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:
2025-12-26 @ 12:15 PM
Ignite Modification Date:
2025-12-26 @ 12:15 PM
NCT ID:
NCT04145700
Description:
All randomized participants who received at least one dose of study drug.
Frequency Threshold:
0
Time Frame:
Baseline Up to 6.94 months
Study:
NCT04145700
Study Brief:
CAMPFIRE: A Study of Ramucirumab (LY3009806) in Children and Young Adults With Synovial Sarcoma
Event Groups(If Any):
Event Groups
| Title | Description | Deaths # Affected | Deaths # At Risk | Serious # Affected | Serious # At Risk | Other # Affected | Other # At Risk | View |
|---|---|---|---|---|---|---|---|---|
| Ramucirumab + Gemcitabine + Docetaxel | Participants received intravenous infusions of ramucirumab 9 mg/kg, gemcitabine 900 mg/m2 on days 1, 8, and docetaxel 75 mg/m2 on day 8 of a 21-day cycle until disease progression or a criterion for discontinuation were met. | 8 | None | 8 | 16 | 15 | 16 | View |
| Gemcitabine + Docetaxel | Participants received intravenous infusions of gemcitabine 900 mg/m2 on days 1, 8, and docetaxel 75 mg/m2 on day 8 of a 21-day cycle until disease progression or a criterion for discontinuation were met. | 4 | None | 2 | 6 | 6 | 6 | View |
Serious Events(If Any):
Serious Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Febrile neutropenia | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | MedDRA 25.1 | View |
| Mallory-weiss syndrome | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 25.1 | View |
| Vomiting | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 25.1 | View |
| Pyrexia | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA 25.1 | View |
| Anaphylactic reaction | SYSTEMATIC_ASSESSMENT | Immune system disorders | MedDRA 25.1 | View |
| Pneumonia | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 25.1 | View |
| Sepsis | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 25.1 | View |
| Platelet count decreased | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA 25.1 | View |
| Laryngeal haemorrhage | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA 25.1 | View |
| Pleural effusion | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA 25.1 | View |
| Pneumothorax | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA 25.1 | View |
| Embolism | SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDRA 25.1 | View |
Other Events(If Any):
Other Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Anaemia | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | MedDRA 25.1 | View |
| Leukopenia | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | MedDRA 25.1 | View |
| Neutropenia | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | MedDRA 25.1 | View |
| Thrombocytopenia | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | MedDRA 25.1 | View |
| Sinus tachycardia | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA 25.1 | View |
| Ear pain | SYSTEMATIC_ASSESSMENT | Ear and labyrinth disorders | MedDRA 25.1 | View |
| Blepharitis | SYSTEMATIC_ASSESSMENT | Eye disorders | MedDRA 25.1 | View |
| Periorbital oedema | SYSTEMATIC_ASSESSMENT | Eye disorders | MedDRA 25.1 | View |
| Retinal haemorrhage | SYSTEMATIC_ASSESSMENT | Eye disorders | MedDRA 25.1 | View |
| Abdominal pain | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 25.1 | View |
| Abdominal pain upper | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 25.1 | View |
| Aphthous ulcer | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 25.1 | View |
| Constipation | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 25.1 | View |
| Diarrhoea | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 25.1 | View |
| Dyspepsia | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 25.1 | View |
| Enterocolitis haemorrhagic | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 25.1 | View |
| Gingival pain | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 25.1 | View |
| Nausea | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 25.1 | View |
| Odynophagia | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 25.1 | View |
| Stomatitis | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 25.1 | View |
| Vomiting | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 25.1 | View |
| Asthenia | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA 25.1 | View |
| Fatigue | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA 25.1 | View |
| Mucosal inflammation | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA 25.1 | View |
| Non-cardiac chest pain | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA 25.1 | View |
| Oedema peripheral | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA 25.1 | View |
| Pain | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA 25.1 | View |
| Pyrexia | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA 25.1 | View |
| Asymptomatic covid-19 | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 25.1 | View |
| Cellulitis | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 25.1 | View |
| Conjunctivitis | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 25.1 | View |
| Covid-19 | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 25.1 | View |
| Eye infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 25.1 | View |
| Folliculitis | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 25.1 | View |
| Paronychia | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 25.1 | View |
| Pneumonia | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 25.1 | View |
| Skin infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 25.1 | View |
| Urinary tract infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 25.1 | View |
| Wound dehiscence | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA 25.1 | View |
| Activated partial thromboplastin time prolonged | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA 25.1 | View |
| Alanine aminotransferase | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA 25.1 | View |
| Alanine aminotransferase increased | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA 25.1 | View |
| Aspartate aminotransferase increased | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA 25.1 | View |
| Blood alkaline phosphatase increased | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA 25.1 | View |
| Blood glucose increased | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA 25.1 | View |
| Lymphocyte count decreased | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA 25.1 | View |
| Neutrophil count decreased | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA 25.1 | View |
| Platelet count decreased | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA 25.1 | View |
| Weight increased | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA 25.1 | View |
| White blood cell count decreased | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA 25.1 | View |
| Decreased appetite | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA 25.1 | View |
| Fluid retention | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA 25.1 | View |
| Hyperglycaemia | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA 25.1 | View |
| Hyperkalaemia | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA 25.1 | View |
| Hyperphosphataemia | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA 25.1 | View |
| Hypoalbuminaemia | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA 25.1 | View |
| Hypocalcaemia | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA 25.1 | View |
| Hypoglycaemia | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA 25.1 | View |
| Hypokalaemia | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA 25.1 | View |
| Hypomagnesaemia | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA 25.1 | View |
| Hyponatraemia | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA 25.1 | View |
| Hypophosphataemia | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA 25.1 | View |
| Arthralgia | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA 25.1 | View |
| Back pain | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA 25.1 | View |
| Bone pain | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA 25.1 | View |
| Muscle spasms | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA 25.1 | View |
| Muscular weakness | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA 25.1 | View |
| Musculoskeletal chest pain | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA 25.1 | View |
| Myalgia | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA 25.1 | View |
| Neck pain | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA 25.1 | View |
| Pain in extremity | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA 25.1 | View |
| Dizziness | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA 25.1 | View |
| Headache | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA 25.1 | View |
| Neuropathy peripheral | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA 25.1 | View |
| Peripheral sensory neuropathy | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA 25.1 | View |
| Presyncope | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA 25.1 | View |
| Sciatic nerve neuropathy | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA 25.1 | View |
| Syncope | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA 25.1 | View |
| Taste disorder | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA 25.1 | View |
| Anxiety | SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MedDRA 25.1 | View |
| Haematuria | SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | MedDRA 25.1 | View |
| Proteinuria | SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | MedDRA 25.1 | View |
| Urinary retention | SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | MedDRA 25.1 | View |
| Cough | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA 25.1 | View |
| Dyspnoea | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA 25.1 | View |
| Emphysema | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA 25.1 | View |
| Epistaxis | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA 25.1 | View |
| Nasal congestion | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA 25.1 | View |
| Nasal dryness | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA 25.1 | View |
| Pleuritic pain | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA 25.1 | View |
| Pneumothorax | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA 25.1 | View |
| Productive cough | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA 25.1 | View |
| Rhinalgia | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA 25.1 | View |
| Alopecia | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA 25.1 | View |
| Dermatitis acneiform | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA 25.1 | View |
| Dry skin | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA 25.1 | View |
| Erythema | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA 25.1 | View |
| Nail disorder | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA 25.1 | View |
| Onychomadesis | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA 25.1 | View |
| Pain of skin | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA 25.1 | View |
| Palmar-plantar erythrodysaesthesia syndrome | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA 25.1 | View |
| Pruritus | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA 25.1 | View |
| Rash | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA 25.1 | View |
| Rash maculo-papular | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA 25.1 | View |
| Skin discolouration | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA 25.1 | View |
| Skin disorder | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA 25.1 | View |
| Skin ulcer | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA 25.1 | View |
| Hypertension | SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDRA 25.1 | View |
| Hypotension | SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDRA 25.1 | View |
| Lymphoedema | SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDRA 25.1 | View |
| Superficial vein thrombosis | SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDRA 25.1 | View |