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 @ 11:05 PM
Ignite Modification Date:
2025-12-25 @ 8:36 PM
NCT ID:
NCT02927769
Description:
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication. Data prespecified to be reported per treatment modality received in:
1. induction phase and consolidation phase only for those who did not progress to intensification phase in each cohort.
2. induction phase, intensification phase, and consolidation phase for those who proceeded to the intensification phase in each cohort.
Frequency Threshold:
5
Time Frame:
Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 86 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 7 months up until a maximum of 10 months).
Study:
NCT02927769
Study Brief:
A Study of Nivolumab Plus Brentuximab Vedotin in Patients Between 5 and 30 Years Old, With Hodgkin's Lymphoma (cHL), Relapsed or Refractory From First Line Treatment
Event Groups(If Any):
Event Groups
| Title | Description | Deaths # Affected | Deaths # At Risk | Serious # Affected | Serious # At Risk | Other # Affected | Other # At Risk | View |
|---|---|---|---|---|---|---|---|---|
| Cohort 1: Relapsed/Refractory Classic Hodgkin Lymphoma - Low Risk Relapse (Nivo + Bv) | Participants started in the induction phase and received nivolumab + brentuximab vedotin (N+Bv) for 2 cycles (6 weeks). Participants with radiographic progression, as assessed by Investigator at Cycle 2 entered follow-up. The rest of the participants continued in the induction phase and received 2 additional cycles of N+Bv study therapy (total 4 cycles = 12 weeks). \- Participants who had a complete metabolic response (CMR) by BICR after a total of 4 cycles (12 weeks) of N+Bv received an additional 2 cycles of treatment of N+Bv (for a total of 6 cycles \[18 weeks\]), followed by Radiation Therapy (RT) (consolidation phase). | 0 | None | 6 | 22 | 18 | 22 | View |
| Cohort 1: Relapsed/Refractory Classic Hodgkin Lymphoma - Low Risk Relapse (Nivo + Bv) + (Bv + B) | Participants started in the induction phase and received nivolumab + brentuximab vedotin (N+Bv) for 2 cycles (6 weeks). Participants with radiographic progression, as assessed by Investigator at Cycle 2 entered follow-up. The rest of the participants continued in the induction phase and received 2 additional cycles of N+Bv study therapy (total 4 cycles = 12 weeks). * Participants who had a complete metabolic response (CMR) by BICR after a total of 4 cycles (12 weeks) of N+Bv received an additional 2 cycles of treatment of N+Bv (for a total of 6 cycles \[18 weeks\]), followed by Radiation Therapy (RT) (consolidation phase). * Participants without a CMR after 4 cycles of N+Bv, by BICR, entered the intensification phase and received 2 cycles of brentuximab + bendamustine (Bv+B); participants who achieved CMR after these 2 cycles proceeded with RT (consolidation phase). * Participants who had radiographic progression after Cycle 4 N+Bv, as assessed by BICR, or those who did not achieve CMR, by BICR, after 2 cycles of Bv+B were taken off study treatment and entered follow-up. | 0 | None | 3 | 6 | 6 | 6 | View |
| Cohort 2: Relapsed/Refractory Classic Hodgkin Lymphoma - Standard Risk Relapse (Nivo + Bv) | Participants started in the induction phase and received nivolumab + brentuximab vedotin (N+Bv) for 2 cycles (6 weeks). Participants with radiographic progression, as assessed by Investigator at Cycle 2 entered follow-up. The rest of the participants received 2 additional cycles of N+Bv study therapy (total 4 cycles = 12 weeks). \- Participants who had complete metabolic response (CMR), by BICR, after a total of 4 cycles (12 weeks) of N+Bv proceeded with high-dose chemotherapy followed by an autologous stem cell transplant (HDCT/ASCT) (consolidation phase). Participants with CMR had the option to receive up to 2 additional cycles of N+Bv if their HDCT/ASCT was postponed for any reason. | 0 | None | 11 | 33 | 33 | 33 | View |
