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
Event Groups
| Title | Description | Deaths # Affected | Deaths # At Risk | Serious # Affected | Serious # At Risk | Other # Affected | Other # At Risk | View |
|---|---|---|---|---|---|---|---|---|
| Standard Care | Patients will be stratified based on cancer type (breast cancer vs colorectal cancer). In standard care arm, patients will not receive additional therapy for CIPN. Patient will complete a weekly questionnaire during the study to determine severity of nerve pain symptoms. Each week record the total amount of chemotherapy received in the past week. Record how much chemotherapy received all together. Each week patient will have blood drawn (about 1 teaspoon) to check nerve growth factors levels. All patients will follow the same chemotherapy dose reduction algorithm. No concomitant anti-neuropathy medication is allowed. | None | None | 0 | 2 | 0 | 2 | View |
| Acupuncture | Patients stratified based on cancer (breast vs colorectal). Patients randomly assigned to get acupuncture until the end of their chemo. Patient will complete a weekly questionnaire to determine severity of nerve pain symptoms. Each week record the total amount of chemo received in the past week. Record how much chemotherapy received all together. Each week patient will have blood drawn (about 1 tsp) to check nerve growth factors levels. All patients will follow the same chemo dose reduction algorithm. No concomitant anti-neuropathy medication is allowed. In standard care arm, patients will not get additional therapy for CIPN. Acupuncture using Seirin® needles: Participants will receive acupuncture weekly until the end of chemotherapy. Subjects will get acupuncture at documented acupoints. To improve blinding effect, the acupuncturist will tap 2 guiding tubes at 2 sham points \& affix a pair of needles to the surface of the same points with adhesive tape, without needle insertion. | None | None | 0 | 4 | 3 | 4 | View |
| Sham Acupuncture | Patients stratified based on cancer (breast vs colorectal). The patients get sham acupuncture til the end of chemo with same chemo dose reduction algorithm. No concomitant anti-neuropathy medication is allowed. Patient complete a weekly questionnaire to determine severity of nerve pain symptoms. Weekly record total amount of chemo received in the past week \& all together. Each week patient have blood drawn (about 1 tsp) to check nerve growth factors levels. Sham Acupuncture using Park Sham placebo acupuncture device: Particip will get sham acupuncture til the end of chemo. Acupuncturist will insert Park Sham Devices, non-penetrating sham acupuncture device consisting of a retractable needle \& adhesive tube into the sham points, \& then apply 2 pieces of adhesive tape next to needles. Will tap mock plastic needle guiding tube on the surface of each of 8 true points in arm \& leg to produce sensation \& apply a needle with piece of adhesive tape to dermal surface, no needle insertion. | None | None | 0 | 13 | 0 | 13 | View |
Other Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| rash, bruising & scabs | NON_SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | None | View |
| swelling | NON_SYSTEMATIC_ASSESSMENT | General disorders | None | View |
| visual impairment, numbness, trouble writing, loss of balance | NON_SYSTEMATIC_ASSESSMENT | General disorders | None | View |