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 @ 10:49 PM
Ignite Modification Date:
2025-12-25 @ 8:18 PM
NCT ID:
NCT03801369
Description:
No participants were enrolled in Arm II - Arm IV.
Frequency Threshold:
0
Time Frame:
6 years
Study:
NCT03801369
Study Brief:
Olaparib in Combination With Either Durvalumab, Selumetinib, or Capivasertib or Ceralasertib Alone in Treating Patients With Metastatic Triple Negative Breast Cancer
Event Groups(If Any):
Event Groups
| Title | Description | Deaths # Affected | Deaths # At Risk | Serious # Affected | Serious # At Risk | Other # Affected | Other # At Risk | View |
|---|---|---|---|---|---|---|---|---|
| Arm I (olaparib, durvalumab) | Patients receive olaparib PO BID on days 1-28 of each cycle and durvalumab intravenously (IV) over 1 hour on day 1 of each cycle. Treatment repeats every 28 days for up to 12 cycles in the absence of disease progression or unacceptable toxicity. Patients deriving clinical benefit from treatment may, at the investigator's discretion and in the absence of disease progression or unacceptable toxicity, continue on therapy beyond the planned 13 cycles. Biopsy: Undergo biopsy Durvalumab: Given IV (infusion) Olaparib: Given PO (orally) Quality-of-Life Assessment: Ancillary studies | 19 | None | 2 | 24 | 24 | 24 | View |
| Arm II (olaparib, selumetinib) | Patients receive olaparib PO BID on days 1-28 of each cycle and selumetinib PO BID on days 1-28 of each cycle. Treatment repeats every 28 days for up to 12 cycles in the absence of disease progression or unacceptable toxicity. Patients deriving clinical benefit from treatment may, at the investigator's discretion and in the absence of disease progression or unacceptable toxicity, continue on therapy beyond the planned 13 cycles. Biopsy: Undergo biopsy Olaparib: Given PO (orally) Quality-of-Life Assessment: Ancillary studies Selumetinib: Given PO (orally) | 0 | None | 0 | 0 | 0 | 0 | View |
| Arm III (olaparib, capivasertib) | Patients receive olaparib PO BID on days 1-28 of each cycle and capivasertib PO BID 4 days on and 3 days off of each cycle. Treatment repeats every 28 days for up to 12 cycles in the absence of disease progression or unacceptable toxicity. Patients deriving clinical benefit from treatment may, at the investigator's discretion and in the absence of disease progression or unacceptable toxicity, continue on therapy beyond the planned 13 cycles. Biopsy: Undergo biopsy Capivasertib: Given PO (orally) Olaparib: Given PO (orally) Quality-of-Life Assessment: Ancillary studies | 0 | None | 0 | 0 | 0 | 0 | View |
| Arm IV (ceralasertib) | Patients receive ceralasertib PO BID on days 1-14 of each cycle. Treatment repeats every 28 days for up to 12 cycles in the absence of disease progression or unacceptable toxicity. Patients deriving clinical benefit from treatment may, at the investigator's discretion and in the absence of disease progression or unacceptable toxicity, continue on therapy beyond the planned 13 cycles. Biopsy: Undergo biopsy Ceralasertib: Given PO (orally) Quality-of-Life Assessment: Ancillary studies | 0 | None | 0 | 0 | 0 | 0 | View |
Other Events(If Any):
Other Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Blood and lymphatic system disorders | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | CTCAE (4.0) | View |
| Cardiac disorders | SYSTEMATIC_ASSESSMENT | Cardiac disorders | CTCAE (4.0) | View |
| Endocrine disorders | SYSTEMATIC_ASSESSMENT | Endocrine disorders | CTCAE (4.0) | View |
| Eye disorders | SYSTEMATIC_ASSESSMENT | Eye disorders | CTCAE (4.0) | View |
| Gastrointestinal disorders | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | CTCAE (4.0) | View |
| General disorders and administration site conditions | SYSTEMATIC_ASSESSMENT | General disorders | CTCAE (4.0) | View |
| Infections and infestations | SYSTEMATIC_ASSESSMENT | Infections and infestations | CTCAE (4.0) | View |
| Injury, poisoning and procedural complications | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | CTCAE (4.0) | View |
| Investigations | SYSTEMATIC_ASSESSMENT | Investigations | CTCAE (4.0) | View |
| Metabolism and nutrition disorders | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | CTCAE (4.0) | View |
| Musculoskeletal and connective tissue disorders | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | CTCAE (4.0) | View |
| Nervous system disorders | SYSTEMATIC_ASSESSMENT | Nervous system disorders | CTCAE (4.0) | View |
| Psychiatric disorders | SYSTEMATIC_ASSESSMENT | Psychiatric disorders | CTCAE (4.0) | View |
| Renal and urinary disorders | SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | CTCAE (4.0) | View |
| Respiratory, thoracic and mediastinal disorders | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | CTCAE (4.0) | View |
| Skin and subcutaneous tissue disorders | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | CTCAE (4.0) | View |
| Surgical and Medical Procedure | SYSTEMATIC_ASSESSMENT | Surgical and medical procedures | CTCAE (4.0) | View |
| Vascular disorders | SYSTEMATIC_ASSESSMENT | Vascular disorders | CTCAE (4.0) | View |