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 @ 12:45 AM
Ignite Modification Date:
2025-12-25 @ 10:59 PM
NCT ID:
NCT03261167
Description:
Safety1 Population was used for assessment of nSAE and SAE during double-blind (Treatment Cycle 1). Safety2, Safety3 and Safety4 Population were used for assessment of nSAEs and SAEs during Treatment Cycles 2, 3 and 4, respectively. All participants received GSK1358820 400 U in open-label phase (Treatment Cycles 2, 3 and 4).
Frequency Threshold:
3
Time Frame:
Non-serious AE and SAE were collected from start of the study drug until Week 48 in double blind-phase (Treatment cycle1) and from day of injection in Treatment cycles 2, 3 and 4 until Week 48 (48 weeks after first treatment) for participants in the respective treatment cycles in Open-label phase.
Study:
NCT03261167
Study Brief:
A Phase III Study to Evaluate the Efficacy and Safety of GSK1358820 in Subjects With Post-stroke Upper Limb Spasticity
Event Groups(If Any):
Event Groups
| Title | Description | Deaths # Affected | Deaths # At Risk | Serious # Affected | Serious # At Risk | Other # Affected | Other # At Risk | View |
|---|---|---|---|---|---|---|---|---|
| GSK1358820 400 U (Double Blind-Treatment Cycle 1) | Participants were injected with a single dose of GSK1358820 240 U into the muscles that act on the wrist and GSK1358820 160 U was injected into the muscles that acted on elbow flexors on Day 1 during the double-blind phase. | 1 | None | 5 | 61 | 24 | 61 | View |
| GSK1358820 240 U (Open Label-Treatment Cycle 2) | Participants were injected with a single dose of GSK1358820 240 U into the muscles that act on the wrist and matching placebo was injected into the muscles that acted on elbow flexors on Day 1 during the double-blind phase. Participants who met the eligibility criteria for re-treatment between Week 12 to Week 36 were treated with GSK1358820 400 U injection in the open-label phase (Treatment cycle 2). | 0 | None | 1 | 60 | 7 | 60 | View |
| GSK1358820 400 U (Open labelTreatment Cycle 2) | Participants were injected with a single dose of GSK1358820 240 U into the muscles that act on the wrist and GSK1358820 160 U was injected into the muscles that acted on elbow flexors on Day 1 during the double-blind phase. Participants who met the eligibility criteria for re-treatment between Week 12 to Week 36 were treated with GSK1358820 400 U injection in the open-label phase (Treatment cycle 2). | 0 | None | 2 | 57 | 11 | 57 | View |
| GSK1358820 240 U (Double Blind-Treatment Cycle 1) | Participants were injected with a single dose of GSK1358820 240 U into the muscles that act on the wrist and matching placebo was injected into the muscles that acted on elbow flexors on Day 1 during the double-blind phase. | 0 | None | 4 | 63 | 19 | 63 | View |
| GSK1358820 240 U (Open Label-Treatment Cycle 3) | Participants were injected with a single dose of GSK1358820 240 U into the muscles that act on the wrist and matching placebo was injected into the muscles that acted on elbow flexors on Day 1 during the double-blind phase. Participants who met the eligibility criteria for re-treatment between Week 12 to Week 36 were treated with GSK1358820 400 U injections in Treatment cycle 2 and 3 of open-label phase with an interval of 12 weeks between treatments. | 0 | None | 2 | 55 | 12 | 55 | View |
| GSK1358820 400 U (Open Label-Treatment Cycle 3) | Participants were injected with a single dose of GSK1358820 240 U into the muscles that act on the wrist and GSK1358820 160 U was injected into the muscles that acted on elbow flexors on Day 1 during the double-blind phase. Participants who met the eligibility criteria for re-treatment between Week 12 to Week 36 were treated with GSK1358820 400 U injections in Treatment cycles 2 and 3 of open-label phase with an interval of 12 weeks between treatments. | 0 | None | 1 | 56 | 6 | 56 | View |
| GSK1358820 240 U (Open Label-Treatment Cycle 4) | Participants were injected with a single dose of GSK1358820 240 U into the muscles that act on the wrist and matching placebo was injected into the muscles that acted on elbow flexors on Day 1 during the double-blind phase. Participants who met the eligibility criteria for re-treatment between Week 12 to Week 36 were treated with GSK1358820 400 U injections in Treatment cycle 2, 3 and 4 of open-label phase with an interval of 12 weeks between treatments. | 0 | None | 0 | 43 | 7 | 43 | View |
| GSK1358820 400 U (Open Label-Treatment Cycle 4) | Participants were injected with a single dose of GSK1358820 240 U into the muscles that act on the wrist and GSK1358820 160 U was injected into the muscles that acted on elbow flexors on Day 1 during the double-blind phase. Participants who met the eligibility criteria for re-treatment between Week 12 to Week 36 were treated with GSK1358820 400 U injections in Treatment cycles 2, 3 and 4 of open-label phase with an interval of 12 weeks between treatments. | 0 | None | 2 | 40 | 13 | 40 | View |
Serious Events(If Any):
Serious Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Dementia Alzheimer's type | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA 21.1 | View |
| Pneumonia | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 21.1 | View |
| Lung infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 21.1 | View |
| Pyelonephritis | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 21.1 | View |
| Ankle fracture | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA 21.1 | View |
| Pelvic fracture | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA 21.1 | View |
| Spinal compression fracture | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA 21.1 | View |
| Altered state of consciousness | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA 21.1 | View |
| Cerebral haemorrhage | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA 21.1 | View |
| Decreased activity | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA 21.1 | View |
| Uterine leiomyoma | SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 21.1 | View |
| Delirium | SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MedDRA 21.1 | View |
| Cellulitis | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 21.1 | View |
| Prostate cancer | SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 21.1 | View |
| Cerebral infarction | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA 21.1 | View |
| Dysuria | SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | MedDRA 21.1 | View |
Other Events(If Any):
Other Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Nasopharyngitis | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 21.1 | View |
| Fall | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA 21.1 | View |
| Contusion | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA 21.1 | View |
| Insomnia | SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MedDRA 21.1 | View |
| Gingivitis | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 21.1 | View |
| Acute sinusitis | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 21.1 | View |
| Sinusitis | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 21.1 | View |
| Upper respiratory tract infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 21.1 | View |
| Cystitis | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 21.1 | View |
| Oral herpes | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 21.1 | View |
| Ligament sprain | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA 21.1 | View |
| Joint dislocation | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA 21.1 | View |
| Joint swelling | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA 21.1 | View |
| Limb injury | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA 21.1 | View |
| Contrast media allergy | SYSTEMATIC_ASSESSMENT | Immune system disorders | MedDRA 21.1 | View |
| Stomatitis | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 21.1 | View |
| Hypertension | SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDRA 21.1 | View |
| Seasonal allergy | SYSTEMATIC_ASSESSMENT | Immune system disorders | MedDRA 21.1 | View |
| Back pain | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA 21.1 | View |
| Alanine aminotransferase increased | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA 21.1 | View |
| Oxygen saturation decreased | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA 21.1 | View |
| Dental caries | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 21.1 | View |
| Musculoskeletal pain | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA 21.1 | View |
| Parkinsonism | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA 21.1 | View |
| Influenza | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 21.1 | View |
| Arthralgia | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA 21.1 | View |
| Muscle spasms | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA 21.1 | View |
| Constipation | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 21.1 | View |
| Haemorrhage subcutaneous | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA 21.1 | View |
| Hiccups | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA 21.1 | View |
| Nodule | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA 21.1 | View |