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A Study of V950 in People With Alzheimer Disease (V950-001 AM7)
This study has been completed.
Sponsor:
Merck Sharp & Dohme Corp.
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier:
NCT00464334
First received: April 20, 2007
Last updated: September 24, 2015
Last verified: September 2015
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Results First Received: November 19, 2012
| Study Type: | Interventional |
|---|---|
| Study Design: | Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Double Blind (Participant, Investigator); Primary Purpose: Diagnostic |
| Condition: |
Alzheimer Disease |
| Interventions: |
Biological: V950 Biological: ISCOMATRIX™ Biological: Placebo to V950 |
Participant Flow
Hide Participant Flow
Recruitment Details
| Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations |
|---|
| Participants were recruited from 51 sites in Europe, South America and the United States. The primary treatment period was from June 2007 to August 2010, with follow up through January 2012. |
Pre-Assignment Details
| Significant events and approaches for the overall study following participant enrollment, but prior to group assignment |
|---|
| No text entered. |
Reporting Groups
| Description | |
|---|---|
| Placebo to V950/IMX 0 mcg | Participants receive Placebo to V950/ISCOMATRIX™ (IMX) 0 mcg |
| Placebo to V950/IMX 16 mcg | Participants receive Placebo to V950/IMX 16 mcg |
| V950 0.5 mcg/IMX 0 mcg | Participants receive V950 0.5 mcg/IMX 0 mcg |
| V950 0.5 mcg/IMX 16 mcg | Participants receive V950 0.5 mcg/IMX 16 mcg |
| V950 0.5 mcg/IMX 47 mcg | Participants receive V950 0.5 mcg/IMX 47 mcg |
| V950 0.5 mcg/IMX 94 mcg | Participants receive V950 0.5 mcg/IMX 94 mcg |
| V950 5 mcg/IMX 0 mcg | Participants receive V950 5 mcg/IMX 0 mcg |
| V950 5 mcg/IMX 16 mcg | Participants receive V950 5 mcg/IMX 16 mcg |
| V950 5 mcg/IMX 47 mcg | Participants receive V950 5 mcg/IMX 47 mcg |
| V950 50 mcg/IMX 0 mcg | Participants receive V950 50 mcg/IMX 0 mcg |
| V950 50 mcg/IMX 16 mcg | Participants receive V950 50 mcg/IMX 16 mcg |
Participant Flow: Overall Study
| Placebo to V950/IMX 0 mcg | Placebo to V950/IMX 16 mcg | V950 0.5 mcg/IMX 0 mcg | V950 0.5 mcg/IMX 16 mcg | V950 0.5 mcg/IMX 47 mcg | V950 0.5 mcg/IMX 94 mcg | V950 5 mcg/IMX 0 mcg | V950 5 mcg/IMX 16 mcg | V950 5 mcg/IMX 47 mcg | V950 50 mcg/IMX 0 mcg | V950 50 mcg/IMX 16 mcg | |
|---|---|---|---|---|---|---|---|---|---|---|---|
| STARTED | 5 | 13 | 8 | 8 | 7 | 7 | 9 | 8 | 8 | 5 | 8 |
| COMPLETED | 4 | 5 | 3 | 4 | 3 | 3 | 6 | 7 | 2 | 4 | 4 |
| NOT COMPLETED | 1 | 8 | 5 | 4 | 4 | 4 | 3 | 1 | 6 | 1 | 4 |
| Adverse Event | 0 | 0 | 0 | 1 | 1 | 1 | 0 | 0 | 2 | 1 | 2 |
| Lack of Efficacy | 0 | 1 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| Lost to Follow-up | 0 | 0 | 1 | 0 | 1 | 0 | 1 | 0 | 0 | 0 | 2 |
| Progressive Disease | 0 | 0 | 0 | 0 | 0 | 1 | 0 | 0 | 1 | 0 | 0 |
| Study Terminated by Sponsor | 0 | 0 | 0 | 1 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| Withdrawal by Subject | 1 | 7 | 4 | 2 | 2 | 2 | 2 | 1 | 3 | 0 | 0 |
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. |
|---|
| No text entered. |
Reporting Groups
| Description | |
|---|---|
| Placebo to V950/IMX 0 mcg | Participants receive Placebo to V950/IMX 0 mcg |
| Placebo to V950/IMX 16 mcg | Participants receive Placebo to V950/IMX 16 mcg |
| V950 0.5 mcg/IMX 0 mcg | Participants receive V950 0.5 mcg/IMX 0 mcg |
| V950 0.5 mcg/IMX 16 mcg | Participants receive V950 0.5 mcg/IMX 16 mcg |
| V950 0.5 mcg/IMX 47 mcg | Participants receive V950 0.5 mcg/IMX 47 mcg |
| V950 0.5 mcg/IMX 94 mcg | Participants receive V950 0.5 mcg/IMX 94 mcg |
| V950 5 mcg/IMX 0 mcg | Participants receive V950 5 mcg/IMX 0 mcg |
| V950 5 mcg/IMX 16 mcg | Participants receive V950 5 mcg/IMX 16 mcg |
| V950 5 mcg/IMX 47 mcg | Participants receive V950 5 mcg/IMX 47 mcg |
| V950 50 mcg/IMX 0 mcg | Participants receive V950 50 mcg/IMX 0 mcg |
| V950 50 mcg/IMX 16 mcg | Participants receive V950 50 mcg/IMX 16 mcg |
| Total | Total of all reporting groups |
Baseline Measures
| Placebo to V950/IMX 0 mcg | Placebo to V950/IMX 16 mcg | V950 0.5 mcg/IMX 0 mcg | V950 0.5 mcg/IMX 16 mcg | V950 0.5 mcg/IMX 47 mcg | V950 0.5 mcg/IMX 94 mcg | V950 5 mcg/IMX 0 mcg | V950 5 mcg/IMX 16 mcg | V950 5 mcg/IMX 47 mcg | V950 50 mcg/IMX 0 mcg | V950 50 mcg/IMX 16 mcg | Total | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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Overall Participants Analyzed [Units: Participants] |
5 | 13 | 8 | 8 | 7 | 7 | 9 | 8 | 8 | 5 | 8 | 86 | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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Age [Units: Years] Mean (Standard Deviation) |
73.6 (10.69) | 70.7 (9.6) | 76.9 (4.39) | 73.6 (8.07) | 76.1 (8.01) | 73.4 (10.89) | 72.6 (9.26) | 72.5 (10.10) | 81.5 (5.48) | 70.6 (8.38) | 75.5 (10.04) | 74.2 (8.85) | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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Gender [Units: Participants] |
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| Female | 3 | 7 | 3 | 5 | 5 | 6 | 4 | 5 | 1 | 3 | 3 | 45 | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Male | 2 | 6 | 5 | 3 | 2 | 1 | 5 | 3 | 7 | 2 | 5 | 41 | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Outcome Measures
Show All Outcome Measures
| 1. Primary: | Number of Participants Who Experienced at Least One Adverse Event [ Time Frame: Up to 4 years after first dose of vaccine ] |
| 2. Primary: | Number of Participants Who Discontinued Study Drug Due to an Adverse Event [ Time Frame: Up to 6 months after first dose of vaccine ] |
| 3. Primary: | Geometric Mean Titer (GMT) of Amyloid Beta (Aβ) Peptide 1-40 Specific Antibodies at Month 7 [ Time Frame: Month 7 ] |
| 4. Primary: | Mean Fold Change From Baseline in GMT of Aβ Peptide 1-40 Specific Antibodies [ Time Frame: Baseline and Month 7 ] |
Serious Adverse Events Other Adverse Events
| Time Frame | Up to 4 years after first dose of vaccine |
|---|---|
| Additional Description | The Safety Population consisted of all participants who received at least one dose of vaccine. |
Frequency Threshold
| Threshold above which other adverse events are reported | 5% |
|---|
Reporting Groups
| Description | |
|---|---|
| Placebo to V950/ IMX 0 mcg | Participants receive Placebo to V950/IMX 0 mcg |
| Placebo to V950/ IMX 16 mcg | Participants receive Placebo to V950/IMX 16 mcg |
| V950 0.5 mcg / IMX 0 mcg | Participants receive V950 0.5 mcg/IMX 0 mcg |
| V950 0.5 mcg / IMX 16 mcg | Participants receive V950 0.5 mcg/IMX 16 mcg |
| V950 0.5 mcg / IMX 47 mcg | Participants receive V950 0.5 mcg/IMX 47 mcg |
| V950 0.5 mcg / IMX 94 mcg | Participants receive V950 0.5 mcg/IMX 94 mcg |
| V950 5 mcg / IMX 0 mcg | Participants receive V950 5 mcg/IMX 0 mcg |
| V950 5 mcg / IMX 16 mcg | Participants receive V950 5 mcg/IMX 16 mcg |
