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 @ 4:40 PM
Ignite Modification Date:
2025-12-25 @ 2:29 PM
NCT ID:
NCT01401166
Description:
Analysis Population Description: Safety Population
Frequency Threshold:
5
Time Frame:
During treatment from Cycles 1 to 8 (crossover period) and Cycles 9 to 18 (continuation period); cycle length of 3 weeks
Study:
NCT01401166
Study Brief:
Participant Preference of Subcutaneous (SC) Versus Intravenous (IV) Herceptin (Trastuzumab) in Human Epidermal Growth Factor Receptor (HER) 2-Positive Early 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 |
|---|---|---|---|---|---|---|---|---|
| Cohort 1: SC (SID) Herceptin (Crossover) | Participants received Herceptin on Day 1 of each 3-week cycle for 18 cycles. SC Herceptin was administered via SID as a 600-mg dose during four consecutive cycles of the crossover period. Administration was performed by HCP. | None | None | 4 | 242 | 81 | 242 | View |
| Cohort 1: IV Herceptin (Crossover) | Participants received Herceptin on Day 1 of each 3-week cycle for 18 cycles. IV Herceptin was given as a 6-mg/kg dose during four consecutive cycles of the crossover period. If study treatment for Cycle 1 was IV Herceptin, the initial dose was a loading dose of 8 mg/kg (instead of 6 mg/kg) for de novo participants who started Herceptin treatment in the study. Administration was performed by HCP. | None | None | 2 | 241 | 55 | 241 | View |
| Cohort 1: IV Herceptin (Continuation) | Participants received Herceptin on Day 1 of each 3-week cycle for 18 cycles. In the continuation period, participants received IV Herceptin as a 6-mg/kg dose for up to 10 remaining cycles. Administration was performed by HCP. | None | None | 6 | 226 | 46 | 226 | View |
| Cohort 1: SC (SID) Herceptin (Continuation) | Participants received Herceptin on Day 1 of each 3-week cycle for 18 cycles. Those with at least 2 treatment cycles remaining of the 18-cycle treatment course after the crossover period were offered the opportunity to self-administer SC Herceptin via SID as a 600-mg dose under the direction of a trained HCP. | None | None | 1 | 43 | 7 | 43 | View |
| Cohort 2: SC (Vial) Herceptin (Crossover) | Participants received Herceptin on Day 1 of each 3-week cycle for 18 cycles. SC Herceptin was administered via handheld syringe using the vial formulation as a 600-mg dose during four consecutive cycles of the crossover period. Administration was performed by HCP. | None | None | 0 | 237 | 107 | 237 | View |
| Cohort 2: IV Herceptin (Crossover) | Participants received Herceptin on Day 1 of each 3-week cycle for 18 cycles. IV Herceptin was given as a 6-mg/kg dose during four consecutive cycles of the crossover period. If study treatment for Cycle 1 was IV Herceptin, the initial dose was a loading dose of 8 mg/kg (instead of 6 mg/kg) for de novo participants who started Herceptin treatment in the study. Administration was performed by HCP. | None | None | 2 | 237 | 76 | 237 | View |
| Cohort 2: IV Herceptin (Continuation) | Participants received Herceptin on Day 1 of each 3-week cycle for 18 cycles. In the continuation period, participants were planned to receive SC Herceptin via handheld syringe using the vial formulation for up to 10 remaining cycles. However, under protocol deviation a small number of participants received IV Herceptin as a 6-mg/kg dose for this period. Administration was performed by HCP. | None | None | 0 | 10 | 6 | 10 | View |
| Cohort 2: SC (Vial) Herceptin (Continuation) | Participants received Herceptin on Day 1 of each 3-week cycle for 18 cycles. In the continuation period, participants received SC Herceptin via handheld syringe using the vial formulation for up to 10 remaining cycles. Administration was performed by HCP. | None | None | 5 | 208 | 61 | 208 | View |
| Cohort 2 Overall: SC (Vial) and IV Herceptin | Participants received Herceptin on Day 1 of each 3-week cycle for 18 cycles, randomized to one of two crossover sequences: SC Herceptin via handheld syringe using the vial formulation for Cycles 1 to 4 followed by IV Herceptin for Cycles 5 to 8, or vice versa. In the continuation period, participants received SC Herceptin for up to 10 remaining cycles. Administration was performed by HCP throughout the study. If study treatment for Cycle 1 was IV Herceptin, the initial dose was a loading dose of 8 mg/kg for de novo participants who started Herceptin treatment in the study. For all other cycles where IV Herceptin was given and for non-de novo participants, the dose was 6 mg/kg. The SC dose was 600 mg for all cycles where SC Herceptin was given. | None | None | 7 | 239 | 154 | 239 | View |
