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 @ 7:35 PM
Ignite Modification Date: 2025-12-25 @ 5:16 PM
NCT ID: NCT04003103
Description: All treated participants are included.
Frequency Threshold: 5
Time Frame: Up to 36 weeks
Study: NCT04003103
Study Brief: Safety and Pharmacokinetics of Oral Islatravir (MK-8591) Once Monthly in Participants at Low Risk of Human Immunodeficiency Virus 1 (HIV-1) Infection (MK-8591-016)
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Islatravir 60 mg Participants receive two ISL 30 mg capsules + two ISL placebo capsules once monthly from Day 1 to Week 24 plus 12 weeks of follow-up in the Treatment Phase. The Extended Follow-up Phase is from Week 36 to Week 68. 1 None 1 97 24 97 View
Islatravir 120 mg Participants receive four ISL 30 mg capsules once monthly from Day 1 to Week 24 plus 12 weeks of follow-up in the Treatment Phase. The Extended Follow-up Phase is from Week 36 to Week 68. 0 None 0 97 23 97 View
Placebo Participants receive four placebo capsules once monthly from Day 1 to Week 24 plus 12 weeks of follow-up in the Treatment Phase. The Extended Follow-up Phase is from Week 36 to Week 68. 0 None 0 48 16 48 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Loss of consciousness SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 25.0 View
Intentional self-injury SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA 25.0 View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Blood pressure increased SYSTEMATIC_ASSESSMENT Investigations MedDRA 25.0 View
Dizziness SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 25.0 View
Headache SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 25.0 View
Abdominal pain SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 25.0 View
Diarrhoea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 25.0 View
Nausea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 25.0 View
Upper respiratory tract infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 25.0 View
Accidental overdose SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 25.0 View
Alanine aminotransferase increased SYSTEMATIC_ASSESSMENT Investigations MedDRA 25.0 View