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 @ 4:23 AM
Ignite Modification Date:
2025-12-26 @ 3:25 AM
NCT ID:
NCT02825420
Description:
Two patients were excluded from the safety set because of missing PLD treatment data
Frequency Threshold:
5
Time Frame:
From Day 1 of study treatment to 30 days post last dose of study treatment, up to 4.5 years (Jan 2015 to Sept 2019)
Study:
NCT02825420
Study Brief:
Non-interventional European Study of Trabectedin + PLD in the Treatment of Relapsed Ovarian Cancer (ROC) Patients
Event Groups(If Any):
Event Groups
| Title | Description | Deaths # Affected | Deaths # At Risk | Serious # Affected | Serious # At Risk | Other # Affected | Other # At Risk | View |
|---|---|---|---|---|---|---|---|---|
| Prior Use of Antiangiogenics | Patients who used a prior Antiangiogenics defined as type of therapy reported in the CRF categorized as "antiangiogenic" by the investigator or prior treatment reported by the investigator being bevacizumab (or Avastin®), pazopanib, or trabananib | 30 | None | 23 | 129 | 106 | 129 | View |
| No Prior Use of Antiangiogenics | Antiangiogenics-naïve Patients. Antiangiogenics defined as type of therapy reported in the CRF categorized as "antiangiogenic" by the investigator or prior treatment reported by the investigator being bevacizumab (or Avastin®), pazopanib, or trabananib | 12 | None | 14 | 89 | 78 | 89 | View |
Serious Events(If Any):
Serious Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Anaemia | NON_SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | MedDRA (17.0) | View |
| Febrile neutropenia | NON_SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | MedDRA (17.0) | View |
| Neutropenia | NON_SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | MedDRA (17.0) | View |
| Pancytopenia | NON_SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | MedDRA (17.0) | View |
| Thrombocytopenia | NON_SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | MedDRA (17.0) | View |
| Leukopenia | NON_SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | MedDRA (17.0) | View |
| Diarrhoea | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (17.0) | View |
| Dysphagia | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (17.0) | View |
| Gastrointestinal haemorrhage | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (17.0) | View |
| Gastrointestinal obstruction | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (17.0) | View |
| Gastrooesophageal reflux disease | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (17.0) | View |
| Nausea | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (17.0) | View |
| Oesophagitis | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (17.0) | View |
| Retching | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (17.0) | View |
| Vomiting | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (17.0) | View |
| Abdominal pain | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (17.0) | View |
| Enteritis | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (17.0) | View |
| Intestinal obstruction | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (17.0) | View |
| Asthenia | NON_SYSTEMATIC_ASSESSMENT | General disorders | MedDRA (17.0) | View |
| Disease progression | NON_SYSTEMATIC_ASSESSMENT | General disorders | MedDRA (17.0) | View |
| Fatigue | NON_SYSTEMATIC_ASSESSMENT | General disorders | MedDRA (17.0) | View |
| Oedema | NON_SYSTEMATIC_ASSESSMENT | General disorders | MedDRA (17.0) | View |
| Pyrexia | NON_SYSTEMATIC_ASSESSMENT | General disorders | MedDRA (17.0) | View |
| Drug hypersensitivity | NON_SYSTEMATIC_ASSESSMENT | Immune system disorders | MedDRA (17.0) | View |
| Device related infection | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (17.0) | View |
| Escherichia infection | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (17.0) | View |
| Infusion site infection | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (17.0) | View |
| Pneumocystis jirovecii pneumonia | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (17.0) | View |
| Pneumonia | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (17.0) | View |
| Respiratory tract infection | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (17.0) | View |
| Sepsis | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (17.0) | View |
| Upper respiratory tract infection | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (17.0) | View |
| Urosepsis | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (17.0) | View |
| Bacteraemia | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (17.0) | View |
| Clostridium difficile infection | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (17.0) | View |
| Blood alkaline phosphatase increased | NON_SYSTEMATIC_ASSESSMENT | Investigations | MedDRA (17.0) | View |
| Blood electrolytes decreased | NON_SYSTEMATIC_ASSESSMENT | Investigations | MedDRA (17.0) | View |
| Platelet count decreased | NON_SYSTEMATIC_ASSESSMENT | Investigations | MedDRA (17.0) | View |
| Transaminases increased | NON_SYSTEMATIC_ASSESSMENT | Investigations | MedDRA (17.0) | View |
| Back pain | NON_SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA (17.0) | View |
| Hepatic cancer metastatic | NON_SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (17.0) | View |
| Cerebral haemorrhage | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA (17.0) | View |
| Convulsion | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA (17.0) | View |
| Azotaemia | NON_SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | MedDRA (17.0) | View |
| Renal failure | NON_SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | MedDRA (17.0) | View |
| Dysphonia | NON_SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA (17.0) | View |
| Dyspnoea | NON_SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA (17.0) | View |
| Pleural effusion | NON_SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA (17.0) | View |
| Pulmonary embolism | NON_SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA (17.0) | View |
| Pyoderma gangrenosum | NON_SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA (17.0) | View |
| Mood altered | NON_SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MedDRA (17.0) | View |
| Off label use | NON_SYSTEMATIC_ASSESSMENT | Surgical and medical procedures | MedDRA (17.0) | View |
| Embolism | NON_SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDRA (17.0) | View |
| Renal failure acute | NON_SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | MedDRA (17.0) | View |
Other Events(If Any):
Other Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Mucosal inflammation | NON_SYSTEMATIC_ASSESSMENT | General disorders | MedDRA (17.0) | View |
| Neutrophil count decreased | NON_SYSTEMATIC_ASSESSMENT | Investigations | MedDRA (17.0) | View |
| Anaemia | NON_SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | MedDRA (17.0) | View |
| Leukopenia | NON_SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | MedDRA (17.0) | View |
| Neutropenia | NON_SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | MedDRA (17.0) | View |
| Thrombocytopenia | NON_SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | MedDRA (17.0) | View |
| Constipation | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (17.0) | View |
| Diarrhoea | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (17.0) | View |
| Nausea | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (17.0) | View |
| Stomatitis | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (17.0) | View |
| Vomiting | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (17.0) | View |
| Asthenia | NON_SYSTEMATIC_ASSESSMENT | General disorders | MedDRA (17.0) | View |
| Fatigue | NON_SYSTEMATIC_ASSESSMENT | General disorders | MedDRA (17.0) | View |
| Decreased appetite | NON_SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA (17.0) | View |
| Palmar-plantar erythrodysaesthesia syndrome | NON_SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA (17.0) | View |
| Skin hyperpigmentation | NON_SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA (17.0) | View |