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 @ 3:54 AM
Ignite Modification Date:
2025-12-26 @ 2:44 AM
NCT ID:
NCT02654002
Description:
The Safety Analysis Set included all randomized participants who took at least 1 dose of study drug. Participants were grouped according to the treatment they actually received.
Frequency Threshold:
5
Time Frame:
First dose date up to last dose date (Maximum: 20 days) plus 30 days
Study:
NCT02654002
Study Brief:
Study in Healthy Volunteers to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of GS-9674 (Cilofexor), and the Effect of Food on GS-9674 Pharmacokinetics and Pharmacodynamics
Event Groups(If Any):
Event Groups
| Title | Description | Deaths # Affected | Deaths # At Risk | Serious # Affected | Serious # At Risk | Other # Affected | Other # At Risk | View |
|---|---|---|---|---|---|---|---|---|
| Cohort 3: Cilofexor 100 mg | Participants in fasted state received cilofexor 100 mg tablet, orally, once on Day 1 followed by a 5-day washout period then received cilofexor 100 mg tablet, orally, once daily from Day 7 to Day 20. | 0 | None | 0 | 12 | 4 | 12 | View |
| All Placebo | Participants in fasted state (cohorts 1-4) and fed state (cohorts 5-8) received placebo tablet(s), orally, once or twice on Day 1 followed by a 5-day washout period then received placebo tablet(s), orally, once or twice daily from Day 7 to Day 20. | 0 | None | 0 | 24 | 6 | 24 | View |
| Cohort 1: Cilofexor 10 mg | Participants in fasted state received cilofexor 10 mg tablet, orally, once on Day 1 followed by a 5-day washout period then received cilofexor 10 mg tablet, orally, once daily from Day 7 to Day 20. | 0 | None | 0 | 12 | 4 | 12 | View |
| Cohort 2: Cilofexor 30 mg | Participants in fasted state received cilofexor 30 mg tablet, orally, once on Day 1 followed by a 5-day washout period then received cilofexor 30 mg tablet, orally, once daily from Day 7 to Day 20. | 0 | None | 0 | 12 | 3 | 12 | View |
| Cohort 4: Cilofexor 300 mg | Participants in fasted state received cilofexor 300 mg tablet, orally, once on Day 1 followed by a 5-day washout period then received cilofexor 300 mg tablet, orally, once daily from Day 7 to Day 20. | 0 | None | 0 | 12 | 3 | 12 | View |
| Cohort 5: Cilofexor 100 mg | Participants in fed state received cilofexor 100 mg tablet, orally, once with food on Day 1 followed by a 5-day washout period then received cilofexor 100 mg tablet, orally, once daily with food from Day 7 to Day 20. | 0 | None | 0 | 12 | 5 | 12 | View |
| Cohort 6: Cilofexor 50 mg | Participants in fed state received cilofexor 50 mg tablet, orally, twice with food on Day 1 followed by a 5-day washout period then received cilofexor 50 mg tablet, orally, twice daily from Day 7 to Day 20. | 0 | None | 0 | 11 | 3 | 11 | View |
| Cohort 7: Cilofexor 15 mg | Participants in fed state received cilofexor 15 mg tablet orally, twice with food on Day 1 followed by a 5-day washout period then received cilofexor 15 mg tablet orally, twice daily from Day 7 to Day 20. | 0 | None | 0 | 12 | 9 | 12 | View |
| Cohort 8: Cilofexor 10 mg | Participants in fed state received cilofexor 10 mg tablet, orally, once with food on Day 1 followed by a 5-day washout period then received cilofexor 10 mg tablet, orally, once daily from Day 7 to Day 20. | 0 | None | 0 | 11 | 2 | 11 | View |
Serious Events(If Any):
Other Events(If Any):
Other Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Toothache | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (19.1) | View |
| Vomiting | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (19.1) | View |
| Headache | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA (19.1) | View |
| Sciatica | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA (19.1) | View |
| Dysfunctional uterine bleeding | SYSTEMATIC_ASSESSMENT | Reproductive system and breast disorders | MedDRA (19.1) | View |
| Vaginal discharge | SYSTEMATIC_ASSESSMENT | Reproductive system and breast disorders | MedDRA (19.1) | View |
| Dermatitis | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA (19.1) | View |
| Rash | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA (19.1) | View |
| Anaemia | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | MedDRA (19.1) | View |
| Iron deficiency anaemia | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | MedDRA (19.1) | View |
| Ocular discomfort | SYSTEMATIC_ASSESSMENT | Eye disorders | MedDRA (19.1) | View |
| Abdominal pain | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (19.1) | View |
| Constipation | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (19.1) | View |
| Diarrhoea | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (19.1) | View |
| Dyspepsia | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (19.1) | View |
| Gastritis | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (19.1) | View |
| Nausea | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (19.1) | View |
| Hypersensitivity | SYSTEMATIC_ASSESSMENT | Immune system disorders | MedDRA (19.1) | View |
| Conjunctivitis | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (19.1) | View |
| Oral herpes | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (19.1) | View |
| Rhinitis | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (19.1) | View |
| Viral infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (19.1) | View |
| Viral upper respiratory tract infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (19.1) | View |
| Muscle injury | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA (19.1) | View |
| Transaminases increased | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA (19.1) | View |
| Diabetes mellitus | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA (19.1) | View |
| Back pain | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA (19.1) | View |
| Muscle spasms | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA (19.1) | View |
| Tendonitis | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA (19.1) | View |
| Dizziness | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA (19.1) | View |
| Presyncope | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA (19.1) | View |
| Dysuria | SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | MedDRA (19.1) | View |
| Menorrhagia | SYSTEMATIC_ASSESSMENT | Reproductive system and breast disorders | MedDRA (19.1) | View |
| Dermatitis contact | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA (19.1) | View |
| Ecchymosis | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA (19.1) | View |
| Pruritus generalised | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA (19.1) | View |