Adverse Events Module

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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 @ 1:34 PM
Ignite Modification Date: 2025-12-25 @ 12:34 PM
NCT ID: NCT01687595
Description: Safety population included all randomized participants who received at least 1 dose of study medication according to initial randomization.
Frequency Threshold: 0
Time Frame: Baseline up to Week 76
Study: NCT01687595
Study Brief: Biological Efficacy Study of HerpV Vaccine With QS-21 to Treat Participants With Recurrent Genital Herpes
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
HerpV + QS-21 Participants received a combination of HerpV 240 μg and QS-21 50 μg injection subcutaneously at Weeks 0, 2 and 4 in treatment period 1. At Week 24, participants who completed treatment period 1 received a booster dose of combination of HerpV 240 μg and QS-21 50 μg in treatment period 2. Each treatment period was followed by a washout period of 1 week. None None 3 70 67 70 View
Placebo Participants received placebo (PBS) injection subcutaneously at Weeks 0, 2 and 4 in treatment period 1 and at Week 24 in treatment period 2. Each treatment period was followed by a washout period of 1 week. None None 0 10 10 10 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Cholecystitis SYSTEMATIC_ASSESSMENT Hepatobiliary disorders MedDRA 15.1 View
Rhabdomyolysis SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 15.1 View
Pneumothorax SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 15.1 View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Anemia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA 15.1 View
Lymphadenopathy SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA 15.1 View
Ear discomfort SYSTEMATIC_ASSESSMENT Ear and labyrinth disorders MedDRA 15.1 View
Hyperacusis SYSTEMATIC_ASSESSMENT Ear and labyrinth disorders MedDRA 15.1 View
Thyroid mass SYSTEMATIC_ASSESSMENT Endocrine disorders MedDRA 15.1 View
Erythema of eyelid SYSTEMATIC_ASSESSMENT Eye disorders MedDRA 15.1 View
Eye pruritus SYSTEMATIC_ASSESSMENT Eye disorders MedDRA 15.1 View
Eyelid edema SYSTEMATIC_ASSESSMENT Eye disorders MedDRA 15.1 View
Abdominal pain SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 15.1 View
Abdominal pain, upper SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 15.1 View
Anorectal discomfort SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 15.1 View
Aphthous stomatitis SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 15.1 View
Constipation SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 15.1 View
Diarrhea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 15.1 View
Dry mouth SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 15.1 View
Dyspepsia SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 15.1 View
Gastritis SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 15.1 View
Gastroesophageal reflux disease SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 15.1 View
Hemorrhoids SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 15.1 View
Irritable bowel syndrome SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 15.1 View
Nausea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 15.1 View
Paresthesia, oral SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 15.1 View
Tongue disorder SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 15.1 View
Tooth impacted SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 15.1 View
Vomiting SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 15.1 View
Asthenia SYSTEMATIC_ASSESSMENT General disorders MedDRA 15.1 View
Axillary pain SYSTEMATIC_ASSESSMENT General disorders MedDRA 15.1 View
Chills SYSTEMATIC_ASSESSMENT General disorders MedDRA 15.1 View
Fatigue SYSTEMATIC_ASSESSMENT General disorders MedDRA 15.1 View
Feeling cold SYSTEMATIC_ASSESSMENT General disorders MedDRA 15.1 View
Induration SYSTEMATIC_ASSESSMENT General disorders MedDRA 15.1 View
Inflammation SYSTEMATIC_ASSESSMENT General disorders MedDRA 15.1 View
Influenza-like illness SYSTEMATIC_ASSESSMENT General disorders MedDRA 15.1 View
Injection-site cyst SYSTEMATIC_ASSESSMENT General disorders MedDRA 15.1 View
Injection-site erythema SYSTEMATIC_ASSESSMENT General disorders MedDRA 15.1 View
Injection-site hematoma SYSTEMATIC_ASSESSMENT General disorders MedDRA 15.1 View
Injection-site induration SYSTEMATIC_ASSESSMENT General disorders MedDRA 15.1 View
Injection-site pain SYSTEMATIC_ASSESSMENT General disorders MedDRA 15.1 View
Injection-site paresthesia SYSTEMATIC_ASSESSMENT General disorders MedDRA 15.1 View
Injection-site pruritus SYSTEMATIC_ASSESSMENT General disorders MedDRA 15.1 View
Injection-site rash SYSTEMATIC_ASSESSMENT General disorders MedDRA 15.1 View
Injection-site swelling SYSTEMATIC_ASSESSMENT General disorders MedDRA 15.1 View
Injection-site ulcer SYSTEMATIC_ASSESSMENT General disorders MedDRA 15.1 View
Injection-site vesicles SYSTEMATIC_ASSESSMENT General disorders MedDRA 15.1 View
Injection-site warmth SYSTEMATIC_ASSESSMENT General disorders MedDRA 15.1 View
Pyrexia SYSTEMATIC_ASSESSMENT General disorders MedDRA 15.1 View
Vaccination-site warmth SYSTEMATIC_ASSESSMENT General disorders MedDRA 15.1 View
Hypertransaminasemia SYSTEMATIC_ASSESSMENT Hepatobiliary disorders MedDRA 15.1 View
Seasonal allergy SYSTEMATIC_ASSESSMENT Immune system disorders MedDRA 15.1 View
Bronchitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 15.1 View
Chlamydial infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 15.1 View
Ear infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 15.1 View
Folliculitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 15.1 View
Furuncle SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 15.1 View
Gastroenteritis, viral SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 15.1 View
Herpes zoster SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 15.1 View
Influenza SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 15.1 View
Nasopharyngitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 15.1 View
Oral herpes SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 15.1 View
Otitis media SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 15.1 View
Perirectal abscess SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 15.1 View
Pharyngitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 15.1 View
Pharyngitis, streptococcal SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 15.1 View
Rash, pustular SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 15.1 View
Sinusitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 15.1 View
