Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| 2015-004904-50 | EudraCT Number |
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This trial consists of 3 parts: a pilot safety phase, a pivotal randomized controlled phase, and an open-label extension phase. The open-label extension phase only will be described in this record. All participants will receive GWP42003-P.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| GWP42003-P | Experimental | Administered orally, up to the target dose recommended by the data safety monitoring committee. Participants continue at the target dose, or the highest tolerated dose up to the target dose, for a total of 12 months' treatment. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| GWP42003-P | Drug | Clear, colorless to yellow solution containing cannabidiol dissolved in the excipients sesame oil and anhydrous ethanol with added sweetener (sucralose) and strawberry flavoring. |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Severe Treatment-emergent Adverse Events (TEAEs) | TEAEs were collected in members of the Safety Population, comprised of all participants who received at least 1 dose of GWP42003-P. TEAEs are defined as all adverse events not present prior to the first investigational medicinal product (IMP) or placebo administration or any event already present that worsened in severity or frequency following IMP. | From signing of informed consent up to Day 417 |
| Number of Participants With Any Low or High Hematology Laboratory Parameter Value | Days 19, 29, 43, 71, 127, 211, 295, 379, and 389 | |
| Number of Participants With Any Low or High Biochemistry Laboratory Parameter Value | Days 19, 29, 43, 71, 127, 211, 295, 379, and 389 | |
| Number of Participants With Any Clinically Relevant Urinalysis Parameter Value | Clinical relevance was determined by the investigator. | Days 19, 29, 43, 71, 127, 211, 295, 379, and 389 |
| Number of Participants With Clinically Significant Electrocardiogram Findings | Clinical significance was determined by the investigator. | From signing of informed consent up to Day 389 |
| Number of Participants With Clinically Significant Vital Sign Findings | Clinical significance was determined by the investigator. | From signing of informed consent up to Day 389 |
| Number of Participants With Clinically Significant Physical Examination Findings |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants Free of Clinical Spasms | Clinical spasms were determined by video-electroencephalography (VEEG) for at least 8 hours and up to 24 hours. | Days 29, 43, 127, 211, 295, and 379 |
| Percentage of Participants Free of Clinical Spasms |
Not provided
Only participants who completed the pilot or pivotal phases of the trial may proceed to take part in this open-label extension phase of the trial.
Key eligibility criteria for the blinded phase were as follows:
Key Inclusion Criteria:
Key Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Arkansas Children's Hospital | Little Rock | Arkansas | 72202 | United States | ||
| Wake Forest Baptist Medical Center |
Not provided
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | GWP42003-P OS | Following completion of the Pilot Phase (NCT02953548), participants were eligible to participate in the Open Label Extension Phase. Participants continued on the same dose administered in the Pilot Phase for a maximum of 1 year and completed a 10-day taper after completing the study or withdrawing. Participants were administered GWP42003-P oral solution (OS) orally, twice daily, or three times daily if poorly tolerated. The dosage was split evenly across the two or three daily administrations to equal the target or most tolerable dose. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | GWP42003-P OS | Following completion of the Pilot Phase (NCT02953548), participants were eligible to participate in the Open Label Extension Phase. Participants continued on the same dose administered in the Pilot Phase for a maximum of 1 year and completed a 10-day taper after completing the study or withdrawing. Participants were administered GWP42003-P oral solution (OS) orally, twice daily, or three times daily if poorly tolerated. The dosage was split evenly across the two or three daily administrations to equal the target or most tolerable dose. |
| 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 | Number of Participants With Severe Treatment-emergent Adverse Events (TEAEs) | TEAEs were collected in members of the Safety Population, comprised of all participants who received at least 1 dose of GWP42003-P. TEAEs are defined as all adverse events not present prior to the first investigational medicinal product (IMP) or placebo administration or any event already present that worsened in severity or frequency following IMP. | Safety Analysis Set: all participants who had received ≥ 1 dose of GWP42003-P | Posted | Count of Participants | Participants | From signing of informed consent up to Day 417 |
|
From signing of informed consent up to Day 417
Treatment-emergent adverse events (TEAEs) were collected in members of the Safety Population, comprised of all participants who received at least 1 dose of GWP42003-P. TEAEs are defined as all adverse events not present prior to the first investigational medicinal product (IMP) or placebo administration or any event already present that worsened in severity or frequency following IMP.