| Cohort 2: Relapsed/Refractory Classic Hodgkin Lymphoma - Standard Risk Relapse (Nivo + Bv)+(Bv + B) | Participants started in the induction phase and received nivolumab + brentuximab vedotin (N+Bv) for 2 cycles (6 weeks). Participants with radiographic progression, as assessed by Investigator at Cycle 2 entered follow-up. The rest of the participants received 2 additional cycles of N+Bv study therapy (total 4 cycles = 12 weeks). * Participants who had complete metabolic response (CMR), by BICR, after a total of 4 cycles (12 weeks) of N+Bv proceeded with high-dose chemotherapy followed by an autologous stem cell transplant (HDCT/ASCT) (consolidation phase). Participants with CMR had the option to receive up to 2 additional cycles of N+Bv if their HDCT/ASCT was postponed for any reason. * Participants without a CMR, by BICR, after 4 cycles of N+Bv received 2 cycles of brentuximab + bendamustine (Bv+B) (intensification phase). * Participants in CMR, by BICR, after 2 cycles of Bv+B received HDCT/ASCT (consolidation phase). * Participants without CMR by BICR could receive 2 additional cycles of Bv+B. If these participants attained CMR, they proceeded with HDCT/ASCT (consolidation phase). * Participants with CMR had the option to receive up to 2 additional cycles of B+Bv if their HDCT/ASCT was postponed. * Participants who had radiographic progression after Cycle 4 N+Bv, during study treatment or those who did not achieve CMR after final cycle of Bv+B were taken off study treatment and entered follow-up. | 1 | None | 4 | 11 | 11 | 11 | View |
Serious Events(If Any):
Serious Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Disseminated intravascular coagulation | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | 27.0 | View |
| Febrile neutropenia | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | 27.0 | View |
| Pericardial effusion | SYSTEMATIC_ASSESSMENT | Cardiac disorders | 27.0 | View |
| Enteritis | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | 27.0 | View |
| Stomatitis | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | 27.0 | View |
| Chest pain | SYSTEMATIC_ASSESSMENT | General disorders | 27.0 | View |
| Pyrexia | SYSTEMATIC_ASSESSMENT | General disorders | 27.0 | View |
| Anaphylactic reaction | SYSTEMATIC_ASSESSMENT | Immune system disorders | 27.0 | View |
| Hypersensitivity | SYSTEMATIC_ASSESSMENT | Immune system disorders | 27.0 | View |
| Otitis media | SYSTEMATIC_ASSESSMENT | Infections and infestations | 27.0 | View |
| Sepsis | SYSTEMATIC_ASSESSMENT | Infections and infestations | 27.0 | View |
| Infusion related reaction | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | 27.0 | View |
| Vascular access complication | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | 27.0 | View |
| Activated partial thromboplastin time prolonged | SYSTEMATIC_ASSESSMENT | Investigations | 27.0 | View |
| Blood phosphorus increased | SYSTEMATIC_ASSESSMENT | Investigations | 27.0 | View |
| Pain in extremity | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | 27.0 | View |
| Synovial cyst | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | 27.0 | View |
| Acute kidney injury | SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | 27.0 | View |
| Dyspnoea | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | 27.0 | View |
| Hypoxia | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | 27.0 | View |
| Orthopnoea | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | 27.0 | View |
| Pulmonary veno-occlusive disease | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | 27.0 | View |
| Rash | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | 27.0 | View |
| Urticaria | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | 27.0 | View |
| Hypotension | SYSTEMATIC_ASSESSMENT | Vascular disorders | 27.0 | View |
Other Events(If Any):
Other Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Neutropenia | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | 27.0 | View |
| Thrombocytopenia | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | 27.0 | View |
| Sinus bradycardia | SYSTEMATIC_ASSESSMENT | Cardiac disorders | 27.0 | View |
| Tachycardia | SYSTEMATIC_ASSESSMENT | Cardiac disorders | 27.0 | View |
| Hyperthyroidism | SYSTEMATIC_ASSESSMENT | Endocrine disorders | 27.0 | View |
| Hypothyroidism | SYSTEMATIC_ASSESSMENT | Endocrine disorders | 27.0 | View |
| Eye pain | SYSTEMATIC_ASSESSMENT | Eye disorders | 27.0 | View |
| Abdominal pain | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | 27.0 | View |
| Dysphagia | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | 27.0 | View |
| Enterocolitis | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | 27.0 | View |
| Gastrooesophageal reflux disease | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | 27.0 | View |
| Nausea | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | 27.0 | View |
| Oral pain | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | 27.0 | View |
| Paraesthesia oral | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | 27.0 | View |
