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 @ 7:39 PM
Ignite Modification Date:
2025-12-25 @ 5:19 PM
NCT ID:
NCT02010203
Description:
None
Frequency Threshold:
5
Time Frame:
AEs were defined as all reported events with a start date on or after Study Day 1. All AEs were collected through 30 days post last dose, up to 3 years.
Study:
NCT02010203
Study Brief:
A Phase 1/2 Study of HS-410 in Patients With Non-Muscle Invasive Bladder Cancer After TURBT
Event Groups(If Any):
Event Groups
| Title | Description | Deaths # Affected | Deaths # At Risk | Serious # Affected | Serious # At Risk | Other # Affected | Other # At Risk | View |
|---|---|---|---|---|---|---|---|---|
| Phase I: HS-410 Low Dose | In the open label Phase 1 portion, HS-410 is given as 1\*10\^6 cells per dose for 12 weekly injections followed by 3 monthly injections. HS-410: Vaccine derived from irradiated cancer cells genetically engineered to continually secrete gp96 | 0 | None | 0 | 10 | 7 | 10 | View |
| Phase II: HS-410 Low-Dose Plus BCG | In the Phase 2 portion, HS-410 is given as 1\*10\^6 cells per dose weekly for 6 weeks in combination with BCG, followed by 6 weeks of HS-410 alone, and then 3 courses of three once-weekly doses of HS-410 in combination with BCG. HS-410: Vaccine derived from irradiated cancer cells genetically engineered to continually secrete gp96 BCG: Vaccine derived from a live bacterium | 0 | None | 8 | 26 | 24 | 26 | View |
| Phase II: High-Dose HS-410 Plus BCG | In the Phase 2 portion, HS-410 is given as 1\*10\^7 cells per dose weekly for 6 weeks in combination with BCG, followed by 6 weeks of HS-410 alone, and then 3 courses of three once-weekly doses of HS-410 in combination with BCG. HS-410: Vaccine derived from irradiated cancer cells genetically engineered to continually secrete gp96 BCG: Vaccine derived from a live bacterium | 0 | None | 4 | 26 | 19 | 26 | View |
| Phase II: Placebo Plus BCG | In the Phase 2 portion, a placebo is given weekly for 6 weeks in combination with BCG, followed by 6 weeks of placebo alone, and then 3 courses of three once-weekly doses of placebo in combination with BCG. Placebo: Injection containing sterile solution but no cells BCG: Vaccine derived from a live bacterium | 0 | None | 1 | 26 | 20 | 26 | View |
| Phase II: High-Dose HS-410 | In the Phase II portion, if patients will not receive BCG, HS-410 is given as 1\*10\^7 cells per dose weekly for 12 weeks, and then 3 courses of three once-weekly doses of HS-410. HS-410: Vaccine derived from irradiated cancer cells genetically engineered to continually secrete gp96 | 0 | None | 2 | 16 | 9 | 16 | View |
Serious Events(If Any):
Serious Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Cystoprostatectomy | SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | medDRA v20.1 | View |
| Hypoxia | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | medDRA v20.1 | View |
| Prostate Cancer | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | medDRA v20.1 | View |
| Urinary Tract Infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | medDRA v20.1 | View |
| Pyrexia | SYSTEMATIC_ASSESSMENT | General disorders | medDRA v20.1 | View |
| Aneurysm | SYSTEMATIC_ASSESSMENT | Vascular disorders | medDRA v20.1 | View |
| Transient Ischaemic Attack | SYSTEMATIC_ASSESSMENT | Nervous system disorders | medDRA v20.1 | View |
| Mental Status Changes | SYSTEMATIC_ASSESSMENT | Psychiatric disorders | medDRA v20.1 | View |
| Anaemia | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | medDRA v20.1 | View |
| Haematoma | SYSTEMATIC_ASSESSMENT | Vascular disorders | medDRA v20.1 | View |
| Sepsis | SYSTEMATIC_ASSESSMENT | Infections and infestations | medDRA v20.1 | View |
| Squamous Cell Carcinoma | SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | medDRA v20.1 | View |
| Cerebrovascular Accident | SYSTEMATIC_ASSESSMENT | Nervous system disorders | medDRA v20.1 | View |
| Rectal Haemorrhage | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | medDRA v20.1 | View |
| Cardiac Failure Congestive | SYSTEMATIC_ASSESSMENT | Cardiac disorders | medDRA v20.1 | View |
| Atrial Fibrillation | SYSTEMATIC_ASSESSMENT | Cardiac disorders | medDRA v20.1 | View |
| Priapism | SYSTEMATIC_ASSESSMENT | Reproductive system and breast disorders | medDRA v20.1 | View |
| Disease Progression | SYSTEMATIC_ASSESSMENT | General disorders | medDRA v20.1 | View |
| Urinary Retention | SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | medDRA v20.1 | View |
| Bladder Perforation | SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | medDRA v20.1 | View |
Other Events(If Any):
Other Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Anemia | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | medDRA v20.1 | View |
| Vertigo | SYSTEMATIC_ASSESSMENT | Ear and labyrinth disorders | medDRA v20.1 | View |
| Dry Eye | SYSTEMATIC_ASSESSMENT | Eye disorders | medDRA v20.1 | View |
| Vision Blurred | SYSTEMATIC_ASSESSMENT | Eye disorders | medDRA v20.1 | View |
| Constipation | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | medDRA v20.1 | View |
| Diarrhoea | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | medDRA v20.1 | View |
| Dizziness | SYSTEMATIC_ASSESSMENT | Nervous system disorders | medDRA v20.1 | View |