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Cannabidiol OS | Following completion of the Pilot Phase (NCT02953548), participants were eligible to participate in the Open Label Extension Phase. Participants continued on the same dose administered in the Pilot Phase for a maximum of 1 year and completed a 10-day taper after completing the study or withdrawing. Participants were administered GWP42003-P oral solution (OS) orally, twice daily, or three times daily if poorly tolerated. The dosage was split evenly across the two or three daily administrations to equal the target or most tolerable dose. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Acute respiratory failure | Respiratory, thoracic and mediastinal disorders | MedDRA (19.0) | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Hypertension | Vascular disorders | MedDRA (19.0) | Systematic Assessment |
This study met No Go Criteria. The Pilot Phase concluded after 9 participants completed treatment, and the Pivotal Phase was not initiated. Participants completing the Pilot Phase could roll into the Open Label Extension Phase for up to 1 year.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Medical Enquires | GW Research Ltd | +44 01223 238170; 18778862810 | medinfo@gwpharm.com, medinfo@greenwichbiosciences.com |
Not provided
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Sep 20, 2016 | Jun 10, 2020 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Sep 25, 2019 | Jun 10, 2020 | SAP_001.pdf |
Not provided
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| ID | Term |
|---|---|
| D013036 | Spasms, Infantile |
| ID | Term |
|---|---|
| D004829 | Epilepsy, Generalized |
| D004827 | Epilepsy |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| D002185 | Cannabidiol |
| ID | Term |
|---|---|
| D002186 | Cannabinoids |
| D013729 | Terpenes |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
Not provided
Not provided
Not provided
Not provided
Not provided
Open-label
Not provided
|
Clinical significance was determined by the investigator.
| From signing of informed consent up to Day 389 |
Clinical spasms were determined by VEEG for at least 8 hours and up to 24 hours.
| Days 29, 43, 127, 211, 295, and 379 |
| Number of Participants With a Resolution of Hypsarrhythmia | Resolution of hypsarrhythmia was determined by VEEG for at least 8 hours and up to 24 hours. | Days 29, 43, 127, 211, 295, and 379 |
| Percentage of Participants With a Resolution of Hypsarrhythmia | Resolution of hypsarrhythmia was determined by VEEG for at least 8 hours and up to 24 hours. | Days 29, 43, 127, 211, 295, and 379 |
| Number of Participants Experiencing Spasms and Seizures by Subtype | Caregivers recorded the participant's spasms and seizures by category in a daily diary. Subtypes of spasms and seizure included, clonic, tonic-clonic, myoclonic, focal, and absence. | Days 19, 29, 127, 211, 295, and 379 |
| Caregiver Global Impression of Change (CGIC) | The CGIC is a single-question assessment completed by the caregiver. The question assessed the status of the participant's condition since treatment start. The caregiver provided a rating on a 7-point scale: 1, very much improved; 2, much Improved; 3, slightly improved; 4, no change; 5, slightly worse; 6, much worse; 7, very much worse. | Baseline; Days 29, 43, 71, 127, 211, 295, and 379 |
| Physician Global Impression of Change (PGIC) | The PGIC is a single-question assessment completed by the investigator. The question assessed the status of the participant's condition since treatment start. The investigator provided a rating on a 7-point scale: 1, very much improved; 2, much Improved; 3, slightly improved; 4, no change; 5, slightly worse; 6, much worse; 7, very much worse. | Baseline; Days 29, 43, 71, 127, 211, 295, and 379 |
| Number of Responders | A responder is defined as a participant experiencing a resolution of hypsarrhythmia and free of spasms. Test for responders was conducted by VEEG for at least 8 hours and up to 24 hours. | Days 29, 43, 127, 211, 295, and 379 |
| Percentage of Responders | A responder is defined as a participant experiencing a resolution of hypsarrhythmia and free of spasms. Test for responders was conducted by VEEG for at least 8 hours and up to 24 hours. | Days 29, 43, 127, 211, 295, and 379 |
| Change From Baseline in Height | A positive change indicates an increase in the average participant's height. A negative change indicates a decrease in the average participant's height. Change from Baseline was calculated as the post-Baseline value minus the Baseline value. | Baseline (Day 1 of Pilot Study); Days 29, 43, 71, 127, 211, 295, 379, and 389 |
| Change From Baseline in Body Weight. | A positive change indicates an increase in the average participant's weight. A negative change indicates a decrease in the average participant's weight. Change from Baseline was calculated as the post-Baseline value minus the Baseline value. | Baseline (Day 1 of Pilot Study); Days 29, 43, 71, 127, 211, 295, 379, and 389 |
| Change From Baseline in Head Circumference | A positive change indicates an increase in the average participant's head circumference. A negative change indicates a decrease in the average participant's head circumference. Change from Baseline was calculated as the post-Baseline value minus the Baseline value. | Baseline (Day 1 of PIlot Study); Days 29, 43, 71, 127, 211, 295, 379, and 389 |
