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| ID | Type | Description | Link |
|---|---|---|---|
| OTA-21-015G | Other Grant/Funding Number | NIH grant to RTI; RTI subcontracting with DCRI |
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This is an appendix of master protocol (NCT05595369) designed to be flexible so that it is suitable for a wide range of settings within health care systems and in community settings where it can be integrated into COVID-19 programs and subsequent treatment plans. This sub-study is a prospective, multi-center, double-blind, randomized, controlled trial evaluating nirmatrelvir/ritonavir (Paxlovid) in two dosing durations for the treatment of Post-Acute Sequelae of SARS-CoV-2 Infection (PASC). The study is evaluating potential mechanisms of action, efficacy, and safety of antivirals and other therapeutics in individuals with PASC, according to the platform protocol objectives. The hypothesis is that persistent viral infection and/or overactive/chronic immune response and inflammation are underlying contributors to PASC and that antiviral and other applicable therapies may result in viral clearance or decreased inflammation and improvement in PASC symptoms.
For this appendix of the master protocol (NCT05595369), participants will be randomized to Paxlovid (nirmatrelvir/ritonavir) vs. ritonavir control plus nirmatrelvir-matching placebo.
When there are multiple study interventions (sub-studies) available under the master protocol (NCT05595369), randomization will occur based on the specific inclusion/exclusion criteria of each appendix.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Paxlovid 25 day dosing | Experimental | Paxlovid (nirmatrelvir 300mg, ritonavir 100mg) BID (twice a day) x 25 days |
|
| Paxlovid 15 day dosing | Experimental | Paxlovid (nirmatrelvir 300mg, ritonavir 100mg) BID (twice a day) x 15 days then ritonavir 100mg plus nirmatrelvir-matching placebo x 10 days |
|
| Ritonavir plus nirmatrelvir-matching placebo | Placebo Comparator | Ritonavir 100mg plus nirmatrelvir-matching placebo BID (twice a day) x 25 days |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Paxlovid | Drug | Nirmatrelvir 300mg and ritonavir 100mg taken BID (twice a day) |
|
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants Who Improved in Cognitive Dysfunction Symptom Cluster, as Measured by Patient-Reported Outcomes Measurement Information System (PROMIS) Cognitive 8a Function T-score | PROMIS Cognitive 8a is a questionnaire assessing self-reported cognitive impairments over the past 7 days using 8 items. It assesses the frequency that respondents experienced cognitive impairments on a scale ranging from 5 (never) to 1 (very often; several times a day). The total raw score is transformed into a T-score, with higher scores representing better cognitive function. The T-scores are interpreted in relation to a US reference population and are scaled to have mean = 50 and SD = 10 in the reference population. The primary endpoint for the cognitive dysfunction symptom cluster is improvement of at least 5 T-score points on the PROMIS-cognitive 8a as measured at Day 90 compared to baseline. | Baseline, Day 90 |
| Percentage of Participants Who Improved in Autonomic Dysfunction Symptom Cluster, as Measured by the Orthostatic Hypotension Questionnaire (OHQ) | The Orthostatic Hypotension Questionnaire (OHQ) is a patient reported outcome designed to assess the severity and impact of orthostatic hypotension (OH), a condition characterized by a sudden drop in blood pressure when standing. The OHQ consists of two main components: the Orthostatic Hypotension Symptom Assessment (OHSA) and the Orthostatic Hypotension Daily Activity Scale (OHDAS). The OHSA consists of 6 items measuring severity on a scale ranging from 0 (none) to 10 (worst possible). The OHDAS assesses the extent to which OH interferes with daily life on a scale ranging from 0 (no interference) to 10 (total interference). The primary endpoint for the autonomic dysfunction symptom cluster is improvement as defined by at least a 1-point decrease in the response to OHQ question 1 at Day 90 compared to baseline. | Baseline, Day 90 |
| Percentage of Participants Who Improved in Exercise Intolerance Symptom Cluster, as Measured by the Modified Depaul Symptom Questionnaire-Post Exertional Malaise (DSQ-PEM) | The Modified Depaul Symptom Questionnaire-Post Exertional Malaise (DSQ-PEM) is a patient-reported outcome designed to assess the frequency and severity of symptoms worsening after physical or mental exertion. The first 10 items of DSQ-PEM assess frequency and severity of the following 5 exercise-related impairments. These items were modified for the current study to use a 7-day instead of 6-month look back period. Frequency is rated on a 5-point Likert scale: 0 = none of the time, 1 = a little of the time, 2 = about half the time, 3 = most of the time, and 4 = all of the time. Severity is also rated on a 5-point Likert scale: 0 = symptom not present, 1 = mild, 2 = moderate, 3 = severe, 4 = very severe. The primary endpoint for the exercise symptom cluster is improvement in PEM, defined as having no symptoms of moderate or greater severity with 50% or more frequency as determined by the DSQ-PEM short form at Day 90. |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants Who Improved in Cognitive Dysfunction Symptom Cluster, as Measured by a Neurocognitive Battery | The Neurocognitive battery is a performance measure used to assess various elements related to cognition. The neurocognitive battery consists of a cognitive assessment sequence of the following: WHO/UCLA Auditory Verbal Learning Test (WHO/UCLA AVLT) and Symbol Digit Modalities Test (SDMT). The major secondary endpoint for the cognitive dysfunction symptom cluster is a binary endpoint defined as an increase by at least 1 point in either or both of the AVLT delayed recall Z-score and/or SDMT number of correct substitutions Z-score, and no decrease exceeding 0.15 in either of these measures, at Day 90 compared to baseline. |
| Measure | Description | Time Frame |
|---|---|---|
| Adherence as Measured by Number of Missed Doses | Each randomized participant was scheduled to take two doses of study drug per day for 25 days. The number of completed doses is calculated as 50 planned doses minus the number of planned missed doses. | Up to 25 days |
See NCT NCT05595369 for RECOVER-VITAL: Platform Protocol level exclusion criteria which applies to this appendix
Additional Appendix Level Exclusion Criteria:
Known pregnancy*
Active or expected breastfeeding during the study
Known eGFR < 30 mL/min
Known severe hepatic impairment (Child-Pugh Class C)
Current use of drugs highly dependent on CYP3A for clearance** and for which elevated concentrations are associated with serious and/or life-threatening reactions and which cannot be interrupted during the time of study administration and within seven days before and after study drug administration
Current use of potent CYP3A inducers** where significantly reduced nirmatrelvir or ritonavir plasma concentrations may be associated with the potential for loss of virologic response and possible resistance
A pregnancy test must be performed at the Baseline Visit for participants who are capable of becoming pregnant.
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| All sites listed under NCT05595369 | Durham | North Carolina | 27710 | United States |
The investigators will share the summary of results on the study website: https:// recovercovid.org/
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Study recruitment period was from late July 2023 to mid-August 2024 at 69 US sites. Recruiting centers were a mix of large academic and small independent research sites in rural and urban, outpatient settings.
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| ID | Title | Description |
|---|---|---|
| FG000 | Paxlovid 25 Day Dosing | Paxlovid (nirmatrelvir 300mg, ritonavir 100mg) BID (twice a day) x 25 days Paxlovid 25 day dosing: Nirmatrelvir 300mg and ritonavir 100mg taken BID (twice a day) for 25 days |
| FG001 | Paxlovid 15 Day Dosing | Paxlovid (nirmatrelvir 300mg, ritonavir 100mg) BID (twice a day) x 15 days then ritonavir 100mg plus nirmatrelvir-matching placebo x 10 days Paxlovid 15 day dosing: Nirmatrelvir 300mg and ritonavir 100mg taken BID (twice a day) for 15 days then ritonavir 100mg taken BID plus nirmatrelvir matching placebo BID for 10 days |
| FG002 | Ritonavir Plus Nirmatrelvir-matching Placebo | Ritonavir 100mg plus nirmatrelvir-matching placebo BID (twice a day) x 25 days Ritonavir plus nirmatrelvir-matching placebo: Ritonavir 100mg taken BID (twice a day) plus nirmatrelvir matching placebo BID for 25 days |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
Participants who were randomized into a symptom cluster and received at least part of 1 dose of study intervention or control. From the beginning of the study up to 4 months (<100 participants), a participant could be randomized into multiple symptom clusters. Therefore, the number of individual participants randomized and the number of slots in a symptom cluster will not match. One randomized participant did not initiate treatment and four were later found to not meet eligibility criteria.
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| ID | Title | Description |
|---|---|---|
| BG000 | Paxlovid 25 Day Dosing | Paxlovid (nirmatrelvir 300mg, ritonavir 100mg) BID (twice a day) x 25 days Paxlovid 25 day dosing: Nirmatrelvir 300mg and ritonavir 100mg taken BID (twice a day) for 25 days |
| BG001 | Paxlovid 15 Day Dosing |
| 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 | Percentage of Participants Who Improved in Cognitive Dysfunction Symptom Cluster, as Measured by Patient-Reported Outcomes Measurement Information System (PROMIS) Cognitive 8a Function T-score | PROMIS Cognitive 8a is a questionnaire assessing self-reported cognitive impairments over the past 7 days using 8 items. It assesses the frequency that respondents experienced cognitive impairments on a scale ranging from 5 (never) to 1 (very often; several times a day). The total raw score is transformed into a T-score, with higher scores representing better cognitive function. The T-scores are interpreted in relation to a US reference population and are scaled to have mean = 50 and SD = 10 in the reference population. The primary endpoint for the cognitive dysfunction symptom cluster is improvement of at least 5 T-score points on the PROMIS-cognitive 8a as measured at Day 90 compared to baseline. | Modified Intent to Treat population (the population that was randomized, received at least part of 1 dose of study intervention or control and who are eligible, enrolled and randomized into a symptom cluster) with PROMIS cognitive 8a function data collected. | Posted | Number | 95% Confidence Interval | percentage of participants | Baseline, Day 90 |
Up to 190 days
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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 | Paxlovid 25 Day Dosing | Paxlovid (nirmatrelvir 300mg, ritonavir 100mg) BID (twice a day) x 25 days Paxlovid 25 day dosing: Nirmatrelvir 300mg and ritonavir 100mg taken BID (twice a day) for 25 days |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Appendicitis | Infections and infestations | Non-systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Diarrhoea | Gastrointestinal disorders | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Kanecia Zimmerman, MD, PhD, MPH | Duke University | (919) 668-8651 | kanecia.zimmerman@duke.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | May 18, 2023 | Mar 4, 2026 | Prot_SAP_001.pdf |
| ICF | No | No | Yes | Informed Consent Form | May 30, 2024 | Oct 14, 2024 | ICF_000.pdf |
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| ID | Term |
|---|---|
| D000094024 | Post-Acute COVID-19 Syndrome |
| ID | Term |
|---|---|
| D000086382 | COVID-19 |
| D011024 | Pneumonia, Viral |
| D011014 | Pneumonia |
| D012141 | Respiratory Tract Infections |
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| ID | Term |
|---|---|
| C000719967 | nirmatrelvir and ritonavir drug combination |
| D019438 | Ritonavir |
| ID | Term |
|---|---|
| D013844 | Thiazoles |
| D013457 | Sulfur Compounds |
| D009930 | Organic Chemicals |
| D001393 | Azoles |
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As part of screening, potential participants will answer symptom questions. Eligible participants will then complete relevant Symptom Cluster assessments at the Screening visit. Participants will subsequently be assigned to one of the three Symptom Clusters based on the assessments.
Participants must meet certain criteria within a specific symptom cluster in order to be included in the cluster. After study enrollment and initial cluster assignment, further assessments will be performed. Participants will undergo assessments for the symptom clusters for which the participants qualify.
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Double-blind
| Ritonavir | Drug | Ritonavir 100mg taken BID (twice a day) |
|
| Nirmatrelvir-matching placebo | Drug | A nirmatrelvir-matching placebo taken BID (twice a day) |
|
| Baseline, Day 90 |
| Baseline, Day 90 |
| Percentage of Participants Who Improved in Autonomic Dysfunction Symptom Cluster, as Measured by the Active Stand Test | The active stand test is performed to assess presence of orthostatic intolerance, orthostatic hypotension, and postural orthostatic tachycardia syndrome. The participant's blood pressure and heart rate are recorded after 5 minutes of lying and then at minutes 1, 3, 5, and 10 after standing. Changes in systolic blood pressure (SBP), diastolic blood pressure (DBP), and heart rate beats per minute (HR BPM) are assessed from lying to standing for 10 minutes. The major secondary endpoint for the autonomic dysfunction cluster is a binary endpoint defined as improvement in change from lying to standing in at least one of HR, DBP, or DBP from baseline to Day 90 (defined as an increase of at least 10mmHg in SBP, an increase of at least 5mmHg on DBP, or a decrease of at least 10 BPM on HR) and no worsening in any of HR, DBP, or DBP from baseline to Day 90 (defined as any decrease in SBP or DBP, or any increase in HR. | Baseline, Day 90 |
| Percentage of Participants Who Improved in Exercise Intolerance Symptom Cluster, as Measured by the Endurance Shuttle Walk Test (ESWT) | The endurance shuttle walk test (ESWT) is a performance measure that consists of timed walking on a 10 meter course. The major secondary endpoint for the exercise intolerance symptom cluster is defined as an increase of at least 3 minutes in walk time at Day 90 compared to baseline. | Baseline, Day 90 |
| Total Number of SAEs (Serious Adverse Events) | Up to 190 days |
| Number of Participants Experiencing One or More SAEs (Serious Adverse Events) | Up to 190 days |
| Number of Participants Experiencing AEs (Adverse Events) or SAEs (Serious Adverse Events) Leading to Treatment Discontinuation | Up to 25 days |
| Number of Participants With an Event of Special Interest (ESI) | Up to 190 days |
| Physician Decision |
|
| Withdrawal by Subject |
|
| Did not meet eligibility criteria |
|
| Non-compliance with study drug |
|
| Other |
|
Paxlovid (nirmatrelvir 300mg, ritonavir 100mg) BID (twice a day) x 15 days then ritonavir 100mg plus nirmatrelvir-matching placebo x 10 days
Paxlovid 15 day dosing: Nirmatrelvir 300mg and ritonavir 100mg taken BID (twice a day) for 15 days then ritonavir 100mg taken BID plus nirmatrelvir matching placebo BID for 10 days
| BG002 | Ritonavir Plus Nirmatrelvir-matching Placebo | Ritonavir 100mg plus nirmatrelvir-matching placebo BID (twice a day) x 25 days Ritonavir plus nirmatrelvir-matching placebo: Ritonavir 100mg taken BID (twice a day) plus nirmatrelvir matching placebo BID for 25 days |
| BG003 | Total | Total of all reporting groups |
| years |
|
| Sex/Gender, Customized | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Count of Participants | Participants |
|
| ID | Title | Description |
|---|---|---|
| OG000 | Paxlovid 25 Day Dosing | Paxlovid (nirmatrelvir 300mg, ritonavir 100mg) BID (twice a day) x 25 days Paxlovid 25 day dosing: Nirmatrelvir 300mg and ritonavir 100mg taken BID (twice a day) for 25 days |
| OG001 | Paxlovid 15 Day Dosing | Paxlovid (nirmatrelvir 300mg, ritonavir 100mg) BID (twice a day) x 15 days then ritonavir 100mg plus nirmatrelvir-matching placebo x 10 days Paxlovid 15 day dosing: Nirmatrelvir 300mg and ritonavir 100mg taken BID (twice a day) for 15 days then ritonavir 100mg taken BID plus nirmatrelvir matching placebo BID for 10 days |
| OG002 | Ritonavir Plus Nirmatrelvir-matching Placebo | Ritonavir 100mg plus nirmatrelvir-matching placebo BID (twice a day) x 25 days Ritonavir plus nirmatrelvir-matching placebo: Ritonavir 100mg taken BID (twice a day) plus nirmatrelvir matching placebo BID for 25 days |
|
|
|
| Primary | Percentage of Participants Who Improved in Autonomic Dysfunction Symptom Cluster, as Measured by the Orthostatic Hypotension Questionnaire (OHQ) | The Orthostatic Hypotension Questionnaire (OHQ) is a patient reported outcome designed to assess the severity and impact of orthostatic hypotension (OH), a condition characterized by a sudden drop in blood pressure when standing. The OHQ consists of two main components: the Orthostatic Hypotension Symptom Assessment (OHSA) and the Orthostatic Hypotension Daily Activity Scale (OHDAS). The OHSA consists of 6 items measuring severity on a scale ranging from 0 (none) to 10 (worst possible). The OHDAS assesses the extent to which OH interferes with daily life on a scale ranging from 0 (no interference) to 10 (total interference). The primary endpoint for the autonomic dysfunction symptom cluster is improvement as defined by at least a 1-point decrease in the response to OHQ question 1 at Day 90 compared to baseline. | Modified Intent to Treat population (the population that was randomized, received at least part of 1 dose of study intervention or control and who are eligible, enrolled and randomized into a symptom cluster) with OHQ data collected. | Posted | Number | 95% Confidence Interval | percentage of participants | Baseline, Day 90 |
|
|
|
|
| Primary | Percentage of Participants Who Improved in Exercise Intolerance Symptom Cluster, as Measured by the Modified Depaul Symptom Questionnaire-Post Exertional Malaise (DSQ-PEM) | The Modified Depaul Symptom Questionnaire-Post Exertional Malaise (DSQ-PEM) is a patient-reported outcome designed to assess the frequency and severity of symptoms worsening after physical or mental exertion. The first 10 items of DSQ-PEM assess frequency and severity of the following 5 exercise-related impairments. These items were modified for the current study to use a 7-day instead of 6-month look back period. Frequency is rated on a 5-point Likert scale: 0 = none of the time, 1 = a little of the time, 2 = about half the time, 3 = most of the time, and 4 = all of the time. Severity is also rated on a 5-point Likert scale: 0 = symptom not present, 1 = mild, 2 = moderate, 3 = severe, 4 = very severe. The primary endpoint for the exercise symptom cluster is improvement in PEM, defined as having no symptoms of moderate or greater severity with 50% or more frequency as determined by the DSQ-PEM short form at Day 90. | Modified Intent to Treat population (the population that was randomized, received at least part of 1 dose of study intervention or control and who are eligible, enrolled and randomized into a symptom cluster) with DSQ-PEM data collected. | Posted | Number | 95% Confidence Interval | percentage of participants | Baseline, Day 90 |
|
|
|
|
| Secondary | Percentage of Participants Who Improved in Cognitive Dysfunction Symptom Cluster, as Measured by a Neurocognitive Battery | The Neurocognitive battery is a performance measure used to assess various elements related to cognition. The neurocognitive battery consists of a cognitive assessment sequence of the following: WHO/UCLA Auditory Verbal Learning Test (WHO/UCLA AVLT) and Symbol Digit Modalities Test (SDMT). The major secondary endpoint for the cognitive dysfunction symptom cluster is a binary endpoint defined as an increase by at least 1 point in either or both of the AVLT delayed recall Z-score and/or SDMT number of correct substitutions Z-score, and no decrease exceeding 0.15 in either of these measures, at Day 90 compared to baseline. | Modified Intent to Treat population (the population that was randomized, received at least part of 1 dose of study intervention or control and who are eligible, enrolled and randomized into a symptom cluster) with neurocognitive battery data collected. | Posted | Number | 95% Confidence Interval | percentage of participants | Baseline, Day 90 |
|
|
|
|
| Secondary | Percentage of Participants Who Improved in Autonomic Dysfunction Symptom Cluster, as Measured by the Active Stand Test | The active stand test is performed to assess presence of orthostatic intolerance, orthostatic hypotension, and postural orthostatic tachycardia syndrome. The participant's blood pressure and heart rate are recorded after 5 minutes of lying and then at minutes 1, 3, 5, and 10 after standing. Changes in systolic blood pressure (SBP), diastolic blood pressure (DBP), and heart rate beats per minute (HR BPM) are assessed from lying to standing for 10 minutes. The major secondary endpoint for the autonomic dysfunction cluster is a binary endpoint defined as improvement in change from lying to standing in at least one of HR, DBP, or DBP from baseline to Day 90 (defined as an increase of at least 10mmHg in SBP, an increase of at least 5mmHg on DBP, or a decrease of at least 10 BPM on HR) and no worsening in any of HR, DBP, or DBP from baseline to Day 90 (defined as any decrease in SBP or DBP, or any increase in HR. | Modified Intent to Treat population (the population that was randomized, received at least part of 1 dose of study intervention or control and who are eligible, enrolled and randomized into a symptom cluster) with active stand test data collected. | Posted | Number | 95% Confidence Interval | percentage of participants | Baseline, Day 90 |
|
|
|
|
| Secondary | Percentage of Participants Who Improved in Exercise Intolerance Symptom Cluster, as Measured by the Endurance Shuttle Walk Test (ESWT) | The endurance shuttle walk test (ESWT) is a performance measure that consists of timed walking on a 10 meter course. The major secondary endpoint for the exercise intolerance symptom cluster is defined as an increase of at least 3 minutes in walk time at Day 90 compared to baseline. | Modified Intent to Treat population (the population that was randomized, received at least part of 1 dose of study intervention or control and who are eligible, enrolled and randomized into a symptom cluster) with ESWT data collected. | Posted | Number | 95% Confidence Interval | percentage of participants | Baseline, Day 90 |
|
|
|
|
| Secondary | Total Number of SAEs (Serious Adverse Events) | Safety population | Posted | Number | events | Up to 190 days |
|
|
|
| Secondary | Number of Participants Experiencing One or More SAEs (Serious Adverse Events) | Safety population | Posted | Count of Participants | Participants | Up to 190 days |
|
|
|
| Secondary | Number of Participants Experiencing AEs (Adverse Events) or SAEs (Serious Adverse Events) Leading to Treatment Discontinuation | Safety population | Posted | Count of Participants | Participants | Up to 25 days |
|
|
|
| Secondary | Number of Participants With an Event of Special Interest (ESI) | Safety population | Posted | Count of Participants | Participants | Up to 190 days |
|
|
|
| Other Pre-specified | Adherence as Measured by Number of Missed Doses | Each randomized participant was scheduled to take two doses of study drug per day for 25 days. The number of completed doses is calculated as 50 planned doses minus the number of planned missed doses. | Posted | Mean | Standard Deviation | doses | Up to 25 days |
|
|
|
| 0 |
| 323 |
| 13 |
| 323 |
| 212 |
| 323 |
| EG001 | Paxlovid 15 Day Dosing | Paxlovid (nirmatrelvir 300mg, ritonavir 100mg) BID (twice a day) x 15 days then ritonavir 100mg plus nirmatrelvir-matching placebo x 10 days Paxlovid 15 day dosing: Nirmatrelvir 300mg and ritonavir 100mg taken BID (twice a day) for 15 days then ritonavir 100mg taken BID plus nirmatrelvir matching placebo BID for 15 days | 0 | 320 | 13 | 320 | 203 | 320 |
| EG002 | Ritonavir Plus Nirmatrelvir-matching Placebo | Ritonavir 100mg plus nirmatrelvir-matching placebo BID (twice a day) x 25 days Ritonavir plus nirmatrelvir-matching placebo: Ritonavir 100mg taken BID (twice a day) plus nirmatrelvir matching placebo BID for 25 days | 0 | 320 | 16 | 320 | 180 | 320 |
| Covid-19 | Infections and infestations | Non-systematic Assessment |
|
| Cellulitis | Infections and infestations | Non-systematic Assessment |
|
| Diverticulitis | Infections and infestations | Non-systematic Assessment |
|
| Large Intestine Infection | Infections and infestations | Non-systematic Assessment |
|
| Pneumonia, Bacterial | Infections and infestations | Non-systematic Assessment |
|
| Sepsis | Infections and infestations | Non-systematic Assessment |
|
| Urosepsis | Infections and infestations | Non-systematic Assessment |
|
| Wound Infection | Infections and infestations | Non-systematic Assessment |
|
| Cavernous Sinus Syndrome | Nervous system disorders | Non-systematic Assessment |
|
| Cererovascular Accident | Nervous system disorders | Non-systematic Assessment |
|
| Dizziness | Nervous system disorders | Non-systematic Assessment |
|
| Facial Paralysis | Nervous system disorders | Non-systematic Assessment |
|
| Headache | Nervous system disorders | Non-systematic Assessment |
|
| Migraine | Nervous system disorders | Non-systematic Assessment |
|
| Drug Intolerance | Product Issues | Non-systematic Assessment |
|
| Drug Withdrawal Syndrome | Product Issues | Non-systematic Assessment |
|
| Fatigue | Product Issues | Non-systematic Assessment |
|
| Systemic Inframmatory Response Syndrome | Product Issues | Non-systematic Assessment |
|
| Cholecystitis, Acute | Hepatobiliary disorders | Non-systematic Assessment |
|
| Cholelithiasis | Hepatobiliary disorders | Non-systematic Assessment |
|
| Suspected Drug-Induced Liver Injury | Hepatobiliary disorders | Non-systematic Assessment |
|
| Accidential Poisoning | Injury, poisoning and procedural complications | Non-systematic Assessment |
|
| Hip Fracture | Injury, poisoning and procedural complications | Non-systematic Assessment |
|
| Post Lumbar Puncture Syndrome | Injury, poisoning and procedural complications | Non-systematic Assessment |
|
| Seroma | Injury, poisoning and procedural complications | Non-systematic Assessment |
|
| Suicidal Ideation | Psychiatric disorders | Non-systematic Assessment |
|
| Mental Status Changes | Psychiatric disorders | Non-systematic Assessment |
|
| Acute Respiratory Failure | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
|
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
|
| Pneumonitis | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
|
| Pulmonary Embolism | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
|
| Anal Fissure | Gastrointestinal disorders | Non-systematic Assessment |
|
| Cyclic Vomiting Syndrome | Gastrointestinal disorders | Non-systematic Assessment |
|
| Proctitis | Gastrointestinal disorders | Non-systematic Assessment |
|
| Small Intestinal Perforation | Gastrointestinal disorders | Non-systematic Assessment |
|
| Deep Vein Thrombosis | Vascular disorders | Non-systematic Assessment |
|
| Hypertension | Vascular disorders | Non-systematic Assessment |
|
| Hypertensive Emergency | Vascular disorders | Non-systematic Assessment |
|
| Acute Myocardial Infarction | Cardiac disorders | Non-systematic Assessment |
|
| Atrial Fibrillation | Cardiac disorders | Non-systematic Assessment |
|
| Right To Left Cardiac Shunt | Congenital, familial and genetic disorders | Non-systematic Assessment |
|
| Transaminases Increased | Investigations | Non-systematic Assessment |
|
| Muscle Spasms | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
|
| Neoplasm Recurrence | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | Non-systematic Assessment |
|
| Abortion, Spontaneous | Pregnancy, puerperium and perinatal conditions | Non-systematic Assessment |
|
| Acute Kidney Injury | Renal and urinary disorders | Non-systematic Assessment |
|
| Nausea | Gastrointestinal disorders | Non-systematic Assessment |
|
| Vomiting | Gastrointestinal disorders | Non-systematic Assessment |
|
| Abdominal pain | Gastrointestinal disorders | Non-systematic Assessment |
|
| Dry mouth | Gastrointestinal disorders | Non-systematic Assessment |
|
| Constipation | Gastrointestinal disorders | Non-systematic Assessment |
|
| Abdominal pain upper | Gastrointestinal disorders | Non-systematic Assessment |
|
| Abdominal discomfort | Gastrointestinal disorders | Non-systematic Assessment |
|
| Dyspepsia | Gastrointestinal disorders | Non-systematic Assessment |
|
| Abdominal distension | Gastrointestinal disorders | Non-systematic Assessment |
|
| Dysphagia | Gastrointestinal disorders | Non-systematic Assessment |
|
| Flatulence | Gastrointestinal disorders | Non-systematic Assessment |
|
| Gastrointestinal disorder | Gastrointestinal disorders | Non-systematic Assessment |
|
| Gastrooesophageal reflux disease | Gastrointestinal disorders | Non-systematic Assessment |
|
| Haemorrhoids | Gastrointestinal disorders | Non-systematic Assessment |
|
| Aphthous ulcer | Gastrointestinal disorders | Non-systematic Assessment |
|
| Frequent bowel movements | Gastrointestinal disorders | Non-systematic Assessment |
|
| Gastritis | Gastrointestinal disorders | Non-systematic Assessment |
|
| Gastrointestinal pain | Gastrointestinal disorders | Non-systematic Assessment |
|
| Paraesthesia oral | Gastrointestinal disorders | Non-systematic Assessment |
|
| Stomatitis | Gastrointestinal disorders | Non-systematic Assessment |
|
| Toothache | Gastrointestinal disorders | Non-systematic Assessment |
|
| Abdominal pain lower | Gastrointestinal disorders | Non-systematic Assessment |
|
| Anal incontinence | Gastrointestinal disorders | Non-systematic Assessment |
|
