Safety Study of CB-5945 for the Treatment of Opioid-Induced Constipation

ID: NCT01696643
Status: Terminated
Phase: Phase 3
Start Date: October 01, 2012
First Submitted: September 21, 2012
Last Updated: January 05, 2016
Results: Available
Success Rate: 24%
Sponsors & Collaborators: Cubist Pharmaceuticals LLC
Location: Canada, United States
Conditions: Opioid-Induced Constipation
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.

Study Description

Brief Summary

The purpose of this study is to evaluate the long-term safety and tolerability of CB-5945 for the treatment of opioid-induced constipation (OIC) in adults taking opioid therapy for chronic non-cancer pain.

Detailed Description

This is a multicenter, double-blind, placebo-controlled, parallel-group study in participants with OIC taking opioid therapy for chronic non-cancer pain. Approximately 1,400 participants (approximately 700 participants per treatment group) with OIC will be randomized at approximately 225 study centers to receive either 0.25 milligrams (mg) CB-5945 twice daily (BID) or a matching placebo BID for the 52-week double-blind treatment period, followed by a 4-week follow-up period. All randomized participants will be evaluated for safety, tolerability, and quality of life from the first dose of study drug through Week 56.
Condition or disease Intervention/treatment Phase

Opioid-Induced Constipation

Drug: CB-5945
Other Names
Bevenopran
Drug: Placebo
Other Names
Phase 3

Tracking Information

First Submitted DateSeptember 21, 2012
Last Update Posted DateJanuary 05, 2016
Start DateOctober 01, 2012
Actual Completion DateOctober 01, 2014
Primary Completion DateJune 01, 2014
Results First Submitted DateJuly 14, 2015
Received Results Disposit DateN/A

Current Primary Outcome Measures

  • Percentage of Participants With Treatment-Emergent Adverse Events (TEAEs) [Time Frame: Baseline through Week 56]

    A TEAE was defined as any adverse event (AE) that occurred from the time of first dose of the study drug through the last study evaluation or pre-existing AEs that were aggravated in severity or frequency during the dosing period. The percentages of participants with at least 1 TEAE, with at least 1 drug-related TEAE (drug-related included "possibly related" or "related" as deemed by the Investigator; it also included events if causality was missing), and who discontinued from treatment due to a TEAE are presented. A summary of serious and other non-serious AEs regardless of causality is located in the Reported Adverse Events module.

Original Primary Outcome Measures

  • Percentage of Participants With Treatment-Emergent Adverse Events (TEAEs)

    A TEAE was defined as any adverse event (AE) that occurred from the time of first dose of the study drug through the last study evaluation or pre-existing AEs that were aggravated in severity or frequency during the dosing period. The percentages of participants with at least 1 TEAE, with at least 1 drug-related TEAE (drug-related included “possibly related” or “related” as deemed by the Investigator; it also included events if causality was missing), and who discontinued from treatment due to a TEAE are presented. A summary of serious and other non-serious AEs regardless of causality is located in the Reported Adverse Events module.

Current Secondary Outcome Measures

  • Change From Baseline in Mean Daily Opioid Dose at Weeks 49-52 [Time Frame: Baseline, Weeks 49-52]

    Throughout the study, participants were asked to record changes in maintenance opioid consumption and use of opioid analgesics for breakthrough or exacerbation of pain in a paper diary. Opioid consumption (including rescue opioids) of each participant was converted to an oral morphine-equivalent total daily dose (METDD). Opioid consumption (in milligrams of METDD) was summarized in 4-week intervals. The change from baseline to Weeks 49-52 is summarized.

  • Change From Baseline in Patient Assessment of Constipation-Quality of Life (PAC-QOL) Questionnaire at Week 52 [Time Frame: Baseline, Week 52]

    The PAC-QOL questionnaire contains a total of 28 items, each rated within 4 subscales: physical discomfort, psychosocial discomfort, worries and concerns, and satisfaction. Each item was rated on a 5-point Likert scale with the following score definitions, depending on the question: 0 = not at all (or none of the time), 1 = a little bit (or a little of the time), 2 = moderately (or some of the time), 3 = quite a bit (or most of the time), and 4 = extremely (or all of the time). The total score is the mean of all non-missing items. The range of the total score is 0 (response is 'not at all' for each item) to 4 (response is 'extremely' for each item). Negative change from baseline values indicate improvement in constipation quality of life. Each participant completed the PAC-QOL at Baseline and Week 52 using a 2-week recall period.

  • Change From Baseline in Patient-Reported Constipation Severity Assessment (PCSA) at Week 52 [Time Frame: Baseline, Week 52]

    The PCSA asked participants to rate the severity of their overall constipation during the 24 hours prior to the assessment, using a scale of 0 to 10, where 0 is no constipation and 10 is the worst constipation imaginable.

  • Plasma Trough Concentrations of CB-5945 [Time Frame: Weeks 4, 12, 24, 36, and 52]

    Blood samples for trough concentrations of CB-5945 were collected before the participant's morning dose of study drug at Weeks 4, 12, 24, 36, and 52. Overall concentration was based on the mean trough level for each participant across all weeks.

Original Secondary Outcome Measures

  • Plasma Trough Concentrations of CB-5945

    Blood samples for trough concentrations of CB-5945 were collected before the participant's morning dose of study drug at Weeks 4, 12, 24, 36, and 52. Overall concentration was based on the mean trough level for each participant across all weeks.

  • Change From Baseline in Patient-Reported Constipation Severity Assessment (PCSA) at Week 52

    The PCSA asked participants to rate the severity of their overall constipation during the 24 hours prior to the assessment, using a scale of 0 to 10, where 0 is no constipation and 10 is the worst constipation imaginable.

  • Change From Baseline in Patient Assessment of Constipation-Quality of Life (PAC-QOL) Questionnaire at Week 52

    The PAC-QOL questionnaire contains a total of 28 items, each rated within 4 subscales: physical discomfort, psychosocial discomfort, worries and concerns, and satisfaction. Each item was rated on a 5-point Likert scale with the following score definitions, depending on the question: 0 = not at all (or none of the time), 1 = a little bit (or a little of the time), 2 = moderately (or some of the time), 3 = quite a bit (or most of the time), and 4 = extremely (or all of the time). The total score is the mean of all non-missing items. The range of the total score is 0 (response is 'not at all' for each item) to 4 (response is 'extremely' for each item). Negative change from baseline values indicate improvement in constipation quality of life. Each participant completed the PAC-QOL at Baseline and Week 52 using a 2-week recall period.

  • Change From Baseline in Mean Daily Opioid Dose at Weeks 49-52

    Throughout the study, participants were asked to record changes in maintenance opioid consumption and use of opioid analgesics for breakthrough or exacerbation of pain in a paper diary. Opioid consumption (including rescue opioids) of each participant was converted to an oral morphine-equivalent total daily dose (METDD). Opioid consumption (in milligrams of METDD) was summarized in 4-week intervals. The change from baseline to Weeks 49-52 is summarized.

Study Design

Brief TitleSafety Study of CB-5945 for the Treatment of Opioid-Induced Constipation
Official TitlePhase 3 Study to Evaluate the Long-Term Safety and Tolerability of CB-5945 for the Treatment of Opioid-Induced Constipation in Adults Taking Opioid Therapy for Chronic Non-Cancer Pain
Brief Summary

The purpose of this study is to evaluate the long-term safety and tolerability of CB-5945 for the treatment of opioid-induced constipation (OIC) in adults taking opioid therapy for chronic non-cancer pain.

Detailed Description

This is a multicenter, double-blind, placebo-controlled, parallel-group study in participants with OIC taking opioid therapy for chronic non-cancer pain. Approximately 1,400 participants (approximately 700 participants per treatment group) with OIC will be randomized at approximately 225 study centers to receive either 0.25 milligrams (mg) CB-5945 twice daily (BID) or a matching placebo BID for the 52-week double-blind treatment period, followed by a 4-week follow-up period. All randomized participants will be evaluated for safety, tolerability, and quality of life from the first dose of study drug through Week 56.

Study TypeInterventional
Study PhasePhase 3
Estimated Enrollment
1407
Allocation
Randomized
Interventional Model
Parallel Assignment
Masking
Triple
Primary Purpose
Treatment
Conditions
Opioid-Induced Constipation
Target Follow-Up Duration N/A
Biospecimen:
N/A
Sampling MethodN/A
Study PopulationN/A
Intervention
Drug: CB-5945

Other Names
Bevenopran
Drug: Placebo

Other Names
Study Groups/Cohorts
CB-5945
0.25 milligrams (mg) CB-5945, administered orally, twice daily (BID) for 52 weeks

Placebo
Placebo, administered orally, BID for 52 weeks

Study Arms
Experimental CB-5945
0.25 milligrams (mg) CB-5945, administered orally, twice daily (BID) for 52 weeks
Drug : CB-5945

Placebo Comparator Placebo
Placebo, administered orally, BID for 52 weeks
Drug : Placebo

Arm Intervention/Treatment
Experimental CB-5945
0.25 milligrams (mg) CB-5945, administered orally, twice daily (BID) for 52 weeks
Drug : CB-5945
Placebo Comparator Placebo
Placebo, administered orally, BID for 52 weeks
Drug : Placebo

Recruitment Information

Recruitment Status:Terminated
Enrollment1407
Completion DateOctober 01, 2014
Eligibility Criteria: Inclusion Criteria:
- Is taking a stable daily dose of opioids of ≥30-mg morphine-equivalent total daily dose (METDD) for chronic non-cancer pain
- Has constipation that is caused by the chronic use of opioids
- Is willing to use only the study-provided laxative(s) and to discontinue use of all other laxatives, enemas, stool softeners, and other medications to treat constipation (for example, lubiprostone) during the study period (from Screening until the last study assessment).
- Is able and willing to refrain from facilitating defecation via manual maneuvers (for example, digital evacuation or support of the pelvic floor) during the study period (from Screening to the last study assessment)

