Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| ACCESS Community Health Network | OTHER |
| University of Sydney | OTHER |
Not provided
Not provided
Not provided
Not provided
To investigate, in a double-blind randomized controlled trial, whether initiating treatment with ultra-low-dose quadruple-combination therapy ("LDQT") will lower office blood pressure more effectively, and with fewer side effects, compared to initiating standard dose monotherapy as per current guidelines in patients with hypertension.
Primary hypothesis: A combination pill comprising four types of blood pressure lowering medications, each at one-quarter standard doses, will lower office blood pressure more effectively than initiating patients with standard dose monotherapy as per contemporary clinical practice guideline recommendations.
This trial will investigate whether initiating treatment with ultra-low-dose quadruple-combination therapy (LDQT; including candesartan 2 mg, amlodipine 1.25 mg, indapamide 0.625 mg, and bisoprolol 2.5 mg) will lower automated office blood pressure and 24-hour ambulatory blood pressure at 12 weeks more effectively, and with no increase in side effects, compared to initiating standard dose monotherapy (candesartan 8 mg) in adults with raised blood pressure (SBP>130 mmHg or DBP>80 mmHg) and without cardiovascular disease. Our preliminary data from a short-term (4-week) crossover trial of 18 participants suggest that LDQT lowers office blood pressure by 22/13 mmHg on average compared with placebo with no difference in serious adverse events. Effects on 24-hour ambulatory blood pressure were similar.
The investigators will perform this phase II, single site, randomized controlled trial in a network of federally qualified health centers in Chicago because this population bears a disproportionate burden of blood pressure related diseases, and the investigators have previously successfully conducted clinical studies in this population.
While the investigators hypothesize this intervention will be easily implemented and efficacious for all patients and clinicians, the investigators will explore variation in treatment effect by potential moderating variables, including age, sex, race/ethnicity, and health literacy level. Beyond examining efficacy, the investigators also plan to assess feasibility of implementing this intervention in a clinical setting by simultaneously evaluating implementation outcomes of acceptability, preferences, and lessons of LDQT among patients and clinicians.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| QUARTET LDQT | Experimental | Patients randomized to the intervention arm will take a once daily ultra-low-dose quadruple combination therapy (QUARTET LDQT). The LDQT is an overencapsulated combination pill comprising four types of blood pressure lowering medications each at ¼ standard doses. QUARTET includes candesartan 2mg, amlodipine besylate 1.25mg, indapamide 0.625mg, and bisoprolol 2.5mg. The individual components are currently approved and marketed within the United States. |
|
| Candesartan | Active Comparator | Patients randomized to the comparison arm will take a once daily 8mg candesartan. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| QUARTET LDQT | Drug | Ultra-low-dose combination therapy comprising four different blood pressure lowering drugs at 1/4 dosages. Taken once daily for 12 weeks. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change in Mean Systolic Blood Pressure | Mean change (from baseline) in automated office systolic blood pressure adjusted for baseline values. | 12 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Mean Systolic Blood Pressure | Mean automated office systolic blood pressure adjusted for baseline values. | 6 weeks |
| Change in Mean Diastolic Blood Pressure | Mean change (from baseline) in automated office diastolic blood pressure adjusted for baseline values. |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants With Serious Adverse Events (SAEs) | Percentage of participants with any Serious Adverse Events (SAE) according to Good Clinical Practice definition: adverse events that result in death, are life threatening, require hospitalization or prolong existing hospitalization, result in persistent disability, result in congenital anomaly or birth defect, or unimportant medical event that requires intervention to prevent any of the above. |
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Mark D Huffman, PhD, MD | Northwestern University | Principal Investigator |
| Jody D Ciolino, PhD | Overall Study Officials: | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| ACCESS Martin T. Russo Family Health Center | Bloomingdale | Illinois | 60108 | United States | ||
| Ashland Family Health Center |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 38584159 | Derived | Huffman MD, Baldridge AS, Lazar D, Abbas H, Mejia J, Flowers FM, Quintana A, Jackson A, Kandula NR, Lloyd-Jones DM, Persell SD, Khan SS, Paparello JJ, Chopra A, Tripathi P, Vu MH, Chow CK, Ciolino JD. Efficacy and safety of a four-drug, quarter-dose treatment for hypertension: the QUARTET USA randomized trial. Hypertens Res. 2024 Jun;47(6):1668-1677. doi: 10.1038/s41440-024-01658-y. Epub 2024 Apr 8. | |
| 38156601 |
Not provided
Not provided
Individual participant data will be shared through NHLBI BioLINCC.
