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| ID | Type | Description | Link |
|---|---|---|---|
| F1J-JE-HMHF | Other Identifier | Eli Lilly and Company | |
| 1702A3632 | Other Identifier | Shionogi |
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Business decision
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| Name | Class |
|---|---|
| Eli Lilly and Company | INDUSTRY |
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The purpose of this long-term study is to evaluate the safety and efficacy of duloxetine hydrochloride in Japanese children and adolescents with depressive disorder.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Duloxetine hydrochloride | Experimental | Duloxetine hydrochloride administered orally. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Duloxetine Hydrochloride | Drug | Administered orally |
|
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants With Adverse Events (AEs), Drug Related Adverse Events (ADRs) or Any Serious Adverse Events (SAEs) | A summary of AEs, ADRs (considered by the investigator) and SAEs is located in the Reported Adverse Events module. An AE was included if the onset date is on or after the first dose of study drug and within 7 days after the last dose, or it is consecutive from the preceding study at the initiation of study drug administration in this study. | Baseline through Week 53 |
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline on the Children's Depression Rating Scale-Revised (CDRS-R) | Children's Depression Rating Scale-Revised (CDRS-R) Total score measures the presence and severity of depression in children. The scale consists of 17 items scored on a 1-to-5- or 1-to-7-point scale. A rating of 1 indicates normal functioning and higher numbers indicate a higher degree of depression. The total sum of scores range from 17 to 113. In general, scores below 20 indicate an absence of depression, scores of 20 to 30 indicate borderline depression, scores of 40 to 60 indicate moderate depression, and scores greater than 60 indicate severe depression. |
Not provided
Inclusion Criteria
Exclusion Criteria:
a, b) Have a current or previous diagnosis (DSM-5) of the following as judged by the investigator:
a, b) Have a current diagnosis (DSM-5) of the following as judged by the investigator:
a, b) Have personality disorders, in the judgment of the investigator.
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| Name | Affiliation | Role |
|---|---|---|
| Shionogi Clinical Trials Administrator Clinical Support Help Line | Shionogi | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Shionogi | Osaka | 541-0045 | Japan |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 37244205 | Derived | Shibata RY, Kubota R, Uenaka K, Kaibara A, Wajima T. Population pharmacokinetics of duloxetine in Japanese pediatric patients with major depressive disorder. Drug Metab Pharmacokinet. 2023 Aug;51:100496. doi: 10.1016/j.dmpk.2023.100496. Epub 2023 Feb 15. |
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59 and 64 subjects, respectively, were enrolled consecutively from the placebo- and duloxetine-group in the preceding study 1701A3631/F1J-JE-B058, NCT03315793. 28 new participants were also enrolled.
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| ID | Title | Description |
|---|---|---|
| FG000 | Duloxetine | 20 mg Duloxetine was administered every day for 1 week. Then 40 mg Duloxetine was administered for 1 week. Then flexible doses of 40 mg or 60 mg Duloxetine were administered for 48 weeks till end of treatment period. Lower doses of Duloxetine were administered for 1 to 2 weeks during tapering off period. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
All enrolled participants who received at least one dose of study drug. One participant received no dose of study drug and was not included in the analysis.
