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 @ 11:58 AM
Ignite Modification Date:
2025-12-25 @ 11:56 AM
NCT ID:
NCT02229461
Description:
Tables represent all adverse events in the Safety Population (all randomized participants who took at least 1 dose of investigational product) during the aspirin mono-therapy run-in phase, the treatment phase and the aspirin mono-therapy run-out phase.
Frequency Threshold:
0
Time Frame:
Treatment emergent adverse events were collected after first dose of investigational product on Day 1 until completion of all study procedures throughout the study.
Study:
NCT02229461
Study Brief:
Naproxen Sodium/ASA Platelet 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 |
|---|---|---|---|---|---|---|---|---|
| Group 0-IR ASA 81 mg qd in Run-in Period | Participants, subsequently randomized to treatment period, were administered the first dose of immediate release acetylsalicylic acid (IR ASA, Aspirin, BAYE4465) 81 mg once daily at the clinical study site and instructed to take the remaining 5 doses in a fasted state with a full glass of water once daily in the morning in an outpatient setting. | None | None | 0 | 102 | 0 | 102 | View |
| Group 2-IR ASA 30 Min After Naproxen Sodium | Confirmed eligible participants were randomized to be administered immediate release acetylsalicylic acid (IR ASA, Aspirin, BAYE4465) 81 mg qd 30 minutes after naproxen sodium (Aleve, BAY117031) 220 mg qd for 10 consecutive days. A 3-day IR ASA 81 mg qd Run-Out period was followed. | None | None | 0 | 17 | 1 | 17 | View |
| Group 1-IR ASA Co-administered With Naproxen Sodium | Confirmed eligible participants were randomized to be administered immediate release acetylsalicylic acid (IR ASA, Aspirin, BAYE4465) 81 mg once daily (qd) in parallel with naproxen sodium (Aleve, BAY117031) 220 mg qd for 10 consecutive days. A 3-day IR ASA 81 mg qd Run-Out period was followed. | None | None | 0 | 17 | 4 | 17 | View |
| Group 3-IR ASA 8 Hours After Naproxen Sodium | Confirmed eligible participants were randomized to be administered immediate release acetylsalicylic acid (IR ASA, Aspirin, BAYE4465) 81 mg qd 8 hours after naproxen sodium (Aleve, BAY117031) 220 mg qd for 10 consecutive days. A 3-day IR ASA 81 mg qd Run-Out period was followed. | None | None | 0 | 17 | 4 | 17 | View |
| Group 4-IR ASA Only | Confirmed eligible participants were randomized to be administered immediate release acetylsalicylic acid (IR ASA, Aspirin, BAYE4465) 81 mg qd. A 3-day IR ASA 81 mg qd Run-Out period was followed. | None | None | 0 | 17 | 3 | 17 | View |
| Group 5-IR ASA 30 Min Before Naproxen Sodium | Confirmed eligible participants were randomized to be administered immediate release acetylsalicylic acid (IR ASA, Aspirin, BAYE4465) 81 mg qd 30 minutes before naproxen sodium (Aleve, BAY117031) 220 mg qd for 10 consecutive days. A 3-day IR ASA 81 mg qd Run-Out period was followed. | None | None | 0 | 17 | 2 | 17 | View |
| Group 6-IR ASA 30 Min After First Dose of Naproxen Sodium Bid | Confirmed eligible participants were randomized to be administered immediate release acetylsalicylic acid (IR ASA, Aspirin, BAYE4465) 81 mg qd 30 minutes after first dose of naproxen sodium (Aleve, BAY117031) 220 mg, followed by second dose of naproxen sodium 220 mg 12 hours after first dose, for 10 consecutive days. A 3-day IR ASA 81 mg qd Run-Out period was followed. | None | None | 0 | 17 | 4 | 17 | View |
Serious Events(If Any):
Other Events(If Any):
Other Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Diarrhoea | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (18.0) | View |
| Ear pain | NON_SYSTEMATIC_ASSESSMENT | Ear and labyrinth disorders | MedDRA (18.0) | View |
| Frequent bowel movements | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (18.0) | View |
| Rectal haemorrhage | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (18.0) | View |
| Fatigue | NON_SYSTEMATIC_ASSESSMENT | General disorders | MedDRA (18.0) | View |
| Coagulation time prolonged | NON_SYSTEMATIC_ASSESSMENT | Investigations | MedDRA (18.0) | View |
| Dizziness | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA (18.0) | View |
| Pelvic discomfort | NON_SYSTEMATIC_ASSESSMENT | Reproductive system and breast disorders | MedDRA (18.0) | View |
| Skin irritation | NON_SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA (18.0) | View |
| Infrequent bowel movements | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (18.0) | View |
| Nausea | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (18.0) | View |
| Chest discomfort | NON_SYSTEMATIC_ASSESSMENT | General disorders | MedDRA (18.0) | View |
| Vessel puncture site bruise | NON_SYSTEMATIC_ASSESSMENT | General disorders | MedDRA (18.0) | View |
| Contusion | NON_SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA (18.0) | View |
| Musculoskeletal chest pain | NON_SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA (18.0) | View |
| Syncope | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA (18.0) | View |
| Dysmenorrhoea | NON_SYSTEMATIC_ASSESSMENT | Reproductive system and breast disorders | MedDRA (18.0) | View |
| Dry skin | NON_SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA (18.0) | View |