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 @ 12:14 AM
Ignite Modification Date:
2025-12-25 @ 10:15 PM
NCT ID:
NCT03010358
Description:
Per protocol; "Safety data will be summarized for the safety population separately for phase 1 and phase 2 portions by dose level. All AEs will be coded by system organ class, MedDRA preferred term, and severity grade using NCI CTCAE (v 4.03)." Since Phase 2 and the subset of Phase I patients who received MTD both received 800 mg daily, these are reported together. Those who received 400 mg daily were reported separately.
Frequency Threshold:
5
Time Frame:
Up to 45 months. For the participants, the median follow-up time for adverse events was 17 months.
Study:
NCT03010358
Study Brief:
Entospletinib and Obinutuzumab in Treating Patients With Relapsed Chronic Lymphocytic Leukemia, Small Lymphocytic Lymphoma, or Non-Hodgkin Lymphoma
Event Groups(If Any):
Event Groups
| Title | Description | Deaths # Affected | Deaths # At Risk | Serious # Affected | Serious # At Risk | Other # Affected | Other # At Risk | View |
|---|---|---|---|---|---|---|---|---|
| Phase 1, Dose 1 (400 mg Entospletinib Daily) | Patients receive entospletinib PO either QD or BID on days -7 to -1 (run-in phase) according to dose level 1 (200 mg twice daily). Patients also receive obinutuzumab IV on days 1, 2, 8, and 15 of the first cycle, and on day 1 of subsequent cycles. Treatment with obinutuzumab repeats every 28 days for up to 6 cycles and daily treatment with entospletinib continues every 28 days for up to 12 cycles in the absence of disease progression or unexpected toxicity. | 0 | None | 3 | 6 | 6 | 6 | View |
| Phase 2 and MTD (800 mg Entospletinib Daily) | Patients receive entospletinib PO either QD or BID on days -7 to -1 (run-in phase) according to dose level 2 (400 mg twice daily). Patients also receive obinutuzumab IV on days 1, 2, 8 and 15 of the first cycle, and on day 1 of subsequent cycles. Treatment with obinutuzumab repeats every 28 days for up to 6 cycles and daily treatment with entospletinib continues every 28 days for up to 12 cycles in the absence of disease progression or unexpected toxicity. | 1 | None | 5 | 17 | 17 | 17 | View |
Serious Events(If Any):
Serious Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Infusion Related Reaction | NON_SYSTEMATIC_ASSESSMENT | General disorders | None | View |
| Tumor Lysis Syndrome | NON_SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | None | View |
| Interoperative Hemorrhage | NON_SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | None | View |
| Febrile neutropenia | NON_SYSTEMATIC_ASSESSMENT | Investigations | None | View |
| Sepsis | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | None | View |
| Infections and infestations - Other, specify | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | None | View |
| Acute Coronary Syndrome | NON_SYSTEMATIC_ASSESSMENT | Cardiac disorders | None | View |
| Infections and infestations - Other, specify | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | None | View |
Other Events(If Any):
Other Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Alanine aminotransferase increased | NON_SYSTEMATIC_ASSESSMENT | Investigations | None | View |
| Aspartate aminotransferase increased | NON_SYSTEMATIC_ASSESSMENT | Investigations | None | View |
| Bronchial infection | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | None | View |
| Febrile neutropenia | NON_SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | None | View |
| Infusion related reaction | NON_SYSTEMATIC_ASSESSMENT | General disorders | None | View |
| Nail infection | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | None | View |
| Neutrophil count decreased | NON_SYSTEMATIC_ASSESSMENT | Investigations | None | View |
| Otitis externa | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | None | View |
| Platelet count decreased | NON_SYSTEMATIC_ASSESSMENT | Investigations | None | View |
| Rhinitis infective | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | None | View |
| Sinusitis | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | None | View |
| Tooth infection | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | None | View |
| Tumor lysis syndrome | NON_SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | None | View |
| Upper respiratory infection | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | None | View |
| Wound infection | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | None | View |
| Urinary tract infection | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | None | View |