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| ID | Type | Description | Link |
|---|---|---|---|
| 2015-002154-12 | EudraCT Number |
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| Name | Class |
|---|---|
| GW Pharmaceuticals Ltd | INDUSTRY |
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This trial consists of 2 parts: a double-blinded phase and an open-label extension phase. The open-label extension phase only will be described in this record. All participants will receive the same dose of GWP42003-P. However, investigators may subsequently decrease or increase the participant's dose until the optimal dose is found.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| GWP42003-P | Experimental | 100 mg/mL GWP42003-P oral solution taken twice daily (morning and evening). Participants will be dosed up to a maximum of 50 mg/kg/day. Dose may be lower if Investigator judges benefit and/or tolerability issues. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| GWP42003-P | Drug | Yellow oily 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 Any Treatment-emergent Adverse Events, Discontinuations Due to AEs, Serious AEs, and Treatment-related AEs (TEAE) | An adverse event (AE) was defined as any new unfavorable/unintended signs/symptoms (including abnormal laboratory findings), or diagnosis or worsening of a pre-existing condition, which occurred following screening and at any point up to the post-treatment safety follow-up visit, which may or may not be related to the IMP. An AE that started, or worsened in severity or seriousness, following the first dose of IMP was considered a TEAE. A serious AE was defined as any AE that results in any of the following outcomes: death, life-threatening adverse experience, inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability/incapacity, congenital anomaly/birth defect, or cancer, any other experience that suggests a significant hazard, contraindication, side effect or precaution that may require medical or surgical intervention to prevent one of the outcomes listed above, or an event that changes the risk/benefit ratio of the study. | OLE Day 1 up to 4 years |
| Number of Participants With Any TEAE, by Severity | An adverse event (AE) was defined as any new unfavorable/unintended signs/symptoms (including abnormal laboratory findings), or diagnosis or worsening of a pre-existing condition, which occurred following screening and at any point up to the post-treatment safety follow-up visit, which may or may not be related to the IMP. An AE that started, or worsened in severity or seriousness, following the first dose of IMP was considered a TEAE. Grade 1 (Mild) is defined as asymptomatic or mild symptoms; clinical or diagnostic observations only; intervention not indicated. Grade 2 (Moderate) is defined as minimal, local or noninvasive intervention indicated; limiting age appropriate instrumental activities of daily living (ADL). Grade 3 (Severe) is defined as medically significant but not immediately life-threatening; hospitalization or prolongation of hospitalization indicated; disabling; limiting self care ADL. | OLE Day 1 up to 4 years |
| Measure | Description | Time Frame |
|---|---|---|
| Percent Change From Baseline in the Number of TSC-associated Seizures During the OLE Treatment Period | TSC-associated seizures include: focal motor seizures without impairment of consciousness or awareness; focal seizures with impairment of consciousness or awareness; focal seizures evolving to bilateral generalized convulsive seizures and tonic-clonic, tonic, clonic or atonic seizures. A negative percent change from baseline indicates improvement. |
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Key Inclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Massachusetts General Hospital | Boston | Massachusetts | 02114 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 33346789 | Background | Thiele EA, Bebin EM, Bhathal H, Jansen FE, Kotulska K, Lawson JA, O'Callaghan FJ, Wong M, Sahebkar F, Checketts D, Knappertz V; GWPCARE6 Study Group. Add-on Cannabidiol Treatment for Drug-Resistant Seizures in Tuberous Sclerosis Complex: A Placebo-Controlled Randomized Clinical Trial. JAMA Neurol. 2021 Mar 1;78(3):285-292. doi: 10.1001/jamaneurol.2020.4607. | |
| 34957550 |
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OLE investigational medicinal product (IMP) was titrated up to 25 mg/kg/day while blinded IMP was simultaneously tapered down to zero to accommodate those participants who had been randomized to placebo during the double-blind phase (DBP) of the study. All participants were to complete the transition and enter the OLE taking 25 mg/kg/day GWP42003-P.
