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 @ 4:14 AM
Ignite Modification Date:
2025-12-26 @ 3:14 AM
NCT ID:
NCT03747120
Description:
22 patients were randomized to Arm C; however, two patients withdrew consent before study treatment was initiated. SAE/AE analysis was conducted in the safety population which is defined as patients who had a least one dose of study treatment.
Frequency Threshold:
5
Time Frame:
Averse event data were collected during the neoadjuvant phase, which spans from the initiation of treatment to the day of surgery, 16 weeks.
Study:
NCT03747120
Study Brief:
Neoadjuvant Her2-targeted Therapy and Immunotherapy With Pembrolizumab [IIT2018-04-MCARTHUR-NEOHP]
Event Groups(If Any):
Event Groups
| Title | Description | Deaths # Affected | Deaths # At Risk | Serious # Affected | Serious # At Risk | Other # Affected | Other # At Risk | View |
|---|---|---|---|---|---|---|---|---|
| Arm A: THP | Arm A: Paclitaxel weekly x12 + Trastuzumab + Pertuzumab All subjects may receive standard of care systemic therapy after surgery per their treating physician's discretion. Paclitaxel: All subjects will receive Paclitaxel weekly for 12 weeks Trastuzumab: All subjects will receive Trastuzumab every 3 weeks Pertuzumab: Arm A and Arm B subjects will receive Pertuzumab every 3 weeks | 0 | None | 2 | 58 | 39 | 58 | View |
| Arm B: THP-Pembrolizumab | Arm B: Paclitaxel weekly x12 + Trastuzumab + Pertuzumab + Pembrolizumab All subjects may receive standard of care systemic therapy after surgery per their treating physician's discretion. Paclitaxel: All subjects will receive Paclitaxel weekly for 12 weeks Trastuzumab: All subjects will receive Trastuzumab every 3 weeks Pertuzumab: Arm A and Arm B subjects will receive Pertuzumab every 3 weeks Pembrolizumab: Arm B and Arm C subjects will receive Pembrolizumab every 3 weeks | 0 | None | 3 | 58 | 33 | 58 | View |
| Arm C: TH-Pembrolizumab | Arm C: Paclitaxel weekly x12 + Trastuzumab + Pembrolizumab All subjects may receive standard of care systemic therapy after surgery per their treating physician's discretion. Paclitaxel: All subjects will receive Paclitaxel weekly for 12 weeks Trastuzumab: All subjects will receive Trastuzumab every 3 weeks Pembrolizumab: Arm B and Arm C subjects will receive Pembrolizumab every 3 weeks | 0 | None | 1 | 20 | 11 | 20 | View |
Serious Events(If Any):
Serious Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Diarrhea | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | CTCAEv.5.0 | View |
| Anemia | NON_SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | CTCAEv.5.0 | View |
| pneumonitis | NON_SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | CTCAEv.5.0 | View |
| congestive heart failure | NON_SYSTEMATIC_ASSESSMENT | Cardiac disorders | CTCAEv.5.0 | View |
Other Events(If Any):
Other Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Alopecia | NON_SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | CTCAEv.5.0 | View |
| Anemia | NON_SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | CTCAEv.5.0 | View |
| Diarrhea | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | CTCAEv.5.0 | View |
| Elevated ALT | NON_SYSTEMATIC_ASSESSMENT | Hepatobiliary disorders | CTCAEv.5.0 | View |
| Epistaxis | NON_SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | CTCAEv.5.0 | View |
| Fatigue | NON_SYSTEMATIC_ASSESSMENT | General disorders | CTCAEv.5.0 | View |
| Headache | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | CTCAEv.5.0 | View |
| Insomnia | NON_SYSTEMATIC_ASSESSMENT | Psychiatric disorders | CTCAEv.5.0 | View |
| Nausea | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | CTCAEv.5.0 | View |
| Peripheral Neuropathy | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | CTCAEv.5.0 | View |
| Rash | NON_SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | CTCAEv.5.0 | View |
| Constipation | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | CTCAEv.5.0 | View |
| Vomitting | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | CTCAEv.5.0 | View |