| Stomatitis | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | 27.0 | View |
| Vomiting | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | 27.0 | View |
| Asthenia | SYSTEMATIC_ASSESSMENT | General disorders | 27.0 | View |
| Face oedema | SYSTEMATIC_ASSESSMENT | General disorders | 27.0 | View |
| Fatigue | SYSTEMATIC_ASSESSMENT | General disorders | 27.0 | View |
| Gait disturbance | SYSTEMATIC_ASSESSMENT | General disorders | 27.0 | View |
| Influenza like illness | SYSTEMATIC_ASSESSMENT | General disorders | 27.0 | View |
| Mucosal inflammation | SYSTEMATIC_ASSESSMENT | General disorders | 27.0 | View |
| Non-cardiac chest pain | SYSTEMATIC_ASSESSMENT | General disorders | 27.0 | View |
| Oedema peripheral | SYSTEMATIC_ASSESSMENT | General disorders | 27.0 | View |
| Cellulitis | SYSTEMATIC_ASSESSMENT | Infections and infestations | 27.0 | View |
| Device related infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | 27.0 | View |
| Epstein-Barr virus infection reactivation | SYSTEMATIC_ASSESSMENT | Infections and infestations | 27.0 | View |
| Gastroenteritis | SYSTEMATIC_ASSESSMENT | Infections and infestations | 27.0 | View |
| Nasopharyngitis | SYSTEMATIC_ASSESSMENT | Infections and infestations | 27.0 | View |
| Otitis media | SYSTEMATIC_ASSESSMENT | Infections and infestations | 27.0 | View |
| Pharyngitis | SYSTEMATIC_ASSESSMENT | Infections and infestations | 27.0 | View |
| Rhinitis | SYSTEMATIC_ASSESSMENT | Infections and infestations | 27.0 | View |
| Infusion related reaction | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | 27.0 | View |
| Post procedural complication | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | 27.0 | View |
| Procedural pain | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | 27.0 | View |
| Radiation associated pain | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | 27.0 | View |
| Radiation skin injury | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | 27.0 | View |
| Vascular access site pruritus | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | 27.0 | View |
| Alanine aminotransferase increased | SYSTEMATIC_ASSESSMENT | Investigations | 27.0 | View |
| Body temperature increased | SYSTEMATIC_ASSESSMENT | Investigations | 27.0 | View |
| Gamma-glutamyltransferase increased | SYSTEMATIC_ASSESSMENT | Investigations | 27.0 | View |
| Heart rate increased | SYSTEMATIC_ASSESSMENT | Investigations | 27.0 | View |
| International normalised ratio increased | SYSTEMATIC_ASSESSMENT | Investigations | 27.0 | View |
| Lipase decreased | SYSTEMATIC_ASSESSMENT | Investigations | 27.0 | View |
| Lipase increased | SYSTEMATIC_ASSESSMENT | Investigations | 27.0 | View |
| Lymphocyte count decreased | SYSTEMATIC_ASSESSMENT | Investigations | 27.0 | View |
| Neutrophil count decreased | SYSTEMATIC_ASSESSMENT | Investigations | 27.0 | View |
| Decreased appetite | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | 27.0 | View |
| Hyperglycaemia | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | 27.0 | View |
| Hyperuricaemia | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | 27.0 | View |
| Hypoalbuminaemia | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | 27.0 | View |
| Anaemia | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | 27.0 | View |
| Febrile neutropenia | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | 27.0 | View |
| Leukopenia | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | 27.0 | View |
| Abdominal pain upper | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | 27.0 | View |
| Coating in mouth | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | 27.0 | View |
| Constipation | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | 27.0 | View |
| Diarrhoea | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | 27.0 | View |
| Pyrexia | SYSTEMATIC_ASSESSMENT | General disorders | 27.0 | View |
| Drug hypersensitivity | SYSTEMATIC_ASSESSMENT | Immune system disorders | 27.0 | View |
| Hypersensitivity | SYSTEMATIC_ASSESSMENT | Immune system disorders | 27.0 | View |
| Infusion related hypersensitivity reaction | SYSTEMATIC_ASSESSMENT | Immune system disorders | 27.0 | View |
| Staphylococcal infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | 27.0 | View |
| Upper respiratory tract infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | 27.0 | View |
| Urinary tract infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | 27.0 | View |
| Amylase increased | SYSTEMATIC_ASSESSMENT | Investigations | 27.0 | View |