Data will be available within 1 year of study conclusion.
Access to study data will be managed through NHLBI BioLINCC
Not provided
NA - all enrolled participants were randomized.
120 were consented and assessed for eligibility. 58 were excluded for not meeting either inclusion or exclusion criteria, declining participation, or not showing up for randomization visits. Thus, these 58 individuals were not randomized, and 62 participants were randomized
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | QUARTET LDQT | Patients randomized to the intervention arm took a once daily ultra-low-dose quadruple combination therapy (QUARTET LDQT). The LDQT is an overencapsulated combination pill comprising four types of blood pressure lowering medications each at ¼ standard doses. QUARTET includes candesartan 2mg, amlodipine besylate 1.25mg, indapamide 0.625mg, and bisoprolol 2.5mg. The individual components are currently approved and marketed within the United States. QUARTET LDQT: Ultra-low-dose combination therapy comprising four different blood pressure lowering drugs at 1/4 dosages. Taken once daily for 12 weeks. |
| FG001 | Candesartan | Patients randomized to the comparison arm took a once daily 8mg candesartan. Candesartan: Standard monotherapy of 8mg candesartan. Taken once daily for 12 weeks. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | QUARTET LDQT | Patients randomized to the intervention arm took a once daily ultra-low-dose quadruple combination therapy (QUARTET LDQT). The LDQT is an overencapsulated combination pill comprising four types of blood pressure lowering medications each at ¼ standard doses. QUARTET includes candesartan 2mg, amlodipine besylate 1.25mg, indapamide 0.625mg, and bisoprolol 2.5mg. The individual components are currently approved and marketed within the United States. QUARTET LDQT: Ultra-low-dose combination therapy comprising four different blood pressure lowering drugs at 1/4 dosages. Taken once daily for 12 weeks. |
| 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 in Mean Systolic Blood Pressure | Mean change (from baseline) in automated office systolic blood pressure adjusted for baseline values. | Modified intent to treat whereby all those participants with data at any follow-up time point and baseline to contribute to analyses will be included in analyses according to arm to which they were randomized, regardless of adherence to the study protocol. | Posted | Least Squares Mean | 95% Confidence Interval | mm Hg | 12 weeks |
|
12 weeks
Same as clinicaltrials.gov definition.
A known side effects checklist (included in protocol and consent) was used as a dropdown list for site staff to populate as appropriate at each participant encounter. Any reported side effects from this list were documented as an AE. If an AE did not meet any of these pre-specified terms, the site staff would document 'other' and specify. At specified intervals, a blinded third party MedDRA coder would enter the MedDRA terms into the safety database.
