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 @ 9:22 PM
Ignite Modification Date: 2025-12-25 @ 7:08 PM
NCT ID: NCT02722304
Description: Study was terminated early. One arm/ group (ARALAST NP 120 mg/kg (Group 2)) did not have any participants randomized to it at the time of the study termination. Therefore there are zero participants at risk. This applies to the following fields, below for the ARALAST NP 120 mg/kg (Group 2) arm/group: - participants at risk for Serious Adverse Events - participants at risk for All-Cause Mortality - participants at risk for Other (Not Including Serious) Adverse Events
Frequency Threshold: 0
Time Frame: From start of study treatment up to early termination of the study (approximately 22 months)
Study: NCT02722304
Study Brief: Stage 1 Study of ARALAST NP and GLASSIA in A1PI Deficiency
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
ARALAST NP 60 mg/kg (Group 1) Participants received 60 milligram per kilogram body weight per week (mg/kg BW/week) of ARALAST NP intravenous (IV) infusion for a total of 96 weeks. 0 None 0 1 1 1 View
ARALAST NP 120 mg/kg (Group 2) Participants received 120 mg/kg BW/week of ARALAST NP IV infusion for a total of 96 weeks. 0 None 0 0 0 0 View
GLASSIA 60 mg/kg (Group 3) Participants received 60 mg/kg BW/week of GLASSIA IV infusion for a total of 96 weeks. 0 None 0 1 0 1 View
GLASSIA 120 mg/kg (Group 4) Participants received 120 mg/kg BW/week of GLASSIA IV infusion for a total of 96 weeks. 0 None 0 1 0 1 View
Placebo (Group 5) Participants received 6 milliliter per kilogram body weight per week (ml/kg BW/week) of placebo (human albumin two percent \[%\]) in normal saline for a total of 96 weeks. 0 None 0 2 2 2 View
Serious Events(If Any):
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Right Eye Retinal Detachment NON_SYSTEMATIC_ASSESSMENT Eye disorders MedDRA 21.0 View
Headache NON_SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 21.0 View
Nausea NON_SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 21.0 View
CONTACT DERMATITIS NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 21.0 View
site conditions/ Catheter site rash/ MILD RASH AT THE SITE OF TAPE USED AT IV CANNULA SITE NON_SYSTEMATIC_ASSESSMENT General disorders MedDRA 21.0 View
Vaginal haemorrhage/ PER VAGINAL BLEEDING NON_SYSTEMATIC_ASSESSMENT Reproductive system and breast disorders MedDRA 21.0 View
Chronic obstructive pulmonary disease/ COPD EXACERBATION NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 21.0 View
DIARRHOEA NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 21.0 View