| Aspartate aminotransferase increased | SYSTEMATIC_ASSESSMENT | Investigations | 27.0 | View |
| Blood alkaline phosphatase increased | SYSTEMATIC_ASSESSMENT | Investigations | 27.0 | View |
| Blood bilirubin increased | SYSTEMATIC_ASSESSMENT | Investigations | 27.0 | View |
| Platelet count decreased | SYSTEMATIC_ASSESSMENT | Investigations | 27.0 | View |
| Weight decreased | SYSTEMATIC_ASSESSMENT | Investigations | 27.0 | View |
| White blood cell count decreased | SYSTEMATIC_ASSESSMENT | Investigations | 27.0 | View |
| Hypocalcaemia | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | 27.0 | View |
| Hypochloraemia | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | 27.0 | View |
| Hypokalaemia | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | 27.0 | View |
| Hyponatraemia | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | 27.0 | View |
| Hypophosphataemia | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | 27.0 | View |
| Hypouricaemia | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | 27.0 | View |
| Arthralgia | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | 27.0 | View |
| Back pain | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | 27.0 | View |
| Bone pain | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | 27.0 | View |
| Flank pain | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | 27.0 | View |
| Groin pain | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | 27.0 | View |
| Myalgia | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | 27.0 | View |
| Pain in extremity | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | 27.0 | View |
| Pain in jaw | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | 27.0 | View |
| Disturbance in attention | SYSTEMATIC_ASSESSMENT | Nervous system disorders | 27.0 | View |
| Dizziness | SYSTEMATIC_ASSESSMENT | Nervous system disorders | 27.0 | View |
| Headache | SYSTEMATIC_ASSESSMENT | Nervous system disorders | 27.0 | View |
| Presyncope | SYSTEMATIC_ASSESSMENT | Nervous system disorders | 27.0 | View |
| Somnolence | SYSTEMATIC_ASSESSMENT | Nervous system disorders | 27.0 | View |
| Agitation | SYSTEMATIC_ASSESSMENT | Psychiatric disorders | 27.0 | View |
| Anxiety | SYSTEMATIC_ASSESSMENT | Psychiatric disorders | 27.0 | View |
| Insomnia | SYSTEMATIC_ASSESSMENT | Psychiatric disorders | 27.0 | View |
| Acute kidney injury | SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | 27.0 | View |
| Haematuria | SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | 27.0 | View |
| Dysmenorrhoea | SYSTEMATIC_ASSESSMENT | Reproductive system and breast disorders | 27.0 | View |
| Cough | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | 27.0 | View |
| Dyspnoea | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | 27.0 | View |
| Epistaxis | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | 27.0 | View |
| Hypoxia | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | 27.0 | View |
| Nasal congestion | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | 27.0 | View |
| Oropharyngeal pain | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | 27.0 | View |
| Pharyngeal inflammation | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | 27.0 | View |
| Rhinorrhoea | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | 27.0 | View |
| Acne | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | 27.0 | View |
| Alopecia | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | 27.0 | View |
| Dermatitis allergic | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | 27.0 | View |
| Dry skin | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | 27.0 | View |
| Erythema | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | 27.0 | View |
| Hyperhidrosis | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | 27.0 | View |
| Night sweats | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | 27.0 | View |
| Pruritus | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | 27.0 | View |
| Psoriasis | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | 27.0 | View |
| Purpura | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | 27.0 | View |
| Rash | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | 27.0 | View |
| Rash maculo-papular | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | 27.0 | View |
| Urticaria | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | 27.0 | View |
| Hypertension | SYSTEMATIC_ASSESSMENT | Vascular disorders | 27.0 | View |
| Hypotension | SYSTEMATIC_ASSESSMENT | Vascular disorders | 27.0 | View |