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| ID | Type | Description | Link |
|---|---|---|---|
| 2015-005035-41 | EudraCT Number |
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This Phase 2 study is a 8-site, double-blind, randomised, placebo-controlled, 3-way cross-over trial, involving 3 treatments with Modafinil 300 mg or the combination drug THN102 (Modafinil/Flecainide 300 /3 mg, Modafinil/Flecainide 300 /27 mg).
The 3 double blind periods (2-week) follow a stabilisation period for modafinil at 300 mg/day (open, 2-week) and are followed by a one-week washout period with the same modafinil dose.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Modafinil + placebo | Active Comparator | 3 tablets modafinil 100 mg per day and 3 capsules flecainide placebo per day for 2 weeks |
|
| THN102 300/3 | Experimental | 3 tablets modafinil 100 mg per day and 3 capsules flecainide 1 mg per day (THN102 as 300 + 3 mg) for 2 weeks |
|
| THN102 300/27 | Experimental | 3 tablets modafinil 100 mg per day and 3 capsules flecainide 9 mg per day(THN102 as 300 + 27 mg) for 2 weeks |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Active comparator: Modafinil + placebo | Drug |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| Epworth Sleepiness Scale (ESS) | Range 0 to 24, low score indicates good outcome | 14 days after the beginning of treatment period |
| Measure | Description | Time Frame |
|---|---|---|
| 14-item Fatigue Scale | Fatigue scale is a rating scale completed by the participants at each visit starting from baseline to last visit; 14 questions to be ticked off by "yes" or "No" by the patient. 0 : No fatigue 14 : worst fatigue condition | 14 days after the beginning of treatment period |
| Questionnaire EQ-5D (European Quality of Life EQ-5D) (Questionnaire Part) |
Not provided
Main inclusion Criteria:
Main exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Yves Dauvilliers, MD, PhD | CHRU Montpellier, France | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| RespiSom | Erpent | Belgium | ||||
| CHU Pellegrin |
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Study starts with open-label run in period with modafinil 300 mg/d. 51 patients met study inclusion/exclusion criteria and entered the run-in period, 48 subjects still fulfilled inclusion criteria after run-in and entered the double-blind period.
54 patients were screened, 51 patients were randomized and 48 started the double-blind treatment period
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| ID | Title | Description |
|---|---|---|
| FG000 | Sequence 1 : ABC | Treatment A : 300 mg modafinil + 0 mg flecainide per day Treatment B : 300 mg modafinil and 3 mg flecainide per day Treatment C: 300 mg modafinil and 27 mg flecainide per day Treatment period A, B and C duration = 2 weeks No wash out between each period |
| FG001 | Sequence 2 : BCA | Treatment A : 300 mg modafinil + 0 mg flecainide per day Treatment B : 300 mg modafinil and 3 mg flecainide per day Treatment C: 300 mg modafinil and 27 mg flecainide per day Treatment period A, B and C duration = 2 weeks No wash out between each period |
| FG002 | Sequence 3: CAB | Treatment A : 300 mg modafinil + 0 mg flecainide per day Treatment B : 300 mg modafinil and 3 mg flecainide per day Treatment C: 300 mg modafinil and 27 mg flecainide per day Treatment period A, B and C duration = 2 weeks No wash out between each period |
| FG003 | Sequence 4: ACB | Treatment A : 300 mg modafinil + 0 mg flecainide per day Treatment B : 300 mg modafinil and 3 mg flecainide per day Treatment C: 300 mg modafinil and 27 mg flecainide per day Treatment period A, B and C duration = 2 weeks No wash out between each period |
| FG004 | Sequence 5: CBA | Treatment A : 300 mg modafinil + 0 mg flecainide per day Treatment B : 300 mg modafinil and 3 mg flecainide per day Treatment C: 300 mg modafinil and 27 mg flecainide per day Treatment period A, B and C duration = 2 weeks No wash out between each period |
| FG005 | Sequence 6: BAC | Treatment A : 300 mg modafinil + 0 mg flecainide per day Treatment B : 300 mg modafinil and 3 mg flecainide per day Treatment C: 300 mg modafinil and 27 mg flecainide per day Treatment period A, B and C duration = 2 weeks No wash out between each period |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
Ethnicity data not collected at baseline
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| ID | Title | Description |
|---|---|---|
| BG000 | All Participants | Participants received either: A Modafinil 300mg/d/Flecainide placebo, B Modafinil 300mg/d/Flecainide 3mg/d C Modafinil 300mg/d/Flecainide 27mg/d |
| 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 | Epworth Sleepiness Scale (ESS) | Range 0 to 24, low score indicates good outcome | modified Intent To Treat population | Posted | Least Squares Mean | Standard Error | score on a scale | 14 days after the beginning of treatment period |
|
Adverse Events were collected for each 2 week treatment period during the 3 crossover periods.
