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
| Title | Description | Deaths # Affected | Deaths # At Risk | Serious # Affected | Serious # At Risk | Other # Affected | Other # At Risk | View |
|---|---|---|---|---|---|---|---|---|
| Carfilzomib 20/20 mg/m² | Participants received carfilzomib 20 mg/m² on days 2, 3, 9, and 10 of each 21-day cycle, carboplatin at a target AUC of 5 on day 1 of each cycle, and etoposide 100 mg/m² on days 1, 2, and 3 of each 21-day cycle for up to 6 cycles. Participants with stable disease or better continued to receive carfilzomib alone until PD, unacceptable toxicity, withdrawal of consent, study closure, or death, whichever occurred earliest. | None | None | 1 | 5 | 5 | 5 | View |
| Carfilzomib 20/56 mg/m² | Participants received carfilzomib 20 mg/m² on cycle 1 days 2 and 3, then 56 mg/m² on days 9 and 10 and thereafter for each subsequent 21-day cycle, carboplatin at a target AUC of 5 on day 1 of each cycle, and etoposide 100 mg/m² on days 1, 2, and 3 of each cycle for up to 6 cycles. Participants with stable disease or better continued to receive carfilzomib alone until PD, unacceptable toxicity, withdrawal of consent, study closure, or death, whichever occurred earliest. | None | None | 2 | 6 | 5 | 6 | View |
| Carfilzomib 20/27 mg/m² | Participants received carfilzomib 20 mg/m² on cycle 1 days 2 and 3, then 27 mg/m² on days 9 and 10 and thereafter for each subsequent 21-day cycle, carboplatin at a target AUC of 5 on day 1 of each cycle, and etoposide 100 mg/m² on days 1, 2, and 3 of each cycle for up to 6 cycles. Participants with stable disease or better continued to receive carfilzomib alone until progressive disease (PD), unacceptable toxicity, withdrawal of consent, study closure, or death, whichever occurred earliest. | None | None | 1 | 3 | 3 | 3 | View |
| Carfilzomib 20/36 mg/m² | Participants received carfilzomib 20 mg/m² on cycle 1 days 2 and 3, then 36 mg/m² on days 9 and 10 and thereafter for each subsequent 21-day cycle, carboplatin at a target AUC of 5 on day 1 of each cycle, and etoposide 100 mg/m² on days 1, 2, and 3 of each cycle for up to 6 cycles. Participants with stable disease or better continued to receive carfilzomib alone until PD, unacceptable toxicity, withdrawal of consent, study closure, or death, whichever occurred earliest. | None | None | 1 | 3 | 3 | 3 | View |
| Carfilzomib 20/45 mg/m² | Participants received carfilzomib 20 mg/m² on cycle 1 days 2 and 3, then 45 mg/m² on days 9 and 10 and thereafter for each subsequent 21-day cycle, carboplatin at a target AUC of 5 on day 1 of each cycle, and etoposide 100 mg/m² on days 1, 2, and 3 of each cycle for up to 6 cycles. Participants with stable disease or better continued to receive carfilzomib alone until PD, unacceptable toxicity, withdrawal of consent, study closure, or death, whichever occurred earliest. | None | None | 7 | 15 | 15 | 15 | View |
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Anaemia | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | MedDRA 19.0 | View |
| Febrile neutropenia | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | MedDRA 19.0 | View |
| Atrial fibrillation | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA 19.0 | View |
| Clostridium difficile colitis | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 19.0 | View |
| Injection site abscess | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 19.0 | View |
| Pneumonia | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 19.0 | View |
| Fluid overload | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA 19.0 | View |
| Hypoalbuminaemia | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA 19.0 | View |
| Back pain | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA 19.0 | View |
| Cerebrovascular accident | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA 19.0 | View |
| Nervous system disorder | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA 19.0 | View |
| Chronic obstructive pulmonary disease | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA 19.0 | View |
| Pulmonary embolism | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA 19.0 | View |
| Pulmonary haemorrhage | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA 19.0 | View |
| Pulmonary oedema | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA 19.0 | View |
| Peripheral artery thrombosis | SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDRA 19.0 | View |
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Anaemia | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | MedDRA 19.0 | View |
| Leukocytosis | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | MedDRA 19.0 | View |
| Leukopenia | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | MedDRA 19.0 | View |
| Neutropenia | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | MedDRA 19.0 | View |
| Thrombocytopenia | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | MedDRA 19.0 | View |
| Ear congestion | SYSTEMATIC_ASSESSMENT | Ear and labyrinth disorders | MedDRA 19.0 | View |
| Ear discomfort | SYSTEMATIC_ASSESSMENT | Ear and labyrinth disorders | MedDRA 19.0 | View |
| Ear pain | SYSTEMATIC_ASSESSMENT | Ear and labyrinth disorders | MedDRA 19.0 | View |
| Hypoacusis | SYSTEMATIC_ASSESSMENT | Ear and labyrinth disorders | MedDRA 19.0 | View |
| Vertigo | SYSTEMATIC_ASSESSMENT | Ear and labyrinth disorders | MedDRA 19.0 | View |
| Abdominal discomfort | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 19.0 | View |
| Abdominal distension | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 19.0 | View |
| Abdominal pain | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 19.0 | View |
| Constipation | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 19.0 | View |