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| ID | Title | Description |
|---|---|---|
| BG000 | Duloxetine | 20 mg Duloxetine was administered every day for 1 week. Then 40 mg Duloxetine was administered for 1 week. Then flexible doses of 40 mg or 60 mg Duloxetine were administered for 48 weeks till end of treatment period. Lower doses of Duloxetine were administered for 1 to 2 weeks during tapering off 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 | Percentage of Participants With Adverse Events (AEs), Drug Related Adverse Events (ADRs) or Any Serious Adverse Events (SAEs) | A summary of AEs, ADRs (considered by the investigator) and SAEs is located in the Reported Adverse Events module. An AE was included if the onset date is on or after the first dose of study drug and within 7 days after the last dose, or it is consecutive from the preceding study at the initiation of study drug administration in this study. | All enrolled participants who received at least one dose of study drug. | Posted | Number | percentage of participants | Baseline through Week 53 |
|
Baseline to 53 Weeks
All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
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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 | Duloxetine | 20 mg Duloxetine was administered every day for 1 week. Then 40 mg Duloxetine was administered for 1 week. Then flexible doses of 40 mg or 60 mg Duloxetine were administered for 48 weeks till end of treatment period. Lower doses of Duloxetine were administered for 1 to 2 weeks during tapering off period. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Abnormal behaviour | Psychiatric disorders | MedDRA 20.1 | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | MedDRA 20.1 | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Corporate Communications Department | Shionogi | +81-6-6209-7885 | shionogiclintrials-admin@shionogi.co.jp |
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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 | Aug 8, 2018 | Apr 30, 2021 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Aug 25, 2020 | Apr 30, 2021 | SAP_001.pdf |
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| ID | Term |
|---|---|
| D003866 | Depressive Disorder |
| ID | Term |
|---|---|
| D019964 | Mood Disorders |
| D001523 | Mental Disorders |
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| ID | Term |
|---|---|
| D000068736 | Duloxetine Hydrochloride |
| ID | Term |
|---|---|
| D013876 | Thiophenes |
| D013457 | Sulfur Compounds |
| D009930 | Organic Chemicals |
| D006573 | Heterocyclic Compounds, 1-Ring |
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| Baseline, Week 50 |
| Change From Baseline on the Clinical Global Impression-Severity of Illness (CGI-S) | CGI-S measures severity of illness at the time of assessment compared with start of treatment with scores ranging from 1 (normal, not at all ill) to 7 (among the most extremely ill participants). | Baseline, Week 50 |
| Pharmacokinetics (PK): Trough Concentration of Duloxetine | Trough concentrations of duloxetine are defined as the plasma concentrations in 18 - 30 hours post the previous dose. PK samples were obtained from each subject from Week 4 to the end of treatment period (Week 50) for analysis of steady state duloxetine concentrations. If duloxetine dose changed, PK samples were taken after 2 week or more administration of the new dose. Principally 1 or 2 blood samples were drawn from each subject at pre-dose for trough concentrations. | Week 4 through Week 50 |
| Withdrawal by Subject |
|
| Discontinued visit |
|
| Refrain from visit due to COVID-19 |
|
| Physician Decision |
|
| Early termination of overall study |
|
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
|
|