Adverse events were collected by investigator - open question to patient. No scale or questionnaire based collection of events.
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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 | THN102 300/0 | Treatment A : THN102 300/0 Modafinil 300 mg/d Flecainide placebo Duration : 2 weeks |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Abdominal pain upper | Gastrointestinal disorders | MedDRA (16.0) | Systematic Assessment |
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Chief medical officer | Theranexus | +33680026779 | werner.rein@theranexus.fr |
Not provided
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| SAP | No | Yes | No | Statistical Analysis Plan | Jan 24, 2019 | May 11, 2020 | SAP_000.pdf |
| Prot | Yes | No | No | Study Protocol | May 11, 2018 | May 25, 2020 | Prot_001.pdf |
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| ID | Term |
|---|---|
| D009290 | Narcolepsy |
| ID | Term |
|---|---|
| D006970 | Disorders of Excessive Somnolence |
| D020919 | Sleep Disorders, Intrinsic |
| D020920 | Dyssomnias |
| D012893 | Sleep Wake Disorders |
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| ID | Term |
|---|---|
| D000077408 | Modafinil |
| D005424 | Flecainide |
| ID | Term |
|---|---|
| D001559 | Benzhydryl Compounds |
| D001555 | Benzene Derivatives |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
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| THN102 300/3 | Drug |
|
|
| THN102 300/27 | Drug |
|
|
EQ-5D is a quality of life questionnaire filled in by the participants from screening to the last visit (all visits). The EQ-5D assesses the status on the day of visit and not over the past week. It has two parts: The first part is a descriptive system that assesses five distinct health states/dimensions: Mobility (MO), Self-care (SC), Usual activities (UA), Pain/discomfort, Anxiety/depression (AD). A higher score signifies a higher number of symptoms present. The second part is a 100 mm VAS (EQ-VAS). An increase in VAS indicates an improvement in health state. |
| 14 days after the beginning of the screening |
| Patient Global Impression of Change (PGI-C) | PGI-C is a scale completed by the participants starting from screening to last Last visit (all the visits). Participants have to chose 1 condition among 7 : Very much improved/ Much improved/ Minimally improved/ No change/ Minimally worse/ Much worse/ Very much worse. 1 is the best score (very much improved) 7 is the worse score (very much worse) | 14 days after the beginning of treatment period |
| Clinical Global Impression of Change (CGI-C) Global Impression | CGI-C (change from baseline) is a scale completed by the investigator at V3, V4 , V5 and V6 for global impression the investigator or his/her designee has to score 3 items : global impression/ sleepiness and Cataplexy. For each item the investigator or his/her designee has to chose 1 condition among 7 : Very much improved/ Much improved/ Minimally improved/ No change/ Minimally worse/ Much worse/ Very much worse. 1 is the best score (very much improved) 7 is the worse score (very much worse) | 14 days after the end of treatment period I |
| Beck Depression Inventory (BDI) | Beck Depression Inventory (BDI) evaluation for depressive symptoms (including suicidal thoughts). The scale is completed by the participants from baseline, to last visit (all except screening visit). The questionnaire contains 21 items. Each must be scored from 0 to 3, minimum score = 0, maximum score = 63. A high score indicates increased severity of depression. | 14 days |
| Patient Global Impression for Severity (PGI-S) Global Score | PGI-S us a scale filled by the participant from screening to last visit (all the visits) Participants have to chose 1 condition among 7 : 1 Normal-Not ill at all/ 2 borderline ill/ 3 mildly ill/ 4 moderately ill/ 5 markedly ill/ 6 severely ill/ 7 among the most extremely ill patient 1 is the best score (very much improved) 7 is the worse score (very much worse) | 14 days |
