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 @ 2:27 AM
Ignite Modification Date: 2025-12-26 @ 1:01 AM
NCT ID: NCT03382834
Description: The protocol required reporting of all diagnoses, all signs/symptoms/laboratory values Grade ≥ 3, and all diagnoses/signs/symptoms/laboratory values that led to treatment change or met SAE or EAE reporting requirements through Day 65 (Step 1), and all new cancer diagnoses/deaths during the subsequent 240 week long-term safety follow-up (Step 2). For grading, sites referred to the Division of AIDS AE Grading Table, corrected Version 2.1, July 2017.
Frequency Threshold: 0
Time Frame: From study entry to end of study
Study: NCT03382834
Study Brief: Selective Estrogen Receptor Modulators to Enhance the Efficacy of Viral Reactivation With Histone Deacetylase Inhibitors
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Arm A: Tamoxifen + Vorinostat From Day 0 to Day 38, participants will receive tamoxifen orally once a day. On Days 35 and 38, participants will receive a single dose of vorinostat orally. Tamoxifen: 20 mg orally Vorinostat: 400 mg orally Antiretroviral drugs: Participants will receive antiretroviral drugs provided by their own doctors. Antiretroviral drugs will not be provided by the study. 1 None 0 21 3 21 View
Arm B: Vorinostat Alone Day 0 to Day 38 will be an observation period with no tamoxifen. On Days 35 and 38, participants will receive a single dose of vorinostat orally. Vorinostat: 400 mg orally Antiretroviral drugs: Participants will receive antiretroviral drugs provided by their own doctors. Antiretroviral drugs will not be provided by the study. 0 None 0 10 0 10 View
Serious Events(If Any):
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Hyperglycaemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 27.0 View
Dysgeusia SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 27.0 View
Thirst SYSTEMATIC_ASSESSMENT General disorders MedDRA 27.0 View
Metastatic squamous cell carcinoma SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA 27.0 View