| Change From Baseline in Vineland Adaptive Behavior Scales, Second Edition (Vineland-II) Score | The Vineland-II scores were assessed by the participant's caregiver. Caregivers were asked to score questions in the following categories: the participant's communication, daily living, physical activity, problem behaviors, and social skills and relationships. Scoring was slightly different for each section, but generally ranged from "usually" (2) to "never" (0). The total score is calculated as the sum of standard scores from the domains and converted into the adaptive behavior composite score (ranging from 20 to 160). Higher scores represent greater levels of functioning, and lower scores represent lower levels of functioning. Change from Baseline was calculated as the post-Baseline value minus the Baseline value. | Baseline (Day 1 of Pilot Study); Day 211, Day 379 |
| Number of Participants With Relapse of Spasms | Analysis could not be conducted for this outcome measure because the study met No Go Criteria. The Pilot Phase concluded after 9 participants completed treatment and demonstrated continued hypsarrhythmia and spasms on follow-up VEEG. The Pivotal Phase was not initiated; however, participants completing the Pilot Phase could roll into the Open Label Extension Phase for up to 1 year. | Day 16 to Day 379 |
| Percentage of Participants With Relapse of Spasms | Analysis could not be conducted for this outcome measure because the study met No Go Criteria. The Pilot Phase concluded after 9 participants completed treatment and demonstrated continued hypsarrhythmia and spasms on follow-up VEEG. The Pivotal Phase was not initiated; however, participants completing the Pilot Phase could roll into the Open Label Extension Phase for up to 1 year. | Day 16 to Day 379 |
| Average Time to Cessation of Spasms | Analysis could not be conducted for this outcome measure because the study met No Go Criteria. The Pilot Phase concluded after 9 participants completed treatment and demonstrated continued hypsarrhythmia and spasms on follow-up VEEG. The Pivotal Phase was not initiated; however, participants completing the Pilot Phase could roll into the Open Label Extension Phase for up to 1 year. | Day 1 to Day 379 |
| Average Time to Relapse | Analysis could not be conducted for this outcome measure because the study met No Go Criteria. The Pilot Phase concluded after 9 participants completed treatment and demonstrated continued hypsarrhythmia and spasms on follow-up VEEG. The Pivotal Phase was not initiated; however, participants completing the Pilot Phase could roll into the Open Label Extension Phase for up to 1 year. | Day 16 to Day 379 |
| Winston-Salem |
| North Carolina |
| 27157 |
| United States |
| Nationwide Children's Hospital | Columbus | Ohio | 43205 | United States |
| Le Bonheur Children's Hospital | Memphis | Tennessee | 38103 | United States |
| Valley Health Clinical Research | Winchester | Virginia | 22601 | United States |
| Uniwersyteckie Centrum Kliniczne | Gdansk | Poland |
| Centrum Medyczne POMOC | Lodz | Poland |
| years |
|
| Age, Customized | Count of Participants | Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
|
|
| Primary | Number of Participants With Any Low or High Hematology Laboratory Parameter Value | Safety Analysis Set. Only participants with evaluable data were analyzed. | Posted | Count of Participants | Participants | Days 19, 29, 43, 71, 127, 211, 295, 379, and 389 |
|
|
|
| Primary | Number of Participants With Any Low or High Biochemistry Laboratory Parameter Value | Safety Analysis Set. Only participants with evaluable data were analyzed. | Posted | Count of Participants | Participants | Days 19, 29, 43, 71, 127, 211, 295, 379, and 389 |
|
|
|
| Primary | Number of Participants With Any Clinically Relevant Urinalysis Parameter Value | Clinical relevance was determined by the investigator. | Safety Analysis Set. Only participants with evaluable data were analyzed. | Posted | Count of Participants | Participants | Days 19, 29, 43, 71, 127, 211, 295, 379, and 389 |
|
|
|
| Primary | Number of Participants With Clinically Significant Electrocardiogram Findings | Clinical significance was determined by the investigator. | Safety Analysis Set | Posted | Count of Participants | Participants | From signing of informed consent up to Day 389 |
|
|
|
| Primary | Number of Participants With Clinically Significant Vital Sign Findings | Clinical significance was determined by the investigator. | Safety Analysis Set | Posted | Count of Participants | Participants | From signing of informed consent up to Day 389 |
|
|
|
| Primary | Number of Participants With Clinically Significant Physical Examination Findings | Clinical significance was determined by the investigator. | Safety Analysis Set | Posted | Count of Participants | Participants | From signing of informed consent up to Day 389 |
|
|
|
| Secondary | Number of Participants Free of Clinical Spasms | Clinical spasms were determined by video-electroencephalography (VEEG) for at least 8 hours and up to 24 hours. | Safety Analysis Set. Only participants with evaluable data were analyzed. | Posted | Count of Participants | Participants | Days 29, 43, 127, 211, 295, and 379 |
|
|
|
| Secondary | Percentage of Participants Free of Clinical Spasms | Clinical spasms were determined by VEEG for at least 8 hours and up to 24 hours. | Safety Analysis Set. Only participants with evaluable data were analyzed. | Posted | Number | percentage of participants | Days 29, 43, 127, 211, 295, and 379 |
|
|
|
| Secondary | Number of Participants With a Resolution of Hypsarrhythmia | Resolution of hypsarrhythmia was determined by VEEG for at least 8 hours and up to 24 hours. | Safety Analysis Set. Only participants with evaluable data were analyzed. | Posted | Count of Participants | Participants | Days 29, 43, 127, 211, 295, and 379 |
|
|
|
| Secondary | Percentage of Participants With a Resolution of Hypsarrhythmia | Resolution of hypsarrhythmia was determined by VEEG for at least 8 hours and up to 24 hours. | Safety Analysis Set. Only participants with evaluable data were analyzed. | Posted | Number | percentage of participants | Days 29, 43, 127, 211, 295, and 379 |
|
|
|
| Secondary | Number of Participants Experiencing Spasms and Seizures by Subtype | Caregivers recorded the participant's spasms and seizures by category in a daily diary. Subtypes of spasms and seizure included, clonic, tonic-clonic, myoclonic, focal, and absence. | Safety Analysis Set | Posted | Count of Participants | Participants | Days 19, 29, 127, 211, 295, and 379 |
|
|
|
| Secondary | Caregiver Global Impression of Change (CGIC) | The CGIC is a single-question assessment completed by the caregiver. The question assessed the status of the participant's condition since treatment start. The caregiver provided a rating on a 7-point scale: 1, very much improved; 2, much Improved; 3, slightly improved; 4, no change; 5, slightly worse; 6, much worse; 7, very much worse. | Safety Analysis Set | Posted | Number | participants | Baseline; Days 29, 43, 71, 127, 211, 295, and 379 |
|
|
|
| Secondary | Physician Global Impression of Change (PGIC) | The PGIC is a single-question assessment completed by the investigator. The question assessed the status of the participant's condition since treatment start. The investigator provided a rating on a 7-point scale: 1, very much improved; 2, much Improved; 3, slightly improved; 4, no change; 5, slightly worse; 6, much worse; 7, very much worse. | Safety Analysis Set | Posted | Number | participants | Baseline; Days 29, 43, 71, 127, 211, 295, and 379 |
|
|
|
| Secondary | Number of Responders | A responder is defined as a participant experiencing a resolution of hypsarrhythmia and free of spasms. Test for responders was conducted by VEEG for at least 8 hours and up to 24 hours. | Safety Analysis Set. Only participants with evaluable data were analyzed. | Posted | Count of Participants | Participants | Days 29, 43, 127, 211, 295, and 379 |
|
|
|
| Secondary | Percentage of Responders | A responder is defined as a participant experiencing a resolution of hypsarrhythmia and free of spasms. Test for responders was conducted by VEEG for at least 8 hours and up to 24 hours. | Safety Analysis Set. Only participants with evaluable data were analyzed. | Posted | Number | percentage of participants | Days 29, 43, 127, 211, 295, and 379 |
|
|
|
| Secondary | Change From Baseline in Height | A positive change indicates an increase in the average participant's height. A negative change indicates a decrease in the average participant's height. Change from Baseline was calculated as the post-Baseline value minus the Baseline value. | Safety Analysis Set. Only participants with evaluable data were analyzed. | Posted | Mean | Standard Deviation | centimeters | Baseline (Day 1 of Pilot Study); Days 29, 43, 71, 127, 211, 295, 379, and 389 |
|
|
|
| Secondary | Change From Baseline in Body Weight. | A positive change indicates an increase in the average participant's weight. A negative change indicates a decrease in the average participant's weight. Change from Baseline was calculated as the post-Baseline value minus the Baseline value. | Safety Analysis Set. Only participants with evaluable data were analyzed. | Posted | Mean | Standard Deviation | kilograms | Baseline (Day 1 of Pilot Study); Days 29, 43, 71, 127, 211, 295, 379, and 389 |
|
|
|
| Secondary | Change From Baseline in Head Circumference | A positive change indicates an increase in the average participant's head circumference. A negative change indicates a decrease in the average participant's head circumference. Change from Baseline was calculated as the post-Baseline value minus the Baseline value. | Safety Analysis Set. Only participants with evaluable data were analyzed. | Posted | Mean | Standard Deviation | centimeters | Baseline (Day 1 of PIlot Study); Days 29, 43, 71, 127, 211, 295, 379, and 389 |
|
|
|
| Secondary | Change From Baseline in Vineland Adaptive Behavior Scales, Second Edition (Vineland-II) Score | The Vineland-II scores were assessed by the participant's caregiver. Caregivers were asked to score questions in the following categories: the participant's communication, daily living, physical activity, problem behaviors, and social skills and relationships. Scoring was slightly different for each section, but generally ranged from "usually" (2) to "never" (0). The total score is calculated as the sum of standard scores from the domains and converted into the adaptive behavior composite score (ranging from 20 to 160). Higher scores represent greater levels of functioning, and lower scores represent lower levels of functioning. Change from Baseline was calculated as the post-Baseline value minus the Baseline value. | Safety Analysis Set. Only participants with evaluable data were analyzed. | Posted | Mean | Standard Deviation | score on a scale | Baseline (Day 1 of Pilot Study); Day 211, Day 379 |