| Clinical Global Impression of Change (CGI-C) Sleepiness | CGI-C (change from baseline) is a scale completed by the investigator at V3, V4 , V5 and V6 for sleepiness the investigator or his/her designee has to score 3 items : global impression/ sleepiness and Cataplexy. For each item the investigator or his/her designee has to chose 1 condition among 7 : Very much improved/ Much improved/ Minimally improved/ No change/ Minimally worse/ Much worse/ Very much worse. 1 is the best score (very much improved) 7 is the worse score (very much worse) | 14 days after the end of treatment period I |
| Clinical Global Impression of Change (CGI-C) Cataplexy | CGI-C (change from baseline) is a scale completed by the investigator at V3, V4 , V5 and V6 for Cataplexy the investigator or his/her designee has to score 3 items : global impression/ sleepiness and Cataplexy. For each item the investigator or his/her designee has to chose 1 condition among 7 : Very much improved/ Much improved/ Minimally improved/ No change/ Minimally worse/ Much worse/ Very much worse. 1 is the best score (very much improved) 7 is the worse score (very much worse) | 14 days after the end of treatment period I |
| Clinical Global Impression for Severity (CGI-S) Global Score | CGI-S is a scale completed by the investigator at each visit : Item global impression CGI-S us a scale filled by the Investigator or his/her designee from screening to last visit (all the visits) Investigators have to chose 1 condition among 7 : 1 normal-not ill at all/ 2 borderline ill/ 3 mildly ill/ 4 moderately ill/ 5 markedly ill/ 6 severely ill/ 7 among hte most extremely ill patient 1 is the best score (very much improved) 7 is the worse score (very much worse) CGI-S scale explores 3 items : Global impression/ Sleepiness/ Cataplexy | 14 days after the end of treatment period I |
| Clinical Global Impression for Severity (CGI-S) Sleepiness | CGI-S is a scale completed by the investigator at each visit for Sleepiness CGI-S us a scale filled by the Investigator or his/her designee from screening to last visit (all the visits) Investigators have to chose 1 condition among 7 : 1 Normal-Not ill at all/ 2 Borderline ill/ 3 Mildly ill/ 4 Moderately ill/ 5 Markedly ill/ 6 severely ill/ 7 Among the most extremely ill patient 1 is the best score (very much improved) 7 is the worse score (very much worse) CGI-S scale explores 3 items : Global impression/ Sleepiness/ Cataplexy | 14 days after the end of treatment period I |
| Clinical Global Impression for Severity (CGI-S) Cataplexy | CGI-S is a scale completed by the investigator at each visit for Cataplexy CGI-S us a scale filled by the Investigator or his/her designee from screening to last visit (all the visits) Investigators have to chose 1 condition among 7 : 1 Normal-Not ill at all/ 2 Borderline ill/ 3 Mildly ill/ 4 Moderately ill/ 5 Markedly ill/ 6 severely ill/ 7 Among the most extremely ill patient 1 is the best score (very much improved) 7 is the worse score (very much worse) CGI-S scale explores 3 items : Global impression/ Sleepiness/ Cataplexy | 14 days after the end of treatment period I |
| EQ-5D European Quality of Life EQ-5D (Visual Analogic Scale Part) | EQ-5D is a quality of life questionnaire filled in by the participants from screening to the last visit (all visits). The EQ-5D is a questionnaire assessing the quality of life of the patient. It has two parts: The first part is a descriptive system that assesses five distinct health states/dimensions: Mobility (MO), Self-care (SC), Usual activities (UA), Pain/discomfort, Anxiety/depression (AD). A higher score signifies a higher number of symptoms present. The second part is a 100 mm Visual analogic scale (EQ-VAS). An higher score in VAS indicates a better health state. The questionnaire is assessed at baseline and all subsequent visits | 14 days |
| Bordeaux |
| 33076 |
| France |
| CHU Dijon Bourgogne | Dijon | France |
| Hôpital Raymond Poincaré | Garches | 92380 | France |
| CHU Grenoble Alpes | Grenoble | France |
| CHRU Lilles | Lille | 59037 | France |
| University Hospital | Montpellier | 34090 | France |
| Groupe Hospitalier Pitié Salpêtrière | Paris | 75013 | France |
| years |
|
