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 @ 3:24 AM
Ignite Modification Date:
2025-12-26 @ 2:03 AM
NCT ID:
NCT03927105
Description:
An AE is any untoward medical occurrence whether or not related to the study drug that appears to change in intensity during the course of the study.
Abnormal laboratory values or diagnostic test results constitute AEs only if they induce clinical signs or symptoms or require treatment or further diagnostic tests Hospitalization for elective surgery or routine clinical procedures that are not the result of an AE (e.g.,surgical insertion of central line) should not be recorded as an AE.
Frequency Threshold:
0
Time Frame:
From time of consent through 100 days post treatment discontinuation. Longest actual collection for AEs: 13 months
Study:
NCT03927105
Study Brief:
Nivolumab and the Antagonistic CSF-1R Monoclonal Antibody Cabiralizumab (BMS-986227) in Patients With Relapsed/Refractory Peripheral T Cell 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 |
|---|---|---|---|---|---|---|---|---|
| Nivolumab + Cabiralizumab | Nivolumab 240mg IV + Cabiralizumab 4mg/kg on day 1 of every 14 day cycle. Nivolumab is a human monoclonal antibody (HuMAb; immunoglobulin G4 \[IgG4\]-S228P) that targets the programmed death-1 (PD-1) cluster of differentiation 279 (CD279) cell surface membrane receptor. PD-1 is a negative regulatory molecule expressed by activated T and B lymphocytes.1 Binding of PD-1 to its ligands, programmed death-ligands 1 (PD-L1) and 2 (PD-L2), results in the down-regulation of lymphocyte activation. Inhibition of the interaction between PD-1 and its ligands promotes immune responses and antigen-specific T-cell responses to both foreign antigens as well as self-antigens. Cabiralizumab is a recombinant, humanized Immunoglobulin G4 (IgG4) monoclonal antibody that binds to human colony stimulating factor 1 receptor (CSF1R; c-fms). | 1 | None | 2 | 3 | 3 | 3 | View |
Serious Events(If Any):
Other Events(If Any):
Other Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| PERIORBITAL EDEMA | NON_SYSTEMATIC_ASSESSMENT | Eye disorders | CTCAEv5 | View |
| ABDOMINAL PAIN | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | CTCAEv5 | View |
| DIARRHEA | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | CTCAEv5 | View |
| NAUSEA | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | CTCAEv5 | View |
| VOMITING | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | CTCAEv5 | View |
| CHILLS | NON_SYSTEMATIC_ASSESSMENT | General disorders | CTCAEv5 | View |
| FATIGUE | NON_SYSTEMATIC_ASSESSMENT | General disorders | CTCAEv5 | View |
| FEVER | NON_SYSTEMATIC_ASSESSMENT | General disorders | CTCAEv5 | View |
| NON-CARDIAC CHEST PAIN | NON_SYSTEMATIC_ASSESSMENT | General disorders | CTCAEv5 | View |
| INFECTIONS AND INFESTATIONS - OTHER, SPECIFY | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | CTCAEv5 | View |
| UPPER RESPIRATORY INFECTION | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | CTCAEv5 | View |
| WEIGHT LOSS | NON_SYSTEMATIC_ASSESSMENT | Investigations | CTCAEv5 | View |
| ANOREXIA | NON_SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | CTCAEv5 | View |
| NEOPLASMS BENIGN, MALIGNANT AND UNSPECIFIED (INCL CYSTS AND POLYPS) - OTHER, SPECIFY | NON_SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | CTCAEv5 | View |
| HEADACHE | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | CTCAEv5 | View |
| INSOMNIA | NON_SYSTEMATIC_ASSESSMENT | Psychiatric disorders | CTCAEv5 | View |
| NASAL CONGESTION | NON_SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | CTCAEv5 | View |
| SORE THROAT | NON_SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | CTCAEv5 | View |
| PRURITUS | NON_SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | CTCAEv5 | View |
| MUCOSITIS ORAL | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | CTCAEv5 | View |
| COUGH | NON_SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | CTCAEv5 | View |