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 @ 5:19 PM
Ignite Modification Date:
2025-12-26 @ 5:19 PM
NCT ID:
NCT01121406
Description:
None
Frequency Threshold:
5
Time Frame:
From first treatment administration to 21 days after the last drug administration (Up to 1403 days)
Study:
NCT01121406
Study Brief:
BI 6727 (Volasertib) Randomised Trial in Ovarian Cancer
Event Groups(If Any):
Event Groups
| Title | Description | Deaths # Affected | Deaths # At Risk | Serious # Affected | Serious # At Risk | Other # Affected | Other # At Risk | View |
|---|---|---|---|---|---|---|---|---|
| Volasertib (BI 6727) | Volasertib (BI 6727 300 mg) was administered as intravenous infusion over 2 hours at Day 1 of each 21-day treatment course. Treatment was to be administered until disease progression or occurrence of toxicity leading to treatment discontinuation. Patients withdrawn from volasertib treatment could receive a treatment according to investigator's choice. The patients were to be followed for survival status. | None | None | 24 | 54 | 53 | 54 | View |
| Cytotoxic | Patients received a non-platinum cytotoxic single agent. The investigator chose the most appropriate drug according to patient status (previous chemotherapy effects, cumulative toxic effects, performance status, and nutritional status), the product Summary of Product Characteristics (SPC), and the local standard of care. The following non-platinum regimens were recommended because they are regarded efficacious and safe in patients with resistant ovarian cancer: * Pegylated liposomal doxorubicin (PLD): 40 mg/m² at Day 1 (1 course = 28 days) * Topotecan: 1.25 mg/m² from Days 1 to 5 (1 course = 21 days), or 4 mg/m² at Days 1, 8, and 15 (1 course = 28 days) * Paclitaxel: 80 mg/m² at Days 1, 8, 15, and 21 (1 course = 28 days) * Gemcitabine: 1000 mg/m² at Days 1 and 8 (1 course = 21 days) | None | None | 19 | 55 | 53 | 55 | View |
| Cytotoxic to Volasertib Switch | Patients of the cytotoxic arm who switched to treatment with Volasertib (BI 6727). | None | None | 12 | 24 | 21 | 24 | View |
Serious Events(If Any):
Serious Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Anaemia | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | MEDDRA 17.0 | View |
| Febrile neutropenia | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | MEDDRA 17.0 | View |
| Neutropenia | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | MEDDRA 17.0 | View |
| Thrombocytopenia | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | MEDDRA 17.0 | View |
| Atrial fibrillation | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MEDDRA 17.0 | View |
| Abdominal distension | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MEDDRA 17.0 | View |
| Abdominal pain | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MEDDRA 17.0 | View |
| Abdominal pain upper | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MEDDRA 17.0 | View |
| Ascites | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MEDDRA 17.0 | View |
| Constipation | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MEDDRA 17.0 | View |
| Diarrhoea | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MEDDRA 17.0 | View |
| Gastrointestinal haemorrhage | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MEDDRA 17.0 | View |
| Gastrointestinal obstruction | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MEDDRA 17.0 | View |
| Ileal perforation | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MEDDRA 17.0 | View |
| Ileus | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MEDDRA 17.0 | View |
| Intestinal obstruction | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MEDDRA 17.0 | View |
| Large intestine perforation | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MEDDRA 17.0 | View |
| Nausea | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MEDDRA 17.0 | View |
| Rectal haemorrhage | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MEDDRA 17.0 | View |
| Small intestinal obstruction | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MEDDRA 17.0 | View |
| Subileus | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MEDDRA 17.0 | View |
| Vomiting | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MEDDRA 17.0 | View |
| Chest pain | SYSTEMATIC_ASSESSMENT | General disorders | MEDDRA 17.0 | View |
| Condition aggravated | SYSTEMATIC_ASSESSMENT | General disorders | MEDDRA 17.0 | View |
| Death | SYSTEMATIC_ASSESSMENT | General disorders | MEDDRA 17.0 | View |
| Euthanasia | SYSTEMATIC_ASSESSMENT | General disorders | MEDDRA 17.0 | View |
