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 @ 6:59 PM
Ignite Modification Date:
2025-12-25 @ 4:32 PM
NCT ID:
NCT02573857
Description:
None
Frequency Threshold:
0
Time Frame:
Until end of study, 28 +/- 3 days
Study:
NCT02573857
Study Brief:
A Study to Characterise the Antimalarial and Transmission Blocking Activity of a Single Dose of DSM265 or OZ439 in Healthy Subjects With Induced Blood Stage Plasmodium Falciparum or Plasmodium Vivax Infection
Event Groups(If Any):
Event Groups
| Title | Description | Deaths # Affected | Deaths # At Risk | Serious # Affected | Serious # At Risk | Other # Affected | Other # At Risk | View |
|---|---|---|---|---|---|---|---|---|
| DSM265 P. Falciparum | Cohort 1: the efficacy of a single administration of 400 mg DSM265 for the clearance of asexual blood stages of P. falciparum will be determined. Activity of a second single dose of 400 mg DSM265 against gametocytes will be assessed in this cohort only if sexual stages are identified by PCR following the initial drug treatment. DSM265: Oral suspension from bulk powder | 0 | None | 0 | 8 | 8 | 8 | View |
| OZ439 P. Vivax | Cohort 2: subjects will be infected with P. vivax by IBSM, then treated with a single 200 mg dose OZ439. If recrudescence occurs following initial drug treatment with 200 mg OZ439, then affected participants who reach the treatment threshold will receive a single 400 mg dose of OZ439. OZ439: Oral suspension from powder in a bottle | 0 | None | 0 | 8 | 8 | 8 | View |
Serious Events(If Any):
Other Events(If Any):
Other Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Petechiae | NON_SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | (MedDRA® version19 | View |
| Pruritus | NON_SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | (MedDRA® version19 | View |
| Rash | NON_SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | (MedDRA® version19 | View |
| Rash generalised | NON_SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | (MedDRA® version19 | View |
| Urticaria | NON_SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | (MedDRA® version19 | View |
| Tachycardia | NON_SYSTEMATIC_ASSESSMENT | Cardiac disorders | (MedDRA® version19 | View |
| Abdominal discomfort | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | (MedDRA® version19 | View |
| Abdominal pain | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | (MedDRA® version19 | View |
| Abdominal tenderness | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | (MedDRA® version19 | View |
| Diarrhoea | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | (MedDRA® version19 | View |
| Gingival swelling | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | (MedDRA® version19 | View |
| Nausea | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | (MedDRA® version19 | View |
| Vomiting | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | (MedDRA® version19 | View |
| Administration site haematoma | NON_SYSTEMATIC_ASSESSMENT | General disorders | (MedDRA® version19 | View |
| Catheter site bruise | NON_SYSTEMATIC_ASSESSMENT | General disorders | (MedDRA® version19 | View |
| Catheter site pain | NON_SYSTEMATIC_ASSESSMENT | General disorders | (MedDRA® version19 | View |
| Chills | NON_SYSTEMATIC_ASSESSMENT | General disorders | (MedDRA® version19 | View |
| Fatigue | NON_SYSTEMATIC_ASSESSMENT | General disorders | (MedDRA® version19 | View |
| Influenza like illness | NON_SYSTEMATIC_ASSESSMENT | General disorders | (MedDRA® version19 | View |
| Malaise | NON_SYSTEMATIC_ASSESSMENT | General disorders | (MedDRA® version19 | View |
| Peripheral swelling | NON_SYSTEMATIC_ASSESSMENT | General disorders | (MedDRA® version19 | View |
| Pyrexia | NON_SYSTEMATIC_ASSESSMENT | General disorders | (MedDRA® version19 | View |
| Vessel puncture site thrombosis | NON_SYSTEMATIC_ASSESSMENT | General disorders | (MedDRA® version19 | View |
| Upper respiratory tract infection | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | (MedDRA® version19 | View |
| Arthropod bite | NON_SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | (MedDRA® version19 | View |
| Contusion | NON_SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | (MedDRA® version19 | View |
| Alanine aminotransferase increased | SYSTEMATIC_ASSESSMENT | Investigations | (MedDRA® version19 | View |
| Aspartate aminotransferase increased | SYSTEMATIC_ASSESSMENT | Investigations | (MedDRA® version19 | View |
| Cardiac murmur | NON_SYSTEMATIC_ASSESSMENT | Investigations | (MedDRA® version19 | View |
| Decreased appetite | NON_SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | (MedDRA® version19 | View |
| Arthralgia | NON_SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | (MedDRA® version19 | View |
| Muscle rigidity | NON_SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | (MedDRA® version19 | View |
| Musculoskeletal pain | NON_SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | (MedDRA® version19 | View |
| Myalgia | NON_SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | (MedDRA® version19 | View |
| Neck pain | NON_SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | (MedDRA® version19 | View |
| Headache | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | (MedDRA® version19 | View |
| Lethargy | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | (MedDRA® version19 | View |
| Diaphragmalgia | NON_SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | (MedDRA® version19 | View |
| Oropharyngeal pain | NON_SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | (MedDRA® version19 | View |
| Erythema | NON_SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | (MedDRA® version19 | View |
| Hyperhidrosis | NON_SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | (MedDRA® version19 | View |