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A study of the safety, tolerability and pharmacokinetics of NNZ-2591 and measures of efficacy in children and adolescents with Pitt Hopkins Syndrome.
The primary purpose of this study is to investigate the safety, tolerability and pharmacokinetics of treatment with NNZ-2591 oral solution in children and adolescents with Pitt Hopkins Syndrome. The secondary purpose is to investigate measures of efficacy. Subjects will receive treatment with NNZ-2591 oral solution (50 mg/mL) doses for a total of 13 weeks.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| NNZ-2591 | Experimental | NNZ-2591 oral solution (50mg/mL) to be administered twice daily dose for 13 weeks. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| NNZ-2591 | Drug | NNZ-2591 oral solution (50mg/mL) to be administered twice daily dose for 13 weeks. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Safety and Tolerability | To examine the incidence, severity and frequency of adverse events (AEs), including serious adverse events (SAEs) during treatment with NNZ-2591. | 13 weeks |
| Pharmacokinetic - Mean AUC24 | Approximately nine sparse pharmacokinetic (PK) samples were collected from each participant under steady-state conditions. These samples were taken at pre-dose, 1-3 hours post-dose, and/or 4-7 hours post-dose during Weeks 2, 6, and 13. The individual pharmacokinetic parameters for NNZ-2591, including half-life (t1/2) and area under the curve over 24 hours (AUC24), were derived using subject-level concentration-time profiles from the study population model. | Pre-dose, 1-3 h post-dose and/or 4-7 h post-dose at Weeks 2, 6 and 13. |
| Pharmacokinetic - t1/2 | Approximately nine sparse pharmacokinetic (PK) samples were collected from each participant under steady-state conditions. These samples were taken at pre-dose, 1-3 hours post-dose, and/or 4-7 hours post-dose during Weeks 2, 6, and 13. The individual pharmacokinetic parameters for NNZ-2591, including half-life (t1/2) and area under the curve over 24 hours (AUC24), were derived using subject-level concentration-time profiles from the study population model. | Pre-dose, 1-3 h post-dose and/or 4-7 h post-dose at Weeks 2, 6 and 13. |
| Measure | Description | Time Frame |
|---|---|---|
| Pitt Hopkins Syndrome-specific Clinical Global Impression Scale (CGI-I) - Overall Improvement | Pitt Hopkins Syndrome-specific Clinical Global Impression Scale (CGI-I) - Overall Improvement. Score on a Likert scale (1-7) where lower scores are better. | CGI-I was assessed at weeks 6, 13/EOT & 15. Overall improvement scores relate to week 13/EOT visit. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| James Shaw | Neuren Pharmaceuticals | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Alabama at Birmingham | Birmingham | Alabama | 35294 | United States | ||
| University of California at San Francisco |
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Following completion of informed consent, participants (28) underwent 4 weeks of baselining/screening. During this process 12 participants failed screening. The remaining 16 participants commenced treatment.
Participants were recruited based on physician referral at 5 academic medical centers between August 2022 and December 2023
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| ID | Title | Description |
|---|---|---|
| FG000 | NNZ-2591 | All participants consenting |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Screening |
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| ||||||||||||||||||
| Treatment & Follow Up |
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| ID | Title | Description |
|---|---|---|
| BG000 | NNZ-2591 | All participants who successfully completed 4 week post consent screening period. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| 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 | Safety and Tolerability | To examine the incidence, severity and frequency of adverse events (AEs), including serious adverse events (SAEs) during treatment with NNZ-2591. | Safety population - all participants receiving at least one dose of NNZ-2591 | Posted | Count of Participants | Participants | 13 weeks |
|
|
15 weeks for each participant starting on the day of first dosing
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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 | NNZ-2591 | All enrolled participants who received at least one dose of IMP | 0 |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Constipation | Gastrointestinal disorders | MedDRA 24.0 | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Chief Medical Officer | Neuren Pharmaceuticals | +61 (3) 9092 0480 | MedicalInformation@neurenpharma.com |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Oct 30, 2023 | Mar 5, 2025 | Prot_002.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Apr 30, 2024 | Mar 5, 2025 | SAP_003.pdf |
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| ID | Term |
|---|---|
| C537403 | Pitt-Hopkins syndrome |
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| ID | Term |
|---|---|
| C540261 | cyclo-L-glycyl-L-2-allylproline |
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| Caregiver Impression of Improvement: Overall Score | Caregiver Impression of Improvement: Overall Score. Measured on a 7 point Likert scale (1-7) where lower scores are better. | CIC was assessed at Week13/EOT |
| Pitt Hopkins Syndrome-specific Clinical Global Impression Scale - Severity (CGI-S) - Overall Score | Pitt Hopkins syndrome-specific Clinical Global Impression Scale - Severity (CGI-S) - Change from baselines on overall Score based on a 7 point Likert scale (1-7) where lower scores are better. | Change in score assessed from baseline (visit 3, week 0) to visit 16 (week 13/EOT). |
| Caregiver Top 3 Concerns | Caregiver Top 3 Concerns: Change from baseline in Average Concern Severity. The average concern severity defined as the average of the severity scores for the three concerns evaluated at a given visit, and was calculated as long as at least one concern was useable for analysis at the visit. Scores range from 0 - 10 with higher scores indicating greater concern severity. A negative change from baseline indicates improvement. | Change from baseline (visit 3, week 0) to visit 16/EOT (week 13) in average concern severity. |
| MacArthur-Bates Communicative Development Inventory (MB-CDI) | MacArthur-Bates Communicative Development Inventory (MB-CDI): Words Understood Domain. Scores ranges from 0-396, with higher scores indicating greater language ability. A positive change from baseline indicates improvement. | Change from baseline (visit 3, week 0) to visit 16/EOT (week 13). |
| Observer-Reported Communication Ability (ORCA) | Observer-Reported Communication Ability (ORCA): Change from baseline in Modified t-score. The ORCA measures an individual's communication abilities based on observations made by caregivers, parents, or other relevant observers, and is based on 4 domains: Expressive Communication, Receptive Communication, Social Communication, and Pragmatic Language Skills. Scores range from 25.8 - 83.8, with higher scores indicating greater communication ability. A positive change from baseline indicates improvement. A T-score standardizes the individual's performance relative to a normative sample. It typically has a mean of 50 and a standard deviation of 10. T score = 50 + 10 × (X-µ)/σ Where: X is the individual's raw score μ is the population mean σ is the standard deviation | Change from baseline (visit 3, week 0) to visit 16/EOT (week 13) in Total Score. |
| Aberrant Behavior Checklist-2 (ABC-2) | Aberrant Behavior Checklist-2 (ABC-2): Change from baseline in Total Score. Range of scores is 0-174, with higher scores indicating more behavioral issues. A negative change from baseline indicates improvement. | Change from baseline (visit 3, week 0) to visit 16/EOT (week 13) in total score. |
| CSHQ | Child Sleep Habits Questionnaire (CSHQ). Total Score. Change from baseline. Range of scores was (33-99) with higher scores being worse. | Change from baseline (visit 3, week 0) to visit 16/EOT (week 13) in total score. |
| GIHQ | Gastrointestinal Health Questionnaire (GIHQ). Change from baseline in total frequency score. Range of scores was (0-197) with higher scores being worse. | Change from baseline (visit 3, week 0) to visit 16/EOT (week 13) in total frequency score. |
| Vineland Adaptive Behavior Scales-3, Interview Version | Vineland Adaptive Behavior Scales-3 (VABS-3), Interview version, Change from baseline in Adaptive Behavior Composite Standard Score. Scores range from 20 - 140 with higher scores indicating greater functional abilities. A positive change from baseline indicates improvement. | Change from baseline (visit 3, week 0) to visit 16/EOT (week 13) in composite standard score. |
| Modified Two-minute Walk Test | Modified two-minute walk test. Change from baseline in distance travelled (m) on 2 minute walk test. The test was only administered for participants who were ambulatory and able to complete the assessment. A positive score on change from baseline indicates improvement in distance walked. | Change from baseline (visit 3, week 0) to visit 16/EOT (week 13) in distance travelled on two minute walk test. |
| QI-Disability | Quality of Life Inventory-Disability (QI-Disability). Overall Score change from baseline. Scores range from 0 - 100 with higher scores indicating better quality of life. A positive change from baseline indicates improvement. | Change from baseline (visit 3, week 0) to visit 16/EOT (week 13) in overall score score. |
| ICND | Impact of Childhood Neurological Disability (ICND)-Overall quality of life rating, change from baseline. Score ranges from 1 - 6, with a higher score indicating better quality of life. A positive change from baseline indicates improvement. | Change from baseline (visit 3, week 0) to visit 16/EOT (week 13) in overall quality of life rating score. |
| Behavior Problems Inventory - Short Form | Change from baseline in Behavior Problems Inventory - Short Form Total Frequency Score. Scores range from 0-120, with higher scores indicating greater frequency in behavior problems. A negative change from baseline indicates improvement. | Change from baseline (visit 3, week 0) to visit 16/EOT (week 13) in Total Frequency score. |
| Bayley Scales of Infant Development (BSID-4): Non Verbal Development Quotient (NVDQ) | Change from baseline in Non Verbal Development Quotient (NVDQ). Scores range from 40 - 160, with higher scores indicating greater development. A positive change from baseline indicates improvement. | Change from baseline (visit 3, week 0) to visit 16/EOT (week 13) in NVDQ score. |
| San Francisco |
| California |
| 94143 |
| United States |
| Children's Hospital Colorado | Aurora | Colorado | 80045 | United States |
| Rush University Medical Center | Chicago | Illinois | 60612 | United States |
| UT Southwestern | Dallas | Texas | 75390 | United States |
|
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Count of Participants | Participants |
|
| Clinical Global Impression of Severity (CGI-S) | Mean | Standard Deviation | units on a scale |
|
| Height (cm) | Mean | Standard Deviation | centimetres |
|
| Weight (kg) | Mean | Standard Deviation | kilograms |
|
| Body Mass Index (kg/m^2) | Mean | Standard Deviation | kg/m^2 |
|
| PTHS variant | Number | participants |
|
| History of Developmental Regression | Count of Participants | Participants |
|
| Autism Mental Status Exam | The AMSE is an observational assessment that looks at 8 items of social, communicative and behavioral functioning in individuals with Autism Spectrum Disorder, with each item yielding a potential score of 0, 1 or 2, with range of 0-16. Higher scores indicate greater levels of impairment. | Mean | Standard Deviation | score on a scale |
|
| Presence of Co-morbid Psychiatric Disorders | Number | participants |
|
| BSID-4 NVDQ | Bayley Scales of Infant Development-4 (BSID-4) is used to measure the developmental functioning of children aged 1 to 42 months. The Non-Verbal Developmental Quotient (NVDQ) is derived from the Cognitive scale of the BSID-4 and focuses on tasks that require no verbal responses. Each non-verbal task is scored and the raw scores are summed up and converted to a quotient comparing the child's developmental age to their chronological age This standardization allows comparison across children of different ages. | Participants who could not be assessed on the Stanford-Binet Intelligence (SB-5) due to their developmental level were assessed using the Bayley Scales of Infant Development instead. | Mean | Standard Deviation | score on a scale |
|
|
| Primary | Pharmacokinetic - Mean AUC24 | Approximately nine sparse pharmacokinetic (PK) samples were collected from each participant under steady-state conditions. These samples were taken at pre-dose, 1-3 hours post-dose, and/or 4-7 hours post-dose during Weeks 2, 6, and 13. The individual pharmacokinetic parameters for NNZ-2591, including half-life (t1/2) and area under the curve over 24 hours (AUC24), were derived using subject-level concentration-time profiles from the study population model. | All participants enrolled in this study who receive the study drug through to the morning dose of Week 2 (Visit 5) as a minimum, and who underwent PK sample collection at least one of the specified post-dose time point(s). | Posted | Mean | Standard Deviation | ug.h/mL | Pre-dose, 1-3 h post-dose and/or 4-7 h post-dose at Weeks 2, 6 and 13. |
|
|
|
| Primary | Pharmacokinetic - t1/2 | Approximately nine sparse pharmacokinetic (PK) samples were collected from each participant under steady-state conditions. These samples were taken at pre-dose, 1-3 hours post-dose, and/or 4-7 hours post-dose during Weeks 2, 6, and 13. The individual pharmacokinetic parameters for NNZ-2591, including half-life (t1/2) and area under the curve over 24 hours (AUC24), were derived using subject-level concentration-time profiles from the study population model. | All participants enrolled in this study who receive the study drug through to the morning dose of Week 2 (Visit 5) as a minimum, and who undergo PK sample collection at least one of the specified post-dose time point(s). | Posted | Mean | Standard Deviation | hours | Pre-dose, 1-3 h post-dose and/or 4-7 h post-dose at Weeks 2, 6 and 13. |
|
|
|
| Secondary | Pitt Hopkins Syndrome-specific Clinical Global Impression Scale (CGI-I) - Overall Improvement | Pitt Hopkins Syndrome-specific Clinical Global Impression Scale (CGI-I) - Overall Improvement. Score on a Likert scale (1-7) where lower scores are better. | Modified intention to treat (MITT) | Posted | Mean | Standard Deviation | score on a scale | CGI-I was assessed at weeks 6, 13/EOT & 15. Overall improvement scores relate to week 13/EOT visit. |
|
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|
|
| Secondary | Caregiver Impression of Improvement: Overall Score | Caregiver Impression of Improvement: Overall Score. Measured on a 7 point Likert scale (1-7) where lower scores are better. | Posted | Mean | Standard Deviation | score on a scale | CIC was assessed at Week13/EOT |
|
|
|
|
| Secondary | Pitt Hopkins Syndrome-specific Clinical Global Impression Scale - Severity (CGI-S) - Overall Score | Pitt Hopkins syndrome-specific Clinical Global Impression Scale - Severity (CGI-S) - Change from baselines on overall Score based on a 7 point Likert scale (1-7) where lower scores are better. | Modified intention to treat (MITT) population | Posted | Mean | Standard Deviation | score on a scale | Change in score assessed from baseline (visit 3, week 0) to visit 16 (week 13/EOT). |
|
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|
|
| Secondary | Caregiver Top 3 Concerns | Caregiver Top 3 Concerns: Change from baseline in Average Concern Severity. The average concern severity defined as the average of the severity scores for the three concerns evaluated at a given visit, and was calculated as long as at least one concern was useable for analysis at the visit. Scores range from 0 - 10 with higher scores indicating greater concern severity. A negative change from baseline indicates improvement. | Modified intention to treat population | Posted | Mean | Standard Deviation | score on a scale | Change from baseline (visit 3, week 0) to visit 16/EOT (week 13) in average concern severity. |
|
|
|
|
| Secondary | MacArthur-Bates Communicative Development Inventory (MB-CDI) | MacArthur-Bates Communicative Development Inventory (MB-CDI): Words Understood Domain. Scores ranges from 0-396, with higher scores indicating greater language ability. A positive change from baseline indicates improvement. | Posted | Mean | Standard Deviation | score on a scale | Change from baseline (visit 3, week 0) to visit 16/EOT (week 13). |
|
|
|
|
| Secondary | Observer-Reported Communication Ability (ORCA) | Observer-Reported Communication Ability (ORCA): Change from baseline in Modified t-score. The ORCA measures an individual's communication abilities based on observations made by caregivers, parents, or other relevant observers, and is based on 4 domains: Expressive Communication, Receptive Communication, Social Communication, and Pragmatic Language Skills. Scores range from 25.8 - 83.8, with higher scores indicating greater communication ability. A positive change from baseline indicates improvement. A T-score standardizes the individual's performance relative to a normative sample. It typically has a mean of 50 and a standard deviation of 10. T score = 50 + 10 × (X-µ)/σ Where: X is the individual's raw score μ is the population mean σ is the standard deviation | Posted | Mean | Standard Deviation | T-score | Change from baseline (visit 3, week 0) to visit 16/EOT (week 13) in Total Score. |
|
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|
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| Secondary | Aberrant Behavior Checklist-2 (ABC-2) | Aberrant Behavior Checklist-2 (ABC-2): Change from baseline in Total Score. Range of scores is 0-174, with higher scores indicating more behavioral issues. A negative change from baseline indicates improvement. | Posted | Mean | Standard Deviation | score on a scale | Change from baseline (visit 3, week 0) to visit 16/EOT (week 13) in total score. |
|
|
|
|
| Secondary | CSHQ | Child Sleep Habits Questionnaire (CSHQ). Total Score. Change from baseline. Range of scores was (33-99) with higher scores being worse. | Posted | Mean | Standard Deviation | score on a scale | Change from baseline (visit 3, week 0) to visit 16/EOT (week 13) in total score. |
|
|
|
|
| Secondary | GIHQ | Gastrointestinal Health Questionnaire (GIHQ). Change from baseline in total frequency score. Range of scores was (0-197) with higher scores being worse. | Posted | Mean | Standard Deviation | score on a scale | Change from baseline (visit 3, week 0) to visit 16/EOT (week 13) in total frequency score. |
|
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|
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| Secondary | Vineland Adaptive Behavior Scales-3, Interview Version | Vineland Adaptive Behavior Scales-3 (VABS-3), Interview version, Change from baseline in Adaptive Behavior Composite Standard Score. Scores range from 20 - 140 with higher scores indicating greater functional abilities. A positive change from baseline indicates improvement. | one participant completed baseline VABS-3 but did not complete VABS-3 at EOT visit. Hence number analysed is only 10. | Posted | Mean | Standard Deviation | score on a scale | Change from baseline (visit 3, week 0) to visit 16/EOT (week 13) in composite standard score. |
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| Secondary | Modified Two-minute Walk Test | Modified two-minute walk test. Change from baseline in distance travelled (m) on 2 minute walk test. The test was only administered for participants who were ambulatory and able to complete the assessment. A positive score on change from baseline indicates improvement in distance walked. | Posted | Mean | Standard Deviation | meters | Change from baseline (visit 3, week 0) to visit 16/EOT (week 13) in distance travelled on two minute walk test. |
|
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| Secondary | QI-Disability | Quality of Life Inventory-Disability (QI-Disability). Overall Score change from baseline. Scores range from 0 - 100 with higher scores indicating better quality of life. A positive change from baseline indicates improvement. | Posted | Mean | Standard Deviation | score on a scale | Change from baseline (visit 3, week 0) to visit 16/EOT (week 13) in overall score score. |
|
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|
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| Secondary | ICND | Impact of Childhood Neurological Disability (ICND)-Overall quality of life rating, change from baseline. Score ranges from 1 - 6, with a higher score indicating better quality of life. A positive change from baseline indicates improvement. | Posted | Mean | Standard Deviation | score on a scale | Change from baseline (visit 3, week 0) to visit 16/EOT (week 13) in overall quality of life rating score. |
|
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|
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| Secondary | Behavior Problems Inventory - Short Form | Change from baseline in Behavior Problems Inventory - Short Form Total Frequency Score. Scores range from 0-120, with higher scores indicating greater frequency in behavior problems. A negative change from baseline indicates improvement. | Posted | Mean | Standard Deviation | score on a scale | Change from baseline (visit 3, week 0) to visit 16/EOT (week 13) in Total Frequency score. |
|
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| Secondary | Bayley Scales of Infant Development (BSID-4): Non Verbal Development Quotient (NVDQ) | Change from baseline in Non Verbal Development Quotient (NVDQ). Scores range from 40 - 160, with higher scores indicating greater development. A positive change from baseline indicates improvement. | Standard domain scores only calculated for participants 42 months of age and younger. | Posted | Mean | Standard Deviation | score on a scale | Change from baseline (visit 3, week 0) to visit 16/EOT (week 13) in NVDQ score. |
|
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|
|
| 16 |
| 0 |
| 16 |
| 15 |
| 16 |
| Diarrhea | Gastrointestinal disorders | MedDRA 24.0 | Systematic Assessment |
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| Vomiting | Gastrointestinal disorders | MedDRA 24.0 | Systematic Assessment |
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| Fatigue | General disorders | MedDRA 24.0 | Systematic Assessment |
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| Somnolence | Nervous system disorders | MedDRA 24.0 | Systematic Assessment |
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| Irritability | Psychiatric disorders | MedDRA 24.0 | Systematic Assessment |
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| Contusion | Injury, poisoning and procedural complications | MedDRA 24.0 | Systematic Assessment |
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| Gastroenteritis - viral | Infections and infestations | MedDRA 24.0 | Systematic Assessment |
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| Nasopharyngitis | Infections and infestations | MedDRA 24.0 | Systematic Assessment |
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| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA 24.0 | Systematic Assessment |
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| Rhinorrhea | Respiratory, thoracic and mediastinal disorders | MedDRA 24.0 | Systematic Assessment |
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| Covid-10 | Infections and infestations | MedDRA 24.0 | Systematic Assessment |
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| Ear Infection | Infections and infestations | MedDRA 24.0 | Systematic Assessment |
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| Escherichia urinary tract infection | Infections and infestations | MedDRA 24.0 | Systematic Assessment |
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| Influenza | Infections and infestations | MedDRA 24.0 | Systematic Assessment |
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| Otitis Media | Infections and infestations | MedDRA 24.0 | Systematic Assessment |
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| Pharyngitis streptococcal | Infections and infestations | MedDRA 24.0 | Systematic Assessment |
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| Abdominal Distension | Gastrointestinal disorders | MedDRA 24.0 | Systematic Assessment |
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| Abdominal Pain | Gastrointestinal disorders | MedDRA 24.0 | Systematic Assessment |
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| Breath Odour | Gastrointestinal disorders | MedDRA 24.0 | Systematic Assessment |
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| Faeces Hard | Gastrointestinal disorders | MedDRA 24.0 | Systematic Assessment |
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| Tongue Dry | Gastrointestinal disorders | MedDRA 24.0 | Systematic Assessment |
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| Pyrexia | General disorders | MedDRA 24.0 | Systematic Assessment |
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| Arthropod Bite | Injury, poisoning and procedural complications | MedDRA 24.0 | Systematic Assessment |
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| Fall | Injury, poisoning and procedural complications | MedDRA 24.0 | Systematic Assessment |
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| Headache | Nervous system disorders | MedDRA 24.0 | Systematic Assessment |
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| Lethargy | Nervous system disorders | MedDRA 24.0 | Systematic Assessment |
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| Insomnia | Psychiatric disorders | MedDRA 24.0 | Systematic Assessment |
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| Intentional Self Injury | Psychiatric disorders | MedDRA 24.0 | Systematic Assessment |
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| Middle Insomnia | Psychiatric disorders | MedDRA 24.0 | Systematic Assessment |
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| Sleep Disorder | Psychiatric disorders | MedDRA 24.0 | Systematic Assessment |
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| Productive Cough | Respiratory, thoracic and mediastinal disorders | MedDRA 24.0 | Systematic Assessment |
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| Refraction Disorder | Eye disorders | MedDRA 24.0 | Systematic Assessment |
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| Alanine aminotransferase increased | Investigations | MedDRA 24.0 | Systematic Assessment |
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| Decreased Appetite | Metabolism and nutrition disorders | MedDRA 24.0 | Systematic Assessment |
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| Pyelocaliectasis | Renal and urinary disorders | MedDRA 24.0 | Systematic Assessment |
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| Rash | Skin and subcutaneous tissue disorders | MedDRA 24.0 | Systematic Assessment |
|
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