Study Evaluating Long-Term Safety of Desvenlafaxine Succinate Sustained Release With Japanese Adult Subjects in Major Depressive Disorder (MDD)
This study has been completed.
Sponsor:
Pfizer
Information provided by (Responsible Party):
Pfizer
ClinicalTrials.gov Identifier:
NCT00831415
First received: January 27, 2009
Last updated: December 22, 2011
Last verified: December 2011
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Results First Received: December 22, 2011
| Study Type: | Interventional |
|---|---|
| Study Design: | Endpoint Classification: Safety/Efficacy Study; Intervention Model: Single Group Assignment; Masking: Open Label; Primary Purpose: Treatment |
| Condition: |
Major Depressive Disorder |
| Intervention: |
Drug: desvenlafaxine succinate sustained release tablets |
Participant Flow
Recruitment Details
| Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations |
|---|
| This was a 10-month, open-label, multicenter study of Japanese participants with Major Depressive Disorder (MDD) conducted from March 2009 to March 2011 at 61 sites in Japan. |
Pre-Assignment Details
| Significant events and approaches for the overall study following participant enrollment, but prior to group assignment |
|---|
| A total of 304 participants who completed the short-term Core Study (NCT00798707 [3151A1-3359 / B2061003]) consented to enroll in this long-term, open-label, flexible dosing Extension study (NCT00831415 [3151A1-3350 / B2061002]). Baseline in this Extension study = Day 56 of the Core study. |
Reporting Groups
| Description | |
|---|---|
| DVS SR | Desvenlafaxine succinate sustained release formulation (DVS SR) flexible dose 25 milligrams per day (mg/day) up to 100 mg/day. |
Participant Flow: Overall Study
| DVS SR | |
|---|---|
| STARTED | 304 |
| Completers for "Exposure" | 227 [1] |
| Study "Completers" | 227 [2] |
| COMPLETED | 229 [3] |
| NOT COMPLETED | 75 |
| Adverse Event | 14 |
| Failed to return | 3 |
| Physician Decision | 6 |
| Lost to Follow-up | 9 |
| Protocol Violation | 3 |
| Withdrawal by Subject | 35 |
| Unsatisfactory response - Efficacy | 4 |
| Death | 1 |
| [1] | Participants with ≥ 301 days of exposure to study drug and completed study day 308 evaluations. |
|---|---|
| [2] | Defined as participants whose conclusion of study participation status was “study completed.” |
| [3] | In addition to Completers for Study includes 2 participants who discontinued after on-therapy period |
Baseline Characteristics
Reporting Groups
| Description | |
|---|---|
| DVS SR | DVS SR flexible dose 25 mg/day up to 100 mg/day. |
Baseline Measures
| DVS SR | |
|---|---|
|
Number of Participants
[units: participants] |
304 |
|
Age
[units: years] Mean ± Standard Deviation |
38.45 ± 10.81 |
|
Gender
[units: participants] |
|
| Female | 149 |
| Male | 155 |
|
Hamilton Psychiatric Scale for Depression-17 Item (HAM-D17) score
[1] [units: scores on a scale] Mean ± Standard Deviation |
12.86 ± 6.30 |
|
Categorical scores on Clinical Global Impression-Improvement [CGI-I]
[2] [units: participants] |
|
| 1=Very much improved | 75 |
| 2=Much improved | 81 |
| 3=Minimally improved | 94 |
| 4=No change | 51 |
| 5=Minimally worse | 3 |
|
Clinical Global Impression-Severity of Illness [CGI-S] score
[3] [units: scores on a scale] Mean ± Standard Deviation |
3.25 ± 1.11 |
| [1] | HAM-D17 is a standardized, clinician-administered rating scale that assesses 17 items characteristically associated with major depression. Items are scored on either a 3-point (0 to 2) or a 5-point scale (0 to 4) with 0=none/absent and 4=most severe, for a maximum total score of 50. Higher scores indicate greater severity. |