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | QUARTET LDQT | Patients randomized to the intervention arm will take a once daily ultra-low-dose quadruple combination therapy (QUARTET LDQT). The LDQT is an overencapsulated combination pill comprising four types of blood pressure lowering medications each at ¼ standard doses. QUARTET includes candesartan 2mg, amlodipine besylate 1.25mg, indapamide 0.625mg, and bisoprolol 2.5mg. The individual components are currently approved and marketed within the United States. QUARTET LDQT: Ultra-low-dose combination therapy comprising four different blood pressure lowering drugs at 1/4 dosages. Taken once daily for 12 weeks. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Road Traffic Accident | Injury, poisoning and procedural complications | MedDRA 23.0 | Systematic Assessment | Motor Vehicle Accident. Severity: Severe. Outcome: Resolved with sequelae. Blinded relatedness assessment: Unrelated. Investigational product action taken: Temporarily Withdrawn. Resulted in hospitalization. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Vision blurred | Eye disorders | MedDRA 23.0 | Systematic Assessment | 2 Total events:
|
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Guhan Iyer | Washington University in St. Louis | 3147479487 | guhaniyer@wustl.edu |
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 | Apr 20, 2022 | May 30, 2023 | Prot_001.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Feb 9, 2022 | May 30, 2023 | SAP_002.pdf |
| ICF | No | No | Yes | Informed Consent Form | Aug 13, 2020 | Aug 14, 2020 | ICF_000.pdf |
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D006973 | Hypertension |
| ID | Term |
|---|---|
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| C081643 | candesartan |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Candesartan | Drug | Standard monotherapy of 8mg candesartan. Taken once daily for 12 weeks. |
|
| 6 weeks |
| Mean Diastolic Blood Pressure | Mean automated office diastolic blood pressure adjusted for baseline values. | 6 weeks |
| Proportion of Patients With Hypertension Control | Proportion of patients with hypertension control (percent with SBP < 130 mmHg and DBP <80 mmHg). | 6 and 12 weeks |
| Number of Patients Requiring Step up Treatment | Number of patients requiring step-up treatment. | 6 weeks |
| Proportion of Patients With Adverse Event Free Hypertension Control | Proportion of patients with adverse event free hypertension control (percent with SBP < 130 mmHg and DBP <80 mmHg). | 12 weeks |
| Medication Adherence | Medication adherence defined by objective pill counts | 12 weeks |
| Health-related Quality of Life | Mean change (from baseline) in health-related quality of life using Patient-Reported Outcomes Measurement Information System (PROMIS) Global Health instrument. PROMIS Global Health is a gauge of general health-care related quality of life. Possible PROMIS Global Physical Health and Global Mental Health scores range from 0-20, with 20 indicating best possible state of health. Raw scores are converted to T-scores to compare to a standardized population. A PROMIS T-score of 50 represents the mean of the population (SD = 10). Higher values here also indicate better health. A positive change in T score, as reported in this outcome measure, would represent an improvement in Global Physical Health or Global Mental Health at 12 weeks compared to baseline. | 12 weeks |
| Change in Mean Systolic Blood Pressure | Mean change (from baseline) in automated office systolic blood pressure adjusted for baseline values. | 6 weeks |
| 12 weeks |
| Percentage of Participants With Potentially Related Adverse Events | Percentage of participants with occurrence of any potentially related adverse event (pre-specified as in study procedures). Defined as: At least possibly related to study drug. | 12 weeks |
| Rate of Adverse Events of Special Interest | Rate of pre-specified adverse events that are known side effects of active ingredients at the participant level. | 12 weeks |
| Mean Change in Serum Potassium | Mean change (from baseline) in continuous serum potassium. | 12 weeks |
| Mean Change in Serum Sodium | Mean change (from baseline) in continuous serum sodium. | 12 weeks |
| Mean Change in Blood Urea Nitrogen | Mean change (from baseline) in continuous blood urea nitrogen. | 12 weeks |
| Mean Change in Serum Creatinine | Mean change in continuous serum creatinine. | 12 weeks |
| Chicago |
| Illinois |
| 60609 |
| United States |
| Derived |
| Sanuade OA, Jacobson TA, Quintana A, Flowers FM, Abbasi H, Vu MH, Baldridge AS, Mejia J, Lazar D, Ciolino JD, Huffman MD, Kandula NR. Process Evaluation of a Double-Blind Randomized Controlled Trial to Assess the Efficacy and Safety of a Quadruple Ultra-Low-Dose Treatment for Hypertension Within a Federally Qualified Health Center Network (QUARTET USA). J Am Heart Assoc. 2024 Jan 2;13(1):e032236. doi: 10.1161/JAHA.123.032236. Epub 2023 Dec 29. |
| 36116516 | Derived | Baldridge AS, Huffman MD, Lazar D, Abbas H, Flowers FM, Quintana A, Jackson A, Khan SS, Chopra A, Vu M, Tripathi P, Jacobson T, Sanuade OA, Kandula NR, Persell SD, Paparello JJ, Rosul LL, Mejia J, Lloyd-Jones DM, Chow CK, Ciolino JD. Efficacy and safety of a quadruple ultra-low-dose treatment for hypertension (QUARTET USA): Rationale and design for a randomized controlled trial. Am Heart J. 2022 Dec;254:183-193. doi: 10.1016/j.ahj.2022.09.004. Epub 2022 Sep 15. |
| BG001 | Candesartan | Patients randomized to the comparison arm took a once daily 8mg candesartan. Candesartan: Standard monotherapy of 8mg candesartan. Taken once daily for 12 weeks. |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Count of Participants | Participants |
|
| Body Mass Index, kg/m^2 | Mean | Standard Deviation | kg/m^2 |
|
| Heart rate, beats per minute | Mean | Standard Deviation | beats per minute |
|
| History of diabetes, n (%) | Count of Participants | Participants |
|
| History of smoking, n (%) | Count of Participants | Participants |
|
| History of depression, n (%) | Count of Participants | Participants |
|
| Weekly alcohol use, n (%) | Count of Participants | Participants |
|
| Systolic Blood Pressure, mm Hg | Mean | Standard Deviation | mm Hg |
|
| Diastolic Blood Pressure, mm Hg | Mean | Standard Deviation | mm Hg |
|
| OG001 | Candesartan | Patients randomized to the comparison arm took a once daily 8mg candesartan. Candesartan: Standard monotherapy of 8mg candesartan. Taken once daily for 12 weeks. |
|
|
|
| Secondary | Mean Systolic Blood Pressure | Mean automated office systolic blood pressure adjusted for baseline values. | Modified intent to treat whereby all those participants with data at any follow-up time point and baseline to contribute to analyses will be included in analyses according to arm to which they were randomized, regardless of adherence to the study protocol. | Posted | Least Squares Mean | 95% Confidence Interval | mm Hg | 6 weeks |
|
|
|
|
| Secondary | Change in Mean Diastolic Blood Pressure | Mean change (from baseline) in automated office diastolic blood pressure adjusted for baseline values. | Modified intent to treat whereby all those participants with data at any follow-up time point and baseline to contribute to analyses will be included in analyses according to arm to which they were randomized, regardless of adherence to the study protocol. | Posted | Least Squares Mean | 95% Confidence Interval | mm Hg | 6 weeks |
|
|
|
|
| Secondary | Mean Diastolic Blood Pressure | Mean automated office diastolic blood pressure adjusted for baseline values. | Modified intent to treat whereby all those participants with data at any follow-up time point and baseline to contribute to analyses will be included in analyses according to arm to which they were randomized, regardless of adherence to the study protocol. | Posted | Least Squares Mean | 95% Confidence Interval | mm Hg | 6 weeks |
|
|
|
|
| Secondary | Proportion of Patients With Hypertension Control | Proportion of patients with hypertension control (percent with SBP < 130 mmHg and DBP <80 mmHg). | Modified intent to treat whereby all those participants with data at any follow-up time point and baseline to contribute to analyses will be included in analyses according to arm to which they were randomized, regardless of adherence to the study protocol. | Posted | Number | proportion of participants | 6 and 12 weeks |
|
|
|
|
| Secondary | Number of Patients Requiring Step up Treatment | Number of patients requiring step-up treatment. | Modified intent to treat whereby all those participants with data at any follow-up time point and baseline to contribute to analyses will be included in analyses according to arm to which they were randomized, regardless of adherence to the study protocol. | Posted | Count of Participants | Participants | 6 weeks |
|
|
|
|
| Secondary | Proportion of Patients With Adverse Event Free Hypertension Control | Proportion of patients with adverse event free hypertension control (percent with SBP < 130 mmHg and DBP <80 mmHg). | Modified intent to treat whereby all those participants with data at any follow-up time point and baseline to contribute to analyses will be included in analyses according to arm to which they were randomized, regardless of adherence to the study protocol. | Posted | Count of Participants | Participants | 12 weeks |
|
|
|
|
| Secondary | Medication Adherence | Medication adherence defined by objective pill counts | Modified intent to treat whereby all those participants with data at any follow-up time point and baseline to contribute to analyses will be included in analyses according to arm to which they were randomized, regardless of adherence to the study protocol. | Posted | Count of Participants | Participants | 12 weeks |
|
|
|
|
| Secondary | Health-related Quality of Life | Mean change (from baseline) in health-related quality of life using Patient-Reported Outcomes Measurement Information System (PROMIS) Global Health instrument. PROMIS Global Health is a gauge of general health-care related quality of life. Possible PROMIS Global Physical Health and Global Mental Health scores range from 0-20, with 20 indicating best possible state of health. Raw scores are converted to T-scores to compare to a standardized population. A PROMIS T-score of 50 represents the mean of the population (SD = 10). Higher values here also indicate better health. A positive change in T score, as reported in this outcome measure, would represent an improvement in Global Physical Health or Global Mental Health at 12 weeks compared to baseline. | Data are available on only 28 participants in the intervention group for the mental health T score. | Posted | Least Squares Mean | Standard Deviation | score on a scale | 12 weeks |
|
|
|
|
| Secondary | Change in Mean Systolic Blood Pressure | Mean change (from baseline) in automated office systolic blood pressure adjusted for baseline values. | Modified intent to treat whereby all those participants with data at any follow-up time point and baseline to contribute to analyses will be included in analyses according to arm to which they were randomized, regardless of adherence to the study protocol. | Posted | Least Squares Mean | 95% Confidence Interval | mm Hg | 6 weeks |
|
|
|
|
| Other Pre-specified | Percentage of Participants With Serious Adverse Events (SAEs) | Percentage of participants with any Serious Adverse Events (SAE) according to Good Clinical Practice definition: adverse events that result in death, are life threatening, require hospitalization or prolong existing hospitalization, result in persistent disability, result in congenital anomaly or birth defect, or unimportant medical event that requires intervention to prevent any of the above. | All randomized participants | Posted | Count of Participants | Participants | 12 weeks |
|
|
|
|
| Other Pre-specified | Percentage of Participants With Potentially Related Adverse Events | Percentage of participants with occurrence of any potentially related adverse event (pre-specified as in study procedures). Defined as: At least possibly related to study drug. | All randomized participants | Posted | Count of Participants | Participants | 12 weeks |
|
|
|
|
| Other Pre-specified | Rate of Adverse Events of Special Interest | Rate of pre-specified adverse events that are known side effects of active ingredients at the participant level. | Posted | Count of Participants | Participants | 12 weeks |
|
|
|
|
| Other Pre-specified | Mean Change in Serum Potassium | Mean change (from baseline) in continuous serum potassium. | Modified intent to treat whereby all those participants with data at any follow-up time point and baseline to contribute to analyses will be included in analyses according to arm to which they were randomized, regardless of adherence to the study protocol. | Posted | Mean | Standard Deviation | mEq/L | 12 weeks |
|
|
|
|
| Other Pre-specified | Mean Change in Serum Sodium | Mean change (from baseline) in continuous serum sodium. | Modified intent to treat whereby all those participants with data at any follow-up time point and baseline to contribute to analyses will be included in analyses according to arm to which they were randomized, regardless of adherence to the study protocol. | Posted | Mean | Standard Deviation | mEq/L | 12 weeks |
|
|
|
|
| Other Pre-specified | Mean Change in Blood Urea Nitrogen | Mean change (from baseline) in continuous blood urea nitrogen. | Modified intent to treat whereby all those participants with data at any follow-up time point and baseline to contribute to analyses will be included in analyses according to arm to which they were randomized, regardless of adherence to the study protocol. | Posted | Mean | Standard Deviation | mg/dL | 12 weeks |
|
|
|
|
| Other Pre-specified | Mean Change in Serum Creatinine | Mean change in continuous serum creatinine. | Modified intent to treat whereby all those participants with data at any follow-up time point and baseline to contribute to analyses will be included in analyses according to arm to which they were randomized, regardless of adherence to the study protocol. | Posted | Mean | Standard Deviation | mg/dL | 12 weeks |
|
|
|
|
| 0 |
| 32 |
| 2 |
| 32 |
| 20 |
| 32 |
| EG001 | Candesartan | Patients randomized to the comparison arm will take a once daily 8mg candesartan. Candesartan: Standard monotherapy of 8mg candesartan. Taken once daily for 12 weeks. | 0 | 30 | 0 | 30 | 14 | 30 |
|
| Chest Pain | General disorders | MedDRA 23.0 | Systematic Assessment | Severity: Severe. Outcome: Resolved with Sequelae. Relatedness Assessment: Unrelated. Investigational Product action taken: Temporarily Withdrawn. Resulted in hospitalization. |
|
|
| Palpitations | Cardiac disorders | MedDRA 23.0 | Systematic Assessment | Palpitations, mild, resolved without sequelae, possible relatedness, no IP action taken. |
|
| Tinnitus | Ear and labyrinth disorders | MedDRA 23.0 | Systematic Assessment | Ringing in ears, mild, ongoing at study exit, assessed unrelated, no IP action taken. |
|
| Eye pruritis | Eye disorders | MedDRA 23.0 | Systematic Assessment | Itchy eyes, mild, resolved without sequelae, unlikely relatedness, no IP action taken |
|
| Diarrhea | Gastrointestinal disorders | MedDRA 23.0 | Systematic Assessment | 5 total events (2 control, 3 LDQT) Diarrhea, mild (5/5), resolved w/o sequelae (4/5) ongoing at study exit (1/5), unlikely (2/5) unrelated (3/5), no IP action taken (4/5) temporarily withdrawn (1/5). |
|
| Abdominal pain upper | Gastrointestinal disorders | MedDRA 23.0 | Systematic Assessment | 3 total Stomach cramping (1/3) stomach gas/pain (2/3), mild (3/3), resolved without sequelae (2/3) ongoing at study exit (1/3), unrelated (3/3), no IP action taken (1/3) temporarily withdrawn (1/3) permanently discontinued (1/3) |
|
| Dry Mouth | Gastrointestinal disorders | MedDRA 23.0 | Systematic Assessment | mild, resolved without sequelae, unrelated, no IP action taken |
|
| Constipation | Gastrointestinal disorders | MedDRA 23.0 | Systematic Assessment | mild, resolved without sequelae, unrelated, no IP action taken |
|
| Throat irritation | Gastrointestinal disorders | MedDRA 23.0 | Systematic Assessment | mild, resolved without sequelae, possible relatedness, no IP action taken |
|
| Nausea | Gastrointestinal disorders | MedDRA 23.0 | Systematic Assessment | Nausea/vomiting, mild, resolved without sequelae, possible relatedness, permanently discontinued |
|
| Dry throat | Gastrointestinal disorders | MedDRA 23.0 | Systematic Assessment | mild, resolved without sequelae, possible relatedness, temporarily withdrawn |
|
| Vomiting | Gastrointestinal disorders | MedDRA 23.0 | Systematic Assessment | Nausea/Vomiting, mild, resolved without sequelae, unrelated, temporarily withdrawn |
|
| Feeling Hot | General disorders | MedDRA 23.0 | Systematic Assessment | Feeling warm, moderate, resolved without sequelae, possible relatedness, permanently discontinued |
|
| Influenza like illness | General disorders | MedDRA 23.0 | Systematic Assessment | Flu-like symptoms, moderate, ongoing at study exit, unrelated, no IP action taken |
|
| Fatigue | General disorders | MedDRA 23.0 | Systematic Assessment | 4 total mild (4/4), resolved without sequelae (4/4), unrelated (1/4) unlikely (2/4), possible (1/4), no IP action taken (4/4) |
|
| Peripheral swelling | General disorders | MedDRA 23.0 | Systematic Assessment | 4 total Swelling of legs/ankles (2/4) swelling of hands/feet (2/4), mild (4/4), resolved without sequelae (3/4) ongoing at study exit (1/4), unrelated (2/4) possible (2/4), no IP action taken (3/4) permanently discontinued (1/4) |
