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 @ 12:03 AM
Ignite Modification Date:
2025-12-25 @ 10:01 PM
NCT ID:
NCT01443858
Description:
Eight subjects discontinued study participation after the first study session; therefore, no side effects data were collected. Six of these subjects were in the control group, two of these subjects were in the 25mg Meclizine group and none were in the 50mg Meclizine group.
Frequency Threshold:
5
Time Frame:
Subjects were receiving study drugs for nine weeks. At each study session during this period subjects completed a questionnaire about side effects. Subjects were also told to contact us between study sessions if side effects were bothersome.
Study:
NCT01443858
Study Brief:
Meclizine as a Potential Smoking Cessation Treatment
Event Groups(If Any):
Event Groups
| Title | Description | Deaths # Affected | Deaths # At Risk | Serious # Affected | Serious # At Risk | Other # Affected | Other # At Risk | View |
|---|---|---|---|---|---|---|---|---|
| Control | Subjects in this group will take placebo meclizine daily for the three weeks prior to their quit date. Subjects will also apply a 21mg/24h nicotine patch daily starting in the second week of pre-quit treatment. Placebo meclizine will be administered in two doses each day. Nicotine patches: Pre-Quit Period: During weeks two and three, participants will apply active 21mg/24h nicotine patches daily. Post-Quit Period: Following the quit-day these participants will apply active nicotine patches daily using the following dose schedule: 21mg/24h for four weeks, 14mg/24h for one week, and 7mg/24h for one week. | None | None | 0 | 19 | 14 | 19 | View |
| 25mg Meclizine | Subjects in this group will take 25mg of meclizine daily for the three weeks prior to their quit date. Subjects will also apply a 21mg/24h nicotine patch daily starting in the second week of pre-quit treatment. Meclizine will be administered in two doses each day. Meclizine: Pre-Quit Period: In this group, participants will take meclizine daily during the three week pre-quit period. The meclizine will be taken in two doses daily, one capsule with breakfast and one with dinner. Nicotine patches: Pre-Quit Period: During weeks two and three, participants will apply active 21mg/24h nicotine patches daily. Post-Quit Period: Following the quit-day these participants will apply active nicotine patches daily using the following dose schedule: 21mg/24h for four weeks, 14mg/24h for one week, and 7mg/24h for one week. | None | None | 0 | 23 | 14 | 23 | View |
| 50mg Meclizine | Subjects in this group will take 50mg of meclizine daily for the three weeks prior to their quit date. Subjects will also apply a 21mg/24h nicotine patch daily starting in the second week of pre-quit treatment. Meclizine will be administered in two doses each day. Meclizine: Pre-Quit Period: In this group, participants will take meclizine daily during the three week pre-quit period. The meclizine will be taken in two doses daily, one capsule with breakfast and one with dinner. Nicotine patches: Pre-Quit Period: During weeks two and three, participants will apply active 21mg/24h nicotine patches daily. Post-Quit Period: Following the quit-day these participants will apply active nicotine patches daily using the following dose schedule: 21mg/24h for four weeks, 14mg/24h for one week, and 7mg/24h for one week. | None | None | 0 | 25 | 15 | 25 | View |
Serious Events(If Any):
Other Events(If Any):
Other Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Headache | SYSTEMATIC_ASSESSMENT | Nervous system disorders | None | View |
| Diarrhea / Constipation | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | None | View |
| Mouth / Throat Irritation | SYSTEMATIC_ASSESSMENT | General disorders | None | View |
| Heartburn | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | None | View |
| Coughing | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | None | View |
| Irritability | SYSTEMATIC_ASSESSMENT | Nervous system disorders | None | View |
| Difficulty Concentrating | SYSTEMATIC_ASSESSMENT | Nervous system disorders | None | View |
| Drowsiness | SYSTEMATIC_ASSESSMENT | Nervous system disorders | None | View |
| Fatigue | SYSTEMATIC_ASSESSMENT | Nervous system disorders | None | View |
| Nightmares | SYSTEMATIC_ASSESSMENT | Nervous system disorders | None | View |
| Vivid Dreams | SYSTEMATIC_ASSESSMENT | Nervous system disorders | None | View |
| Insomnia | SYSTEMATIC_ASSESSMENT | Nervous system disorders | None | View |
| Itching at Patch Site | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | None | View |
| Rash at Patch Site | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | None | View |
| Rash Distant from Patch Site | SYSTEMATIC_ASSESSMENT | General disorders | None | View |
| Nausea | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | None | View |