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 @ 5:14 PM
Ignite Modification Date: 2025-12-25 @ 2:51 PM
NCT ID: NCT01404650
Description: Patients were permitted to continue treatment in the absence of disease progression or intolerable toxicity. 25 patients received a median of 2 cycles (6 weeks) of treatment
Frequency Threshold: 5
Time Frame: Adverse events collected on Days 1, 8 and 15 of each 21-day cycle and up to 30 days post-treatment.
Study: NCT01404650
Study Brief: Study of Hsp90 Inhibitor AUY922 for the Treatment of Patients With Refractory Gastrointestinal Stromal Tumor
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
AUY922 AUY922: 70 mg/m2 IV over 60 minutes on Days 1, 8, and 15 of each cycle. Treatment cycles repeated every 21 days. Patients are evaluated for response at 6 and 12 weeks and then every 9 weeks (i.e., every 3 cycles) thereafter until evidence of disease progression or intolerable toxicity. None None 8 25 25 25 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Confusional state SYSTEMATIC_ASSESSMENT Psychiatric disorders NCI CTCAE 4.0 View
Abdominal pain SYSTEMATIC_ASSESSMENT Gastrointestinal disorders NCI CTCAE 4.0 View
Chest pain SYSTEMATIC_ASSESSMENT Cardiac disorders NCI CTCAE 4.0 View
Gastrointestinal hemmorhage SYSTEMATIC_ASSESSMENT Gastrointestinal disorders NCI CTCAE 4.0 View
Intestinal obstruction SYSTEMATIC_ASSESSMENT Gastrointestinal disorders NCI CTCAE 4.0 View
Haemorrhage SYSTEMATIC_ASSESSMENT Vascular disorders NCI CTCAE 4.0 View
Bacteraemia SYSTEMATIC_ASSESSMENT Infections and infestations NCI CTCAE 4.0 View
Pulmonary embolism SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders NCI CTCAE 4.0 View
Septic shock SYSTEMATIC_ASSESSMENT Infections and infestations NCI CTCAE 4.0 View
Feeding tube complication SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications NCI CTCAE 4.0 View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Constipation SYSTEMATIC_ASSESSMENT Gastrointestinal disorders NCI CTCAE 4.0 View
Nausea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders NCI CTCAE 4.0 View
Vomiting SYSTEMATIC_ASSESSMENT Gastrointestinal disorders NCI CTCAE 4.0 View
Fatigue SYSTEMATIC_ASSESSMENT General disorders NCI CTCAE 4.0 View
Asthenia SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders NCI CTCAE 4.0 View
Blurred vision SYSTEMATIC_ASSESSMENT Eye disorders NCI CTCAE 4.0 View
Delayed light/dark adaptation SYSTEMATIC_ASSESSMENT Eye disorders NCI CTCAE 4.0 View
Decreased color perception SYSTEMATIC_ASSESSMENT Eye disorders NCI CTCAE 4.0 View
Anemia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders NCI CTCAE 4.0 View
Pain SYSTEMATIC_ASSESSMENT Nervous system disorders NCI CTCAE 4.0 View
Dehydration SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders NCI CTCAE 4.0 View
Dysgeusia SYSTEMATIC_ASSESSMENT Nervous system disorders NCI CTCAE 4.0 View
Floaters SYSTEMATIC_ASSESSMENT Eye disorders NCI CTCAE 4.0 View
Light sensitivity SYSTEMATIC_ASSESSMENT Eye disorders NCI CTCAE 4.0 View
Vision darkening SYSTEMATIC_ASSESSMENT Eye disorders NCI CTCAE 4.0 View
Abdominal pain SYSTEMATIC_ASSESSMENT Gastrointestinal disorders NCI CTCAE 4.0 View
Diarrhea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders NCI CTCAE 4.0 View
Alkaline phosphatase increased SYSTEMATIC_ASSESSMENT Investigations NCI CTCAE 4.0 View
Flashing lights SYSTEMATIC_ASSESSMENT Eye disorders NCI CTCAE 4.0 View
Headache SYSTEMATIC_ASSESSMENT Nervous system disorders NCI CTCAE 4.0 View
Anorexia SYSTEMATIC_ASSESSMENT Gastrointestinal disorders NCI CTCAE 4.0 View
Night blindness SYSTEMATIC_ASSESSMENT Eye disorders NCI CTCAE 4.0 View
vision change NOS SYSTEMATIC_ASSESSMENT Eye disorders NCI CTCAE 4.0 View