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 @ 4:18 PM
Ignite Modification Date: 2025-12-25 @ 2:16 PM
NCT ID: NCT00605566
Description: None
Frequency Threshold: 5
Time Frame: Adverse event data were collected over a total of 160 treatment cycles (1 cycle = 28 days) for all study participants, for as long as 7 years.
Study: NCT00605566
Study Brief: Efficacy Study of Sorafenib and Cyclophosphamide to Treat Neuroendocrine Tumors
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Sorafenib Plus Cyclophosphamide Patients will receive sorafenib and cyclophosphamide. sorafenib and cyclophosphamide: During a run-in period, patient will start taking 50 mg QD of oral cyclophosphamide and 200 mg BID of sorafenib. On day 8 of run-in the patient will be evaluated for toxicity. In the absence of toxicity, the patient will be escalated to sorafenib 400 mg BID and continue on daily 50 mg of cyclophosphamide, or the patient will be informed to continue on sorafenib 200 mg BID and cyclophosphamide 50 mg QD. Dose escalation procedure will be repeated every 2 weeks until unable to tolerate the study drug, or a maximum of 800 mg BID is reached, or achievement of \> 90% inhibition of phosphorylation of PDGFR/Raf axis in PBMC. After "run-in" period, patient begins cycle 1, each cycle will last 28 days. Both cyclophosphamide and sorafenib will be taken orally. None None 11 22 22 22 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Palmar-plantar erythrodysesthesia syndrome None Skin and subcutaneous tissue disorders None View
Protein Urine Positive None Renal and urinary disorders None View
Dyspepsia None Gastrointestinal disorders None View
Weight Gain None Investigations None View
Bilirubin increased None Investigations None View
Lipase increased None Investigations None View
Amylase increased None Investigations None View
Fever None General disorders None View
Diarrhea None Gastrointestinal disorders None View
Infection None Infections and infestations None View
Neck pain None Musculoskeletal and connective tissue disorders None View
Small intestinal obstruction None Gastrointestinal disorders None View
Disease progression None General disorders None View
Ileal perforation None Gastrointestinal disorders None View
Abdominal Pain None Gastrointestinal disorders None View
Flushing None Vascular disorders None View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Alopecia None Skin and subcutaneous tissue disorders None View
Hypophosphatemia None Metabolism and nutrition disorders None View
Rash None Skin and subcutaneous tissue disorders None View
Lymphopenia None Investigations None View
Weight loss None Investigations None View
Aspartate aminotransferase elevation None Investigations None View
Nausea None Gastrointestinal disorders None View
Thrombocytopenia None Investigations None View
Lipase elevation None Investigations None View
Palmar-plantar erythrodysesthesia syndrome None Skin and subcutaneous tissue disorders None View
Dysgeusia None Nervous system disorders None View
Hypertension None Vascular disorders None View
Fatigue None General disorders None View
Diarrhoea None Gastrointestinal disorders None View
Peripheral sensory neuropathy None Nervous system disorders None View
Amylase elevation None Investigations None View
Vomiting None Gastrointestinal disorders None View
Alanine aminotransferase elevation None Investigations None View
Hypocalcemia None Metabolism and nutrition disorders None View