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 @ 12:56 AM
Ignite Modification Date: 2025-12-25 @ 11:11 PM
NCT ID: NCT01055067
Description: Treatment-emergent adverse events (TEAEs) were defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 30 days after the last dose.
Frequency Threshold: 0
Time Frame: Treatment-emergent adverse events (TEAEs) were collected from baseline up to 30 days after last dose, up to 1 year 9 months.
Study: NCT01055067
Study Brief: ARQ 197 for Participants With Relapsed or Refractory Germ Cell 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
Stage 1: ARQ 197 360 mg BID Participants who were enrolled in Stage 1 of the Simon 2-stage design and received ARQ 197 360 mg twice a day (BID) (with a 720 mg total daily dose) in participants with relapsed or refractory non-central nervous system germ cell tumor (non-CNS GCT). 0 None 6 21 11 21 View
Total All enrolled participants who received at least 1 dose of study drug in the study. 0 None 9 27 15 27 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Peritoneal haemorrhage SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 13.0 View
Anaemia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA 13.0 View
Vision blurred SYSTEMATIC_ASSESSMENT Eye disorders MedDRA 13.0 View
Hypersensitivity SYSTEMATIC_ASSESSMENT Immune system disorders MedDRA 13.0 View
Cellulitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 13.0 View
Pneumonia SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 13.0 View
Back pain SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 13.0 View
Cerebral haemorrhage SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 13.0 View
Headache SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 13.0 View
Sciatica SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 13.0 View
Spinal cord compression SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 13.0 View
Superior vena caval occlusion SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA 13.0 View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Constipation SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 13.0 View
Vomiting SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 13.0 View
Decreased appetite SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 13.0 View
Syncope SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 13.0 View
Dry skin SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 13.0 View
Anaemia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA 13.0 View
Neutropenia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA 13.0 View
Dry mouth SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 13.0 View
Nausea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 13.0 View
Fatigue SYSTEMATIC_ASSESSMENT General disorders MedDRA 13.0 View
Pneumonia SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 13.0 View
Arthralgia SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 13.0 View
Dysgeusia SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 13.0 View
Insomnia SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA 13.0 View
Cough SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 13.0 View