Tooth infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 15.1 View
Upper respiratory tract infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 15.1 View
Urinary tract infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 15.1 View
Vaginal abscess SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 15.1 View
Vulvovaginal candidiasis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 15.1 View
Vulvovaginitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 15.1 View
Arthropod bite SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 15.1 View
Joint injury SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 15.1 View
Ligament sprain SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 15.1 View
Limb injury SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 15.1 View
Muscle strain SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 15.1 View
Procedural nausea SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 15.1 View
Procedural pain SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 15.1 View
Activated partial thromboplastin time prolonged SYSTEMATIC_ASSESSMENT Investigations MedDRA 15.1 View
Alanine aminotransferase increased SYSTEMATIC_ASSESSMENT Investigations MedDRA 15.1 View
Blood creatine phosphokinase increased SYSTEMATIC_ASSESSMENT Investigations MedDRA 15.1 View
Blood glucose increased SYSTEMATIC_ASSESSMENT Investigations MedDRA 15.1 View
Blood growth hormone decreased SYSTEMATIC_ASSESSMENT Investigations MedDRA 15.1 View
Liver function test abnormal SYSTEMATIC_ASSESSMENT Investigations MedDRA 15.1 View
Vitamin D deficiency SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 15.1 View
Arthralgia SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 15.1 View
Axillary mass SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 15.1 View
Back pain SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 15.1 View
Muscle spasms SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 15.1 View
Muscle tightness SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 15.1 View
Musculoskeletal chest pain SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 15.1 View
Musculoskeletal stiffness SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 15.1 View
Myalgia SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 15.1 View
Neck mass SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 15.1 View
Neck pain SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 15.1 View
Pain in extremity SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 15.1 View
Breast cancer, in situ SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA 15.1 View
Lung neoplasm SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA 15.1 View
Rectal cancer, stage II SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA 15.1 View
Balance disorder SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 15.1 View
Disturbance in attention SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 15.1 View
Dizziness SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 15.1 View
Headache SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 15.1 View
Hyperesthesia SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 15.1 View
Nerve compression SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 15.1 View
Paresthesia SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 15.1 View
Presyncope SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 15.1 View
Syncope SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 15.1 View
Tremor SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 15.1 View
Mid-cycle spotting SYSTEMATIC_ASSESSMENT Reproductive system and breast disorders MedDRA 15.1 View
Pregnancy SYSTEMATIC_ASSESSMENT Pregnancy, puerperium and perinatal conditions MedDRA 15.1 View
Anxiety SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA 15.1 View
Depression SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA 15.1 View
Insomnia SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA 15.1 View
Restlessness SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA 15.1 View
Sleep disorder SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA 15.1 View
Bladder discomfort SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA 15.1 View
Dysuria SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA 15.1 View
Nephrolithiasis SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA 15.1 View
Pyuria SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA 15.1 View
Cervical polyp SYSTEMATIC_ASSESSMENT Reproductive system and breast disorders MedDRA 15.1 View
Menstrual disorder SYSTEMATIC_ASSESSMENT Reproductive system and breast disorders MedDRA 15.1 View
Pelvic pain SYSTEMATIC_ASSESSMENT Reproductive system and breast disorders MedDRA 15.1 View
Penile pain SYSTEMATIC_ASSESSMENT Reproductive system and breast disorders MedDRA 15.1 View
Sexual dysfunction SYSTEMATIC_ASSESSMENT Reproductive system and breast disorders MedDRA 15.1 View
Vaginal laceration SYSTEMATIC_ASSESSMENT Reproductive system and breast disorders MedDRA 15.1 View
Cough SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 15.1 View
Nasal congestion SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 15.1 View
Oropharyngeal pain SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 15.1 View
Sinus congestion SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 15.1 View
Tonsillar hypertrophy SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 15.1 View
Alopecia SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 15.1 View
Cold sweat SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 15.1 View
Dermatitis SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 15.1 View
Dermatitis, contact SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 15.1 View
Erythema SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 15.1 View
Erythema, multiforme SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 15.1 View
Pruritis SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 15.1 View
Pruritis, generalized SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 15.1 View
Rash SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 15.1 View
Rash, pruritic SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 15.1 View
Urticaria SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 15.1 View
Flushing SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA 15.1 View
Hot flush SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA 15.1 View
Hypertension SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA 15.1 View
Breast mass SYSTEMATIC_ASSESSMENT Reproductive system and breast disorders MedDRA 15.1 View