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 @ 12:31 AM
Ignite Modification Date:
2025-12-25 @ 10:38 PM
NCT ID:
NCT01875367
Description:
AE were reported after Informed Consent Document (ICD) and before study drugs until approximately 30 days following the discontinuation of study treatment.
AEs were recorded for each Arm group Arm A and Arm B, so information can not be provided separately per intervention.
Frequency Threshold:
0
Time Frame:
Through study treatment, an average of 12 weeks
Study:
NCT01875367
Study Brief:
Phase III to Evaluate Patient´s Preference of Subcutaneous Trastuzumab vs Intravenous in HER2+ Advanced Breast Cancer
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: T-IV + T-SC Vial + T-SC Device | Trastuzumab intravenous (T-IV) x 1 cycle (usual dose of Trastuzumab), followed by 600mg of Trastuzumab Subcutaneous (T-SC) with vial (Injectable Solution) x 2 cycles, followed by 600mg of T-SC with single injection device (SID) x 2 cycles. | 0 | None | 2 | 81 | 76 | 81 | View |
| Arm B: T-IV + T-SC Device + T-SC Vial | Trastuzumab intravenous (T-IV) x 1 cycle (usual dose of Trastuzumab), followed by 600mg of Trastuzumab Subcutaneous (T-SC) with single injection device (SID) x 2 cycles, followed by 600mg of T-SC with vial (Injectable Solution) x 2 cycles. | 0 | None | 10 | 85 | 84 | 85 | View |
Serious Events(If Any):
Serious Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Hematuria | SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | NCI-CTCAE 4.03 | View |
| Nodule in left breast | SYSTEMATIC_ASSESSMENT | Reproductive system and breast disorders | NCI-CTCAE 4.03 | View |
| Cold | SYSTEMATIC_ASSESSMENT | Infections and infestations | NCI-CTCAE 4.03 | View |
| Nodule in right breast | SYSTEMATIC_ASSESSMENT | Reproductive system and breast disorders | NCI-CTCAE 4.03 | View |
| Lack of strength in left leg | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | NCI-CTCAE 4.03 | View |
| Catheter related infection (Bacteriemia) | SYSTEMATIC_ASSESSMENT | Infections and infestations | NCI-CTCAE 4.03 | View |
| Stroke | SYSTEMATIC_ASSESSMENT | Nervous system disorders | NCI-CTCAE 4.03 | View |
| Surgery for surgical castration | SYSTEMATIC_ASSESSMENT | Reproductive system and breast disorders | NCI-CTCAE 4.03 | View |
| Gastric cancer | SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | NCI-CTCAE 4.03 | View |
| Ostenecrosis produced by biphosphonates | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | NCI-CTCAE 4.03 | View |
| Fever | SYSTEMATIC_ASSESSMENT | General disorders | NCI-CTCAE 4.03 | View |
| Heart failure | SYSTEMATIC_ASSESSMENT | Cardiac disorders | NCI-CTCAE 4.03 | View |
Other Events(If Any):
Other Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Platelet count decreased | SYSTEMATIC_ASSESSMENT | Investigations | NCI-CTCAE 4.03 | View |
| Platelet count decreased | SYSTEMATIC_ASSESSMENT | Investigations | NCI-CTCAE 4.03 | View |
| Creatinine increased | SYSTEMATIC_ASSESSMENT | Investigations | NCI-CTCAE 4.03 | View |
| Creatinine increased | SYSTEMATIC_ASSESSMENT | Investigations | NCI-CTCAE 4.03 | View |
| Creatinine increased | SYSTEMATIC_ASSESSMENT | Investigations | NCI-CTCAE 4.03 | View |
| Alanine aminotransferase increased | SYSTEMATIC_ASSESSMENT | Investigations | NCI-CTCAE 4.03 | View |
| Alanine aminotransferase increased | SYSTEMATIC_ASSESSMENT | Investigations | NCI-CTCAE 4.03 | View |
| Alanine aminotransferase increased | SYSTEMATIC_ASSESSMENT | Investigations | NCI-CTCAE 4.03 | View |
| Aspartate aminotransferase increased | SYSTEMATIC_ASSESSMENT | Investigations | NCI-CTCAE 4.03 | View |
| Aspartate aminotransferase increased | SYSTEMATIC_ASSESSMENT | Investigations | NCI-CTCAE 4.03 | View |
| Fatigue | SYSTEMATIC_ASSESSMENT | General disorders | NCI-CTCAE 4.03 | View |
| Fatigue | SYSTEMATIC_ASSESSMENT | General disorders | NCI-CTCAE 4.03 | View |
| Fatigue | SYSTEMATIC_ASSESSMENT | General disorders | NCI-CTCAE 4.03 | View |
| Heart failure | SYSTEMATIC_ASSESSMENT | Cardiac disorders | NCI-CTCAE 4.03 | View |
| Osteonecrosis of jaw | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | NCI-CTCAE 4.03 | View |
| Nodule in left breast | SYSTEMATIC_ASSESSMENT | Reproductive system and breast disorders | NCI-CTCAE 4.03 | View |
| Alkaline phosphatase increased | SYSTEMATIC_ASSESSMENT | Investigations | NCI-CTCAE 4.03 | View |
| Alkaline phosphatase increased | SYSTEMATIC_ASSESSMENT | Investigations | NCI-CTCAE 4.03 | View |
| Alkaline phosphatase increased | SYSTEMATIC_ASSESSMENT | Investigations | NCI-CTCAE 4.03 | View |
| Diarrhea | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | NCI-CTCAE 4.03 | View |
| Diarrhea | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | NCI-CTCAE 4.03 | View |
| Diarrhea | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | NCI-CTCAE 4.03 | View |
| Hemoglobin increased | SYSTEMATIC_ASSESSMENT | Investigations | NCI-CTCAE 4.03 | View |
| Neutrophil count decreased | SYSTEMATIC_ASSESSMENT | Investigations | NCI-CTCAE 4.03 | View |
| Neutrophil count decreased | SYSTEMATIC_ASSESSMENT | Investigations | NCI-CTCAE 4.03 | View |
| Neutrophil count decreased | SYSTEMATIC_ASSESSMENT | Investigations | NCI-CTCAE 4.03 | View |
| Nausea | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | NCI-CTCAE 4.03 | View |
| Nausea | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | NCI-CTCAE 4.03 | View |
| Nausea | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | NCI-CTCAE 4.03 | View |
| Voice alteration | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | NCI-CTCAE 4.03 | View |
| Vomiting | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | NCI-CTCAE 4.03 | View |
| Vomiting | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | NCI-CTCAE 4.03 | View |
| Vomiting | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | NCI-CTCAE 4.03 | View |
| White blood cells decreased | SYSTEMATIC_ASSESSMENT | Investigations | NCI-CTCAE 4.03 | View |
| White blood cells decreased | SYSTEMATIC_ASSESSMENT | Investigations | NCI-CTCAE 4.03 | View |
| Anemia | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | NCI-CTCAE 4.03 | View |
| Anemia | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | NCI-CTCAE 4.03 | View |
| Injection site reaction | SYSTEMATIC_ASSESSMENT | General disorders | NCI-CTCAE 4.03 | View |
| Injection site reaction | SYSTEMATIC_ASSESSMENT | General disorders | NCI-CTCAE 4.03 | View |