|
|
|
| Secondary | Number of Participants With Relapse of Spasms | Analysis could not be conducted for this outcome measure because the study met No Go Criteria. The Pilot Phase concluded after 9 participants completed treatment and demonstrated continued hypsarrhythmia and spasms on follow-up VEEG. The Pivotal Phase was not initiated; however, participants completing the Pilot Phase could roll into the Open Label Extension Phase for up to 1 year. | Safety Analysis Set | Posted | Day 16 to Day 379 |
|
|
| Secondary | Percentage of Participants With Relapse of Spasms | Analysis could not be conducted for this outcome measure because the study met No Go Criteria. The Pilot Phase concluded after 9 participants completed treatment and demonstrated continued hypsarrhythmia and spasms on follow-up VEEG. The Pivotal Phase was not initiated; however, participants completing the Pilot Phase could roll into the Open Label Extension Phase for up to 1 year. | Safety Analysis Set | Posted | Day 16 to Day 379 |
|
|
| Secondary | Average Time to Cessation of Spasms | Analysis could not be conducted for this outcome measure because the study met No Go Criteria. The Pilot Phase concluded after 9 participants completed treatment and demonstrated continued hypsarrhythmia and spasms on follow-up VEEG. The Pivotal Phase was not initiated; however, participants completing the Pilot Phase could roll into the Open Label Extension Phase for up to 1 year. | Safety Analysis Set | Posted | Day 1 to Day 379 |
|
|
| Secondary | Average Time to Relapse | Analysis could not be conducted for this outcome measure because the study met No Go Criteria. The Pilot Phase concluded after 9 participants completed treatment and demonstrated continued hypsarrhythmia and spasms on follow-up VEEG. The Pivotal Phase was not initiated; however, participants completing the Pilot Phase could roll into the Open Label Extension Phase for up to 1 year. | Safety Analysis Set | Posted | Day 16 to Day 379 |
|
|
| 0 |
| 9 |
| 2 |
| 9 |
| 7 |
| 9 |
| Hypoxia | Respiratory, thoracic and mediastinal disorders | MedDRA (19.0) | Systematic Assessment |
|
| Pneumonia aspiration | Respiratory, thoracic and mediastinal disorders | MedDRA (19.0) | Systematic Assessment |
|
| Respiratory distress | Respiratory, thoracic and mediastinal disorders | MedDRA (19.0) | Systematic Assessment |
|
| Respiratory failure | Respiratory, thoracic and mediastinal disorders | MedDRA (19.0) | Systematic Assessment |
|
| Diarrhoea | Gastrointestinal disorders | MedDRA (19.0) | Systematic Assessment |
|
| Urinary retention | Renal and urinary disorders | MedDRA (19.0) | Systematic Assessment |
|
| Enterovirus infection | Infections and infestations | MedDRA (19.0) | Systematic Assessment |
|
| Pneumonia | Infections and infestations | MedDRA (19.0) | Systematic Assessment |
|
| Rhinovirus infection | Infections and infestations | MedDRA (19.0) | Systematic Assessment |
|
| Bronchiolitis | Infections and infestations | MedDRA (19.0) | Systematic Assessment |
|
| Pneumonia bacterial | Infections and infestations | MedDRA (19.0) | Systematic Assessment |
|
| Pneumonia klebsiella | Infections and infestations | MedDRA (19.0) | Systematic Assessment |
|
| Urinary tract infection bacterial | Infections and infestations | MedDRA (19.0) | Systematic Assessment |
|
| Viral upper respiratory infection | Infections and infestations | MedDRA (19.0) | Systematic Assessment |
|
| Hypotension | Vascular disorders | MedDRA (19.0) | Systematic Assessment |
|
| Pyrexia | General disorders | MedDRA (19.0) | Systematic Assessment |
|
| Drug tolerance | General disorders | MedDRA (19.0) | Systematic Assessment |
|
| Irritability | Psychiatric disorders | MedDRA (19.0) | Systematic Assessment |
|
| Sleep disorder | Psychiatric disorders | MedDRA (19.0) | Systematic Assessment |
|
| Blood triglycerides increased | Investigations | MedDRA (19.0) | Systematic Assessment |
|
| Upper respiratory tract congestion | Respiratory, thoracic and mediastinal disorders | MedDRA (19.0) | Systematic Assessment |
|
| Adenoidal hypertrophy | Respiratory, thoracic and mediastinal disorders | MedDRA (19.0) | Systematic Assessment |
|
| Anaemia | Blood and lymphatic system disorders | MedDRA (19.0) | Systematic Assessment |
|
| Somnolence | Nervous system disorders | MedDRA (19.0) | Systematic Assessment |
|
| Myoclonic epilepsy | Nervous system disorders | MedDRA (19.0) | Systematic Assessment |
|
| Petit mal epilepsy | Nervous system disorders | MedDRA (19.0) | Systematic Assessment |
|
| Pupils unequal | Eye disorders | MedDRA (19.0) | Systematic Assessment |
|
| Deafness | Ear and labyrinth disorders | MedDRA (19.0) | Systematic Assessment |
|
| Middle ear effusion | Ear and labyrinth disorders | MedDRA (19.0) | Systematic Assessment |
|
| Gingival pain | Gastrointestinal disorders | MedDRA (19.0) | Systematic Assessment |
|
| Dermatitis diaper | Skin and subcutaneous tissue disorders | MedDRA (19.0) | Systematic Assessment |
|