|---|---|
| [2] | CGI-I is a 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. Baseline for CGI-I in this Extension study (NCT00831415 [3151A1-3350 / B2061002]) was measured against CGI-I baseline (Day -1) data in Core study (NCT00798707 [3151A1-3359 / B2061003]). |
| [3] | CGI-S is a 7-point clinician rated scale to assess severity of current illness state. Range is 1 (normal - not ill at all) to 7 (among the most extremely ill). Higher score = more affected. |
Outcome Measures
| 1. Primary: | Change From Baseline in Hamilton Psychiatric Scale for Depression-17 Item (HAM-D17) Score [ Time Frame: Baseline (Extension Study) up to Day 308 or Final On-Therapy (FOT) Evaluation ] |
| 2. Primary: | Percentage of Participants With Adverse Events (AEs) or Serious Adverse Events (SAEs) [ Time Frame: Baseline (Extension Study) up to Day 329 or 15 days after last dose of study treatment ] |
| 3. Secondary: | Number of Participants With Categorical Scores on Clinical Global Impression-Improvement (CGI-I) [ Time Frame: Day 308 or FOT Evaluation ] |
| 4. Secondary: | Change From Baseline in Clinical Global Impression-Severity of Illness [CGI-S] Score [ Time Frame: Baseline (Extension Study) up to Day 308 or FOT Evaluation ] |
Serious Adverse Events Other Adverse Events
| Time Frame | Events were collected from the time of the signing of the informed consent form up to 15 days after the last dose of study treatment was administered. |
|---|---|
| Additional Description | The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. |
Frequency Threshold
| Threshold above which other adverse events are reported | 0% |
|---|
Reporting Groups
| Description | |
|---|---|
| DVS SR | DVS SR flexible dose 25 mg/day up to 100 mg/day. |
Other Adverse Events
| DVS SR | |
|---|---|
| Total, other (not including serious) adverse events | |
| # participants affected / at risk | 247/304 |
| Blood and lymphatic system disorders | |
| Anaemia † 1 | |
| # participants affected / at risk | 1/304 (0.33%) |
| Iron deficiency anaemia † 1 | |
| # participants affected / at risk | 1/304 (0.33%) |
| Leukopenia † 1 | |
| # participants affected / at risk | 1/304 (0.33%) |
| Lymphadenitis † 1 | |
| # participants affected / at risk | 1/304 (0.33%) |
| Lymphadenopathy † 1 | |
| # participants affected / at risk | 1/304 (0.33%) |
| Neutropenia † 1 | |
| # participants affected / at risk | 1/304 (0.33%) |
| Cardiac disorders | |
| Atrioventricular block first degree † 1 | |
| # participants affected / at risk | 1/304 (0.33%) |
| Palpitations † 1 | |
| # participants affected / at risk | 6/304 (1.97%) |
| Ventricular extrasystoles † 1 | |
| # participants affected / at risk | 1/304 (0.33%) |
| Ear and labyrinth disorders | |
| Ear pain † 1 | |
| # participants affected / at risk | 1/304 (0.33%) |
| Meniere’s disease † 1 | |
| # participants affected / at risk | 2/304 (0.66%) |
| Motion sickness † 1 | |
| # participants affected / at risk | 1/304 (0.33%) |
| Tinnitus † 1 | |
| # participants affected / at risk | 12/304 (3.95%) |
| Vertigo † 1 | |
| # participants affected / at risk | 5/304 (1.64%) |
| Eye disorders | |
| Blepharospasm † 1 | |
| # participants affected / at risk | 1/304 (0.33%) |
| Cataract † 1 | |
| # participants affected / at risk | 1/304 (0.33%) |
| Conjunctivitis † 1 | |
| # participants affected / at risk | 1/304 (0.33%) |
| Conjunctivitis allergic † 1 | |
| # participants affected / at risk | 1/304 (0.33%) |
| Eye pain † 1 | |
| # participants affected / at risk | 1/304 (0.33%) |
| Lacrimation increased † 1 | |
| # participants affected / at risk | 1/304 (0.33%) |
| Retinal vein occlusion † 1 | |
