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 @ 2:13 AM
Ignite Modification Date: 2025-12-26 @ 12:41 AM
NCT ID: NCT03997760
Description: SAS included all participants randomized and who received any dose of IP.
Frequency Threshold: 5
Time Frame: From date of signing informed consent up to end of study visit (Day 28)
Study: NCT03997760
Study Brief: A Study of SHP655 (rADAMTS13) in Sickle Cell Disease
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Placebo Participants with SCD at their baseline health received a single IV infusion of placebo matched to TAK-755 at 3 dose levels of 40 IU/kg, 80 IU/kg, and 160 IU/kg on Day 1 and followed up for to 28 days. 0 None 0 5 2 5 View
TAK-755: 40 IU/kg Participants with SCD at their baseline health received a single IV infusion of TAK-755 at a dose level of 40 IU/kg on Day 1 and followed for up to 28 days. 0 None 1 4 2 4 View
TAK-755: 80 IU/kg Participants with SCD at their baseline health received a single IV infusion of TAK-755 at a dose level of 80 IU/kg on Day 1 and followed for up to 28 days. 0 None 0 6 4 6 View
TAK-755: 160 IU/kg Participants with SCD at their baseline health received a single IV infusion of TAK-755 at a dose level of 160 IU/kg on Day 1 and followed for up to 28 days. 0 None 0 4 2 4 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Sickle cell anaemia with crisis SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA 25 View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Abdominal pain SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 25 View
Alanine aminotransferase increased SYSTEMATIC_ASSESSMENT Investigations MedDRA 25 View
Arthralgia SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 25 View
Aspartate aminotransferase increased SYSTEMATIC_ASSESSMENT Investigations MedDRA 25 View
Back pain SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 25 View
Blood lactate dehydrogenase increased SYSTEMATIC_ASSESSMENT Investigations MedDRA 25 View
Dizziness SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 25 View
Fibrin D dimer increased SYSTEMATIC_ASSESSMENT Investigations MedDRA 25 View
Foot fracture SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 25 View
Headache SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 25 View
Hypokalaemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 25 View
Laryngitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 25 View
Muscle spasms SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 25 View
Musculoskeletal chest pain SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 25 View
Nasal congestion SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 25 View
Nausea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 25 View
Pain SYSTEMATIC_ASSESSMENT General disorders MedDRA 25 View
Pain in extremity SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 25 View
Pyrexia SYSTEMATIC_ASSESSMENT General disorders MedDRA 25 View
Rhinitis allergic SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 25 View
Sickle cell anaemia with crisis SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA 25 View
Upper respiratory tract infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 25 View
Vomiting SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 25 View