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This is a randomized, double-blind, placebo-controlled, parallel group, Phase 3 trial to evaluate the safety and efficacy of NT0102 in the treatment of Attention Deficit Hyperactivity Disorder (ADHD) in pediatric patients 6 to 12 years of age in a laboratory classroom study.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| NT0102 | Experimental | After the screening/washout period, all participants will receive study drug NT0102 once daily for 4 weeks during the dose optimization period. After completion of the dose optimization period, the optimized dose of the study drug will be selected, and participants will stay on that dose for 1 week (dose stabilization period). At the end of this period, participants will be randomized to a treatment. Participants in this arm will be given 20-60 mg of NT0102 as oral disintegrating tablet (ODT) once daily for one week during the double-blind treatment period. |
|
| Placebo | Placebo Comparator | After the screening/washout period, all participants will receive study drug NT0102 once daily for 4 weeks during the dose optimization period. After completion of the dose optimization period, the optimized dose of the study drug will be selected, and participants will stay on that dose for 1 week (dose stabilization period). At the end of this period, participants will be randomized to a treatment. Participants in this arm will be given placebo as matching ODT once daily for one week during the double-blind treatment period. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| NT0102 | Drug | NT0102 (methylphenidate polistirex [MPP] extended release [XR] ODT) was given once daily at a dose equivalent to 20-60 mg methylphenidate hydrochloride. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Swanson, Kotkin, Agler, M-Flynn, and Pelham (SKAMP) Score | The primary efficacy endpoint was derived from the SKAMP-Combined score calculated as the total score of all 13 items of the SKAMP-Combined score. The SKAMP-Combined score was obtained by summing up each item score where each item is rated on a 7-point impairment scale (0=normal to 6=maximal impairment) for a total possible score of 0 to 78. A lower score indicates less symptomatology (i.e., is better). The SKAMP was a rating scale that specifically measures the classroom manifestations of ADHD. The SKAMP ratings were completed for all subjects at baseline (pre-dose) and at 1, 3, 5, 7, 10, 12, and 13 hours post-dose on the classroom testing day (Visit 8). The primary analysis time point for the primary efficacy endpoint was the average of all post-dose SKAMP scores during the 13-hour period. | Visit 8 (Day 42) |
| Measure | Description | Time Frame |
|---|---|---|
| Onset of Effect | Onset of effect was defined as the first time point at which NT0102 separates from placebo on SKAMP-Combined scores. A separation was defined as a statistically significant difference at the 5% level of active drug over placebo. Data was collected separately for NT0102 and Placebo arms and is reported as a comparison analysis of the two arms. This assessment was collected on the full classroom day, Visit 8. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Carolyn Sikes, PhD | Neos Tx | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Florida Clinical Research Center | Bradenton | Florida | 34208 | United States | ||
| Florida Clinical Research Center |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 34081560 | Derived | Childress AC, Kollins SH, Cutler AJ, Marraffino A, Sikes CR. Open-Label Dose Optimization of Methylphenidate Extended-Release Orally Disintegrating Tablet in a Laboratory Classroom Study of Children with Attention-Deficit/Hyperactivity Disorder. J Child Adolesc Psychopharmacol. 2021 Jun;31(5):342-349. doi: 10.1089/cap.2020.0142. Epub 2021 Jun 2. | |
| 27183299 |
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| ID | Title | Description |
|---|---|---|
| FG000 | NT0102 | After the screening/washout period, all participants received study drug NT0102 once daily for 4 weeks during the dose optimization period. After completion of the dose optimization period, the optimized dose of the study drug was selected, and participants were to stay on that dose for 1 week (dose stabilization period). At the end of this period, participants were randomized to a treatment. Participants in this arm were given 20-60 mg of NT0102 as oral disintegrating tablet (ODT) once daily for one week during the double-blind treatment period. |
| FG001 | Placebo | After the screening/washout period, all participants received study drug NT0102 once daily for 4 weeks during the dose optimization period. After completion of the dose optimization period, the optimized dose of the study drug was selected, and participants were to stay on that dose for 1 week (dose stabilization period). At the end of this period, participants were randomized to a treatment. Participants in this arm were given placebo as matching ODT once daily for one week during the double-blind treatment period. |
| FG002 | All Participants | All participants in the study went through the screening/washout period, then received study drug NT0102 once daily for 4 weeks during the dose optimization period. After completion of the dose optimization period, the optimized dose of the study drug was selected, and participants stayed on that dose for 1 week during the dose stabilization period before randomization into the double-blind treatment period. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Screening/Washout Period |
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| Dose Optimization Period |
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| Dose Stabilization Period |
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| Double-Blind Treatment Period |
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The full analysis set (FAS) consisted of all participants randomized to treatment who had at least 1 post-dose Swanson, Kotkin, Agler, M-Flynn, and Pelham (SKAMP)-Combined treatment assessment during the classroom testing session on Visit 8. Participants were analyzed as randomized.