| Secondary | Change From Baseline on the Children's Depression Rating Scale-Revised (CDRS-R) | Children's Depression Rating Scale-Revised (CDRS-R) Total score measures the presence and severity of depression in children. The scale consists of 17 items scored on a 1-to-5- or 1-to-7-point scale. A rating of 1 indicates normal functioning and higher numbers indicate a higher degree of depression. The total sum of scores range from 17 to 113. In general, scores below 20 indicate an absence of depression, scores of 20 to 30 indicate borderline depression, scores of 40 to 60 indicate moderate depression, and scores greater than 60 indicate severe depression. | All enrolled participants who received at least one dose of study drug and had at least 1 post-dose CDRS-R Total score. Missing values due to discontinuation of study or missing data were imputed using last observation carried forward (LOCF). | Posted | Mean | Standard Deviation | units on a scale | Baseline, Week 50 |
|
|
|
| Secondary | Change From Baseline on the Clinical Global Impression-Severity of Illness (CGI-S) | CGI-S measures severity of illness at the time of assessment compared with start of treatment with scores ranging from 1 (normal, not at all ill) to 7 (among the most extremely ill participants). | All enrolled participants who received at least one dose of study drug and had at least 1 post-dose CDRS-R Total score. Missing values due to discontinuation of study or missing data were imputed using last observation carried forward (LOCF). | Posted | Mean | Standard Deviation | units on a scale | Baseline, Week 50 |
|
|
|
| Secondary | Pharmacokinetics (PK): Trough Concentration of Duloxetine | Trough concentrations of duloxetine are defined as the plasma concentrations in 18 - 30 hours post the previous dose. PK samples were obtained from each subject from Week 4 to the end of treatment period (Week 50) for analysis of steady state duloxetine concentrations. If duloxetine dose changed, PK samples were taken after 2 week or more administration of the new dose. Principally 1 or 2 blood samples were drawn from each subject at pre-dose for trough concentrations. | All enrolled participants who received at least 1 dose of study drug. 512 plasma concentrations were from 141 subjects, 20 of which were excluded due to discontinuation, overdose and subjects being non-Japanese. 492 concentration values from 136 Japanese subjects were included in the analysis. Of the 492 concentration values, 133 from 106 subjects were trough concentrations. Sum of subjects(3, 47, 6, 54) is 110, 4 more than 106, as 4 subjects of 12-17 years old are redundant in 40mg and 60mg. | Posted | Mean | Standard Deviation | ng/mL | Week 4 through Week 50 | Trough Concentration | Trough Concentration |
|
|
|
| 0 |
| 150 |
| 3 |
| 150 |
| 134 |
| 150 |
| Mania | Psychiatric disorders | MedDRA 20.1 | Systematic Assessment |
|
| Suicide attempt | Psychiatric disorders | MedDRA 20.1 | Systematic Assessment |
|
| Palpitations | Cardiac disorders | MedDRA 20.1 | Systematic Assessment |
|
| Sinus arrhythmia | Cardiac disorders | MedDRA 20.1 | Systematic Assessment |
|
| Tachycardia | Cardiac disorders | MedDRA 20.1 | Systematic Assessment |
|
| Tinnitus | Ear and labyrinth disorders | MedDRA 20.1 | Systematic Assessment |
|
| Vertigo | Ear and labyrinth disorders | MedDRA 20.1 | Systematic Assessment |
|
| Ear pain | Ear and labyrinth disorders | MedDRA 20.1 | Systematic Assessment |
|
| Hyperacusis | Ear and labyrinth disorders | MedDRA 20.1 | Systematic Assessment |
|
| Otorrhoea | Ear and labyrinth disorders | MedDRA 20.1 | Systematic Assessment |
|
| Blepharitis allergic | Eye disorders | MedDRA 20.1 | Systematic Assessment |
|
| Conjunctivitis allergic | Eye disorders | MedDRA 20.1 | Systematic Assessment |
|
| Myopia | Eye disorders | MedDRA 20.1 | Systematic Assessment |
|
| Nausea | Gastrointestinal disorders | MedDRA 20.1 | Systematic Assessment |
|
| Constipation | Gastrointestinal disorders | MedDRA 20.1 | Systematic Assessment |
|
| Abdominal pain | Gastrointestinal disorders | MedDRA 20.1 | Systematic Assessment |
|
| Dental caries | Gastrointestinal disorders | MedDRA 20.1 | Systematic Assessment |
|
| Diarrhoea | Gastrointestinal disorders | MedDRA 20.1 | Systematic Assessment |