| V950 5 mcg / IMX 47 mcg | Participants receive V950 5 mcg/IMX 47 mcg |
| V950 50 mcg / IMX 0 mcg | Participants receive V950 50 mcg/IMX 0 mcg |
| V950 50 mcg / IMX 16 mcg | Participants receive V950 50 mcg/IMX 16 mcg |
Other Adverse Events
| Placebo to V950/ IMX 0 mcg | Placebo to V950/ IMX 16 mcg | V950 0.5 mcg / IMX 0 mcg | V950 0.5 mcg / IMX 16 mcg | V950 0.5 mcg / IMX 47 mcg | V950 0.5 mcg / IMX 94 mcg | V950 5 mcg / IMX 0 mcg | V950 5 mcg / IMX 16 mcg | V950 5 mcg / IMX 47 mcg | V950 50 mcg / IMX 0 mcg | V950 50 mcg / IMX 16 mcg | |
|---|---|---|---|---|---|---|---|---|---|---|---|
| Total, Other (not including serious) Adverse Events | |||||||||||
| # participants affected / at risk | 4/5 (80.00%) | 11/13 (84.62%) | 7/8 (87.50%) | 8/8 (100.00%) | 6/7 (85.71%) | 7/7 (100.00%) | 9/9 (100.00%) | 8/8 (100.00%) | 8/8 (100.00%) | 5/5 (100.00%) | 8/8 (100.00%) |
| Blood and lymphatic system disorders | |||||||||||
| Anaemia † 1 | |||||||||||
| # participants affected / at risk | 0/5 (0.00%) | 1/13 (7.69%) | 0/8 (0.00%) | 0/8 (0.00%) | 0/7 (0.00%) | 0/7 (0.00%) | 2/9 (22.22%) | 0/8 (0.00%) | 2/8 (25.00%) | 0/5 (0.00%) | 1/8 (12.50%) |
| # events | 0 | 1 | 0 | 0 | 0 | 0 | 2 | 0 | 2 | 0 | 1 |
| Leukocytosis † 1 | |||||||||||
| # participants affected / at risk | 0/5 (0.00%) | 0/13 (0.00%) | 0/8 (0.00%) | 0/8 (0.00%) | 0/7 (0.00%) | 0/7 (0.00%) | 1/9 (11.11%) | 0/8 (0.00%) | 0/8 (0.00%) | 0/5 (0.00%) | 0/8 (0.00%) |
| # events | 0 | 0 | 0 | 0 | 0 | 0 | 1 | 0 | 0 | 0 | 0 |
| Cardiac disorders | |||||||||||
| Atrial fibrillation † 1 | |||||||||||
| # participants affected / at risk | 0/5 (0.00%) | 0/13 (0.00%) | 0/8 (0.00%) | 0/8 (0.00%) | 1/7 (14.29%) | 0/7 (0.00%) | 0/9 (0.00%) | 0/8 (0.00%) | 0/8 (0.00%) | 0/5 (0.00%) | 0/8 (0.00%) |
| # events | 0 | 0 | 0 | 0 | 1 | 0 | 0 | 0 | 0 | 0 | 0 |
| Tachycardia paroxysmal † 1 | |||||||||||
| # participants affected / at risk | 0/5 (0.00%) | 0/13 (0.00%) | 1/8 (12.50%) | 0/8 (0.00%) | 0/7 (0.00%) | 0/7 (0.00%) | 0/9 (0.00%) | 0/8 (0.00%) | 0/8 (0.00%) | 0/5 (0.00%) | 0/8 (0.00%) |
| # events | 0 | 0 | 2 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| Ear and labyrinth disorders | |||||||||||
| Middle ear effusion † 1 | |||||||||||
| # participants affected / at risk | 0/5 (0.00%) | 0/13 (0.00%) | 0/8 (0.00%) | 0/8 (0.00%) | 0/7 (0.00%) | 0/7 (0.00%) | 0/9 (0.00%) | 0/8 (0.00%) | 0/8 (0.00%) | 1/5 (20.00%) | 0/8 (0.00%) |
| # events | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 1 | 0 |
| Tinnitus † 1 | |||||||||||
| # participants affected / at risk | 0/5 (0.00%) | 1/13 (7.69%) | 0/8 (0.00%) | 0/8 (0.00%) | 0/7 (0.00%) | 0/7 (0.00%) | 0/9 (0.00%) | 0/8 (0.00%) | 0/8 (0.00%) | 0/5 (0.00%) | 0/8 (0.00%) |
| # events | 0 | 1 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| Endocrine disorders | |||||||||||
| Hypothyroidism † 1 | |||||||||||
| # participants affected / at risk | 0/5 (0.00%) | 0/13 (0.00%) | 0/8 (0.00%) | 1/8 (12.50%) | 0/7 (0.00%) | 0/7 (0.00%) | 0/9 (0.00%) | 0/8 (0.00%) | 0/8 (0.00%) | 1/5 (20.00%) | 0/8 (0.00%) |
| # events | 0 | 0 | 0 | 1 | 0 | 0 | 0 | 0 | 0 | 1 | 0 |
| Eye disorders | |||||||||||
| Conjunctivitis † 1 | |||||||||||
| # participants affected / at risk | 0/5 (0.00%) | 0/13 (0.00%) | 0/8 (0.00%) | 0/8 (0.00%) | 0/7 (0.00%) | 0/7 (0.00%) | 1/9 (11.11%) | 0/8 (0.00%) | 0/8 (0.00%) | 0/5 (0.00%) | 0/8 (0.00%) |
| # events | 0 | 0 | 0 | 0 | 0 | 0 | 1 | 0 | 0 | 0 | 0 |
| Glaucoma † 1 | |||||||||||
| # participants affected / at risk | 0/5 (0.00%) | 0/13 (0.00%) | 0/8 (0.00%) | 0/8 (0.00%) | 0/7 (0.00%) | 1/7 (14.29%) | 0/9 (0.00%) | 0/8 (0.00%) | 0/8 (0.00%) | 0/5 (0.00%) | 0/8 (0.00%) |
| # events | 0 | 0 | 0 | 0 | 0 | 1 | 0 | 0 | 0 | 0 | 0 |
| Macular degeneration † 1 | |||||||||||
| # participants affected / at risk | 0/5 (0.00%) | 0/13 (0.00%) | 0/8 (0.00%) | 0/8 (0.00%) | 0/7 (0.00%) | 0/7 (0.00%) | 1/9 (11.11%) | 0/8 (0.00%) | 0/8 (0.00%) | 0/5 (0.00%) | 0/8 (0.00%) |
| # events | 0 | 0 | 0 | 0 | 0 | 0 | 1 | 0 | 0 | 0 | 0 |
| Visual impairment † 1 | |||||||||||
| # participants affected / at risk | 0/5 (0.00%) | 0/13 (0.00%) | 0/8 (0.00%) | 0/8 (0.00%) | 0/7 (0.00%) | 0/7 (0.00%) | 0/9 (0.00%) | 0/8 (0.00%) | 0/8 (0.00%) | 1/5 (20.00%) | 0/8 (0.00%) |
| # events | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 1 | 0 |
| Vitreous floaters † 1 | |||||||||||
| # participants affected / at risk | 0/5 (0.00%) | 1/13 (7.69%) | 0/8 (0.00%) | 0/8 (0.00%) | 0/7 (0.00%) | 0/7 (0.00%) | 0/9 (0.00%) | 0/8 (0.00%) | 0/8 (0.00%) | 0/5 (0.00%) | 0/8 (0.00%) |
| # events | 0 | 1 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| Gastrointestinal disorders | |||||||||||
| Abdominal discomfort † 1 | |||||||||||
| # participants affected / at risk | 1/5 (20.00%) | 0/13 (0.00%) | 0/8 (0.00%) | 0/8 (0.00%) | 0/7 (0.00%) | 0/7 (0.00%) | 0/9 (0.00%) | 0/8 (0.00%) | 0/8 (0.00%) | 0/5 (0.00%) | 0/8 (0.00%) |
| # events | 1 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| Abdominal pain † 1 | |||||||||||
| # participants affected / at risk | 0/5 (0.00%) | 1/13 (7.69%) | 0/8 (0.00%) | 0/8 (0.00%) | 0/7 (0.00%) | 0/7 (0.00%) | 0/9 (0.00%) | 0/8 (0.00%) | 1/8 (12.50%) | 0/5 (0.00%) | 0/8 (0.00%) |
| # events | 0 | 1 | 0 | 0 | 0 | 0 | 0 | 0 | 1 | 0 | 0 |
| Abdominal pain lower † 1 | |||||||||||
| # participants affected / at risk | 0/5 (0.00%) | 0/13 (0.00%) | 1/8 (12.50%) | 0/8 (0.00%) | 0/7 (0.00%) | 0/7 (0.00%) | 0/9 (0.00%) | 0/8 (0.00%) | 0/8 (0.00%) | 0/5 (0.00%) | 0/8 (0.00%) |
| # events | 0 | 0 | 1 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| Constipation † 1 | |||||||||||
| # participants affected / at risk | 1/5 (20.00%) | 0/13 (0.00%) | 1/8 (12.50%) | 1/8 (12.50%) | 0/7 (0.00%) | 0/7 (0.00%) | 1/9 (11.11%) | 0/8 (0.00%) | 0/8 (0.00%) | 0/5 (0.00%) | 0/8 (0.00%) |
| # events | 1 | 0 | 1 | 1 | 0 | 0 | 1 | 0 | 0 | 0 | 0 |
| Diarrhoea † 1 | |||||||||||
| # participants affected / at risk | 0/5 (0.00%) | 3/13 (23.08%) | 1/8 (12.50%) | 1/8 (12.50%) | 2/7 (28.57%) | 0/7 (0.00%) | 2/9 (22.22%) | 0/8 (0.00%) | 0/8 (0.00%) | 1/5 (20.00%) | 0/8 (0.00%) |
| # events | 0 | 3 | 1 | 1 | 2 | 0 | 2 | 0 | 0 | 1 | 0 |
| Diverticulum † 1 | |||||||||||
| # participants affected / at risk | 0/5 (0.00%) | 0/13 (0.00%) | 0/8 (0.00%) | 0/8 (0.00%) | 0/7 (0.00%) | 0/7 (0.00%) | 1/9 (11.11%) | 0/8 (0.00%) | 0/8 (0.00%) | 0/5 (0.00%) | 0/8 (0.00%) |
| # events | 0 | 0 | 0 | 0 | 0 | 0 | 1 | 0 | 0 | 0 | 0 |
| Dyspepsia † 1 | |||||||||||
| # participants affected / at risk | 1/5 (20.00%) | 0/13 (0.00%) | 0/8 (0.00%) | 1/8 (12.50%) | 1/7 (14.29%) | 1/7 (14.29%) | 0/9 (0.00%) | 0/8 (0.00%) | 0/8 (0.00%) | 0/5 (0.00%) | 0/8 (0.00%) |
| # events | 1 | 0 | 0 | 1 | 1 | 1 | 0 | 0 | 0 | 0 | 0 |
| Dysphagia † 1 | |||||||||||
| # participants affected / at risk | 1/5 (20.00%) | 0/13 (0.00%) | 0/8 (0.00%) | 0/8 (0.00%) | 0/7 (0.00%) | 0/7 (0.00%) | 0/9 (0.00%) | 0/8 (0.00%) | 0/8 (0.00%) | 0/5 (0.00%) | 0/8 (0.00%) |
