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 @ 11:52 AM
Ignite Modification Date:
2025-12-24 @ 11:52 AM
NCT ID:
NCT01894061
Description:
None
Frequency Threshold:
5
Time Frame:
5 years, 9 months
Study:
NCT01894061
Study Brief:
NovoTTF-100A With Bevacizumab (Avastin) in Patients With Recurrent Glioblastoma
Event Groups(If Any):
Event Groups
| Title | Description | Deaths # Affected | Deaths # At Risk | Serious # Affected | Serious # At Risk | Other # Affected | Other # At Risk | View |
|---|---|---|---|---|---|---|---|---|
| Bevacizumab and NovoTTF-100A | Bevacizumab will be administered intravenously on days 1 and 15 of each 28 day cycle.The dose of bevacizumab will be 10 mg/kg of actual body weight. Bevacizumab: Bevacizumab will be administered intravenously on days 1 and 15 of each 28 day cycle. The dose of bevacizumab will be 10 mg/kg of actual body weight. NovoTTF-l00A: NovoTTF-100A will be worn continuously. Quality of Life Assessment: Functional Assessment of Cancer Therapy including Brain Tumor module (FACT-Br) questionnaire | 21 | None | 5 | 25 | 20 | 25 | View |
Serious Events(If Any):
Serious Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Generalized muscle weakness | NON_SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | CTCAE v4.0 | View |
| Seizure | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | CTCAE v4.0 | View |
| Stroke | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | CTCAE v4.0 | View |
| Cough | NON_SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | CTCAE v4.0 | View |
Other Events(If Any):
Other Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Anemia | NON_SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | CTCAE v4.0 | View |
| Mucostis oral | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | CTCAE v4.0 | View |
| Edema limbs | NON_SYSTEMATIC_ASSESSMENT | General disorders | CTCAE v4.0 | View |
| Fatigue | NON_SYSTEMATIC_ASSESSMENT | General disorders | CTCAE v4.0 | View |
| Gaid disturbance | NON_SYSTEMATIC_ASSESSMENT | General disorders | CTCAE v4.0 | View |
| Irritability | NON_SYSTEMATIC_ASSESSMENT | General disorders | CTCAE v4.0 | View |
| Pain | NON_SYSTEMATIC_ASSESSMENT | General disorders | CTCAE v4.0 | View |
| Bronchial infection | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | CTCAE v4.0 | View |
| Urinary tract infection | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | CTCAE v4.0 | View |
| Bruising | NON_SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | CTCAE v4.0 | View |
| Fall | NON_SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | CTCAE v4.0 | View |
| Alanine amiotransferase increased | NON_SYSTEMATIC_ASSESSMENT | Investigations | CTCAE v4.0 | View |
| Lymphocyte count decreased | NON_SYSTEMATIC_ASSESSMENT | Investigations | CTCAE v4.0 | View |
| Platelet count decreased | NON_SYSTEMATIC_ASSESSMENT | Investigations | CTCAE v4.0 | View |
| Generalized muscle weakness | NON_SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | CTCAE v4.0 | View |
| Muscle weakness lower limb | NON_SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | CTCAE v4.0 | View |
| Cognitive disturbance | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | CTCAE v4.0 | View |
| Dysphasia | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | CTCAE v4.0 | View |
| Headache | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | CTCAE v4.0 | View |
| Memory imparement | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | CTCAE v4.0 | View |
| Paresthesia | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | CTCAE v4.0 | View |
| Seizure | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | CTCAE v4.0 | View |
| Productive cough | NON_SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | CTCAE v4.0 | View |
| Dry Skin | NON_SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | CTCAE v4.0 | View |
| Erythema multiforme | NON_SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | CTCAE v4.0 | View |
| Pruritus | NON_SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | CTCAE v4.0 | View |
| Rash acneiform | NON_SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | CTCAE v4.0 | View |
| Hypertension | NON_SYSTEMATIC_ASSESSMENT | Vascular disorders | CTCAE v4.0 | View |
| Throboembolic event | NON_SYSTEMATIC_ASSESSMENT | Vascular disorders | CTCAE v4.0 | View |