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 @ 11:36 PM
Ignite Modification Date:
2025-12-25 @ 9:26 PM
NCT ID:
NCT01435356
Description:
It was pre-specified in the Protocol that Foreseeable AEs and SAEs specifically related to the cystectomy prior to first study treatment administration will not be considered as "Adverse Events". It was left to the investigator to asses the relation between the (S)AEs and the cystectomy. Progression/recurrence of the tumor were recorded in the clinical assessments in the eCRF and not as SAE.
Death due to a progressive disease were recorded on a specific form in the eCRF but not as a SAE.
Frequency Threshold:
5
Time Frame:
Adverse event data were collected over a period of 5 years (between Informed Consent First Patient and Last Visit Last Patient).
Study:
NCT01435356
Study Brief:
Safety and Efficacy Study of MAGE-A3 + AS-15 in Patients With Muscle-invasive Bladder Cancer After Cystectomy
Event Groups(If Any):
Event Groups
| Title | Description | Deaths # Affected | Deaths # At Risk | Serious # Affected | Serious # At Risk | Other # Affected | Other # At Risk | View |
|---|---|---|---|---|---|---|---|---|
| recMage-A3 + AS15 ASCI | MAGE A3 positive patients treated with recMAGE-A3 + AS15 ASCI recMAGE-A3 + AS15 ASCI: 5 doses were administered (intramuscular) at 3-week intervals followed by 8 doses administered at 3-month intervals for a total maximum duration of study treatment administration of 27 months | 6 | None | 13 | 48 | 30 | 48 | View |
| Placebo | Placebo: 5 doses were administered (intramuscular) at 3-week intervals followed by 8 doses administered at 3-month intervals for a total maximum duration of study treatment administration of 27 months | 5 | None | 5 | 29 | 10 | 29 | View |
Serious Events(If Any):
Serious Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| MASSIVE PROGRESSION OF LYMPHADENOPATHY | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | CTCAE (4.0) | View |
| TACHYCARDIA VENTRICULAR | SYSTEMATIC_ASSESSMENT | Cardiac disorders | CTCAE (4.0) | View |
| INGUINAL HERNIA | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | CTCAE (4.0) | View |
| PYELONEPHRITIS | SYSTEMATIC_ASSESSMENT | Infections and infestations | CTCAE (4.0) | View |
| DEVICE RELATED SEPSIS | SYSTEMATIC_ASSESSMENT | Infections and infestations | CTCAE (4.0) | View |
| URINARY INFECTION | SYSTEMATIC_ASSESSMENT | Infections and infestations | CTCAE (4.0) | View |
| URINARY TRACT INFECTION | SYSTEMATIC_ASSESSMENT | Infections and infestations | CTCAE (4.0) | View |
| STENOSIS OF GASTROINTESTINAL STOMA | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | CTCAE (4.0) | View |
| RADIOGRAPHIC EVIDENCE OF CENTRAL TUMOR RENAL PELVIS LEFT | SYSTEMATIC_ASSESSMENT | Investigations | CTCAE (4.0) | View |
| LOW BACK PAIN | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | CTCAE (4.0) | View |
| PULMONARY CARCINOMA | SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | CTCAE (4.0) | View |
| SYNCOPE | SYSTEMATIC_ASSESSMENT | Nervous system disorders | CTCAE (4.0) | View |
| RIGHT URETERAL STENOSIS | SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | CTCAE (4.0) | View |
| LEFT URETERAL STENOSIS | SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | CTCAE (4.0) | View |
| HYDRONEPHROSIS | SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | CTCAE (4.0) | View |
| PULMONARY THROMBOEMBOLISM | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | CTCAE (4.0) | View |
| FEMORAL ARTERY ANEURYSM | SYSTEMATIC_ASSESSMENT | Vascular disorders | CTCAE (4.0) | View |
| LEFT FEMORAL ATERY OCCLUSION | SYSTEMATIC_ASSESSMENT | Vascular disorders | CTCAE (4.0) | View |
| PHLEBOTHROMBOSIS | SYSTEMATIC_ASSESSMENT | Vascular disorders | CTCAE (4.0) | View |
| UROSEPSIS | SYSTEMATIC_ASSESSMENT | Infections and infestations | CTCAE (4.0) | View |
Other Events(If Any):
Other Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Influenza like illness | SYSTEMATIC_ASSESSMENT | General disorders | CTCAE (4.0) | View |
| Injection site erythema | SYSTEMATIC_ASSESSMENT | General disorders | CTCAE (4.0) | View |
| Injection site induration | SYSTEMATIC_ASSESSMENT | General disorders | CTCAE (4.0) | View |
| Injection site pain | SYSTEMATIC_ASSESSMENT | General disorders | CTCAE (4.0) | View |
| Pyrexia | SYSTEMATIC_ASSESSMENT | General disorders | CTCAE (4.0) | View |
| Urinary tract infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | CTCAE (4.0) | View |