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 @ 12:59 AM
Ignite Modification Date:
2025-12-25 @ 11:13 PM
NCT ID:
NCT00128193
Description:
Solicited reactions were assessed by clinic staff at Days 0, 3, and 7, and at Day 28 if reactions were present at Day 7. Participants are counting as having the reaction if present at any of these days. Events are counted separately for the solicited reactions at each injection site.
Frequency Threshold:
5
Time Frame:
Serious and non-serious adverse events were collected for the duration of the participant's participation in the study, up to 28 days after study product administration.
Study:
NCT00128193
Study Brief:
Leprosy Skin Test Antigens Trial
Event Groups(If Any):
Event Groups
| Title | Description | Deaths # Affected | Deaths # At Risk | Serious # Affected | Serious # At Risk | Other # Affected | Other # At Risk | View |
|---|---|---|---|---|---|---|---|---|
| A1 - MLSA in Healthy Non-Exposed Participants | 5 healthy non-exposed participants received 1.0 mcg of Mycobacterium (M.) leprae Soluble Antigen (MLSA)-Lipoarabinomannan (LAM), 0.1 mcg of MLSA-LAM, 5 tuberculin units (TU) Purified Protein Derivative(PPD)/Tubersol®, saline (NaCl) | None | None | 0 | 5 | 5 | 5 | View |
| A2 - MLC in Healthy Non-Exposed Participants | 5 healthy non-exposed participants received 1.0 mcg of M. leprae Cell Wall Antigen (MLCwA), 0.1 mcg of MLCwA, 5 TU Purified Protein Derivative/Tubersol®, saline (NaCl) | None | None | 0 | 5 | 4 | 5 | View |
| B1 - MLSA in Healthy Non-Exposed Participants | 45 healthy non-exposed participants received 1.0 mcg of MLSA-LAM, 0.1 mcg of MLSA-LAM, 5 TU Purified Protein Derivative/Tubersol®, saline (NaCl) | None | None | 2 | 45 | 36 | 45 | View |
| B2 - MLC in Healthy Non-Exposed Participants | 45 healthy non-exposed participants received 1.0 mcg of MLCwA, 0.1 mcg of MLCwA, 5 TU Purified Protein Derivative/Tubersol®, saline (NaCl) | None | None | 0 | 45 | 35 | 45 | View |
| C1 - High Dose MLSA and MLC in BL/LL Leprosy Patients | 20 borderline lepromatous/lepromatous (BL/LL) leprosy patients received 1.0 mcg of MLSA-LAM, 1.0 mcg of MLCwA and 2TU Purified Protein Derivative/RT-23 | None | None | 0 | 20 | 13 | 20 | View |
| C1 - High Dose MLSA and MLC in BT/TT Leprosy Patients | 20 borderline tuberculoid/tuberculoid (BT/TT) leprosy patients received 1.0 mcg of MLSA-LAM, 1.0 mcg of MLCwA and 2TU Purified Protein Derivative/RT-23 | None | None | 0 | 20 | 15 | 20 | View |
| C1 - High Dose MLSA and MLC in BL/LL Healthy Contacts | 20 healthy contacts of BL/LL leprosy patients received 1.0 mcg of MLSA-LAM, 1.0 mcg of MLCwA and 2TU Purified Protein Derivative/RT-23 | None | None | 0 | 20 | 19 | 20 | View |
| CI - High Dose MLSA and MLC in TB Patients | 20 tuberculosis (TB) patients received 1.0 mcg of MLSA-LAM, 1.0 mcg of MLCwA and 2TU Purified Protein Derivative/RT-23 | None | None | 0 | 20 | 20 | 20 | View |
| C1b - Low Dose MLSA and MLC in BT/TT Leprosy Patients | 20 borderline tuberculoid/tuberculoid (BT/TT) leprosy patients received 0.1 mcg MLSA-LAM, 0.1 mcg MLCwA, 2 TU Purified Protein Derivative/RT-23. | None | None | 0 | 20 | 16 | 20 | View |
| C1b - Low Dose MLSA and MLC in TB Patients | 20 TB patients received 0.1 mcg MLSA-LAM, 0.1 mcg MLCwA, 2 TU Purified Protein Derivative/RT-23. | None | None | 0 | 20 | 20 | 20 | View |
| C1b - Low Dose MLSA and MLC in BL/LL Leprosy Patients | 20 borderline lepromatous/lepromatous (BL/LL) leprosy patients received 0.1 mcg MLSA-LAM, 0.1 mcg MLCwA, 2 TU Purified Protein Derivative/RT-23 | None | None | 0 | 20 | 11 | 20 | View |
| C1b - Low Dose MLSA and MLC in Healthy Contacts | 20 healthy contacts of BL/LL leprosy patients received 0.1 mcg MLSA-LAM, 0.1 mcg MLCwA, 2 TU Purified Protein Derivative/RT-23. | None | None | 0 | 20 | 18 | 20 | View |
Other Events(If Any):
Other Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Erythema | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA 13.1 | View |
| Induration | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA 13.1 | View |
| Pruritis | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA 13.1 | View |
| Pain | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA 13.1 | View |
| Haemorrhage | SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDRA 13.1 | View |
| Urticaria | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA 13.1 | View |
| Infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 13.1 | View |
| Blister | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA 13.1 | View |
| Type IV hypersensitivity reaction | NON_SYSTEMATIC_ASSESSMENT | Immune system disorders | MedDRA 12.1 | View |