Exclusion Criteria:
- Has gastrointestinal (GI) or pelvic disorders known to affect bowel transit (for example, obstruction) or contribute to bowel dysfunction
- Has evidence of intestinal obstruction
- Has a history of rectal bleeding not due to hemorrhoids or fissures
- Has an active malignancy of any type (participants with a history of successfully treated malignancy >5 years before the scheduled administration of study medication and participants with treated basal or squamous cell cancer may be enrolled)
- Is taking antispasmodics (for example, dicyclomine), antidiarrheals (for example, loperamide), prokinetics (for example, metoclopramide), or locally acting chloride channel activators (for example, lubiprostone)
- Is taking non-opioid medications known to cause constipation (for example, iron sulfate therapy or tricyclic antidepressants)
GenderAll
Age18 Years to 80 Years
Accepts Healthy VolunteersNo
Contacts
Not Available
Listed Location Countries
Canada
United States

Administrative Information

NCT Number:NCT01696643
Other Study ID Numbers
2402-006
5945-SOIC-12-05
Has Data Monitoring CommitteeNo
U.S. FDA-regulated Product Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Device Product Not Approved or Cleared by U.S. FDA: No
IPD Sharing Statement
Not Available
Responsible Party,
Study Sponsor
Cubist Pharmaceuticals LLC
Collaborators
Not Available
Investigators
Study Director
Medical Monitor
Cubist Pharmaceuticals LLC

Participant Flow

Recruitment Details

Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
Not Available

Pre-Assignment Details

Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
Not Available

Reporting Groups

TitleDescription
CB-5945
0.25 milligrams (mg) CB-5945, administered orally, twice daily (BID) for 52 weeks
Placebo
Placebo, administered orally, BID for 52 weeks

Participant Flow: Overall

CB-5945Placebo
701702
Started703704
Completed174169
Not Completed529535
Adverse Event157
Death12
Lack of Efficacy30
Lost to Follow-up6767
Medical Monitor Decision02
Participant Did Not Receive Study Drug22
Participant Incarcerated01
Participant on Restricted Bed Rest10
Physician Decision32
Pregnancy01
Protocol Violation77
Site Error21
Study Terminated by Sponsor286294
Withdrawal by Subject142149

Baseline Characteristics

Population Description

Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
All randomized participants who received at least 1 dose of study drug. Two participants were randomized to the Placebo Arm but were administered CB-5945 instead. As a result, these 2 participants were included in the CB-5945 Arm for analysis.

Reporting Groups

TitleDescription
CB-5945
0.25 mg CB-5945, administered orally, BID for 52 weeks
Placebo
Placebo, administered orally, BID for 52 weeks
Total
Total of all reporting groups

Baseline Measures

CB-5945PlaceboTotal
Overall Participants Analyzed
Units: Participants
Participants Analyzed
7037001403
7037001403
Age
Units: years - Mean (Standard Deviation)
Participants Analyzed
7037001403
54.5 (10.00)53.9 (10.21)54.2 (10.11)
Gender
Units: participants - Number
Participants Analyzed
7037001403
Female437417854
Male266283549
Ethnicity (NIH/OMB)
Units: participants - Number
Participants Analyzed
7037001403
Hispanic or Latino194160
Not Hispanic or Latino6766491325
Unknown or Not Reported81018
Race (NIH/OMB)
Units: participants - Number
Participants Analyzed
7037001403
American Indian or Alaska Native7411
Asian111122
Black or African American117122239
More than one race369
Native Hawaiian or Other Pacific Islander213
Unknown or Not Reported011
White5635551118
Region of Enrollment
Units: participants - Number
Participants Analyzed
7037001403
Canada262854
United States6776721349

Outcome Measures

1. Primary: Percentage of Participants With Treatment-Emergent Adverse Events (TEAEs)

Measure Type
Primary
Measure Title
Percentage of Participants With Treatment-Emergent Adverse Events (TEAEs)
Measure Description
A TEAE was defined as any adverse event (AE) that occurred from the time of first dose of the study drug through the last study evaluation or pre-existing AEs that were aggravated in severity or frequency during the dosing period. The percentages of participants with at least 1 TEAE, with at least 1 drug-related TEAE (drug-related included “possibly related” or “related” as deemed by the Investigator; it also included events if causality was missing), and who discontinued from treatment due to a TEAE are presented. A summary of serious and other non-serious AEs regardless of causality is located in the Reported Adverse Events module.
Time Frame
Baseline through Week 56

Population Description

Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
All randomized participants who received at least 1 dose of study drug. Two participants were randomized to the Placebo Arm but were administered CB-5945 instead. As a result, these 2 participants were included in the CB-5945 Arm for analysis.

Reporting Groups

TitleDescription
CB-5945
0.25 mg CB-5945, administered orally, BID for 52 weeks
Placebo
Placebo, administered orally, BID for 52 weeks

Outcome Measures

CB-5945Placebo
Participants Analyzed
Units: Participants
703700
Percentage of Participants With Treatment-Emergent Adverse Events (TEAEs)
Units: percentage of participants - Number
Discontinued treatment due to a TEAE10.05.7
Had at least 1 drug-related TEAE19.912.1
Had at least 1 TEAE58.554.0

2. Secondary: Change From Baseline in Mean Daily Opioid Dose at Weeks 49-52

Measure Type
Secondary
Measure Title
Change From Baseline in Mean Daily Opioid Dose at Weeks 49-52
Measure Description
Throughout the study, participants were asked to record changes in maintenance opioid consumption and use of opioid analgesics for breakthrough or exacerbation of pain in a paper diary. Opioid consumption (including rescue opioids) of each participant was converted to an oral morphine-equivalent total daily dose (METDD). Opioid consumption (in milligrams of METDD) was summarized in 4-week intervals. The change from baseline to Weeks 49-52 is summarized.
Time Frame
Baseline, Weeks 49-52

Population Description

Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
All randomized participants who received at least 1 dose of study drug and had evaluable METDD data. Two participants were randomized to the Placebo Arm but were administered CB-5945 instead. As a result, these 2 participants were included in the CB-5945 Arm for analysis.

Reporting Groups

TitleDescription
CB-5945
0.25 mg CB-5945, administered orally, BID for 52 weeks
Placebo
Placebo, administered orally, BID for 52 weeks

Outcome Measures

CB-5945Placebo
Participants Analyzed
Units: Participants
672664
Change From Baseline in Mean Daily Opioid Dose at Weeks 49-52
Units: milligrams of METDD - Mean (Standard Deviation)
-12.456 (90.2190)-12.297 (88.8681)

3. Secondary: Change From Baseline in Patient Assessment of Constipation-Quality of Life (PAC-QOL) Questionnaire at Week 52

Measure Type
Secondary
Measure Title
Change From Baseline in Patient Assessment of Constipation-Quality of Life (PAC-QOL) Questionnaire at Week 52
Measure Description
The PAC-QOL questionnaire contains a total of 28 items, each rated within 4 subscales: physical discomfort, psychosocial discomfort, worries and concerns, and satisfaction. Each item was rated on a 5-point Likert scale with the following score definitions, depending on the question: 0 = not at all (or none of the time), 1 = a little bit (or a little of the time), 2 = moderately (or some of the time), 3 = quite a bit (or most of the time), and 4 = extremely (or all of the time). The total score is the mean of all non-missing items. The range of the total score is 0 (response is 'not at all' for each item) to 4 (response is 'extremely' for each item). Negative change from baseline values indicate improvement in constipation quality of life. Each participant completed the PAC-QOL at Baseline and Week 52 using a 2-week recall period.
Time Frame
Baseline, Week 52

Population Description

Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
All randomized participants who received at least 1 dose of study drug and had evaluable PAC-QOL data. Two participants were randomized to the Placebo Arm but were administered CB-5945 instead. As a result, these 2 participants were included in the CB-5945 Arm for analysis.

Reporting Groups

TitleDescription
CB-5945
0.25 mg CB-5945, administered orally, BID for 52 weeks
Placebo
Placebo, administered orally, BID for 52 weeks

Outcome Measures

CB-5945Placebo
Participants Analyzed
Units: Participants
240236
Change From Baseline in Patient Assessment of Constipation-Quality of Life (PAC-QOL) Questionnaire at Week 52
Units: units on a scale - Mean (Standard Deviation)
-0.63 (0.699)-0.45 (0.583)

4. Secondary: Change From Baseline in Patient-Reported Constipation Severity Assessment (PCSA) at Week 52

Measure Type
Secondary
Measure Title
Change From Baseline in Patient-Reported Constipation Severity Assessment (PCSA) at Week 52
Measure Description
The PCSA asked participants to rate the severity of their overall constipation during the 24 hours prior to the assessment, using a scale of 0 to 10, where 0 is no constipation and 10 is the worst constipation imaginable.
Time Frame
Baseline, Week 52

Population Description

Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
All randomized participants who received at least 1 dose of study drug and had evaluable PCSA data. Two participants were randomized to the Placebo Arm but were administered CB-5945 instead. As a result, these 2 participants were included in the CB-5945 Arm for analysis.

Reporting Groups

TitleDescription
CB-5945
0.25 mg CB-5945, administered orally, BID for 52 weeks
Placebo
Placebo, administered orally, BID for 52 weeks

Outcome Measures

CB-5945Placebo
Participants Analyzed
Units: Participants
208193
Change From Baseline in Patient-Reported Constipation Severity Assessment (PCSA) at Week 52
Units: units on a scale - Mean (Standard Deviation)
-3.0 (3.24)-2.2 (3.19)

5. Secondary: Plasma Trough Concentrations of CB-5945

Measure Type
Secondary
Measure Title
Plasma Trough Concentrations of CB-5945
Measure Description
Blood samples for trough concentrations of CB-5945 were collected before the participant's morning dose of study drug at Weeks 4, 12, 24, 36, and 52. Overall concentration was based on the mean trough level for each participant across all weeks.
Time Frame
Weeks 4, 12, 24, 36, and 52

Population Description

Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
All participants randomized to CB-5945 who received at least 1 dose of study drug and had evaluable CB-5945 concentration data. Two participants were randomized to the Placebo Arm but were administered CB-5945 instead. As a result, these 2 participants were included in the CB-5945 Arm for analysis.