| # events | 1 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| Flatulence † 1 | |||||||||||
| # participants affected / at risk | 0/5 (0.00%) | 0/13 (0.00%) | 0/8 (0.00%) | 1/8 (12.50%) | 0/7 (0.00%) | 0/7 (0.00%) | 0/9 (0.00%) | 0/8 (0.00%) | 0/8 (0.00%) | 0/5 (0.00%) | 0/8 (0.00%) |
| # events | 0 | 0 | 0 | 1 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| Gastritis † 1 | |||||||||||
| # participants affected / at risk | 0/5 (0.00%) | 1/13 (7.69%) | 0/8 (0.00%) | 0/8 (0.00%) | 0/7 (0.00%) | 0/7 (0.00%) | 0/9 (0.00%) | 0/8 (0.00%) | 0/8 (0.00%) | 0/5 (0.00%) | 0/8 (0.00%) |
| # events | 0 | 1 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| Gingival bleeding † 1 | |||||||||||
| # participants affected / at risk | 1/5 (20.00%) | 0/13 (0.00%) | 0/8 (0.00%) | 0/8 (0.00%) | 0/7 (0.00%) | 0/7 (0.00%) | 0/9 (0.00%) | 0/8 (0.00%) | 0/8 (0.00%) | 0/5 (0.00%) | 0/8 (0.00%) |
| # events | 1 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| Gingivitis † 1 | |||||||||||
| # participants affected / at risk | 1/5 (20.00%) | 0/13 (0.00%) | 0/8 (0.00%) | 0/8 (0.00%) | 0/7 (0.00%) | 0/7 (0.00%) | 0/9 (0.00%) | 0/8 (0.00%) | 0/8 (0.00%) | 0/5 (0.00%) | 0/8 (0.00%) |
| # events | 1 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| Haemorrhoids † 1 | |||||||||||
| # participants affected / at risk | 0/5 (0.00%) | 0/13 (0.00%) | 0/8 (0.00%) | 1/8 (12.50%) | 0/7 (0.00%) | 0/7 (0.00%) | 1/9 (11.11%) | 0/8 (0.00%) | 0/8 (0.00%) | 0/5 (0.00%) | 0/8 (0.00%) |
| # events | 0 | 0 | 0 | 2 | 0 | 0 | 1 | 0 | 0 | 0 | 0 |
| Hyperchlorhydria † 1 | |||||||||||
| # participants affected / at risk | 0/5 (0.00%) | 0/13 (0.00%) | 0/8 (0.00%) | 1/8 (12.50%) | 0/7 (0.00%) | 0/7 (0.00%) | 0/9 (0.00%) | 0/8 (0.00%) | 0/8 (0.00%) | 0/5 (0.00%) | 0/8 (0.00%) |
| # events | 0 | 0 | 0 | 1 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| Lip swelling † 1 | |||||||||||
| # participants affected / at risk | 0/5 (0.00%) | 1/13 (7.69%) | 0/8 (0.00%) | 0/8 (0.00%) | 0/7 (0.00%) | 0/7 (0.00%) | 0/9 (0.00%) | 0/8 (0.00%) | 0/8 (0.00%) | 0/5 (0.00%) | 0/8 (0.00%) |
| # events | 0 | 1 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| Nausea † 1 | |||||||||||
| # participants affected / at risk | 0/5 (0.00%) | 0/13 (0.00%) | 0/8 (0.00%) | 0/8 (0.00%) | 1/7 (14.29%) | 2/7 (28.57%) | 2/9 (22.22%) | 0/8 (0.00%) | 0/8 (0.00%) | 0/5 (0.00%) | 0/8 (0.00%) |
| # events | 0 | 0 | 0 | 0 | 1 | 2 | 2 | 0 | 0 | 0 | 0 |
| Oral mucosal erythema † 1 | |||||||||||
| # participants affected / at risk | 0/5 (0.00%) | 0/13 (0.00%) | 0/8 (0.00%) | 0/8 (0.00%) | 0/7 (0.00%) | 0/7 (0.00%) | 0/9 (0.00%) | 0/8 (0.00%) | 0/8 (0.00%) | 1/5 (20.00%) | 0/8 (0.00%) |
| # events | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 1 | 0 |
| Peptic ulcer † 1 | |||||||||||
| # participants affected / at risk | 0/5 (0.00%) | 0/13 (0.00%) | 0/8 (0.00%) | 0/8 (0.00%) | 0/7 (0.00%) | 0/7 (0.00%) | 1/9 (11.11%) | 0/8 (0.00%) | 0/8 (0.00%) | 0/5 (0.00%) | 0/8 (0.00%) |
| # events | 0 | 0 | 0 | 0 | 0 | 0 | 1 | 0 | 0 | 0 | 0 |
| Proctalgia † 1 | |||||||||||
| # participants affected / at risk | 0/5 (0.00%) | 0/13 (0.00%) | 0/8 (0.00%) | 0/8 (0.00%) | 0/7 (0.00%) | 0/7 (0.00%) | 1/9 (11.11%) | 0/8 (0.00%) | 0/8 (0.00%) | 0/5 (0.00%) | 0/8 (0.00%) |
| # events | 0 | 0 | 0 | 0 | 0 | 0 | 1 | 0 | 0 | 0 | 0 |
| Rectal haemorrhage † 1 | |||||||||||
| # participants affected / at risk | 0/5 (0.00%) | 0/13 (0.00%) | 0/8 (0.00%) | 1/8 (12.50%) | 0/7 (0.00%) | 0/7 (0.00%) | 1/9 (11.11%) | 0/8 (0.00%) | 0/8 (0.00%) | 0/5 (0.00%) | 0/8 (0.00%) |
| # events | 0 | 0 | 0 | 1 | 0 | 0 | 1 | 0 | 0 | 0 | 0 |
| Salivary hypersecretion † 1 | |||||||||||
| # participants affected / at risk | 0/5 (0.00%) | 1/13 (7.69%) | 0/8 (0.00%) | 0/8 (0.00%) | 0/7 (0.00%) | 0/7 (0.00%) | 0/9 (0.00%) | 0/8 (0.00%) | 0/8 (0.00%) | 0/5 (0.00%) | 0/8 (0.00%) |
| # events | 0 | 1 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| Stomatitis † 1 | |||||||||||
| # participants affected / at risk | 0/5 (0.00%) | 0/13 (0.00%) | 0/8 (0.00%) | 0/8 (0.00%) | 0/7 (0.00%) | 0/7 (0.00%) | 0/9 (0.00%) | 1/8 (12.50%) | 0/8 (0.00%) | 0/5 (0.00%) | 0/8 (0.00%) |
| # events | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 1 | 0 | 0 | 0 |
| Toothache † 1 | |||||||||||
| # participants affected / at risk | 0/5 (0.00%) | 0/13 (0.00%) | 1/8 (12.50%) | 0/8 (0.00%) | 0/7 (0.00%) | 0/7 (0.00%) | 0/9 (0.00%) | 0/8 (0.00%) | 0/8 (0.00%) | 0/5 (0.00%) | 0/8 (0.00%) |
| # events | 0 | 0 | 1 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| Vomiting † 1 | |||||||||||
| # participants affected / at risk | 0/5 (0.00%) | 0/13 (0.00%) | 0/8 (0.00%) | 0/8 (0.00%) | 1/7 (14.29%) | 0/7 (0.00%) | 0/9 (0.00%) | 0/8 (0.00%) | 0/8 (0.00%) | 0/5 (0.00%) | 0/8 (0.00%) |
| # events | 0 | 0 | 0 | 0 | 1 | 0 | 0 | 0 | 0 | 0 | 0 |
| General disorders | |||||||||||
| Adverse drug reaction † 1 | |||||||||||
| # participants affected / at risk | 0/5 (0.00%) | 0/13 (0.00%) | 0/8 (0.00%) | 0/8 (0.00%) | 0/7 (0.00%) | 0/7 (0.00%) | 0/9 (0.00%) | 0/8 (0.00%) | 1/8 (12.50%) | 0/5 (0.00%) | 0/8 (0.00%) |
| # events | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 1 | 0 | 0 |
| Asthenia † 1 | |||||||||||
| # participants affected / at risk | 0/5 (0.00%) | 1/13 (7.69%) | 0/8 (0.00%) | 0/8 (0.00%) | 0/7 (0.00%) | 0/7 (0.00%) | 0/9 (0.00%) | 0/8 (0.00%) | 0/8 (0.00%) | 0/5 (0.00%) | 0/8 (0.00%) |
| # events | 0 | 2 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| Fatigue † 1 | |||||||||||
| # participants affected / at risk | 0/5 (0.00%) | 1/13 (7.69%) | 0/8 (0.00%) | 2/8 (25.00%) | 0/7 (0.00%) | 1/7 (14.29%) | 2/9 (22.22%) | 0/8 (0.00%) | 0/8 (0.00%) | 0/5 (0.00%) | 0/8 (0.00%) |
| # events | 0 | 1 | 0 | 3 | 0 | 1 | 2 | 0 | 0 | 0 | 0 |
| Feeling cold † 1 | |||||||||||
| # participants affected / at risk | 0/5 (0.00%) | 0/13 (0.00%) | 0/8 (0.00%) | 0/8 (0.00%) | 0/7 (0.00%) | 0/7 (0.00%) | 0/9 (0.00%) | 1/8 (12.50%) | 0/8 (0.00%) | 0/5 (0.00%) | 0/8 (0.00%) |
| # events | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 1 | 0 | 0 | 0 |
| Gait disturbance † 1 | |||||||||||
| # participants affected / at risk | 0/5 (0.00%) | 0/13 (0.00%) | 0/8 (0.00%) | 0/8 (0.00%) | 0/7 (0.00%) | 0/7 (0.00%) | 0/9 (0.00%) | 0/8 (0.00%) | 0/8 (0.00%) | 1/5 (20.00%) | 0/8 (0.00%) |
| # events | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 1 | 0 |
| Influenza like illness † 1 | |||||||||||
| # participants affected / at risk | 0/5 (0.00%) | 0/13 (0.00%) | 0/8 (0.00%) | 0/8 (0.00%) | 0/7 (0.00%) | 0/7 (0.00%) | 0/9 (0.00%) | 0/8 (0.00%) | 0/8 (0.00%) | 0/5 (0.00%) | 1/8 (12.50%) |
| # events | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 1 |
| Injection site discomfort † 1 | |||||||||||
| # participants affected / at risk | 0/5 (0.00%) | 0/13 (0.00%) | 0/8 (0.00%) | 0/8 (0.00%) | 0/7 (0.00%) | 1/7 (14.29%) | 0/9 (0.00%) | 0/8 (0.00%) | 0/8 (0.00%) | 0/5 (0.00%) | 0/8 (0.00%) |
| # events | 0 | 0 | 0 | 0 | 0 | 1 | 0 | 0 | 0 | 0 | 0 |
| Injection site erythema † 1 | |||||||||||
| # participants affected / at risk | 1/5 (20.00%) | 2/13 (15.38%) | 0/8 (0.00%) | 1/8 (12.50%) | 2/7 (28.57%) | 3/7 (42.86%) | 2/9 (22.22%) | 2/8 (25.00%) | 3/8 (37.50%) | 2/5 (40.00%) | 6/8 (75.00%) |
| # events | 2 | 2 | 0 | 2 | 3 | 3 | 2 | 4 | 5 | 4 | 11 |
| Injection site haematoma † 1 | |||||||||||
| # participants affected / at risk | 0/5 (0.00%) | 0/13 (0.00%) | 0/8 (0.00%) | 1/8 (12.50%) | 0/7 (0.00%) | 0/7 (0.00%) | 0/9 (0.00%) | 0/8 (0.00%) | 0/8 (0.00%) | 1/5 (20.00%) | 0/8 (0.00%) |
| # events | 0 | 0 | 0 | 1 | 0 | 0 | 0 | 0 | 0 | 1 | 0 |
| Injection site hypersensitivity † 1 | |||||||||||
| # participants affected / at risk | 0/5 (0.00%) | 0/13 (0.00%) | 0/8 (0.00%) | 0/8 (0.00%) | 0/7 (0.00%) | 0/7 (0.00%) | 1/9 (11.11%) | 0/8 (0.00%) | 0/8 (0.00%) | 0/5 (0.00%) | 0/8 (0.00%) |
| # events | 0 | 0 | 0 | 0 | 0 | 0 | 1 | 0 | 0 | 0 | 0 |
| Injection site mass † 1 | |||||||||||
| # participants affected / at risk | 0/5 (0.00%) | 0/13 (0.00%) | 0/8 (0.00%) | 0/8 (0.00%) | 0/7 (0.00%) | 0/7 (0.00%) | 0/9 (0.00%) | 0/8 (0.00%) | 0/8 (0.00%) | 0/5 (0.00%) | 1/8 (12.50%) |
| # events | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 1 |
| Injection site pain † 1 | |||||||||||
| # participants affected / at risk | 1/5 (20.00%) | 3/13 (23.08%) | 1/8 (12.50%) | 4/8 (50.00%) | 1/7 (14.29%) | 7/7 (100.00%) | 4/9 (44.44%) | 3/8 (37.50%) | 4/8 (50.00%) | 5/5 (100.00%) | 5/8 (62.50%) |
| # events | 3 | 4 | 2 | 9 | 2 | 10 | 6 | 4 | 9 | 13 | 13 |
| Injection site pruritus † 1 | |||||||||||
| # participants affected / at risk | 0/5 (0.00%) | 0/13 (0.00%) | 0/8 (0.00%) | 1/8 (12.50%) | 0/7 (0.00%) | 0/7 (0.00%) | 0/9 (0.00%) | 0/8 (0.00%) | 0/8 (0.00%) | 0/5 (0.00%) | 0/8 (0.00%) |
| # events | 0 | 0 | 0 | 1 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| Injection site rash † 1 | |||||||||||
| # participants affected / at risk | 0/5 (0.00%) | 0/13 (0.00%) | 0/8 (0.00%) | 0/8 (0.00%) | 0/7 (0.00%) | 0/7 (0.00%) | 1/9 (11.11%) | 0/8 (0.00%) | 0/8 (0.00%) | 0/5 (0.00%) | 0/8 (0.00%) |
| # events | 0 | 0 | 0 | 0 | 0 | 0 | 1 | 0 | 0 | 0 | 0 |
| Injection site swelling † 1 | |||||||||||
| # participants affected / at risk | 1/5 (20.00%) | 2/13 (15.38%) | 1/8 (12.50%) | 3/8 (37.50%) | 2/7 (28.57%) | 2/7 (28.57%) | 0/9 (0.00%) | 2/8 (25.00%) | 3/8 (37.50%) | 3/5 (60.00%) | 5/8 (62.50%) |
| # events | 2 | 2 | 1 | 4 | 3 | 3 | 0 | 3 | 6 | 6 | 5 |
| Malaise † 1 | |||||||||||
| # participants affected / at risk | 0/5 (0.00%) | 0/13 (0.00%) | 1/8 (12.50%) | 0/8 (0.00%) | 0/7 (0.00%) | 0/7 (0.00%) | 0/9 (0.00%) | 0/8 (0.00%) | 0/8 (0.00%) | 0/5 (0.00%) | 0/8 (0.00%) |
| # events | 0 | 0 | 1 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| Oedema peripheral † 1 | |||||||||||
| # participants affected / at risk | 0/5 (0.00%) | 0/13 (0.00%) | 0/8 (0.00%) | 0/8 (0.00%) | 0/7 (0.00%) | 0/7 (0.00%) | 1/9 (11.11%) | 0/8 (0.00%) | 0/8 (0.00%) | 0/5 (0.00%) | 0/8 (0.00%) |
| # events | 0 | 0 | 0 | 0 | 0 | 0 | 2 | 0 | 0 | 0 | 0 |
| Pain † 1 | |||||||||||
| # participants affected / at risk | 0/5 (0.00%) | 0/13 (0.00%) | 0/8 (0.00%) | 0/8 (0.00%) | 0/7 (0.00%) | 0/7 (0.00%) | 0/9 (0.00%) | 0/8 (0.00%) | 1/8 (12.50%) | 0/5 (0.00%) | 0/8 (0.00%) |
| # events | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 1 | 0 | 0 |
| Pyrexia † 1 | |||||||||||
| # participants affected / at risk | 0/5 (0.00%) | 1/13 (7.69%) | 3/8 (37.50%) | 1/8 (12.50%) | 1/7 (14.29%) | 0/7 (0.00%) | 1/9 (11.11%) | 0/8 (0.00%) | 0/8 (0.00%) | 0/5 (0.00%) | 0/8 (0.00%) |
| # events | 0 | 1 | 3 | 1 | 1 | 0 | 1 | 0 | 0 | 0 | 0 |
| Infections and infestations | |||||||||||
| Bronchitis † 1 | |||||||||||
| # participants affected / at risk | 0/5 (0.00%) | 1/13 (7.69%) | 0/8 (0.00%) | 0/8 (0.00%) | 1/7 (14.29%) | 0/7 (0.00%) | 0/9 (0.00%) | 1/8 (12.50%) | 0/8 (0.00%) | 0/5 (0.00%) | 0/8 (0.00%) |
| # events | 0 | 1 | 0 | 0 | 1 | 0 | 0 | 1 | 0 | 0 | 0 |
| Cellulitis † 1 | |||||||||||
| # participants affected / at risk | 0/5 (0.00%) | 1/13 (7.69%) | 0/8 (0.00%) | 0/8 (0.00%) | 0/7 (0.00%) | 0/7 (0.00%) | 1/9 (11.11%) | 0/8 (0.00%) | 0/8 (0.00%) | 0/5 (0.00%) | 0/8 (0.00%) |
| # events | 0 | 2 | 0 | 0 | 0 | 0 | 1 | 0 | 0 | 0 | 0 |
| Cystitis † 1 | |||||||||||
| # participants affected / at risk | 0/5 (0.00%) | 0/13 (0.00%) | 0/8 (0.00%) | 1/8 (12.50%) | 0/7 (0.00%) | 0/7 (0.00%) | 0/9 (0.00%) | 0/8 (0.00%) | 0/8 (0.00%) | 0/5 (0.00%) | 0/8 (0.00%) |
| # events | 0 | 0 | 0 | 1 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| Diverticulitis † 1 | |||||||||||
| # participants affected / at risk | 0/5 (0.00%) | 0/13 (0.00%) | 1/8 (12.50%) | 0/8 (0.00%) | 0/7 (0.00%) | 0/7 (0.00%) | 0/9 (0.00%) | 0/8 (0.00%) | 0/8 (0.00%) | 0/5 (0.00%) | 0/8 (0.00%) |
| # events | 0 | 0 | 1 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| Fungal skin infection † 1 | |||||||||||
| # participants affected / at risk | 0/5 (0.00%) | 0/13 (0.00%) | 0/8 (0.00%) | 0/8 (0.00%) | 0/7 (0.00%) | 0/7 (0.00%) | 0/9 (0.00%) | 0/8 (0.00%) | 0/8 (0.00%) | 0/5 (0.00%) | 1/8 (12.50%) |
| # events | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 1 |
| Herpes zoster † 1 | |||||||||||
| # participants affected / at risk | 0/5 (0.00%) | 0/13 (0.00%) | 0/8 (0.00%) | 0/8 (0.00%) | 0/7 (0.00%) | 1/7 (14.29%) | 0/9 (0.00%) | 0/8 (0.00%) | 0/8 (0.00%) | 0/5 (0.00%) | 0/8 (0.00%) |
| # events | 0 | 0 | 0 | 0 | 0 | 1 | 0 | 0 | 0 | 0 | 0 |
| Localised infection † 1 | |||||||||||
| # participants affected / at risk | 1/5 (20.00%) | 0/13 (0.00%) | 0/8 (0.00%) | 0/8 (0.00%) | 0/7 (0.00%) | 0/7 (0.00%) | 0/9 (0.00%) | 0/8 (0.00%) | 0/8 (0.00%) | 0/5 (0.00%) | 0/8 (0.00%) |
| # events | 1 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| Nasopharyngitis † 1 | |||||||||||
| # participants affected / at risk | 0/5 (0.00%) | 1/13 (7.69%) | 1/8 (12.50%) | 1/8 (12.50%) | 0/7 (0.00%) | 0/7 (0.00%) | 1/9 (11.11%) | 0/8 (0.00%) | 0/8 (0.00%) | 1/5 (20.00%) | 0/8 (0.00%) |
| # events | 0 | 1 | 1 | 1 | 0 | 0 | 1 | 0 | 0 | 1 | 0 |
| Otitis externa † 1 | |||||||||||
| # participants affected / at risk | 0/5 (0.00%) | 1/13 (7.69%) | 0/8 (0.00%) | 0/8 (0.00%) | 0/7 (0.00%) | 0/7 (0.00%) | 0/9 (0.00%) | 0/8 (0.00%) | 0/8 (0.00%) | 0/5 (0.00%) | 0/8 (0.00%) |
| # events | 0 | 1 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| Pneumonia † 1 | |||||||||||
| # participants affected / at risk | 0/5 (0.00%) | 0/13 (0.00%) | 0/8 (0.00%) | 0/8 (0.00%) | 0/7 (0.00%) | 0/7 (0.00%) | 0/9 (0.00%) | 0/8 (0.00%) | 0/8 (0.00%) | 1/5 (20.00%) | 0/8 (0.00%) |
| # events | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 1 | 0 |
| Prostate infection † 1 | |||||||||||
| # participants affected / at risk | 0/5 (0.00%) | 0/13 (0.00%) | 0/8 (0.00%) | 0/8 (0.00%) | 0/7 (0.00%) | 0/7 (0.00%) | 0/9 (0.00%) | 0/8 (0.00%) | 0/8 (0.00%) | 0/5 (0.00%) | 1/8 (12.50%) |
