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 @ 12:39 AM
Ignite Modification Date:
2025-12-25 @ 10:50 PM
NCT ID:
NCT01513967
Description:
All AEs reported from the time of informed consent for study participation were recorded. The investigator or designee and research site staff were responsible for the detection, documentation, and reporting of events meeting the definition of an AE or SAE.
Frequency Threshold:
0
Time Frame:
Part A - SAE. 24-hour post-dose. A Follow-up visit within 5 to 7 days, approximately, of the drug administration. Part B - MAD. 4 Weeks Treatment Phase. A Follow-up visit within 5 to 7 days, approximately, of their last drug administration.
Study:
NCT01513967
Study Brief:
A Randomized SAD and MAD Study Evaluating the Safety and Tolerability of RPh201 in Healthy Subjects and in Adults With Alzheimer's 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 |
|---|---|---|---|---|---|---|---|---|
| Part A, SAD Treatment 2 (10mg) | RPh201 single dose (SAD 10mg) RPh201, botanical drug product: SC administration at varying doses | None | None | 0 | 4 | 2 | 4 | View |
| Part B, MAD Treatment 1 (5mg) | RPh201 multiple dose (MAD 5mg) RPh201, botanical drug product: SC administration at varying doses | None | None | 0 | 4 | 3 | 4 | View |
| Part A, SAD Treatment 1 (5mg) | RPh201 single dose (SAD 5mg) RPh201, botanical drug product: SC administration at varying doses | None | None | 0 | 4 | 2 | 4 | View |
| Part A, SAD Treatment 3 (20mg) | RPh201 single dose (SAD 20mg) RPh201, botanical drug product: SC administration at varying doses | None | None | 0 | 4 | 1 | 4 | View |
| Part A, SAD Placebo | Placebo single dose (SAD) Placebo: SC administration at varying doses | None | None | 0 | 6 | 2 | 6 | View |
| Part B, MAD Treatment 2 (10mg) | RPh201 multiple dose (MAD 10mg) RPh201, botanical drug product: SC administration at varying doses | None | None | 0 | 4 | 4 | 4 | View |
| Part B, MAD Treatment 3 (20mg) | RPh201 multiple dose (MAD 20mg) RPh201, botanical drug product: SC administration at varying doses | None | None | 1 | 5 | 4 | 5 | View |
| Part B, MAD Placebo | Placebo multiple dose (MAD) Placebo: SC administration at varying doses | None | None | 0 | 8 | 4 | 8 | View |
Serious Events(If Any):
Serious Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Pregnancy | SYSTEMATIC_ASSESSMENT | Pregnancy, puerperium and perinatal conditions | MedDRA (15.0) | View |
Other Events(If Any):
Other Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Lymphadenopathy | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | MedDRA (15.0) | View |
| Eye discharge | SYSTEMATIC_ASSESSMENT | Eye disorders | MedDRA (15.0) | View |
| Paraesthesia oral | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA (15.0) | View |
| Injection site erythema | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA (15.0) | View |
| Injection site pain | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA (15.0) | View |
| Injection site pruritus | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA (15.0) | View |
| Headache | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA (15.0) | View |
| Hypermetropia | SYSTEMATIC_ASSESSMENT | Eye disorders | MedDRA (15.0) | View |
| Abdominal Pain | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (15.0) | View |
| Diarrhoea | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (15.0) | View |
| Dry mouth | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (15.0) | View |
| Oral mucosal erthema | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (15.0) | View |
| Fatigue | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA (15.0) | View |
| Injection site anaethesia | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA (15.0) | View |
| Injection site haematoma | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA (15.0) | View |
| Injection site induration | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA (15.0) | View |
| Injection site reaction | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA (15.0) | View |
| Local swelling | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA (15.0) | View |
| Malaise | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA (15.0) | View |
| Pain | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA (15.0) | View |
| Hordeolum | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (15.0) | View |
| Nasopharyngitis | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (15.0) | View |
| Upper respiratory tract infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (15.0) | View |
| Laceration | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA (15.0) | View |
| Urine analysis abnormal | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA (15.0) | View |
| Arthalgia | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA (15.0) | View |
| Pain in extremity | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA (15.0) | View |
| Dizziness | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA (15.0) | View |
| Hypoaesthesia | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA (15.0) | View |
| Rhinorrhoea | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA (15.0) | View |
| Ecchymosis | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA (15.0) | View |
| Erythema | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA (15.0) | View |
| Pruritis | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA (15.0) | View |
| Rash | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA (15.0) | View |
| Urticaria | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA (15.0) | View |
| Peripheral coldness | SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDRA (15.0) | View |
| Paraesthesia | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA (15.0) | View |