| Rash | Skin and subcutaneous tissue disorders | MedDRA (19.0) | Systematic Assessment |
|
| Skin irritation | Skin and subcutaneous tissue disorders | MedDRA (19.0) | Systematic Assessment |
|
| Scoliosis | Musculoskeletal and connective tissue disorders | MedDRA (19.0) | Systematic Assessment |
|
| Decreased appetite | Metabolism and nutrition disorders | MedDRA (19.0) | Systematic Assessment |
|
| Feeding intolerance | Metabolism and nutrition disorders | MedDRA (19.0) | Systematic Assessment |
|
| Fluid overload | Metabolism and nutrition disorders | MedDRA (19.0) | Systematic Assessment |
|
| Hypokalaemia | Metabolism and nutrition disorders | MedDRA (19.0) | Systematic Assessment |
|
| Hyponatraemia | Metabolism and nutrition disorders | MedDRA (19.0) | Systematic Assessment |
|
| Urinary tract infection | Infections and infestations | MedDRA (19.0) | Systematic Assessment |
|
| Viral infection | Infections and infestations | MedDRA (19.0) | Systematic Assessment |
|
| Bronchiolitis | Infections and infestations | MedDRA (19.0) | Systematic Assessment |
|
| Ear infection | Infections and infestations | MedDRA (19.0) | Systematic Assessment |
|
| Nasopharyngitis | Infections and infestations | MedDRA (19.0) | Systematic Assessment |
|
| Otitis media | Infections and infestations | MedDRA (19.0) | Systematic Assessment |
|
| Pneumonia | Infections and infestations | MedDRA (19.0) | Systematic Assessment |
|
| Sinusitis | Infections and infestations | MedDRA (19.0) | Systematic Assessment |
|
| Viral upper respiratory tract infection | Infections and infestations | MedDRA (19.0) | Systematic Assessment |
|
Not provided
| D009422 |
| Nervous System Diseases |
| D000073376 | Epileptic Syndromes |
|
| Day 29, Low |
|
|
| Day 29, High |
|
|
| Day 43, Low |
|
|
| Day 43, High |
|
|
| Day 71, Low |
|
|
| Day 71, High |
|
|
| Day 127, Low |
|
|
| Day 127, High |
|
|
| Day 211, Low |
|
|
| Day 211, High |
|
|
| Day 295, Low |
|
|
| Day 295, High |
|
|
| Day 379, Low |
|
|
| Day 379, High |
|
|
| Day 389, Low |
|
|
| Day 389, High |
|
|
|
| Day 29, Low |
|
|
| Day 29, High |
|
|
| Day 43, Low |
|
|
| Day 43, High |
|
|
| Day 71, Low |
|
|
| Day 71, High |
|
|
| Day 127, Low |
|
|
| Day 127, High |
|
|
| Day 211, Low |
|
|
| Day 211, High |
|
|
| Day 295, Low |
|
|
| Day 295, High |
|
|
| Day 379, Low |
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| Day 379, High |
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| Day 389, Low |
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| Day 389, High |
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| Day 43 |
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| Day 71 |
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| Day 127 |
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| Day 211 |
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| Day 295 |
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| Day 379 |
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| Day 389 |
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| Day 127 |
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| Day 211 |
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| Day 295 |
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| Day 379 |
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| Day 127 |
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| Day 211 |
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| Day 295 |
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| Day 379 |
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| Day 127 |
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| Day 211 |
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| Day 295 |
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| Day 379 |
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| Day 127 |
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| Day 211 |
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| Day 295 |
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| Day 379 |
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| Title | Measurements |
|---|---|
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| Day 19, Myoclonic |
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| Day 19, Focal |
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| Day 19, Absence |
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| Day 19, Not Done |
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| Day 29, Clonic |
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| Day 29, Tonic-Clonic |
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| Day 29, Atonic |
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| Day 29, Myoclonic |
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| Day 29, Focal |
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| Day 29, Absence |
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| Day 29, Not Done |
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| Day 127, Clonic |
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| Day 127, Tonic-Clonic |
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| Day 127, Atonic |
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| Day 127, Myoclonic |
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| Day 127, Focal |
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| Day 127, Absence |
