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 @ 10:52 PM
Ignite Modification Date:
2025-12-25 @ 8:21 PM
NCT ID:
NCT03705169
Description:
The DAIDS Adverse Event Grading Table(V2.1), July 2017 was used. Participants receiving placebo are pooled w/in arm per the analysis plan. AEs were recorded if:
* Grade ≥2 AE
* Any AE leading to change in study treatment
* AE meeting the Serious Adverse Event definition or Expedited Adverse Event reporting requirement
* Grade ≥1 rash, urticaria, angioedema, ALT, AST, WBC counts, eosinophilia, AIDS-defining illness, or lab finding the day of or w/in 2 wks of treatment administration
Frequency Threshold:
0
Time Frame:
From study entry to study completion (36 weeks after the final infusion for Cohort 4 and 24 weeks after the first infusion/injection for other cohorts) or premature study discontinuation.
Study:
NCT03705169
Study Brief:
Pharmacokinetics and Safety of SAR441236
Event Groups(If Any):
Event Groups
| Title | Description | Deaths # Affected | Deaths # At Risk | Serious # Affected | Serious # At Risk | Other # Affected | Other # At Risk | View |
|---|---|---|---|---|---|---|---|---|
| Arm A: 1mg/kg SAR441236 | Participants continued on non-study-provided ART and received 1 mg/kg of SAR441236, administered as a single intravenous (IV) infusion on Day 0 (Cohort 1). SAR441236: Administered by intravenous (IV) infusion(s) or subcutaneous (SC) injection(s) | 0 | None | 1 | 4 | 2 | 4 | View |
| Arm A: 3 mg/kg SAR441236 | Experimental: Arm A: 3 mg/kg SAR441236 Participants continued on non-study-provided ART, and received 3 mg/kg of SAR441236, administered as a single IV infusion on Day 0 (Cohort 2). SAR441236: Administered by intravenous (IV) infusion(s) or subcutaneous (SC) injection(s) | 0 | None | 0 | 4 | 4 | 4 | View |
| Arm A: 10 mg/kg SAR441236 | Participants continued non-study-provided ART and received 10 mg/kg of SAR441236, administered as a single IV infusion on Day 0 (Cohort 3). SAR441236: Administered by intravenous (IV) infusion(s) or subcutaneous (SC) injection(s) | 0 | None | 0 | 4 | 3 | 4 | View |
| Arm A: 30 mg/kg SAR441236 | Participants continued non-study-provided ART and received 30 mg/kg of SAR441236, administered as an IV infusion on Day 0 and then every 12 weeks for a total of four doses (Cohort 4). SAR441236: Administered by intravenous (IV) infusion(s) or subcutaneous (SC) injection(s) | 0 | None | 2 | 11 | 8 | 11 | View |
| Arm C: 0.3 mg/kg SAR441236 | Participants continued non-study-provided ART and received 0.3 mg/kg of SAR441236, administered as a subcutaneous (SC) injection(s) on Day 0 (Cohort 10). SAR441236: Administered by intravenous (IV) infusion(s) or subcutaneous (SC) injection(s) | 0 | None | 0 | 4 | 1 | 4 | View |
| Arm C: 0 mg/kg SAR441236 | Placebo participants were pooled across those receiving: * 0.3 mg/kg dose volume-equivalent administered as an SC injection(s) (Cohort 10). * 1 mg/kg dose volume-equivalent administered as an SC injection(s) (Cohort 11). All continued on non-study provided ART. Placebo: Administered by intravenous (IV) infusion(s) or subcutaneous (SC) injection(s) | 0 | None | 0 | 4 | 3 | 4 | View |
| Arm A: 0 mg/kg SAR441236 | Placebo participants were pooled across those receiving: * 1 mg/kg dose volume-equivalent administered as a single IV infusion (Cohort 1). * 3 mg/kg dose volume-equivalent administered as a single IV infusion (Cohort 2). * 10 mg/kg dose volume-equivalent administered as a single IV infusion (Cohort 3) * 30 mg/kg dose volume-equivalent administered as an IV infusion on Day 0 and then every 12 weeks for a total of four doses (Cohort 4) All continued on non-study provided ART. Placebo: Administered by intravenous (IV) infusion(s) or subcutaneous (SC) injection(s) | 0 | None | 0 | 10 | 8 | 10 | View |
| Arm B: 1 mg/kg SAR441236 | Participants received 1 mg/kg of SAR441236, administered as a single IV infusion on Day 0. Antiretroviral treatment was initiated or re-initiated by Day 28 (Cohort 5). SAR441236: Administered by intravenous (IV) infusion(s) or subcutaneous (SC) injection(s) | 0 | None | 1 | 5 | 5 | 5 | View |
| Arm B: 30 mg/kg SAR441236 | Participants received 30 mg/kg of SAR441236, administered as a single IV infusion on Day 0. Antiretroviral treatment was initiated or re-initiated by Day 28 (Cohort 8). SAR441236: Administered by intravenous (IV) infusion(s) or subcutaneous (SC) injection(s) | 0 | None | 0 | 2 | 0 | 2 | View |
| Arm C: 1 mg/kg SAR441236 | Participants continued non-study-provided ART and received 1 mg/kg of SAR441236, administered as an SC injection(s) on Day 0 (Cohort 11). SAR441236: Administered by intravenous (IV) infusion(s) or subcutaneous (SC) injection(s) | 0 | None | 0 | 4 | 3 | 4 | View |
Serious Events(If Any):
Serious Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Pneumonia | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 26.0 | View |
| Soft tissue infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 26.0 | View |
| Malignant melanoma | SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 26.0 | View |
| Suicidal ideation | SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MedDRA 26.0 | View |
Other Events(If Any):
Other Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Spondylolisthesis | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA 26.0 | View |