A total of 199 participants with tuberous sclerosis complex (TSC) who met all inclusion criteria and no exclusion criteria and completed the double-blind study GWEP1521 (NCT02544763) were enrolled into this Open-label Extension (OLE) study to receive GWP42003-P.
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| ID | Title | Description |
|---|---|---|
| FG000 | GWP42003-P (Double-blind Phase) | Participants who had received GWP42003-P during the double-blind phase and then GWP42003-P in the OLE phase. |
| FG001 | Placebo (Double-blind Phase) | Participants who had received placebo during the double-blind phase and then GWP42003-P in the OLE phase. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | GWP42003-P (Double-blind Phase) | Participants who had received GWP42003-P during the double-blind phase and then GWP42003-P in the OLE phase. |
| BG001 | Placebo (Double-blind Phase) |
| 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 Any Treatment-emergent Adverse Events, Discontinuations Due to AEs, Serious AEs, and Treatment-related AEs (TEAE) | An adverse event (AE) was defined as any new unfavorable/unintended signs/symptoms (including abnormal laboratory findings), or diagnosis or worsening of a pre-existing condition, which occurred following screening and at any point up to the post-treatment safety follow-up visit, which may or may not be related to the IMP. An AE that started, or worsened in severity or seriousness, following the first dose of IMP was considered a TEAE. A serious AE was defined as any AE that results in any of the following outcomes: death, life-threatening adverse experience, inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability/incapacity, congenital anomaly/birth defect, or cancer, any other experience that suggests a significant hazard, contraindication, side effect or precaution that may require medical or surgical intervention to prevent one of the outcomes listed above, or an event that changes the risk/benefit ratio of the study. | Adverse events were assessed in the OLE Safety Analysis Set. | Posted | Count of Participants | Participants | OLE Day 1 up to 4 years |
Treatment-emergent adverse events (TEAEs) were collected from OLE Day 1 up to 4 years.
An adverse event (AE) was defined as any new unfavorable/unintended signs/symptoms (including abnormal laboratory findings), or diagnosis or worsening of a pre-existing condition, which occurred following screening and at any point up to the post-treatment safety follow-up visit, which may or may not be related to the IMP. TEAEs were defined as AEs with a start date on or after the first dose of IMP in the OLE Day 1.
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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 | Placebo (Double-blind Phase) | Participants who had received placebo during double-blind phase and then GWP42003-P in the OLE phase. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Leukocytosis | Blood and lymphatic system disorders | MedDra 19.1 | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | MedDra 19.1 | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Clinical Trial Disclosure & Transparency | Jazz Pharmaceuticals | 215-832-3750 | ClinicalTrialDisclosure@JazzPharma.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 | Apr 23, 2019 | May 25, 2022 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Apr 24, 2019 | Jul 11, 2022 | SAP_001.pdf |
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| ID | Term |
|---|---|
| D014402 | Tuberous Sclerosis |
| D012640 | Seizures |
| ID | Term |
|---|---|
| D006222 | Hamartoma |
| D009369 | Neoplasms |
| D009378 | Neoplasms, Multiple Primary |
| D009386 | Neoplastic Syndromes, Hereditary |
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| ID | Term |
|---|---|
| D002185 | Cannabidiol |
| ID | Term |
|---|---|
| D002186 | Cannabinoids |
| D013729 | Terpenes |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
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|
| OLE Day 1 up to 4 years |
| Number of Participants Considered Treatment Responders During the OLE Treatment Period | Treatment responders were defined as those participants with a ≥50% reduction from baseline in TSC-associated seizure frequency, during the treatment period, for participants who had not withdrawn from the trial during the treatment period. TSC-associated seizures included: focal motor seizures without impairment of consciousness or awareness (Type 1 focal motor); focal seizures with impairment of consciousness or awareness (Type 2 focal); focal seizures evolving to bilateral generalized convulsive seizures (Type 3 focal); and tonic-clonic, tonic, clonic, or atonic seizures that were countable. Participants who withdrew from the trial during the treatment period were considered non-responders. | OLE Day 1 up to 4 years |
| Caregiver Global Impression of Change (CGIC) and Subject Global Impression of Change (SGIC) Score During the OLE Treatment Period | The CGIC comprised the following question to be rated 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): "Since your child started treatment, please assess the status of your child's overall condition (comparing their condition now to their condition before treatment)." The SGIC comprised the following question to be rated 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): "Since you started treatment, please assess the status of your overall condition (comparing your condition now to your condition before treatment)." The average CGIC and SGIC scores are being reported, with higher values indicating worse condition. | OLE Day 1 and up to 4 years |
| Percent Change From Baseline in Total Seizure Frequency During the OLE Treatment Period | Total seizures included all seizure types, eg. combination of TSC-associated and other seizures. TSC-associated seizures included: focal motor seizures without impairment of consciousness or awareness (Type 1 focal motor); focal seizures with impairment of consciousness or awareness (Type 2 focal); focal seizures evolving to bilateral generalized convulsive seizures (Type 3 focal); and tonic-clonic, tonic, clonic, or atonic seizures that were countable. A negative percent change from baseline indicates improvement in total seizure frequency. | OLE Day 1 up to 4 years |
| Thiele EA, Bebin EM, Filloux F, Kwan P, Loftus R, Sahebkar F, Sparagana S, Wheless J. Long-term cannabidiol treatment for seizures in patients with tuberous sclerosis complex: An open-label extension trial. Epilepsia. 2022 Feb;63(2):426-439. doi: 10.1111/epi.17150. Epub 2021 Dec 27. |
| Met withdrawal criteria |
|
| Transition To Commercial Product |
|
| Withdrawal by Parent/Guardian |
|
| Adverse Event |
|
| Withdrawal by Subject |
|
| Lost to Follow-up |
|
Participants who had received placebo during the double-blind phase and then GWP42003-P in the OLE phase.
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Count of Participants | Participants |
|
| Baseline Tuberous Sclerosis Complex (TSC)-Associated Seizures | TSC-associated seizures included: focal motor seizures without impairment of consciousness or awareness (Type 1 focal motor); focal seizures with impairment of consciousness or awareness (Type 2 focal); focal seizures evolving to bilateral generalized convulsive seizures (Type 3 focal); and tonic clonic, tonic, clonic, or atonic seizures that are countable. The Baseline Period included all data prior to Day 1. | Seizure frequency was assessed in the OLE Safety Analysis Set. | Median | Full Range | Seizures |
|
| Baseline Total Seizures | Total seizures included all seizure types combined. The Baseline Period included all data prior to Day 1. | OLE Safety Analysis Set | Median | Full Range | Seizures |
|
| ID | Title | Description |
|---|---|---|
| OG000 | GWP42003-P (Double-blind Phase) | Participants who had received GWP42003-P during the double-blind phase and then GWP42003-P in the OLE phase. |
| OG001 | Placebo (Double-blind Phase) | Participants who had received placebo during double-blind phase and then GWP42003-P in the OLE phase. |
|
|
| Primary | Number of Participants With Any TEAE, by Severity | An adverse event (AE) was defined as any new unfavorable/unintended signs/symptoms (including abnormal laboratory findings), or diagnosis or worsening of a pre-existing condition, which occurred following screening and at any point up to the post-treatment safety follow-up visit, which may or may not be related to the IMP. An AE that started, or worsened in severity or seriousness, following the first dose of IMP was considered a TEAE. Grade 1 (Mild) is defined as asymptomatic or mild symptoms; clinical or diagnostic observations only; intervention not indicated. Grade 2 (Moderate) is defined as minimal, local or noninvasive intervention indicated; limiting age appropriate instrumental activities of daily living (ADL). Grade 3 (Severe) is defined as medically significant but not immediately life-threatening; hospitalization or prolongation of hospitalization indicated; disabling; limiting self care ADL. | Adverse events were assessed in the OLE Safety Analysis Set. | Posted | Count of Participants | Participants | OLE Day 1 up to 4 years |
|
|
|
| Secondary | Percent Change From Baseline in the Number of TSC-associated Seizures During the OLE Treatment Period | TSC-associated seizures include: focal motor seizures without impairment of consciousness or awareness; focal seizures with impairment of consciousness or awareness; focal seizures evolving to bilateral generalized convulsive seizures and tonic-clonic, tonic, clonic or atonic seizures. A negative percent change from baseline indicates improvement. | TSC-associated seizures were assessed in the OLE Safety Analysis Set. | Posted | Median | Inter-Quartile Range | percent change | OLE Day 1 up to 4 years |
|
|
|
| Secondary | Number of Participants Considered Treatment Responders During the OLE Treatment Period | Treatment responders were defined as those participants with a ≥50% reduction from baseline in TSC-associated seizure frequency, during the treatment period, for participants who had not withdrawn from the trial during the treatment period. TSC-associated seizures included: focal motor seizures without impairment of consciousness or awareness (Type 1 focal motor); focal seizures with impairment of consciousness or awareness (Type 2 focal); focal seizures evolving to bilateral generalized convulsive seizures (Type 3 focal); and tonic-clonic, tonic, clonic, or atonic seizures that were countable. Participants who withdrew from the trial during the treatment period were considered non-responders. | Treatment responders were assessed in the OLE Safety Analysis Set. | Posted | Count of Participants | Participants | OLE Day 1 up to 4 years |
|
|
|
| Secondary | Caregiver Global Impression of Change (CGIC) and Subject Global Impression of Change (SGIC) Score During the OLE Treatment Period | The CGIC comprised the following question to be rated 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): "Since your child started treatment, please assess the status of your child's overall condition (comparing their condition now to their condition before treatment)." The SGIC comprised the following question to be rated 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): "Since you started treatment, please assess the status of your overall condition (comparing your condition now to your condition before treatment)." The average CGIC and SGIC scores are being reported, with higher values indicating worse condition. | Caregiver Global Impression of Change and Subject Global Impression of Change were assessed in the OLE Safety Analysis Set in participants with available data. | Posted | Mean | Standard Deviation | score on a scale | OLE Day 1 and up to 4 years |
