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 @ 3:15 PM
Ignite Modification Date:
2025-12-25 @ 1:37 PM
NCT ID:
NCT03405792
Description:
Adverse event (AE) data for historical controls was reported and presented by Stupp et al. 2017. 466 patients were randomized to treatment in the TMZ+TTFields arm (the comparator for this study); 10 didn't complete treatment. For all cause mortality, we used the intent to treat population (all patients randomized to receive the intended treatment regardless of whether they completed) which was 466. AEs/SAEs were monitored/assessed for the 456 participants who completed the intended treatment.
Frequency Threshold:
5
Time Frame:
Adverse events were collected from the initiation of treatment with the adjuvant treatment with TMZ and the Optune device, and ended at least 30-days following last study treatment for up to 24 months. Twenty-eight participants met criteria for AE collection; two of those did not receive pembrolizumab.
Study:
NCT03405792
Study Brief:
Study Testing The Safety and Efficacy of Adjuvant Temozolomide Plus TTFields (Optune®) Plus Pembrolizumab in Patients With Newly Diagnosed Glioblastoma (2-THE-TOP)
Event Groups(If Any):
Event Groups
| Title | Description | Deaths # Affected | Deaths # At Risk | Serious # Affected | Serious # At Risk | Other # Affected | Other # At Risk | View |
|---|---|---|---|---|---|---|---|---|
| Historical Control Optune System Combined With Temozolomide (TMZ) | Historical control of patients treated with Optune System combined with Temozolomide alone from the EF-14 study based on data published by Stupp et al, 2017. | 265 | None | 0 | 456 | 218 | 456 | View |
| Optune System Combined With Temozolomide (TMZ) + Pembrolizumab | Patients with newly-diagnosed GBM who undergo maximal safe resection (biopsy alone is eligible) followed by chemoradiation consisting of concomitant TMZ daily and radiation therapy (RT) with minimal RT will be eligible for this trial. Four to six weeks after finishing chemoradiation, patients will start monthly cycles of adjuvant TMZ. Treatment with Optune will start at approximately the same time as the first cycle of adjuvant TMZ and continue until second disease progression or a maximum of 2 years. Within one week after starting Cycle 2 of adjuvant TMZ and Optune therapy, patients will begin open-label treatment with pembrolizumab every 3 weeks until first disease progression or unacceptable toxicities or 2 years, whichever comes first. Temozolomide (TMZ): Patients will begin treatment with adjuvant TMZ at least 4 weeks but no more than 6 weeks from last dose of concomitant temozolomide or radiation therapy (the latter of the two). A minimum of 6 and maximum of 12 cycles of adjuvant TMZ will be given depending on tolerability and toxicity. Optune System: Patients will undergo 24-months of planned treatment with Optune therapy. Pembrolizumab: Pembrolizumab will be given intravenously every 3 weeks beginning on Day 1 of Cycle 2 of adjuvant TMZ. Treatment with pembrolizumab every 3 weeks until first disease progression or unacceptable toxicities or 2 years, whichever comes first. | 25 | None | 18 | 28 | 28 | 28 | View |
Serious Events(If Any):
Serious Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Platelets, thrombocytopenia | NON_SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | CTCAE version 4.0 | View |
| Hypotension | NON_SYSTEMATIC_ASSESSMENT | Cardiac disorders | CTCAE version 4.0 | View |
| Supraventricular and nodal arrhythmia - Atrial fibrillation | NON_SYSTEMATIC_ASSESSMENT | Cardiac disorders | CTCAE version 4.0 | View |
| Vomiting | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | CTCAE version 4.0 | View |
| Cholecystitis | NON_SYSTEMATIC_ASSESSMENT | Hepatobiliary disorders | CTCAE version 4.0 | View |
| Infection | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | CTCAE version 4.0 | View |
| Confusion | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | CTCAE version 4.0 | View |
| Hydrocephalus | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | CTCAE version 4.0 | View |
| Memory Impairment | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | CTCAE version 4.0 | View |
| Pain, Headache | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | CTCAE version 4.0 | View |
| Seizure | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | CTCAE version 4.0 | View |
| Bruising | NON_SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | CTCAE version 4.0 | View |
| Intra-operative injury - Brain | NON_SYSTEMATIC_ASSESSMENT | Surgical and medical procedures | CTCAE version 4.0 | View |
| Intra-operative injury, Acute Kidney Injury | NON_SYSTEMATIC_ASSESSMENT | Surgical and medical procedures | CTCAE version 4.0 | View |
| Intra-operative injury, extremity-lower | NON_SYSTEMATIC_ASSESSMENT | Surgical and medical procedures | CTCAE version 4.0 | View |
| Intra-operative injury, muscle | NON_SYSTEMATIC_ASSESSMENT | Surgical and medical procedures | CTCAE version 4.0 | View |
| Generalized Edema | NON_SYSTEMATIC_ASSESSMENT | Vascular disorders | CTCAE version 4.0 | View |
| Edema, head and neck | NON_SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | CTCAE version 4.0 | View |
| Allergy/Immunology | NON_SYSTEMATIC_ASSESSMENT | Immune system disorders | CTCAE version 4.0 | View |
| Neurology, other | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | CTCAE version 4.0 | View |
| Pruritis | NON_SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | CTCAE version 4.0 | View |
| Deep Vein Thrombosis | NON_SYSTEMATIC_ASSESSMENT | Vascular disorders | CTCAE version 4.0 | View |
Other Events(If Any):
Other Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Gastrointestinal Disorders | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | CTCAE version 4.0 | View |
| Blood and Bone Marrow | NON_SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | CTCAE version 4.0 | View |
| Infections | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | CTCAE version 4.0 | View |
| Injury, poisoning and procedural complications | NON_SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | CTCAE version 4.0 | View |
| Metabolism | NON_SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | CTCAE version 4.0 | View |
| Nervous System Disorders | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | CTCAE version 4.0 | View |
| Respiratory | NON_SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | CTCAE version 4.0 | View |
| Musculoskeletal | NON_SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | CTCAE version 4.0 | View |