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 @ 1:27 AM
Ignite Modification Date: 2025-12-25 @ 11:38 PM
NCT ID: NCT00359294
Description: All patients treated with PM00104 were evaluable for safety
Frequency Threshold: 5
Time Frame: From first infusion to study termination, up to 2 years
Study: NCT00359294
Study Brief: A Phase I Study of Zalypsis (PM00104) in Subjects With Advanced Malignant Solid Tumors or Lymphoma
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
PM00104 All patients were to receive treatment for at least one 3-week cycle, which consisted of PM00104 administrations daily for 5 days and all study evaluations up to the next treatment cycle. Cycles were to be repeated every three weeks until disease progression, unacceptable toxicity, intercurrent serious illness, withdrawal of informed consent by the patient, Investigator's opinion, or treatment delay \> 2 weeks. Patients were considered to be on study for the duration of their treatment and for the first 30 days following treatment discontinuation, defined as the day of the last PM00104 administration 0 None 5 11 11 11 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Dehydration NON_SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA View
Failure to thrive NON_SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA View
Nausea NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA View
Pain in limb NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA View
Pancreatitis NOS NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA View
Pyrexia (Febrile Nonhaemolytic transfusion reaction) NON_SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA View
Radiation pneumonitis NON_SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Abdominal discomfort NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA View
Abdominal distension NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA View
Abdominal pain NOS NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA View
Dyspepsia NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA View
Dyspnoea NOS NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA View
Dysuria NON_SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA View
Visual disturbance NOS NON_SYSTEMATIC_ASSESSMENT Eye disorders MedDRA View
Visual field defect NOS NON_SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA View
Vitreous detachment NON_SYSTEMATIC_ASSESSMENT Eye disorders MedDRA View
Vomiting NOS NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA View
Weakness NON_SYSTEMATIC_ASSESSMENT General disorders MedDRA View
Weight decreased NON_SYSTEMATIC_ASSESSMENT Investigations MedDRA View
Wheezing NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA View
Arthralgia NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA View
Eyelid ptosis NON_SYSTEMATIC_ASSESSMENT Eye disorders MedDRA View
Fatigue NON_SYSTEMATIC_ASSESSMENT General disorders MedDRA View
Flatulence NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA View
Groin infection NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA View
Haematoma NOS NON_SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA View
Haematuria NON_SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA View
Headache NOS NON_SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA View
Herpes zoster NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA View
Hypercalcaemia NON_SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA View
Hypersensitivity NOS NON_SYSTEMATIC_ASSESSMENT Immune system disorders MedDRA View
Hypoglycaemia NOS NON_SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA View
Hypomagnesaemia NON_SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA View
Hypotension NOS NON_SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA View
Infection NOS NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA View
Influenza like illness NON_SYSTEMATIC_ASSESSMENT General disorders MedDRA View
Injection site pain NON_SYSTEMATIC_ASSESSMENT General disorders MedDRA View
Injection site reaction NOS NON_SYSTEMATIC_ASSESSMENT General disorders MedDRA View
Injection site vesicles NON_SYSTEMATIC_ASSESSMENT General disorders MedDRA View
Insomnia NON_SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA View
Lymphadenopathy NON_SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA View
Lymphoedema NOS NON_SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA View
Muscle weakness NOS NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA View
Myalgia NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA View
Nasopharyngitis NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA View
Nausea NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA View
Night sweats NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA View
Palpitations NON_SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA View
Paraesthesia NON_SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA View
Pharyngitis NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA View
Phlebitis NOS NON_SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA View
Pleuritic pain NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA View
Pruritus NOS NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA View
Pyrexia NON_SYSTEMATIC_ASSESSMENT General disorders MedDRA View
Rash NOS NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA View
Retching NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA View
Rhinitis NOS NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA View
Rhinorrhoea NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA View
Seasonal allergy NON_SYSTEMATIC_ASSESSMENT Immune system disorders MedDRA View
Skin disorder NOS NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA View
Stomatitis NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA View
Subcutaneous nodule NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA View
Supraventricular arrhythmia NOS NON_SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA View
Sweating increased NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA View
Tachycardia NOS NON_SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA View
Tenderness NOS NON_SYSTEMATIC_ASSESSMENT General disorders MedDRA View
Thrombosis NON_SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA View
Tongue oedema NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA View
Toothache NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA View
Tumour associated fever NON_SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA View
Tumour pain NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA View
Upper respiratory tract infection NOS NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA View
Urethral obstruction NON_SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA View
Urinary frequency NON_SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA View
Urinary tract infection NOS NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA View
Urine odour abnormal NON_SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA View
Urticaria NOS NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA View
Anorexia NON_SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA View
Anxiety NON_SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA View
Atrial fibrillation NON_SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA View
Back pain NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA View
Breast mass NOS NON_SYSTEMATIC_ASSESSMENT Reproductive system and breast disorders MedDRA View
Chest pressure sensation NON_SYSTEMATIC_ASSESSMENT General disorders MedDRA View
Confusional state NON_SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA View
Constipation NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA View
Contusion NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA View
Cough NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA View
Dehydration NON_SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA View
Depression NON_SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA View
Diarrhoea NOS NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA View
Difficulty in micturition NON_SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA View
Dizziness NON_SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA View
Dry eye NOS NON_SYSTEMATIC_ASSESSMENT Eye disorders MedDRA View
Anaemia NOS NON_SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA View