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 @ 5:07 PM
Ignite Modification Date: 2025-12-25 @ 2:45 PM
NCT ID: NCT01247350
Description: None
Frequency Threshold: 5
Time Frame: From starting of the dose to follow-up. Adverse events (AE) for single dose were observed from Day 1 to Day 10±2 days (Cohorts 1&2) or Day 7 (Cohorts 3&4). AE for multiple doses were observed from Day 8 to Day 31±3 days.
Study: NCT01247350
Study Brief: A Study of LY3009104(Baricitinib) for Healthy Subjects
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
14 mg LY3009104 - Multiple Dose Following a 7-day washout period, participants in the 14 mg LY3009104 single-dose group received 14 mg LY3009104 once daily for 10 days None None 0 6 4 6 View
Placebo - Multiple Dose Following a 7-day washout period, participants in the placebo single-dose group received placebo once daily for 10 days. None None 0 5 2 5 View
2 mg LY3009104 - Single Dose 2 mg administered orally once on Day 1 None None 0 6 1 6 View
5 mg LY3009104 - Single Dose 5 mg administered orally once on Day 1 None None 0 6 1 6 View
10 mg LY3009104 - Single Dose 10 mg administered orally on Day 1 None None 0 6 2 6 View
14 mg LY3009104 - Single Dose 14 mg administered orally on Day 1 None None 0 7 7 7 View
Placebo - Single Dose administered orally on Day 1 None None 0 9 6 9 View
10 mg LY3009104 - Multiple Dose Following a 7-day washout period, participants in the 10 mg LY3009104 single-dose group received 10 mg LY3009104 once daily for 10 days None None 0 6 5 6 View
Serious Events(If Any):
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Headache SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 13.1 View
Vessel Puncture Site Haematoma SYSTEMATIC_ASSESSMENT General disorders MedDRA 13.1 View
Oral Herpes SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 13.1 View
Excoriation SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 13.1 View
Skin Laceration SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 13.1 View
Neutrophil Count Decreased SYSTEMATIC_ASSESSMENT Investigations MedDRA 13.1 View
Reticulocyte Count Decreased SYSTEMATIC_ASSESSMENT Investigations MedDRA 13.1 View
Back Pain SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 13.1 View
Dizziness Postural SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 13.1 View
Lymphadenopathy SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA 13.1 View
Thrombocytosis SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA 13.1 View
Abdominal Discomfort SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 13.1 View
Constipation SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 13.1 View
Diarrhoea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 13.1 View
Nausea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 13.1 View
Application Site Reaction SYSTEMATIC_ASSESSMENT General disorders MedDRA 13.1 View
Chest Discomfort SYSTEMATIC_ASSESSMENT General disorders MedDRA 13.1 View
Discomfort SYSTEMATIC_ASSESSMENT General disorders MedDRA 13.1 View
Fatigue SYSTEMATIC_ASSESSMENT General disorders MedDRA 13.1 View
Presyncope SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 13.1 View
Cough SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 13.1 View
Nasal Congestion SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 13.1 View
Rhinorrhoea SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 13.1 View
Throat Irritation SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 13.1 View