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| ID | Type | Description | Link |
|---|---|---|---|
| PHS-APIS-004-MEX-SOL-TAB | Other Identifier | Ministry of Health, Russian Federation |
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The main purpose of the clinical trial is to evaluate the efficacy and safety of Mexidol® in sequential treatment for patients in the acute and early recovery periods of ischemic stroke compared to placebo. The effect of adding Mexidol® to standard therapy on the degree of impairment of vital functions was assessed including the degree of disability (according to the Modified Rankin Scale, mRS), the severity of neurological symptoms (according to the National Institutes of Health Stroke Scale, NIHSS) and the level of mobility of patients (according to the Rivermead Mobility Index).
As the main purpose of the clinical study is to evaluate safety and efficacy of a neuroprotector (Mexidol®), it was crucial to develop strict protocol requirements that would help to avoid the challenges of estimation of neuroprotective effect for stroke therapy. The current treatment options for stroke are still limited and do not take into account rehabilitation period and patients' further quality of life.
As per protocol requirements, 313 participants were screened, 304 participants met all comprehensive eligibility criteria, 25 participants dropped out during the clinical trial period. The Modified Rankin Scale (mRS) was selected as the most representative primary outcome measuring tool due to the adequate representation of functional outcome. Additionally, the neuroprotective efficacy of Mexidol® was assessed for its ability to reduce stroke-related neurologic deficit, to improve mobility after stroke and to influence cognitive impairment and mood disorder symptoms.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Mexidol® | Experimental | Participants received Mexidol® IV 500 mg 2 times a day for 10 days, then Mexidol® FORTE 250 orally 250 mg 1 tablet 3 times a day for 60 days |
|
| Placebo | Placebo Comparator | Participants received Placebo matching Mexidol® IV 500 mg 2 times a day for 10 days, then Mexidol® FORTE 250 orally 250 mg 1 tablet 3 times a day for 60 days |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Mexidol (Ethylmethylhydroxypyridine Succinate) | Drug | 50 mg/ml IV solution, 250 mg tablets |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline in the Modified Rankin Scale (mRS) Scores at the End of the Course of Therapy | The Modified Rankin Scale (mRS) is used to measure the degree of disability in patients who have had a stroke. Possible scores range from 0 (no symptoms at all) to 5 (dead) [6 point scale: min value 0, max value 5, higher scores mean a worse outcome]. Change = (Visit 4, Day 71(+2) - Visit 0, Day 0-1 Scores). | Baseline, Day 71 |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Subjects Having Modified Rankin Scale (mRS) Scores >3 (Higher Degree of Disability) at the End of the Course of Therapy | The Modified Rankin Scale (mRS) is used to measure the degree of disability in patients who have had a stroke. Possible scores range from 0 (no symptoms at all) to 5 (dead) [6 point scale: min value 0, max value 5, higher scores mean a worse outcome]. | Day 71 |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Almaty City Hospital â„– 7 | Almaty | 050006 | Kazakhstan | |||
| Kazan City Hospital â„– 7 |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 40898634 | Background | Shamalov NA, Fedin AI, Rakhimbaeva GS, Nurguzhaev ES, Khasanova DR, Solovyova EY, Melnikova EV, Yanishevsky SN, Mashin VV, Pizova NV, Poverennova IE, Chuprina SE, Agafina AS, Roshkovskaya LV. [Results of the international multicenter randomized, double-blind, placebo-controlled clinical trial for the evaluation of the efficacy and safety of the sequential therapy with ethylmethylhydroxypyridine succinate in patients in the acute and early recovery periods of ischemic stroke (MIR)]. Zh Nevrol Psikhiatr Im S S Korsakova. 2025;125(8. Vyp. 2):40-53. doi: 10.17116/jnevro202512508240. Russian. | |
| 41456191 |
| Label | URL |
|---|---|
| Related Info | View source |
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| ID | Title | Description |
|---|---|---|
| FG000 | Mexidol® | Participants received Mexidol® IV 500 mg 2 times a day for 10 days, then Mexidol® FORTE 250 orally 250 mg 1 tablet 3 times a day for 60 days Mexidol: 50 mg/ml IV solution, 250 mg tablets |
| FG001 | Placebo | Participants received Mexidol Placebo matching Mexidol® IV 500 mg 2 times a day for 10 days, then Mexidol® FORTE 250 orally 250 mg 1 tablet 3 times a day for 60 days Placebo: Placebo IV solution, Placebo tablets |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Mexidol® | Participants received Mexidol® IV 500 mg 2 times a day for 10 days, then Mexidol® FORTE 250 orally 250 mg 1 tablet 3 times a day for 60 days Mexidol: 50 mg/ml IV solution, 250 mg tablets |
| BG001 | Placebo |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Change From Baseline in the Modified Rankin Scale (mRS) Scores at the End of the Course of Therapy | The Modified Rankin Scale (mRS) is used to measure the degree of disability in patients who have had a stroke. Possible scores range from 0 (no symptoms at all) to 5 (dead) [6 point scale: min value 0, max value 5, higher scores mean a worse outcome]. Change = (Visit 4, Day 71(+2) - Visit 0, Day 0-1 Scores). | Posted | Mean | 95% Confidence Interval | score on a scale | Baseline, Day 71 |
|
Throughout the study [From Day 1 up to Day 71]
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Mexidol® | Participants received Mexidol® IV 500 mg 2 times a day for 10 days, then Mexidol® FORTE 250 orally 250 mg 1 tablet 3 times a day for 60 days Mexidol: 50 mg/ml IV solution, 250 mg tablets |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Pneumonia | Infections and infestations | MedDRA version 26.1 | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Abdominal pain upper | Gastrointestinal disorders | MedDRA version 26.1 | Systematic Assessment |
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Meshcherskiy Y.E., Medical director | Pharmasoft | + 7 (495) 626-47-55 | 140 | pharmasoft@pharmasoft.ru |
Not provided
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Dec 14, 2022 | Oct 23, 2025 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Nov 12, 2021 | Apr 4, 2025 | SAP_001.pdf |
Not provided
| ID | Term |
|---|---|
| D000083242 | Ischemic Stroke |
| D020521 | Stroke |
| D002545 | Brain Ischemia |
| ID | Term |
|---|---|
| D002561 | Cerebrovascular Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
Not provided
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| ID | Term |
|---|---|
| C070020 | emoxypine succinate |
| C517040 | ethylmethylhydroxypyridine succinate |
Not provided
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| Placebo |
| Drug |
Placebo IV solution, Placebo tablets |
|
| Percentage of Subjects Having Modified Rankin Scale (mRS) Scores 0-1 (Normal or Lower Degree of Disability) at the End of the Course of Therapy | The Modified Rankin Scale (mRS) is used to measure the degree of disability in patients who have had a stroke. Possible scores range from 0 (no symptoms at all) to 5 (dead) [6 point scale: min value 0, max value 5, higher scores mean a worse outcome]. | Day 71 |
| Change From Baseline in the National Institutes of Health Stroke Scale (NIHSS) Score at the End of the Course of Therapy | The National Institutes of Health Stroke Scale (NIHSS) is a systematic assessment tool that provides a quantitative measure of stroke-related neurologic deficit. The NIHSS is a 15-item neurologic examination stroke scale used to evaluate the effect of acute cerebral infarction on the levels of consciousness, language, neglect, visual-field loss, extraocular movement, motor strength, ataxia, dysarthria, and sensory loss. Ratings for each item are scored with 3 to 5 grades with 0 as normal, and there is an allowance for untestable items. The individual scores from each item are summed in order to calculate a patient's total NIHSS score. The maximum possible score is 42 (severe stroke), with the minimum score being a 0 (no stroke symptoms) [43 point scale: min value 0, max value 42, higher scores mean a worse outcome]. Change = (Visit 4, Day 71(+2) - Visit 0, Day 0-1 Scores). | Baseline, Day 71 |
| Change From Baseline in the Rivermead Mobility Index (RMI) Score at the End of the Course of Therapy | The Rivermead Mobility Index (RMI) is a hierarchical mobility scale used in neurological rehabilitation. It includes 15 items related to bed mobility, transfers, walking, stair use, and running. The test is comprised of 14 questions, and the patient is then asked to stand for 10 seconds without any aid. Each response is scored yes or no with 1 point for each yes answer. The scores are summed with a range from 0 (poor mobility) to 15 (excellent mobility) [16 point scale: min value 0, max value 15, higher scores mean a better outcome]. Change = (Visit 4, Day 71(+2) - Visit 1, Day 1 Scores). | Baseline, Day 71 |
| Change From Baseline in the Montreal Cognitive Assessment (MoCA) Score at the End of the Course of Therapy | The Montreal Cognitive Assessment (MoCA) is a 30-point validated scale that covers multiple cognitive domains including spatiotemporal orientation, sustained attention, visuospatial function, executive function, verbal memory, language, naming, and abstract thinking [31 point scale: min value 0, max value 30, higher scores mean a better outcome]. Change = (Visit 4, Day 71(+2) - Visit 1, Day 1 Scores). | Baseline, Day 71 |
| Change From Baseline in the Hospital Anxiety and Depression Scale Score, Domain ANXIETY (HADS-A), at the End of the Course of Therapy | The Hospital Anxiety and Depression Scale (HADS) is a brief self-report measure that was specifically designed to screen for distinct dimensions of anxiety and depression in nonpsychiatric hospital departments; somatic symptoms were excluded [22 point scale for each domain (Anxiety or Depression): min value 0, max value 21, higher scores mean a worse outcome]. Change = (Visit 4, Day 71(+2) - Visit 1, Day 1 Scores). | Baseline, Day 71 |
| Change From Baseline in the Hospital Anxiety and Depression Scale Score, Domain DEPRESSION (HADS-D), at the End of the Course of Therapy | The Hospital Anxiety and Depression Scale (HADS) is a brief self-report measure that was specifically designed to screen for distinct dimensions of anxiety and depression in nonpsychiatric hospital departments; somatic symptoms were excluded [22 point scale for each domain (Anxiety or Depression): min value 0, max value 21, higher scores mean a worse outcome]. Change = (Visit 4, Day 71(+2) - Visit 1, Day 1 Scores). | Baseline, Day 71 |
| Kazan' |
| 420103 |
| Russia |
| Kemerovo City Clinical Hospital â„– 11 | Kemerovo | 650014 | Russia |
| Research Institute - Regional Clinical Hospital â„– 1 | Krasnodar | 350086 | Russia |
| Federal Center for Brain and Neurotechnology | Moscow | 117997 | Russia |
| Russian National Research Medical University n.a. N. I. Pirogov | Moscow | 117997 | Russia |
| Rostov State Medical University | Rostov-on-Don | 344022 | Russia |
| Alexandrovskaya Hospital | Saint Petersburg | 193312 | Russia |
| St. Petersburg Clinical Hospital â„– 26 | Saint Petersburg | 196247 | Russia |
| City Hospital â„– 40 of Kurortny District | Saint Petersburg | 197706 | Russia |
| Samara Regional Clinical Hospital n.a. V. D. Seredavin | Samara | 443095 | Russia |
| Central Clinical Medical and Sanitary Unit n.a. V. A. Egorov | Ulyanovsk | 432026 | Russia |
| Voronezh Regional Clinical Hospital â„– 1 | Voronezh | 394066 | Russia |
| Vsevolozhsk Clinical Interdistrict Hospital | Vsevolozhsk | 188643 | Russia |
| Yaroslavl Clinical Hospital â„– 2 (ICU) | Yaroslavl | 150030 | Russia |
| Yaroslavl Clinical Hospital â„– 2 | Yaroslavl | 150030 | Russia |
| The first clinic of the Tashkent Medical Academy | Tashkent | 100109 | Uzbekistan |
| Derived |
| Koltsov IA, Shchukin IA, Fidler MS, Glukhareva AP, Chubykin VI. [Multimodal antioxidant therapy in ischemic stroke: from MIR trial to bedside]. Zh Nevrol Psikhiatr Im S S Korsakova. 2025;125(12. Vyp. 2):64-71. doi: 10.17116/jnevro202512512264. Russian. |
Participants received Mexidol Placebo matching Mexidol® IV 500 mg 2 times a day for 10 days, then Mexidol® FORTE 250 orally 250 mg 1 tablet 3 times a day for 60 days
Placebo: Placebo IV solution, Placebo tablets
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Modified Rankin Scale (mRS) | The Modified Rankin Scale (mRS) is used to measure the degree of disability in patients who have had a stroke. Possible scores range from 0 (no symptoms at all) to 5 (dead). | Mean | Standard Deviation | units on a scale |
|
| Percentage of Subjects Having Modified Rankin Scale (mRS) Scores >3 (Higher Degree of Disability) | Count of Participants | Participants |
|
| Percentage of Subjects Having Modified Rankin Scale (mRS) Scores 0-1 (Normal or Lower Degree of Disa | Count of Participants | Participants |
|
| National Institutes of Health Stroke Scale (NIHSS) | The NIHSS is a systematic assessment tool for a quantitative measure of stroke-related neurologic deficit. It is a 15-item neurologic examination stroke scale used to evaluate the levels of consciousness, language, neglect, visual-field loss, extraocular movement, motor strength, ataxia, dysarthria, and sensory loss. The individual scores from each item are summed in order to calculate a patient's total NIHSS score. The maximum possible score is 42 (severe stroke), with the minimum score being a 0 (no stroke symptoms). | Median | Inter-Quartile Range | units on a scale |
|
| Rivermead Mobility Index (RMI) | The Rivermead Mobility Index (RMI) is a hierarchical mobility scale used in neurological rehabilitation. It includes 15 items related to bed mobility, transfers, standing, walking, stair use, and running. Each response is scored yes or no with 1 point for each yes answer. The scores are summed with a range from 0 (poor mobility) to 15 (excellent mobility). | Median | Inter-Quartile Range | units on a scale |
|
| Montreal Cognitive Assessment (MoCA test) | The Montreal Cognitive Assessment (MoCA) is a 30-point validated scale that covers multiple cognitive domains including spatiotemporal orientation, sustained attention, visuospatial function, executive function, verbal memory, language, naming, and abstract thinking. | Median | Inter-Quartile Range | units on a scale |
|
| Hospital Anxiety and Depression Scale, domain ANXIETY (HADS-A) | The Hospital Anxiety and Depression Scale (HADS) is a brief self-report measure that was specifically designed to screen for distinct dimensions of anxiety and depression in nonpsychiatric hospital departments; somatic symptoms were excluded [22 point scale for each domain (Anxiety or Depression): min value 0, max value 21, higher scores mean a worse outcome]. | Median | Inter-Quartile Range | units on a scale |
|
| Hospital Anxiety and Depression Scale, domain DEPRESSION (HADS-D) | The Hospital Anxiety and Depression Scale (HADS) is a brief self-report measure that was specifically designed to screen for distinct dimensions of anxiety and depression in nonpsychiatric hospital departments; somatic symptoms were excluded [22 point scale for each domain (Anxiety or Depression): min value 0, max value 21, higher scores mean a worse outcome]. | Median | Inter-Quartile Range | units on a scale |
|
Participants received Mexidol Placebo matching Mexidol® IV 500 mg 2 times a day for 10 days, then Mexidol® FORTE 250 orally 250 mg 1 tablet 3 times a day for 60 days
Placebo: Placebo IV solution, Placebo tablets
|
|
| Secondary | Percentage of Subjects Having Modified Rankin Scale (mRS) Scores >3 (Higher Degree of Disability) at the End of the Course of Therapy | The Modified Rankin Scale (mRS) is used to measure the degree of disability in patients who have had a stroke. Possible scores range from 0 (no symptoms at all) to 5 (dead) [6 point scale: min value 0, max value 5, higher scores mean a worse outcome]. | Posted | Count of Participants | Participants | Day 71 |
|
|
|
| Secondary | Percentage of Subjects Having Modified Rankin Scale (mRS) Scores 0-1 (Normal or Lower Degree of Disability) at the End of the Course of Therapy | The Modified Rankin Scale (mRS) is used to measure the degree of disability in patients who have had a stroke. Possible scores range from 0 (no symptoms at all) to 5 (dead) [6 point scale: min value 0, max value 5, higher scores mean a worse outcome]. | Posted | Count of Participants | Participants | Day 71 |
|
|
|
| Secondary | Change From Baseline in the National Institutes of Health Stroke Scale (NIHSS) Score at the End of the Course of Therapy | The National Institutes of Health Stroke Scale (NIHSS) is a systematic assessment tool that provides a quantitative measure of stroke-related neurologic deficit. The NIHSS is a 15-item neurologic examination stroke scale used to evaluate the effect of acute cerebral infarction on the levels of consciousness, language, neglect, visual-field loss, extraocular movement, motor strength, ataxia, dysarthria, and sensory loss. Ratings for each item are scored with 3 to 5 grades with 0 as normal, and there is an allowance for untestable items. The individual scores from each item are summed in order to calculate a patient's total NIHSS score. The maximum possible score is 42 (severe stroke), with the minimum score being a 0 (no stroke symptoms) [43 point scale: min value 0, max value 42, higher scores mean a worse outcome]. Change = (Visit 4, Day 71(+2) - Visit 0, Day 0-1 Scores). | The number of participants assessed with this scale is 276 as it does not include the assessment of fatal outcomes, unlike the modified Rankin scale. | Posted | Median | Inter-Quartile Range | score on a scale | Baseline, Day 71 |
|
|
|
| Secondary | Change From Baseline in the Rivermead Mobility Index (RMI) Score at the End of the Course of Therapy | The Rivermead Mobility Index (RMI) is a hierarchical mobility scale used in neurological rehabilitation. It includes 15 items related to bed mobility, transfers, walking, stair use, and running. The test is comprised of 14 questions, and the patient is then asked to stand for 10 seconds without any aid. Each response is scored yes or no with 1 point for each yes answer. The scores are summed with a range from 0 (poor mobility) to 15 (excellent mobility) [16 point scale: min value 0, max value 15, higher scores mean a better outcome]. Change = (Visit 4, Day 71(+2) - Visit 1, Day 1 Scores). | The number of participants assessed with this scale is 276 as it does not include the assessment of fatal outcomes, unlike the modified Rankin scale. | Posted | Median | Inter-Quartile Range | score on a scale | Baseline, Day 71 |
|
|
|
| Secondary | Change From Baseline in the Montreal Cognitive Assessment (MoCA) Score at the End of the Course of Therapy | The Montreal Cognitive Assessment (MoCA) is a 30-point validated scale that covers multiple cognitive domains including spatiotemporal orientation, sustained attention, visuospatial function, executive function, verbal memory, language, naming, and abstract thinking [31 point scale: min value 0, max value 30, higher scores mean a better outcome]. Change = (Visit 4, Day 71(+2) - Visit 1, Day 1 Scores). | The number of participants assessed with this scale is 276 as it does not include the assessment of fatal outcomes, unlike the modified Rankin scale. | Posted | Median | Inter-Quartile Range | score on a scale | Baseline, Day 71 |
|
|
|
| Secondary | Change From Baseline in the Hospital Anxiety and Depression Scale Score, Domain ANXIETY (HADS-A), at the End of the Course of Therapy | The Hospital Anxiety and Depression Scale (HADS) is a brief self-report measure that was specifically designed to screen for distinct dimensions of anxiety and depression in nonpsychiatric hospital departments; somatic symptoms were excluded [22 point scale for each domain (Anxiety or Depression): min value 0, max value 21, higher scores mean a worse outcome]. Change = (Visit 4, Day 71(+2) - Visit 1, Day 1 Scores). | The number of participants assessed with this scale is 276 as it does not include the assessment of fatal outcomes, unlike the modified Rankin scale. | Posted | Median | Inter-Quartile Range | score on a scale | Baseline, Day 71 |
|
|
|
| Secondary | Change From Baseline in the Hospital Anxiety and Depression Scale Score, Domain DEPRESSION (HADS-D), at the End of the Course of Therapy | The Hospital Anxiety and Depression Scale (HADS) is a brief self-report measure that was specifically designed to screen for distinct dimensions of anxiety and depression in nonpsychiatric hospital departments; somatic symptoms were excluded [22 point scale for each domain (Anxiety or Depression): min value 0, max value 21, higher scores mean a worse outcome]. Change = (Visit 4, Day 71(+2) - Visit 1, Day 1 Scores). | The number of participants assessed with this scale is 276 as it does not include the assessment of fatal outcomes, unlike the modified Rankin scale. | Posted | Median | Inter-Quartile Range | score on a scale | Baseline, Day 71 |
|
|
|
| 2 |
| 152 |
| 6 |
| 152 |
| 36 |
| 152 |
| EG001 | Placebo | Participants received Mexidol Placebo matching Mexidol® IV 500 mg 2 times a day for 10 days, then Mexidol® FORTE 250 orally 250 mg 1 tablet 3 times a day for 60 days Placebo: Placebo IV solution, Placebo tablets | 1 | 152 | 4 | 152 | 39 | 152 |
| Ischaemic stroke | Nervous system disorders | MedDRA version 26.1 | Systematic Assessment |
|
| Brain oedema | Nervous system disorders | MedDRA version 26.1 | Systematic Assessment |
|
| Cerebral infarction | Nervous system disorders | MedDRA version 26.1 | Systematic Assessment |
|
| Pneumonia viral | Infections and infestations | MedDRA version 26.1 | Systematic Assessment |
|
| COVID-19 pneumonia | Infections and infestations | MedDRA version 26.1 | Systematic Assessment |
|
| Cerebrovascular accident | Nervous system disorders | MedDRA version 26.1 | Systematic Assessment |
|
| COVID-19 | Infections and infestations | MedDRA version 26.1 | Systematic Assessment |
|
| Diarrhoea | Gastrointestinal disorders | MedDRA version 26.1 | Systematic Assessment |
|
| Constipation | Gastrointestinal disorders | MedDRA version 26.1 | Systematic Assessment |
|
| Epigastric discomfort | Gastrointestinal disorders | MedDRA version 26.1 | Systematic Assessment |
|
| Dyspepsia | Gastrointestinal disorders | MedDRA version 26.1 | Systematic Assessment |
|
| Upper respiratory tract infection | Infections and infestations | MedDRA version 26.1 | Systematic Assessment |
|
| COVID-19 | Infections and infestations | MedDRA version 26.1 | Systematic Assessment |
|
| Pharyngitis | Infections and infestations | MedDRA version 26.1 | Systematic Assessment |
|
| Rhinitis | Infections and infestations | MedDRA version 26.1 | Systematic Assessment |
|
| Urinary tract infection | Infections and infestations | MedDRA version 26.1 | Systematic Assessment |
|
| Pyelonephritis acute | Infections and infestations | MedDRA version 26.1 | Systematic Assessment |
|
| Latent syphilis | Infections and infestations | MedDRA version 26.1 | Systematic Assessment |
|
| Hepatitis C | Infections and infestations | MedDRA version 26.1 | Systematic Assessment |
|
| Blood pressure increased | Investigations | MedDRA version 26.1 | Systematic Assessment |
|
| Blood pressure decreased | Investigations | MedDRA version 26.1 | Systematic Assessment |
|
| Transaminases increased | Investigations | MedDRA version 26.1 | Systematic Assessment |
|
| Hepatic enzyme increased | Investigations | MedDRA version 26.1 | Systematic Assessment |
|
| Hyperglycaemia | Metabolism and nutrition disorders | MedDRA version 26.1 | Systematic Assessment |
|
| Cell death | Metabolism and nutrition disorders | MedDRA version 26.1 | Systematic Assessment |
|
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA version 26.1 | Systematic Assessment |
|
| Bronchitis chronic | Respiratory, thoracic and mediastinal disorders | MedDRA version 26.1 | Systematic Assessment |
|
| Rhinorrhoea | Respiratory, thoracic and mediastinal disorders | MedDRA version 26.1 | Systematic Assessment |
|
| Skin exfoliation | Skin and subcutaneous tissue disorders | MedDRA version 26.1 | Systematic Assessment |
|
| Dermatitis | Skin and subcutaneous tissue disorders | MedDRA version 26.1 | Systematic Assessment |
|
| Night sweats | Skin and subcutaneous tissue disorders | MedDRA version 26.1 | Systematic Assessment |
|
| Thrombocytosis | Blood and lymphatic system disorders | MedDRA version 26.1 | Systematic Assessment |
|
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA version 26.1 | Systematic Assessment |
|
| Pain in extremity | Musculoskeletal and connective tissue disorders | MedDRA version 26.1 | Systematic Assessment |
|
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA version 26.1 | Systematic Assessment |
|
| Osteoarthritis | Musculoskeletal and connective tissue disorders | MedDRA version 26.1 | Systematic Assessment |
|
| Muscle spasms | Musculoskeletal and connective tissue disorders | MedDRA version 26.1 | Systematic Assessment |
|
| Headache | Nervous system disorders | MedDRA version 26.1 | Systematic Assessment |
|
| Muscular weakness | Nervous system disorders | MedDRA version 26.1 | Systematic Assessment |
|
| Carotid artery occlusion | Nervous system disorders | MedDRA version 26.1 | Systematic Assessment |
|
| Insomnia | Psychiatric disorders | MedDRA version 26.1 | Systematic Assessment |
|
| Dysuria | Renal and urinary disorders | MedDRA version 26.1 | Systematic Assessment |
|
| Urinary retention | Renal and urinary disorders | MedDRA version 26.1 | Systematic Assessment |
|
| Bradycardia | Cardiac disorders | MedDRA version 26.1 | Systematic Assessment |
|
| Palpitations | Cardiac disorders | MedDRA version 26.1 | Systematic Assessment |
|
| Tachycardia | Cardiac disorders | MedDRA version 26.1 | Systematic Assessment |
|
| Atrial fibrillation | Cardiac disorders | MedDRA version 26.1 | Systematic Assessment |
|
| Hypertensive crisis | Vascular disorders | MedDRA version 26.1 | Systematic Assessment |
|
Not provided
Not provided
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |