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 @ 4:14 AM
Ignite Modification Date:
2025-12-26 @ 3:13 AM
NCT ID:
NCT03003520
Description:
Participants treated with lenalidomide during any stage of the study will be continued to be followed for Second Primary Malignancies (SPM) for up to 5 years after enrollment (C1D1) of the last participant to receive lenalidomide as part of their study treatment.
Frequency Threshold:
5
Time Frame:
AEs and SAEs were assessed from first dose to 90 days after the last dose of durvalumab or 28 days after the last dose of any other IP, whichever is later (up to approximately 72 weeks) and up to 5 years after enrollment (C1D1) of the last participant to receive lenalidomide (up to approximately 5 years). All-Cause Mortality was assessed in participants from their first dose to their study completion (up to approximately 5 years).
Study:
NCT03003520
Study Brief:
A Study of Durvalumab in Combination With R-CHOP or Lenalidomide Plus R-CHOP in Previously Untreated High-Risk Diffuse Large B-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 |
|---|---|---|---|---|---|---|---|---|
| DUR + R-CHOP | Participants receive Induction Therapy (21-day cycles): Durvalumab 1125 mg intravenously (IV) on Day 1 of each 21-day cycle in combination with 6 to 8 cycles R-CHOP (IV rituximab, doxorubicin, vincristine and cyclophosphamide on Day 1; daily oral/IV prednisone/prednisolone from Day 1 to 5). Participants then receive Consolidation Therapy (28-day cycles): Durvalumab 1500 mg IV on Day 1 of each 28-day cycle for up to a total of 12 months from C1D1 of induction therapy. | 5 | None | 23 | 43 | 43 | 43 | View |
| DUR + R2-CHOP | Participants receive Induction Therapy (21-day cycles): Cycle 1 - induction therapy of durvalumab in combination with R-CHOP (as described in DUR + R-CHOP arm). Starting at cycle 2 - Durvalumab 1125 mg IV on Day 1 of each 21-day cycle in combination with 6 to 8 cycles R2-CHOP (IV rituximab, doxorubicin, vincristine and cyclophosphamide on Day 1; daily oral/IV prednisone/prednisolone from Day 1 to 5; daily oral lenalidomide 15 mg from Day 1 to 14) from the cycle following COO determination until end of induction therapy (Cycle 6 or Cycle 8) or starting Cycle 1 if ABC subtype is identified prior to C1D1. Participants then receive Consolidation Therapy (28-day cycles): Durvalumab 1500 mg IV on Day 1 of each 28-day cycle for up to a total of 12 months from C1D1 of induction therapy. | 1 | None | 1 | 3 | 3 | 3 | View |
Serious Events(If Any):
Serious Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Anaemia | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | 22.0 | View |
| Febrile neutropenia | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | 22.0 | View |
| Leukopenia | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | 22.0 | View |
| Neutropenia | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | 22.0 | View |
| Pancytopenia | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | 22.0 | View |
| Atrial fibrillation | SYSTEMATIC_ASSESSMENT | Cardiac disorders | 22.0 | View |
| Cardiac arrest | SYSTEMATIC_ASSESSMENT | Cardiac disorders | 22.0 | View |
| Myocardial ischaemia | SYSTEMATIC_ASSESSMENT | Cardiac disorders | 22.0 | View |
| Nausea | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | 22.0 | View |
| Vomiting | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | 22.0 | View |
| Fatigue | SYSTEMATIC_ASSESSMENT | General disorders | 22.0 | View |
| General physical health deterioration | SYSTEMATIC_ASSESSMENT | General disorders | 22.0 | View |
| Pyrexia | SYSTEMATIC_ASSESSMENT | General disorders | 22.0 | View |
| Autoimmune hepatitis | SYSTEMATIC_ASSESSMENT | Hepatobiliary disorders | 22.0 | View |
| Haemophagocytic lymphohistiocytosis | SYSTEMATIC_ASSESSMENT | Immune system disorders | 22.0 | View |
| Device related infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | 22.0 | View |
| Infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | 22.0 | View |
| Influenza | SYSTEMATIC_ASSESSMENT | Infections and infestations | 22.0 | View |
| Lung infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | 22.0 | View |
| Meningitis bacterial | SYSTEMATIC_ASSESSMENT | Infections and infestations | 22.0 | View |
| Perirectal abscess | SYSTEMATIC_ASSESSMENT | Infections and infestations | 22.0 | View |
| Pneumonia | SYSTEMATIC_ASSESSMENT | Infections and infestations | 22.0 | View |
| Staphylococcal bacteraemia | SYSTEMATIC_ASSESSMENT | Infections and infestations | 22.0 | View |
| Viral diarrhoea | SYSTEMATIC_ASSESSMENT | Infections and infestations | 22.0 | View |
| Infusion related reaction | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | 22.0 | View |
| Hyponatraemia | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | 22.0 | View |
| Spinal pain | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | 22.0 | View |
| Clear cell renal cell carcinoma | SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | 22.0 | View |
| Diffuse large B-cell lymphoma recurrent | SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | 22.0 | View |
| Lymphoma | SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | 22.0 | View |
| Tumour pain | SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | 22.0 | View |
| Cerebrovascular accident | SYSTEMATIC_ASSESSMENT | Nervous system disorders | 22.0 | View |
| Acute kidney injury | SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | 22.0 | View |
| Seborrhoeic dermatitis | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | 22.0 | View |
| Deep vein thrombosis | SYSTEMATIC_ASSESSMENT | Vascular disorders | 22.0 | View |
| Venous thrombosis | SYSTEMATIC_ASSESSMENT | Vascular disorders | 22.0 | View |
Other Events(If Any):
Other Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Peripheral sensory neuropathy | SYSTEMATIC_ASSESSMENT | Nervous system disorders | 22.0 | View |
| Restless legs syndrome | SYSTEMATIC_ASSESSMENT | Nervous system disorders | 22.0 | View |
| Sensory disturbance | SYSTEMATIC_ASSESSMENT | Nervous system disorders | 22.0 | View |
| Taste disorder | SYSTEMATIC_ASSESSMENT | Nervous system disorders | 22.0 | View |
| Depression | SYSTEMATIC_ASSESSMENT | Psychiatric disorders | 22.0 | View |
| Insomnia | SYSTEMATIC_ASSESSMENT | Psychiatric disorders | 22.0 | View |
| Anaemia | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | 22.0 | View |
| Leukopenia | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | 22.0 | View |
| Neutropenia | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | 22.0 | View |
| Thrombocytopenia | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | 22.0 | View |
| Hypoacusis | SYSTEMATIC_ASSESSMENT | Ear and labyrinth disorders | 22.0 | View |
| Vision blurred | SYSTEMATIC_ASSESSMENT | Eye disorders | 22.0 | View |
| Abdominal pain | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | 22.0 | View |
| Abdominal pain upper | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | 22.0 | View |
| Constipation | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | 22.0 | View |
| Diarrhoea | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | 22.0 | View |
| Dry mouth | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | 22.0 | View |
| Gastrooesophageal reflux disease | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | 22.0 | View |
| Nausea | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | 22.0 | View |
| Stomatitis | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | 22.0 | View |
| Vomiting | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | 22.0 | View |
| Chills | SYSTEMATIC_ASSESSMENT | General disorders | 22.0 | View |
| Fatigue | SYSTEMATIC_ASSESSMENT | General disorders | 22.0 | View |
| Mucosal inflammation | SYSTEMATIC_ASSESSMENT | General disorders | 22.0 | View |
| Oedema peripheral | SYSTEMATIC_ASSESSMENT | General disorders | 22.0 | View |
| Pyrexia | SYSTEMATIC_ASSESSMENT | General disorders | 22.0 | View |
| Influenza | SYSTEMATIC_ASSESSMENT | Infections and infestations | 22.0 | View |
| Lung infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | 22.0 | View |
| Nasopharyngitis | SYSTEMATIC_ASSESSMENT | Infections and infestations | 22.0 | View |
| Oral candidiasis | SYSTEMATIC_ASSESSMENT | Infections and infestations | 22.0 | View |
| Oral herpes | SYSTEMATIC_ASSESSMENT | Infections and infestations | 22.0 | View |
| Pneumonia | SYSTEMATIC_ASSESSMENT | Infections and infestations | 22.0 | View |
| Upper respiratory tract infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | 22.0 | View |
| Urinary tract infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | 22.0 | View |
| Fall | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | 22.0 | View |
| Infusion related reaction | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | 22.0 | View |
| Blood pressure increased | SYSTEMATIC_ASSESSMENT | Investigations | 22.0 | View |
| Weight decreased | SYSTEMATIC_ASSESSMENT | Investigations | 22.0 | View |
| Decreased appetite | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | 22.0 | View |
| Hypokalaemia | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | 22.0 | View |
| Hypomagnesaemia | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | 22.0 | View |
| Arthralgia | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | 22.0 | View |
| Back pain | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | 22.0 | View |
| Muscle spasms | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | 22.0 | View |
| Myalgia | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | 22.0 | View |
| Dysuria | SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | 22.0 | View |
| Pain in extremity | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | 22.0 | View |
| Spinal pain | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | 22.0 | View |
| Histiocytic necrotising lymphadenitis | SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | 22.0 | View |
| Cognitive disorder | SYSTEMATIC_ASSESSMENT | Nervous system disorders | 22.0 | View |
| Dizziness | SYSTEMATIC_ASSESSMENT | Nervous system disorders | 22.0 | View |
| Dysgeusia | SYSTEMATIC_ASSESSMENT | Nervous system disorders | 22.0 | View |
| Headache | SYSTEMATIC_ASSESSMENT | Nervous system disorders | 22.0 | View |
| Cough | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | 22.0 | View |
| Dyspnoea | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | 22.0 | View |
| Oropharyngeal pain | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | 22.0 | View |
| Pulmonary embolism | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | 22.0 | View |
| Alopecia | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | 22.0 | View |
| Dry skin | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | 22.0 | View |
| Erythema | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | 22.0 | View |
| Generalised erythema | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | 22.0 | View |
| Pruritus | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | 22.0 | View |
| Rash | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | 22.0 | View |
| Hot flush | SYSTEMATIC_ASSESSMENT | Vascular disorders | 22.0 | View |
| Hypotension | SYSTEMATIC_ASSESSMENT | Vascular disorders | 22.0 | View |
| Platelet count decreased | SYSTEMATIC_ASSESSMENT | Investigations | 22.0 | View |