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 @ 2:33 AM
Ignite Modification Date:
2025-12-26 @ 1:09 AM
NCT ID:
NCT02966834
Description:
Safety Population consisted of all randomized participants who received at least 1 dose of study intervention.
Frequency Threshold:
5
Time Frame:
Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks during Main study period; up to 4 weeks during Final study period and up to 4 weeks during Follow-up period.
Study:
NCT02966834
Study Brief:
Dose Response Study of GSK2330672 for the Treatment of Pruritus in Participants With Primary Biliary Cholangitis
Event Groups(If Any):
Event Groups
| Title | Description | Deaths # Affected | Deaths # At Risk | Serious # Affected | Serious # At Risk | Other # Affected | Other # At Risk | View |
|---|---|---|---|---|---|---|---|---|
| GSK2330672 20 mg QD - Main Study Period | Eligible participants were randomized to receive GSK2330672 20 milligrams (mg) once daily (QD) for 12 weeks in the Main Study period. | 0 | None | 0 | 16 | 11 | 16 | View |
| GSK2330672 90 mg BID - Main Study Period | Eligible participants were randomized to receive GSK2330672 90 mg BID for 12 weeks in the Main study period. | 0 | None | 0 | 22 | 18 | 22 | View |
| GSK2330672 20 mg QD - Final Study Period | Eligible participants were randomized to receive GSK2330672 matching placebo via oral route for 4 weeks in Final Study Period. Participants received GSK2330672 20 mg QD during Main study period. | 0 | None | 0 | 16 | 6 | 16 | View |
| GSK2330672 90 mg QD - Final Study Period | Eligible participants were randomized to receive GSK2330672 matching placebo via oral route for 4 weeks in Final Study Period. Participants received GSK2330672 90 mg QD during Main study period. | 0 | None | 0 | 19 | 8 | 19 | View |
| GSK2330672 40 mg BID - Final Study Period | Eligible participants were randomized to receive GSK2330672 matching placebo via oral route for 4 weeks in Final Study Period. Participants received GSK2330672 40 mg BID during Main study period. | 0 | None | 0 | 21 | 2 | 21 | View |
| Placebo - Follow-up | Participants who received GSK2330672 matching placebo in Main study period and Final study period entered in a 4-week no-treatment follow-up period. | 0 | None | 0 | 35 | 0 | 35 | View |
| GSK2330672 20 mg QD - Follow-up | Participants who received treatment (active or placebo) in Main study period and Final study period entered in a 4-week no-treatment follow-up period. | 0 | None | 1 | 16 | 0 | 16 | View |
| GSK2330672 90 mg QD - Follow-up | Participants who received treatment (active or placebo) in Main study period and Final study period entered in a 4-week no-treatment follow-up period. | 0 | None | 0 | 23 | 0 | 23 | View |
| GSK2330672 180 mg QD - Follow-up | Participants who received treatment (active or placebo) in Main study period and Final study period entered in a 4-week no-treatment follow-up period. | 0 | None | 1 | 27 | 0 | 27 | View |
| GSK2330672 40 mg BID - Follow-up | Participants who received treatment (active or placebo) in Main study period and Final study period entered in a 4-week no-treatment follow-up period. | 0 | None | 0 | 22 | 0 | 22 | View |
| GSK2330672 90 mg BID - Follow-up | Participants who received treatment (active or placebo) in Main study period and Final study period entered in a 4-week no-treatment follow-up period. | 0 | None | 0 | 22 | 0 | 22 | View |
| Placebo - Main Study Period | Eligible participants were randomized to receive GSK2330672 matching placebo via oral route for 12 weeks in Main Study Period. | 0 | None | 0 | 36 | 17 | 36 | View |
| GSK2330672 90 mg QD - Main Study Period | Eligible participants were randomized to receive GSK2330672 90 mg QD for 12 weeks in the Main study period. | 0 | None | 1 | 23 | 19 | 23 | View |
| GSK2330672 180 mg QD - Main Study Period | Eligible participants were randomized to receive GSK2330672 180 mg QD for 12 weeks in the Main study period. | 0 | None | 0 | 27 | 24 | 27 | View |
| GSK2330672 40 mg BID - Main Study Period | Eligible participants were randomized to receive GSK2330672 40 mg twice daily (BID) for 12 weeks in the Main study period. | 0 | None | 0 | 23 | 16 | 23 | View |
| Placebo - Final Study Period | Eligible participants were randomized to receive GSK2330672 matching placebo via oral route for 4 weeks in Final Study Period. | 0 | None | 0 | 35 | 2 | 35 | View |
| GSK2330672 180 mg QD - Final Study Period | Eligible participants were randomized to receive GSK2330672 matching placebo via oral route for 4 weeks in Final Study Period. Participants received GSK2330672 180 mg QD during Main study period. | 0 | None | 0 | 19 | 2 | 19 | View |
| GSK2330672 90 mg BID - Final Study Period | Eligible participants were randomized to receive GSK2330672 matching placebo via oral route for 4 weeks in Final Study Period. Participants received GSK2330672 90 mg BID during Main study period. | 0 | None | 0 | 17 | 2 | 17 | View |
Serious Events(If Any):
Serious Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Constipation | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 23.0 | View |
