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 @ 2:31 AM
Ignite Modification Date: 2025-12-26 @ 1:06 AM
NCT ID: NCT00171834
Description: None
Frequency Threshold: 5
Time Frame: None
Study: NCT00171834
Study Brief: Dose Escalating Study of the Safety and Efficacy of Patupilone, q3w, in Patients With Non-small Cell Lung 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
Patupilone ≤7.0 mg/m^2 (Phase I) Patupilone was administered as a single i.v. infusion over 5 to 10 minutes (Amendment 1) until (Amendment 2) and over 10 to 20 minutes (Amendment 2) until the completion of Phase I part of the study. None None 3 6 6 6 View
Patupilone 7.5-8.0 mg/m^2 (Phase I) Patupilone was administered as a single i.v. infusion over 5 to 10 minutes (Amendment 1) until (Amendment 2) and over 10 to 20 minutes (Amendment 2) until the completion of Phase I part of the study. None None 3 12 11 12 View
Patupilone 8.5-9.5 mg/m^2 (Phase I) Patupilone was administered as a single i.v. infusion over 5 to 10 minutes (Amendment 1) until (Amendment 2) and over 10 to 20 minutes (Amendment 2) until the completion of Phase I part of the study. None None 2 12 12 12 View
Patupilone 10.0-11.5 mg/m^2 (Phase I) Patupilone was administered as a single i.v. infusion over 5 to 10 minutes (Amendment 1) until (Amendment 2) and over 10 to 20 minutes (Amendment 2) until the completion of Phase I part of the study. None None 3 12 10 12 View
Patupilone 10 mg/m^2 (Phase II) NSCLC w. Brain Metastases (BM) Patupilone was administered as a single i.v. infusion over 20 minutes (Amendment 4), once every 3 weeks. None None 2 4 4 4 View
Patupilone 12.0-13.0 mg/m^2 (Phase I) Patupilone was administered as a single i.v. infusion over 5 to 10 minutes (Amendment 1) until (Amendment 2) and over 10 to 20 minutes (Amendment 2) until the completion of Phase I part of the study. None None 4 8 8 8 View
Patupilone 10 mg/m^2 (Phase II) NSCLC Cohort Patupilone was administered as a single i.v. infusion over 20 minutes (Amendment 4), once every 3 weeks. None None 14 35 33 35 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Pericardial effusion SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 10.X View
Abdominal pain SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 10.X View
Colitis SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 10.X View
Diarrhoea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 10.X View
Enteritis SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 10.X View
Intestinal obstruction SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 10.X View
Nausea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 10.X View
Vomiting SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 10.X View
Asthenia SYSTEMATIC_ASSESSMENT General disorders MedDRA 10.X View
Fatigue SYSTEMATIC_ASSESSMENT General disorders MedDRA 10.X View
Oedema peripheral SYSTEMATIC_ASSESSMENT General disorders MedDRA 10.X View
Escherichia infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 10.X View
Pneumonia SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 10.X View
Pseudomonas infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 10.X View
Respiratory tract infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 10.X View
Urinary tract infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 10.X View
Dehydration SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 10.X View
Paraparesis SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 10.X View
Peripheral sensorimotor neuropathy SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 10.X View
Confusional state SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA 10.X View
Acute respiratory failure SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 10.X View
Dyspnoea SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 10.X View
Pleural effusion SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 10.X View
Pulmonary embolism SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 10.X View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Anaemia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA 10.X View
Neutropenia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA 10.X View
Supraventricular tachycardia SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 10.X View
Vertigo SYSTEMATIC_ASSESSMENT Ear and labyrinth disorders MedDRA 10.X View
Eyelid oedema SYSTEMATIC_ASSESSMENT Eye disorders MedDRA 10.X View
Scotoma SYSTEMATIC_ASSESSMENT Eye disorders MedDRA 10.X View
Vision blurred SYSTEMATIC_ASSESSMENT Eye disorders MedDRA 10.X View
Abdominal distension SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 10.X View
Abdominal pain SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 10.X View
Abdominal pain upper SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 10.X View
Abnormal faeces SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 10.X View
Constipation SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 10.X View
Diarrhoea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 10.X View
Dyspepsia SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 10.X View
Dysphagia SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 10.X View
Faecal incontinence SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 10.X View
Flatulence SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 10.X View
Ileus SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 10.X View
Nausea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 10.X View
Stomatitis SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 10.X View
Tooth loss SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 10.X View
