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 @ 4:04 PM
Ignite Modification Date:
2025-12-25 @ 2:06 PM
NCT ID:
NCT02742766
Description:
Serious adverse events and non-serious adverse events were collected for the Safety Population which comprised of all participants who received at least one dose of study medication. Non-serious adverse events and serious adverse events were not collected in Part 3 as no participants were enrolled. All non-serious adverse events with a frequency threshold of more than 3 occurrences in any part is presented.
Frequency Threshold:
0
Time Frame:
Serious adverse events and non-serious adverse events were collected from the start of study treatment until the follow-up contact (Up to 8 days for Part 1 and up to 22 days for Part 2)
Study:
NCT02742766
Study Brief:
Safety, Tolerability and Preliminary Pharmacokinetics (PK) and Pharmacodynamics (PD) of Single and Repeat Oral Doses of GSK3008356 in Healthy and Obese 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 |
|---|---|---|---|---|---|---|---|---|
| Part 1- Placebo | Eligible participants received GSK3008356 matching placebo tablets via oral route (as either single or multiple doses) along with a 30% fat by calorie meal approximately 2 hours after the morning dose for a single day. | 0 | None | 0 | 20 | 0 | 20 | View |
| Part 1-Cohort A1: GSK3008356 5 mg | Eligible participants received a single morning dose of GSK3008356 tablets via oral route (total dose of 5 mg) along with a 30% fat by calorie meal approximately 2 hours after the morning dose. | 0 | None | 0 | 6 | 1 | 6 | View |
| Part 1-Cohort A2: GSK3008356 10 mg | Eligible participants received a single morning dose of GSK3008356 tablets via oral route (total dose of 10 mg) along with a 30% fat by calorie meal approximately 2 hours after the morning dose. | 0 | None | 0 | 6 | 0 | 6 | View |
| Part 1-Cohort A3: GSK3008356 30 mg | Eligible participants received a single morning dose of GSK3008356 tablets via oral route (total dose of 30 mg) along with a 30% fat by calorie meal approximately 2 hours after the morning dose. | 0 | None | 0 | 6 | 1 | 6 | View |
| Part 1-Cohort A4: GSK3008356 75 mg | Eligible participants received a single morning dose of GSK3008356 tablets via oral route (total dose of 75 mg) along with a 30% fat by calorie meal approximately 2 hours after the morning dose. | 0 | None | 0 | 6 | 1 | 6 | View |
| Part 1-Cohort A5: GSK3008356 200 mg | Eligible participants received a single morning dose of GSK3008356 tablets via oral route (total dose of 200 mg) along with a 30% fat by calorie meal approximately 2 hours after the morning dose. | 0 | None | 0 | 6 | 3 | 6 | View |
| Part 1-Cohort A6: GSK3008356 125 mg | Eligible participants received a single morning dose of GSK3008356 tablets via oral route (total dose of 125 mg) along with a 30% fat by calorie meal approximately 2 hours after the morning dose. | 0 | None | 0 | 6 | 3 | 6 | View |
| Part 1-Cohort A7: GSK3008356 100 mg BID (0 h, 4 h) | Eligible participants received GSK3008356 tablets via oral route (total dose of 200 mg such that one 100 mg dose was administered at 0 h and 4 h) along with a 30% fat by calorie meal approximately 2 hours after the morning dose in a single day. | 0 | None | 0 | 6 | 3 | 6 | View |
| Part 1-Cohort A8: GSK3008356 100 mg BID (0 h, 16 h) | Eligible participants received GSK3008356 tablets via oral route (total dose of 200 mg such that one 100 mg dose was administered at 0 h and 16 h) along with a 30% fat by calorie meal approximately 2 hours after the morning dose in a single day. | 0 | None | 0 | 6 | 3 | 6 | View |
| Part 1-Cohort A9: GSK3008356 200 mg Evening Dose | Participants in this arm were planned to receive a single evening dose of GSK3008356 tablets via oral route (total dose of 200 mg) along with a 30% fat by calorie meal approximately 2 hours after the evening dose; but this arm was cancelled. | 0 | None | 0 | 0 | 0 | 0 | View |