| # participants affected / at risk | 1/304 (0.33%) |
| Vision blurred † 1 | |
| # participants affected / at risk | 1/304 (0.33%) |
| Vitreous floaters † 1 | |
| # participants affected / at risk | 1/304 (0.33%) |
| Gastrointestinal disorders | |
| Abdominal discomfort † 1 | |
| # participants affected / at risk | 10/304 (3.29%) |
| Abdominal distension † 1 | |
| # participants affected / at risk | 2/304 (0.66%) |
| Abdominal pain † 1 | |
| # participants affected / at risk | 6/304 (1.97%) |
| Abdominal pain lower † 1 | |
| # participants affected / at risk | 3/304 (0.99%) |
| Abdominal pain upper † 1 | |
| # participants affected / at risk | 20/304 (6.58%) |
| Aphthous stomatitis † 1 | |
| # participants affected / at risk | 3/304 (0.99%) |
| Cheilitis † 1 | |
| # participants affected / at risk | 2/304 (0.66%) |
| Constipation † 1 | |
| # participants affected / at risk | 17/304 (5.59%) |
| Dental caries † 1 | |
| # participants affected / at risk | 9/304 (2.96%) |
| Diarrhoea † 1 | |
| # participants affected / at risk | 29/304 (9.54%) |
| Dry mouth † 1 | |
| # participants affected / at risk | 6/304 (1.97%) |
| Dyspepsia † 1 | |
| # participants affected / at risk | 3/304 (0.99%) |
| Enterocolitis † 1 | |
| # participants affected / at risk | 1/304 (0.33%) |
| Flatulence † 1 | |
| # participants affected / at risk | 3/304 (0.99%) |
| Food poisoning † 1 | |
| # participants affected / at risk | 1/304 (0.33%) |
| Gastritis † 1 | |
| # participants affected / at risk | 6/304 (1.97%) |
| Gastrointestinal disorder † 1 | |
| # participants affected / at risk | 3/304 (0.99%) |
| Gastrointestinal sounds abnormal † 1 | |
| # participants affected / at risk | 1/304 (0.33%) |
| Gastrooesophageal reflux disease † 1 | |
| # participants affected / at risk | 1/304 (0.33%) |
| Glossitis † 1 | |
| # participants affected / at risk | 1/304 (0.33%) |
| Haemorrhoidal haemorrhage † 1 | |
| # participants affected / at risk | 1/304 (0.33%) |
| Haemorrhoids † 1 | |
| # participants affected / at risk | 2/304 (0.66%) |
| Irritable bowel syndrome † 1 | |
| # participants affected / at risk | 1/304 (0.33%) |
| Nausea † 1 | |
| # participants affected / at risk | 38/304 (12.50%) |
| Oral discomfort † 1 | |
| # participants affected / at risk | 2/304 (0.66%) |
| Oral pain † 1 | |
| # participants affected / at risk | 1/304 (0.33%) |
| Stomatitis † 1 | |
| # participants affected / at risk | 6/304 (1.97%) |
| Toothache † 1 | |
| # participants affected / at risk | 4/304 (1.32%) |
| Vomiting † 1 | |
| # participants affected / at risk | 8/304 (2.63%) |
| General disorders | |
| Chills † 1 | |
| # participants affected / at risk | 2/304 (0.66%) |
| Condition aggravated † 1 | |
| # participants affected / at risk | 1/304 (0.33%) |
| Device dislocation † 1 | |
| # participants affected / at risk | 1/304 (0.33%) |
| Drug withdrawal syndrome † 1 | |
| # participants affected / at risk | 7/304 (2.30%) |
| Eye complication associated with device † 1 | |
| # participants affected / at risk | 1/304 (0.33%) |
| Fatigue † 1 | |
| # participants affected / at risk | 4/304 (1.32%) |
| Feeling abnormal † 1 | |
| # participants affected / at risk | 6/304 (1.97%) |
| Feeling hot † 1 | |
| # participants affected / at risk | 1/304 (0.33%) |
| Hangover † 1 | |
| # participants affected / at risk | 1/304 (0.33%) |
| Irritability † 1 | |
| # participants affected / at risk | 3/304 (0.99%) |
| Malaise † 1 | |
| # participants affected / at risk | 8/304 (2.63%) |
| Oedema † 1 | |
| # participants affected / at risk | 2/304 (0.66%) |
| Oedema peripheral † 1 | |
| # participants affected / at risk | 1/304 (0.33%) |
