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 @ 3:05 PM
Ignite Modification Date:
2025-12-25 @ 1:27 PM
NCT ID:
NCT02792959
Description:
None
Frequency Threshold:
0
Time Frame:
All adverse events are recorded from the first visit (J0 inclusion) until 4 weeks after the third PET/MRI examination. Beyond this period, only SAE likely to be related to the research or the medical device or to the procedure of implementation of the medical device are reported.
Study:
NCT02792959
Study Brief:
Evaluation of Response to the Neoadjuvant Chemotherapy for Advanced Ovarian Cancer by Multimodal Functional Imaging
Event Groups(If Any):
Event Groups
| Title | Description | Deaths # Affected | Deaths # At Risk | Serious # Affected | Serious # At Risk | Other # Affected | Other # At Risk | View |
|---|---|---|---|---|---|---|---|---|
| Functional Imaging | A pilot study to evaluate the response to neoadjuvant chemotherapy for advanced ovarian cancer by multimodal functional imaging (Fusion MRI and FDG-PET-CT) Functional Imaging previous the second course: Functional Imaging before and after 1 cycle of chemotherapy treatment, in the previous 4 days before the second course: PET1 and MRI1 Functional Imaging previous the surgery: Functional Imaging after 4 cycles of chemotherapy treatment, in the 3 weeks after the chemotherapy, before the interval surgery: PET4 and MRI4 The RECIST evaluation will be done, usually, by scanner to 4 courses of chemotherapy before the surgery interval | 1 | None | 3 | 11 | 11 | 11 | View |
Serious Events(If Any):
Serious Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Anemia | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | CTCAE v5.0 | View |
| Colonic obstruction | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | CTCAE v5.0 | View |
| Vomiting | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | CTCAE v5.0 | View |
| Sepsis | SYSTEMATIC_ASSESSMENT | Infections and infestations | CTCAE v5.0 | View |
Other Events(If Any):
Other Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Anemia | NON_SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | CTCAE v5.0 | View |
| Sinus tachycardia | NON_SYSTEMATIC_ASSESSMENT | Cardiac disorders | CTCAE v5.0 | View |
| Abdominal pain | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | CTCAE v5.0 | View |
| Ascites | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | CTCAE v5.0 | View |
| Bloating | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | CTCAE v5.0 | View |
| Constipation | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | CTCAE v5.0 | View |
| Diarrhea | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | CTCAE v5.0 | View |
| Nausea | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | CTCAE v5.0 | View |
| Fatigue | NON_SYSTEMATIC_ASSESSMENT | General disorders | CTCAE v5.0 | View |
| Fever | NON_SYSTEMATIC_ASSESSMENT | General disorders | CTCAE v5.0 | View |
| Allergic reaction | NON_SYSTEMATIC_ASSESSMENT | Immune system disorders | CTCAE v5.0 | View |
| Bronchial infection | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | CTCAE v5.0 | View |
| Enterocolitis infectious | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | CTCAE v5.0 | View |
| Peritoneal infection | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | CTCAE v5.0 | View |
| Urinary tract infection | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | CTCAE v5.0 | View |
| Creatinine increased | NON_SYSTEMATIC_ASSESSMENT | Investigations | CTCAE v5.0 | View |
| Neutrophil count decreased | NON_SYSTEMATIC_ASSESSMENT | Investigations | CTCAE v5.0 | View |
| Platelet count decreased | NON_SYSTEMATIC_ASSESSMENT | Investigations | CTCAE v5.0 | View |
| Musculoskeletal and connective tissue disorder - Other, specify | NON_SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | CTCAE v5.0 | View |
| Myalgia | NON_SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | CTCAE v5.0 | View |
| Peripheral sensory neuropathy | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | CTCAE v5.0 | View |
| Cystitis noninfective | NON_SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | CTCAE v5.0 | View |
| Renal and urinary disorders - Other, specify | NON_SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | CTCAE v5.0 | View |
| Reproductive system and breast disorders - Other, specify | NON_SYSTEMATIC_ASSESSMENT | Reproductive system and breast disorders | CTCAE v5.0 | View |
| Vaginal hemorrhage | NON_SYSTEMATIC_ASSESSMENT | Reproductive system and breast disorders | CTCAE v5.0 | View |
| Pleural effusion | NON_SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | CTCAE v5.0 | View |
| Alopecia | NON_SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | CTCAE v5.0 | View |
| Nail discoloration | NON_SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | CTCAE v5.0 | View |
| Hypertension | NON_SYSTEMATIC_ASSESSMENT | Vascular disorders | CTCAE v5.0 | View |
| Thromboembolic event | NON_SYSTEMATIC_ASSESSMENT | Vascular disorders | CTCAE v5.0 | View |