| Anorectal discomfort | Gastrointestinal disorders | Non-systematic Assessment |
|
| Bowel movement irregularity | Gastrointestinal disorders | Non-systematic Assessment |
|
| Coeliac disease | Gastrointestinal disorders | Non-systematic Assessment |
|
| Colitis ulcerative | Gastrointestinal disorders | Non-systematic Assessment |
|
| Dental caries | Gastrointestinal disorders | Non-systematic Assessment |
|
| Dysbiosis | Gastrointestinal disorders | Non-systematic Assessment |
|
| Eructation | Gastrointestinal disorders | Non-systematic Assessment |
|
| Hypoaesthesia oral | Gastrointestinal disorders | Non-systematic Assessment |
|
| Inguinal hernia | Gastrointestinal disorders | Non-systematic Assessment |
|
| Intestinal barrier dysfunction | Gastrointestinal disorders | Non-systematic Assessment |
|
| Lip blister | Gastrointestinal disorders | Non-systematic Assessment |
|
| Oesophageal spasm | Gastrointestinal disorders | Non-systematic Assessment |
|
| Proctalgia | Gastrointestinal disorders | Non-systematic Assessment |
|
| Rectal haemorrhage | Gastrointestinal disorders | Non-systematic Assessment |
|
| Retching | Gastrointestinal disorders | Non-systematic Assessment |
|
| Tongue discolouration | Gastrointestinal disorders | Non-systematic Assessment |
|
| Dysgeusia | Nervous system disorders | Non-systematic Assessment |
|
| Headache | Nervous system disorders | Non-systematic Assessment |
|
| Dizziness | Nervous system disorders | Non-systematic Assessment |
|
| Taste disorder | Nervous system disorders | Non-systematic Assessment |
|
| Migraine | Nervous system disorders | Non-systematic Assessment |
|
| Tremor | Nervous system disorders | Non-systematic Assessment |
|
| Brain fog | Nervous system disorders | Non-systematic Assessment |
|
| Syncope | Nervous system disorders | Non-systematic Assessment |
|
| Somnolence | Nervous system disorders | Non-systematic Assessment |
|
| Cognitive disorder | Nervous system disorders | Non-systematic Assessment |
|
| Hypoaesthesia | Nervous system disorders | Non-systematic Assessment |
|
| Paraesthesia | Nervous system disorders | Non-systematic Assessment |
|
| Parosmia | Nervous system disorders | Non-systematic Assessment |
|
| Ageusia | Nervous system disorders | Non-systematic Assessment |
|
| Balance disorder | Nervous system disorders | Non-systematic Assessment |
|
| Neuralgia | Nervous system disorders | Non-systematic Assessment |
|
| Restless legs syndrome | Nervous system disorders | Non-systematic Assessment |
|
| Anosmia | Nervous system disorders | Non-systematic Assessment |
|
| Head discomfort | Nervous system disorders | Non-systematic Assessment |
|
| Sciatica | Nervous system disorders | Non-systematic Assessment |
|
| Amnesia | Nervous system disorders | Non-systematic Assessment |
|
| Autonomic nervous system imbalance | Nervous system disorders | Non-systematic Assessment |
|
| Burning sensation | Nervous system disorders | Non-systematic Assessment |
|
| Cerebrovascular accident | Nervous system disorders | Non-systematic Assessment |
|
| Complex regional pain syndrome | Nervous system disorders | Non-systematic Assessment |
|
| Dizziness postural | Nervous system disorders | Non-systematic Assessment |
|
| Dyskinesia | Nervous system disorders | Non-systematic Assessment |
|
| Electric shock sensation | Nervous system disorders | Non-systematic Assessment |
|
| Hypersomnia | Nervous system disorders | Non-systematic Assessment |
|
| Memory impairment | Nervous system disorders | Non-systematic Assessment |
|
| Parkinson's disease | Nervous system disorders | Non-systematic Assessment |
|
| Presyncope | Nervous system disorders | Non-systematic Assessment |
|
| Vestibular migraine | Nervous system disorders | Non-systematic Assessment |
|
| COVID-19 | Infections and infestations | Non-systematic Assessment |
|
| Sinusitis | Infections and infestations | Non-systematic Assessment |
|
| Urinary tract infection | Infections and infestations | Non-systematic Assessment |
|
| Upper respiratory tract infection | Infections and infestations | Non-systematic Assessment |
|
| Nasopharyngitis | Infections and infestations | Non-systematic Assessment |
|
| Viral infection | Infections and infestations | Non-systematic Assessment |
|
| Bronchitis | Infections and infestations | Non-systematic Assessment |
|
| Influenza | Infections and infestations | Non-systematic Assessment |
|
| Ear infection | Infections and infestations | Non-systematic Assessment |
|
| Herpes zoster | Infections and infestations | Non-systematic Assessment |
|
| Hordeolum | Infections and infestations | Non-systematic Assessment |
|
| Oral candidiasis | Infections and infestations | Non-systematic Assessment |
|
| Oral herpes | Infections and infestations | Non-systematic Assessment |
|
| Pneumonia | Infections and infestations | Non-systematic Assessment |
|
| Vulvovaginal candidiasis | Infections and infestations | Non-systematic Assessment |
|
| Atypical pneumonia | Infections and infestations | Non-systematic Assessment |
|
| Bacterial vaginosis | Infections and infestations | Non-systematic Assessment |
|
| Bronchiolitis | Infections and infestations | Non-systematic Assessment |
|
| Cellulitis | Infections and infestations | Non-systematic Assessment |
|
| Conjunctivitis | Infections and infestations | Non-systematic Assessment |
|
| Conjunctivitis bacterial | Infections and infestations | Non-systematic Assessment |
|
| Cystitis | Infections and infestations | Non-systematic Assessment |
|
| Diverticulitis | Infections and infestations | Non-systematic Assessment |
|
| Folliculitis | Infections and infestations | Non-systematic Assessment |
|
| Fungal infection | Infections and infestations | Non-systematic Assessment |
|
| Gastroenteritis | Infections and infestations | Non-systematic Assessment |
|
| Gastroenteritis viral | Infections and infestations | Non-systematic Assessment |
|
| Gastrointestinal infection | Infections and infestations | Non-systematic Assessment |
|
| Gingivitis | Infections and infestations | Non-systematic Assessment |
|
| Helicobacter infection | Infections and infestations | Non-systematic Assessment |
|
| Herpes virus infection | Infections and infestations | Non-systematic Assessment |
|
| Localised infection | Infections and infestations | Non-systematic Assessment |
|
| Overgrowth fungal | Infections and infestations | Non-systematic Assessment |
|
| Papilloma viral infection | Infections and infestations | Non-systematic Assessment |
|
| Pharyngitis streptococcal | Infections and infestations | Non-systematic Assessment |
|
| Post-acute COVID-19 syndrome | Infections and infestations | Non-systematic Assessment |
|
| Respiratory syncytial virus infection | Infections and infestations | Non-systematic Assessment |
|
| Rhinitis | Infections and infestations | Non-systematic Assessment |
|
| Staphylococcal skin infection | Infections and infestations | Non-systematic Assessment |
|
| Tooth infection | Infections and infestations | Non-systematic Assessment |
|
| Ureaplasma cervicitis | Infections and infestations | Non-systematic Assessment |
|
| Viral upper respiratory tract infection | Infections and infestations | Non-systematic Assessment |
|
| Fatigue | General disorders | Non-systematic Assessment |
|
| Chest pain | General disorders | Non-systematic Assessment |
|
| Pain | General disorders | Non-systematic Assessment |
|
| Malaise | General disorders | Non-systematic Assessment |
|
| Pyrexia | General disorders | Non-systematic Assessment |
|
| Chills | General disorders | Non-systematic Assessment |
|
| Influenza like illness | General disorders | Non-systematic Assessment |
|
| Oedema peripheral | General disorders | Non-systematic Assessment |
|
| Chest discomfort | General disorders | Non-systematic Assessment |
|
| Thirst | General disorders | Non-systematic Assessment |
|
| Asthenia | General disorders | Non-systematic Assessment |
|
| Non-cardiac chest pain | General disorders | Non-systematic Assessment |
|
| Early satiety | General disorders | Non-systematic Assessment |
|
| Facial pain | General disorders | Non-systematic Assessment |
|
| Feeling cold | General disorders | Non-systematic Assessment |
|
| Feeling hot | General disorders | Non-systematic Assessment |
|
| Generalised oedema | General disorders | Non-systematic Assessment |
|
| Hunger | General disorders | Non-systematic Assessment |
|
| Illness | General disorders | Non-systematic Assessment |
|
| Peripheral swelling | General disorders | Non-systematic Assessment |
|
| Swelling face | General disorders | Non-systematic Assessment |
|
| Tenderness | General disorders | Non-systematic Assessment |
|
| Blood thyroid stimulating hormone increased | Investigations | Non-systematic Assessment |
|
| C-reactive protein increased | Investigations | Non-systematic Assessment |
|
| Alanine aminotransferase increased | Investigations | Non-systematic Assessment |
|
| Aspartate aminotransferase increased | Investigations | Non-systematic Assessment |
|
| Blood pressure increased | Investigations | Non-systematic Assessment |
|
| Fibrin D dimer increased | Investigations | Non-systematic Assessment |
|
| SARS-CoV-2 test positive | Investigations | Non-systematic Assessment |
|
| Activated partial thromboplastin time prolonged | Investigations | Non-systematic Assessment |
|
| Thyroxine free decreased | Investigations | Non-systematic Assessment |
|
| Tri-iodothyronine decreased | Investigations | Non-systematic Assessment |
|
| White blood cell count decreased | Investigations | Non-systematic Assessment |
|
| Anion gap increased | Investigations | Non-systematic Assessment |
|
| Heart rate increased | Investigations | Non-systematic Assessment |
|
| Thyroid function test abnormal | Investigations | Non-systematic Assessment |
|
| Thyroxine decreased | Investigations | Non-systematic Assessment |
|
| Blood creatinine increased | Investigations | Non-systematic Assessment |
|
| Blood glucose increased | Investigations | Non-systematic Assessment |
|
| Glomerular filtration rate decreased | Investigations | Non-systematic Assessment |
|
| Haemoglobin decreased | Investigations | Non-systematic Assessment |
|
| Transaminases increased | Investigations | Non-systematic Assessment |
|
| Tri-iodothyronine increased | Investigations | Non-systematic Assessment |
|
| Blood pressure decreased | Investigations | Non-systematic Assessment |
|
| Carbon dioxide decreased | Investigations | Non-systematic Assessment |
|
| Glomerular filtration rate abnormal | Investigations | Non-systematic Assessment |
|
| Glomerular filtration rate increased | Investigations | Non-systematic Assessment |
|
| Influenza A virus test positive | Investigations | Non-systematic Assessment |
|
| Liver function test increased | Investigations | Non-systematic Assessment |
|
| Protein total increased | Investigations | Non-systematic Assessment |
|
| Prothrombin time prolonged | Investigations | Non-systematic Assessment |
|
| Thyroxine increased | Investigations | Non-systematic Assessment |
|
| Weight decreased | Investigations | Non-systematic Assessment |
|
| Weight increased | Investigations | Non-systematic Assessment |
|
| Blood albumin decreased | Investigations | Non-systematic Assessment |
|
| Blood alkaline phosphatase increased | Investigations | Non-systematic Assessment |
|
| Blood bicarbonate decreased | Investigations | Non-systematic Assessment |
|
| Blood bilirubin increased | Investigations | Non-systematic Assessment |
|
| Blood calcium decreased | Investigations | Non-systematic Assessment |
|
| Blood glucose decreased | Investigations | Non-systematic Assessment |
|
| Blood sodium decreased | Investigations | Non-systematic Assessment |
|
| Blood thyroid stimulating hormone decreased | Investigations | Non-systematic Assessment |
|
| Blood urea decreased | Investigations | Non-systematic Assessment |
|
| Body temperature fluctuation | Investigations | Non-systematic Assessment |
|
| Computerised tomogram abnormal | Investigations | Non-systematic Assessment |
|
| Electrocardiogram abnormal | Investigations | Non-systematic Assessment |
|
| Eosinophil count increased | Investigations | Non-systematic Assessment |
|
| Hepatic enzyme increased | Investigations | Non-systematic Assessment |
|
| International normalised ratio increased | Investigations | Non-systematic Assessment |
|
| Lymphocyte count decreased | Investigations | Non-systematic Assessment |
|
| Neutrophil count decreased | Investigations | Non-systematic Assessment |
|
| Thrombin time abnormal | Investigations | Non-systematic Assessment |
|
| Tri-iodothyronine free abnormal | Investigations | Non-systematic Assessment |
|
| Tri-iodothyronine free increased | Investigations | Non-systematic Assessment |
|
| Cough | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
|
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
|
| Oropharyngeal pain | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
|
| Nasal congestion | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
|
| Rhinorrhoea | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
|
| Asthma | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
|
| Dysphonia | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
|
| Dyspnoea exertional | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
|
| Epistaxis | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
|
| Sinus congestion | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
|
| Sleep apnoea syndrome | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
|
| Sneezing | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
|
| Throat irritation | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
|
| Throat tightness | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
|
| Aphonia | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
|
| Aspiration | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
|
| Hiccups | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
|
| Hypoxia | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
|
| Lower respiratory tract congestion | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
|
| Nasal dryness | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
|
| Pleuritic pain | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
|
| Pulmonary congestion | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
|
| Pulmonary pain | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
|
| Respiratory tract irritation | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
|
| Sinonasal obstruction | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
|
| Upper respiratory tract congestion | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
|
| Wheezing | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
|
| Rash | Skin and subcutaneous tissue disorders | Non-systematic Assessment |
|
| Pruritus | Skin and subcutaneous tissue disorders | Non-systematic Assessment |
|
| Hyperhidrosis | Skin and subcutaneous tissue disorders | Non-systematic Assessment |
|
| Night sweats | Skin and subcutaneous tissue disorders | Non-systematic Assessment |
|
| Urticaria | Skin and subcutaneous tissue disorders | Non-systematic Assessment |
|
| Dry skin | Skin and subcutaneous tissue disorders | Non-systematic Assessment |
|
| Alopecia | Skin and subcutaneous tissue disorders | Non-systematic Assessment |
|
| Erythema | Skin and subcutaneous tissue disorders | Non-systematic Assessment |
|
| Dermatitis | Skin and subcutaneous tissue disorders | Non-systematic Assessment |
|
| Dermatitis contact | Skin and subcutaneous tissue disorders | Non-systematic Assessment |
|
| Petechiae | Skin and subcutaneous tissue disorders | Non-systematic Assessment |
|
| Rash pruritic | Skin and subcutaneous tissue disorders | Non-systematic Assessment |
|
| Skin discolouration | Skin and subcutaneous tissue disorders | Non-systematic Assessment |
|
| Angioedema | Skin and subcutaneous tissue disorders | Non-systematic Assessment |
|
| Blister | Skin and subcutaneous tissue disorders | Non-systematic Assessment |
|
| Dermal cyst | Skin and subcutaneous tissue disorders | Non-systematic Assessment |
|
| Ecchymosis | Skin and subcutaneous tissue disorders | Non-systematic Assessment |
|
| Eczema | Skin and subcutaneous tissue disorders | Non-systematic Assessment |
|
| Ingrowing nail | Skin and subcutaneous tissue disorders | Non-systematic Assessment |
|
| Pemphigoid | Skin and subcutaneous tissue disorders | Non-systematic Assessment |
|
| Rash erythematous | Skin and subcutaneous tissue disorders | Non-systematic Assessment |
|
| Transient acantholytic dermatosis | Skin and subcutaneous tissue disorders | Non-systematic Assessment |
|
| Arthralgia | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
|
| Myalgia | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
|
| Back pain | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
|
| Pain in extremity | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
|
| Muscle spasms | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
|
| Muscular weakness | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
|
| Neck pain | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
|
| Musculoskeletal stiffness | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
|
| Arthritis | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
|
| Bone pain | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
|
| Dermatomyositis | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
|
| Facet joint syndrome | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
|
| Fibromyalgia | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
|
| Intervertebral disc degeneration | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
|
| Joint swelling | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
|
| Limb discomfort | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
|
| Medial tibial stress syndrome | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
|
| Muscle fatigue | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
|
| Muscle tightness | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
|
| Muscle twitching | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
|
| Musculoskeletal disorder | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
|
| Plantar fasciitis | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
|
| Insomnia | Psychiatric disorders | Non-systematic Assessment |
|
| Anxiety | Psychiatric disorders | Non-systematic Assessment |
|
| Nightmare | Psychiatric disorders | Non-systematic Assessment |
|
| Sleep disorder | Psychiatric disorders | Non-systematic Assessment |
|
| Confusional state | Psychiatric disorders | Non-systematic Assessment |
|
| Depressive symptom | Psychiatric disorders | Non-systematic Assessment |
|
| Irritability | Psychiatric disorders | Non-systematic Assessment |
|
| Depression | Psychiatric disorders | Non-systematic Assessment |
|
| Attention deficit hyperactivity disorder | Psychiatric disorders | Non-systematic Assessment |
|
| Depressed mood | Psychiatric disorders | Non-systematic Assessment |
|
| Disorientation | Psychiatric disorders | Non-systematic Assessment |
|
| Euphoric mood | Psychiatric disorders | Non-systematic Assessment |
|
| Hallucination, auditory | Psychiatric disorders | Non-systematic Assessment |
|
| Initial insomnia | Psychiatric disorders | Non-systematic Assessment |
|
| Mental disorder | Psychiatric disorders | Non-systematic Assessment |
|
| Mood altered | Psychiatric disorders | Non-systematic Assessment |
|
| Mood swings | Psychiatric disorders | Non-systematic Assessment |
|
| Nervousness | Psychiatric disorders | Non-systematic Assessment |
|
| Paranoia | Psychiatric disorders | Non-systematic Assessment |
|
| Restlessness | Psychiatric disorders | Non-systematic Assessment |
|
| Sleep terror | Psychiatric disorders | Non-systematic Assessment |
|
| Tachyphrenia | Psychiatric disorders | Non-systematic Assessment |
|
| Fall | Injury, poisoning and procedural complications | Non-systematic Assessment |
|
| Arthropod bite | Injury, poisoning and procedural complications | Non-systematic Assessment |
|
| Contusion | Injury, poisoning and procedural complications | Non-systematic Assessment |
|
| Joint injury | Injury, poisoning and procedural complications | Non-systematic Assessment |
|
| Ligament sprain | Injury, poisoning and procedural complications | Non-systematic Assessment |
|
| Foot fracture | Injury, poisoning and procedural complications | Non-systematic Assessment |
|
| Road traffic accident | Injury, poisoning and procedural complications | Non-systematic Assessment |
|
| Animal bite | Injury, poisoning and procedural complications | Non-systematic Assessment |
|
| Craniocerebral injury | Injury, poisoning and procedural complications | Non-systematic Assessment |
|
| Hand fracture | Injury, poisoning and procedural complications | Non-systematic Assessment |
|
| Head injury | Injury, poisoning and procedural complications | Non-systematic Assessment |
|
| Infusion related reaction | Injury, poisoning and procedural complications | Non-systematic Assessment |
|
| Limb injury | Injury, poisoning and procedural complications | Non-systematic Assessment |
|
| Meniscus injury | Injury, poisoning and procedural complications | Non-systematic Assessment |
|
| Muscle strain | Injury, poisoning and procedural complications | Non-systematic Assessment |
|
| Post procedural complication | Injury, poisoning and procedural complications | Non-systematic Assessment |
|
| Post vaccination syndrome | Injury, poisoning and procedural complications | Non-systematic Assessment |
|
| Seroma | Injury, poisoning and procedural complications | Non-systematic Assessment |
|
| Thermal burn | Injury, poisoning and procedural complications | Non-systematic Assessment |
|
| Traumatic haematoma | Injury, poisoning and procedural complications | Non-systematic Assessment |
|
| Wrist fracture | Injury, poisoning and procedural complications | Non-systematic Assessment |
|
| Vision blurred | Eye disorders | Non-systematic Assessment |
|
| Dry eye | Eye disorders | Non-systematic Assessment |
|
| Photophobia | Eye disorders | Non-systematic Assessment |
|
| Blepharospasm | Eye disorders | Non-systematic Assessment |
|
| Chalazion | Eye disorders | Non-systematic Assessment |
|
| Conjunctival haemorrhage | Eye disorders | Non-systematic Assessment |
|
| Dark circles under eyes | Eye disorders | Non-systematic Assessment |
|
| Eczema eyelids | Eye disorders | Non-systematic Assessment |
|
| Eye allergy | Eye disorders | Non-systematic Assessment |
|
| Eye disorder | Eye disorders | Non-systematic Assessment |
|
| Eye irritation | Eye disorders | Non-systematic Assessment |
|
| Eye swelling | Eye disorders | Non-systematic Assessment |
|
| Swelling of eyelid | Eye disorders | Non-systematic Assessment |
|
| Uveitis | Eye disorders | Non-systematic Assessment |
|
| Visual impairment | Eye disorders | Non-systematic Assessment |
|
| Vitreous floaters | Eye disorders | Non-systematic Assessment |
|
| Decreased appetite | Metabolism and nutrition disorders | Non-systematic Assessment |
|
| Hyperglycaemia | Metabolism and nutrition disorders | Non-systematic Assessment |
|
| Hypokalaemia | Metabolism and nutrition disorders | Non-systematic Assessment |
|
| Dehydration | Metabolism and nutrition disorders | Non-systematic Assessment |
|
| Hypercalcaemia | Metabolism and nutrition disorders | Non-systematic Assessment |
|
| Hyperlipidaemia | Metabolism and nutrition disorders | Non-systematic Assessment |
|
| Hypoalbuminaemia | Metabolism and nutrition disorders | Non-systematic Assessment |
|
| Hypoglycaemia | Metabolism and nutrition disorders | Non-systematic Assessment |
|
| Hyponatraemia | Metabolism and nutrition disorders | Non-systematic Assessment |
|
| Hot flush | Vascular disorders | Non-systematic Assessment |
|
| Hypertension | Vascular disorders | Non-systematic Assessment |
|
| Flushing | Vascular disorders | Non-systematic Assessment |
|
| Hypotension | Vascular disorders | Non-systematic Assessment |
|
| Blood pressure fluctuation | Vascular disorders | Non-systematic Assessment |
|
| Haematoma | Vascular disorders | Non-systematic Assessment |
|
| Peripheral coldness | Vascular disorders | Non-systematic Assessment |
|
| Thrombophlebitis | Vascular disorders | Non-systematic Assessment |
|
| Withdrawal hypertension | Vascular disorders | Non-systematic Assessment |
|
| Pollakiuria | Renal and urinary disorders | Non-systematic Assessment |
|
| Micturition urgency | Renal and urinary disorders | Non-systematic Assessment |
|
| Renal impairment | Renal and urinary disorders | Non-systematic Assessment |
|
| Urinary retention | Renal and urinary disorders | Non-systematic Assessment |
|
| Haematuria | Renal and urinary disorders | Non-systematic Assessment |
|
| Bladder discomfort | Renal and urinary disorders | Non-systematic Assessment |
|
| Chromaturia | Renal and urinary disorders | Non-systematic Assessment |
|
| Dysuria | Renal and urinary disorders | Non-systematic Assessment |
|
| Nephrolithiasis | Renal and urinary disorders | Non-systematic Assessment |
|
| Nocturia | Renal and urinary disorders | Non-systematic Assessment |
|
| Polyuria | Renal and urinary disorders | Non-systematic Assessment |
|
| Stress urinary incontinence | Renal and urinary disorders | Non-systematic Assessment |
|
| Urinary incontinence | Renal and urinary disorders | Non-systematic Assessment |
|
| Palpitations | Cardiac disorders | Non-systematic Assessment |
|
| Tachycardia | Cardiac disorders | Non-systematic Assessment |
|
| Angina pectoris | Cardiac disorders | Non-systematic Assessment |
|
| Atrial fibrillation | Cardiac disorders | Non-systematic Assessment |
|
| Sinus node dysfunction | Cardiac disorders | Non-systematic Assessment |
|
| Vertigo | Ear and labyrinth disorders | Non-systematic Assessment |
|
| Tinnitus | Ear and labyrinth disorders | Non-systematic Assessment |
|
| Ear pain | Ear and labyrinth disorders | Non-systematic Assessment |
|
| Mastoid disorder | Ear and labyrinth disorders | Non-systematic Assessment |
|
| Hypothyroidism | Endocrine disorders | Non-systematic Assessment |
|
| Adrenal insufficiency | Endocrine disorders | Non-systematic Assessment |
|
| Cushing's syndrome | Endocrine disorders | Non-systematic Assessment |
|
| Goitre | Endocrine disorders | Non-systematic Assessment |
|
| Graves' disease | Endocrine disorders | Non-systematic Assessment |
|
| Hyperthyroidism | Endocrine disorders | Non-systematic Assessment |
|
| Thyroid cyst | Endocrine disorders | Non-systematic Assessment |
|
| Thyroid mass | Endocrine disorders | Non-systematic Assessment |
|
| Heavy menstrual bleeding | Reproductive system and breast disorders | Non-systematic Assessment |
|
| Intermenstrual bleeding | Reproductive system and breast disorders | Non-systematic Assessment |
|
| Menstrual disorder | Reproductive system and breast disorders | Non-systematic Assessment |
|
| Abnormal uterine bleeding | Reproductive system and breast disorders | Non-systematic Assessment |
|
| Amenorrhoea | Reproductive system and breast disorders | Non-systematic Assessment |
|
| Breast enlargement | Reproductive system and breast disorders | Non-systematic Assessment |
|
| Breast mass | Reproductive system and breast disorders | Non-systematic Assessment |
|
| Dysmenorrhoea | Reproductive system and breast disorders | Non-systematic Assessment |
|
| Prostatitis | Reproductive system and breast disorders | Non-systematic Assessment |
|
| Vaginal haemorrhage | Reproductive system and breast disorders | Non-systematic Assessment |
|
| Withdrawal bleed | Reproductive system and breast disorders | Non-systematic Assessment |
|
| Anaemia | Blood and lymphatic system disorders | Non-systematic Assessment |
|
| Lymphadenopathy | Blood and lymphatic system disorders | Non-systematic Assessment |
|
| Thrombocytopenia | Blood and lymphatic system disorders | Non-systematic Assessment |
|
| Hepatic mass | Hepatobiliary disorders | Non-systematic Assessment |
|
| Hypertransaminasaemia | Hepatobiliary disorders | Non-systematic Assessment |
|
| Autoimmune disorder | Immune system disorders | Non-systematic Assessment |
|
| Reaction to colouring | Immune system disorders | Non-systematic Assessment |
|
| Benign breast neoplasm | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | Non-systematic Assessment |
|
| Loss of personal independence in daily activities | Social circumstances | Non-systematic Assessment |
|
Not provided
Not provided
Not provided
| D007239 |
| Infections |
| D014777 | Virus Diseases |
| D018352 | Coronavirus Infections |
| D003333 | Coronaviridae Infections |
| D030341 | Nidovirales Infections |
| D012327 | RNA Virus Infections |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D000094025 | Post-Infectious Disorders |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D006573 |
| Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| 0.988 |
| Difference |
| -0.1 |
| 2-Sided |
| 95 |
| -12.5 |
| 12.3 |
| Superiority |
| Treatment pairwise comparison of adjusted proportion | G-computation | 0.307 | Difference | -6.3 | 2-Sided | 95 | -18.3 | 5.8 | Superiority |
| 0.884 |
| Difference |
| 0.9 |
| 2-Sided |
| 95 |
| -11.4 |
| 13.2 |
| Superiority |
| Treatment pairwise comparison of adjusted proportion | G-computation | 0.155 | Difference | -8.8 | 2-Sided | 95 | -20.8 | 3.3 | Superiority |
| 0.175 |
| Difference |
| -5.9 |
| 2-Sided |
| 95 |
| -14.5 |
| 2.6 |
| Superiority |
| Treatment pairwise comparison of adjusted proportion | G-computation | 0.720 | Difference | 1.4 | 2-Sided | 95 | -6.3 | 9.2 | Superiority |
| 0.931 |
| Difference |
| -0.4 |
| 2-Sided |
| 95 |
| -9.7 |
| 9.0 |
| Superiority |
| Treatment pairwise comparison of adjusted proportion | G-computation | 0.479 | Difference | -3.2 | 2-Sided | 95 | -12.1 | 5.7 | Superiority |
| 0.430 |
| Difference |
| -4.9 |
| 2-Sided |
| 95 |
| -17.2 |
| 7.3 |
| Superiority |
| Treatment pairwise comparison of adjusted proportion | G-computation | 0.117 | Difference | -8.9 | 2-Sided | 95 | -20.1 | 2.2 | Superiority |