| General physical health deterioration | SYSTEMATIC_ASSESSMENT | General disorders | MEDDRA 17.0 | View |
| Multi-organ failure | SYSTEMATIC_ASSESSMENT | General disorders | MEDDRA 17.0 | View |
| Obstruction | SYSTEMATIC_ASSESSMENT | General disorders | MEDDRA 17.0 | View |
| Pyrexia | SYSTEMATIC_ASSESSMENT | General disorders | MEDDRA 17.0 | View |
| Cholecystitis | SYSTEMATIC_ASSESSMENT | Hepatobiliary disorders | MEDDRA 17.0 | View |
| Drug hypersensitivity | SYSTEMATIC_ASSESSMENT | Immune system disorders | MEDDRA 17.0 | View |
| Device related sepsis | SYSTEMATIC_ASSESSMENT | Infections and infestations | MEDDRA 17.0 | View |
| Pneumonia | SYSTEMATIC_ASSESSMENT | Infections and infestations | MEDDRA 17.0 | View |
| Pyelonephritis | SYSTEMATIC_ASSESSMENT | Infections and infestations | MEDDRA 17.0 | View |
| Sepsis | SYSTEMATIC_ASSESSMENT | Infections and infestations | MEDDRA 17.0 | View |
| Urinary tract infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | MEDDRA 17.0 | View |
| Blood alkaline phosphatase increased | SYSTEMATIC_ASSESSMENT | Investigations | MEDDRA 17.0 | View |
| Blood creatinine increased | SYSTEMATIC_ASSESSMENT | Investigations | MEDDRA 17.0 | View |
| Gamma-glutamyltransferase increased | SYSTEMATIC_ASSESSMENT | Investigations | MEDDRA 17.0 | View |
| Neutrophil count decreased | SYSTEMATIC_ASSESSMENT | Investigations | MEDDRA 17.0 | View |
| Decreased appetite | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MEDDRA 17.0 | View |
| Dehydration | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MEDDRA 17.0 | View |
| Invasive ductal breast carcinoma | SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MEDDRA 17.0 | View |
| Metastases to heart | SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MEDDRA 17.0 | View |
| Neoplasm progression | SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MEDDRA 17.0 | View |
| Tumour invasion | SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MEDDRA 17.0 | View |
| Cerebrovascular accident | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MEDDRA 17.0 | View |
| Anxiety | SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MEDDRA 17.0 | View |
| Panic reaction | SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MEDDRA 17.0 | View |
| Pyelocaliectasis | SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | MEDDRA 17.0 | View |
| Atelectasis | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MEDDRA 17.0 | View |
| Dyspnoea | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MEDDRA 17.0 | View |
| Pleural effusion | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MEDDRA 17.0 | View |
| Pulmonary embolism | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MEDDRA 17.0 | View |
| Respiratory distress | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MEDDRA 17.0 | View |
| Hypertension | SYSTEMATIC_ASSESSMENT | Vascular disorders | MEDDRA 17.0 | View |
| Poor venous access | SYSTEMATIC_ASSESSMENT | Vascular disorders | MEDDRA 17.0 | View |
Other Events(If Any):
Other Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Anaemia | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | MEDDRA 17.0 | View |
| Leukopenia | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | MEDDRA 17.0 | View |
| Lymphopenia | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | MEDDRA 17.0 | View |
| Neutropenia | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | MEDDRA 17.0 | View |
| Thrombocytopenia | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | MEDDRA 17.0 | View |
| Abdominal distension | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MEDDRA 17.0 | View |
| Abdominal pain | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MEDDRA 17.0 | View |
| Abdominal pain upper | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MEDDRA 17.0 | View |
| Ascites | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MEDDRA 17.0 | View |
| Constipation | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MEDDRA 17.0 | View |
| Diarrhoea | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MEDDRA 17.0 | View |
| Dyspepsia | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MEDDRA 17.0 | View |
| Intestinal obstruction | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MEDDRA 17.0 | View |
| Nausea | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MEDDRA 17.0 | View |
| Rectal haemorrhage | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MEDDRA 17.0 | View |
| Stomatitis | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MEDDRA 17.0 | View |
| Vomiting | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MEDDRA 17.0 | View |
