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:
2025-12-25 @ 3:01 AM
Ignite Modification Date:
2025-12-26 @ 1:41 AM
NCT ID:
NCT04648033
Description:
None
Frequency Threshold:
0
Time Frame:
Adverse events (including serious events) are reported from first dose of atovaquone to last follow up visit at 6 months post chemoradiotherapy (up to 38 weeks).
Study:
NCT04648033
Study Brief:
Atovaquone With Radical ChemorADIotherapy in Locally Advanced NSCLC
Event Groups(If Any):
Event Groups
| Title | Description | Deaths # Affected | Deaths # At Risk | Serious # Affected | Serious # At Risk | Other # Affected | Other # At Risk | View |
|---|---|---|---|---|---|---|---|---|
| Dose Level 1 - 450 mg BD Atovaquone + Concurrent CRT | Atovaquone: * Taken during an initial run in period (2 weeks +/- 7 days), then continued during standard of care chemoradiotherapy. * One of 4 dose levels is allocated to each patient by a TiTE-CRM statistical model which takes into account all toxicity data to date. * Dose levels - 450 mg, 600 mg, 675 mg or 750 mg (all doses PO BD). * Last dose atovaquone taken on the last day of radiotherapy. * Total duration of atovaquone treatment is 59 days (+/- 7 days), unless stopped earlier for toxicity or any other reason. Chemotherapy: * 2 x 21-day cycles. * 80 mg/m2 cisplatin on day 1 and 22 of chemoradiotherapy. * 15 mg/m2 vinorelbine on days 1,8, 22 and 29 of chemoradiotherapy. Radiotherapy: * 66 Gy in 33 fractions. * Delivered once daily, 5 days a week (Monday-Friday) for 6.5 weeks. | 0 | None | 2 | 3 | 3 | 3 | View |
| Dose Level 2 - 600 mg BD Atovaquone + Concurrent CRT | Atovaquone: * Taken during an initial run in period (2 weeks +/- 7 days), then continued during standard of care chemoradiotherapy. * One of 4 dose levels is allocated to each patient by a TiTE-CRM statistical model which takes into account all toxicity data to date. * Dose levels - 450 mg, 600 mg, 675 mg or 750 mg (all doses PO BD). * Last dose atovaquone taken on the last day of radiotherapy. * Total duration of atovaquone treatment is 59 days (+/- 7 days), unless stopped earlier for toxicity or any other reason. Chemotherapy: * 2 x 21-day cycles. * 80 mg/m2 cisplatin on day 1 and 22 of chemoradiotherapy. * 15 mg/m2 vinorelbine on days 1,8, 22 and 29 of chemoradiotherapy. Radiotherapy: * 66 Gy in 33 fractions. * Delivered once daily, 5 days a week (Monday-Friday) for 6.5 weeks. | 0 | None | 1 | 2 | 2 | 2 | View |
| Dose Level 3 - 675 mg BD Atovaquone + Concurrent CRT | Atovaquone: * Taken during an initial run in period (2 weeks +/- 7 days), then continued during standard of care chemoradiotherapy. * One of 4 dose levels is allocated to each patient by a TiTE-CRM statistical model which takes into account all toxicity data to date. * Dose levels - 450 mg, 600 mg, 675 mg or 750 mg (all doses PO BD). * Last dose atovaquone taken on the last day of radiotherapy. * Total duration of atovaquone treatment is 59 days (+/- 7 days), unless stopped earlier for toxicity or any other reason. Chemotherapy: * 2 x 21-day cycles. * 80 mg/m2 cisplatin on day 1 and 22 of chemoradiotherapy. * 15 mg/m2 vinorelbine on days 1,8, 22 and 29 of chemoradiotherapy. Radiotherapy: * 66 Gy in 33 fractions. * Delivered once daily, 5 days a week (Monday-Friday) for 6.5 weeks. | 0 | None | 0 | 1 | 1 | 1 | View |
| Dose Level 4 - 750 mg BD Atovaquone + Concurrent CRT | Atovaquone: * Taken during an initial run in period (2 weeks +/- 7 days), then continued during standard of care chemoradiotherapy. * One of 4 dose levels is allocated to each patient by a TiTE-CRM statistical model which takes into account all toxicity data to date. * Dose levels - 450 mg, 600 mg, 675 mg or 750 mg (all doses PO BD). * Last dose atovaquone taken on the last day of radiotherapy. * Total duration of atovaquone treatment is 59 days (+/- 7 days), unless stopped earlier for toxicity or any other reason. Chemotherapy: * 2 x 21-day cycles. * 80 mg/m2 cisplatin on day 1 and 22 of chemoradiotherapy. * 15 mg/m2 vinorelbine on days 1,8, 22 and 29 of chemoradiotherapy. Radiotherapy: * 66 Gy in 33 fractions. * Delivered once daily, 5 days a week (Monday-Friday) for 6.5 weeks. | 2 | None | 7 | 15 | 15 | 15 | View |
Serious Events(If Any):
Serious Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Ataxia | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA 23.0 | View |
| Angina pectoris | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA 23.0 | View |
| Vomiting | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 23.0 | View |
| Pneumonitis | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA 23.0 | View |
| Diarrhoea | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 23.0 | View |
| Hyperglycaemia | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA 23.0 | View |
| Pneumonia | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 23.0 | View |
| Chest pain | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA 23.0 | View |
| Pneumocystis jirovecii pneumonia | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 23.0 | View |
| Acute kidney injury | SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | MedDRA 23.0 | View |
| Inflammatory bowel disease | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 23.0 | View |
Other Events(If Any):
Other Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Blood & Lymphatic System Disorders | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | MedDRA 23.0 | View |
| Cardiac Disorders | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA 23.0 | View |
| Ear and labyrinth disorders | SYSTEMATIC_ASSESSMENT | Ear and labyrinth disorders | MedDRA 23.0 | View |
| Endocrine disorders | SYSTEMATIC_ASSESSMENT | Endocrine disorders | MedDRA 23.0 | View |
| Eye disorders | SYSTEMATIC_ASSESSMENT | Eye disorders | MedDRA 23.0 | View |
| Gastrointestinal Disorders | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 23.0 | View |
| General Disorders & Administration Site Conditions | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA 23.0 | View |
| Hepatobiliary disorders | SYSTEMATIC_ASSESSMENT | Hepatobiliary disorders | MedDRA 23.0 | View |
| Infections & Infestations | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 23.0 | View |
| Injury, poisoning and procedural complications | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA 23.0 | View |
| Investigations | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA 23.0 | View |
| Metabolism & Nutrition Disorders | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA 23.0 | View |
| Musculoskeletal & Connective Tissue Disorders | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA 23.0 | View |
| Nervous System Disorders | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA 23.0 | View |
| Psychiatric disorders | SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MedDRA 23.0 | View |
| Renal and urinary disorders | SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | MedDRA 23.0 | View |
| Respiratory, thoracic and mediastinal disorders | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA 23.0 | View |
| Skin and subcutaneous tissue disorders | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA 23.0 | View |
| Vascular disorders | SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDRA 23.0 | View |