| # events | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 1 |
| Rhinitis † 1 | |||||||||||
| # participants affected / at risk | 0/5 (0.00%) | 0/13 (0.00%) | 0/8 (0.00%) | 0/8 (0.00%) | 0/7 (0.00%) | 1/7 (14.29%) | 0/9 (0.00%) | 0/8 (0.00%) | 0/8 (0.00%) | 0/5 (0.00%) | 0/8 (0.00%) |
| # events | 0 | 0 | 0 | 0 | 0 | 1 | 0 | 0 | 0 | 0 | 0 |
| Sinusitis † 1 | |||||||||||
| # participants affected / at risk | 1/5 (20.00%) | 0/13 (0.00%) | 0/8 (0.00%) | 1/8 (12.50%) | 0/7 (0.00%) | 0/7 (0.00%) | 0/9 (0.00%) | 0/8 (0.00%) | 1/8 (12.50%) | 0/5 (0.00%) | 0/8 (0.00%) |
| # events | 1 | 0 | 0 | 1 | 0 | 0 | 0 | 0 | 1 | 0 | 0 |
| Tooth abscess † 1 | |||||||||||
| # participants affected / at risk | 0/5 (0.00%) | 0/13 (0.00%) | 0/8 (0.00%) | 0/8 (0.00%) | 0/7 (0.00%) | 0/7 (0.00%) | 0/9 (0.00%) | 0/8 (0.00%) | 0/8 (0.00%) | 1/5 (20.00%) | 0/8 (0.00%) |
| # events | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 1 | 0 |
| Tooth infection † 1 | |||||||||||
| # participants affected / at risk | 0/5 (0.00%) | 0/13 (0.00%) | 1/8 (12.50%) | 0/8 (0.00%) | 1/7 (14.29%) | 0/7 (0.00%) | 0/9 (0.00%) | 0/8 (0.00%) | 0/8 (0.00%) | 0/5 (0.00%) | 0/8 (0.00%) |
| # events | 0 | 0 | 1 | 0 | 1 | 0 | 0 | 0 | 0 | 0 | 0 |
| Upper respiratory tract infection † 1 | |||||||||||
| # participants affected / at risk | 1/5 (20.00%) | 1/13 (7.69%) | 1/8 (12.50%) | 0/8 (0.00%) | 2/7 (28.57%) | 1/7 (14.29%) | 1/9 (11.11%) | 0/8 (0.00%) | 0/8 (0.00%) | 0/5 (0.00%) | 0/8 (0.00%) |
| # events | 1 | 1 | 1 | 0 | 2 | 1 | 1 | 0 | 0 | 0 | 0 |
| Urinary tract infection † 1 | |||||||||||
| # participants affected / at risk | 0/5 (0.00%) | 0/13 (0.00%) | 1/8 (12.50%) | 0/8 (0.00%) | 0/7 (0.00%) | 1/7 (14.29%) | 0/9 (0.00%) | 0/8 (0.00%) | 0/8 (0.00%) | 1/5 (20.00%) | 0/8 (0.00%) |
| # events | 0 | 0 | 1 | 0 | 0 | 1 | 0 | 0 | 0 | 1 | 0 |
| Wound infection † 1 | |||||||||||
| # participants affected / at risk | 0/5 (0.00%) | 0/13 (0.00%) | 1/8 (12.50%) | 0/8 (0.00%) | 0/7 (0.00%) | 0/7 (0.00%) | 0/9 (0.00%) | 0/8 (0.00%) | 0/8 (0.00%) | 0/5 (0.00%) | 0/8 (0.00%) |
| # events | 0 | 0 | 1 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| Injury, poisoning and procedural complications | |||||||||||
| Arthropod bite † 1 | |||||||||||
| # participants affected / at risk | 0/5 (0.00%) | 0/13 (0.00%) | 0/8 (0.00%) | 0/8 (0.00%) | 1/7 (14.29%) | 0/7 (0.00%) | 0/9 (0.00%) | 0/8 (0.00%) | 0/8 (0.00%) | 0/5 (0.00%) | 0/8 (0.00%) |
| # events | 0 | 0 | 0 | 0 | 1 | 0 | 0 | 0 | 0 | 0 | 0 |
| Concussion † 1 | |||||||||||
| # participants affected / at risk | 0/5 (0.00%) | 0/13 (0.00%) | 0/8 (0.00%) | 0/8 (0.00%) | 0/7 (0.00%) | 0/7 (0.00%) | 0/9 (0.00%) | 0/8 (0.00%) | 0/8 (0.00%) | 1/5 (20.00%) | 0/8 (0.00%) |
| # events | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 1 | 0 |
| Contusion † 1 | |||||||||||
| # participants affected / at risk | 0/5 (0.00%) | 0/13 (0.00%) | 2/8 (25.00%) | 0/8 (0.00%) | 0/7 (0.00%) | 0/7 (0.00%) | 0/9 (0.00%) | 0/8 (0.00%) | 0/8 (0.00%) | 0/5 (0.00%) | 0/8 (0.00%) |
| # events | 0 | 0 | 4 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| Documented hypersensitivity to administered drug † 1 | |||||||||||
| # participants affected / at risk | 0/5 (0.00%) | 0/13 (0.00%) | 1/8 (12.50%) | 0/8 (0.00%) | 0/7 (0.00%) | 0/7 (0.00%) | 0/9 (0.00%) | 0/8 (0.00%) | 0/8 (0.00%) | 0/5 (0.00%) | 0/8 (0.00%) |
| # events | 0 | 0 | 1 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| Excoriation † 1 | |||||||||||
| # participants affected / at risk | 0/5 (0.00%) | 0/13 (0.00%) | 0/8 (0.00%) | 1/8 (12.50%) | 0/7 (0.00%) | 0/7 (0.00%) | 0/9 (0.00%) | 0/8 (0.00%) | 0/8 (0.00%) | 0/5 (0.00%) | 0/8 (0.00%) |
| # events | 0 | 0 | 0 | 2 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| Fall † 1 | |||||||||||
| # participants affected / at risk | 2/5 (40.00%) | 1/13 (7.69%) | 0/8 (0.00%) | 1/8 (12.50%) | 0/7 (0.00%) | 1/7 (14.29%) | 1/9 (11.11%) | 0/8 (0.00%) | 1/8 (12.50%) | 0/5 (0.00%) | 0/8 (0.00%) |
| # events | 2 | 1 | 0 | 2 | 0 | 1 | 1 | 0 | 1 | 0 | 0 |
| Foot fracture † 1 | |||||||||||
| # participants affected / at risk | 1/5 (20.00%) | 0/13 (0.00%) | 0/8 (0.00%) | 1/8 (12.50%) | 0/7 (0.00%) | 0/7 (0.00%) | 0/9 (0.00%) | 0/8 (0.00%) | 0/8 (0.00%) | 0/5 (0.00%) | 0/8 (0.00%) |
| # events | 1 | 0 | 0 | 1 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| Laceration † 1 | |||||||||||
| # participants affected / at risk | 1/5 (20.00%) | 1/13 (7.69%) | 0/8 (0.00%) | 0/8 (0.00%) | 0/7 (0.00%) | 0/7 (0.00%) | 0/9 (0.00%) | 0/8 (0.00%) | 0/8 (0.00%) | 0/5 (0.00%) | 0/8 (0.00%) |
| # events | 1 | 1 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| Ligament sprain † 1 | |||||||||||
| # participants affected / at risk | 0/5 (0.00%) | 1/13 (7.69%) | 0/8 (0.00%) | 0/8 (0.00%) | 0/7 (0.00%) | 0/7 (0.00%) | 0/9 (0.00%) | 0/8 (0.00%) | 0/8 (0.00%) | 0/5 (0.00%) | 0/8 (0.00%) |
| # events | 0 | 1 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| Procedural headache † 1 | |||||||||||
| # participants affected / at risk | 0/5 (0.00%) | 0/13 (0.00%) | 1/8 (12.50%) | 0/8 (0.00%) | 0/7 (0.00%) | 0/7 (0.00%) | 0/9 (0.00%) | 0/8 (0.00%) | 0/8 (0.00%) | 0/5 (0.00%) | 0/8 (0.00%) |
| # events | 0 | 0 | 1 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| Rib fracture † 1 | |||||||||||
| # participants affected / at risk | 1/5 (20.00%) | 0/13 (0.00%) | 0/8 (0.00%) | 1/8 (12.50%) | 0/7 (0.00%) | 0/7 (0.00%) | 1/9 (11.11%) | 0/8 (0.00%) | 0/8 (0.00%) | 0/5 (0.00%) | 0/8 (0.00%) |
| # events | 1 | 0 | 0 | 1 | 0 | 0 | 1 | 0 | 0 | 0 | 0 |
| Road traffic accident † 1 | |||||||||||
| # participants affected / at risk | 0/5 (0.00%) | 0/13 (0.00%) | 0/8 (0.00%) | 0/8 (0.00%) | 0/7 (0.00%) | 0/7 (0.00%) | 1/9 (11.11%) | 0/8 (0.00%) | 0/8 (0.00%) | 1/5 (20.00%) | 0/8 (0.00%) |
| # events | 0 | 0 | 0 | 0 | 0 | 0 | 1 | 0 | 0 | 1 | 0 |
| Spinal fracture † 1 | |||||||||||
| # participants affected / at risk | 0/5 (0.00%) | 0/13 (0.00%) | 0/8 (0.00%) | 0/8 (0.00%) | 1/7 (14.29%) | 0/7 (0.00%) | 0/9 (0.00%) | 0/8 (0.00%) | 0/8 (0.00%) | 0/5 (0.00%) | 0/8 (0.00%) |
| # events | 0 | 0 | 0 | 0 | 1 | 0 | 0 | 0 | 0 | 0 | 0 |
| Tooth fracture † 1 | |||||||||||
| # participants affected / at risk | 0/5 (0.00%) | 0/13 (0.00%) | 1/8 (12.50%) | 0/8 (0.00%) | 0/7 (0.00%) | 0/7 (0.00%) | 0/9 (0.00%) | 0/8 (0.00%) | 0/8 (0.00%) | 0/5 (0.00%) | 0/8 (0.00%) |
| # events | 0 | 0 | 1 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| Investigations | |||||||||||
| Blood alkaline phosphatase increased † 1 | |||||||||||
| # participants affected / at risk | 0/5 (0.00%) | 0/13 (0.00%) | 0/8 (0.00%) | 1/8 (12.50%) | 0/7 (0.00%) | 0/7 (0.00%) | 0/9 (0.00%) | 0/8 (0.00%) | 0/8 (0.00%) | 0/5 (0.00%) | 0/8 (0.00%) |
| # events | 0 | 0 | 0 | 1 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| Blood amylase increased † 1 | |||||||||||
