Event Group
Event Groups are part of the Adverse Events Module within the Results Section. They provide a way to organize and summarize adverse event data by grouping related events together.
Each Event Group typically represents a category or class of adverse events and includes statistical information such as the number of participants affected and at risk for different event types: deaths, serious events, and other events.
Event Group path is as follows:
Study -> Results Section -> Adverse Events Module -> Event Group
Event Group
Ignite Creation Date:
2025-12-24 @ 12:21 PM
Ignite Modification Date:
2025-12-25 @ 12:03 PM
NCT ID:
NCT01303861
Group ID:
EG002
Title:
Nicotine Patches With Nicotine Inhaler
Description:
This group will consist of smokers who, based on smoking behavior, respond favorably to pre-cessation nicotine patches (assessed at Session P2). They will continue to receive nicotine patches and will receive a nicotine inhaler to use as needed after their quit date.
Nicotine patches: Nicotine Replacement Therapy Groups:
1. For smokers with high baseline CO: 42 mg/24 h for 2 weeks before the quit date and 3 weeks after the quit date, 21 mg/24 h for 4 weeks, 14 mg/24 h for 2 weeks, and 7 mg/24 h for 2 weeks; or
2. For smokers with low baseline CO: 21 mg/24 h for 2 weeks before the quit date and 7 weeks after the quit date, 14 mg/24 h for 2 weeks, and 7 mg/ 24 h for 2 weeks.
Varenicline and varenicline in combination with bupropion groups:
1. For smokers with high baseline CO: 42 mg/24 h for 1 week
2. For smokers with low baseline CO: 21 mg/24 h for 1 week
Nicotine Inhaler: Nicotine inhaler to use as needed after quit date
Deaths Number Affected:
None
Deaths Number At Risk:
None
Serious Number Affected:
0
Serious Number At Risk:
55
Other Number Affected:
38
Other Number At Risk:
55
Study:
NCT01303861
Results Section:
NCT01303861
Adverse Events Module:
NCT01303861