|
|
|
| Secondary | Percent Change From Baseline in Total Seizure Frequency During the OLE Treatment Period | Total seizures included all seizure types, eg. combination of TSC-associated and other seizures. TSC-associated seizures included: focal motor seizures without impairment of consciousness or awareness (Type 1 focal motor); focal seizures with impairment of consciousness or awareness (Type 2 focal); focal seizures evolving to bilateral generalized convulsive seizures (Type 3 focal); and tonic-clonic, tonic, clonic, or atonic seizures that were countable. A negative percent change from baseline indicates improvement in total seizure frequency. | Total seizure frequency was assessed in the OLE Safety Analysis Set. | Posted | Median | Inter-Quartile Range | percent change | OLE Day 1 up to 4 years |
|
|
|
| 1 |
| 124 |
| 38 |
| 124 |
| 117 |
| 124 |
| EG001 | GWP42003-P (Double-blind Phase) | Participants who had received GWP42003-P during the double-blind phase and then GWP42003-P in the OLE phase. | 0 | 75 | 18 | 75 | 75 | 75 |
| Neutropenia | Blood and lymphatic system disorders | MedDra 19.1 | Systematic Assessment |
|
| Thrombocytopenia | Blood and lymphatic system disorders | MedDra 19.1 | Systematic Assessment |
|
| Cardiopulmonary failure | Cardiac disorders | MedDra 19.1 | Systematic Assessment |
|
| Dental caries | Gastrointestinal disorders | MedDra 19.1 | Systematic Assessment |
|
| Diarrhoea | Gastrointestinal disorders | MedDra 19.1 | Systematic Assessment |
|
| Pancreatitis | Gastrointestinal disorders | MedDra 19.1 | Systematic Assessment |
|
| Vomiting | Gastrointestinal disorders | MedDra 19.1 | Systematic Assessment |
|
| Pyrexia | General disorders | MedDra 19.1 | Systematic Assessment |
|
| Soft tissue inflammation | General disorders | MedDra 19.1 | Systematic Assessment |
|
| Adenoiditis | Infections and infestations | MedDra 19.1 | Systematic Assessment |
|
| Adenovirus infection | Infections and infestations | MedDra 19.1 | Systematic Assessment |
|
| Bronchitis | Infections and infestations | MedDra 19.1 | Systematic Assessment |
|
| Enterovirus infection | Infections and infestations | MedDra 19.1 | Systematic Assessment |
|
| Gastroenteritis | Infections and infestations | MedDra 19.1 | Systematic Assessment |
|
| Gastroenteritis astroviral | Infections and infestations | MedDra 19.1 | Systematic Assessment |
|
| Gastroenteritis viral | Infections and infestations | MedDra 19.1 | Systematic Assessment |
|
| Implant site infection | Infections and infestations | MedDra 19.1 | Systematic Assessment |
|
| Infective myositis | Infections and infestations | MedDra 19.1 | Systematic Assessment |
|
| Influenza | Infections and infestations | MedDra 19.1 | Systematic Assessment |
|
| Laryngitis | Infections and infestations | MedDra 19.1 | Systematic Assessment |
|
| Lower respiratory tract infection | Infections and infestations | MedDra 19.1 | Systematic Assessment |
|
| Parainfluenzae virus infection | Infections and infestations | MedDra 19.1 | Systematic Assessment |
|
| Pharyngitis | Infections and infestations | MedDra 19.1 | Systematic Assessment |
|
| Pharyngitis streptococcal | Infections and infestations | MedDra 19.1 | Systematic Assessment |
|
| Pneumonia | Infections and infestations | MedDra 19.1 | Systematic Assessment |
|
| Pneumonia bacterial | Infections and infestations | MedDra 19.1 | Systematic Assessment |
|
| Pneumonia viral | Infections and infestations | MedDra 19.1 | Systematic Assessment |
|
| Respiratory tract infection | Infections and infestations | MedDra 19.1 | Systematic Assessment |
|
| Rhinovirus infection | Infections and infestations | MedDra 19.1 | Systematic Assessment |
|
| Septic shock | Infections and infestations | MedDra 19.1 | Systematic Assessment |
|
| Urinary tract infection | Infections and infestations | MedDra 19.1 | Systematic Assessment |
|
| Fall | Injury, poisoning and procedural complications | MedDra 19.1 | Systematic Assessment |
|
| Head injury | Injury, poisoning and procedural complications | MedDra 19.1 | Systematic Assessment |
|
| Joint dislocation | Injury, poisoning and procedural complications | MedDra 19.1 | Systematic Assessment |
|
| Toxicity to various agents | Injury, poisoning and procedural complications | MedDra 19.1 | Systematic Assessment |
|
| Alanine aminotransferase increased | Investigations | MedDra 19.1 | Systematic Assessment |
|
| Anticonvulsant drug level increased | Investigations | MedDra 19.1 | Systematic Assessment |
|
| Aspartate aminotransferase increased | Investigations | MedDra 19.1 | Systematic Assessment |
|
| Astrovirus test positive | Investigations | MedDra 19.1 | Systematic Assessment |
|
| Blood bilirubin increased | Investigations | MedDra 19.1 | Systematic Assessment |
|
| Eosinophil count increased | Investigations | MedDra 19.1 | Systematic Assessment |
|
| Influenza A virus test positive | Investigations | MedDra 19.1 | Systematic Assessment |
|
| Investigation | Investigations | MedDra 19.1 | Systematic Assessment |
|
| Liver function test abnormal | Investigations | MedDra 19.1 | Systematic Assessment |
|
| Liver function test increased | Investigations | MedDra 19.1 | Systematic Assessment |
|
| Platelet count decreased | Investigations | MedDra 19.1 | Systematic Assessment |
|
| Respiratory syncytial virus test positive | Investigations | MedDra 19.1 | Systematic Assessment |
|
| Sapovirus test positive | Investigations | MedDra 19.1 | Systematic Assessment |
|
| Transaminases increased | Investigations | MedDra 19.1 | Systematic Assessment |
|
| Weight decreased | Investigations | MedDra 19.1 | Systematic Assessment |
|
| Acidosis | Metabolism and nutrition disorders | MedDra 19.1 | Systematic Assessment |
|
| Decreased appetite | Metabolism and nutrition disorders | MedDra 19.1 | Systematic Assessment |
|
| Dehydration | Metabolism and nutrition disorders | MedDra 19.1 | Systematic Assessment |
|
| Fluid intake reduced | Metabolism and nutrition disorders | MedDra 19.1 | Systematic Assessment |
|
| Hypokalaemia | Metabolism and nutrition disorders | MedDra 19.1 | Systematic Assessment |
|
| Hyponatraemia | Metabolism and nutrition disorders | MedDra 19.1 | Systematic Assessment |
|
| Flank pain | Musculoskeletal and connective tissue disorders | MedDra 19.1 | Systematic Assessment |
|
| Myositis | Musculoskeletal and connective tissue disorders | MedDra 19.1 | Systematic Assessment |
|
| Kidney angiomyolipoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDra 19.1 | Systematic Assessment |
|
| Ataxia | Nervous system disorders | MedDra 19.1 | Systematic Assessment |
|
| Change in seizure presentation | Nervous system disorders | MedDra 19.1 | Systematic Assessment |
|
| Dizziness | Nervous system disorders | MedDra 19.1 | Systematic Assessment |
|
| Encephalopathy | Nervous system disorders | MedDra 19.1 | Systematic Assessment |
|
| Epileptic encephalopathy | Nervous system disorders | MedDra 19.1 | Systematic Assessment |
|
| Generalised tonic-clonic seizure | Nervous system disorders | MedDra 19.1 | Systematic Assessment |
|
| Lethargy | Nervous system disorders | MedDra 19.1 | Systematic Assessment |
|
| Memory impairment | Nervous system disorders | MedDra 19.1 | Systematic Assessment |
|
| Postictal state | Nervous system disorders | MedDra 19.1 | Systematic Assessment |
|
| Sedation | Nervous system disorders | MedDra 19.1 | Systematic Assessment |
|
| Seizure | Nervous system disorders | MedDra 19.1 | Systematic Assessment |
|
| Seizure cluster | Nervous system disorders | MedDra 19.1 | Systematic Assessment |
|
| Status epilepticus | Nervous system disorders | MedDra 19.1 | Systematic Assessment |
|
| Syncope | Nervous system disorders | MedDra 19.1 | Systematic Assessment |
|
| Mental status changes | Psychiatric disorders | MedDra 19.1 | Systematic Assessment |
|
| Acute kidney injury | Renal and urinary disorders | MedDra 19.1 | Systematic Assessment |
|
| Nephrolithiasis | Renal and urinary disorders | MedDra 19.1 | Systematic Assessment |
|
| Asthma | Respiratory, thoracic and mediastinal disorders | MedDra 19.1 | Systematic Assessment |
|
| Cough | Respiratory, thoracic and mediastinal disorders | MedDra 19.1 | Systematic Assessment |
|
| Lung infiltration | Respiratory, thoracic and mediastinal disorders | MedDra 19.1 | Systematic Assessment |
|
| Pneumonitis | Respiratory, thoracic and mediastinal disorders | MedDra 19.1 | Systematic Assessment |
|
| Respiratory distress | Respiratory, thoracic and mediastinal disorders | MedDra 19.1 | Systematic Assessment |
|
| Respiratory failure | Respiratory, thoracic and mediastinal disorders | MedDra 19.1 | Systematic Assessment |
|
| Wheezing | Respiratory, thoracic and mediastinal disorders | MedDra 19.1 | Systematic Assessment |
|
| Alcohol use | Social circumstances | MedDra 19.1 | Systematic Assessment |
|
| Abdominal pain | Gastrointestinal disorders | MedDra 19.1 | Systematic Assessment |
|
| Constipation | Gastrointestinal disorders | MedDra 19.1 | Systematic Assessment |
|
| Diarrhoea | Gastrointestinal disorders | MedDra 19.1 | Systematic Assessment |
|
| Nausea | Gastrointestinal disorders | MedDra 19.1 | Systematic Assessment |
|
| Retching | Gastrointestinal disorders | MedDra 19.1 | Systematic Assessment |
|
| Vomiting | Gastrointestinal disorders | MedDra 19.1 | Systematic Assessment |
|
| Fatigue | General disorders | MedDra 19.1 | Systematic Assessment |
|
| Pyrexia | General disorders | MedDra 19.1 | Systematic Assessment |
|
| Bronchitis | Infections and infestations | MedDra 19.1 | Systematic Assessment |
|
| Conjunctivitis | Infections and infestations | MedDra 19.1 | Systematic Assessment |
|
| Ear infection | Infections and infestations | MedDra 19.1 | Systematic Assessment |
|
| Gastroenteritis | Infections and infestations | MedDra 19.1 | Systematic Assessment |
|
| Gastroenteritis viral | Infections and infestations | MedDra 19.1 | Systematic Assessment |
|
| Influenza | Infections and infestations | MedDra 19.1 | Systematic Assessment |
|
| Nasopharyngitis | Infections and infestations | MedDra 19.1 | Systematic Assessment |
|
| Otitis media | Infections and infestations | MedDra 19.1 | Systematic Assessment |
|
| Pharyngitis | Infections and infestations | MedDra 19.1 | Systematic Assessment |
|
| Pharyngitis streptococcal | Infections and infestations | MedDra 19.1 | Systematic Assessment |
|
| Pneumonia | Infections and infestations | MedDra 19.1 | Systematic Assessment |
|
| Rhinitis | Infections and infestations | MedDra 19.1 | Systematic Assessment |
|
| Sinusitis | Infections and infestations | MedDra 19.1 | Systematic Assessment |
|
| Upper respiratory tract infection | Infections and infestations | MedDra 19.1 | Systematic Assessment |
|
| Urinary tract infection | Infections and infestations | MedDra 19.1 | Systematic Assessment |
|
| Viral infection | Infections and infestations | MedDra 19.1 | Systematic Assessment |
|
| Viral upper respiratory tract infection | Infections and infestations | MedDra 19.1 | Systematic Assessment |
|
| Accident | Injury, poisoning and procedural complications | MedDra 19.1 | Systematic Assessment |
|
| Contusion | Injury, poisoning and procedural complications | MedDra 19.1 | Systematic Assessment |
|
| Fall | Injury, poisoning and procedural complications | MedDra 19.1 | Systematic Assessment |
|
| Head injury | Injury, poisoning and procedural complications | MedDra 19.1 | Systematic Assessment |
|
| Laceration | Injury, poisoning and procedural complications | MedDra 19.1 | Systematic Assessment |
|
| Ligament sprain | Injury, poisoning and procedural complications | MedDra 19.1 | Systematic Assessment |
|
| Skin abrasion | Injury, poisoning and procedural complications | MedDra 19.1 | Systematic Assessment |
|
| Tooth fracture | Injury, poisoning and procedural complications | MedDra 19.1 | Systematic Assessment |
