell count decline of \> 50% from Week 60 prior to ATI up to Week 96. | 0 | None | 1 | 17 | 15 | 17 | View |
| Placebo | Participants from study RV254 who started on ART during acute HIV infection, who were on a current stable ART for at least 4 weeks prior to screening received placebo IM injection at Weeks 0, 12, 24, and 48 (Stage 1). Participants who met immunologic response criteria (more than 50% vaccines had an increase of IFN-gamma producing cells in the vaccine arm) (36 weeks of follow-up) were verified at Week 60 (Stage 2). For eligible participants, an ATI was started and all ARTs were discontinued. Participants had to reinitiate ART after ATI using the same regimen as their previous treatment (before Week 60) when HIV-1 RNA \>1,000 copies/mL twice at least 1 week apart or CD 4+ T cell counts \<350/mm\^3 twice at least 2 weeks apart or CD4+ T cell count decline of \> 50% from Week 60 prior to ATI up to Week 96. | 0 | None | 0 | 9 | 7 | 9 | View |
Serious Events(If Any):
Other Events(If Any):
Other Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Lymphadenopathy | NON_SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | MedDRA Version 21.0 | View |
| Abdominal Distension | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA Version 21.0 | View |
| Anogenital Dysplasia | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA Version 21.0 | View |
| Diarrhoea | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA Version 21.0 | View |
| Feeling Hot | NON_SYSTEMATIC_ASSESSMENT | General disorders | MedDRA Version 21.0 | View |
| Pyrexia | NON_SYSTEMATIC_ASSESSMENT | General disorders | MedDRA Version 21.0 | View |
| Food Allergy | NON_SYSTEMATIC_ASSESSMENT | Immune system disorders | MedDRA Version 21.0 | View |
| Anal Chlamydia Infection | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA Version 21.0 | View |
| Chlamydial Infection | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA Version 21.0 | View |
| Nasopharyngitis | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA Version 21.0 | View |
| Oropharyngeal Gonococcal Infection | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA Version 21.0 | View |
| Pharyngitis | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA Version 21.0 | View |
| Rhinitis | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA Version 21.0 | View |
| Subcutaneous Abscess | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA Version 21.0 | View |
| Syphilis | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA Version 21.0 | View |
| Upper Respiratory Tract Infection | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA Version 21.0 | View |
| Urethritis | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA Version 21.0 | View |
| Urethritis Chlamydial | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA Version 21.0 | View |
| Animal Bite | NON_SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA Version 21.0 | View |
| Skin Abrasion | NON_SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA Version 21.0 | View |
| Cd4 Lymphocytes Decreased | NON_SYSTEMATIC_ASSESSMENT | Investigations | MedDRA Version 21.0 | View |
| Hepatic Enzyme Increased | NON_SYSTEMATIC_ASSESSMENT | Investigations | MedDRA Version 21.0 | View |
| Liver Function Test Increased | NON_SYSTEMATIC_ASSESSMENT | Investigations | MedDRA Version 21.0 | View |
| Weight Decreased | NON_SYSTEMATIC_ASSESSMENT | Investigations | MedDRA Version 21.0 | View |
| Abnormal Loss of Weight | NON_SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA Version 21.0 | View |
| Folate Deficiency | NON_SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA Version 21.0 | View |
| Hypophagia | NON_SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA Version 21.0 | View |
| Myalgia | NON_SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA Version 21.0 | View |
| Dizziness | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA Version 21.0 | View |
| Headache | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA Version 21.0 | View |
| Cough | NON_SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA Version 21.0 | View |
| Dyspnoea | NON_SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA Version 21.0 | View |
| Nasal Congestion | NON_SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA Version 21.0 | View |
| Rhinitis Allergic | NON_SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA Version 21.0 | View |
| Dermatitis Contact | NON_SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA Version 21.0 | View |
| Rash | NON_SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA Version 21.0 | View |