| Pyrexia † 1 | |
| # participants affected / at risk | 4/304 (1.32%) |
| Thirst † 1 | |
| # participants affected / at risk | 10/304 (3.29%) |
| Hepatobiliary disorders | |
| Gallbladder polyp † 1 | |
| # participants affected / at risk | 1/304 (0.33%) |
| Hepatic function abnormal † 1 | |
| # participants affected / at risk | 1/304 (0.33%) |
| Hepatic steatosis † 1 | |
| # participants affected / at risk | 1/304 (0.33%) |
| Immune system disorders | |
| Allergy to arthropod sting † 1 | |
| # participants affected / at risk | 1/304 (0.33%) |
| Drug hypersensitivity † 1 | |
| # participants affected / at risk | 1/304 (0.33%) |
| Seasonal allergy † 1 | |
| # participants affected / at risk | 2/304 (0.66%) |
| Infections and infestations | |
| Acute sinusitis † 1 | |
| # participants affected / at risk | 1/304 (0.33%) |
| Adenoviral conjunctivitis † 1 | |
| # participants affected / at risk | 1/304 (0.33%) |
| Body tinea † 1 | |
| # participants affected / at risk | 1/304 (0.33%) |
| Bronchitis † 1 | |
| # participants affected / at risk | 1/304 (0.33%) |
| Cystitis † 1 | |
| # participants affected / at risk | 1/304 (0.33%) |
| Enteritis infectious † 1 | |
| # participants affected / at risk | 2/304 (0.66%) |
| Gastroenteritis † 1 | |
| # participants affected / at risk | 9/304 (2.96%) |
| Gastroenteritis viral † 1 | |
| # participants affected / at risk | 1/304 (0.33%) |
| Helicobacter infection † 1 | |
| # participants affected / at risk | 1/304 (0.33%) |
| Herpangina † 1 | |
| # participants affected / at risk | 1/304 (0.33%) |
| Herpes simplex † 1 | |
| # participants affected / at risk | 1/304 (0.33%) |
| Herpes virus infection † 1 | |
| # participants affected / at risk | 2/304 (0.66%) |
| Herpes zoster † 1 | |
| # participants affected / at risk | 1/304 (0.33%) |
| Hordeolum † 1 | |
| # participants affected / at risk | 2/304 (0.66%) |
| Influenza † 1 | |
| # participants affected / at risk | 7/304 (2.30%) |
| Laryngitis † 1 | |
| # participants affected / at risk | 1/304 (0.33%) |
| Nasopharyngitis † 1 | |
| # participants affected / at risk | 122/304 (40.13%) |
| Oral herpes † 1 | |
| # participants affected / at risk | 3/304 (0.99%) |
| Otitis externa † 1 | |
| # participants affected / at risk | 1/304 (0.33%) |
| Otitis media † 1 | |
| # participants affected / at risk | 1/304 (0.33%) |
| Paronychia † 1 | |
| # participants affected / at risk | 2/304 (0.66%) |
| Parotitis † 1 | |
| # participants affected / at risk | 1/304 (0.33%) |
| Periodontal infection † 1 | |
| # participants affected / at risk | 1/304 (0.33%) |
| Pharyngitis † 1 | |
| # participants affected / at risk | 5/304 (1.64%) |
| Rhinitis † 1 | |
| # participants affected / at risk | 2/304 (0.66%) |
| Tinea infection † 1 | |
| # participants affected / at risk | 1/304 (0.33%) |
| Tinea pedis † 1 | |
| # participants affected / at risk | 1/304 (0.33%) |
| Tonsillitis † 1 | |
| # participants affected / at risk | 1/304 (0.33%) |
| Injury, poisoning and procedural complications | |
| Arthropod bite † 1 | |
| # participants affected / at risk | 1/304 (0.33%) |
| Arthropod sting † 1 | |
| # participants affected / at risk | 1/304 (0.33%) |
| Bone fissure † 1 | |
| # participants affected / at risk | 1/304 (0.33%) |
| Chillblains † 1 | |
| # participants affected / at risk | 1/304 (0.33%) |
| Contusion † 1 | |
| # participants affected / at risk | 9/304 (2.96%) |
| Excoriation † 1 | |
| # participants affected / at risk | 2/304 (0.66%) |
| Fall † 1 | |
| # participants affected / at risk | 2/304 (0.66%) |
| Head injury † 1 | |
| # participants affected / at risk | 1/304 (0.33%) |
| Heat illness † 1 | |
| # participants affected / at risk | 2/304 (0.66%) |
| Heat stroke † 1 | |
| # participants affected / at risk | 1/304 (0.33%) |
| Injury corneal † 1 | |
| # participants affected / at risk | 2/304 (0.66%) |
| Intentional overdose † 1 | |
| # participants affected / at risk | 1/304 (0.33%) |
| Joint sprain † 1 | |
| # participants affected / at risk | 4/304 (1.32%) |
| Laceration † 1 | |
| # participants affected / at risk | 2/304 (0.66%) |
| Meniscus lesion † 1 | |
| # participants affected / at risk | 1/304 (0.33%) |
| Mouth injury † 1 | |
| # participants affected / at risk | 1/304 (0.33%) |
| Muscle strain † 1 | |
| # participants affected / at risk | 1/304 (0.33%) |
| Road traffic accident † 1 | |
| # participants affected / at risk | 1/304 (0.33%) |
| Thermal burn † 1 | |
| # participants affected / at risk | 1/304 (0.33%) |
| Whiplash injury † 1 | |
| # participants affected / at risk | 1/304 (0.33%) |
| Investigations | |
| Alanine aminotransferase increased † 1 | |
| # participants affected / at risk | 9/304 (2.96%) |
| Aspartate aminotransferase increased † 1 | |
| # participants affected / at risk | 5/304 (1.64%) |
| Blood alkaline phosphatase increased † 1 | |
| # participants affected / at risk | 2/304 (0.66%) |
| Blood bilirubin increased † 1 | |
| # participants affected / at risk | 1/304 (0.33%) |
| Blood creatine phosphokinase increased † 1 | |
| # participants affected / at risk | 1/304 (0.33%) |
| Blood glucose increased † 1 | |
| # participants affected / at risk | 2/304 (0.66%) |
| Blood potassium decreased † 1 | |
| # participants affected / at risk | 1/304 (0.33%) |
| Blood pressure diastolic increased † 1 | |
| # participants affected / at risk | 1/304 (0.33%) |
| Blood pressure increased † 1 | |
| # participants affected / at risk | 6/304 (1.97%) |
| Blood prolactin increased † 1 | |
| # participants affected / at risk | 7/304 (2.30%) |
| Blood triglycerides increased † 1 | |
| # participants affected / at risk | 7/304 (2.30%) |
| Blood uric acid increased † 1 | |
| # participants affected / at risk | 4/304 (1.32%) |
| Blood urine present † 1 | |
| # participants affected / at risk | 2/304 (0.66%) |
| Electrocardiogram QT prolonged † 1 | |
| # participants affected / at risk | 1/304 (0.33%) |
| Gamma−glutamyltransferase increased † 1 | |
| # participants affected / at risk | 8/304 (2.63%) |
| Glucose urine present † 1 | |
| # participants affected / at risk | 2/304 (0.66%) |
| Haematocrit decreased † 1 | |
| # participants affected / at risk | 1/304 (0.33%) |
| Haemoglobin decreased † 1 | |
| # participants affected / at risk | 1/304 (0.33%) |
| Lipids abnormal † 1 | |
| # participants affected / at risk | 1/304 (0.33%) |
| Lipids increased † 1 | |
| # participants affected / at risk | 1/304 (0.33%) |
| Liver function test abnormal † 1 | |
| # participants affected / at risk | 6/304 (1.97%) |
| Neutrophil count decreased † 1 | |
| # participants affected / at risk | 1/304 (0.33%) |
| Occult blood positive † 1 | |
| # participants affected / at risk | 1/304 (0.33%) |
| Platelet count decreased † 1 | |
| # participants affected / at risk | 1/304 (0.33%) |
| Protein urine present † 1 | |
| # participants affected / at risk | 3/304 (0.99%) |
| Red blood cell count decreased † 1 | |
| # participants affected / at risk | 2/304 (0.66%) |
| Urine ketone body present † 1 | |
| # participants affected / at risk | 1/304 (0.33%) |
| Weight decreased † 1 | |
| # participants affected / at risk | 1/304 (0.33%) |
| Weight increased † 1 | |
| # participants affected / at risk | 19/304 (6.25%) |
| White blood cell count decreased † 1 | |
| # participants affected / at risk | 3/304 (0.99%) |