Reporting Groups

TitleDescription
CB-5945
0.25 mg CB-5945, administered orally, BID for 52 weeks

Outcome Measures

CB-5945
Participants Analyzed
Units: Participants
631
Plasma Trough Concentrations of CB-5945
Units: picograms per milliliter (pg/mL) - Mean (Standard Deviation)
Overall (n=631)517.19 (375.963)
Week 12 (n=522)549.66 (425.131)
Week 24 (n=419)547.31 (453.548)
Week 36 (n=288)573.57 (517.118)
Week 4 (n=615)517.51 (403.391)
Week 52 (n=203)616.57 (725.849)

6. Other Pre-specified: Number of Participants With Adjudicated Cardiovascular, Gastrointestinal, or Central Opioid Withdrawal Events

Measure Type
Other Pre-specified
Measure Title
Number of Participants With Adjudicated Cardiovascular, Gastrointestinal, or Central Opioid Withdrawal Events
Measure Description
Cardiovascular (CV) events of interested included mycardial infarction, unstable angina, CV accident, congestive heart failure, serious arrhythmia, resuscitated cardiac arrest, and death. Gastrointestinal (GI) events of interest included emergency department visits for the serious adverse events of gastroenteritis, hepatitis, pancreatitis, nausea, vomiting, diarrhea, and abdominal pain or cramping. Central opioid withdrawal (OW) events of interest included opioid withdrawal syndrome. The adverse events that indicated central OW included, but were not limited to, hyperhidrosis, tremor, dysphoria, and myalgia. The number of participants with at least 1 confirmed CV, GI, or Central OW event is presented.
Time Frame
Baseline through Week 56

Population Description

Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
All randomized participants who received at least 1 dose of study drug. Two participants were randomized to the Placebo Arm but were administered CB-5945 instead. As a result, these 2 participants were included in the CB-5945 Arm for analysis.

Reporting Groups

TitleDescription
CB-5945
0.25 mg CB-5945, administered orally, BID for 52 weeks
Placebo
Placebo, administered orally, BID for 52 weeks

Outcome Measures

CB-5945Placebo
Participants Analyzed
Units: Participants
703700
Number of Participants With Adjudicated Cardiovascular, Gastrointestinal, or Central Opioid Withdrawal Events
Units: participants - Number
Central OW event72
CV event12
GI event167

Serious Adverse Events

Time Frame
Not Available
Additional Description
Two participants were randomized to the Placebo Arm but were administered CB-5945 instead. As a result, these 2 participants were included in the CB-5945 Arm for analysis.
Frequency Threshold0% (Threshold above which other adverse events are reported)

Reporting Groups

TitleDescription
CB-5945
0.25 mg CB-5945, administered orally, BID for 52 weeks
Placebo
Placebo, administered orally, BID for 52 weeks

Serious Adverse Events

CB-5945Placebo
Total, serious adverse events
No. of participants affected / at risk40/703 (0.00%)36/700 (0.00%)
Bradycardia
No. of participants affected / at risk1/703 (0.00%)0/700 (0.00%)
Sinus tachycardia
No. of participants affected / at risk1/703 (0.00%)0/700 (0.00%)
Angina pectoris
No. of participants affected / at risk0/703 (0.00%)1/700 (0.00%)
Angina unstable
No. of participants affected / at risk0/703 (0.00%)1/700 (0.00%)
Faecaloma
No. of participants affected / at risk1/703 (0.00%)0/700 (0.00%)
Haemorrhoids
No. of participants affected / at risk1/703 (0.00%)0/700 (0.00%)
Mallory-Weiss syndrome
No. of participants affected / at risk1/703 (0.00%)0/700 (0.00%)
Vomiting
No. of participants affected / at risk1/703 (0.00%)0/700 (0.00%)
Abdominal pain
No. of participants affected / at risk0/703 (0.00%)1/700 (0.00%)
Colitis
No. of participants affected / at risk0/703 (0.00%)1/700 (0.00%)
Gastroesophageal reflux disease
No. of participants affected / at risk0/703 (0.00%)1/700 (0.00%)
Intestinal obstruction
No. of participants affected / at risk0/703 (0.00%)1/700 (0.00%)
Pancreatitis acute
No. of participants affected / at risk0/703 (0.00%)1/700 (0.00%)
Pancreatitis chronic
No. of participants affected / at risk0/703 (0.00%)1/700 (0.00%)
Non-cardiac chest pain
No. of participants affected / at risk2/703 (0.00%)2/700 (0.00%)
Oedema peripheral
No. of participants affected / at risk1/703 (0.00%)0/700 (0.00%)
Cholelithiasis
No. of participants affected / at risk1/703 (0.00%)0/700 (0.00%)
Cholecystitis
No. of participants affected / at risk0/703 (0.00%)1/700 (0.00%)
Gastroenteritis
No. of participants affected / at risk3/703 (0.00%)0/700 (0.00%)
Cellulitis
No. of participants affected / at risk1/703 (0.00%)3/700 (0.00%)
Clostridium difficile colitis
No. of participants affected / at risk1/703 (0.00%)0/700 (0.00%)
Empyema
No. of participants affected / at risk1/703 (0.00%)0/700 (0.00%)
Enteritis infectious
No. of participants affected / at risk1/703 (0.00%)0/700 (0.00%)
Gastroenteritis viral
No. of participants affected / at risk1/703 (0.00%)0/700 (0.00%)
Kidney infection
No. of participants affected / at risk1/703 (0.00%)0/700 (0.00%)
Lobar pneumonia
No. of participants affected / at risk1/703 (0.00%)0/700 (0.00%)
Localised infection
No. of participants affected / at risk1/703 (0.00%)0/700 (0.00%)
Septic shock
No. of participants affected / at risk1/703 (0.00%)0/700 (0.00%)
Wound infection
No. of participants affected / at risk1/703 (0.00%)0/700 (0.00%)
Appendicitis
No. of participants affected / at risk0/703 (0.00%)1/700 (0.00%)
Infected bites
No. of participants affected / at risk0/703 (0.00%)1/700 (0.00%)
Influenza
No. of participants affected / at risk0/703 (0.00%)1/700 (0.00%)
Meningitis staphylococcal
No. of participants affected / at risk0/703 (0.00%)1/700 (0.00%)
Pneumonia
No. of participants affected / at risk0/703 (0.00%)1/700 (0.00%)
Pyelonephritis
No. of participants affected / at risk0/703 (0.00%)1/700 (0.00%)
Cervical vertebral fracture
No. of participants affected / at risk1/703 (0.00%)0/700 (0.00%)
Fibula fracture
No. of participants affected / at risk1/703 (0.00%)0/700 (0.00%)
Road traffic accident
No. of participants affected / at risk1/703 (0.00%)0/700 (0.00%)
Fall
No. of participants affected / at risk0/703 (0.00%)1/700 (0.00%)
Overdose
No. of participants affected / at risk0/703 (0.00%)1/700 (0.00%)
Diabetic ketoacidosis
No. of participants affected / at risk1/703 (0.00%)0/700 (0.00%)
Hyperglycaemia
No. of participants affected / at risk1/703 (0.00%)0/700 (0.00%)
Dehydration
No. of participants affected / at risk0/703 (0.00%)1/700 (0.00%)
Hypovolaemia
No. of participants affected / at risk0/703 (0.00%)1/700 (0.00%)
Osteoarthritis
No. of participants affected / at risk2/703 (0.00%)1/700 (0.00%)
Rhabdomyolysis
No. of participants affected / at risk2/703 (0.00%)1/700 (0.00%)
Intervertebral disc protrusion
No. of participants affected / at risk1/703 (0.00%)0/700 (0.00%)
Rotator cuff syndrome
No. of participants affected / at risk1/703 (0.00%)0/700 (0.00%)
Arthralgia
No. of participants affected / at risk0/703 (0.00%)2/700 (0.00%)
Arthropathy
No. of participants affected / at risk0/703 (0.00%)1/700 (0.00%)
Back pain
No. of participants affected / at risk0/703 (0.00%)2/700 (0.00%)
Breast cancer in situ
No. of participants affected / at risk1/703 (0.00%)0/700 (0.00%)
Ovarian neoplasm
No. of participants affected / at risk1/437 (0.00%)0/417 (0.00%)
Basal cell carcinoma
No. of participants affected / at risk0/703 (0.00%)1/700 (0.00%)
Benign anorectal neoplasm
No. of participants affected / at risk0/703 (0.00%)1/700 (0.00%)
Lung neoplasm malignant
No. of participants affected / at risk0/703 (0.00%)1/700 (0.00%)
Uterine leiomyoma
No. of participants affected / at risk0/437 (0.00%)1/417 (0.00%)
Altered state of consciousness
No. of participants affected / at risk1/703 (0.00%)0/700 (0.00%)
Convulsion
No. of participants affected / at risk1/703 (0.00%)0/700 (0.00%)
Encephalopathy
No. of participants affected / at risk1/703 (0.00%)0/700 (0.00%)
Metabolic encephalopathy
No. of participants affected / at risk1/703 (0.00%)0/700 (0.00%)
Carotid artery stenosis
No. of participants affected / at risk0/703 (0.00%)1/700 (0.00%)
Cerebrovascular accident
No. of participants affected / at risk0/703 (0.00%)1/700 (0.00%)
Subarachnoid haemorrhage
No. of participants affected / at risk0/703 (0.00%)1/700 (0.00%)
Transient ischaemic attack
No. of participants affected / at risk0/703 (0.00%)2/700 (0.00%)
Psychotic disorder
No. of participants affected / at risk1/703 (0.00%)0/700 (0.00%)
Suicidal ideation
No. of participants affected / at risk1/703 (0.00%)1/700 (0.00%)
Violence-related symptom
No. of participants affected / at risk1/703 (0.00%)0/700 (0.00%)
Depression
No. of participants affected / at risk0/703 (0.00%)1/700 (0.00%)
Renal failure
No. of participants affected / at risk1/703 (0.00%)0/700 (0.00%)
Renal failure acute
No. of participants affected / at risk0/703 (0.00%)2/700 (0.00%)
Asthma
No. of participants affected / at risk1/703 (0.00%)0/700 (0.00%)
Pneumonia aspiration
No. of participants affected / at risk1/703 (0.00%)0/700 (0.00%)
Pulmonary embolism
No. of participants affected / at risk1/703 (0.00%)1/700 (0.00%)
Deep vein thrombosis
No. of participants affected / at risk2/703 (0.00%)0/700 (0.00%)
Orthostatic hypotension
No. of participants affected / at risk1/703 (0.00%)0/700 (0.00%)
Hypertension
No. of participants affected / at risk0/703 (0.00%)1/700 (0.00%)
Peripheral vascular disorder
No. of participants affected / at risk0/703 (0.00%)1/700 (0.00%)

Other Adverse Events

Time Frame
Not Available
Additional Description
Two participants were randomized to the Placebo Arm but were administered CB-5945 instead. As a result, these 2 participants were included in the CB-5945 Arm for analysis.
Frequency Threshold0% (Threshold above which other adverse events are reported)

Reporting Groups

TitleDescription
CB-5945
0.25 mg CB-5945, administered orally, BID for 52 weeks
Placebo
Placebo, administered orally, BID for 52 weeks

Other Adverse Events

CB-5945Placebo
Total, other adverse events
No. of participants affected / at risk403/703 (0.00%)373/700 (0.00%)
Anaemia
No. of participants affected / at risk5/703 (0.00%)7/700 (0.00%)
Lymphadenopathy
No. of participants affected / at risk1/703 (0.00%)1/700 (0.00%)
Haemorrhagic Anaemia
No. of participants affected / at risk0/703 (0.00%)1/700 (0.00%)
Iron Deficiency Anaemia
No. of participants affected / at risk0/703 (0.00%)1/700 (0.00%)
Leukocytosis
No. of participants affected / at risk0/703 (0.00%)1/700 (0.00%)
Leukopenia
No. of participants affected / at risk0/703 (0.00%)1/700 (0.00%)
Lymphadenitis
No. of participants affected / at risk0/703 (0.00%)1/700 (0.00%)
Normochromic Normocytic Anaemia
No. of participants affected / at risk0/703 (0.00%)1/700 (0.00%)
Thrombocytopenia
No. of participants affected / at risk0/703 (0.00%)1/700 (0.00%)
Tachycardia
No. of participants affected / at risk2/703 (0.00%)2/700 (0.00%)
Angina Pectoris
No. of participants affected / at risk1/703 (0.00%)1/700 (0.00%)
Atrioventricular Block First Degree
No. of participants affected / at risk1/703 (0.00%)0/700 (0.00%)
Cardiac Failure Congestive
No. of participants affected / at risk1/703 (0.00%)0/700 (0.00%)
Cyanosis
No. of participants affected / at risk1/703 (0.00%)0/700 (0.00%)
Palpitations
No. of participants affected / at risk1/703 (0.00%)0/700 (0.00%)
Sinus Arrhythmia
No. of participants affected / at risk1/703 (0.00%)0/700 (0.00%)
Sinus Tachycardia
No. of participants affected / at risk1/703 (0.00%)2/700 (0.00%)
Ventricular Extrasystoles
No. of participants affected / at risk1/703 (0.00%)0/700 (0.00%)
Angina Unstable
No. of participants affected / at risk0/703 (0.00%)1/700 (0.00%)
Atrial Fibrillation
No. of participants affected / at risk0/703 (0.00%)1/700 (0.00%)
Bradycardia
No. of participants affected / at risk0/703 (0.00%)1/700 (0.00%)
Coronary Artery Disease
No. of participants affected / at risk0/703 (0.00%)1/700 (0.00%)
Cerumen Impaction
No. of participants affected / at risk1/703 (0.00%)0/700 (0.00%)
Otorrhoea
No. of participants affected / at risk1/703 (0.00%)0/700 (0.00%)
Deafness
No. of participants affected / at risk0/703 (0.00%)1/700 (0.00%)
Ear Pain
No. of participants affected / at risk0/703 (0.00%)3/700 (0.00%)
Vertigo
No. of participants affected / at risk0/703 (0.00%)2/700 (0.00%)
Goitre
No. of participants affected / at risk1/703 (0.00%)0/700 (0.00%)
Hypogonadism
No. of participants affected / at risk1/703 (0.00%)1/700 (0.00%)
Adrenal Mass
No. of participants affected / at risk0/703 (0.00%)1/700 (0.00%)
Androgen Deficiency
No. of participants affected / at risk0/703 (0.00%)1/700 (0.00%)
Hypogonadism Male
No. of participants affected / at risk0/266 (0.00%)1/283 (0.00%)
Hypothyroidism
No. of participants affected / at risk0/703 (0.00%)3/700 (0.00%)
Lacrimation Increased
No. of participants affected / at risk4/703 (0.00%)2/700 (0.00%)
Cataract
No. of participants affected / at risk3/703 (0.00%)2/700 (0.00%)
Conjunctivitis
No. of participants affected / at risk2/703 (0.00%)3/700 (0.00%)
Blepharitis
No. of participants affected / at risk1/703 (0.00%)0/700 (0.00%)
Blindness Unilateral
No. of participants affected / at risk1/703 (0.00%)0/700 (0.00%)
Dry Eye
No. of participants affected / at risk1/703 (0.00%)0/700 (0.00%)
Eye Pruritus
No. of participants affected / at risk1/703 (0.00%)1/700 (0.00%)
Eyelid Ptosis
No. of participants affected / at risk1/703 (0.00%)1/700 (0.00%)
Panophthalmitis
No. of participants affected / at risk1/703 (0.00%)0/700 (0.00%)
Vision Blurred
No. of participants affected / at risk1/703 (0.00%)1/700 (0.00%)
Conjunctival Haemorrhage
No. of participants affected / at risk0/703 (0.00%)1/700 (0.00%)
Iritis
No. of participants affected / at risk0/703 (0.00%)2/700 (0.00%)
Diarrhoea
No. of participants affected / at risk90/703 (0.00%)33/700 (0.00%)
Abdominal Pain
No. of participants affected / at risk57/703 (0.00%)32/700 (0.00%)
Nausea
No. of participants affected / at risk51/703 (0.00%)39/700 (0.00%)
Vomiting
No. of participants affected / at risk35/703 (0.00%)20/700 (0.00%)
Abdominal Pain Upper
No. of participants affected / at risk20/703 (0.00%)11/700 (0.00%)
Flatulence
No. of participants affected / at risk17/703 (0.00%)16/700 (0.00%)
Gastrooesophageal Reflux Disease
No. of participants affected / at risk9/703 (0.00%)2/700 (0.00%)
Constipation
No. of participants affected / at risk8/703 (0.00%)11/700 (0.00%)
Abdominal Distension
No. of participants affected / at risk7/703 (0.00%)8/700 (0.00%)
Dyspepsia
No. of participants affected / at risk5/703 (0.00%)3/700 (0.00%)
Haemorrhoids
No. of participants affected / at risk4/703 (0.00%)6/700 (0.00%)
Abdominal Discomfort
No. of participants affected / at risk3/703 (0.00%)4/700 (0.00%)
Abdominal Pain Lower
No. of participants affected / at risk3/703 (0.00%)2/700 (0.00%)
Haematochezia
No. of participants affected / at risk3/703 (0.00%)2/700 (0.00%)
Rectal Haemorrhage
No. of participants affected / at risk3/703 (0.00%)3/700 (0.00%)
Colonic Polyp
No. of participants affected / at risk2/703 (0.00%)1/700 (0.00%)
Faecal Incontinence
No. of participants affected / at risk2/703 (0.00%)2/700 (0.00%)
Frequent Bowel Movements
No. of participants affected / at risk2/703 (0.00%)0/700 (0.00%)
Gastritis
No. of participants affected / at risk2/703 (0.00%)0/700 (0.00%)
Abdominal Tenderness
No. of participants affected / at risk1/703 (0.00%)0/700 (0.00%)
Abdominal Wall Mass
No. of participants affected / at risk1/703 (0.00%)0/700 (0.00%)
Anorectal Discomfort
No. of participants affected / at risk1/703 (0.00%)0/700 (0.00%)
Aphthous Stomatitis
No. of participants affected / at risk1/703 (0.00%)0/700 (0.00%)
Ascites
No. of participants affected / at risk1/703 (0.00%)0/700 (0.00%)
Bowel Movement Irregularity
No. of participants affected / at risk1/703 (0.00%)0/700 (0.00%)
Dental Caries
No. of participants affected / at risk1/703 (0.00%)3/700 (0.00%)
Dry Mouth
No. of participants affected / at risk1/703 (0.00%)1/700 (0.00%)
Enteritis
No. of participants affected / at risk1/703 (0.00%)0/700 (0.00%)
Erosive Oesophagitis
No. of participants affected / at risk1/703 (0.00%)0/700 (0.00%)
Eructation
No. of participants affected / at risk1/703 (0.00%)0/700 (0.00%)
Faecaloma
No. of participants affected / at risk1/703 (0.00%)1/700 (0.00%)
Faeces Discoloured
No. of participants affected / at risk1/703 (0.00%)0/700 (0.00%)
Food Poisoning
No. of participants affected / at risk1/703 (0.00%)0/700 (0.00%)
Gastric Polyps
No. of participants affected / at risk1/703 (0.00%)0/700 (0.00%)
Gastric Ulcer
No. of participants affected / at risk1/703 (0.00%)0/700 (0.00%)
Gingival Pain
No. of participants affected / at risk1/703 (0.00%)0/700 (0.00%)
Haemorrhoidal Haemorrhage
No. of participants affected / at risk1/703 (0.00%)0/700 (0.00%)
Hiatus Hernia
No. of participants affected / at risk1/703 (0.00%)2/700 (0.00%)
Oral Papule
No. of participants affected / at risk1/703 (0.00%)0/700 (0.00%)
Peptic Ulcer
No. of participants affected / at risk1/703 (0.00%)0/700 (0.00%)
Rectal Discharge
No. of participants affected / at risk1/703 (0.00%)0/700 (0.00%)
Retching
No. of participants affected / at risk1/703 (0.00%)0/700 (0.00%)
Abdominal Adhesions
No. of participants affected / at risk0/703 (0.00%)1/700 (0.00%)
Abnormal Faeces
No. of participants affected / at risk0/703 (0.00%)1/700 (0.00%)
Diverticulum
No. of participants affected / at risk0/703 (0.00%)1/700 (0.00%)
Diverticulum Intestinal