|
| Alanine aminotransferase increased | Investigations | MedDra 19.1 | Systematic Assessment |
|
| Aspartate aminotransferase increased | Investigations | MedDra 19.1 | Systematic Assessment |
|
| Blood prolactin increased | Investigations | MedDra 19.1 | Systematic Assessment |
|
| Gamma-glutamyltransferase increased | Investigations | MedDra 19.1 | Systematic Assessment |
|
| Liver function test increased | Investigations | MedDra 19.1 | Systematic Assessment |
|
| Weight decreased | Investigations | MedDra 19.1 | Systematic Assessment |
|
| Weight increased | Investigations | MedDra 19.1 | Systematic Assessment |
|
| Decreased appetite | Metabolism and nutrition disorders | MedDra 19.1 | Systematic Assessment |
|
| Ataxia | Nervous system disorders | MedDra 19.1 | Systematic Assessment |
|
| Dizziness | Nervous system disorders | MedDra 19.1 | Systematic Assessment |
|
| Generalised tonic-clonic seizure | Nervous system disorders | MedDra 19.1 | Systematic Assessment |
|
| Headache | Nervous system disorders | MedDra 19.1 | Systematic Assessment |
|
| Lethargy | Nervous system disorders | MedDra 19.1 | Systematic Assessment |
|
| Sedation | Nervous system disorders | MedDra 19.1 | Systematic Assessment |
|
| Seizure | Nervous system disorders | MedDra 19.1 | Systematic Assessment |
|
| Somnolence | Nervous system disorders | MedDra 19.1 | Systematic Assessment |
|
| Abnormal behaviour | Psychiatric disorders | MedDra 19.1 | Systematic Assessment |
|
| Aggression | Psychiatric disorders | MedDra 19.1 | Systematic Assessment |
|
| Agitation | Psychiatric disorders | MedDra 19.1 | Systematic Assessment |
|
| Anxiety | Psychiatric disorders | MedDra 19.1 | Systematic Assessment |
|
| Insomnia | Psychiatric disorders | MedDra 19.1 | Systematic Assessment |
|
| Intentional self-injury | Psychiatric disorders | MedDra 19.1 | Systematic Assessment |
|
| Irritability | Psychiatric disorders | MedDra 19.1 | Systematic Assessment |
|
| Sleep disorder | Psychiatric disorders | MedDra 19.1 | Systematic Assessment |
|
| Urinary retention | Renal and urinary disorders | MedDra 19.1 | Systematic Assessment |
|
| Cough | Respiratory, thoracic and mediastinal disorders | MedDra 19.1 | Systematic Assessment |
|
| Nasal congestion | Respiratory, thoracic and mediastinal disorders | MedDra 19.1 | Systematic Assessment |
|
| Oropharyngeal pain | Respiratory, thoracic and mediastinal disorders | MedDra 19.1 | Systematic Assessment |
|
| Respiration abnormal | Respiratory, thoracic and mediastinal disorders | MedDra 19.1 | Systematic Assessment |
|
| Rhinorrhoea | Respiratory, thoracic and mediastinal disorders | MedDra 19.1 | Systematic Assessment |
|
| Rash | Skin and subcutaneous tissue disorders | MedDra 19.1 | Systematic Assessment |
|
| Gastrooesophageal reflux disease | Gastrointestinal disorders | MedDra 19.1 | Systematic Assessment |
|
| Toothache | Gastrointestinal disorders | MedDra 19.1 | Systematic Assessment |
|
| Gait disturbance | General disorders | MedDra 19.1 | Systematic Assessment |
|
| Dehydration | Metabolism and nutrition disorders | MedDra 19.1 | Systematic Assessment |
|
| Status epilepticus | Nervous system disorders | MedDra 19.1 | Systematic Assessment |
|
| Mental status changes | Psychiatric disorders | MedDra 19.1 | Systematic Assessment |
|
Not provided
| D065703 |
| Malformations of Cortical Development, Group I |
| D054220 | Malformations of Cortical Development |
| D009421 | Nervous System Malformations |
| D009422 | Nervous System Diseases |
| D020752 | Neurocutaneous Syndromes |
| D020271 | Heredodegenerative Disorders, Nervous System |
| D019636 | Neurodegenerative Diseases |
| D000013 | Congenital Abnormalities |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D030342 | Genetic Diseases, Inborn |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| Severe TEAE |
|
| Subjects |
|
|
| Combined Caregiver and Subjects |
|
|