| Cohort 1 Overall: SC (SID) and IV Herceptin | Participants received Herceptin on Day 1 of each 3-week cycle for 18 cycles, randomized to one of two crossover sequences: SC Herceptin via SID for Cycles 1 to 4 followed by IV Herceptin for Cycles 5 to 8, or vice versa. In the continuation period, participants received IV Herceptin for up to 10 remaining cycles. Administration was performed by HCP. Those with at least 2 treatment cycles remaining of the 18-cycle treatment course after the crossover period were offered the opportunity to self-administer SC Herceptin via SID under the direction of a trained HCP. If study treatment for Cycle 1 was IV Herceptin, the initial dose was a loading dose of 8 mg/kg for de novo participants who started Herceptin treatment in the study. For all other cycles where IV Herceptin was given and for non-de novo participants, the dose was 6 mg/kg. The SC dose was 600 mg for all cycles where SC Herceptin was given. | None | None | 12 | 244 | 130 | 244 | View |
Serious Events(If Any):
Serious Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Breast abscess | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (18.1) | View |
| Device related infection | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (18.1) | View |
| Influenza | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (18.1) | View |
| Postoperative wound infection | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (18.1) | View |
| Pyelonephritis | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (18.1) | View |
| Subcutaneous abscess | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (18.1) | View |
| Adverse drug reaction | NON_SYSTEMATIC_ASSESSMENT | General disorders | MedDRA (18.1) | View |
| Chest pain | NON_SYSTEMATIC_ASSESSMENT | General disorders | MedDRA (18.1) | View |
| Adenoma benign | NON_SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (18.1) | View |
| Cerebral haemangioma | NON_SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (18.1) | View |
| Dizziness | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA (18.1) | View |
| Mental disorder | NON_SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MedDRA (18.1) | View |
| Endometrial hypertrophy | NON_SYSTEMATIC_ASSESSMENT | Reproductive system and breast disorders | MedDRA (18.1) | View |
| Haematoma | NON_SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDRA (18.1) | View |
| Breast reconstruction | NON_SYSTEMATIC_ASSESSMENT | Surgical and medical procedures | MedDRA (18.1) | View |
| Knee arthroplasty | NON_SYSTEMATIC_ASSESSMENT | Surgical and medical procedures | MedDRA (18.1) | View |
| Mammoplasty | NON_SYSTEMATIC_ASSESSMENT | Surgical and medical procedures | MedDRA (18.1) | View |
| Wound infection | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (18.1) | View |
| Left ventricular dysfunction | NON_SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA (18.1) | View |
| Cholelithiasis | NON_SYSTEMATIC_ASSESSMENT | Hepatobiliary disorders | MedDRA (18.1) | View |
| Suture related complication | NON_SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA (18.1) | View |
Other Events(If Any):
Other Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Asthenia | NON_SYSTEMATIC_ASSESSMENT | General disorders | MedDRA (18.1) | View |
| Fatigue | NON_SYSTEMATIC_ASSESSMENT | General disorders | MedDRA (18.1) | View |
| Injection site reaction | NON_SYSTEMATIC_ASSESSMENT | General disorders | MedDRA (18.1) | View |
| Injection site erythema | NON_SYSTEMATIC_ASSESSMENT | General disorders | MedDRA (18.1) | View |
| Injection site pain | NON_SYSTEMATIC_ASSESSMENT | General disorders | MedDRA (18.1) | View |
| Arthralgia | NON_SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA (18.1) | View |
| Hot flush | NON_SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDRA (18.1) | View |
| Hypertension | NON_SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDRA (18.1) | View |
| Nausea | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (18.1) | View |
| Headache | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA (18.1) | View |
| Nasopharyngitis | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (18.1) | View |
| Chest pain | NON_SYSTEMATIC_ASSESSMENT | General disorders | MedDRA (18.1) | View |
| Medical device discomfort | NON_SYSTEMATIC_ASSESSMENT | General disorders | MedDRA (18.1) | View |
| Pain in extremity | NON_SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA (18.1) | View |
| Myalgia | NON_SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA (18.1) | View |
| Back pain | NON_SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA (18.1) | View |
| Bone pain | NON_SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA (18.1) | View |
| Lymphoedema | NON_SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDRA (18.1) | View |
| Thrombosis | NON_SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDRA (18.1) | View |
| Dizziness | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA (18.1) | View |
| Diarrhoea | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (18.1) | View |
| Dyspepsia | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (18.1) | View |
| Erythema | NON_SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA (18.1) | View |
| Toxic skin eruption | NON_SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA (18.1) | View |
| Cough | NON_SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA (18.1) | View |
| Sinus bradycardia | NON_SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA (18.1) | View |