No. of participants affected / at risk0/703 (0.00%)1/700 (0.00%)
Dysphagia
No. of participants affected / at risk0/703 (0.00%)1/700 (0.00%)
Gastrointestinal Pain
No. of participants affected / at risk0/703 (0.00%)1/700 (0.00%)
Haematemesis
No. of participants affected / at risk0/703 (0.00%)1/700 (0.00%)
Inguinal Hernia
No. of participants affected / at risk0/703 (0.00%)1/700 (0.00%)
Intestinal Obstruction
No. of participants affected / at risk0/703 (0.00%)1/700 (0.00%)
Rectal Spasm
No. of participants affected / at risk0/703 (0.00%)1/700 (0.00%)
Salivary Hypersecretion
No. of participants affected / at risk0/703 (0.00%)1/700 (0.00%)
Toothache
No. of participants affected / at risk0/703 (0.00%)3/700 (0.00%)
Drug Withdrawal Syndrome
No. of participants affected / at risk10/703 (0.00%)7/700 (0.00%)
Pain
No. of participants affected / at risk9/703 (0.00%)4/700 (0.00%)
Fatigue
No. of participants affected / at risk8/703 (0.00%)6/700 (0.00%)
Oedema Peripheral
No. of participants affected / at risk4/703 (0.00%)13/700 (0.00%)
Pyrexia
No. of participants affected / at risk4/703 (0.00%)3/700 (0.00%)
Chest Discomfort
No. of participants affected / at risk2/703 (0.00%)0/700 (0.00%)
Chest Pain
No. of participants affected / at risk2/703 (0.00%)0/700 (0.00%)
Chills
No. of participants affected / at risk2/703 (0.00%)1/700 (0.00%)
Influenza Like Illness
No. of participants affected / at risk2/703 (0.00%)3/700 (0.00%)
Medical Device Pain
No. of participants affected / at risk2/703 (0.00%)0/700 (0.00%)
Non-Cardiac Chest Pain
No. of participants affected / at risk2/703 (0.00%)2/700 (0.00%)
Oedema
No. of participants affected / at risk2/703 (0.00%)3/700 (0.00%)
Adverse Drug Reaction
No. of participants affected / at risk1/703 (0.00%)1/700 (0.00%)
Feeling Cold
No. of participants affected / at risk1/703 (0.00%)0/700 (0.00%)
Malaise
No. of participants affected / at risk1/703 (0.00%)0/700 (0.00%)
Spinal Pain
No. of participants affected / at risk1/703 (0.00%)0/700 (0.00%)
Temperature Intolerance
No. of participants affected / at risk1/703 (0.00%)0/700 (0.00%)
Asthenia
No. of participants affected / at risk0/703 (0.00%)1/700 (0.00%)
Cyst
No. of participants affected / at risk0/703 (0.00%)1/700 (0.00%)
Face Oedema
No. of participants affected / at risk0/703 (0.00%)1/700 (0.00%)
Tenderness
No. of participants affected / at risk0/703 (0.00%)1/700 (0.00%)
Ulcer
No. of participants affected / at risk0/703 (0.00%)1/700 (0.00%)
Hepatic Cyst
No. of participants affected / at risk1/703 (0.00%)0/700 (0.00%)
Hepatic Mass
No. of participants affected / at risk1/703 (0.00%)0/700 (0.00%)
Hepatic Steatosis
No. of participants affected / at risk1/703 (0.00%)0/700 (0.00%)
Liver Disorder
No. of participants affected / at risk1/703 (0.00%)0/700 (0.00%)
Biliary Dilatation
No. of participants affected / at risk0/703 (0.00%)1/700 (0.00%)
Cholecystitis
No. of participants affected / at risk0/703 (0.00%)1/700 (0.00%)
Seasonal Allergy
No. of participants affected / at risk2/703 (0.00%)3/700 (0.00%)
Allergy To Arthropod Bite
No. of participants affected / at risk1/703 (0.00%)0/700 (0.00%)
Allergy To Metals
No. of participants affected / at risk1/703 (0.00%)0/700 (0.00%)
Allergy To Vaccine
No. of participants affected / at risk0/703 (0.00%)1/700 (0.00%)
Urinary Tract Infection
No. of participants affected / at risk25/703 (0.00%)22/700 (0.00%)
Upper Respiratory Tract Infection
No. of participants affected / at risk18/703 (0.00%)28/700 (0.00%)
Bronchitis
No. of participants affected / at risk17/703 (0.00%)10/700 (0.00%)
Nasopharyngitis
No. of participants affected / at risk17/703 (0.00%)13/700 (0.00%)
Sinusitis
No. of participants affected / at risk17/703 (0.00%)22/700 (0.00%)
Gastroenteritis Viral
No. of participants affected / at risk16/703 (0.00%)12/700 (0.00%)
Influenza
No. of participants affected / at risk13/703 (0.00%)12/700 (0.00%)
Gastroenteritis
No. of participants affected / at risk8/703 (0.00%)5/700 (0.00%)
Tooth Abscess
No. of participants affected / at risk8/703 (0.00%)7/700 (0.00%)
Pneumonia
No. of participants affected / at risk6/703 (0.00%)6/700 (0.00%)
Ear Infection
No. of participants affected / at risk4/703 (0.00%)2/700 (0.00%)
Oral Candidiasis
No. of participants affected / at risk4/703 (0.00%)0/700 (0.00%)
Laryngitis
No. of participants affected / at risk3/703 (0.00%)0/700 (0.00%)
Pharyngitis Streptococcal
No. of participants affected / at risk3/703 (0.00%)2/700 (0.00%)
Atypical Pneumonia
No. of participants affected / at risk2/703 (0.00%)0/700 (0.00%)
Cellulitis
No. of participants affected / at risk2/703 (0.00%)2/700 (0.00%)
Eye Infection
No. of participants affected / at risk2/703 (0.00%)0/700 (0.00%)
Furuncle
No. of participants affected / at risk2/703 (0.00%)1/700 (0.00%)
Localised Infection
No. of participants affected / at risk2/703 (0.00%)3/700 (0.00%)
Staphylococcal Infection
No. of participants affected / at risk2/703 (0.00%)1/700 (0.00%)
Tooth Infection
No. of participants affected / at risk2/703 (0.00%)4/700 (0.00%)
Viral Infection
No. of participants affected / at risk2/703 (0.00%)2/700 (0.00%)
Vulvovaginal Mycotic Infection
No. of participants affected / at risk2/437 (0.00%)0/417 (0.00%)
Bacteriuria
No. of participants affected / at risk1/703 (0.00%)1/700 (0.00%)
Bronchopneumonia
No. of participants affected / at risk1/703 (0.00%)0/700 (0.00%)
Cellulitis Of Male External Genital Organ
No. of participants affected / at risk1/266 (0.00%)0/283 (0.00%)
Chronic Sinusitis
No. of participants affected / at risk1/703 (0.00%)0/700 (0.00%)
Cystitis
No. of participants affected / at risk1/703 (0.00%)3/700 (0.00%)
Ear Infection Bacterial
No. of participants affected / at risk1/703 (0.00%)0/700 (0.00%)
Gastritis Viral
No. of participants affected / at risk1/703 (0.00%)1/700 (0.00%)
Gastrointestinal Viral Infection
No. of participants affected / at risk1/703 (0.00%)0/700 (0.00%)
Herpes Dermatitis
No. of participants affected / at risk1/703 (0.00%)0/700 (0.00%)
Herpes Zoster
No. of participants affected / at risk1/703 (0.00%)2/700 (0.00%)
Impetigo
No. of participants affected / at risk1/703 (0.00%)0/700 (0.00%)
Infected Bites
No. of participants affected / at risk1/703 (0.00%)0/700 (0.00%)
Kidney Infection
No. of participants affected / at risk1/703 (0.00%)0/700 (0.00%)
Otitis Externa
No. of participants affected / at risk1/703 (0.00%)1/700 (0.00%)
Otitis Media
No. of participants affected / at risk1/703 (0.00%)1/700 (0.00%)
Papilloma Viral Infection
No. of participants affected / at risk1/703 (0.00%)0/700 (0.00%)
Pharyngitis
No. of participants affected / at risk1/703 (0.00%)3/700 (0.00%)
Pyelonephritis
No. of participants affected / at risk1/703 (0.00%)1/700 (0.00%)
Respiratory Tract Infection
No. of participants affected / at risk1/703 (0.00%)1/700 (0.00%)
Sinusitis Bacterial
No. of participants affected / at risk1/703 (0.00%)0/700 (0.00%)
Staphylococcal Skin Infection
No. of participants affected / at risk1/703 (0.00%)0/700 (0.00%)
Vaginitis Bacterial
No. of participants affected / at risk1/437 (0.00%)1/417 (0.00%)
Viral Diarrhoea
No. of participants affected / at risk1/703 (0.00%)0/700 (0.00%)
Acute Sinusitis
No. of participants affected / at risk0/703 (0.00%)2/700 (0.00%)
Chlamydial Infection
No. of participants affected / at risk0/703 (0.00%)1/700 (0.00%)
Fungal Infection
No. of participants affected / at risk0/703 (0.00%)2/700 (0.00%)
Gastroenteritis Norovirus
No. of participants affected / at risk0/703 (0.00%)1/700 (0.00%)
Gastrointestinal Infection
No. of participants affected / at risk0/703 (0.00%)1/700 (0.00%)
Genital Herpes
No. of participants affected / at risk0/703 (0.00%)1/700 (0.00%)
Herpes Simplex
No. of participants affected / at risk0/703 (0.00%)1/700 (0.00%)
Lower Respiratory Tract Infection
No. of participants affected / at risk0/703 (0.00%)2/700 (0.00%)
Oesophageal Candidiasis
No. of participants affected / at risk0/703 (0.00%)1/700 (0.00%)
Paronychia