| # participants affected / at risk | 0/5 (0.00%) | 0/13 (0.00%) | 0/8 (0.00%) | 0/8 (0.00%) | 1/7 (14.29%) | 0/7 (0.00%) | 0/9 (0.00%) | 0/8 (0.00%) | 0/8 (0.00%) | 0/5 (0.00%) | 0/8 (0.00%) |
| # events | 0 | 0 | 0 | 0 | 1 | 0 | 0 | 0 | 0 | 0 | 0 |
| CSF glucose increased † 1 | |||||||||||
| # participants affected / at risk | 0/5 (0.00%) | 0/13 (0.00%) | 0/8 (0.00%) | 0/8 (0.00%) | 0/7 (0.00%) | 1/7 (14.29%) | 0/9 (0.00%) | 0/8 (0.00%) | 0/8 (0.00%) | 0/5 (0.00%) | 0/8 (0.00%) |
| # events | 0 | 0 | 0 | 0 | 0 | 1 | 0 | 0 | 0 | 0 | 0 |
| CSF protein increased † 1 | |||||||||||
| # participants affected / at risk | 0/5 (0.00%) | 0/13 (0.00%) | 0/8 (0.00%) | 0/8 (0.00%) | 0/7 (0.00%) | 1/7 (14.29%) | 0/9 (0.00%) | 0/8 (0.00%) | 0/8 (0.00%) | 0/5 (0.00%) | 0/8 (0.00%) |
| # events | 0 | 0 | 0 | 0 | 0 | 1 | 0 | 0 | 0 | 0 | 0 |
| Haemoglobin decreased † 1 | |||||||||||
| # participants affected / at risk | 0/5 (0.00%) | 0/13 (0.00%) | 0/8 (0.00%) | 0/8 (0.00%) | 0/7 (0.00%) | 0/7 (0.00%) | 0/9 (0.00%) | 0/8 (0.00%) | 1/8 (12.50%) | 0/5 (0.00%) | 0/8 (0.00%) |
| # events | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 1 | 0 | 0 |
| Neurological examination abnormal † 1 | |||||||||||
| # participants affected / at risk | 0/5 (0.00%) | 0/13 (0.00%) | 0/8 (0.00%) | 1/8 (12.50%) | 0/7 (0.00%) | 0/7 (0.00%) | 0/9 (0.00%) | 0/8 (0.00%) | 0/8 (0.00%) | 0/5 (0.00%) | 0/8 (0.00%) |
| # events | 0 | 0 | 0 | 1 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| Temperature perception test decreased † 1 | |||||||||||
| # participants affected / at risk | 0/5 (0.00%) | 0/13 (0.00%) | 0/8 (0.00%) | 0/8 (0.00%) | 0/7 (0.00%) | 0/7 (0.00%) | 0/9 (0.00%) | 0/8 (0.00%) | 1/8 (12.50%) | 0/5 (0.00%) | 0/8 (0.00%) |
| # events | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 1 | 0 | 0 |
| Weight decreased † 1 | |||||||||||
| # participants affected / at risk | 1/5 (20.00%) | 0/13 (0.00%) | 1/8 (12.50%) | 0/8 (0.00%) | 0/7 (0.00%) | 0/7 (0.00%) | 0/9 (0.00%) | 2/8 (25.00%) | 0/8 (0.00%) | 0/5 (0.00%) | 0/8 (0.00%) |
| # events | 1 | 0 | 1 | 0 | 0 | 0 | 0 | 2 | 0 | 0 | 0 |
| Metabolism and nutrition disorders | |||||||||||
| Decreased appetite † 1 | |||||||||||
| # participants affected / at risk | 0/5 (0.00%) | 0/13 (0.00%) | 1/8 (12.50%) | 0/8 (0.00%) | 0/7 (0.00%) | 0/7 (0.00%) | 0/9 (0.00%) | 1/8 (12.50%) | 0/8 (0.00%) | 0/5 (0.00%) | 0/8 (0.00%) |
| # events | 0 | 0 | 1 | 0 | 0 | 0 | 0 | 1 | 0 | 0 | 0 |
| Dehydration † 1 | |||||||||||
| # participants affected / at risk | 0/5 (0.00%) | 0/13 (0.00%) | 0/8 (0.00%) | 0/8 (0.00%) | 1/7 (14.29%) | 0/7 (0.00%) | 0/9 (0.00%) | 0/8 (0.00%) | 1/8 (12.50%) | 0/5 (0.00%) | 0/8 (0.00%) |
| # events | 0 | 0 | 0 | 0 | 1 | 0 | 0 | 0 | 1 | 0 | 0 |
| Diabetes mellitus † 1 | |||||||||||
| # participants affected / at risk | 0/5 (0.00%) | 0/13 (0.00%) | 0/8 (0.00%) | 0/8 (0.00%) | 0/7 (0.00%) | 0/7 (0.00%) | 0/9 (0.00%) | 0/8 (0.00%) | 0/8 (0.00%) | 0/5 (0.00%) | 1/8 (12.50%) |
| # events | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 1 |
| Hypercholesterolaemia † 1 | |||||||||||
| # participants affected / at risk | 0/5 (0.00%) | 0/13 (0.00%) | 0/8 (0.00%) | 1/8 (12.50%) | 0/7 (0.00%) | 0/7 (0.00%) | 0/9 (0.00%) | 0/8 (0.00%) | 0/8 (0.00%) | 0/5 (0.00%) | 0/8 (0.00%) |
| # events | 0 | 0 | 0 | 1 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| Hypoalbuminaemia † 1 | |||||||||||
| # participants affected / at risk | 0/5 (0.00%) | 0/13 (0.00%) | 0/8 (0.00%) | 0/8 (0.00%) | 0/7 (0.00%) | 0/7 (0.00%) | 1/9 (11.11%) | 0/8 (0.00%) | 0/8 (0.00%) | 0/5 (0.00%) | 0/8 (0.00%) |
| # events | 0 | 0 | 0 | 0 | 0 | 0 | 1 | 0 | 0 | 0 | 0 |
| Hypoglycaemia † 1 | |||||||||||
| # participants affected / at risk | 0/5 (0.00%) | 0/13 (0.00%) | 0/8 (0.00%) | 0/8 (0.00%) | 0/7 (0.00%) | 0/7 (0.00%) | 0/9 (0.00%) | 0/8 (0.00%) | 1/8 (12.50%) | 0/5 (0.00%) | 0/8 (0.00%) |
| # events | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 1 | 0 | 0 |
| Hypokalaemia † 1 | |||||||||||
| # participants affected / at risk | 0/5 (0.00%) | 0/13 (0.00%) | 0/8 (0.00%) | 0/8 (0.00%) | 1/7 (14.29%) | 0/7 (0.00%) | 1/9 (11.11%) | 0/8 (0.00%) | 0/8 (0.00%) | 0/5 (0.00%) | 0/8 (0.00%) |
| # events | 0 | 0 | 0 | 0 | 1 | 0 | 1 | 0 | 0 | 0 | 0 |
| Hyponatraemia † 1 | |||||||||||
| # participants affected / at risk | 0/5 (0.00%) | 0/13 (0.00%) | 0/8 (0.00%) | 0/8 (0.00%) | 0/7 (0.00%) | 0/7 (0.00%) | 0/9 (0.00%) | 0/8 (0.00%) | 1/8 (12.50%) | 0/5 (0.00%) | 0/8 (0.00%) |
| # events | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 1 | 0 | 0 |
| Salt craving † 1 | |||||||||||
| # participants affected / at risk | 0/5 (0.00%) | 1/13 (7.69%) | 0/8 (0.00%) | 0/8 (0.00%) | 0/7 (0.00%) | 0/7 (0.00%) | 0/9 (0.00%) | 0/8 (0.00%) | 0/8 (0.00%) | 0/5 (0.00%) | 0/8 (0.00%) |
| # events | 0 | 1 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| Musculoskeletal and connective tissue disorders | |||||||||||
| Arthralgia † 1 | |||||||||||
| # participants affected / at risk | 0/5 (0.00%) | 0/13 (0.00%) | 2/8 (25.00%) | 0/8 (0.00%) | 0/7 (0.00%) | 1/7 (14.29%) | 1/9 (11.11%) | 0/8 (0.00%) | 0/8 (0.00%) | 0/5 (0.00%) | 0/8 (0.00%) |
| # events | 0 | 0 | 2 | 0 | 0 | 2 | 1 | 0 | 0 | 0 | 0 |
| Arthritis † 1 | |||||||||||
| # participants affected / at risk | 0/5 (0.00%) | 0/13 (0.00%) | 1/8 (12.50%) | 0/8 (0.00%) | 0/7 (0.00%) | 0/7 (0.00%) | 0/9 (0.00%) | 0/8 (0.00%) | 0/8 (0.00%) | 0/5 (0.00%) | 0/8 (0.00%) |
| # events | 0 | 0 | 1 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| Back pain † 1 | |||||||||||
| # participants affected / at risk | 0/5 (0.00%) | 0/13 (0.00%) | 0/8 (0.00%) | 0/8 (0.00%) | 1/7 (14.29%) | 1/7 (14.29%) | 0/9 (0.00%) | 0/8 (0.00%) | 0/8 (0.00%) | 0/5 (0.00%) | 0/8 (0.00%) |
| # events | 0 | 0 | 0 | 0 | 1 | 2 | 0 | 0 | 0 | 0 | 0 |
| Bursitis † 1 | |||||||||||
| # participants affected / at risk | 0/5 (0.00%) | 0/13 (0.00%) | 0/8 (0.00%) | 1/8 (12.50%) | 0/7 (0.00%) | 0/7 (0.00%) | 1/9 (11.11%) | 0/8 (0.00%) | 0/8 (0.00%) | 0/5 (0.00%) | 0/8 (0.00%) |
| # events | 0 | 0 | 0 | 1 | 0 | 0 | 1 | 0 | 0 | 0 | 0 |
| Intervertebral disc protrusion † 1 | |||||||||||
| # participants affected / at risk | 0/5 (0.00%) | 0/13 (0.00%) | 0/8 (0.00%) | 0/8 (0.00%) | 1/7 (14.29%) | 0/7 (0.00%) | 0/9 (0.00%) | 0/8 (0.00%) | 0/8 (0.00%) | 1/5 (20.00%) | 0/8 (0.00%) |
| # events | 0 | 0 | 0 | 0 | 1 | 0 | 0 | 0 | 0 | 1 | 0 |
| Joint swelling † 1 | |||||||||||
| # participants affected / at risk | 0/5 (0.00%) | 0/13 (0.00%) | 0/8 (0.00%) | 1/8 (12.50%) | 1/7 (14.29%) | 0/7 (0.00%) | 0/9 (0.00%) | 0/8 (0.00%) | 0/8 (0.00%) | 0/5 (0.00%) | 0/8 (0.00%) |
| # events | 0 | 0 | 0 | 1 | 1 | 0 | 0 | 0 | 0 | 0 | 0 |
| Monarthritis † 1 | |||||||||||
| # participants affected / at risk | 0/5 (0.00%) | 0/13 (0.00%) | 0/8 (0.00%) | 0/8 (0.00%) | 0/7 (0.00%) | 0/7 (0.00%) | 0/9 (0.00%) | 0/8 (0.00%) | 0/8 (0.00%) | 1/5 (20.00%) | 0/8 (0.00%) |
| # events | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 1 | 0 |
| Muscle spasms † 1 | |||||||||||