Toothache SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 10.X View
Vomiting SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 10.X View
Asthenia SYSTEMATIC_ASSESSMENT General disorders MedDRA 10.X View
Axillary pain SYSTEMATIC_ASSESSMENT General disorders MedDRA 10.X View
Chest pain SYSTEMATIC_ASSESSMENT General disorders MedDRA 10.X View
Chills SYSTEMATIC_ASSESSMENT General disorders MedDRA 10.X View
Face oedema SYSTEMATIC_ASSESSMENT General disorders MedDRA 10.X View
Fatigue SYSTEMATIC_ASSESSMENT General disorders MedDRA 10.X View
Feeling hot SYSTEMATIC_ASSESSMENT General disorders MedDRA 10.X View
Localised oedema SYSTEMATIC_ASSESSMENT General disorders MedDRA 10.X View
Oedema peripheral SYSTEMATIC_ASSESSMENT General disorders MedDRA 10.X View
Pyrexia SYSTEMATIC_ASSESSMENT General disorders MedDRA 10.X View
Temperature intolerance SYSTEMATIC_ASSESSMENT General disorders MedDRA 10.X View
Hyperbilirubinaemia SYSTEMATIC_ASSESSMENT Hepatobiliary disorders MedDRA 10.X View
Hypersensitivity SYSTEMATIC_ASSESSMENT Immune system disorders MedDRA 10.X View
Bronchitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 10.X View
Gastroenteritis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 10.X View
Influenza SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 10.X View
Nasopharyngitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 10.X View
Pneumonia SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 10.X View
Urinary tract infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 10.X View
Lumbar vertebral fracture SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 10.X View
Aspartate aminotransferase increased SYSTEMATIC_ASSESSMENT Investigations MedDRA 10.X View
Blood magnesium decreased SYSTEMATIC_ASSESSMENT Investigations MedDRA 10.X View
Gamma-glutamyltransferase increased SYSTEMATIC_ASSESSMENT Investigations MedDRA 10.X View
Weight decreased SYSTEMATIC_ASSESSMENT Investigations MedDRA 10.X View
Decreased appetite SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 10.X View
Dehydration SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 10.X View
Hypoalbuminaemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 10.X View
Hypokalaemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 10.X View
Hypomagnesaemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 10.X View
Arthralgia SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 10.X View
Back pain SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 10.X View
Flank pain SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 10.X View
Groin pain SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 10.X View
Muscular weakness SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 10.X View
Musculoskeletal pain SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 10.X View
Myalgia SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 10.X View
Pain in extremity SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 10.X View
Pain in jaw SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 10.X View
Pathological fracture SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 10.X View
Cancer pain SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA 10.X View
Malignant pleural effusion SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA 10.X View
Tumour pain SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA 10.X View
Dizziness SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 10.X View
Dysaesthesia SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 10.X View
Headache SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 10.X View
Neuropathy peripheral SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 10.X View
Neurotoxicity SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 10.X View
Paraesthesia SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 10.X View
Peripheral motor neuropathy SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 10.X View
Polyneuropathy SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 10.X View
Presyncope SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 10.X View
Speech disorder SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 10.X View
Anxiety SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA 10.X View
Depression SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA 10.X View
Insomnia SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA 10.X View
Restlessness SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA 10.X View
Sleep disorder SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA 10.X View
Haematuria SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA 10.X View
Cough SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 10.X View
Dyspnoea SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 10.X View
Epistaxis SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 10.X View
Haemoptysis SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 10.X View
Hiccups SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 10.X View
Pneumonitis SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 10.X View
Productive cough SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 10.X View
Alopecia SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 10.X View
Rash SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 10.X View
Skin lesion SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 10.X View
Hypertension SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA 10.X View
Hypotension SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA 10.X View
Peripheral coldness SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA 10.X View