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: 2025-12-24 @ 4:50 PM
Ignite Modification Date: 2025-12-25 @ 2:34 PM
NCT ID: NCT00843050
Description: None
Frequency Threshold: 5
Time Frame: None
Study: NCT00843050
Study Brief: A Phase II Study to Evaluate Efficacy and Safety of P276-00 in Relapsed and/or Refractory Mantle Cell 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
P276-00 P276-00: All patients will receive P276-00 185 mg/m2/day as intravenous infusion over 30 minutes in 200 ml of 5% dextrose from day 1 to day 5 in each 21 days cycle for minimum 6 and maximum 12 cycles or until there is progression of disease or unacceptable toxicity None None 2 13 13 13 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Thrombocytopenia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA 11.0 View
Dyspnea SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA (11.0) View
Disease Progression SYSTEMATIC_ASSESSMENT General disorders MedDRA (11.0) View
Elevated Creatinine, SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA (11.0) View
Atrial fibrillation SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA (11.0) View
Herpes Zoster SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA (11.0) View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Anxiety SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA 11.0 View
Arthropod bite SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 11.0 View
Ascites SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 11.0 View
Aspartate aminotransferase increased SYSTEMATIC_ASSESSMENT Investigations MedDRA 11.0 View
Asthenia SYSTEMATIC_ASSESSMENT General disorders MedDRA 11.0 View
Blood Alkaline Phosphatase increased SYSTEMATIC_ASSESSMENT Investigations MedDRA 11.0 View
Blood creatinine increased SYSTEMATIC_ASSESSMENT Investigations MedDRA 11.0 View
Blood lactate dehydrogenase increased SYSTEMATIC_ASSESSMENT Investigations MedDRA 11.0 View
Cardiac murmur SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 11.0 View
Chills SYSTEMATIC_ASSESSMENT General disorders MedDRA 11.0 View
Constipation SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 11.0 View
Cough SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 11.0 View
Decrreased Appetite SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 11.0 View
Dehydration SYSTEMATIC_ASSESSMENT General disorders MedDRA 11.0 View
Diarrhoea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 11.0 View
Dizziness SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 11.0 View
Dry Eye SYSTEMATIC_ASSESSMENT Eye disorders MedDRA 11.0 View
Dry Skin SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 11.0 View
Dyspepsia SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 11.0 View
Electrocardiogram QT prolonged SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 11.0 View
Erythema SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 11.0 View
Fatigue SYSTEMATIC_ASSESSMENT General disorders MedDRA 11.0 View
Gastritis SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 11.0 View
Headache SYSTEMATIC_ASSESSMENT General disorders MedDRA 11.0 View
Hyperglycaemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 11.0 View
hypertriglyceridemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 11.0 View
Hyperuricaemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 11.0 View
Hypocalcaemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 11.0 View
hypokalemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 11.0 View
hypomagnesaemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 11.0 View
hypophosphataemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 11.0 View
Hypotension SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 11.0 View
hypoxia SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 11.0 View
Injection site reaction SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 11.0 View
Injection site swelling SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 11.0 View
Insomnia SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 11.0 View
Lymphadenopathy SYSTEMATIC_ASSESSMENT General disorders MedDRA 11.0 View
Left atrial dilatation SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 11.0 View
lymphocyte count increased SYSTEMATIC_ASSESSMENT Investigations MedDRA 11.0 View
nasal congestion SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 11.0 View
nausea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 11.0 View
neutropenia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA 11.0 View
neutrophil count decreased SYSTEMATIC_ASSESSMENT Investigations MedDRA 11.0 View
nocturia SYSTEMATIC_ASSESSMENT General disorders MedDRA 11.0 View
Non-cardiac chest pain SYSTEMATIC_ASSESSMENT General disorders MedDRA 11.0 View
Oedema SYSTEMATIC_ASSESSMENT General disorders MedDRA 11.0 View
Oedema peripheral SYSTEMATIC_ASSESSMENT General disorders MedDRA 11.0 View
pain SYSTEMATIC_ASSESSMENT General disorders MedDRA 11.0 View
Pain in extremity SYSTEMATIC_ASSESSMENT General disorders MedDRA 11.0 View
Panic attack SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 11.0 View
Penile swelling SYSTEMATIC_ASSESSMENT General disorders MedDRA 11.0 View
Petechiae SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 11.0 View
Platelet count decreased SYSTEMATIC_ASSESSMENT Investigations MedDRA 11.0 View
Pleural effusion SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 11.0 View
Pollakiuria SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 11.0 View
Post operative wound complication SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 11.0 View
Pruritus SYSTEMATIC_ASSESSMENT General disorders MedDRA 11.0 View
Rash SYSTEMATIC_ASSESSMENT General disorders MedDRA 11.0 View
Rash Pruritic SYSTEMATIC_ASSESSMENT General disorders MedDRA 11.0 View
Rash pustular SYSTEMATIC_ASSESSMENT General disorders MedDRA 11.0 View
Rosacea SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 11.0 View
Sinus tachycardia SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 11.0 View
skin burning sensation SYSTEMATIC_ASSESSMENT General disorders MedDRA 11.0 View
spleen palpable SYSTEMATIC_ASSESSMENT General disorders MedDRA 11.0 View
Tachycardia SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 11.0 View
Urinary tract infection SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA 11.0 View
Urticaria papular SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 11.0 View
White blood cell count decreased SYSTEMATIC_ASSESSMENT Investigations MedDRA 11.0 View
White blood cell count increased SYSTEMATIC_ASSESSMENT Investigations MedDRA 11.0 View
Abdominal distension SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 11.0 View
Anaemia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA 11.0 View