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 @ 4:17 AM
Ignite Modification Date: 2025-12-26 @ 3:18 AM
NCT ID: NCT01489020
Description: None
Frequency Threshold: 5
Time Frame: None
Study: NCT01489020
Study Brief: Subcutaneous Immunotherapy in Patients Sensitized to Dermatophagoides Pteronyssinus (DPT)
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Group A Active 6 administrations and 5 weeks duration 1. Vial 2: 0.1 ml, 0.2 ml and 0.5 ml at 1 week intervals 2. Vial 3: 0.1 ml, 0.2 ml and 0.5 ml at 1 week intervals. subcutaneous immunotherapy with DPT extract: Increasing doses of subcutaneous immunotherapy in three different scales up to the maximum dose of 500 TSU (Treatment Standardized Units) or placebo 0 None 1 12 12 12 View
Group B Active 8 administrations and 7 weeks duration 1. Vial 1: 0.2 ml at 1 week intervals 2. Vial 2: 0.1 ml, 0.2 ml, 0.4 ml at 1 week intervals 3. Vial 3: 0.1 ml, 0.2 ml, 0.4 ml and 0.5 ml at 1 week intervals subcutaneous immunotherapy with DPT extract: Increasing doses of subcutaneous immunotherapy in three different scales up to the maximum dose of 500 TSU (Treatment Standardized Units) or placebo 0 None 3 12 11 12 View
Group B Placebo 8 administrations and 7 weeks duration 1. Vial 1: 0.2 ml at 1 week intervals 2. Vial 2: 0.1 ml, 0.2 ml, 0.4 ml at 1 week intervals 3. Vial 3: 0.1 ml, 0.2 ml, 0.4 ml and 0.5 ml at 1 week intervals subcutaneous depot placebo 0 None 0 4 2 4 View
Group C Placebo 8 administrations, 2 administrations in the same day. 1 week interval between 2 doses, during 3 weeks. 1. Week 1: vial 2 - 2 administrations of 0.1 ml with 30 minute interval 2. Week 2: vial 2 - 0.2 ml and 0.3 ml with 30 minute interval 3. Week 3: vial 3 - 2 doses of 0.1 ml with 30 minute interval 4. Week 4: vial 3 - 0.2 ml and 0.3 ml with 30 minute interval subcutaneous depot placebo 0 None 0 4 1 4 View
Group C Active 8 administrations, 2 administrations in the same day. 1 week interval between 2 doses, during 3 weeks. 1. Week 1: vial 2 - 2 administrations of 0.1 ml with 30 minute interval 2. Week 2: vial 2 - 0.2 ml and 0.3 ml with 30 minute interval 3. Week 3: vial 3 - 2 doses of 0.1 ml with 30 minute interval 4. Week 4: vial 3 - 0.2 ml and 0.3 ml with 30 minute interval subcutaneous immunotherapy with DPT extract: Increasing doses of subcutaneous immunotherapy in three different scales up to the maximum dose of 500 TSU (Treatment Standardized Units) or placebo 0 None 3 12 8 12 View
Group A Placebo 6 administrations and 5 weeks duration 1. Vial 2: 0.1 ml, 0.2 ml and 0.5 ml at 1 week intervals 2. Vial 3: 0.1 ml, 0.2 ml and 0.5 ml at 1 week intervals. subcutaneous depot placebo 0 None 0 4 1 4 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Otitis None Ear and labyrinth disorders MedDRA 10.0 View
pyrosis None Gastrointestinal disorders MedDRA 10.0 View
Facial edema None Skin and subcutaneous tissue disorders MedDRA 10.0 View
urticaria None Skin and subcutaneous tissue disorders MedDRA 10.0 View
Edema in upper extremities None Skin and subcutaneous tissue disorders MedDRA 10.0 View
broncoconstriction None Respiratory, thoracic and mediastinal disorders MedDRA 10.0 View
diarrhea None Gastrointestinal disorders MedDRA 10.0 View
allergic rhinoconjunctivitis None Immune system disorders MedDRA 10.0 View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
cephalea None Nervous system disorders MedDRA (10.0) View
Cold None Infections and infestations MedDRA (10.0) View
alterations injection site None General disorders MedDRA (10.0) View