Adverse Events Module

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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 @ 3:27 AM
Ignite Modification Date: 2025-12-26 @ 2:08 AM
NCT ID: NCT01314105
Description: None
Frequency Threshold: 5
Time Frame: From the first drug administration until 28 days after the last drug administration, up to 31months
Study: NCT01314105
Study Brief: BIBF 1120 + Carboplatin/Pegylated Liposomal Doxorubicin (PLD) in Patients With Advanced Ovarian Cancer, Fallopian Tube Carcinoma or Primary Peritoneal 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
Nintedanib 150mg Nintedanib (150 mg twice daily (BID), except the day of chemotherapy infusion) administered orally plus standard therapy of carboplatin (Area Under the Curve (AUC) 5 mg/mL\*min) and PLD (30 mg/m2) which were administered by intravenous infusion once every 28 days. None None 3 7 6 7 View
Nintedanib 200mg Nintedanib (200 mg twice daily (BID), except the day of chemotherapy infusion) administered orally plus standard therapy of carboplatin (Area Under the Curve (AUC) 5 mg/mL\*min) and PLD (30 mg/m2) which were administered by intravenous infusion once every 28 days. None None 4 12 12 12 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Ileus SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 19.0 View
Small intestinal obstruction SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 19.0 View
Hypersensitivity SYSTEMATIC_ASSESSMENT Immune system disorders MedDRA 19.0 View
Alanine aminotransferase increased SYSTEMATIC_ASSESSMENT Investigations MedDRA 19.0 View
Platelet count decreased SYSTEMATIC_ASSESSMENT Investigations MedDRA 19.0 View
Intestinal obstruction SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 19.0 View
Pulmonary embolism SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 19.0 View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Anaemia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA 19.0 View
Leukopenia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA 19.0 View
Lymphopenia 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
Left ventricular dysfunction SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 19.0 View
Ventricular arrhythmia SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 19.0 View
Ear pain SYSTEMATIC_ASSESSMENT Ear and labyrinth disorders MedDRA 19.0 View
Tinnitus SYSTEMATIC_ASSESSMENT Ear and labyrinth disorders MedDRA 19.0 View
Eye pain SYSTEMATIC_ASSESSMENT Eye disorders MedDRA 19.0 View
Xerophthalmia SYSTEMATIC_ASSESSMENT Eye 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
Abdominal pain lower SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 19.0 View
Abdominal pain upper 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
Dyspepsia SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 19.0 View
Epigastric discomfort SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 19.0 View
Flatulence SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 19.0 View
Gastrooesophageal reflux disease SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 19.0 View
Haematochezia SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 19.0 View
Intestinal obstruction SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 19.0 View
Nausea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 19.0 View
Odynophagia SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 19.0 View
Oral pain SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 19.0 View
Rectal haemorrhage 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 erythema SYSTEMATIC_ASSESSMENT General disorders MedDRA 19.0 View
Chest pain SYSTEMATIC_ASSESSMENT General disorders MedDRA 19.0 View
Malaise SYSTEMATIC_ASSESSMENT General disorders MedDRA 19.0 View
Mucosal dryness SYSTEMATIC_ASSESSMENT General disorders MedDRA 19.0 View
Mucosal inflammation SYSTEMATIC_ASSESSMENT General disorders MedDRA 19.0 View
Oedema SYSTEMATIC_ASSESSMENT General disorders MedDRA 19.0 View
Oedema peripheral SYSTEMATIC_ASSESSMENT General disorders MedDRA 19.0 View
Pyrexia SYSTEMATIC_ASSESSMENT General disorders MedDRA 19.0 View
Xerosis SYSTEMATIC_ASSESSMENT General disorders MedDRA 19.0 View
Deficiency of bile secretion SYSTEMATIC_ASSESSMENT Hepatobiliary disorders MedDRA 19.0 View
Hyperbilirubinaemia SYSTEMATIC_ASSESSMENT Hepatobiliary disorders MedDRA 19.0 View
Allergy to animal SYSTEMATIC_ASSESSMENT Immune system disorders MedDRA 19.0 View
Hypersensitivity SYSTEMATIC_ASSESSMENT Immune system disorders MedDRA 19.0 View
Acute sinusitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 19.0 View
Angular cheilitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 19.0 View
Bronchitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 19.0 View
Folliculitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 19.0 View
Gastroenteritis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 19.0 View
Gingivitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 19.0 View
Herpes zoster SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 19.0 View
Nail infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 19.0 View
Nasopharyngitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 19.0 View
Parotitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 19.0 View
Pharyngotonsillitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 19.0 View
Sinusitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 19.0 View
Tooth infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 19.0 View
Upper respiratory tract infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 19.0 View
Vaginal infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 19.0 View
Viral infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 19.0 View
Overdose 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
Amylase increased SYSTEMATIC_ASSESSMENT Investigations MedDRA 19.0 View
Aspartate aminotransferase increased SYSTEMATIC_ASSESSMENT Investigations MedDRA 19.0 View
Blood alkaline phosphatase SYSTEMATIC_ASSESSMENT Investigations MedDRA 19.0 View
Blood alkaline phosphatase increased SYSTEMATIC_ASSESSMENT Investigations MedDRA 19.0 View
Blood bilirubin increased SYSTEMATIC_ASSESSMENT Investigations MedDRA 19.0 View
Blood creatinine decreased SYSTEMATIC_ASSESSMENT Investigations MedDRA 19.0 View
Blood creatinine increased SYSTEMATIC_ASSESSMENT Investigations MedDRA 19.0 View
Blood lactate dehydrogenase increased SYSTEMATIC_ASSESSMENT Investigations MedDRA 19.0 View
Gamma-glutamyltransferase SYSTEMATIC_ASSESSMENT Investigations MedDRA 19.0 View
Gamma-glutamyltransferase increased SYSTEMATIC_ASSESSMENT Investigations MedDRA 19.0 View
Haemoglobin SYSTEMATIC_ASSESSMENT Investigations MedDRA 19.0 View
Haemoglobin decreased SYSTEMATIC_ASSESSMENT Investigations MedDRA 19.0 View
Neutrophil count 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
Platelet count 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
Hypercholesterolaemia 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
Hypocalcaemia 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
Hypophosphataemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 19.0 View
Arthralgia SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 19.0 View
Back pain SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 19.0 View
Groin pain 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 discomfort SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 19.0 View
Musculoskeletal pain SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 19.0 View
Myalgia 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
Pain in jaw SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 19.0 View
Tendonitis SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue 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
Paraesthesia 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
Choluria SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA 19.0 View
Dysuria SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA 19.0 View
Haematuria SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA 19.0 View
Proteinuria SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA 19.0 View
Pelvic pain SYSTEMATIC_ASSESSMENT Reproductive system and breast disorders MedDRA 19.0 View
Vulvovaginal pruritus SYSTEMATIC_ASSESSMENT Reproductive system and breast disorders MedDRA 19.0 View
Cough SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 19.0 View
Dyspnoea SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 19.0 View
Epistaxis SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 19.0 View
Haemoptysis SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 19.0 View
Dermatitis acneiform 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
Petechiae SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 19.0 View
Plantar erythema 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 vesicular SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 19.0 View
Skin hyperpigmentation SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 19.0 View
Skin reaction SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 19.0 View
Haematoma 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
Lymphoedema SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA 19.0 View
Thrombosis SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA 19.0 View
Stomatitis SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 19.0 View
Dry skin SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 19.0 View
Erythema SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 19.0 View
Nail disorder SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 19.0 View
Onychoclasis SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 19.0 View