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 @ 2:19 PM
Ignite Modification Date:
2025-12-25 @ 12:56 PM
NCT ID:
NCT03177395
Description:
None
Frequency Threshold:
0
Time Frame:
Adverse events / adverse reactions were assessed at baseline, 2, 2.5, 10, 20 and 22 hours as well as ad hoc and as part of follow up. Following discharge, patients were followed up using their electronic records. AE data were collected 7, 30 and 90 days after randomisation
Study:
NCT03177395
Study Brief:
PP100-01 (Calmangafodipir) for Overdose of Paracetamol
Event Groups(If Any):
Event Groups
| Title | Description | Deaths # Affected | Deaths # At Risk | Serious # Affected | Serious # At Risk | Other # Affected | Other # At Risk | View |
|---|---|---|---|---|---|---|---|---|
| Acetylcysteine (N-acetylcysteine; NAC) | NAC infusion 100mg/kg in 200ml 'loading dose' at timepoint '0'. 12 hour NAC regime will be continued with the second dose: 200mg/kg NAC in 1000ml i.v. over 10hr as per standard care protocol in NHS Lothian. | 0 | None | 2 | 6 | 6 | 6 | View |
| Group A: PP100-01 (Calmangafodipir 2 Umol/kg)+ NAC | In addition to the standard care NAC regime, participants will be allocated into a dosing cohort to receive: PP100-01 (2 umol/kg calmangafodipir) after the "loading" dose of NAC PP100-01 treatment is administered intravenously over 5 minutes. PP100-01 (calmangafodipir): PP100-01 | 0 | None | 4 | 6 | 6 | 6 | View |
| Group B: PP100-01 (Calmangafodipir 5 Umol/kg)+ NAC | In addition to the standard care NAC regime, participants will be allocated into a dosing cohort to receive: PP100-01 (5 umol/kg calmangafodipir) after the "loading" dose of NAC PP100-01 treatment is administered intravenously over 5 minutes. PP100-01 (calmangafodipir): PP100-01 | 1 | None | 2 | 6 | 6 | 6 | View |
| Group C: PP100-01 (Calmangafodipir 10 Umol/kg)+ NAC | In addition to the standard care NAC regime, participants will be allocated into a dosing cohort to receive: PP100-01 (5 umol/kg calmangafodipir) after the "loading" dose of NAC PP100-01 (10 umol/kg calmangafodipir) after the "loading" dose of NAC PP100-01 treatment is administered intravenously over 5 minutes. PP100-01 (calmangafodipir): PP100-01 | 0 | None | 3 | 6 | 6 | 6 | View |
Serious Events(If Any):
Serious Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| cardiac disorders | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA | View |
| Gastrointestinal disorders | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA | View |
| Infections and infestations | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA | View |
| Injury, poisoning and procedural complications | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA | View |
| Nervous system disorders | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA | View |
| Psychiatric disorders | SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MedDRA | View |
| Vascular disorders | SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDRA | View |
Other Events(If Any):
Other Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Ventricular extrasystoles | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA | View |
| Nausea | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA | View |
| Pyrexia | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA | View |
| Otitis externa | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA | View |
| Overdose | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA | View |
| Hypokalemia | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA | View |
| Back Pain | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA | View |
| Dizziness | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA | View |
| Alcohol withdrawal syndrome | SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MedDRA | View |
| Dysuria | SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | MedDRA | View |
| Respiration abnormal | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA | View |
| Hyperhidrosis | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA | View |
| Hypotension | SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDRA | View |
| Tachycardia | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA | View |
| heart block | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA | View |
| vomiting | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA | View |
| abdominal pain | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA | View |
| Retching | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA | View |
| Hypoaethesia oral | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA | View |
| chest pain | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA | View |
| Pneumonia | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA | View |
| Tubo-ovarian abscess | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA | View |
| Pharyngitis | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA | View |
| Pyelonephritis | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA | View |
| Fall | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA | View |
| Soft tissue injury | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA | View |
| ntentional product misuse | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA | View |
| Headache | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA | View |
| Anxiety | SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MedDRA | View |
| migraine | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA | View |
| substance abuse | SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MedDRA | View |
| Wheezing | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA | View |
| Dyspnoea | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA | View |