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 @ 4:15 PM
Ignite Modification Date:
2025-12-25 @ 2:13 PM
NCT ID:
NCT00894166
Description:
34 subjects withdrew from participation prior to Session P2 and were therefore not randomized into one of the study groups. These participates received nicotine patches for the first week of the study but did not attend the second session so no data about adverse events were collected.
Frequency Threshold:
5
Time Frame:
Subjects were receiving study drugs for 11-13 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:
NCT00894166
Study Brief:
Evaluation of a Tailored Smoking Cessation Treatment Algorithm Based on Initial Treatment Response and Genotype
Event Groups(If Any):
Event Groups
| Title | Description | Deaths # Affected | Deaths # At Risk | Serious # Affected | Serious # At Risk | Other # Affected | Other # At Risk | View |
|---|---|---|---|---|---|---|---|---|
| NRT Responder | Participants in this group showed both a \>50% decrease in expired air CO during the 1st week of pre-cessation nicotine patch treatment and did not lapse during their 1st week after quitting. | None | None | 3 | 132 | 88 | 132 | View |
| Pre-Quit Randomization to Bupropion + NRT | Participants not showing a \>50% decrease in expired air CO during the 1st week of pre-cessation nicotine patch treatment, who are randomly assigned at week 2 to use Zyban (bupropion) in combination with nicotine patches. | None | None | 4 | 109 | 74 | 109 | View |
| Pre-Quit Randomization to Varenicline | Participants not showing a \>50% decrease in expired air CO during the 1st week of pre-cessation nicotine patch treatment, who are randomly assigned at week 2 to use varenicline. | None | None | 3 | 112 | 64 | 112 | View |
| Pre-Quit Randomization to NRT | Participants not showing a \>50% decrease in expired air CO during the 1st week of pre-cessation nicotine patch treatment,who are randomly assigned at week 2 to use continued use of nicotine patches. | None | None | 2 | 114 | 85 | 114 | View |
| Post-Quit Randomization to Bupropion + NRT | Participants who did show \>50% decrease in expired air CO on pre-cessation NRT but who lapsed during the first week post quit date, who are randomly assigned to use of bupropion in combination with nicotine patches. | None | None | 2 | 34 | 31 | 34 | View |
| Post-Quit Randomized to Varenicline | Participants who did show \>50% decrease in expired air CO on pre-cessation NRT but who lapsed during the first week post quit date, who are randomly assigned to use varenicline. | None | None | 1 | 36 | 27 | 36 | View |
| Post-Quit Randomized to NRT | Participants who did show \>50% decrease in expired air CO on pre-cessation NRT but who lapsed during the first week post quit date, who are randomly assigned to use nicotine patches. | None | None | 1 | 35 | 28 | 35 | View |
Serious Events(If Any):
Serious Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Chest Pain, shortness of breath, vision loss | NON_SYSTEMATIC_ASSESSMENT | General disorders | None | View |
| Hives, itching, knot in throat | NON_SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | None | View |
| Chest Pain, myocardial infarction | NON_SYSTEMATIC_ASSESSMENT | Cardiac disorders | None | View |
| Chest Pain worsened with inspiration | NON_SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | None | View |
| psychiatric side effects | NON_SYSTEMATIC_ASSESSMENT | Psychiatric disorders | None | View |
| urticaria and shortness of breath | NON_SYSTEMATIC_ASSESSMENT | Immune system disorders | None | View |
| paroxsymal supraventricular tachycardia and fainting | NON_SYSTEMATIC_ASSESSMENT | Cardiac disorders | None | View |
| chest pain, new left bundle branch block | NON_SYSTEMATIC_ASSESSMENT | Cardiac disorders | None | View |
| cancer | NON_SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | None | View |
| Chest pain, unifocal PVCs | NON_SYSTEMATIC_ASSESSMENT | Cardiac disorders | None | View |
| Rash distant from patch site | NON_SYSTEMATIC_ASSESSMENT | Immune system disorders | None | View |
| Hallucinations, chest pains, vomiting | NON_SYSTEMATIC_ASSESSMENT | General disorders | None | View |
| Body aches, generalized weakness, sensation of throat swelling, lightheadedness,difficulty breathing | NON_SYSTEMATIC_ASSESSMENT | General disorders | None | View |
| stroke and death | NON_SYSTEMATIC_ASSESSMENT | Vascular disorders | None | View |
| myocardial infaction | NON_SYSTEMATIC_ASSESSMENT | Cardiac disorders | None | View |
Other Events(If Any):
Other Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| UPSET STOMACH | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | None | View |
| DIARRHEA | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | None | View |
| IRRITABILITY | 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 |
| DEPRESSION | SYSTEMATIC_ASSESSMENT | Psychiatric disorders | None | View |
| ANXIETY | SYSTEMATIC_ASSESSMENT | Psychiatric disorders | None | View |
| TREMOR | SYSTEMATIC_ASSESSMENT | Nervous system disorders | None | View |
| DECREASED LIBIDO | SYSTEMATIC_ASSESSMENT | Nervous system disorders | None | View |
| ITCHING/BURNING 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 |
| HEADACHE | SYSTEMATIC_ASSESSMENT | Nervous system disorders | None | View |
| EXCESSIVE SWEATING | SYSTEMATIC_ASSESSMENT | General disorders | None | View |
| SWELLING | SYSTEMATIC_ASSESSMENT | General disorders | None | View |
| MOUTH/THROAT IRRITATION | SYSTEMATIC_ASSESSMENT | General disorders | None | View |
| DRY MOUTH | SYSTEMATIC_ASSESSMENT | General disorders | None | View |
| THIRST | SYSTEMATIC_ASSESSMENT | General disorders | None | View |
| COUGHING | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | None | View |
| CHEST PAIN | SYSTEMATIC_ASSESSMENT | General disorders | None | View |
| JOINT / MUSCLE PAIN | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | None | View |
| HEARTBURN | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | None | View |
| NAUSEA | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | None | View |
| CONSTIPATION | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | None | View |