| White blood cell count increased † 1 | |
| # participants affected / at risk | 1/304 (0.33%) |
| Metabolism and nutrition disorders | |
| Decreased appetite † 1 | |
| # participants affected / at risk | 3/304 (0.99%) |
| Dehydration † 1 | |
| # participants affected / at risk | 1/304 (0.33%) |
| Hyperlipidaemia † 1 | |
| # participants affected / at risk | 2/304 (0.66%) |
| Hyperphagia † 1 | |
| # participants affected / at risk | 2/304 (0.66%) |
| Increased appetite † 1 | |
| # participants affected / at risk | 2/304 (0.66%) |
| Musculoskeletal and connective tissue disorders | |
| Arthralgia † 1 | |
| # participants affected / at risk | 6/304 (1.97%) |
| Back pain † 1 | |
| # participants affected / at risk | 17/304 (5.59%) |
| Intervertebral disc protrusion † 1 | |
| # participants affected / at risk | 1/304 (0.33%) |
| Joint stiffness † 1 | |
| # participants affected / at risk | 1/304 (0.33%) |
| Lumbar spinal stenosis † 1 | |
| # participants affected / at risk | 1/304 (0.33%) |
| Muscle spasms † 1 | |
| # participants affected / at risk | 1/304 (0.33%) |
| Muscle tightness † 1 | |
| # participants affected / at risk | 1/304 (0.33%) |
| Muscular weakness † 1 | |
| # participants affected / at risk | 1/304 (0.33%) |
| Musculoskeletal chest pain † 1 | |
| # participants affected / at risk | 1/304 (0.33%) |
| Musculoskeletal pain † 1 | |
| # participants affected / at risk | 1/304 (0.33%) |
| Musculoskeletal stiffness † 1 | |
| # participants affected / at risk | 8/304 (2.63%) |
| Myalgia † 1 | |
| # participants affected / at risk | 2/304 (0.66%) |
| Neck pain † 1 | |
| # participants affected / at risk | 4/304 (1.32%) |
| Pain in extremity † 1 | |
| # participants affected / at risk | 1/304 (0.33%) |
| Pain in jaw † 1 | |
| # participants affected / at risk | 1/304 (0.33%) |
| Periarthritis † 1 | |
| # participants affected / at risk | 3/304 (0.99%) |
| Scoliosis † 1 | |
| # participants affected / at risk | 1/304 (0.33%) |
| Temporomandibular joint syndrome † 1 | |
| # participants affected / at risk | 1/304 (0.33%) |
| Trigger finger † 1 | |
| # participants affected / at risk | 1/304 (0.33%) |
| Neoplasms benign, malignant and unspecified (incl cysts and polyps) | |
| Haemangioma of liver † 1 | |
| # participants affected / at risk | 1/304 (0.33%) |
| Skin papilloma † 1 | |
| # participants affected / at risk | 1/304 (0.33%) |
| Uterine leiomyoma † 1 | |
| # participants affected / at risk | 1/304 (0.33%) |
| Nervous system disorders | |
| Autonomic nervous system imbalance † 1 | |
| # participants affected / at risk | 1/304 (0.33%) |
| Dizziness † 1 | |
| # participants affected / at risk | 36/304 (11.84%) |
| Dizziness postural † 1 | |
| # participants affected / at risk | 10/304 (3.29%) |
| Dysgeusia † 1 | |
| # participants affected / at risk | 3/304 (0.99%) |
| Headache † 1 | |
| # participants affected / at risk | 36/304 (11.84%) |
| Hypoaesthesia † 1 | |
| # participants affected / at risk | 6/304 (1.97%) |
| Intercostal neuralgia † 1 | |
| # participants affected / at risk | 1/304 (0.33%) |
| Irregular sleep phase † 1 | |
| # participants affected / at risk | 1/304 (0.33%) |
| Memory impairment † 1 | |
| # participants affected / at risk | 1/304 (0.33%) |
| Migraine † 1 | |
| # participants affected / at risk | 2/304 (0.66%) |
| Paraesthesia † 1 | |
| # participants affected / at risk | 2/304 (0.66%) |
| Sedation † 1 | |
| # participants affected / at risk | 2/304 (0.66%) |
| Somnolence † 1 | |
| # participants affected / at risk | 38/304 (12.50%) |
| Tremor † 1 | |
| # participants affected / at risk | 3/304 (0.99%) |
| Visual field defect † 1 | |
| # participants affected / at risk | 1/304 (0.33%) |
| Pregnancy, puerperium and perinatal conditions | |
| Abortion spontaneous † 1 | |
| # participants affected / at risk | 1/304 (0.33%) |
| Pregnancy † 1 | |
| # participants affected / at risk | 2/304 (0.66%) |
| Psychiatric disorders | |
| Anger † 1 | |
| # participants affected / at risk | 1/304 (0.33%) |
| Anxiety † 1 | |
| # participants affected / at risk | 2/304 (0.66%) |
| Depression † 1 | |
| # participants affected / at risk | 14/304 (4.61%) |
| Depression suicidal † 1 | |
| # participants affected / at risk | 3/304 (0.99%) |
| Dissociative disorder † 1 | |
| # participants affected / at risk | 1/304 (0.33%) |
| Eating disorder † 1 | |
| # participants affected / at risk | 1/304 (0.33%) |
| Hallucination † 1 | |
| # participants affected / at risk | 1/304 (0.33%) |
| Impulsive behaviour † 1 | |
| # participants affected / at risk | 1/304 (0.33%) |
| Initial insomnia † 1 | |
| # participants affected / at risk | 1/304 (0.33%) |
| Insomnia † 1 | |
| # participants affected / at risk | 13/304 (4.28%) |
| Insomnia related to another mental condition † 1 | |
| # participants affected / at risk | 1/304 (0.33%) |
| Intentional self−injury † 1 | |
| # participants affected / at risk | 1/304 (0.33%) |
| Libido decreased † 1 | |
| # participants affected / at risk | 2/304 (0.66%) |
| Nervousness † 1 | |
| # participants affected / at risk | 1/304 (0.33%) |
| Nightmare † 1 | |
| # participants affected / at risk | 1/304 (0.33%) |
| Restlessness † 1 | |
| # participants affected / at risk | 1/304 (0.33%) |
| Self injurious behaviour † 1 | |
| # participants affected / at risk | 1/304 (0.33%) |
| Suicidal ideation † 1 | |
| # participants affected / at risk | 12/304 (3.95%) |
| Withdrawal syndrome † 1 | |
| # participants affected / at risk | 1/304 (0.33%) |
| Renal and urinary disorders | |
| Calculus ureteric † 1 | |
| # participants affected / at risk | 1/304 (0.33%) |
| Pollakiuria † 1 | |
| # participants affected / at risk | 1/304 (0.33%) |
| Proteinuria † 1 | |
| # participants affected / at risk | 1/304 (0.33%) |
| Reproductive system and breast disorders | |
| Dysmenorrhoea † 1 | |
| # participants affected / at risk | 2/304 (0.66%) |
| Endometriosis † 1 | |
| # participants affected / at risk | 1/304 (0.33%) |
| Erectile dysfunction † 1 | |
| # participants affected / at risk | 2/304 (0.66%) |
| Genital haemorrhage † 1 | |
| # participants affected / at risk | 1/304 (0.33%) |
| Menstrual disorder † 1 | |
| # participants affected / at risk | 1/304 (0.33%) |
| Menstruation delayed † 1 | |
| # participants affected / at risk | 1/304 (0.33%) |
| Menstruation irregular † 1 | |
| # participants affected / at risk | 5/304 (1.64%) |
| Metrorrhagia † 1 | |
| # participants affected / at risk | 2/304 (0.66%) |
| Oligomenorrhoea † 1 | |
| # participants affected / at risk | 1/304 (0.33%) |
| Premenstrual syndrome † 1 | |
| # participants affected / at risk | 1/304 (0.33%) |
| Sexual dysfunction † 1 | |
| # participants affected / at risk | 2/304 (0.66%) |
| Vaginal haemorrhage † 1 | |
| # participants affected / at risk | 1/304 (0.33%) |
| Respiratory, thoracic and mediastinal disorders | |
| Asthma † 1 | |
| # participants affected / at risk | 1/304 (0.33%) |
| Cough † 1 | |
| # participants affected / at risk | 2/304 (0.66%) |
| Epistaxis † 1 | |
| # participants affected / at risk | 2/304 (0.66%) |
| Hiccups † 1 | |
| # participants affected / at risk | 1/304 (0.33%) |
| Hyperventilation † 1 | |
| # participants affected / at risk | 2/304 (0.66%) |
| Oropharyngeal pain † 1 | |
| # participants affected / at risk | 5/304 (1.64%) |
| Rhinitis allergic † 1 | |
| # participants affected / at risk | 3/304 (0.99%) |
| Rhinorrhoea † 1 | |
| # participants affected / at risk | 2/304 (0.66%) |
| Suffocation feeling † 1 | |
| # participants affected / at risk | 1/304 (0.33%) |
| Throat irritation † 1 | |
| # participants affected / at risk | 1/304 (0.33%) |
| Yawning † 1 | |
| # participants affected / at risk | 3/304 (0.99%) |
| Skin and subcutaneous tissue disorders | |
| Alopecia areata † 1 | |
| # participants affected / at risk | 1/304 (0.33%) |
| Dermatitis allergic † 1 | |
| # participants affected / at risk | 1/304 (0.33%) |
| Dermatitis contact † 1 | |
| # participants affected / at risk | 4/304 (1.32%) |
| Dry skin † 1 | |
| # participants affected / at risk | 1/304 (0.33%) |
| Eczema † 1 | |
| # participants affected / at risk | 5/304 (1.64%) |
| Haemorrhage subcutaneous † 1 | |
| # participants affected / at risk | 1/304 (0.33%) |
| Heat rash † 1 | |
| # participants affected / at risk | 2/304 (0.66%) |
| Hyperhidrosis † 1 | |
| # participants affected / at risk | 4/304 (1.32%) |
| Hyperkeratosis † 1 | |
| # participants affected / at risk | 1/304 (0.33%) |
| Night sweats † 1 | |
| # participants affected / at risk | 2/304 (0.66%) |
| Pruritus † 1 | |
| # participants affected / at risk | 1/304 (0.33%) |
| Psoriasis † 1 | |
| # participants affected / at risk | 1/304 (0.33%) |
| Rash † 1 | |
| # participants affected / at risk | 3/304 (0.99%) |
| Rash generalised † 1 | |
| # participants affected / at risk | 1/304 (0.33%) |
| Skin odour abnormal † 1 | |
| # participants affected / at risk | 1/304 (0.33%) |
| Toxic skin eruption † 1 | |
| # participants affected / at risk | 1/304 (0.33%) |
| Urticaria † 1 | |
| # participants affected / at risk | 3/304 (0.99%) |
| Urticaria thermal † 1 | |
| # participants affected / at risk | 1/304 (0.33%) |
| Vitiligo † 1 | |
| # participants affected / at risk | 1/304 (0.33%) |
| Xeroderma † 1 | |
| # participants affected / at risk | 1/304 (0.33%) |
| Social circumstances | |
| Pregnancy of partner † 1 | |
| # participants affected / at risk | 1/304 (0.33%) |
| Vascular disorders | |
| Hot flush † 1 | |
| # participants affected / at risk | 2/304 (0.66%) |
| Hypertension † 1 | |
| # participants affected / at risk | 4/304 (1.32%) |
| Hypotension † 1 | |
| # participants affected / at risk | 1/304 (0.33%) |
| Orthostatic hypotension † 1 | |
| # participants affected / at risk | 4/304 (1.32%) |
| † | Events were collected by systematic assessment |
|---|---|
| 1 | Term from vocabulary, MedDRA (14.0) |
More Information
Certain Agreements:
Limitations and Caveats
Results Point of Contact:
No publications provided
| Principal Investigators are NOT employed by the organization sponsoring the study. | ||||||
| There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed. | ||||||
The agreement is:
|
Limitations and Caveats
| Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data |
|---|
| No text entered. |
Results Point of Contact:
Name/Title: Pfizer ClinicalTrials.gov Call Center
Organization: Pfizer, Inc.
phone: 1-800-718-1021
e-mail: ClinicalTrials.govCallCenter@pfizer.com
Organization: Pfizer, Inc.
phone: 1-800-718-1021
e-mail: ClinicalTrials.govCallCenter@pfizer.com
No publications provided
| Responsible Party: | Pfizer |
| ClinicalTrials.gov Identifier: | NCT00831415 History of Changes |
| Other Study ID Numbers: | 3151A1-3350, B2061002 |
| Study First Received: | January 27, 2009 |
| Results First Received: | December 22, 2011 |
| Last Updated: | December 22, 2011 |
| Health Authority: | Japan: Pharmaceuticals and Medical Devices Agency United States: Institutional Review Board |