| Part 1-Cohort A10: GSK3008356 10 mg q1h x 9 Doses | Eligible participants received GSK3008356 tablets via oral route (total dose of 90 mg such that a 10 mg dose was administered q1h for a total of 9 doses) along with a 30% fat by calorie meal approximately 2 hours after the first morning dose in a single day. | 0 | None | 0 | 6 | 0 | 6 | View |
| Part 1-Cohort A11: GSK3008356 5 mg q1h x 9 Doses | Eligible participants received GSK3008356 tablets via oral route (total dose of 45 mg such that a 5 mg dose was administered q1h for a total of 9 doses) along with a 30% fat by calorie meal approximately 2 hours after the first morning dose in a single day. | 0 | None | 0 | 6 | 3 | 6 | View |
| Part 2-Placebo | Eligible participants received GSK3008356 matching placebo tablets via oral route (repeat doses) for a period of 14 days. Day 1 and Day 14 dosing occurred while receiving a standard 30% fat by calorie meal approximately 2 hours after the morning dose. | 0 | None | 0 | 6 | 2 | 6 | View |
| Part 2-Cohort B1: GSK3008356 10 mg BID (0 h, 16 h) | Eligible participants received GSK3008356 tablets BID via oral route (total daily dose of 20 mg such that a 10 mg dose was administered at 0 h and 16 h) for a period of 14 days. Day 1 and Day 14 dosing occurred while receiving a standard 30% fat by calorie meal approximately 2 hours after the morning dose. | 0 | None | 0 | 6 | 5 | 6 | View |
| Part 2-Cohort B2: GSK3008356 1 mg BID (0 h, 16 h) | Eligible participants received GSK3008356 tablets BID via oral route (total daily dose of 2 mg such that a 1 mg dose was administered at 0 h and 16 h) for a period of 14 days. Day 1 and Day 14 dosing occurred while receiving a standard 30% fat by calorie meal approximately 2 hours after the morning dose. | 0 | None | 0 | 6 | 3 | 6 | View |
| Part 2-Cohort B3: GSK3008356 3 mg BID (0 h, 16 h) | Eligible participants received GSK3008356 tablets BID via oral route (total daily dose of 6 mg such that a 3 mg dose was administered at 0 h and 16 h) for a period of 14 days. Day 1 and Day 14 dosing occurred while receiving a standard 30% fat by calorie meal approximately 2 hours after the morning dose. | 0 | None | 0 | 6 | 3 | 6 | View |
| Part 3: Obese Participants Cohort 1 | Participants in this arm were planned to receive 28 daily doses so as to evaluate 1 dose strength of GSK3008356 (or matching placebo) administered as morning doses. Part 3 was not conducted since a tolerable dose with sufficient pharmacodynamic effects was not identified in Part 2 due to gastrointestinal issues. | 0 | None | 0 | 0 | 0 | 0 | View |
| Part 3: Obese Participants Cohort 2 | Participants in this arm were planned to receive 28 daily doses so as to evaluate 1 dose strength of GSK3008356 (or matching placebo) administered as evening doses. Part 3 was not conducted since a tolerable dose with sufficient pharmacodynamic effects was not identified in Part 2 due to gastrointestinal issues. | 0 | None | 0 | 0 | 0 | 0 | View |
| Part 3: Obese Participants Cohort 3 | Participants in this arm were planned to receive 28 daily doses so as to evaluate 1 dose strength of GSK3008356 (or matching placebo) administered as evening doses. Part 3 was not conducted since a tolerable dose with sufficient pharmacodynamic effects was not identified in Part 2 due to gastrointestinal issues. | 0 | None | 0 | 0 | 0 | 0 | View |
Serious Events(If Any):
Other Events(If Any):
Other Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Abdominal discomfort | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 19.0 | View |
| Dizziness | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA 19.0 | View |
| Headache | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA 19.0 | View |
| Nausea | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 19.0 | View |
| Vomiting | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 19.0 | View |
| Diarrhoea | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 19.0 | View |