|
| Stomatitis | Gastrointestinal disorders | MedDRA 20.1 | Systematic Assessment |
|
| Vomiting | Gastrointestinal disorders | MedDRA 20.1 | Systematic Assessment |
|
| Abdominal discomfort | Gastrointestinal disorders | MedDRA 20.1 | Systematic Assessment |
|
| Abdominal pain upper | Gastrointestinal disorders | MedDRA 20.1 | Systematic Assessment |
|
| Anal fissure | Gastrointestinal disorders | MedDRA 20.1 | Systematic Assessment |
|
| Dyspepsia | Gastrointestinal disorders | MedDRA 20.1 | Systematic Assessment |
|
| Enterocolitis | Gastrointestinal disorders | MedDRA 20.1 | Systematic Assessment |
|
| Gastritis | Gastrointestinal disorders | MedDRA 20.1 | Systematic Assessment |
|
| Lip dry | Gastrointestinal disorders | MedDRA 20.1 | Systematic Assessment |
|
| Melaena | Gastrointestinal disorders | MedDRA 20.1 | Systematic Assessment |
|
| Oral pruritus | Gastrointestinal disorders | MedDRA 20.1 | Systematic Assessment |
|
| Gastrointestinal inflammation | Gastrointestinal disorders | MedDRA 20.1 | Systematic Assessment |
|
| Malaise | General disorders | MedDRA 20.1 | Systematic Assessment |
|
| Withdrawal syndrome | General disorders | MedDRA 20.1 | Systematic Assessment |
|
| Thirst | General disorders | MedDRA 20.1 | Systematic Assessment |
|
| Feeling abnormal | General disorders | MedDRA 20.1 | Systematic Assessment |
|
| Pyrexia | General disorders | MedDRA 20.1 | Systematic Assessment |
|
| Chest pain | General disorders | MedDRA 20.1 | Systematic Assessment |
|
| Fatigue | General disorders | MedDRA 20.1 | Systematic Assessment |
|
| Hepatic function abnormal | Hepatobiliary disorders | MedDRA 20.1 | Systematic Assessment |
|
| Seasonal allergy | Immune system disorders | MedDRA 20.1 | Systematic Assessment |
|
| Anovulatory cycle | Endocrine disorders | MedDRA 20.1 | Systematic Assessment |
|
| Decreased appetite | Metabolism and nutrition disorders | MedDRA 20.1 | Systematic Assessment |
|
| Increased appetite | Metabolism and nutrition disorders | MedDRA 20.1 | Systematic Assessment |
|
| Iron deficiency | Metabolism and nutrition disorders | MedDRA 20.1 | Systematic Assessment |
|
| Nasopharyngitis | Infections and infestations | MedDRA 20.1 | Systematic Assessment |
|
| Gastroenteritis | Infections and infestations | MedDRA 20.1 | Systematic Assessment |
|
| Influenza | Infections and infestations | MedDRA 20.1 | Systematic Assessment |
|
| Sinusitis | Infections and infestations | MedDRA 20.1 | Systematic Assessment |
|
| Bronchitis | Infections and infestations | MedDRA 20.1 | Systematic Assessment |
|
| Pharyngitis | Infections and infestations | MedDRA 20.1 | Systematic Assessment |
|
| Rhinitis | Infections and infestations | MedDRA 20.1 | Systematic Assessment |
|
| Cystitis | Infections and infestations | MedDRA 20.1 | Systematic Assessment |
|
| Dermatitis infected | Infections and infestations | MedDRA 20.1 | Systematic Assessment |
|
| Hordeolum | Infections and infestations | MedDRA 20.1 | Systematic Assessment |
|
| Impetigo | Infections and infestations | MedDRA 20.1 | Systematic Assessment |
|
| Otitis externa | Infections and infestations | MedDRA 20.1 | Systematic Assessment |
|
| Pneumonia | Infections and infestations | MedDRA 20.1 | Systematic Assessment |
|
| Skin bacterial infection | Infections and infestations | MedDRA 20.1 | Systematic Assessment |
|
| Malassezia infection | Infections and infestations | MedDRA 20.1 | Systematic Assessment |
|
| Gastroenteritis bacterial | Infections and infestations | MedDRA 20.1 | Systematic Assessment |
|
| Streptococcal infection | Infections and infestations | MedDRA 20.1 | Systematic Assessment |
|
| Purulence | Infections and infestations | MedDRA 20.1 | Systematic Assessment |
|
| Oral herpes | Infections and infestations | MedDRA 20.1 | Systematic Assessment |
|
| Arthropod sting | Injury, poisoning and procedural complications | MedDRA 20.1 | Systematic Assessment |
|
| Ligament sprain | Injury, poisoning and procedural complications | MedDRA 20.1 | Systematic Assessment |
|
| Wound | Injury, poisoning and procedural complications | MedDRA 20.1 | Systematic Assessment |
|
| Chilblains | Injury, poisoning and procedural complications | MedDRA 20.1 | Systematic Assessment |
|
| Ear canal abrasion | Injury, poisoning and procedural complications | MedDRA 20.1 | Systematic Assessment |
|
| Wisdom teeth removal | Surgical and medical procedures | MedDRA 20.1 | Systematic Assessment |
|
| Weight increased | Investigations | MedDRA 20.1 | Systematic Assessment |
|
| Blood bilirubin increased | Investigations | MedDRA 20.1 | Systematic Assessment |
|
| Blood pressure increased | Investigations | MedDRA 20.1 | Systematic Assessment |
|
| Heart rate increased | Investigations | MedDRA 20.1 | Systematic Assessment |
|
| Weight decreased | Investigations | MedDRA 20.1 | Systematic Assessment |
|
| Blood creatine phosphokinase increased | Investigations | MedDRA 20.1 | Systematic Assessment |
|
| Blood uric acid increased | Investigations | MedDRA 20.1 | Systematic Assessment |
|
| Liver function test increased | Investigations | MedDRA 20.1 | Systematic Assessment |
|
| Aspartate aminotransferase increased | Investigations | MedDRA 20.1 | Systematic Assessment |
|
| Blood pressure decreased | Investigations | MedDRA 20.1 | Systematic Assessment |
|
| Blood triglycerides increased | Investigations | MedDRA 20.1 | Systematic Assessment |
|
| Haematocrit decreased | Investigations | MedDRA 20.1 | Systematic Assessment |
|
| Haemoglobin decreased | Investigations | MedDRA 20.1 | Systematic Assessment |
|
| Protein total decreased | Investigations | MedDRA 20.1 | Systematic Assessment |
|
| White blood cell count decreased | Investigations | MedDRA 20.1 | Systematic Assessment |
|
| White blood cell count increased | Investigations | MedDRA 20.1 | Systematic Assessment |
|
| Protein urine present | Investigations | MedDRA 20.1 | Systematic Assessment |
|
| Myalgia | Musculoskeletal and connective tissue disorders | MedDRA 20.1 | Systematic Assessment |
|
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA 20.1 | Systematic Assessment |
|
| Musculoskeletal pain | Musculoskeletal and connective tissue disorders | MedDRA 20.1 | Systematic Assessment |
|
| Pain in extremity | Musculoskeletal and connective tissue disorders | MedDRA 20.1 | Systematic Assessment |
|
| Somnolence | Nervous system disorders | MedDRA 20.1 | Systematic Assessment |
|
| Headache | Nervous system disorders | MedDRA 20.1 | Systematic Assessment |
|
| Dizziness | Nervous system disorders | MedDRA 20.1 | Systematic Assessment |
|
| Dizziness postural | Nervous system disorders | MedDRA 20.1 | Systematic Assessment |
|
| Paraesthesia | Nervous system disorders | MedDRA 20.1 | Systematic Assessment |
|
| Akathisia | Nervous system disorders | MedDRA 20.1 | Systematic Assessment |
|
| Dysgeusia | Nervous system disorders | MedDRA 20.1 | Systematic Assessment |
|
| Hypoaesthesia | Nervous system disorders | MedDRA 20.1 | Systematic Assessment |
|
| Presyncope | Nervous system disorders | MedDRA 20.1 | Systematic Assessment |
|
| Syncope | Nervous system disorders | MedDRA 20.1 | Systematic Assessment |
|
| Restless legs syndrome | Nervous system disorders | MedDRA 20.1 | Systematic Assessment |
|
| Irregular sleep wake rhythm disorder | Nervous system disorders | MedDRA 20.1 | Systematic Assessment |
|
| Intentional self-injury | Psychiatric disorders | MedDRA 20.1 | Systematic Assessment |
|
| Insomnia | Psychiatric disorders | MedDRA 20.1 | Systematic Assessment |
|
| Sleep disorder | Psychiatric disorders | MedDRA 20.1 | Systematic Assessment |
|
| Suicidal ideation | Psychiatric disorders | MedDRA 20.1 | Systematic Assessment |
|
| Irritability | Psychiatric disorders | MedDRA 20.1 | Systematic Assessment |
|
| Suicide attempt | Psychiatric disorders | MedDRA 20.1 | Systematic Assessment |
|
| Agitation | Psychiatric disorders | MedDRA 20.1 | Systematic Assessment |
|
| Anxiety | Psychiatric disorders | MedDRA 20.1 | Systematic Assessment |
|
| Hallucinations, mixed | Psychiatric disorders | MedDRA 20.1 | Systematic Assessment |
