Adverse Events Module

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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 @ 4:27 PM
Ignite Modification Date: 2025-12-25 @ 2:20 PM
NCT ID: NCT01724866
Description: The Safety Population included all randomized participants who had received at least one dose of any protocol specified drug (i.e., docetaxel, cyclophosphamide, SPI-2012 or pegfilgrastim).
Frequency Threshold: 5
Time Frame: From the first dose up to 30 days post last dose of study drug (up to 4 months)
Study: NCT01724866
Study Brief: Phase 2 Study of SPI-2012 or Pegfilgrastim for the Management of Neutropenia in Participants With 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 1: SPI-2012 45 µg/kg and TC Participants received SPI-2012 45 µg/kg, SC once per cycle on Day 2 of each cycle up to cycle 4 (each cycle was 21 days), approximately 24 hours after the administration of TC chemotherapy. TC chemotherapy was administered on Day 1 of each cycle as follows: Docetaxel 75 mg/m\^2 IV infusion over 60 minutes and Cyclophosphamide 600 mg/m\^2 IV infusion over 30-60 minutes. 0 None 5 39 36 39 View
Arm 2: SPI-2012 135 µg/kg and TC Participants received SPI-2012 135 µg/kg, SC once per cycle on Day 2 of each cycle up to cycle 4 (each cycle was 21 days), approximately 24 hours after the administration of TC chemotherapy. TC chemotherapy was administered on Day 1 of each cycle as follows: Docetaxel 75 mg/m\^2 IV infusion over 60 minutes and Cyclophosphamide 600 mg/m\^2 IV infusion over 30-60 minutes. 0 None 4 37 33 37 View
Arm 3: SPI-2012 270 µg/kg and TC Participants received SPI-2012 270 µg/kg, SC once per cycle on Day 2 of each cycle up to cycle 4 (each cycle was 21 days), approximately 24 hours after the administration of TC chemotherapy. TC chemotherapy was administered on Day 1 of each cycle as follows: Docetaxel 75 mg/m\^2 IV infusion over 60 minutes and Cyclophosphamide 600 mg/m\^2 IV infusion over 30-60 minutes. 0 None 2 36 33 36 View
Arm 4: Pegfilgrastim and TC Participants received Pegfilgrastim 6 mg, SC once per cycle on Day 2 of each cycle up to cycle 4 (each cycle was 21 days), approximately 24 hours after the administration of TC chemotherapy. TC chemotherapy was administered on Day 1 of each cycle as follows: Docetaxel 75 mg/m\^2 IV infusion over 60 minutes and Cyclophosphamide 600 mg/m\^2 IV infusion over 30-60 minutes. 0 None 8 36 35 36 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Febrile neutropenia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA (13.1) View
Angina pectoris SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA (13.1) View
Atrial fibrillation SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA (13.1) View
Diarrhoea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA (13.1) View
Nausea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA (13.1) View
Vomiting SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA (13.1) View
Non-cardiac chest pain SYSTEMATIC_ASSESSMENT General disorders MedDRA (13.1) View
Pyrexia SYSTEMATIC_ASSESSMENT General disorders MedDRA (13.1) View
Bacteraemia SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA (13.1) View
Diverticulitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA (13.1) View
Gastritis viral SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA (13.1) View
Pneumonia SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA (13.1) View
Road traffic accident SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA (13.1) View
Dehydration SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA (13.1) View
Back pain SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA (13.1) View
Renal failure acute SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA (13.1) View
Vaginal haemorrhage SYSTEMATIC_ASSESSMENT Reproductive system and breast disorders MedDRA (13.1) View
Urticaria SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA (13.1) View
Cellulitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA (13.1) View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Bone pain SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA (13.1) View
Headache SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA (13.1) View
Alopecia SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA (13.1) View
Insomnia SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA (13.1) View
Diarrhoea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA (13.1) View
Nausea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA (13.1) View
Asthenia SYSTEMATIC_ASSESSMENT General disorders MedDRA (13.1) View
Fatigue SYSTEMATIC_ASSESSMENT General disorders MedDRA (13.1) View