No. of participants affected / at risk0/703 (0.00%)1/700 (0.00%)
Skin Candida
No. of participants affected / at risk0/703 (0.00%)1/700 (0.00%)
Subcutaneous Abscess
No. of participants affected / at risk0/703 (0.00%)2/700 (0.00%)
Tinea Pedis
No. of participants affected / at risk0/703 (0.00%)1/700 (0.00%)
Wound Infection
No. of participants affected / at risk0/703 (0.00%)2/700 (0.00%)
Ligament Sprain
No. of participants affected / at risk5/703 (0.00%)5/700 (0.00%)
Muscle Strain
No. of participants affected / at risk5/703 (0.00%)2/700 (0.00%)
Arthropod Bite
No. of participants affected / at risk4/703 (0.00%)1/700 (0.00%)
Excoriation
No. of participants affected / at risk4/703 (0.00%)2/700 (0.00%)
Fall
No. of participants affected / at risk4/703 (0.00%)4/700 (0.00%)
Foot Fracture
No. of participants affected / at risk4/703 (0.00%)2/700 (0.00%)
Laceration
No. of participants affected / at risk4/703 (0.00%)3/700 (0.00%)
Contusion
No. of participants affected / at risk3/703 (0.00%)7/700 (0.00%)
Head Injury
No. of participants affected / at risk2/703 (0.00%)1/700 (0.00%)
Joint Dislocation
No. of participants affected / at risk2/703 (0.00%)0/700 (0.00%)
Procedural Pain
No. of participants affected / at risk2/703 (0.00%)2/700 (0.00%)
Tendon Rupture
No. of participants affected / at risk2/703 (0.00%)0/700 (0.00%)
Accidental Exposure
No. of participants affected / at risk1/703 (0.00%)0/700 (0.00%)
Ankle Fracture
No. of participants affected / at risk1/703 (0.00%)0/700 (0.00%)
Hand Fracture
No. of participants affected / at risk1/703 (0.00%)2/700 (0.00%)
Heat Exhaustion
No. of participants affected / at risk1/703 (0.00%)0/700 (0.00%)
Ligament Rupture
No. of participants affected / at risk1/703 (0.00%)0/700 (0.00%)
Limb Injury
No. of participants affected / at risk1/703 (0.00%)1/700 (0.00%)
Lip Injury
No. of participants affected / at risk1/703 (0.00%)0/700 (0.00%)
Meniscus Lesion
No. of participants affected / at risk1/703 (0.00%)3/700 (0.00%)
Overdose
No. of participants affected / at risk1/703 (0.00%)2/700 (0.00%)
Rib Fracture
No. of participants affected / at risk1/703 (0.00%)1/700 (0.00%)
Road Traffic Accident
No. of participants affected / at risk1/703 (0.00%)1/700 (0.00%)
Suture Rupture
No. of participants affected / at risk1/703 (0.00%)0/700 (0.00%)
Tendon Injury
No. of participants affected / at risk1/703 (0.00%)0/700 (0.00%)
Tooth Fracture
No. of participants affected / at risk1/703 (0.00%)0/700 (0.00%)
Upper Limb Fracture
No. of participants affected / at risk1/703 (0.00%)0/700 (0.00%)
Wound
No. of participants affected / at risk1/703 (0.00%)0/700 (0.00%)
Wrist Fracture
No. of participants affected / at risk1/703 (0.00%)1/700 (0.00%)
Anaemia Postoperative
No. of participants affected / at risk0/703 (0.00%)2/700 (0.00%)
Anal Injury
No. of participants affected / at risk0/703 (0.00%)1/700 (0.00%)
Burns Second Degree
No. of participants affected / at risk0/703 (0.00%)1/700 (0.00%)
Concussion
No. of participants affected / at risk0/703 (0.00%)1/700 (0.00%)
Joint Injury
No. of participants affected / at risk0/703 (0.00%)3/700 (0.00%)
Pneumothorax Traumatic
No. of participants affected / at risk0/703 (0.00%)1/700 (0.00%)
Alanine Aminotransferase Increased
No. of participants affected / at risk4/703 (0.00%)0/700 (0.00%)
Weight Increased
No. of participants affected / at risk4/703 (0.00%)2/700 (0.00%)
Aspartate Aminotransferase Increased
No. of participants affected / at risk3/703 (0.00%)0/700 (0.00%)
Blood Creatine Phosphokinase Increased
No. of participants affected / at risk2/703 (0.00%)2/700 (0.00%)
Blood Lactate Dehydrogenase Increased
No. of participants affected / at risk2/703 (0.00%)0/700 (0.00%)
Blood Pressure Increased
No. of participants affected / at risk2/703 (0.00%)2/700 (0.00%)
Blood Uric Acid Increased
No. of participants affected / at risk2/703 (0.00%)0/700 (0.00%)
Gamma-Glutamyltransferase Increased
No. of participants affected / at risk2/703 (0.00%)2/700 (0.00%)
Haemoglobin Decreased
No. of participants affected / at risk2/703 (0.00%)0/700 (0.00%)
Hepatic Enzyme Increased
No. of participants affected / at risk2/703 (0.00%)3/700 (0.00%)
Neutrophil Count Increased
No. of participants affected / at risk2/703 (0.00%)0/700 (0.00%)
Platelet Count Increased
No. of participants affected / at risk2/703 (0.00%)0/700 (0.00%)
Aortic Bruit
No. of participants affected / at risk1/703 (0.00%)0/700 (0.00%)
Blood Cholesterol Increased
No. of participants affected / at risk1/703 (0.00%)0/700 (0.00%)
Blood Creatinine Increased
No. of participants affected / at risk1/703 (0.00%)1/700 (0.00%)
Blood Glucose Increased
No. of participants affected / at risk1/703 (0.00%)0/700 (0.00%)
Blood Sodium Increased
No. of participants affected / at risk1/703 (0.00%)0/700 (0.00%)
Blood Triglycerides Increased
No. of participants affected / at risk1/703 (0.00%)1/700 (0.00%)
Glomerular Filtration Rate Increased
No. of participants affected / at risk1/703 (0.00%)0/700 (0.00%)
Haematocrit Decreased
No. of participants affected / at risk1/703 (0.00%)0/700 (0.00%)
Heart Rate Increased
No. of participants affected / at risk1/703 (0.00%)0/700 (0.00%)
Liver Function Test Abnormal
No. of participants affected / at risk1/703 (0.00%)2/700 (0.00%)
Monocyte Count Decreased
No. of participants affected / at risk1/703 (0.00%)0/700 (0.00%)
Platelet Count Decreased
No. of participants affected / at risk1/703 (0.00%)0/700 (0.00%)
Red Blood Cell Count Decreased
No. of participants affected / at risk1/703 (0.00%)0/700 (0.00%)
Urine Phosphorus Increased
No. of participants affected / at risk1/703 (0.00%)0/700 (0.00%)
Weight Decreased
No. of participants affected / at risk1/703 (0.00%)1/700 (0.00%)
White Blood Cell Count Increased
No. of participants affected / at risk1/703 (0.00%)3/700 (0.00%)
Blood Phosphorus Decreased
No. of participants affected / at risk0/703 (0.00%)1/700 (0.00%)
Blood Sodium Decreased
No. of participants affected / at risk0/703 (0.00%)1/700 (0.00%)
Blood Testosterone Decreased
No. of participants affected / at risk0/703 (0.00%)1/700 (0.00%)
Blood Urine Present
No. of participants affected / at risk0/703 (0.00%)1/700 (0.00%)
Cardiac Murmur
No. of participants affected / at risk0/703 (0.00%)1/700 (0.00%)
Crystal Urine Present
No. of participants affected / at risk0/703 (0.00%)1/700 (0.00%)
Electrocardiogram Qt Prolonged
No. of participants affected / at risk0/703 (0.00%)1/700 (0.00%)
Fungal Test Positive
No. of participants affected / at risk0/703 (0.00%)1/700 (0.00%)
Glomerular Filtration Rate Decreased
No. of participants affected / at risk0/703 (0.00%)1/700 (0.00%)
Haematocrit Increased
No. of participants affected / at risk0/703 (0.00%)1/700 (0.00%)
Heart Rate Decreased
No. of participants affected / at risk0/703 (0.00%)1/700 (0.00%)
Transaminases Increased
No. of participants affected / at risk0/703 (0.00%)2/700 (0.00%)
Hypercholesterolaemia
No. of participants affected / at risk4/703 (0.00%)3/700 (0.00%)
Decreased Appetite
No. of participants affected / at risk3/703 (0.00%)5/700 (0.00%)
Dehydration
No. of participants affected / at risk3/703 (0.00%)2/700 (0.00%)
Hyperlipidaemia
No. of participants affected / at risk3/703 (0.00%)3/700 (0.00%)
Hypokalaemia
No. of participants affected / at risk3/703 (0.00%)7/700 (0.00%)
Diabetes Mellitus
No. of participants affected / at risk2/703 (0.00%)5/700 (0.00%)
Hyperglycaemia
No. of participants affected / at risk1/703 (0.00%)1/700 (0.00%)
Hyponatraemia
No. of participants affected / at risk1/703 (0.00%)0/700 (0.00%)
Hypophosphataemia
No. of participants affected / at risk1/703 (0.00%)0/700 (0.00%)
Hypouricaemia
No. of participants affected / at risk1/703 (0.00%)0/700 (0.00%)
Type 2 Diabetes Mellitus
No. of participants affected / at risk1/703 (0.00%)4/700 (0.00%)
Vitamin D Deficiency
No. of participants affected / at risk1/703 (0.00%)1/700 (0.00%)
Gout
No. of participants affected / at risk0/703 (0.00%)2/700 (0.00%)
Hypercalcaemia
No. of participants affected / at risk0/703 (0.00%)1/700 (0.00%)
