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| ID | Type | Description | Link |
|---|---|---|---|
| B2061006 |
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This is a multicenter study to assess the health and well-being in subjects who are outpatients with major depressive disorder that take desvenlafaxine succinate sustained release (DVS SR) or placebo for 12 weeks.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Placebo Comparator |
| |
| 2 | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| desvenlafaxine succinate sustained release | Drug | 50 mg/day oral tablet for 12 weeks |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline in Hamilton Depression Scale (HAM-D) at Week 12 | HAM-D, clinician-rated interview, measures presence of depressive symptoms in 17 areas (symptoms such as depressed mood, guilt feelings, suicide, sleep disturbances, anxiety levels and weight loss). Total score ranges from 0 to 52; higher scores indicate more depression. Change from baseline: mean at observation minus mean at baseline. | At Baseline and Week 12. |
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline in Sheehan Disability Scale (SDS) Total Score at Week 12 | Participant rated scale was used to assess the effect of the participant's symptoms on their work/social/family life. Total scores range from 0 to 30 with higher values indicating greater disruption in the participant's work/social/family life. Individual item scores range from 0 to 10. | At Baseline and Week 12. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Pfizer CT.gov Call Center | Pfizer | Study Director |
Not provided
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 34183490 | Derived | Zilcha-Mano S, Wang X, Wajsbrot DB, Boucher M, Fine SA, Rutherford BR. Trajectories of Function and Symptom Change in Desvenlafaxine Clinical Trials: Toward Personalized Treatment for Depression. J Clin Psychopharmacol. 2021 Sep-Oct 01;41(5):579-584. doi: 10.1097/JCP.0000000000001435. | |
| 29140227 | Derived | Soares CN, Zhang M, Boucher M. Categorical improvement in functional impairment in depressed patients treated with desvenlafaxine. CNS Spectr. 2019 Jun;24(3):322-332. doi: 10.1017/S1092852917000633. Epub 2017 Nov 15. |
| Label | URL |
|---|---|
| To obtain contact information for a study center near you, click here. | View source |
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A total of 752 potential participants were screened for this study. 437 participants were randomized to treatment groups while 315 participants were not randomized (288: did not meet the study criteria; 27 were not randomized for other reasons). Of the 437 randomized participants, 10 participants did not receive the study treatment.
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| ID | Title | Description |
|---|---|---|
| FG000 | DVS SR 50 mg | Participants were administered an oral dose of Desvenlafaxine Succinate Sustained Release (DVS SR) 50 mg tablet once daily with or without food. |
| FG001 | Placebo | Participants were administered an oral dose of placebo once daily with or without food. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | DVS SR 50 mg | Participants were administered an oral dose of Desvenlafaxine Succinate Sustained Release (DVS SR) 50 mg tablet once daily with or without food. |
| BG001 | Placebo |
| 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 | Change From Baseline in Hamilton Depression Scale (HAM-D) at Week 12 | HAM-D, clinician-rated interview, measures presence of depressive symptoms in 17 areas (symptoms such as depressed mood, guilt feelings, suicide, sleep disturbances, anxiety levels and weight loss). Total score ranges from 0 to 52; higher scores indicate more depression. Change from baseline: mean at observation minus mean at baseline. | Intent-to-treat (ITT) analysis set, Last Observation Carried Forward (LOCF) | Posted | Mean | Standard Error | Scores on a scale | At Baseline and Week 12. |
|
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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 | DVS SR 50 mg | Participants were administered an oral dose of Desvenlafaxine Succinate Sustained Release (DVS SR) 50 mg tablet once daily with or without food. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Major depression | Psychiatric disorders | MedDRA 13.0 | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anemia | Blood and lymphatic system disorders | MedDRA 13.0 | Systematic Assessment |
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Pfizer ClinicalTrials.gov Call Center | Pfizer, Inc | 1-800-718-1021 | ClinicalTrials.gov_Inquiries@pfizer.com |
| ID | Term |
|---|---|
| D003865 | Depressive Disorder, Major |
| ID | Term |
|---|---|
| D003866 | Depressive Disorder |
| D019964 | Mood Disorders |
| D001523 | Mental Disorders |
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| ID | Term |
|---|---|
| D000069468 | Desvenlafaxine Succinate |