| Diarrhoea | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 19.0 | View |
| Flatulence | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 19.0 | View |
| Haematochezia | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 19.0 | View |
| Nausea | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 19.0 | View |
| Oesophagitis | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 19.0 | View |
| Stomatitis | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 19.0 | View |
| Toothache | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 19.0 | View |
| Vomiting | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 19.0 | View |
| Asthenia | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA 19.0 | View |
| Catheter site pain | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA 19.0 | View |
| Chills | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA 19.0 | View |
| Fatigue | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA 19.0 | View |
| Mucosal inflammation | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA 19.0 | View |
| Non-cardiac chest pain | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA 19.0 | View |
| Oedema peripheral | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA 19.0 | View |
| Pain | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA 19.0 | View |
| Pyrexia | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA 19.0 | View |
| Hypersensitivity | SYSTEMATIC_ASSESSMENT | Immune system disorders | MedDRA 19.0 | View |
| Cellulitis | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 19.0 | View |
| Clostridium difficile colitis | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 19.0 | View |
| Influenza | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 19.0 | View |
| Injection site infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 19.0 | View |
| Lower respiratory tract infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 19.0 | View |
| Lung infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 19.0 | View |
| Mucosal infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 19.0 | View |
| Oral candidiasis | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 19.0 | View |
| Oral herpes | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 19.0 | View |
| Pneumonia | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 19.0 | View |
| Respiratory tract infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 19.0 | View |
| Sinusitis | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 19.0 | View |
| Skin infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 19.0 | View |
| Upper respiratory tract infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 19.0 | View |
| Vulvovaginal candidiasis | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 19.0 | View |
| Vulvovaginal mycotic infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 19.0 | View |
| Fall | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA 19.0 | View |
| Head injury | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA 19.0 | View |
| Incision site erythema | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA 19.0 | View |
| Incision site swelling | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA 19.0 | View |
| Infusion related reaction | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA 19.0 | View |
| Laceration | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA 19.0 | View |
| Wound | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA 19.0 | View |
| Alanine aminotransferase increased | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA 19.0 | View |
| Aspartate aminotransferase increased | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA 19.0 | View |
| Blood alkaline phosphatase increased | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA 19.0 | View |
| Blood creatinine increased | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA 19.0 | View |
| Blood glucose increased | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA 19.0 | View |
| Blood phosphorus increased | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA 19.0 | View |
| Blood potassium decreased | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA 19.0 | View |
| Blood urea increased | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA 19.0 | View |
| Blood uric acid increased | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA 19.0 | View |
| Creatinine renal clearance decreased | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA 19.0 | View |
| Ejection fraction decreased | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA 19.0 | View |
| Haemoglobin decreased | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA 19.0 | View |
| Neutrophil count decreased | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA 19.0 | View |
| Platelet count decreased | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA 19.0 | View |
| Weight decreased | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA 19.0 | View |
| Weight increased | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA 19.0 | View |
| White blood cell count decreased | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA 19.0 | View |
| Decreased appetite | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA 19.0 | View |
| Dehydration | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA 19.0 | View |
| Diabetes mellitus | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA 19.0 | View |
| Gout | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA 19.0 | View |
| Hyperglycaemia | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA 19.0 | View |
| Hyperkalaemia | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA 19.0 | View |