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| ID | Title | Description |
|---|---|---|
| BG000 | NT0102 | After the screening/washout period, all participants received study drug NT0102 once daily for 4 weeks during the dose optimization period. After completion of the dose optimization period, the optimized dose of the study drug was selected, and participants were to stay on that dose for 1 week (dose stabilization period). At the end of this period, participants were randomized to a treatment. Participants in this arm were given 20-60 mg of NT0102 as oral disintegrating tablet (ODT) once daily for one week during the double-blind treatment period. |
| 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 | Swanson, Kotkin, Agler, M-Flynn, and Pelham (SKAMP) Score | The primary efficacy endpoint was derived from the SKAMP-Combined score calculated as the total score of all 13 items of the SKAMP-Combined score. The SKAMP-Combined score was obtained by summing up each item score where each item is rated on a 7-point impairment scale (0=normal to 6=maximal impairment) for a total possible score of 0 to 78. A lower score indicates less symptomatology (i.e., is better). The SKAMP was a rating scale that specifically measures the classroom manifestations of ADHD. The SKAMP ratings were completed for all subjects at baseline (pre-dose) and at 1, 3, 5, 7, 10, 12, and 13 hours post-dose on the classroom testing day (Visit 8). The primary analysis time point for the primary efficacy endpoint was the average of all post-dose SKAMP scores during the 13-hour period. | The full analysis set (FAS) consisted of all participants randomized to treatment who had at least 1 post-dose SKAMP-Combined treatment assessment during the classroom testing session on Visit 8. Participants were analyzed as randomized. | Posted | Mean | Standard Deviation | score on a scale | Visit 8 (Day 42) |
Up to Visit 9 (Day 43)
The safety population included all participants who took at least 1 dose of study drug. In the section "Other (Not Including Serious) Adverse Events" all events in the study are reported (frequency threshold 0%).