| Sex: Female, Male | 51 patients were randomised (1 randomized patient never took study medication), Safety set: 50 patients Modified Intent to Treat Set: 48 patients | Count of Participants | Participants |
|
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Epworth Sleepiness Scale (ESS) | Score from 0 to 24, high score = severe sleepiness | Efficacy population (modified Intent to Treat Population) 48 | Mean | Standard Deviation | units on a scale |
|
| OG002 |
| THN102 300/27 |
3 tablets modafinil 100 mg per day and 3 capsules flecainide 9 mg per day(THN102 as 300 + 27 mg) for 2 weeks THN102 300/27 |
|
|
| Secondary | 14-item Fatigue Scale | Fatigue scale is a rating scale completed by the participants at each visit starting from baseline to last visit; 14 questions to be ticked off by "yes" or "No" by the patient. 0 : No fatigue 14 : worst fatigue condition | modified Intent To Treat (mITT) | Posted | Least Squares Mean | Standard Error | score on a scale | 14 days after the beginning of treatment period |
|
|
|
| Secondary | Questionnaire EQ-5D (European Quality of Life EQ-5D) (Questionnaire Part) | EQ-5D is a quality of life questionnaire filled in by the participants from screening to the last visit (all visits). The EQ-5D assesses the status on the day of visit and not over the past week. It has two parts: The first part is a descriptive system that assesses five distinct health states/dimensions: Mobility (MO), Self-care (SC), Usual activities (UA), Pain/discomfort, Anxiety/depression (AD). A higher score signifies a higher number of symptoms present. The second part is a 100 mm VAS (EQ-VAS). An increase in VAS indicates an improvement in health state. | mITT | Posted | Mean | Standard Error | score on a scale | 14 days after the beginning of the screening |
|
|
|
| Secondary | Patient Global Impression of Change (PGI-C) | PGI-C is a scale completed by the participants starting from screening to last Last visit (all the visits). Participants have to chose 1 condition among 7 : Very much improved/ Much improved/ Minimally improved/ No change/ Minimally worse/ Much worse/ Very much worse. 1 is the best score (very much improved) 7 is the worse score (very much worse) | mITT | Posted | Count of Participants | Participants | 14 days after the beginning of treatment period |
|
|
|
| Secondary | Clinical Global Impression of Change (CGI-C) Global Impression | CGI-C (change from baseline) is a scale completed by the investigator at V3, V4 , V5 and V6 for global impression the investigator or his/her designee has to score 3 items : global impression/ sleepiness and Cataplexy. For each item the investigator or his/her designee has to chose 1 condition among 7 : Very much improved/ Much improved/ Minimally improved/ No change/ Minimally worse/ Much worse/ Very much worse. 1 is the best score (very much improved) 7 is the worse score (very much worse) | mITT | Posted | Count of Participants | Participants | 14 days after the end of treatment period I |
|
|
|
| Secondary | Beck Depression Inventory (BDI) | Beck Depression Inventory (BDI) evaluation for depressive symptoms (including suicidal thoughts). The scale is completed by the participants from baseline, to last visit (all except screening visit). The questionnaire contains 21 items. Each must be scored from 0 to 3, minimum score = 0, maximum score = 63. A high score indicates increased severity of depression. | mITT | Posted | Mean | Standard Deviation | score on a scale | 14 days |
|
|
|
| Secondary | Patient Global Impression for Severity (PGI-S) Global Score | PGI-S us a scale filled by the participant from screening to last visit (all the visits) Participants have to chose 1 condition among 7 : 1 Normal-Not ill at all/ 2 borderline ill/ 3 mildly ill/ 4 moderately ill/ 5 markedly ill/ 6 severely ill/ 7 among the most extremely ill patient 1 is the best score (very much improved) 7 is the worse score (very much worse) | mITT | Posted | Count of Participants | Participants | 14 days |
|
|
|
