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 @ 7:02 PM
Ignite Modification Date: 2025-12-25 @ 4:36 PM
NCT ID: NCT00270257
Description: None
Frequency Threshold: 0
Time Frame: None
Study: NCT00270257
Study Brief: Drug Treatment Combined With Drug and Risk Reduction Counseling to Prevent of HIV Infection and Death Among Injection Drug Users
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Short Term Medication Assisted Treatment (ST-MAT) Participants will receive short-term BUP/NX; dosage and length of treatment will be determined by the investigator.Additionally, participants will undergo weekly drug and risk reduction counseling for 12 weeks, and then every 4 weeks through Week 52. Buprenorphine/Naloxone: Oral tablet None None 42 628 1 628 View
Long Term Medication Assisted Treatment (LT-MAT) Participants will receive BUP/NX under the tongue daily for a maximum of three weeks(until dose stabilization) and then three times a week for 52 weeks in addition to weekly drug and risk reduction counseling for 12 weeks, and then every 4 weeks through Week 52 Buprenorphine/Naloxone: Oral tablet None None 38 623 0 623 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Osteomyelitis SYSTEMATIC_ASSESSMENT Infections and infestations None View
Penicilliosis SYSTEMATIC_ASSESSMENT Infections and infestations None View
Pneumonia SYSTEMATIC_ASSESSMENT Infections and infestations None View
Pneumonia staphylococcal SYSTEMATIC_ASSESSMENT Infections and infestations None View
Pulmonary tuberculosis SYSTEMATIC_ASSESSMENT Infections and infestations None View
Sepsis SYSTEMATIC_ASSESSMENT Infections and infestations None View
Septic shock SYSTEMATIC_ASSESSMENT Infections and infestations None View
Craniocerebral injury SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications None View
Fibula fracture SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications None View
Foot fracture SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications None View
Head injury SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications None View
Lower limb fracture SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications None View
Overdose SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications None View
Pelvic fracture SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications None View
Stab wound SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications None View
Alanine aminotransferase increased SYSTEMATIC_ASSESSMENT Investigations None View
Blood bilirubin increased SYSTEMATIC_ASSESSMENT Investigations None View
Intervertebral disc protrusion SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Gastric cancer SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) None View
Hepatic neoplasm malignant SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) None View
Loss of consciousness SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Subarachnoid haemorrhage SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Depression SYSTEMATIC_ASSESSMENT Psychiatric disorders None View
Personality disorder SYSTEMATIC_ASSESSMENT Psychiatric disorders None View
Suicide attempt SYSTEMATIC_ASSESSMENT Psychiatric disorders None View
Pleural effusion SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Vascular rupture SYSTEMATIC_ASSESSMENT Vascular disorders None View
Aortic valve incompetence SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Cardiac failure SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Cardiopulmonary failure SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Myocardial infarction SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Abdominal pain SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Food poisoning SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Gastrointestinal disorder SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Death SYSTEMATIC_ASSESSMENT General disorders None View
Drowning SYSTEMATIC_ASSESSMENT General disorders None View
Appendicitis SYSTEMATIC_ASSESSMENT Infections and infestations None View
Bone tuberculosis SYSTEMATIC_ASSESSMENT Infections and infestations None View
Gastroenteritis SYSTEMATIC_ASSESSMENT Infections and infestations None View
Neurocysticercosis SYSTEMATIC_ASSESSMENT Infections and infestations None View
Staphylococcal bacteraemia SYSTEMATIC_ASSESSMENT Infections and infestations None View
Subcutaneous abscess SYSTEMATIC_ASSESSMENT Infections and infestations None View
Tuberculous pleurisy SYSTEMATIC_ASSESSMENT Infections and infestations None View
Ankle fracture SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications None View
Cerebral haemorrhage traumatic SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications None View
Concussion SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications None View
Platelet count decreased None Investigations None View
Henoch-Schonlein purpura SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
chest Injury SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications None View