Hyperkalaemia
No. of participants affected / at risk0/703 (0.00%)1/700 (0.00%)
Hypertriglyceridaemia
No. of participants affected / at risk0/703 (0.00%)1/700 (0.00%)
Hyperuricaemia
No. of participants affected / at risk0/703 (0.00%)1/700 (0.00%)
Hypomagnesaemia
No. of participants affected / at risk0/703 (0.00%)1/700 (0.00%)
Iron Deficiency
No. of participants affected / at risk0/703 (0.00%)1/700 (0.00%)
Metabolic Acidosis
No. of participants affected / at risk0/703 (0.00%)1/700 (0.00%)
Obesity
No. of participants affected / at risk0/703 (0.00%)1/700 (0.00%)
Back Pain
No. of participants affected / at risk31/703 (0.00%)17/700 (0.00%)
Arthralgia
No. of participants affected / at risk16/703 (0.00%)14/700 (0.00%)
Muscle Spasms
No. of participants affected / at risk10/703 (0.00%)11/700 (0.00%)
Neck Pain
No. of participants affected / at risk8/703 (0.00%)5/700 (0.00%)
Pain In Extremity
No. of participants affected / at risk8/703 (0.00%)11/700 (0.00%)
Musculoskeletal Pain
No. of participants affected / at risk7/703 (0.00%)5/700 (0.00%)
Myalgia
No. of participants affected / at risk6/703 (0.00%)4/700 (0.00%)
Osteoarthritis
No. of participants affected / at risk6/703 (0.00%)7/700 (0.00%)
Joint Swelling
No. of participants affected / at risk4/703 (0.00%)1/700 (0.00%)
Arthritis
No. of participants affected / at risk3/703 (0.00%)0/700 (0.00%)
Exostosis
No. of participants affected / at risk3/703 (0.00%)3/700 (0.00%)
Foot Deformity
No. of participants affected / at risk2/703 (0.00%)0/700 (0.00%)
Muscular Weakness
No. of participants affected / at risk2/703 (0.00%)2/700 (0.00%)
Rheumatoid Arthritis
No. of participants affected / at risk2/703 (0.00%)1/700 (0.00%)
Rotator Cuff Syndrome
No. of participants affected / at risk2/703 (0.00%)2/700 (0.00%)
Temporomandibular Joint Syndrome
No. of participants affected / at risk2/703 (0.00%)0/700 (0.00%)
Bunion
No. of participants affected / at risk1/703 (0.00%)0/700 (0.00%)
Bursitis
No. of participants affected / at risk1/703 (0.00%)4/700 (0.00%)
Flank Pain
No. of participants affected / at risk1/703 (0.00%)1/700 (0.00%)
Intervertebral Disc Degeneration
No. of participants affected / at risk1/703 (0.00%)3/700 (0.00%)
Intervertebral Disc Protrusion
No. of participants affected / at risk1/703 (0.00%)2/700 (0.00%)
Joint Contracture
No. of participants affected / at risk1/703 (0.00%)0/700 (0.00%)
Joint Instability
No. of participants affected / at risk1/703 (0.00%)0/700 (0.00%)
Musculoskeletal Chest Pain
No. of participants affected / at risk1/703 (0.00%)0/700 (0.00%)
Pain In Jaw
No. of participants affected / at risk1/703 (0.00%)0/700 (0.00%)
Synovial Cyst
No. of participants affected / at risk1/703 (0.00%)0/700 (0.00%)
Torticollis
No. of participants affected / at risk1/703 (0.00%)1/700 (0.00%)
Fibromyalgia
No. of participants affected / at risk0/703 (0.00%)1/700 (0.00%)
Groin Pain
No. of participants affected / at risk0/703 (0.00%)1/700 (0.00%)
Joint Range Of Motion Decreased
No. of participants affected / at risk0/703 (0.00%)1/700 (0.00%)
Muscle Fatigue
No. of participants affected / at risk0/703 (0.00%)1/700 (0.00%)
Osteochondrosis
No. of participants affected / at risk0/703 (0.00%)1/700 (0.00%)
Osteopenia
No. of participants affected / at risk0/703 (0.00%)1/700 (0.00%)
Osteoporosis
No. of participants affected / at risk0/703 (0.00%)1/700 (0.00%)
Plantar Fasciitis
No. of participants affected / at risk0/703 (0.00%)1/700 (0.00%)
Spinal Osteoarthritis
No. of participants affected / at risk0/703 (0.00%)1/700 (0.00%)
Spondylitis
No. of participants affected / at risk0/703 (0.00%)1/700 (0.00%)
Tendonitis
No. of participants affected / at risk0/703 (0.00%)3/700 (0.00%)
Trigger Finger
No. of participants affected / at risk0/703 (0.00%)1/700 (0.00%)
Thyroid Neoplasm
No. of participants affected / at risk3/703 (0.00%)0/700 (0.00%)
Colon Adenoma
No. of participants affected / at risk1/703 (0.00%)0/700 (0.00%)
Hepatic Neoplasm
No. of participants affected / at risk1/703 (0.00%)0/700 (0.00%)
Basal Cell Carcinoma
No. of participants affected / at risk0/703 (0.00%)1/700 (0.00%)
Breast Cancer Metastatic
No. of participants affected / at risk0/703 (0.00%)1/700 (0.00%)
Headache
No. of participants affected / at risk20/703 (0.00%)23/700 (0.00%)
Neuralgia
No. of participants affected / at risk8/703 (0.00%)5/700 (0.00%)
Dizziness
No. of participants affected / at risk5/703 (0.00%)10/700 (0.00%)
Hypoaesthesia
No. of participants affected / at risk4/703 (0.00%)0/700 (0.00%)
Migraine
No. of participants affected / at risk4/703 (0.00%)5/700 (0.00%)
Sinus Headache
No. of participants affected / at risk3/703 (0.00%)0/700 (0.00%)
Syncope
No. of participants affected / at risk3/703 (0.00%)2/700 (0.00%)
Dysgeusia
No. of participants affected / at risk2/703 (0.00%)1/700 (0.00%)
Neuropathy Peripheral
No. of participants affected / at risk2/703 (0.00%)5/700 (0.00%)
Restless Legs Syndrome
No. of participants affected / at risk2/703 (0.00%)1/700 (0.00%)
Sciatica
No. of participants affected / at risk2/703 (0.00%)2/700 (0.00%)
Somnolence
No. of participants affected / at risk2/703 (0.00%)0/700 (0.00%)
Tension Headache
No. of participants affected / at risk2/703 (0.00%)0/700 (0.00%)
Amnesia
No. of participants affected / at risk1/703 (0.00%)0/700 (0.00%)
Carpal Tunnel Syndrome
No. of participants affected / at risk1/703 (0.00%)5/700 (0.00%)
Complex Regional Pain Syndrome
No. of participants affected / at risk1/703 (0.00%)0/700 (0.00%)
Convulsion
No. of participants affected / at risk1/703 (0.00%)1/700 (0.00%)
Diabetic Neuropathy
No. of participants affected / at risk1/703 (0.00%)0/700 (0.00%)
Drooling
No. of participants affected / at risk1/703 (0.00%)0/700 (0.00%)
Hyperaesthesia
No. of participants affected / at risk1/703 (0.00%)0/700 (0.00%)
Lethargy
No. of participants affected / at risk1/703 (0.00%)0/700 (0.00%)
Migraine With Aura
No. of participants affected / at risk1/703 (0.00%)0/700 (0.00%)
Mononeuropathy
No. of participants affected / at risk1/703 (0.00%)0/700 (0.00%)
Narcolepsy
No. of participants affected / at risk1/703 (0.00%)1/700 (0.00%)
Occipital Neuralgia
No. of participants affected / at risk1/703 (0.00%)0/700 (0.00%)
Paraesthesia
No. of participants affected / at risk1/703 (0.00%)1/700 (0.00%)
Parkinson's Disease
No. of participants affected / at risk1/703 (0.00%)0/700 (0.00%)
Peroneal Nerve Palsy
No. of participants affected / at risk1/703 (0.00%)0/700 (0.00%)
Speech Disorder
No. of participants affected / at risk1/703 (0.00%)0/700 (0.00%)
Tremor
No. of participants affected / at risk1/703 (0.00%)3/700 (0.00%)
Cognitive Disorder
No. of participants affected / at risk0/703 (0.00%)1/700 (0.00%)
Lumbar Radiculopathy
No. of participants affected / at risk0/703 (0.00%)1/700 (0.00%)
Muscle Contractions Involuntary
No. of participants affected / at risk0/703 (0.00%)1/700 (0.00%)
Radiculitis
No. of participants affected / at risk0/703 (0.00%)1/700 (0.00%)
Tarsal Tunnel Syndrome
No. of participants affected / at risk0/703 (0.00%)1/700 (0.00%)
Anxiety
No. of participants affected / at risk10/703 (0.00%)4/700 (0.00%)
Insomnia
No. of participants affected / at risk7/703 (0.00%)9/700 (0.00%)
Depression
No. of participants affected / at risk6/703 (0.00%)9/700 (0.00%)
Attention Deficit/Hyperactivity Disorder
No. of participants affected / at risk3/703 (0.00%)2/700 (0.00%)
Confusional State
No. of participants affected / at risk2/703 (0.00%)0/700 (0.00%)
Mood Swings
No. of participants affected / at risk2/703 (0.00%)0/700 (0.00%)
Restlessness
No. of participants affected / at risk2/703 (0.00%)1/700 (0.00%)
Affective Disorder
No. of participants affected / at risk1/703 (0.00%)0/700 (0.00%)
Alcoholism
No. of participants affected / at risk1/703 (0.00%)0/700 (0.00%)
Stress
No. of participants affected / at risk1/703 (0.00%)3/700 (0.00%)
Generalised Anxiety Disorder
No. of participants affected / at risk0/703 (0.00%)1/700 (0.00%)
Initial Insomnia