| Asthenia | SYSTEMATIC_ASSESSMENT | General disorders | MEDDRA 17.0 | View |
| Chest pain | SYSTEMATIC_ASSESSMENT | General disorders | MEDDRA 17.0 | View |
| Fatigue | SYSTEMATIC_ASSESSMENT | General disorders | MEDDRA 17.0 | View |
| Mucosal inflammation | SYSTEMATIC_ASSESSMENT | General disorders | MEDDRA 17.0 | View |
| Oedema peripheral | SYSTEMATIC_ASSESSMENT | General disorders | MEDDRA 17.0 | View |
| Pain | SYSTEMATIC_ASSESSMENT | General disorders | MEDDRA 17.0 | View |
| Pyrexia | SYSTEMATIC_ASSESSMENT | General disorders | MEDDRA 17.0 | View |
| Hypersensitivity | SYSTEMATIC_ASSESSMENT | Immune system disorders | MEDDRA 17.0 | View |
| Nasopharyngitis | SYSTEMATIC_ASSESSMENT | Infections and infestations | MEDDRA 17.0 | View |
| Rhinitis | SYSTEMATIC_ASSESSMENT | Infections and infestations | MEDDRA 17.0 | View |
| Urinary tract infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | MEDDRA 17.0 | View |
| Alanine aminotransferase increased | SYSTEMATIC_ASSESSMENT | Investigations | MEDDRA 17.0 | View |
| Aspartate aminotransferase increased | SYSTEMATIC_ASSESSMENT | Investigations | MEDDRA 17.0 | View |
| Blood alkaline phosphatase increased | SYSTEMATIC_ASSESSMENT | Investigations | MEDDRA 17.0 | View |
| Blood creatinine increased | SYSTEMATIC_ASSESSMENT | Investigations | MEDDRA 17.0 | View |
| Blood uric acid increased | SYSTEMATIC_ASSESSMENT | Investigations | MEDDRA 17.0 | View |
| Gamma-glutamyltransferase increased | SYSTEMATIC_ASSESSMENT | Investigations | MEDDRA 17.0 | View |
| Platelet count decreased | SYSTEMATIC_ASSESSMENT | Investigations | MEDDRA 17.0 | View |
| Weight decreased | SYSTEMATIC_ASSESSMENT | Investigations | MEDDRA 17.0 | View |
| Decreased appetite | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MEDDRA 17.0 | View |
| Hyperglycaemia | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MEDDRA 17.0 | View |
| Hyperkalaemia | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MEDDRA 17.0 | View |
| Hyperuricaemia | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MEDDRA 17.0 | View |
| Hypoalbuminaemia | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MEDDRA 17.0 | View |
| Hypocalcaemia | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MEDDRA 17.0 | View |
| Hypokalaemia | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MEDDRA 17.0 | View |
| Hypomagnesaemia | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MEDDRA 17.0 | View |
| Arthralgia | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MEDDRA 17.0 | View |
| Back pain | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MEDDRA 17.0 | View |
| Muscle spasms | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MEDDRA 17.0 | View |
| Myalgia | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MEDDRA 17.0 | View |
| Pain in extremity | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MEDDRA 17.0 | View |
| Dysgeusia | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MEDDRA 17.0 | View |
| Headache | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MEDDRA 17.0 | View |
| Neuropathy peripheral | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MEDDRA 17.0 | View |
| Paraesthesia | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MEDDRA 17.0 | View |
| Peripheral sensory neuropathy | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MEDDRA 17.0 | View |
| Anxiety | SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MEDDRA 17.0 | View |
| Depression | SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MEDDRA 17.0 | View |
| Insomnia | SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MEDDRA 17.0 | View |
| Cough | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MEDDRA 17.0 | View |
| Dyspnoea | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MEDDRA 17.0 | View |
| Epistaxis | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MEDDRA 17.0 | View |
| Oropharyngeal pain | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MEDDRA 17.0 | View |
| Alopecia | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MEDDRA 17.0 | View |
| Erythema | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MEDDRA 17.0 | View |
| Hair colour changes | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MEDDRA 17.0 | View |
| Nail toxicity | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MEDDRA 17.0 | View |
| Palmar-plantar erythrodysaesthesia syndrome | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MEDDRA 17.0 | View |
| Rash | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MEDDRA 17.0 | View |