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 @ 11:14 PM
Ignite Modification Date: 2025-12-25 @ 8:49 PM
NCT ID: NCT02563769
Description: Participants were evaluated daily by a physician for adverse events, and had 24 hour access to medical staff during the inpatient period to report adverse events.
Frequency Threshold: 0
Time Frame: Adverse Event Data was systematically collected daily during the 5 or 6 day inpatient period and up to their follow up visit at day 10. Any subjects who continued to experience adverse events after the follow up visit were followed until all adverse events resolved.
Study: NCT02563769
Study Brief: Clavulanic Acid (CLAV) and Cocaine Interaction Safety Study
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Day 1-IV Cocaine Infusion Only Subjects received IV cocaine 20mg and then at least 2hr 45min later they received IV cocaine 40mg 0 None 0 10 5 10 View
Placebo + IV Cocaine Subjects were randomized to receive oral matched placebo (on day 2, 3 or 4) followed by IV cocaine 40mg 1hr later 0 None 0 10 4 10 View
CLAV 250mg + IV Cocaine Subjects were randomized to receive oral CLAV 250mg (on day 2, 3 or 4) followed by IV cocaine 40mg 1hr later 0 None 0 10 3 10 View
Day 5--CLAV 750mg + IV Cocaine Protocol V2.3 allowed for subjects to proceed to day 5 receiving 750mg after they completed Day 2,3 and 4 and received PBO, CLAV 250mg and CLAV 500mg iper day n some randomized order 0 None 0 5 2 5 View
CLAV 500mg + IV Cocaine Subjects were randomized to receive oral CLAV 500mg (on day 2, 3 or 4) followed by IV cocaine 40mg 1hr later 0 None 0 10 3 10 View
Discharge Day Day after last dose of study drug (Day 6 for those completing day 5 CLAV 750mg; ot Day 5 for those completing days 1-4 only) 0 None 0 10 5 10 View
Day 10-Follow-up All subjects returned for a follow-up visit on Day 10 of the study (5-6 days after discharge) 0 None 0 10 4 10 View
Serious Events(If Any):
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Drowsiness SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA View
Insomnia SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA View
Tooth Ache SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA View
hyperglycemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA View
upper respiratory infection (URI) SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA View
Ventricular tachycardia SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA View
Abdominal gas SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA View
Nausea+vomiting SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA View
Constipation SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA View
Indigestion SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA View
Reaction to Telemetry Pads on Skin SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA View
Itchy Skin SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA View
Teary eyes SYSTEMATIC_ASSESSMENT Eye disorders MedDRA View
Lower eyelid twitch rhythmic SYSTEMATIC_ASSESSMENT Eye disorders MedDRA View
Elevated calcium levels SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA View
Hand bilateral spasms SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA View
Lightheaded SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA View
Headache SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA View