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: 2025-12-25 @ 3:53 AM
Ignite Modification Date: 2025-12-26 @ 2:42 AM
NCT ID: NCT01259102
Description: AEs were learned of by spontaneous reports and subject interview.
Frequency Threshold: 4
Time Frame: All adverse events, whether spontaneously reported or elicited on direct questioning, that occurred after administration of the first dose of study drug and on or before the final visit were reported on the adverse event form.
Study: NCT01259102
Study Brief: Examine Plasma Concentrations of Buprenorphine Following Reapplication of Buprenorphine Transdermal System (BTDS) After Variable Application Site Rest Periods
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
No Rest Each subject applied BTDS (10 mcg/h) on 2 occasions and wore it for 7 days (168 hours). Subjects were assigned to 1 of 5 treatment groups with different application site rest periods from 0 to 4 weeks. For this group, the rest period was 0 days between the removal of BTDS and placement of the second BTDS in the same location. None None 0 13 11 13 View
7-Day Rest Each subject applied BTDS (10 mcg/h) on 2 occasions and wore it for 7 days (168 hours). Subjects were assigned to 1 of 5 treatment groups with different application site rest periods from 0 to 4 weeks. For this group, the rest period was 7 days between the removal of BTDS and placement of the second BTDS in the same location. None None 1 14 14 14 View
14-Day Rest Each subject applied BTDS (10 mcg/h) on 2 occasions and wore it for 7 days (168 hours). Subjects were assigned to 1 of 5 treatment groups with different application site rest periods from 0 to 4 weeks. For this group, the rest period was 14 days between the removal of BTDS and placement of the second BTDS in the same location. None None 0 15 13 15 View
21-Day Rest Each subject applied BTDS (10 mcg/h) on 2 occasions and wore it for 7 days (168 hours). Subjects were assigned to 1 of 5 treatment groups with different application site rest periods from 0 to 4 weeks. For this group, the rest period was 21 days between the removal of BTDS and placement of the second BTDS in the same location. None None 0 14 10 14 View
28-Day Rest Each subject applied BTDS (10 mcg/h) on 2 occasions and wore it for 7 days (168 hours). Subjects were assigned to 1 of 5 treatment groups with different application site rest periods from 0 to 4 weeks. For this group, the rest period was 28 days between the removal of BTDS and placement of the second BTDS in the same location. None None 0 14 11 14 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Neutropenia SYSTEMATIC_ASSESSMENT Hepatobiliary disorders COSTART View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Phlebitis SYSTEMATIC_ASSESSMENT Cardiac disorders COSTART View
Anorexia SYSTEMATIC_ASSESSMENT Gastrointestinal disorders COSTART View
Constipation SYSTEMATIC_ASSESSMENT Gastrointestinal disorders COSTART View
Diarrhea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders COSTART View
Nausea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders COSTART View
Vomiting SYSTEMATIC_ASSESSMENT Gastrointestinal disorders COSTART View
Asthenia SYSTEMATIC_ASSESSMENT General disorders COSTART View
Headache SYSTEMATIC_ASSESSMENT General disorders COSTART View
Thirst SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders COSTART View
Dizziness SYSTEMATIC_ASSESSMENT Nervous system disorders COSTART View
Nervousness SYSTEMATIC_ASSESSMENT Nervous system disorders COSTART View
Vertigo SYSTEMATIC_ASSESSMENT Nervous system disorders COSTART View
Thinking abnormally SYSTEMATIC_ASSESSMENT Psychiatric disorders COSTART View
Pharyngitis SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders COSTART View
Prutitus at site SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders COSTART View
Polyuria SYSTEMATIC_ASSESSMENT Renal and urinary disorders COSTART View
Accidental injury SYSTEMATIC_ASSESSMENT General disorders COSTART View
Back pain SYSTEMATIC_ASSESSMENT General disorders COSTART View
Chest pain substernal SYSTEMATIC_ASSESSMENT General disorders COSTART View
Infection SYSTEMATIC_ASSESSMENT General disorders COSTART View
Infection bacterial SYSTEMATIC_ASSESSMENT General disorders COSTART View
Pain SYSTEMATIC_ASSESSMENT General disorders COSTART View
Reaction unevaluable SYSTEMATIC_ASSESSMENT General disorders COSTART View
Electrocardiogram abnormal SYSTEMATIC_ASSESSMENT Cardiac disorders COSTART View
Palpitation SYSTEMATIC_ASSESSMENT Cardiac disorders COSTART View
Vasodilatation SYSTEMATIC_ASSESSMENT Cardiac disorders COSTART View
Dyspepsia SYSTEMATIC_ASSESSMENT Gastrointestinal disorders COSTART View
Eructation SYSTEMATIC_ASSESSMENT Gastrointestinal disorders COSTART View
Flatulence SYSTEMATIC_ASSESSMENT Gastrointestinal disorders COSTART View
Leukopenia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders COSTART View
Bilirubinemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders COSTART View
Agitation SYSTEMATIC_ASSESSMENT Nervous system disorders COSTART View
Somnolence SYSTEMATIC_ASSESSMENT Nervous system disorders COSTART View
Tremor SYSTEMATIC_ASSESSMENT Nervous system disorders COSTART View
Cough increased SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders COSTART View
Rhinitis SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders COSTART View
Erythema at site SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders COSTART View
Other site reactions SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders COSTART View
Amblyopia SYSTEMATIC_ASSESSMENT Eye disorders COSTART View
Conjunctivitis SYSTEMATIC_ASSESSMENT Eye disorders COSTART View
Photophobia SYSTEMATIC_ASSESSMENT Eye disorders COSTART View
Abnormal ejaculation SYSTEMATIC_ASSESSMENT Renal and urinary disorders COSTART View
Breast pain SYSTEMATIC_ASSESSMENT Reproductive system and breast disorders COSTART View
Nocturia SYSTEMATIC_ASSESSMENT Renal and urinary disorders COSTART View