| Trigger finger | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA 26.0 | View |
| Diabetic neuropathy | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA 26.0 | View |
| Headache | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA 26.0 | View |
| Hypoaesthesia | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA 26.0 | View |
| Paraesthesia | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA 26.0 | View |
| Parkinson's disease | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA 26.0 | View |
| Presyncope | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA 26.0 | View |
| Seizure | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA 26.0 | View |
| Somnolence | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA 26.0 | View |
| Alcohol withdrawal syndrome | SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MedDRA 26.0 | View |
| Insomnia | SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MedDRA 26.0 | View |
| Glycosuria | SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | MedDRA 26.0 | View |
| Cough | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA 26.0 | View |
| Dyspnoea exertional | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA 26.0 | View |
| Nasal congestion | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA 26.0 | View |
| Ecchymosis | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA 26.0 | View |
| Rash | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA 26.0 | View |
| Hot flush | SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDRA 26.0 | View |
| External ear pain | SYSTEMATIC_ASSESSMENT | Ear and labyrinth disorders | MedDRA 26.0 | View |
| Abdominal pain | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 26.0 | View |
| Abdominal pain upper | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 26.0 | View |
| Diarrhoea | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 26.0 | View |
| Gastrooesophageal reflux disease | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 26.0 | View |
| Nausea | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 26.0 | View |
| Asthenia | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA 26.0 | View |
| Chills | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA 26.0 | View |
| Fatigue | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA 26.0 | View |
| Injection site erythema | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA 26.0 | View |
| Injection site swelling | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA 26.0 | View |
| Localised oedema | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA 26.0 | View |
| Malaise | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA 26.0 | View |
| Oedema peripheral | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA 26.0 | View |
| Pain | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA 26.0 | View |
| Bronchitis | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 26.0 | View |
| Cellulitis | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 26.0 | View |
| Fungal foot infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 26.0 | View |
| Fungal skin infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 26.0 | View |
| Influenza | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 26.0 | View |
| Otitis media | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 26.0 | View |
| Pharyngitis streptococcal | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 26.0 | View |
| Tooth infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 26.0 | View |
| Upper respiratory tract infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 26.0 | View |
| Joint dislocation | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA 26.0 | View |
| Skin laceration | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA 26.0 | View |
| Alanine aminotransferase increased | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA 26.0 | View |
| Aspartate aminotransferase increased | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA 26.0 | View |
| Blood albumin decreased | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA 26.0 | View |
| Blood bicarbonate decreased | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA 26.0 | View |
| Blood creatinine increased | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA 26.0 | View |
| Blood glucose increased | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA 26.0 | View |
| Blood sodium increased | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA 26.0 | View |
| Blood uric acid increased | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA 26.0 | View |
| Creatinine renal clearance decreased | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA 26.0 | View |
| Neutrophil count decreased | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA 26.0 | View |
| Decreased appetite | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA 26.0 | View |
| Hyperglycaemia | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA 26.0 | View |
| Hypokalaemia | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA 26.0 | View |
| Back pain | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA 26.0 | View |
| Lumbar spinal stenosis | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA 26.0 | View |
| Muscle spasms | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA 26.0 | View |