No. of participants affected / at risk0/703 (0.00%)1/700 (0.00%)
Nightmare
No. of participants affected / at risk0/703 (0.00%)2/700 (0.00%)
Panic Attack
No. of participants affected / at risk0/703 (0.00%)1/700 (0.00%)
Sleep Disorder
No. of participants affected / at risk0/703 (0.00%)2/700 (0.00%)
Tobacco Withdrawal Symptoms
No. of participants affected / at risk0/703 (0.00%)1/700 (0.00%)
Nephrolithiasis
No. of participants affected / at risk7/703 (0.00%)6/700 (0.00%)
Haematuria
No. of participants affected / at risk3/703 (0.00%)3/700 (0.00%)
Chromaturia
No. of participants affected / at risk1/703 (0.00%)0/700 (0.00%)
Diabetic Nephropathy
No. of participants affected / at risk1/703 (0.00%)0/700 (0.00%)
Dysuria
No. of participants affected / at risk1/703 (0.00%)2/700 (0.00%)
Glycosuria
No. of participants affected / at risk1/703 (0.00%)0/700 (0.00%)
Hypertonic Bladder
No. of participants affected / at risk1/703 (0.00%)1/700 (0.00%)
Pollakiuria
No. of participants affected / at risk1/703 (0.00%)0/700 (0.00%)
Pyuria
No. of participants affected / at risk1/703 (0.00%)1/700 (0.00%)
Renal Failure Acute
No. of participants affected / at risk1/703 (0.00%)2/700 (0.00%)
Renal Impairment
No. of participants affected / at risk1/703 (0.00%)1/700 (0.00%)
Urinary Retention
No. of participants affected / at risk1/703 (0.00%)0/700 (0.00%)
Incontinence
No. of participants affected / at risk0/703 (0.00%)1/700 (0.00%)
Nocturia
No. of participants affected / at risk0/703 (0.00%)1/700 (0.00%)
Polyuria
No. of participants affected / at risk0/703 (0.00%)1/700 (0.00%)
Renal Injury
No. of participants affected / at risk0/703 (0.00%)1/700 (0.00%)
Ovarian Cyst
No. of participants affected / at risk2/437 (0.00%)0/417 (0.00%)
Breast Disorder
No. of participants affected / at risk1/703 (0.00%)1/700 (0.00%)
Breast Mass
No. of participants affected / at risk1/703 (0.00%)1/700 (0.00%)
Breast Pain
No. of participants affected / at risk1/703 (0.00%)0/700 (0.00%)
Endometriosis
No. of participants affected / at risk1/437 (0.00%)0/417 (0.00%)
Genital Rash
No. of participants affected / at risk1/703 (0.00%)0/700 (0.00%)
Vaginal Lesion
No. of participants affected / at risk1/437 (0.00%)0/417 (0.00%)
Benign Prostatic Hyperplasia
No. of participants affected / at risk0/266 (0.00%)1/283 (0.00%)
Dysfunctional Uterine Bleeding
No. of participants affected / at risk0/437 (0.00%)1/417 (0.00%)
Erectile Dysfunction
No. of participants affected / at risk0/266 (0.00%)1/283 (0.00%)
Prostatomegaly
No. of participants affected / at risk0/266 (0.00%)1/283 (0.00%)
Vaginal Haemorrhage
No. of participants affected / at risk0/437 (0.00%)1/417 (0.00%)
Rhinorrhoea
No. of participants affected / at risk8/703 (0.00%)4/700 (0.00%)
Oropharyngeal Pain
No. of participants affected / at risk4/703 (0.00%)6/700 (0.00%)
Chronic Obstructive Pulmonary Disease
No. of participants affected / at risk3/703 (0.00%)3/700 (0.00%)
Dyspnoea
No. of participants affected / at risk3/703 (0.00%)4/700 (0.00%)
Sinus Congestion
No. of participants affected / at risk3/703 (0.00%)0/700 (0.00%)
Wheezing
No. of participants affected / at risk3/703 (0.00%)0/700 (0.00%)
Cough
No. of participants affected / at risk2/703 (0.00%)6/700 (0.00%)
Epistaxis
No. of participants affected / at risk2/703 (0.00%)0/700 (0.00%)
Nasal Congestion
No. of participants affected / at risk2/703 (0.00%)1/700 (0.00%)
Allergic Sinusitis
No. of participants affected / at risk1/703 (0.00%)0/700 (0.00%)
Asthma
No. of participants affected / at risk1/703 (0.00%)1/700 (0.00%)
Bronchial Hyperreactivity
No. of participants affected / at risk1/703 (0.00%)1/700 (0.00%)
Dyspnoea Exertional
No. of participants affected / at risk1/703 (0.00%)0/700 (0.00%)
Lung Hyperinflation
No. of participants affected / at risk1/703 (0.00%)0/700 (0.00%)
Productive Cough
No. of participants affected / at risk1/703 (0.00%)0/700 (0.00%)
Rhinitis Seasonal
No. of participants affected / at risk1/703 (0.00%)1/700 (0.00%)
Upper Respiratory Tract Congestion
No. of participants affected / at risk1/703 (0.00%)0/700 (0.00%)
Yawning
No. of participants affected / at risk1/703 (0.00%)1/700 (0.00%)
Nasal Obstruction
No. of participants affected / at risk0/703 (0.00%)1/700 (0.00%)
Nasal Ulcer
No. of participants affected / at risk0/703 (0.00%)1/700 (0.00%)
Paranasal Sinus Hypersecretion
No. of participants affected / at risk0/703 (0.00%)1/700 (0.00%)
Pleural Effusion
No. of participants affected / at risk0/703 (0.00%)1/700 (0.00%)
Respiratory Tract Congestion
No. of participants affected / at risk0/703 (0.00%)3/700 (0.00%)
Sleep Apnoea Syndrome
No. of participants affected / at risk0/703 (0.00%)2/700 (0.00%)
Hyperhidrosis
No. of participants affected / at risk7/703 (0.00%)5/700 (0.00%)
Cold Sweat
No. of participants affected / at risk2/703 (0.00%)0/700 (0.00%)
Dermatitis Contact
No. of participants affected / at risk2/703 (0.00%)2/700 (0.00%)
Rash
No. of participants affected / at risk2/703 (0.00%)6/700 (0.00%)
Actinic Keratosis
No. of participants affected / at risk1/703 (0.00%)0/700 (0.00%)
Dermatitis Allergic
No. of participants affected / at risk1/703 (0.00%)1/700 (0.00%)
Ecchymosis
No. of participants affected / at risk1/703 (0.00%)0/700 (0.00%)
Erythema
No. of participants affected / at risk1/703 (0.00%)1/700 (0.00%)
Increased Tendency To Bruise
No. of participants affected / at risk1/703 (0.00%)0/700 (0.00%)
Ingrowing Nail
No. of participants affected / at risk1/703 (0.00%)0/700 (0.00%)
Night Sweats
No. of participants affected / at risk1/703 (0.00%)2/700 (0.00%)
Pain Of Skin
No. of participants affected / at risk1/703 (0.00%)0/700 (0.00%)
Piloerection
No. of participants affected / at risk1/703 (0.00%)1/700 (0.00%)
Precancerous Skin Lesion
No. of participants affected / at risk1/703 (0.00%)0/700 (0.00%)
Pruritus
No. of participants affected / at risk1/703 (0.00%)3/700 (0.00%)
Rash Erythematous
No. of participants affected / at risk1/703 (0.00%)1/700 (0.00%)
Skin Irritation
No. of participants affected / at risk1/703 (0.00%)0/700 (0.00%)
Swelling Face
No. of participants affected / at risk1/703 (0.00%)0/700 (0.00%)
Urticaria
No. of participants affected / at risk1/703 (0.00%)3/700 (0.00%)
Xeroderma
No. of participants affected / at risk1/703 (0.00%)0/700 (0.00%)
Acne
No. of participants affected / at risk0/703 (0.00%)2/700 (0.00%)
Blister
No. of participants affected / at risk0/703 (0.00%)1/700 (0.00%)
Dermatitis
No. of participants affected / at risk0/703 (0.00%)1/700 (0.00%)
Dermatitis Atopic
No. of participants affected / at risk0/703 (0.00%)1/700 (0.00%)
Diabetic Foot
No. of participants affected / at risk0/703 (0.00%)1/700 (0.00%)
Eczema
No. of participants affected / at risk0/703 (0.00%)1/700 (0.00%)
Pruritus Generalised
No. of participants affected / at risk0/703 (0.00%)1/700 (0.00%)
Skin Ulcer
No. of participants affected / at risk0/703 (0.00%)3/700 (0.00%)
Tooth Extraction
No. of participants affected / at risk1/703 (0.00%)0/700 (0.00%)
Hypertension
No. of participants affected / at risk14/703 (0.00%)8/700 (0.00%)
Hot Flush
No. of participants affected / at risk8/703 (0.00%)6/700 (0.00%)
Hypotension
No. of participants affected / at risk4/703 (0.00%)4/700 (0.00%)
Raynaud's Phenomenon
No. of participants affected / at risk1/703 (0.00%)0/700 (0.00%)
Thrombophlebitis Superficial
No. of participants affected / at risk1/703 (0.00%)0/700 (0.00%)
Aortic Aneurysm
No. of participants affected / at risk0/703 (0.00%)1/700 (0.00%)
Haematoma
No. of participants affected / at risk0/703 (0.00%)1/700 (0.00%)
Hypertensive Crisis
No. of participants affected / at risk0/703 (0.00%)1/700 (0.00%)
Peripheral Vascular Disorder
No. of participants affected / at risk0/703 (0.00%)1/700 (0.00%)
Post Thrombotic Syndrome
No. of participants affected / at risk0/703 (0.00%)1/700 (0.00%)

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

Results Point of Contact

Name/TitleOrganizationPhoneEmail
Vice President, Clinical Research
Cubist Pharmaceuticals
1.781.860.8660