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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 | Dose Optimization/Stabilization Phase | All participants received study drug NT0102 once daily for 4 weeks during the dose optimization period. After completion of the dose optimization period, the optimized dose of the study drug was selected, and participants were to stay on that dose for 1 week (dose stabilization period). |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Ventricular arrhythmia | Cardiac disorders | MedDRA 16.0 | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Carolyn Sikes, PhD | Neos Tx | 972-408-1300 | 1255 | csikes@neostx.com |
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| ID | Term |
|---|---|
| D001289 | Attention Deficit Disorder with Hyperactivity |
| ID | Term |
|---|---|
| D019958 | Attention Deficit and Disruptive Behavior Disorders |
| D065886 | Neurodevelopmental Disorders |
| D001523 | Mental Disorders |
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| Placebo | Drug | Matching ODT placebo was given once daily. |
|
| Visit 8 (Day 42) at 1 hour (h), 3 h, 5 h, 7 h, 10 h, 12 h and 13 h |
| Duration of Effect | Duration of effect was defined as the last time point at which NT0102 separates from placebo on SKAMP-Combined scores. A separation was defined as a statistically significant difference at the 5% level of active drug over placebo. Data was collected separately for NT0102 and Placebo arms, and is reported as a comparison analysis of the two arms. This assessment was collected on the full classroom day, Visit 8. | Visit 8 (Day 42) at 1 hour (h), 3 h, 5 h, 7 h, 10 h, 12 h and 13 h |
| The Average of the SKAMP-Attention Scores | The SKAMP Rating Scale was comprised of 2 behavioral subscales, including the "Attention" subscale (4 items). The SKAMP-Attention subscore evaluates concentration in the classroom and is obtained by summing up each item score where each item is rated on a 7-point impairment scale (0=normal to 6=maximal impairment) for total possible combined score of 0 to 24. A lower score indicates less symptomatology (i.e. is better). The SKAMP-Attention subscores were derived from 20 minutes of direct observations of participant behavior. Ratings were based on the frequency and quality of behaviors. | Visit 8 (Day 42) |
| The Average of the SKAMP-Deportment Scores | The SKAMP Rating Scale is comprised of 2 behavioural subscales, including the "Deportment" subscale (4 items). The SKAMP-Deportment subscore evaluates behaviour in the classroom and is obtained by summing up each item score where each item is rated on a 7-point impairment scale (0=normal to 6=maximal impairment) for total possible combined score of 0 to 24. A lower score indicates less symptomatology (i.e. is better). The SKAMP-Attention subscores were derived from 20 minutes of direct observations of participant behaviour. Ratings were based on the frequency and quality of behaviours. | Visit 8 (Day 42) |
| The Average of the Permanent Product Measure of Performance - Attempted (PERMP-A) Score | The PERMP consisted of 400 math problems and was graded as number of problems "Attempted" (PERMP-A) and number of problems "Correct." (PERMP-C). It was an objective measure of performance during the classroom testing day. | Visit 8 (Day 42) |
| The Average of the Permanent Product Measure of Performance - Correct (PERMP-C) Score | The PERMP consisted of 400 math problems and was graded as number of problems "Attempted" (PERMP-A) and number of problems "Correct." (PERMP-C). It was an objective measure of performance during the classroom testing day. | Visit 8 (Day 42) |
| Number of Participants With Adverse Events | An adverse event is any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with the treatment. An adverse event can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporally associated with the use of a pharmaceutical product, whether or not considered related to the pharmaceutical product. Preexisting conditions which worsen during a study are also considered as adverse events. | Visit 9 (Day 43) |
| Maitland |
| Florida |
| 32751 |
| United States |
| Center for Psychiatry and Behavioral Medicine | Las Vegas | Nevada | 89128 | United States |
| Duke University | Durham | North Carolina | 27705 | United States |
| Childress AC, Kollins SH, Cutler AJ, Marraffino A, Sikes CR. Efficacy, Safety, and Tolerability of an Extended-Release Orally Disintegrating Methylphenidate Tablet in Children 6-12 Years of Age with Attention-Deficit/Hyperactivity Disorder in the Laboratory Classroom Setting. J Child Adolesc Psychopharmacol. 2017 Feb;27(1):66-74. doi: 10.1089/cap.2016.0002. Epub 2016 May 16. |
| NOT COMPLETED |
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| NOT COMPLETED |
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| NOT COMPLETED |
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|
| BG001 | Placebo | After the screening/washout period, all participants received study drug NT0102 once daily for 4 weeks during the dose optimization period. After completion of the dose optimization period, the optimized dose of the study drug was selected, and participants were to stay on that dose for 1 week (dose stabilization period). At the end of this period, participants were randomized to a treatment. Participants in this arm were given placebo as matching ODT once daily for one week during the double-blind treatment period. |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| ID |
|---|
| Title |
|---|
| Description |
|---|
| OG000 | Placebo | After the screening/washout period, all participants received study drug NT0102 once daily for 4 weeks during the dose optimization period. After completion of the dose optimization period, the optimized dose of the study drug was selected, and participants were to stay on that dose for 1 week (dose stabilization period). At the end of this period, participants were randomized to a treatment. Participants in this arm were given placebo as matching ODT once daily for one week during the double-blind treatment period. |
| OG001 | NT0102 | After the screening/washout period, all participants received study drug NT0102 once daily for 4 weeks during the dose optimization period. After completion of the dose optimization period, the optimized dose of the study drug was selected, and participants were to stay on that dose for 1 week (dose stabilization period). At the end of this period, participants were randomized to a treatment. Participants in this arm were given 20-60 mg of NT0102 as oral disintegrating tablet (ODT) once daily for one week during the double-blind treatment period. |
|
|
|
| Secondary | Onset of Effect | Onset of effect was defined as the first time point at which NT0102 separates from placebo on SKAMP-Combined scores. A separation was defined as a statistically significant difference at the 5% level of active drug over placebo. Data was collected separately for NT0102 and Placebo arms and is reported as a comparison analysis of the two arms. This assessment was collected on the full classroom day, Visit 8. | FAS consisted of all participants randomized to treatment who had at least 1 post-dose SKAMP-Combined treatment assessment during the classroom testing session on Visit 8. Participants were analyzed as randomized. | Posted | Number | hour | Visit 8 (Day 42) at 1 hour (h), 3 h, 5 h, 7 h, 10 h, 12 h and 13 h |
|
|
|
| Secondary | Duration of Effect | Duration of effect was defined as the last time point at which NT0102 separates from placebo on SKAMP-Combined scores. A separation was defined as a statistically significant difference at the 5% level of active drug over placebo. Data was collected separately for NT0102 and Placebo arms, and is reported as a comparison analysis of the two arms. This assessment was collected on the full classroom day, Visit 8. | FAS consisted of all participants randomized to treatment who had at least 1 post-dose SKAMP-Combined treatment assessment during the classroom testing session on Visit 8. Participants were analyzed as randomized. | Posted | Number | hour | Visit 8 (Day 42) at 1 hour (h), 3 h, 5 h, 7 h, 10 h, 12 h and 13 h |
|
|
|
| Secondary | The Average of the SKAMP-Attention Scores | The SKAMP Rating Scale was comprised of 2 behavioral subscales, including the "Attention" subscale (4 items). The SKAMP-Attention subscore evaluates concentration in the classroom and is obtained by summing up each item score where each item is rated on a 7-point impairment scale (0=normal to 6=maximal impairment) for total possible combined score of 0 to 24. A lower score indicates less symptomatology (i.e. is better). The SKAMP-Attention subscores were derived from 20 minutes of direct observations of participant behavior. Ratings were based on the frequency and quality of behaviors. | The per-protocol set were a subset of the FAS consisting of those participants who satisfied all of the inclusion/exclusion criteria and who correctly received the treatment to which they were randomized. | Posted | Mean | Standard Deviation | score on a scale | Visit 8 (Day 42) |
|
|
|
| Secondary | The Average of the SKAMP-Deportment Scores | The SKAMP Rating Scale is comprised of 2 behavioural subscales, including the "Deportment" subscale (4 items). The SKAMP-Deportment subscore evaluates behaviour in the classroom and is obtained by summing up each item score where each item is rated on a 7-point impairment scale (0=normal to 6=maximal impairment) for total possible combined score of 0 to 24. A lower score indicates less symptomatology (i.e. is better). The SKAMP-Attention subscores were derived from 20 minutes of direct observations of participant behaviour. Ratings were based on the frequency and quality of behaviours. | The Per-Protocol Set were a subset of the FAS consisting of those participants who satisfied all of the inclusion/exclusion criteria and who correctly received the treatment to which they were randomized. | Posted | Mean | Standard Deviation | score on a scale | Visit 8 (Day 42) |
|
|
|
| Secondary | The Average of the Permanent Product Measure of Performance - Attempted (PERMP-A) Score | The PERMP consisted of 400 math problems and was graded as number of problems "Attempted" (PERMP-A) and number of problems "Correct." (PERMP-C). It was an objective measure of performance during the classroom testing day. | FAS consisted of all participants randomized to treatment who had at least 1 post-dose SKAMP-Combined treatment assessment during the classroom testing session on Visit 8. Participants were analyzed as randomized. | Posted | Mean | Standard Deviation | number of problems attempted | Visit 8 (Day 42) |
|
|
|
| Secondary | The Average of the Permanent Product Measure of Performance - Correct (PERMP-C) Score | The PERMP consisted of 400 math problems and was graded as number of problems "Attempted" (PERMP-A) and number of problems "Correct." (PERMP-C). It was an objective measure of performance during the classroom testing day. | FAS consisted of all participants randomized to treatment who had at least 1 post-dose SKAMP-Combined treatment assessment during the classroom testing session on Visit 8. Participants were analyzed as randomized. | Posted | Mean | Standard Deviation | number of problems correct | Visit 8 (Day 42) |
|
|
|
| Secondary | Number of Participants With Adverse Events | An adverse event is any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with the treatment. An adverse event can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporally associated with the use of a pharmaceutical product, whether or not considered related to the pharmaceutical product. Preexisting conditions which worsen during a study are also considered as adverse events. | The safety population included all participants who took at least 1 dose of study drug. | Posted | Count of Participants | Participants | Visit 9 (Day 43) |
|
|
|
| 0 |
| 87 |
| 0 |
| 87 |
| 70 |
| 87 |
| EG001 | Double-Blind Phase: Placebo | At the end of the stabilization period, participants were randomized to a treatment. Participants in this arm were given placebo as matching ODT once daily for one week during the double-blind treatment period. | 0 | 41 | 0 | 41 | 10 | 41 |
| EG002 | Double-Blind Phase: NT0102 | At the end of the stabilization period, participants were randomized to a treatment. Participants in this arm were given 20-60 mg of NT0102 as ODT once daily for one week during the double-blind treatment period. | 0 | 44 | 0 | 44 | 11 | 44 |
| Ear pain | Ear and labyrinth disorders | MedDRA 16.0 | Systematic Assessment |
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| Dry eye | Eye disorders | MedDRA 16.0 | Systematic Assessment |
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| Myopia | Eye disorders | MedDRA 16.0 | Systematic Assessment |
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| Abdominal pain upper | Gastrointestinal disorders | MedDRA 16.0 | Systematic Assessment |
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| Constipation | Gastrointestinal disorders | MedDRA 16.0 | Systematic Assessment |
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| Diarrhoea | Gastrointestinal disorders | MedDRA 16.0 | Systematic Assessment |
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| Dyspepsia | Gastrointestinal disorders | MedDRA 16.0 | Systematic Assessment |
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| Oral pain | Gastrointestinal disorders | MedDRA 16.0 | Systematic Assessment |
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| Retching | Gastrointestinal disorders | MedDRA 16.0 | Systematic Assessment |
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| Vomiting | Gastrointestinal disorders | MedDRA 16.0 | Systematic Assessment |
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| Fatigue | General disorders | MedDRA 16.0 | Systematic Assessment |
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| Irritability | General disorders | MedDRA 16.0 | Systematic Assessment |
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| Pyrexia | General disorders | MedDRA 16.0 | Systematic Assessment |
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| Bronchitis | Infections and infestations | MedDRA 16.0 | Systematic Assessment |
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| Gastroenteritis viral | Infections and infestations | MedDRA 16.0 | Systematic Assessment |
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| Influenza | Infections and infestations | MedDRA 16.0 | Systematic Assessment |
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| Nasopharyngitis | Infections and infestations | MedDRA 16.0 | Systematic Assessment |
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| Otitis media | Infections and infestations | MedDRA 16.0 | Systematic Assessment |
|
| Pharyngitis streptococcal | Infections and infestations | MedDRA 16.0 | Systematic Assessment |
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| Upper respiratory tract infection | Infections and infestations | MedDRA 16.0 | Systematic Assessment |
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| Arthropod bite | Injury, poisoning and procedural complications | MedDRA 16.0 | Systematic Assessment |
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| Burns second degree | Injury, poisoning and procedural complications | MedDRA 16.0 | Systematic Assessment |
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| Excoriation | Injury, poisoning and procedural complications | MedDRA 16.0 | Systematic Assessment |
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| Laceration | Injury, poisoning and procedural complications | MedDRA 16.0 | Systematic Assessment |
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| Ligament sprain | Injury, poisoning and procedural complications | MedDRA 16.0 | Systematic Assessment |
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| Muscle strain | Injury, poisoning and procedural complications | MedDRA 16.0 | Systematic Assessment |
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| Periorbital haematoma | Injury, poisoning and procedural complications | MedDRA 16.0 | Systematic Assessment |
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| Wound | Injury, poisoning and procedural complications | MedDRA 16.0 | Systematic Assessment |
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| Blood pressure increased | Investigations | MedDRA 16.0 | Systematic Assessment |
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| Liver function test abnormal | Investigations | MedDRA 16.0 | Systematic Assessment |
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| Weight decreased | Investigations | MedDRA 16.0 | Systematic Assessment |
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| Weight increased | Investigations | MedDRA 16.0 | Systematic Assessment |
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| Decreased appetite | Metabolism and nutrition disorders | MedDRA 16.0 | Systematic Assessment |
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| Polydipsia | Metabolism and nutrition disorders | MedDRA 16.0 | Systematic Assessment |
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| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA 16.0 | Systematic Assessment |
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| Back pain | Musculoskeletal and connective tissue disorders | MedDRA 16.0 | Systematic Assessment |
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| Myalgia | Musculoskeletal and connective tissue disorders | MedDRA 16.0 | Systematic Assessment |
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| Dizziness | Nervous system disorders | MedDRA 16.0 | Systematic Assessment |
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| Dysgeusia | Nervous system disorders | MedDRA 16.0 | Systematic Assessment |
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| Headache | Nervous system disorders | MedDRA 16.0 | Systematic Assessment |
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| Migraine | Nervous system disorders | MedDRA 16.0 | Systematic Assessment |
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| Somnolence | Nervous system disorders | MedDRA 16.0 | Systematic Assessment |
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| Tremor | Nervous system disorders | MedDRA 16.0 | Systematic Assessment |
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| Affect lability | Psychiatric disorders | MedDRA 16.0 | Systematic Assessment |
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| Emotional disorder | Psychiatric disorders | MedDRA 16.0 | Systematic Assessment |
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| Initial insomnia | Psychiatric disorders | MedDRA 16.0 | Systematic Assessment |
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| Insomnia | Psychiatric disorders | MedDRA 16.0 | Systematic Assessment |
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| Middle insomnia | Psychiatric disorders | MedDRA 16.0 | Systematic Assessment |
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| Negativism | Psychiatric disorders | MedDRA 16.0 | Systematic Assessment |
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| Tic | Psychiatric disorders | MedDRA 16.0 | Systematic Assessment |
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| Trichotillomania | Psychiatric disorders | MedDRA 16.0 | Systematic Assessment |
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| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA 16.0 | Systematic Assessment |
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| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA 16.0 | Systematic Assessment |
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| Epistaxis | Respiratory, thoracic and mediastinal disorders | MedDRA 16.0 | Systematic Assessment |
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| Alopecia | Skin and subcutaneous tissue disorders | MedDRA 16.0 | Systematic Assessment |
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| Pruritus | Skin and subcutaneous tissue disorders | MedDRA 16.0 | Systematic Assessment |
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| Rash | Skin and subcutaneous tissue disorders | MedDRA 16.0 | Systematic Assessment |
|
| Rash maculo-papular | Skin and subcutaneous tissue disorders | MedDRA 16.0 | Systematic Assessment |
|
Not provided