| Hypoalbuminaemia | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA 19.0 | View |
| Hypocalcaemia | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA 19.0 | View |
| Hypoglycaemia | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA 19.0 | View |
| Hypokalaemia | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA 19.0 | View |
| Hypomagnesaemia | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA 19.0 | View |
| Hyponatraemia | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA 19.0 | View |
| Metabolic acidosis | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA 19.0 | View |
| Back pain | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA 19.0 | View |
| Bone pain | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA 19.0 | View |
| Costochondritis | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA 19.0 | View |
| Groin pain | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA 19.0 | View |
| Muscular weakness | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA 19.0 | View |
| Musculoskeletal chest pain | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA 19.0 | View |
| Musculoskeletal pain | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA 19.0 | View |
| Neck pain | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA 19.0 | View |
| Pain in extremity | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA 19.0 | View |
| Cancer pain | SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 19.0 | View |
| Ageusia | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA 19.0 | View |
| Cerebrovascular accident | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA 19.0 | View |
| Decreased vibratory sense | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA 19.0 | View |
| Dizziness | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA 19.0 | View |
| Dysgeusia | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA 19.0 | View |
| Headache | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA 19.0 | View |
| Hypoaesthesia | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA 19.0 | View |
| Hyporeflexia | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA 19.0 | View |
| Neuropathy peripheral | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA 19.0 | View |
| Paraesthesia | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA 19.0 | View |
| Peripheral sensory neuropathy | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA 19.0 | View |
| Tremor | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA 19.0 | View |
| Vocal cord paralysis | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA 19.0 | View |
| Anxiety | SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MedDRA 19.0 | View |
| Confusional state | SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MedDRA 19.0 | View |
| Depression | SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MedDRA 19.0 | View |
| Insomnia | SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MedDRA 19.0 | View |
| Dysuria | SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | MedDRA 19.0 | View |
| Micturition disorder | SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | MedDRA 19.0 | View |
| Breast pain | SYSTEMATIC_ASSESSMENT | Reproductive system and breast disorders | MedDRA 19.0 | View |
| Aspiration | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA 19.0 | View |
| Cough | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA 19.0 | View |
| Dry throat | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA 19.0 | View |
| Dyspnoea | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA 19.0 | View |
| Haemoptysis | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA 19.0 | View |
| Hypoxia | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA 19.0 | View |
| Nasal congestion | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA 19.0 | View |
| Oropharyngeal pain | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA 19.0 | View |
| Pleural effusion | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA 19.0 | View |
| Pulmonary embolism | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA 19.0 | View |
| Pulmonary oedema | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA 19.0 | View |
| Rhinorrhoea | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA 19.0 | View |
| Wheezing | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA 19.0 | View |
| Alopecia | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA 19.0 | View |
| Palmar-plantar erythrodysaesthesia syndrome | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA 19.0 | View |
| Pruritus | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA 19.0 | View |
| Rash | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA 19.0 | View |
| Rash macular | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA 19.0 | View |
| Skin discolouration | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA 19.0 | View |
| Skin irritation | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA 19.0 | View |
| Swelling face | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA 19.0 | View |
| Deep vein thrombosis | SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDRA 19.0 | View |
| Flushing | SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDRA 19.0 | View |
| Hypertension | SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDRA 19.0 | View |
| Hypotension | SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDRA 19.0 | View |
| Jugular vein thrombosis | SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDRA 19.0 | View |
| Orthostatic hypotension | SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDRA 19.0 | View |
| Phlebitis | SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDRA 19.0 | View |