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: 2025-12-25 @ 12:02 AM
Ignite Modification Date: 2025-12-25 @ 9:59 PM
NCT ID: NCT00883558
Description: None
Frequency Threshold: 3
Time Frame: An adverse event was considered treatment-emergent if the start date of the event was on or after the date of randomization.
Study: NCT00883558
Study Brief: Safety Study of Subcutaneously-Injected Prandial INSULIN-PH20 NP Compared to Insulin Lispro Injection in Participants With Type 1 Diabetes Mellitus
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
INSULIN-PH20 NP Treatment Period 100 units per milliliter (U/mL) non-preserved formulation of recombinant human insulin with 5.0 micrograms per milliliter (µg/mL) recombinant human hyaluronidase (INSULIN-PH20 NP), injected subcutaneously before meals, with doses titrated to each individual participant's glycemic control needs, for 3 months. None None 2 45 17 45 View
Insulin Lispro Treatment Period 100 units per milliliter (U/mL) insulin lispro, injected subcutaneously before meals, with doses titrated to each individual participant's glycemic control needs, for 3 months. None None 1 43 11 43 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Intervertebral disc degeneration SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA (12.0) View
Uterine haemorrhage SYSTEMATIC_ASSESSMENT Reproductive system and breast disorders MedDRA (12.0) View
Haemothorax SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA (12.0) View
Rib fracture SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA (12.0) View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Cough SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA (12.0) View
Back pain SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA (12.0) View
Hypoglycaemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA (12.0) View
Hypertension SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA (12.0) View
Upper respiratory tract infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA (12.0) View
Bronchitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA (12.0) View
Nasopharyngitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA (12.0) View
Sinusitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA (12.0) View
Fungal infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA (12.0) View
Food poisoning SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA (12.0) View
Injection site haematoma SYSTEMATIC_ASSESSMENT General disorders MedDRA (12.0) View