| Headache | SYSTEMATIC_ASSESSMENT | Nervous system disorders | medDRA v20.1 | View |
| Insomnia | SYSTEMATIC_ASSESSMENT | Psychiatric disorders | medDRA v20.1 | View |
| Bladder Perforation | SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | medDRA v20.1 | View |
| Bladder Spasm | SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | medDRA v20.1 | View |
| Dysuria | SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | medDRA v20.1 | View |
| Haematuria | SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | medDRA v20.1 | View |
| Lower Urinary Tract Symptoms | SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | medDRA v20.1 | View |
| Micturition Urgency | SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | medDRA v20.1 | View |
| Pollakiuria | SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | medDRA v20.1 | View |
| Urinary Incontinence | SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | medDRA v20.1 | View |
| Urinary Retention | SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | medDRA v20.1 | View |
| Breast Tenderness | SYSTEMATIC_ASSESSMENT | Reproductive system and breast disorders | medDRA v20.1 | View |
| Cough | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | medDRA v20.1 | View |
| Oropharyngeal Pain | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | medDRA v20.1 | View |
| Upper Airway Cough Syndrome | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | medDRA v20.1 | View |
| Eczema | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | medDRA v20.1 | View |
| Pruritis | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | medDRA v20.1 | View |
| Urticaria | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | medDRA v20.1 | View |
| Hypertension | SYSTEMATIC_ASSESSMENT | Vascular disorders | medDRA v20.1 | View |
| Injection Site Pain | SYSTEMATIC_ASSESSMENT | General disorders | medDRA v20.1 | View |
| Injection Site Erythema | SYSTEMATIC_ASSESSMENT | General disorders | medDRA v20.1 | View |
| Hyperadrenalism | SYSTEMATIC_ASSESSMENT | Endocrine disorders | medDRA v20.1 | View |
| Eye Haemorrhage | SYSTEMATIC_ASSESSMENT | Eye disorders | medDRA v20.1 | View |
| Dental Caries | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | medDRA v20.1 | View |
| Flank Pain | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | medDRA v20.1 | View |
| Bladder Spasm | SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | medDRA v20.1 | View |
| Nephrolithiasis | SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | medDRA v20.1 | View |
| Nephropathy | SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | medDRA v20.1 | View |
| Pollakiuria | SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | medDRA v20.1 | View |
| Urinary Retention | SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | medDRA v20.1 | View |
| Dry Mouth | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | medDRA v20.1 | View |
| Nausea | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | medDRA v20.1 | View |
| Vomiting | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | medDRA v20.1 | View |
| Asthenia | SYSTEMATIC_ASSESSMENT | General disorders | medDRA v20.1 | View |
| Chills | SYSTEMATIC_ASSESSMENT | General disorders | medDRA v20.1 | View |
| Fatigue | SYSTEMATIC_ASSESSMENT | General disorders | medDRA v20.1 | View |
| Influenza Like Illness | SYSTEMATIC_ASSESSMENT | General disorders | medDRA v20.1 | View |
| Malaise | SYSTEMATIC_ASSESSMENT | General disorders | medDRA v20.1 | View |
| Pain | SYSTEMATIC_ASSESSMENT | General disorders | medDRA v20.1 | View |
| Pyrexia | SYSTEMATIC_ASSESSMENT | General disorders | medDRA v20.1 | View |
| Cystitis | SYSTEMATIC_ASSESSMENT | Infections and infestations | medDRA v20.1 | View |
| Folliculitis | SYSTEMATIC_ASSESSMENT | Infections and infestations | medDRA v20.1 | View |
| Herpes Zoster | SYSTEMATIC_ASSESSMENT | Infections and infestations | medDRA v20.1 | View |
| Nasopharyngitis | SYSTEMATIC_ASSESSMENT | Infections and infestations | medDRA v20.1 | View |
| Pharyngitis Streptococcal | SYSTEMATIC_ASSESSMENT | Infections and infestations | medDRA v20.1 | View |
| Upper Respiratory Tract Infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | medDRA v20.1 | View |
| Urinary Tract Infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | medDRA v20.1 | View |
| Blood Urine Present | SYSTEMATIC_ASSESSMENT | Investigations | medDRA v20.1 | View |
| Hematocrit Decreased | SYSTEMATIC_ASSESSMENT | Investigations | medDRA v20.1 | View |
| White Blood Cell Count Increased | SYSTEMATIC_ASSESSMENT | Investigations | medDRA v20.1 | View |
| Decreased Appetite | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | medDRA v20.1 | View |
| Arthralgia | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | medDRA v20.1 | View |
| Back Pain | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | medDRA v20.1 | View |
| Musculoskeletal Pain | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | medDRA v20.1 | View |
| Myalgia | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | medDRA v20.1 | View |
| Pain in Extremity | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | medDRA v20.1 | View |
| Cerebrovascular Disorder | SYSTEMATIC_ASSESSMENT | Nervous system disorders | medDRA v20.1 | View |