|
| Chest Pain | General disorders | MedDRA 23.0 | Systematic Assessment | mild, resolved without sequelae, unrelated, no IP action taken |
|
| Asthenia | General disorders | MedDRA 23.0 | Systematic Assessment | mild, resolved without sequelae, possible relatedness, temporarily withdrawn |
|
| Pain | General disorders | MedDRA 23.0 | Systematic Assessment | Body aches, mild, resolved without sequelae, unrelated, temporarily withdrawn |
|
| Blood glucose increased | Investigations | MedDRA 23.0 | Systematic Assessment | Elevated blood sugar, mild, ongoing at study exit, unlikely relatedness, no IP action taken |
|
| Heart rate irregular | Investigations | MedDRA 23.0 | Systematic Assessment | 5 total irregular/fast heartbeat (5/5), mild (5/5), resolved without sequelae (4/5) ongoing at study exit (1/5), unrelated (2/5) unlikely (2/5) possible (1/5), no IP action taken (3/5) permanently discontinued (2/5) |
|
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA 23.0 | Systematic Assessment | mild, ongoing at study exit, unlikely relatedness, no IP action taken |
|
| Muscle cramps/spasms | Musculoskeletal and connective tissue disorders | MedDRA 23.0 | Systematic Assessment | 2 total mild (1/2) severe (1/2), resolved without sequelae (2/2), unrelated (1/2) unlikely (1/2), no IP action taken (2/2) |
|
| Headache | Nervous system disorders | MedDRA 23.0 | Systematic Assessment | 8 total mild (8/8), resolved without sequelae (7/8) ongoing at study exit (1/8), unrelated (4/8) unlikely (3/8) possible (1/8), no IP action taken (6/8) permanently discontinued (2/8) |
|
| Dizziness | Nervous system disorders | MedDRA 23.0 | Systematic Assessment | 2 total mild (2/2), resolved without sequelae (2/2), possible relatedness (2/2), no IP action taken (2/2) |
|
| Vision blurred | Nervous system disorders | MedDRA 23.0 | Systematic Assessment | Blurred vision/vision or hearing changes, mild, resolved without sequelae, unlikely relatedness, permanently discontinued |
|
| Hypoaesthesia | Nervous system disorders | MedDRA 23.0 | Systematic Assessment | cold/tingling/numb hands/feet, mild, resolved without sequelae, unrelated, no IP action taken |
|
| Anxiety | Psychiatric disorders | MedDRA 23.0 | Systematic Assessment | 3 total mild (3/3), resolved without sequelae (1/3) resolved with sequelae (1/3) ongoing at study exit (1/3), unrelated (2/3) possible (1/3), no IP action taken (3/3) |
|
| Nasopharyngitis | Respiratory, thoracic and mediastinal disorders | MedDRA 23.0 | Systematic Assessment | Cold symptoms, mild, ongoing at study exit, unrelated, no IP action taken |
|
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA 23.0 | Systematic Assessment | 3 total mild (3/3), resolved without sequelae (1/3) resolved with sequelae (1/3) ongoing at study exit (1/3), unrelated (2/3) unlikely (1/3), no IP action taken (3/3) |
|
| Dyspnea | Respiratory, thoracic and mediastinal disorders | MedDRA 23.0 | Systematic Assessment | 6 total Breathing problems (6/6), mild (5/6) moderate (1/6), resolved without sequelae (3/6) resolved with sequelae (2/6) ongoing at study exit (1/6), unrelated (4/6) unlikely (2/6), no IP action taken (5/6) temporarily withdrawn (1/6) |
|
| Respiration Abnormal | Respiratory, thoracic and mediastinal disorders | MedDRA 23.0 | Systematic Assessment | Breathing problem, severe, resolved without sequelae, unlikely relatedness, no IP action taken |
|
| Hyperhidrosis | Skin and subcutaneous tissue disorders | MedDRA 23.0 | Systematic Assessment | 2 total Sweating (2/2), mild (2/2), resolved without sequelae (2/2), unrealted (2/2), no IP action taken (1/2) permanently discontinued (1/2) |
|
| Rash | Skin and subcutaneous tissue disorders | MedDRA 23.0 | Systematic Assessment | Rash, mild, resolved without sequelae, unlikely relatedness, no IP action taken |
|
| Dizziness | Vascular disorders | MedDRA 23.0 | Systematic Assessment | 5 total Feeling faint/lightheadedness/falling (5/5), mild (4/5) moderate (1/5), resolved without sequelae (5/5), unlikely relatedness (2/5) possible (3/5), no IP action taken (5/5) |
|
Not provided
Not provided
| Change in Mental Health T score (PROMIS) |
|
|
Statistical test for difference in Mental Health T Score
| ANCOVA |
| 0.77 |
Adjusted for baseline mental health T score |
| Mean Difference (Net) |
| 0.55 |
| Standard Error of the Mean |
| 1.88 |
| 2-Sided |
| 95 |
| -3.22 |
| 4.32 |
| Superiority |