Adverse Events Module

Home Icon Home Search Icon Search Certify Doc Icon Certify Doc Certify Doc Icon Genes Certify Doc Icon Clinical Trials Certify Doc Icon CompTox Processes Icon DrugMatrix Open Targets Icon Open Targets Processes Icon Products Support Icon Support Bugs Icon Bugs
Main Search Make This Study a Gene Therapy Make This Study a Not Gene Therapy Report Bug
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 @ 9:46 PM
Ignite Modification Date: 2025-12-25 @ 7:26 PM
NCT ID: NCT02338232
Description: None
Frequency Threshold: 0
Time Frame: From time of consent through +180 days post transplant
Study: NCT02338232
Study Brief: Study of TelmisartanFor the Prevention of Acute GVHD Post Allogeneic Hematopoietic Stem Cell Transplantation
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
160 mg Telmisartan 60 patients will receive 160 of Telmisartan (2 80 mg tablets) for 101 days Telmisartan 6 None 8 29 24 29 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Pain SYSTEMATIC_ASSESSMENT General disorders None View
Hospitalization SYSTEMATIC_ASSESSMENT General disorders None View
Respiratory Failure SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Primary Graft Failure SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders None View
Sepsis SYSTEMATIC_ASSESSMENT Infections and infestations None View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
GVHD (Oral) SYSTEMATIC_ASSESSMENT Immune system disorders None View
GVHD (Skin) SYSTEMATIC_ASSESSMENT Immune system disorders None View
GVHD (Skin/Liver) SYSTEMATIC_ASSESSMENT Immune system disorders None View
H Pylori SYSTEMATIC_ASSESSMENT Infections and infestations None View
Hemorrhagic cystitis SYSTEMATIC_ASSESSMENT Renal and urinary disorders None View
Hyperbilirubinemia SYSTEMATIC_ASSESSMENT Investigations None View
Hypercalcemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders None View
Hyperglycemia (Intermittent) SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders None View
Hyperkalemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders None View
Hypertension SYSTEMATIC_ASSESSMENT Vascular disorders None View
Hypertension (Intermittent) SYSTEMATIC_ASSESSMENT Vascular disorders None View
Hypoglycemia (intermittent) SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders None View
Hypomagnesemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders None View
Hypotension SYSTEMATIC_ASSESSMENT Vascular disorders None View
Infection (Kidney) SYSTEMATIC_ASSESSMENT Infections and infestations None View
Infection/Infestation SYSTEMATIC_ASSESSMENT Infections and infestations None View
Influenza SYSTEMATIC_ASSESSMENT Infections and infestations None View
Insomnia SYSTEMATIC_ASSESSMENT Psychiatric disorders None View
Laryngeal mucositis SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Lethargy SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Malaise SYSTEMATIC_ASSESSMENT General disorders None View
Mucositis SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Nausea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Nausea (Intermittent) SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Neutrophil Count Decreased SYSTEMATIC_ASSESSMENT Investigations None View
Nocturia SYSTEMATIC_ASSESSMENT Renal and urinary disorders None View
Pruritus SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
Rash SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
Rash (Erythematous) SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
Rash on Upper Back SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
Respiratory infection (HAP) SYSTEMATIC_ASSESSMENT Infections and infestations None View
Right lower quadrant pain SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Sacral Decub SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
Streptococcus mitis SYSTEMATIC_ASSESSMENT Infections and infestations None View
Swelling R knee SYSTEMATIC_ASSESSMENT General disorders None View
Syncope SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Urinary frequency SYSTEMATIC_ASSESSMENT Renal and urinary disorders None View
Vaginal abscess SYSTEMATIC_ASSESSMENT Infections and infestations None View
Vomiting SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Weakness SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Weight Loss SYSTEMATIC_ASSESSMENT Investigations None View
Abdominal Cramping SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Abdominal Pail SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Acute GVHD SYSTEMATIC_ASSESSMENT Immune system disorders None View
Acute GVHD (GI) SYSTEMATIC_ASSESSMENT Immune system disorders None View
Acute GVHD (Liver) SYSTEMATIC_ASSESSMENT Immune system disorders None View
Acute GVHD (Skin and GI) SYSTEMATIC_ASSESSMENT Immune system disorders None View
Acute GVHD (Skin) SYSTEMATIC_ASSESSMENT Immune system disorders None View
Acute Kidney Injury SYSTEMATIC_ASSESSMENT Renal and urinary disorders None View
Acute Mental Status Change SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Adeno Viremia SYSTEMATIC_ASSESSMENT Infections and infestations None View
Anemia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders None View
Anorexia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders None View
Anxiety SYSTEMATIC_ASSESSMENT Psychiatric disorders None View
BK Viremia SYSTEMATIC_ASSESSMENT Infections and infestations None View
Bloating SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Chills SYSTEMATIC_ASSESSMENT General disorders None View
Chronic GVHD SYSTEMATIC_ASSESSMENT Immune system disorders None View
Chronic GVHD (skin/liver, ocular, oral mucosa) SYSTEMATIC_ASSESSMENT Immune system disorders None View
CMV Reactivation SYSTEMATIC_ASSESSMENT Infections and infestations None View
CMV Viremia SYSTEMATIC_ASSESSMENT Infections and infestations None View
Creatinine increased SYSTEMATIC_ASSESSMENT Investigations None View
Cystitis SYSTEMATIC_ASSESSMENT Renal and urinary disorders None View
Deep vein thrombosis SYSTEMATIC_ASSESSMENT Vascular disorders None View
Delayed Engraftment SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders None View
Diarrhea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Diarrhea (Intermittent) SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Dizziness SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Dizziness (Intermittent) SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Dry eyes SYSTEMATIC_ASSESSMENT Eye disorders None View
Dry Mouth SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Dysgeusia SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Dysphagia SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Dyspnea SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Dyspnea on Exertion SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Dysuria SYSTEMATIC_ASSESSMENT Renal and urinary disorders None View
Early Satiety SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders None View
Edema BLE SYSTEMATIC_ASSESSMENT General disorders None View
Epstein-Barr Virus SYSTEMATIC_ASSESSMENT Infections and infestations None View
Erythema SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
Erythroderma SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
Fatigue SYSTEMATIC_ASSESSMENT General disorders None View
Fever SYSTEMATIC_ASSESSMENT General disorders None View
Flatulence SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Gastroesophageal Reflux Disease SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Generalized Weakness SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
GVHD (GI) SYSTEMATIC_ASSESSMENT Immune system disorders None View
GVHD (Liver) SYSTEMATIC_ASSESSMENT Immune system disorders None View