| D005838 | Genotype |
| ID | Term |
|---|---|
| D003511 | Cyclohexanols |
| D000441 | Hexanols |
| D005233 | Fatty Alcohols |
| D000438 | Alcohols |
| D009930 |
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| Genotyping | Genetic | CYP2D6 genotyping at randomization |
|
| Clinical Global Impression Scale - Improvement (CGI- I) Score at Week 12 | CGI-I: 7-point clinician rated scale ranging from 1 (very much improved) to 7 (very much worse). Improvement is defined as a score of 1 (very much improved), 2 (much improved), or 3 (minimally improved) on the scale. Higher score = more affected. Change = score at observation minus score at baseline. | At Baseline and Week 12. |
| Clinical Global Impressions Scale - Severity of Illness (CGI-S) at Week 12 | CGI-S: 7-point clinician rated scale to assess severity of participant's current illness state; range: 1 (normal - not ill at all) to 7 (among the most extremely ill patients). Higher score = more affected. Change: score at observation minus score at baseline. | At Baseline and Week 12. |
| Change From Baseline on Work and Activities Item of HAM-D17 at Week 12 | The Work and Activities Item of the HAM-D17 is item 7 of HAM-D17. Scoring range from 0 to 4. | At Baseline and Week 12. |
| Change From Baseline in Adjusted Mean on Montgomery-Asberg Depression Rating Scale (MADRS) at Week 12 | Measures the overall severity of depressive symptoms. The MADRS has a 10-item checklist. Items are rated on a scale of 0-6, for a total score range of 0 (low severity of depressive symptoms) to 60 (high severity of depressive symptoms). | At Baseline and Week 12. |
| Change From Baseline on Worry Anxiety Tension Scale (WATS) at Week 12 | WATS: a self-administered, 3-question rating scale assesses worry, anxiety, and tension. Each item was a visual analog scale on which the participant circles a number from 0 to 10. Higher scores indicated worse function. WATS total score was the sum of the 3 items. If 1 item was missing, the total score would be missing. | At Baseline and Week 12. |
| Change From Baseline on Stress and Social Support Scales at Week 12 | Stress and Social Support Scales: self-administered rating scale where item 1 is the stress vulnerability scale measuring how much the subject was set back by stressful events on an 11-point scale ranging from 0 (not at all) to 10 (extremely) and item 2 is an 11-point scale ranging from 0 to 100 percent of the amount of support the subject received from relatives and friends. | At Baseline and Week 12. |
| 27009044 | Derived | Reddy S, Fayyad R, Edgar CJ, Guico-Pabia CJ, Wesnes K. The effect of desvenlafaxine on cognitive functioning in employed outpatients with major depressive disorder: a substudy of a randomized, double-blind, placebo-controlled trial. J Psychopharmacol. 2016 Jun;30(6):559-67. doi: 10.1177/0269881116631649. Epub 2016 Mar 23. |
| 26709542 | Derived | McIntyre RS, Fayyad R, Mackell JA, Boucher M. Effect of metabolic syndrome and thyroid hormone on efficacy of desvenlafaxine 50 and 100 mg/d in major depressive disorder. Curr Med Res Opin. 2016;32(3):587-99. doi: 10.1185/03007995.2015.1136603. Epub 2016 Jan 13. |
| 26644956 | Derived | McIntyre RS, Fayyad RS, Guico-Pabia CJ, Boucher M. A Post Hoc Analysis of the Effect of Weight on Efficacy in Depressed Patients Treated With Desvenlafaxine 50 mg/d and 100 mg/d. Prim Care Companion CNS Disord. 2015 Jun 4;17(3):10.4088/PCC.14m01741. doi: 10.4088/PCC.14m01741. eCollection 2015. |
| 25758058 | Derived | Thase ME, Fayyad R, Cheng RF, Guico-Pabia CJ, Sporn J, Boucher M, Tourian KA. Effects of desvenlafaxine on blood pressure in patients treated for major depressive disorder: a pooled analysis. Curr Med Res Opin. 2015 Apr;31(4):809-20. doi: 10.1185/03007995.2015.1020365. Epub 2015 Mar 26. |
| 25012446 | Derived | Endicott J, Lam RW, Hsu MA, Fayyad R, Boucher M, Guico-Pabia CJ. Improvements in quality of life with desvenlafaxine 50mg/d vs placebo in employed adults with major depressive disorder. J Affect Disord. 2014 Sep;166:307-14. doi: 10.1016/j.jad.2014.05.011. Epub 2014 May 21. |
| 24583567 | Derived | Lam RW, Endicott J, Hsu MA, Fayyad R, Guico-Pabia C, Boucher M. Predictors of functional improvement in employed adults with major depressive disorder treated with desvenlafaxine. Int Clin Psychopharmacol. 2014 Sep;29(5):239-51. doi: 10.1097/YIC.0000000000000031. |
| 24571916 | Derived | Soares CN, Endicott J, Boucher M, Fayyad RS, Guico-Pabia CJ. Predictors of functional response and remission with desvenlafaxine 50 mg/d in patients with major depressive disorder. CNS Spectr. 2014 Dec;19(6):519-27. doi: 10.1017/S1092852914000066. Epub 2014 Feb 26. |
| Lost to Follow-up |
|
| Non-compliance |
|
| Protocol Violation |
|
| Withdrawal by Subject |
|
| Lack of Efficacy |
|
| Participant on prohibited medication |
|
Participants were administered an oral dose of placebo once daily with or without food.
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
Participants were administered an oral dose of placebo once daily with or without food. |
|
|
|
| Secondary | Change From Baseline in Sheehan Disability Scale (SDS) Total Score at Week 12 | Participant rated scale was used to assess the effect of the participant's symptoms on their work/social/family life. Total scores range from 0 to 30 with higher values indicating greater disruption in the participant's work/social/family life. Individual item scores range from 0 to 10. | ITT, LOCF | Posted | Mean | Standard Error | Scores on a scale | At Baseline and Week 12. |
|
|
|
|
| Secondary | Clinical Global Impression Scale - Improvement (CGI- I) Score at Week 12 | CGI-I: 7-point clinician rated scale ranging from 1 (very much improved) to 7 (very much worse). Improvement is defined as a score of 1 (very much improved), 2 (much improved), or 3 (minimally improved) on the scale. Higher score = more affected. Change = score at observation minus score at baseline. | ITT, LOCF | Posted | Number | Scores on a scale | At Baseline and Week 12. |
|
|
|
|
| Secondary | Clinical Global Impressions Scale - Severity of Illness (CGI-S) at Week 12 | CGI-S: 7-point clinician rated scale to assess severity of participant's current illness state; range: 1 (normal - not ill at all) to 7 (among the most extremely ill patients). Higher score = more affected. Change: score at observation minus score at baseline. | ITT, LOCF | Posted | Number | Scores on a scale | At Baseline and Week 12. |
|
|
|
|
| Secondary | Change From Baseline on Work and Activities Item of HAM-D17 at Week 12 | The Work and Activities Item of the HAM-D17 is item 7 of HAM-D17. Scoring range from 0 to 4. | ITT, LOCF | Posted | Mean | Standard Error | Scores on a scale | At Baseline and Week 12. |
|
|
|
|
| Secondary | Change From Baseline in Adjusted Mean on Montgomery-Asberg Depression Rating Scale (MADRS) at Week 12 | Measures the overall severity of depressive symptoms. The MADRS has a 10-item checklist. Items are rated on a scale of 0-6, for a total score range of 0 (low severity of depressive symptoms) to 60 (high severity of depressive symptoms). | ITT, LOCF | Posted | Mean | Standard Error | Scores on a scale | At Baseline and Week 12. |
|
|
|
|
| Secondary | Change From Baseline on Worry Anxiety Tension Scale (WATS) at Week 12 | WATS: a self-administered, 3-question rating scale assesses worry, anxiety, and tension. Each item was a visual analog scale on which the participant circles a number from 0 to 10. Higher scores indicated worse function. WATS total score was the sum of the 3 items. If 1 item was missing, the total score would be missing. | ITT, LOCF | Posted | Mean | Standard Error | Scores on a scale | At Baseline and Week 12. |
|
|
|
|
| Secondary | Change From Baseline on Stress and Social Support Scales at Week 12 | Stress and Social Support Scales: self-administered rating scale where item 1 is the stress vulnerability scale measuring how much the subject was set back by stressful events on an 11-point scale ranging from 0 (not at all) to 10 (extremely) and item 2 is an 11-point scale ranging from 0 to 100 percent of the amount of support the subject received from relatives and friends. | ITT, LOCF | Posted | Mean | Standard Error | Scores on a scale | At Baseline and Week 12. |
|
|
|
|
| 2 |
| 285 |
| 213 |
| 285 |
| EG001 | Placebo | Participants were administered an oral dose of placebo once daily with or without food. | 2 | 142 | 90 | 142 |
| Amnesia | Nervous system disorders | MedDRA 13.0 | Systematic Assessment |
|
| Cerebrovascular disorder | Nervous system disorders | MedDRA 13.0 | Systematic Assessment |
|
| Road traffic accident | Injury, poisoning and procedural complications | MedDRA 13.0 | Systematic Assessment |
|
| Asthma | Respiratory, thoracic and mediastinal disorders | MedDRA 13.0 | Systematic Assessment |
|
| Bronchitis | Respiratory, thoracic and mediastinal disorders | MedDRA 13.0 | Systematic Assessment |
|
| Leukopenia | Blood and lymphatic system disorders | MedDRA 13.0 | Systematic Assessment |
|
| Palpitations | Cardiac disorders | MedDRA 13.0 | Systematic Assessment |
|
| Sinus bradycardia | Cardiac disorders | MedDRA 13.0 | Systematic Assessment |
|
| Tachycardia | Cardiac disorders | MedDRA 13.0 | Systematic Assessment |
|
| Ear congestion | Ear and labyrinth disorders | MedDRA 13.0 | Systematic Assessment |
|
| Tinnitus | Ear and labyrinth disorders | MedDRA 13.0 | Systematic Assessment |
|
| Vertigo | Ear and labyrinth disorders | MedDRA 13.0 | Systematic Assessment |
|
| Hypothyroidism | Endocrine disorders | MedDRA 13.0 | Systematic Assessment |
|
| Blepharospasm | Eye disorders | MedDRA 13.0 | Systematic Assessment |
|
| Contact lens intolerance | Eye disorders | MedDRA 13.0 | Systematic Assessment |
|
| Eyelid ptosis | Eye disorders | MedDRA 13.0 | Systematic Assessment |
|
| Mydriasis | Eye disorders | MedDRA 13.0 | Systematic Assessment |
|
| Photopsia | Eye disorders | MedDRA 13.0 | Systematic Assessment |
|
| Vision blurred | Eye disorders | MedDRA 13.0 | Systematic Assessment |
|
| Visual impairment | Eye disorders | MedDRA 13.0 | Systematic Assessment |
|
| Abdominal discomfort | Gastrointestinal disorders | MedDRA 13.0 | Systematic Assessment |
|
| Abdominal pain | Gastrointestinal disorders | MedDRA 13.0 | Systematic Assessment |
|
| Abdominal pain upper | Gastrointestinal disorders | MedDRA 13.0 | Systematic Assessment |
|
| Constipation | Gastrointestinal disorders | MedDRA 13.0 | Systematic Assessment |
|
| Diarrhea | Gastrointestinal disorders | MedDRA 13.0 | Systematic Assessment |
|
| Dry mouth | Gastrointestinal disorders | MedDRA 13.0 | Systematic Assessment |
|
| Dyspepsia | Gastrointestinal disorders | MedDRA 13.0 | Systematic Assessment |
|
| Eructation | Gastrointestinal disorders | MedDRA 13.0 | Systematic Assessment |
|
| Flatulence | Gastrointestinal disorders | MedDRA 13.0 | Systematic Assessment |
|
| Food poisoning | Gastrointestinal disorders | MedDRA 13.0 | Systematic Assessment |
|
| Gastrooesophageal reflux disease | Gastrointestinal disorders | MedDRA 13.0 | Systematic Assessment |
|
| Nausea | Gastrointestinal disorders | MedDRA 13.0 | Systematic Assessment |
|
| Toothache | Gastrointestinal disorders | MedDRA 13.0 | Systematic Assessment |
|
| Vomiting | Gastrointestinal disorders | MedDRA 13.0 | Systematic Assessment |
|
| Asthenia | General disorders | MedDRA 13.0 | Systematic Assessment |
|
| Facial pain | General disorders | MedDRA 13.0 | Systematic Assessment |
|
| Fatigue | General disorders | MedDRA 13.0 | Systematic Assessment |
|
| Feeling abnormal | General disorders | MedDRA 13.0 | Systematic Assessment |
|
| Feeling drunk | General disorders | MedDRA 13.0 | Systematic Assessment |
|
| Feeling jittery | General disorders | MedDRA 13.0 | Systematic Assessment |
|
| Influenza like illness | General disorders | MedDRA 13.0 | Systematic Assessment |
|
| Irritability | General disorders | MedDRA 13.0 | Systematic Assessment |
|
| Non-cardiac chest pain | General disorders | MedDRA 13.0 | Systematic Assessment |
|
| Edema peripheral | General disorders | MedDRA 13.0 | Systematic Assessment |
|
| Pyrexia | General disorders | MedDRA 13.0 | Systematic Assessment |
|
| Thirst | General disorders | MedDRA 13.0 | Systematic Assessment |
|
| Seasonal allergy | Immune system disorders | MedDRA 13.0 | Systematic Assessment |
|
| Bronchitis | Infections and infestations | MedDRA 13.0 | Systematic Assessment |
|
| Cystitis | Infections and infestations | MedDRA 13.0 | Systematic Assessment |
|
| Ear infection | Infections and infestations | MedDRA 13.0 | Systematic Assessment |
|
| Fungal infection | Infections and infestations | MedDRA 13.0 | Systematic Assessment |
|
| Gastroenteritis | Infections and infestations | MedDRA 13.0 | Systematic Assessment |
|
| Gastroenteritis viral | Infections and infestations | MedDRA 13.0 | Systematic Assessment |
|
| Giardiasis | Infections and infestations | MedDRA 13.0 | Systematic Assessment |
|
| Herpes simplex | Infections and infestations | MedDRA 13.0 | Systematic Assessment |
|
| Influenza | Infections and infestations | MedDRA 13.0 | Systematic Assessment |
|
| Nasopharyngitis | Infections and infestations | MedDRA 13.0 | Systematic Assessment |
|
| Otitis media | Infections and infestations | MedDRA 13.0 | Systematic Assessment |
|
| Pharyngitis | Infections and infestations | MedDRA 13.0 | Systematic Assessment |
|
| Pharyngitis bacterial | Infections and infestations | MedDRA 13.0 | Systematic Assessment |
|
| Pneumonia | Infections and infestations | MedDRA 13.0 | Systematic Assessment |
|
| Pneumonia primary atypical | Infections and infestations | MedDRA 13.0 | Systematic Assessment |
|
| Tooth abscess | Infections and infestations | MedDRA 13.0 | Systematic Assessment |
|
| Tooth infection | Infections and infestations | MedDRA 13.0 | Systematic Assessment |
|
| Upper respiratory tract infection | Infections and infestations | MedDRA 13.0 | Systematic Assessment |
|
| Urinary tract infection | Infections and infestations | MedDRA 13.0 | Systematic Assessment |
|
| Vaginal infection | General disorders | MedDRA 13.0 | Systematic Assessment |
|
| Vulvovaginal candidiasis | Infections and infestations | MedDRA 13.0 | Systematic Assessment |
|
| Accidental overdose | Injury, poisoning and procedural complications | MedDRA 13.0 | Systematic Assessment |
|
| Burns second degree | Injury, poisoning and procedural complications | MedDRA 13.0 | Systematic Assessment |
|
| Contusion | Injury, poisoning and procedural complications | MedDRA 13.0 | Non-systematic Assessment |
|
| Fall | Injury, poisoning and procedural complications | MedDRA 13.0 | Systematic Assessment |
|
| Foot fracture | Injury, poisoning and procedural complications | MedDRA 13.0 | Systematic Assessment |
|
| Heat exhaustion | Injury, poisoning and procedural complications | MedDRA 13.0 | Systematic Assessment |
|
| Injury | Injury, poisoning and procedural complications | MedDRA 13.0 | Systematic Assessment |
|
| Joint dislocation | Injury, poisoning and procedural complications | MedDRA 13.0 | Systematic Assessment |
|
| Joint sprain | Injury, poisoning and procedural complications | MedDRA 13.0 | Systematic Assessment |
|
| Limb injury | Injury, poisoning and procedural complications | MedDRA 13.0 | Systematic Assessment |
|
| Muscle injury | Injury, poisoning and procedural complications | MedDRA 13.0 | Systematic Assessment |
|
| Procedural pain | Injury, poisoning and procedural complications | MedDRA 13.0 | Systematic Assessment |
|
| Road traffic accident | Injury, poisoning and procedural complications | MedDRA 13.0 | Systematic Assessment |
|
| Sunburn | Injury, poisoning and procedural complications | MedDRA 13.0 | Systematic Assessment |
|
| Thermal burn | Injury, poisoning and procedural complications | MedDRA 13.0 | Systematic Assessment |
|
| Blood cholesterol increased | Investigations | MedDRA 13.0 | Systematic Assessment |
|
| Blood pressure increased | Investigations | MedDRA 13.0 | Systematic Assessment |
|
| Blood pressure systolic increased | Investigations | MedDRA 13.0 | Systematic Assessment |
|
| Blood triglycerides increased | Investigations | MedDRA 13.0 | Systematic Assessment |
|
| Electrocardiogram QT prolonged | Investigations | MedDRA 13.0 | Systematic Assessment |
|
| Gamma-glutamyltransferase increased | Investigations | MedDRA 13.0 | Systematic Assessment |
|
| Heart rate increased | Investigations | MedDRA 13.0 | Systematic Assessment |
|
| Low density lipoprotein increased | Investigations | MedDRA 13.0 | Systematic Assessment |
|
| Thyroxine free decreased | Investigations | MedDRA 13.0 | Systematic Assessment |
|
| Transaminases increased | Investigations | MedDRA 13.0 | Systematic Assessment |
|
| Weight decreased | Investigations | MedDRA 13.0 | Systematic Assessment |
|
| Weight increased | Investigations | MedDRA 13.0 | Systematic Assessment |
|
| White blood cell count increased | Investigations | MedDRA 13.0 | Systematic Assessment |
|
| Decreased appetite | Metabolism and nutrition disorders | MedDRA 13.0 | Systematic Assessment |
|
| Gout | Metabolism and nutrition disorders | MedDRA 13.0 | Systematic Assessment |
|
| Hyperglycemia | Metabolism and nutrition disorders | MedDRA 13.0 | Systematic Assessment |
|
| Hyperlipidemia | Metabolism and nutrition disorders | MedDRA 13.0 | Systematic Assessment |
|
| Hypoglycemia | Metabolism and nutrition disorders | MedDRA 13.0 | Systematic Assessment |
|
| Increased appetite | Metabolism and nutrition disorders | MedDRA 13.0 | Systematic Assessment |
|
| Arthralgia | Metabolism and nutrition disorders | MedDRA 13.0 | Systematic Assessment |
|
| Back pain | Metabolism and nutrition disorders | MedDRA 13.0 | Systematic Assessment |
|
| Bursitis | Metabolism and nutrition disorders | MedDRA 13.0 | Systematic Assessment |
|
| Flank pain | Metabolism and nutrition disorders | MedDRA 13.0 | Systematic Assessment |
|
| Joint stiffness | Metabolism and nutrition disorders | MedDRA 13.0 | Systematic Assessment |
|
| Joint swelling | Metabolism and nutrition disorders | MedDRA 13.0 | Systematic Assessment |
|
| Muscle spasms | Metabolism and nutrition disorders | MedDRA 13.0 | Systematic Assessment |
|
| Muscle tightness | Musculoskeletal and connective tissue disorders | MedDRA 13.0 | Systematic Assessment |
|
| Muscle twitching | Musculoskeletal and connective tissue disorders | MedDRA 13.0 | Systematic Assessment |
|
| Musculoskeletal chest pain | Musculoskeletal and connective tissue disorders | MedDRA 13.0 | Systematic Assessment |
|
| Musculoskeletal pain | Musculoskeletal and connective tissue disorders | MedDRA 13.0 | Systematic Assessment |
|
| Myalgia | Musculoskeletal and connective tissue disorders | MedDRA 13.0 | Systematic Assessment |
|
| Neck pain | Musculoskeletal and connective tissue disorders | MedDRA 13.0 | Systematic Assessment |
|
| Pain in extremity | Musculoskeletal and connective tissue disorders | MedDRA 13.0 | Systematic Assessment |
|
| Sensation of heaviness | Musculoskeletal and connective tissue disorders | MedDRA 13.0 | Systematic Assessment |
|
| Aphasia | Nervous system disorders | MedDRA 13.0 | Systematic Assessment |
|
| Burning sensation | Nervous system disorders | MedDRA 13.0 | Systematic Assessment |
|
| Crying | Nervous system disorders | MedDRA 13.0 | Systematic Assessment |
|
| Disturbance in attention | Nervous system disorders | MedDRA 13.0 | Systematic Assessment |
|
| Dizziness | Nervous system disorders | MedDRA 13.0 | Systematic Assessment |
|
| Dizziness postural | Nervous system disorders | MedDRA 13.0 | Systematic Assessment |
|
| Dysgeusia | Nervous system disorders | MedDRA 13.0 | Systematic Assessment |
|
| Fine motor delay | Nervous system disorders | MedDRA 13.0 | Systematic Assessment |
|
| Headache | Nervous system disorders | MedDRA 13.0 | Systematic Assessment |
|
| Hypersomnia | Nervous system disorders | MedDRA 13.0 | Systematic Assessment |
|
| Hypoaesthesia | Nervous system disorders | MedDRA 13.0 | Systematic Assessment |
|
| Lethargy | Nervous system disorders | MedDRA 13.0 | Systematic Assessment |
|
| Migraine | Nervous system disorders | MedDRA 13.0 | Systematic Assessment |
|
| Paresthesia | Nervous system disorders | MedDRA 13.0 | Systematic Assessment |
|
| Presyncope | Nervous system disorders | MedDRA 13.0 | Systematic Assessment |
|
| Sedation | Nervous system disorders | MedDRA 13.0 | Systematic Assessment |
|
| Sinus headache | Nervous system disorders | MedDRA 13.0 | Systematic Assessment |
|
| Somnolence | Nervous system disorders | MedDRA 13.0 | Systematic Assessment |
|
| Syncope | Nervous system disorders | MedDRA 13.0 | Systematic Assessment |
|
| Tension headache | Nervous system disorders | MedDRA 13.0 | Systematic Assessment |
|
| Tremor | Nervous system disorders | MedDRA 13.0 | Systematic Assessment |
|
| Abnormal dreams | Psychiatric disorders | MedDRA 13.0 | Systematic Assessment |
|
| Anorgasmia | Psychiatric disorders | MedDRA 13.0 | Systematic Assessment |
|
| Anxiety | Psychiatric disorders | MedDRA 13.0 | Systematic Assessment |
|
| Bereavement reaction | Psychiatric disorders | MedDRA 13.0 | Systematic Assessment |
|
| Bruxism | Psychiatric disorders | MedDRA 13.0 | Systematic Assessment |
|
| Depression | Psychiatric disorders | MedDRA 13.0 | Systematic Assessment |
|
| Euphoric mood | Psychiatric disorders | MedDRA 13.0 | Systematic Assessment |
|
| Initial insomnia | Psychiatric disorders | MedDRA 13.0 | Systematic Assessment |
|
| Insomnia | Psychiatric disorders | MedDRA 13.0 | Systematic Assessment |
|
| Libido decreased | Psychiatric disorders | MedDRA 13.0 | Systematic Assessment |
|
| Libido increased | Psychiatric disorders | MedDRA 13.0 | Systematic Assessment |
|
| Major depression | Psychiatric disorders | MedDRA 13.0 | Systematic Assessment |
|
| Middle insomnia | Psychiatric disorders | MedDRA 13.0 | Systematic Assessment |
|
| Nervousness | Psychiatric disorders | MedDRA 13.0 | Systematic Assessment |
|
| Panic attack | Psychiatric disorders | MedDRA 13.0 | Systematic Assessment |
|
| Restlessness | Psychiatric disorders | MedDRA 13.0 | Systematic Assessment |
|
| Sleep disorder | Psychiatric disorders | MedDRA 13.0 | Systematic Assessment |
|
| Violence-related symptom | Psychiatric disorders | MedDRA 13.0 | Systematic Assessment |
|
| Nephrolithiasis | Renal and urinary disorders | MedDRA 13.0 | Systematic Assessment |
|
| Pollakiuria | Psychiatric disorders | MedDRA 13.0 | Systematic Assessment |
|
| Breast discharge | Reproductive system and breast disorders | MedDRA 13.0 | Systematic Assessment |
|
| Breast tenderness | Reproductive system and breast disorders | MedDRA 13.0 | Systematic Assessment |
|
| Dysmenorrhea | Reproductive system and breast disorders | MedDRA 13.0 | Systematic Assessment |
|
| Ejaculation delayed | Reproductive system and breast disorders | MedDRA 13.0 | Systematic Assessment |
|
| Erectile dysfunction | Reproductive system and breast disorders | MedDRA 13.0 | Systematic Assessment |
|
| Menorrhagia | Reproductive system and breast disorders | MedDRA 13.0 | Systematic Assessment |
|
| Menstruation irregular | Reproductive system and breast disorders | MedDRA 13.0 | Systematic Assessment |
|
| Metrorrhagia | Reproductive system and breast disorders | MedDRA 13.0 | Systematic Assessment |
|
| Sexual dysfunction | Reproductive system and breast disorders | MedDRA 13.0 | Systematic Assessment |
|
| Vaginal discharge | Reproductive system and breast disorders | MedDRA 13.0 | Systematic Assessment |
|
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA 13.0 | Systematic Assessment |
|
| Dry throat | Respiratory, thoracic and mediastinal disorders | MedDRA 13.0 | Systematic Assessment |
|
| Dysphonia | Respiratory, thoracic and mediastinal disorders | MedDRA 13.0 | Systematic Assessment |
|
| Dyspnea | Respiratory, thoracic and mediastinal disorders | MedDRA 13.0 | Systematic Assessment |
|
| Epistaxis | Respiratory, thoracic and mediastinal disorders | MedDRA 13.0 | Systematic Assessment |
|
| Nasal congestion | Respiratory, thoracic and mediastinal disorders | MedDRA 13.0 | Systematic Assessment |
|
| Oropharyngeal pain | Respiratory, thoracic and mediastinal disorders | MedDRA 13.0 | Systematic Assessment |
|
| Sinus congestion | Respiratory, thoracic and mediastinal disorders | MedDRA 13.0 | Systematic Assessment |
|
| Upper respiratory tract congestion | Respiratory, thoracic and mediastinal disorders | MedDRA 13.0 | Systematic Assessment |
|
| Yawning | Respiratory, thoracic and mediastinal disorders | MedDRA 13.0 | Systematic Assessment |
|
| Alopecia | Skin and subcutaneous tissue disorders | MedDRA 13.0 | Systematic Assessment |
|
| Dermatitis contact | Skin and subcutaneous tissue disorders | MedDRA 13.0 | Systematic Assessment |
|
| Ecchymosis | Skin and subcutaneous tissue disorders | MedDRA 13.0 | Systematic Assessment |
|
| Erythema | Skin and subcutaneous tissue disorders | MedDRA 13.0 | Systematic Assessment |
|
| Hyperhidrosis | Skin and subcutaneous tissue disorders | MedDRA 13.0 | Systematic Assessment |
|
| Night sweats | Skin and subcutaneous tissue disorders | MedDRA 13.0 | Systematic Assessment |
|
| Pruritus | Skin and subcutaneous tissue disorders | MedDRA 13.0 | Systematic Assessment |
|
| Rash | Skin and subcutaneous tissue disorders | MedDRA 13.0 | Systematic Assessment |
|
| Hot flush | Vascular disorders | MedDRA 13.0 | Systematic Assessment |
|
| Hypertension | Vascular disorders | MedDRA 13.0 | Systematic Assessment |
|
| Hypotension | Vascular disorders | MedDRA 13.0 | Systematic Assessment |
|
| Sinusitis | Infections and infestations | MedDRA 13.0 | Systematic Assessment |
|
| Tri-iodothyronine decreased | Investigations | MedDRA 13.0 | Systematic Assessment |
|
The PIs agreed to allow the sponsor 60 days to review and require changes to presentations or publications but only to protect confidential information and intellectual property, and for the sponsor to file a patent application, as applicable. The PIs also agreed for data to be presented first as a joint, multi-center publication.
| Organic Chemicals |
| D003510 | Cyclohexanes |
| D003516 | Cycloparaffins |
| D006840 | Hydrocarbons, Alicyclic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D010636 | Phenols |
| D001555 | Benzene Derivatives |
| D006841 | Hydrocarbons, Aromatic |
| D008055 | Lipids |
| D055614 | Genetic Phenomena |
| 3 (Minimally Improved) |
|
| 4 (No Change) |
|
| 5 (Minimally Worse) |
|
| 6 (Much Worse) |
|
| 7 (Very Much Worse) |
|
| 3 (Minimally Improved) |
|
| 4 (No Change) |
|
| 5 (Minimally Worse) |
|
| 6 (Much Worse) |
|
| 7 (Very Much Worse) |
|