|
| Mania | Psychiatric disorders | MedDRA 20.1 | Systematic Assessment |
|
| Middle insomnia | Psychiatric disorders | MedDRA 20.1 | Systematic Assessment |
|
| Neurosis | Psychiatric disorders | MedDRA 20.1 | Systematic Assessment |
|
| Nightmare | Psychiatric disorders | MedDRA 20.1 | Systematic Assessment |
|
| Restlessness | Psychiatric disorders | MedDRA 20.1 | Systematic Assessment |
|
| Trichotillomania | Psychiatric disorders | MedDRA 20.1 | Systematic Assessment |
|
| Affect lability | Psychiatric disorders | MedDRA 20.1 | Systematic Assessment |
|
| Abnormal behaviour | Psychiatric disorders | MedDRA 20.1 | Systematic Assessment |
|
| Dysmenorrhoea | Reproductive system and breast disorders | MedDRA 20.1 | Systematic Assessment |
|
| Menstruation irregular | Reproductive system and breast disorders | MedDRA 20.1 | Systematic Assessment |
|
| Menstrual disorder | Reproductive system and breast disorders | MedDRA 20.1 | Systematic Assessment |
|
| Premenstrual syndrome | Reproductive system and breast disorders | MedDRA 20.1 | Systematic Assessment |
|
| Erectile dysfunction | Reproductive system and breast disorders | MedDRA 20.1 | Systematic Assessment |
|
| Colour blindness | Congenital, familial and genetic disorders | MedDRA 20.1 | Systematic Assessment |
|
| Asthma | Respiratory, thoracic and mediastinal disorders | MedDRA 20.1 | Systematic Assessment |
|
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA 20.1 | Systematic Assessment |
|
| Rhinitis allergic | Respiratory, thoracic and mediastinal disorders | MedDRA 20.1 | Systematic Assessment |
|
| Rhinorrhoea | Respiratory, thoracic and mediastinal disorders | MedDRA 20.1 | Systematic Assessment |
|
| Upper respiratory tract inflammation | Respiratory, thoracic and mediastinal disorders | MedDRA 20.1 | Systematic Assessment |
|
| Oropharyngeal pain | Respiratory, thoracic and mediastinal disorders | MedDRA 20.1 | Systematic Assessment |
|
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA 20.1 | Systematic Assessment |
|
| Epistaxis | Respiratory, thoracic and mediastinal disorders | MedDRA 20.1 | Systematic Assessment |
|
| Hyperventilation | Respiratory, thoracic and mediastinal disorders | MedDRA 20.1 | Systematic Assessment |
|
| Nasal congestion | Respiratory, thoracic and mediastinal disorders | MedDRA 20.1 | Systematic Assessment |
|
| Oropharyngeal discomfort | Respiratory, thoracic and mediastinal disorders | MedDRA 20.1 | Systematic Assessment |
|
| Acne | Skin and subcutaneous tissue disorders | MedDRA 20.1 | Systematic Assessment |
|
| Eczema | Skin and subcutaneous tissue disorders | MedDRA 20.1 | Systematic Assessment |
|
| Dermatitis atopic | Skin and subcutaneous tissue disorders | MedDRA 20.1 | Systematic Assessment |
|
| Dry skin | Skin and subcutaneous tissue disorders | MedDRA 20.1 | Systematic Assessment |
|
| Night sweats | Skin and subcutaneous tissue disorders | MedDRA 20.1 | Systematic Assessment |
|
| Urticaria | Skin and subcutaneous tissue disorders | MedDRA 20.1 | Systematic Assessment |
|
| Dermatitis | Skin and subcutaneous tissue disorders | MedDRA 20.1 | Systematic Assessment |
|
| Dermatitis contact | Skin and subcutaneous tissue disorders | MedDRA 20.1 | Systematic Assessment |
|
| Drug eruption | Skin and subcutaneous tissue disorders | MedDRA 20.1 | Systematic Assessment |
|
| Erythema | Skin and subcutaneous tissue disorders | MedDRA 20.1 | Systematic Assessment |
|
| Hyperhidrosis | Skin and subcutaneous tissue disorders | MedDRA 20.1 | Systematic Assessment |
|
| Miliaria | Skin and subcutaneous tissue disorders | MedDRA 20.1 | Systematic Assessment |
|
| Photosensitivity reaction | Skin and subcutaneous tissue disorders | MedDRA 20.1 | Systematic Assessment |
|
| Pruritus | Skin and subcutaneous tissue disorders | MedDRA 20.1 | Systematic Assessment |
|
| Orthostatic hypotension | Vascular disorders | MedDRA 20.1 | Systematic Assessment |
|
Not provided
Not provided
| D006571 |
| Heterocyclic Compounds |
| Trough Concentration |
|