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| Day 127, No Done |
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| Day 211, Clonic |
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| Day 211, Tonic-Clonic |
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| Day 211, Atonic |
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| Day 211, Myoclonic |
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| Day 211, Focal |
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| Day 211, Absence |
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| Day 211, Not Done |
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| Day 295, Clonic |
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| Day 295, Tonic-Clonic |
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| Day 295, Atonic |
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| Day 295, Myoclonic |
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| Day 295, Focal |
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| Day 295, Absence |
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| Day 295, Not Done |
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| Day 379, Clonic |
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| Day 379, Tonic-Clonic |
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| Day 379, Atonic |
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| Day 379, Myoclonic |
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| Day 379, Focal |
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| Day 379, Absence |
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| Day 379, Not Done |
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| Title | Measurements |
|---|---|
|
| Day 29, No Change |
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| Day 29, Slightly Worse |
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| Day 29, Much Worse |
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| Day 29, Very Much Worse |
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| Day 29, Not Done |
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| Day 43, Very Much Improved |
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| Day 43, Much Improved |
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| Day 43, Slightly Improved |
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| Day 43, No Change |
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| Day 43, Slightly Worse |
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| Day 43, Much Worse |
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| Day 43, Very Much Worse |
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| Day 43, Not Done |
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| Day 71, Very Much Improved |
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| Day 71, Much Improved |
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| Day 71, Slightly Improved |
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| Day 71 No Change |
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| Day 71, Slightly Worse |
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| Day 71, Much Worse |
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| Day 71, Very Much Worse |
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| Day 71, Not Done |
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| Day 127, Very Much Improved |
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| Day 127, Much Improved |
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| Day 127, Slightly Improved |
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| Day 127, No Change |
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| Day 127, Slightly Worse |
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| Day 127, Much Worse |
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| Day 127, Very Much Worse |
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| Day 127, Not Done |
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| Day 211, Very Much Improved |
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| Day 211, Much Improved |
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| Day 211, Slightly Improved |
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| Day 211, No Change |
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| Day 211, Slightly Worse |
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| Day 211, Much Worse |
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| Day 211, Very Much Worse |
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| Day 211, Not Done |
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| Day 295, Very Much Improved |
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| Day 295, Much Improved |
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| Day 295, Slightly Improved |
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| Day 295, No Change |
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| Day 295, Slightly Worse |
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| Day 295, Much Worse |
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| Day 295, Very Much Worse |
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| Day 295, Not Done |
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| Day 379, Very Much Improved |
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| Day 379, Much Improved |
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| Day 379, Slightly Improved |
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| Day 379, No Change |
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| Day 379, Slightly Worse |
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| Day 379, Much Worse |
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| Day 379, Very Much Worse |
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| Day 379, Not Done |
|
| Title | Measurements |
|---|---|
|
| Day 29, No Change |
|
| Day 29, Slightly Worse |
|
| Day 29, Much Worse |
|
| Day 29, Very Much Worse |
|
| Day 29, Not Done |
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| Day 43, Very Much Improved |
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| Day 43, Much Improved |
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| Day 43, Slightly Improved |
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| Day 43, No Change |
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| Day 43, Slightly Worse |
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| Day 43, Much Worse |
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| Day 43, Very Much Worse |
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| Day 43, Not Done |
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| Day 71, Very Much Improved |
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| Day 71, Much Improved |
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| Day 71, Slightly Improved |
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| Day 71, No Change |
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| Day 71, Slightly Worse |
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| Day 71, Much Worse |
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| Day 71, Very Much Worse |
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| Day 71, Not Done |
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| Day 127, Very Much Improved |
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| Day 127, Much Improved |
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| Day 127, Slightly Improved |
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| Day 127, No Change |
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| Day 127, Slightly Worse |
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| Day 127, Much Worse |
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| Day 127, Very Much Worse |
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| Day 127, Not Done |
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| Day 211, Very Much Improved |
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| Day 211, Much Improved |
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| Day 211, Slightly Improved |
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| Day 211, No Change |
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| Day 211, Slightly Worse |
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| Day 211, Much Worse |
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| Day 211, Very Much Worse |
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| Day 211, Not Done |
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| Day 295, Very Much Improved |
|
| Day 295, Much Improved |
|
| Day 295, Slightly Improved |
|
| Day 295, No Change |
|
| Day 295, Slightly Worse |
|
| Day 295, Much Worse |
|
| Day 295, Very Much Worse |
|
| Day 295, Not Done |
|
| Day 379, Very Much Improved |
|
| Day 379, Much Improved |
|
| Day 379, Slightly Improved |
|
| Day 379, No Change |
|
| Day 379, Slightly Worse |
|
| Day 379, Much Worse |
|
| Day 379, Very Much Worse |
|
| Day 379, Not Done |
|
|
| Day 127 |
|
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| Day 211 |
|
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| Day 295 |
|
|
| Day 379 |
|
|
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| Day 127 |
|
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| Day 211 |
|
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| Day 295 |
|
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| Day 379 |
|
|
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| Day 43, OLE |
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| Day 71, OLE |
|
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| Day 127, OLE |
|
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| Day 211, OLE |
|
|
| Day 295, OLE |
|
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| Day 379, OLE |
|
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| Day 389, OLE |
|
|
|
| Day 43, OLE |
|
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| Day 71, OLE |
|
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| Day 127, OLE |
|
|
| Day 211, OLE |
|
|
| Day 295, OLE |
|
|
| Day 379, OLE |
|
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| Day 389, OLE |
|
|
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| Day 43, OLE |
|
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| Day 71, OLE |
|
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| Day 127, OLE |
|
|
| Day 211, OLE |
|
|
| Day 295, OLE |
|
|
| Day 379, OLE |
|
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| Day 389, OLE |
|
|
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| Day 379 of OLE |
|
|