| Secondary | Clinical Global Impression of Change (CGI-C) Sleepiness | CGI-C (change from baseline) is a scale completed by the investigator at V3, V4 , V5 and V6 for sleepiness the investigator or his/her designee has to score 3 items : global impression/ sleepiness and Cataplexy. For each item the investigator or his/her designee has to chose 1 condition among 7 : Very much improved/ Much improved/ Minimally improved/ No change/ Minimally worse/ Much worse/ Very much worse. 1 is the best score (very much improved) 7 is the worse score (very much worse) | mITT | Posted | Count of Participants | Participants | 14 days after the end of treatment period I |
|
|
|
| Secondary | Clinical Global Impression of Change (CGI-C) Cataplexy | CGI-C (change from baseline) is a scale completed by the investigator at V3, V4 , V5 and V6 for Cataplexy the investigator or his/her designee has to score 3 items : global impression/ sleepiness and Cataplexy. For each item the investigator or his/her designee has to chose 1 condition among 7 : Very much improved/ Much improved/ Minimally improved/ No change/ Minimally worse/ Much worse/ Very much worse. 1 is the best score (very much improved) 7 is the worse score (very much worse) | mITT | Posted | Count of Participants | Participants | 14 days after the end of treatment period I |
|
|
|
| Secondary | Clinical Global Impression for Severity (CGI-S) Global Score | CGI-S is a scale completed by the investigator at each visit : Item global impression CGI-S us a scale filled by the Investigator or his/her designee from screening to last visit (all the visits) Investigators have to chose 1 condition among 7 : 1 normal-not ill at all/ 2 borderline ill/ 3 mildly ill/ 4 moderately ill/ 5 markedly ill/ 6 severely ill/ 7 among hte most extremely ill patient 1 is the best score (very much improved) 7 is the worse score (very much worse) CGI-S scale explores 3 items : Global impression/ Sleepiness/ Cataplexy | mITT | Posted | Count of Participants | Participants | 14 days after the end of treatment period I |
|
|
|
| Secondary | Clinical Global Impression for Severity (CGI-S) Sleepiness | CGI-S is a scale completed by the investigator at each visit for Sleepiness CGI-S us a scale filled by the Investigator or his/her designee from screening to last visit (all the visits) Investigators have to chose 1 condition among 7 : 1 Normal-Not ill at all/ 2 Borderline ill/ 3 Mildly ill/ 4 Moderately ill/ 5 Markedly ill/ 6 severely ill/ 7 Among the most extremely ill patient 1 is the best score (very much improved) 7 is the worse score (very much worse) CGI-S scale explores 3 items : Global impression/ Sleepiness/ Cataplexy | modified Intent To Treat : mITT | Posted | Count of Participants | Participants | 14 days after the end of treatment period I |
|
|
|
| Secondary | Clinical Global Impression for Severity (CGI-S) Cataplexy | CGI-S is a scale completed by the investigator at each visit for Cataplexy CGI-S us a scale filled by the Investigator or his/her designee from screening to last visit (all the visits) Investigators have to chose 1 condition among 7 : 1 Normal-Not ill at all/ 2 Borderline ill/ 3 Mildly ill/ 4 Moderately ill/ 5 Markedly ill/ 6 severely ill/ 7 Among the most extremely ill patient 1 is the best score (very much improved) 7 is the worse score (very much worse) CGI-S scale explores 3 items : Global impression/ Sleepiness/ Cataplexy | modified Intent To Treat : mITT | Posted | Count of Participants | Participants | 14 days after the end of treatment period I |
|
|
|
| Secondary | EQ-5D European Quality of Life EQ-5D (Visual Analogic Scale Part) | EQ-5D is a quality of life questionnaire filled in by the participants from screening to the last visit (all visits). The EQ-5D is a questionnaire assessing the quality of life of the patient. It has two parts: The first part is a descriptive system that assesses five distinct health states/dimensions: Mobility (MO), Self-care (SC), Usual activities (UA), Pain/discomfort, Anxiety/depression (AD). A higher score signifies a higher number of symptoms present. The second part is a 100 mm Visual analogic scale (EQ-VAS). An higher score in VAS indicates a better health state. The questionnaire is assessed at baseline and all subsequent visits | mITT | Posted | Mean | Standard Error | units on a scale | 14 days |
|
|
|
| 0 |
| 48 |
| 0 |
| 48 |
| 9 |
| 48 |
| EG001 | THN102 300/3 | Treatment B : THN102 300/3 Modafinil 300 mg/d Flecainide 3 mg/d Duration : 2 weeks | 0 | 48 | 0 | 48 | 15 | 47 |
| EG002 | THN102 300/27 | Treatment C : THN102 300/27 Modafinil 300 mg/d Flecainide 27 mg/d Duration : 2 weeks | 0 | 48 | 0 | 48 | 13 | 47 |
| Palpitation | Cardiac disorders | MedDRA (16.0) | Systematic Assessment |
|
| vertigo | Ear and labyrinth disorders | MedDRA (16.0) | Systematic Assessment |
|
| chalazion | Eye disorders | MedDRA (16.0) | Systematic Assessment |
|
| constipation | Gastrointestinal disorders | MedDRA (16.0) | Systematic Assessment |
|
| dry mouth | Gastrointestinal disorders | MedDRA (16.0) | Systematic Assessment |
|
| toothache | Gastrointestinal disorders | MedDRA (16.0) | Systematic Assessment |
|
| asthenia | General disorders | MedDRA (16.0) | Systematic Assessment |
|
| fatigue | General disorders | MedDRA (16.0) | Systematic Assessment |
|
| hunger | General disorders | MedDRA (16.0) | Systematic Assessment |
|
| sluggishness | General disorders | MedDRA (16.0) | Systematic Assessment |
|
| food allergy | Immune system disorders | MedDRA (16.0) | Systematic Assessment |
|
| gastroenteritis | Infections and infestations | MedDRA (16.0) | Systematic Assessment |
|
| influenza | Infections and infestations | MedDRA (16.0) | Systematic Assessment |
|
| laryngitis | Infections and infestations | MedDRA (16.0) | Systematic Assessment |
|
| nasopharyngitis | Infections and infestations | MedDRA (16.0) | Systematic Assessment |
|
| tracheitis | Infections and infestations | MedDRA (16.0) | Systematic Assessment |
|
| urinary tact infection | Infections and infestations | MedDRA (16.0) | Systematic Assessment |
|
| limb injury | Injury, poisoning and procedural complications | MedDRA (16.0) | Systematic Assessment |
|
| hepatic enzyme increase | Investigations | MedDRA (16.0) | Systematic Assessment |
|
| arthralgia | Musculoskeletal and connective tissue disorders | MedDRA (16.0) | Systematic Assessment |
|
| pain in extremity | Metabolism and nutrition disorders | MedDRA (16.0) | Systematic Assessment |
|
| balance disorder | Nervous system disorders | MedDRA (16.0) | Systematic Assessment |
|
| dizziness | Nervous system disorders | MedDRA (16.0) | Systematic Assessment |
|
| dysgeusia | Nervous system disorders | MedDRA (16.0) | Systematic Assessment |
|
| headache | Nervous system disorders | MedDRA (16.0) | Systematic Assessment |
|
| irritability | Psychiatric disorders | MedDRA (16.0) | Systematic Assessment |
|
| nightmare | Psychiatric disorders | MedDRA (16.0) | Systematic Assessment |
|
| violence related symptom | Psychiatric disorders | MedDRA (16.0) | Systematic Assessment |
|
| oropharyngeal pain | Respiratory, thoracic and mediastinal disorders | MedDRA (16.0) | Systematic Assessment |
|
| rhinitis allergic | Respiratory, thoracic and mediastinal disorders | MedDRA (16.0) | Systematic Assessment |
|
| hyperhidrosis | Skin and subcutaneous tissue disorders | MedDRA (16.0) | Systematic Assessment |
|
Not provided
| D009422 | Nervous System Diseases |
| D001523 | Mental Disorders |
| D006838 |
| Hydrocarbons |
| D009930 | Organic Chemicals |
| D010880 | Piperidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| Minimally improved |
|
| No change |
|
| Minimally worse |
|
| Much worse |
|
| Very much worse |
|
| Minimally improved |
|
| no change |
|
| Minimally worse |
|
| Much worse |
|
| Very much worse |
|
| mildly ill |
|
| moderately ill |
|
| markedly ill |
|
| severely ill |
|
| Minimally improved |
|
| No change |
|
| Minimally worse |
|
| Much worse |
|
| Very much worse |
|
| Minimally improved |
|
| No change |
|
| Minimally worse |
|
| Much worse |
|
| very much worse |
|
| mildly ill |
|
| moderately ill |
|
| markedly ill |
|
| severely ill |
|
| among the most extremely ill |
|
| Mildly ill |
|
| Moderately ill |
|
| Markedly ill |
|
| Severely ill |
|
| Among the most extremely ill patients |
|
| Mildly ill |
|
| Moderately ill |
|
| Markedly ill |
|
| Severely ill |
|
| Among the most extremely ill patients |
|