| Lower respiratory tract infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 23.0 | View |
| Lumbar spinal stenosis | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA 23.0 | View |
Other Events(If Any):
Other Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Abdominal pain | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 23.0 | View |
| Abdominal pain lower | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 23.0 | View |
| Abdominal pain upper | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 23.0 | View |
| Arthralgia | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA 23.0 | View |
| Arthritis | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA 23.0 | View |
| Asthenia | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA 23.0 | View |
| Back pain | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA 23.0 | View |
| Bone fissure | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA 23.0 | View |
| Bone pain | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA 23.0 | View |
| Bronchitis | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 23.0 | View |
| Cardiac murmur | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA 23.0 | View |
| Cataract | SYSTEMATIC_ASSESSMENT | Eye disorders | MedDRA 23.0 | View |
| Constipation | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 23.0 | View |
| Diarrhoea | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 23.0 | View |
| Dry eye | SYSTEMATIC_ASSESSMENT | Eye disorders | MedDRA 23.0 | View |
| Dry mouth | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 23.0 | View |
| Dysmenorrhoea | SYSTEMATIC_ASSESSMENT | Reproductive system and breast disorders | MedDRA 23.0 | View |
| Dyspepsia | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 23.0 | View |
| Fatigue | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA 23.0 | View |
| Flatulence | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 23.0 | View |
| Gastrooesophageal reflux disease | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 23.0 | View |
| Gingivitis | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 23.0 | View |
| Haemorrhoids | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 23.0 | View |
| Headache | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA 23.0 | View |
| Hepatic enzyme increased | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA 23.0 | View |
| Humerus fracture | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA 23.0 | View |
| Hypertension | SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDRA 23.0 | View |
| Hypothyroidism | SYSTEMATIC_ASSESSMENT | Endocrine disorders | MedDRA 23.0 | View |
| Impaired healing | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA 23.0 | View |
| Infectious mononucleosis | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 23.0 | View |
| Insomnia | SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MedDRA 23.0 | View |
| Ligament sprain | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA 23.0 | View |
| Lower respiratory tract infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 23.0 | View |
| Melanocytic naevus | SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 23.0 | View |
| Memory impairment | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA 23.0 | View |
| Muscle spasms | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA 23.0 | View |
| Musculoskeletal pain | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA 23.0 | View |
| Myalgia | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA 23.0 | View |
| Nasopharyngitis | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 23.0 | View |
| Nausea | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 23.0 | View |
| Oral candidiasis | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 23.0 | View |
| Pain in extremity | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA 23.0 | View |
| Pruritus | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA 23.0 | View |
| Pyrexia | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA 23.0 | View |
| Rash | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA 23.0 | View |
| Rash macular | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA 23.0 | View |
| Rhinitis | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 23.0 | View |
| Sinusitis | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 23.0 | View |
| Skin bacterial infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 23.0 | View |
| Sleep disorder | SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MedDRA 23.0 | View |
| Tooth fracture | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA 23.0 | View |
| Upper respiratory tract infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 23.0 | View |
| Urinary tract infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 23.0 | View |
| Viral pharyngitis | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 23.0 | View |
| Vitamin A deficiency | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA 23.0 | View |
| Vomiting | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 23.0 | View |
| Vulvovaginal dryness | SYSTEMATIC_ASSESSMENT | Reproductive system and breast disorders | MedDRA 23.0 | View |