| # participants affected / at risk | 1/5 (20.00%) | 2/13 (15.38%) | 0/8 (0.00%) | 0/8 (0.00%) | 0/7 (0.00%) | 0/7 (0.00%) | 0/9 (0.00%) | 0/8 (0.00%) | 0/8 (0.00%) | 0/5 (0.00%) | 0/8 (0.00%) |
| # events | 1 | 2 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| Musculoskeletal pain † 1 | |||||||||||
| # participants affected / at risk | 0/5 (0.00%) | 0/13 (0.00%) | 1/8 (12.50%) | 0/8 (0.00%) | 0/7 (0.00%) | 0/7 (0.00%) | 0/9 (0.00%) | 0/8 (0.00%) | 0/8 (0.00%) | 0/5 (0.00%) | 0/8 (0.00%) |
| # events | 0 | 0 | 1 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| Myalgia † 1 | |||||||||||
| # participants affected / at risk | 0/5 (0.00%) | 0/13 (0.00%) | 0/8 (0.00%) | 1/8 (12.50%) | 0/7 (0.00%) | 0/7 (0.00%) | 0/9 (0.00%) | 0/8 (0.00%) | 0/8 (0.00%) | 0/5 (0.00%) | 0/8 (0.00%) |
| # events | 0 | 0 | 0 | 1 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| Neck pain † 1 | |||||||||||
| # participants affected / at risk | 0/5 (0.00%) | 0/13 (0.00%) | 0/8 (0.00%) | 0/8 (0.00%) | 0/7 (0.00%) | 0/7 (0.00%) | 1/9 (11.11%) | 0/8 (0.00%) | 1/8 (12.50%) | 0/5 (0.00%) | 0/8 (0.00%) |
| # events | 0 | 0 | 0 | 0 | 0 | 0 | 1 | 0 | 1 | 0 | 0 |
| Osteoarthritis † 1 | |||||||||||
| # participants affected / at risk | 0/5 (0.00%) | 0/13 (0.00%) | 0/8 (0.00%) | 0/8 (0.00%) | 0/7 (0.00%) | 0/7 (0.00%) | 0/9 (0.00%) | 1/8 (12.50%) | 0/8 (0.00%) | 0/5 (0.00%) | 0/8 (0.00%) |
| # events | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 1 | 0 | 0 | 0 |
| Pain in extremity † 1 | |||||||||||
| # participants affected / at risk | 1/5 (20.00%) | 0/13 (0.00%) | 0/8 (0.00%) | 0/8 (0.00%) | 0/7 (0.00%) | 0/7 (0.00%) | 0/9 (0.00%) | 0/8 (0.00%) | 0/8 (0.00%) | 1/5 (20.00%) | 0/8 (0.00%) |
| # events | 1 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 1 | 0 |
| Plantar fasciitis † 1 | |||||||||||
| # participants affected / at risk | 0/5 (0.00%) | 1/13 (7.69%) | 0/8 (0.00%) | 0/8 (0.00%) | 0/7 (0.00%) | 0/7 (0.00%) | 0/9 (0.00%) | 0/8 (0.00%) | 0/8 (0.00%) | 0/5 (0.00%) | 0/8 (0.00%) |
| # events | 0 | 1 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| Neoplasms benign, malignant and unspecified (incl cysts and polyps) | |||||||||||
| Melanocytic naevus † 1 | |||||||||||
| # participants affected / at risk | 0/5 (0.00%) | 1/13 (7.69%) | 0/8 (0.00%) | 0/8 (0.00%) | 0/7 (0.00%) | 0/7 (0.00%) | 0/9 (0.00%) | 0/8 (0.00%) | 0/8 (0.00%) | 0/5 (0.00%) | 0/8 (0.00%) |
| # events | 0 | 1 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| Seborrhoeic keratosis † 1 | |||||||||||
| # participants affected / at risk | 0/5 (0.00%) | 0/13 (0.00%) | 0/8 (0.00%) | 0/8 (0.00%) | 0/7 (0.00%) | 0/7 (0.00%) | 0/9 (0.00%) | 1/8 (12.50%) | 0/8 (0.00%) | 0/5 (0.00%) | 0/8 (0.00%) |
| # events | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 1 | 0 | 0 | 0 |
| Nervous system disorders | |||||||||||
| Balance disorder † 1 | |||||||||||
| # participants affected / at risk | 0/5 (0.00%) | 0/13 (0.00%) | 1/8 (12.50%) | 0/8 (0.00%) | 0/7 (0.00%) | 1/7 (14.29%) | 0/9 (0.00%) | 0/8 (0.00%) | 0/8 (0.00%) | 0/5 (0.00%) | 0/8 (0.00%) |
| # events | 0 | 0 | 1 | 0 | 0 | 2 | 0 | 0 | 0 | 0 | 0 |
| Cerebral haemorrhage † 1 | |||||||||||
| # participants affected / at risk | 0/5 (0.00%) | 0/13 (0.00%) | 0/8 (0.00%) | 0/8 (0.00%) | 0/7 (0.00%) | 0/7 (0.00%) | 1/9 (11.11%) | 0/8 (0.00%) | 1/8 (12.50%) | 0/5 (0.00%) | 1/8 (12.50%) |
| # events | 0 | 0 | 0 | 0 | 0 | 0 | 1 | 0 | 1 | 0 | 1 |
| Cerebral microhaemorrhage † 1 | |||||||||||
| # participants affected / at risk | 0/5 (0.00%) | 0/13 (0.00%) | 0/8 (0.00%) | 0/8 (0.00%) | 0/7 (0.00%) | 0/7 (0.00%) | 1/9 (11.11%) | 0/8 (0.00%) | 1/8 (12.50%) | 1/5 (20.00%) | 1/8 (12.50%) |
| # events | 0 | 0 | 0 | 0 | 0 | 0 | 1 | 0 | 1 | 1 | 1 |
| Decreased vibratory sense † 1 | |||||||||||
| # participants affected / at risk | 0/5 (0.00%) | 0/13 (0.00%) | 0/8 (0.00%) | 0/8 (0.00%) | 0/7 (0.00%) | 0/7 (0.00%) | 0/9 (0.00%) | 0/8 (0.00%) | 1/8 (12.50%) | 0/5 (0.00%) | 0/8 (0.00%) |
| # events | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 1 | 0 | 0 |
| Dizziness † 1 | |||||||||||
| # participants affected / at risk | 0/5 (0.00%) | 1/13 (7.69%) | 0/8 (0.00%) | 1/8 (12.50%) | 0/7 (0.00%) | 0/7 (0.00%) | 2/9 (22.22%) | 0/8 (0.00%) | 0/8 (0.00%) | 1/5 (20.00%) | 0/8 (0.00%) |
| # events | 0 | 1 | 0 | 1 | 0 | 0 | 2 | 0 | 0 | 3 | 0 |
| Glabellar reflex abnormal † 1 | |||||||||||
| # participants affected / at risk | 1/5 (20.00%) | 0/13 (0.00%) | 0/8 (0.00%) | 0/8 (0.00%) | 0/7 (0.00%) | 0/7 (0.00%) | 0/9 (0.00%) | 0/8 (0.00%) | 0/8 (0.00%) | 0/5 (0.00%) | 0/8 (0.00%) |
| # events | 1 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| Headache † 1 | |||||||||||
| # participants affected / at risk | 0/5 (0.00%) | 0/13 (0.00%) | 1/8 (12.50%) | 1/8 (12.50%) | 1/7 (14.29%) | 3/7 (42.86%) | 3/9 (33.33%) | 0/8 (0.00%) | 0/8 (0.00%) | 3/5 (60.00%) | 0/8 (0.00%) |
| # events | 0 | 0 | 1 | 2 | 1 | 6 | 3 | 0 | 0 | 5 | 0 |
| Hyporeflexia † 1 | |||||||||||
| # participants affected / at risk | 0/5 (0.00%) | 0/13 (0.00%) | 0/8 (0.00%) | 0/8 (0.00%) | 0/7 (0.00%) | 0/7 (0.00%) | 0/9 (0.00%) | 0/8 (0.00%) | 1/8 (12.50%) | 0/5 (0.00%) | 0/8 (0.00%) |
| # events | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 1 | 0 | 0 |
| Intention tremor † 1 | |||||||||||
| # participants affected / at risk | 1/5 (20.00%) | 0/13 (0.00%) | 0/8 (0.00%) | 1/8 (12.50%) | 0/7 (0.00%) | 0/7 (0.00%) | 0/9 (0.00%) | 0/8 (0.00%) | 0/8 (0.00%) | 0/5 (0.00%) | 0/8 (0.00%) |
| # events | 1 | 0 | 0 | 1 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| Mental impairment † 1 | |||||||||||
| # participants affected / at risk | 0/5 (0.00%) | 0/13 (0.00%) | 2/8 (25.00%) | 0/8 (0.00%) | 0/7 (0.00%) | 0/7 (0.00%) | 0/9 (0.00%) | 0/8 (0.00%) | 0/8 (0.00%) | 0/5 (0.00%) | 0/8 (0.00%) |
| # events | 0 | 0 | 2 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| Neuropathy peripheral † 1 | |||||||||||
| # participants affected / at risk | 0/5 (0.00%) | 0/13 (0.00%) | 0/8 (0.00%) | 0/8 (0.00%) | 0/7 (0.00%) | 0/7 (0.00%) | 0/9 (0.00%) | 0/8 (0.00%) | 0/8 (0.00%) | 0/5 (0.00%) | 1/8 (12.50%) |
| # events | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 1 |
| Parosmia † 1 | |||||||||||
| # participants affected / at risk | 0/5 (0.00%) | 0/13 (0.00%) | 0/8 (0.00%) | 1/8 (12.50%) | 0/7 (0.00%) | 0/7 (0.00%) | 0/9 (0.00%) | 0/8 (0.00%) | 0/8 (0.00%) | 0/5 (0.00%) | 0/8 (0.00%) |
| # events | 0 | 0 | 0 | 1 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| Restless legs syndrome † 1 | |||||||||||
| # participants affected / at risk | 0/5 (0.00%) | 0/13 (0.00%) | 0/8 (0.00%) | 0/8 (0.00%) | 0/7 (0.00%) | 0/7 (0.00%) | 0/9 (0.00%) | 0/8 (0.00%) | 1/8 (12.50%) | 0/5 (0.00%) | 0/8 (0.00%) |
| # events | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 1 | 0 | 0 |
| Sinus headache † 1 | |||||||||||
| # participants affected / at risk | 0/5 (0.00%) | 0/13 (0.00%) | 0/8 (0.00%) | 1/8 (12.50%) | 0/7 (0.00%) | 0/7 (0.00%) | 0/9 (0.00%) | 0/8 (0.00%) | 0/8 (0.00%) | 0/5 (0.00%) | 0/8 (0.00%) |
| # events | 0 | 0 | 0 | 1 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| Somnolence † 1 | |||||||||||
| # participants affected / at risk | 0/5 (0.00%) | 0/13 (0.00%) | 0/8 (0.00%) | 0/8 (0.00%) | 0/7 (0.00%) | 0/7 (0.00%) | 0/9 (0.00%) | 0/8 (0.00%) | 0/8 (0.00%) | 1/5 (20.00%) | 0/8 (0.00%) |
| # events | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 1 | 0 |
| Syncope † 1 | |||||||||||
| # participants affected / at risk | 0/5 (0.00%) | 1/13 (7.69%) | 0/8 (0.00%) | 0/8 (0.00%) | 0/7 (0.00%) | 0/7 (0.00%) | 0/9 (0.00%) | 0/8 (0.00%) | 1/8 (12.50%) | 0/5 (0.00%) | 0/8 (0.00%) |
| # events | 0 | 1 | 0 | 0 | 0 | 0 | 0 | 0 | 1 | 0 | 0 |
| Tremor † 1 | |||||||||||
| # participants affected / at risk | 0/5 (0.00%) | 0/13 (0.00%) | 1/8 (12.50%) | 0/8 (0.00%) | 0/7 (0.00%) | 0/7 (0.00%) | 0/9 (0.00%) | 0/8 (0.00%) | 0/8 (0.00%) | 0/5 (0.00%) | 0/8 (0.00%) |
| # events | 0 | 0 | 1 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| Psychiatric disorders | |||||||||||
| Abnormal dreams † 1 | |||||||||||
| # participants affected / at risk | 0/5 (0.00%) | 0/13 (0.00%) | 0/8 (0.00%) | 0/8 (0.00%) | 0/7 (0.00%) | 0/7 (0.00%) | 1/9 (11.11%) | 0/8 (0.00%) | 0/8 (0.00%) | 0/5 (0.00%) | 0/8 (0.00%) |
| # events | 0 | 0 | 0 | 0 | 0 | 0 | 1 | 0 | 0 | 0 | 0 |
| Agitation † 1 | |||||||||||
| # participants affected / at risk | 1/5 (20.00%) | 0/13 (0.00%) | 0/8 (0.00%) | 1/8 (12.50%) | 0/7 (0.00%) | 0/7 (0.00%) | 1/9 (11.11%) | 0/8 (0.00%) | 0/8 (0.00%) | 1/5 (20.00%) | 0/8 (0.00%) |
| # events | 1 | 0 | 0 | 1 | 0 | 0 | 1 | 0 | 0 | 1 | 0 |
| Anxiety † 1 | |||||||||||
| # participants affected / at risk | 0/5 (0.00%) | 2/13 (15.38%) | 1/8 (12.50%) | 0/8 (0.00%) | 0/7 (0.00%) | 0/7 (0.00%) | 2/9 (22.22%) | 0/8 (0.00%) | 0/8 (0.00%) | 1/5 (20.00%) | 1/8 (12.50%) |
| # events | 0 | 2 | 1 | 0 | 0 | 0 | 2 | 0 | 0 | 2 | 1 |
| Confusional state † 1 | |||||||||||
| # participants affected / at risk | 0/5 (0.00%) | 0/13 (0.00%) | 1/8 (12.50%) | 1/8 (12.50%) | 0/7 (0.00%) | 0/7 (0.00%) | 0/9 (0.00%) | 0/8 (0.00%) | 2/8 (25.00%) | 0/5 (0.00%) | 0/8 (0.00%) |
| # events | 0 | 0 | 1 | 1 | 0 | 0 | 0 | 0 | 2 | 0 | 0 |
| Daydreaming † 1 | |||||||||||
| # participants affected / at risk | 0/5 (0.00%) | 0/13 (0.00%) | 0/8 (0.00%) | 0/8 (0.00%) | 0/7 (0.00%) | 0/7 (0.00%) | 0/9 (0.00%) | 1/8 (12.50%) | 0/8 (0.00%) | 0/5 (0.00%) | 0/8 (0.00%) |
| # events | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 1 | 0 | 0 | 0 |
| Delirium † 1 | |||||||||||
| # participants affected / at risk | 0/5 (0.00%) | 0/13 (0.00%) | 1/8 (12.50%) | 0/8 (0.00%) | 0/7 (0.00%) | 0/7 (0.00%) | 1/9 (11.11%) | 0/8 (0.00%) | 0/8 (0.00%) | 0/5 (0.00%) | 0/8 (0.00%) |
| # events | 0 | 0 | 1 | 0 | 0 | 0 | 1 | 0 | 0 | 0 | 0 |
| Depressed mood † 1 | |||||||||||
| # participants affected / at risk | 0/5 (0.00%) | 0/13 (0.00%) | 0/8 (0.00%) | 1/8 (12.50%) | 0/7 (0.00%) | 0/7 (0.00%) | 0/9 (0.00%) | 0/8 (0.00%) | 0/8 (0.00%) | 0/5 (0.00%) | 0/8 (0.00%) |
| # events | 0 | 0 | 0 | 1 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| Depression † 1 | |||||||||||
| # participants affected / at risk | 1/5 (20.00%) | 1/13 (7.69%) | 1/8 (12.50%) | 2/8 (25.00%) | 0/7 (0.00%) | 0/7 (0.00%) | 1/9 (11.11%) | 1/8 (12.50%) | 1/8 (12.50%) | 0/5 (0.00%) | 0/8 (0.00%) |
| # events | 1 | 1 | 1 | 2 | 0 | 0 | 1 | 1 | 1 | 0 | 0 |
| Depressive symptom † 1 | |||||||||||
| # participants affected / at risk | 0/5 (0.00%) | 1/13 (7.69%) | 0/8 (0.00%) | 0/8 (0.00%) | 0/7 (0.00%) | 0/7 (0.00%) | 0/9 (0.00%) | 0/8 (0.00%) | 0/8 (0.00%) | 0/5 (0.00%) | 0/8 (0.00%) |
| # events | 0 | 1 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| Hallucination † 1 | |||||||||||
| # participants affected / at risk | 0/5 (0.00%) | 0/13 (0.00%) | 1/8 (12.50%) | 0/8 (0.00%) | 0/7 (0.00%) | 0/7 (0.00%) | 0/9 (0.00%) | 0/8 (0.00%) | 0/8 (0.00%) | 0/5 (0.00%) | 0/8 (0.00%) |
| # events | 0 | 0 | 1 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| Hallucination, visual † 1 | |||||||||||
| # participants affected / at risk | 0/5 (0.00%) | 1/13 (7.69%) | 0/8 (0.00%) | 0/8 (0.00%) | 0/7 (0.00%) | 0/7 (0.00%) | 0/9 (0.00%) | 0/8 (0.00%) | 0/8 (0.00%) | 0/5 (0.00%) | 0/8 (0.00%) |
| # events | 0 | 1 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| Insomnia † 1 | |||||||||||
| # participants affected / at risk | 1/5 (20.00%) | 0/13 (0.00%) | 0/8 (0.00%) | 0/8 (0.00%) | 1/7 (14.29%) | 0/7 (0.00%) | 0/9 (0.00%) | 1/8 (12.50%) | 0/8 (0.00%) | 0/5 (0.00%) | 1/8 (12.50%) |
| # events | 1 | 0 | 0 | 0 | 1 | 0 | 0 | 1 | 0 | 0 | 1 |
| Mental status changes † 1 | |||||||||||
| # participants affected / at risk | 1/5 (20.00%) | 0/13 (0.00%) | 1/8 (12.50%) | 1/8 (12.50%) | 0/7 (0.00%) | 0/7 (0.00%) | 0/9 (0.00%) | 0/8 (0.00%) | 0/8 (0.00%) | 2/5 (40.00%) | 0/8 (0.00%) |
| # events | 1 | 0 | 1 | 1 | 0 | 0 | 0 | 0 | 0 | 2 | 0 |
| Psychotic disorder † 1 | |||||||||||
| # participants affected / at risk | 0/5 (0.00%) | 0/13 (0.00%) | 0/8 (0.00%) | 0/8 (0.00%) | 0/7 (0.00%) | 0/7 (0.00%) | 0/9 (0.00%) | 0/8 (0.00%) | 1/8 (12.50%) | 0/5 (0.00%) | 0/8 (0.00%) |
| # events | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 1 | 0 | 0 |
| Restlessness † 1 | |||||||||||
| # participants affected / at risk | 0/5 (0.00%) | 0/13 (0.00%) | 0/8 (0.00%) | 0/8 (0.00%) | 0/7 (0.00%) | 0/7 (0.00%) | 0/9 (0.00%) | 1/8 (12.50%) | 1/8 (12.50%) | 0/5 (0.00%) | 0/8 (0.00%) |
| # events | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 1 | 1 | 0 | 0 |
| Renal and urinary disorders | |||||||||||
| Acute prerenal failure † 1 | |||||||||||
| # participants affected / at risk | 0/5 (0.00%) | 0/13 (0.00%) | 0/8 (0.00%) | 0/8 (0.00%) | 0/7 (0.00%) | 0/7 (0.00%) | 1/9 (11.11%) | 0/8 (0.00%) | 0/8 (0.00%) | 0/5 (0.00%) | 0/8 (0.00%) |
| # events | 0 | 0 | 0 | 0 | 0 | 0 | 1 | 0 | 0 | 0 | 0 |
| Pollakiuria † 1 | |||||||||||
| # participants affected / at risk | 0/5 (0.00%) | 0/13 (0.00%) | 1/8 (12.50%) | 0/8 (0.00%) | 0/7 (0.00%) | 0/7 (0.00%) | 0/9 (0.00%) | 0/8 (0.00%) | 0/8 (0.00%) | 0/5 (0.00%) | 0/8 (0.00%) |
| # events | 0 | 0 | 1 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| Renal failure chronic † 1 | |||||||||||
| # participants affected / at risk | 0/5 (0.00%) | 0/13 (0.00%) | 0/8 (0.00%) | 0/8 (0.00%) | 0/7 (0.00%) | 0/7 (0.00%) | 0/9 (0.00%) | 0/8 (0.00%) | 1/8 (12.50%) | 0/5 (0.00%) | 0/8 (0.00%) |
| # events | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 1 | 0 | 0 |
| Urinary incontinence † 1 | |||||||||||
| # participants affected / at risk | 0/5 (0.00%) | 0/13 (0.00%) | 0/8 (0.00%) | 0/8 (0.00%) | 0/7 (0.00%) | 0/7 (0.00%) | 0/9 (0.00%) | 0/8 (0.00%) | 0/8 (0.00%) | 1/5 (20.00%) | 0/8 (0.00%) |
| # events | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 1 | 0 |
| Reproductive system and breast disorders | |||||||||||
| Benign prostatic hyperplasia † 1 | |||||||||||
| # participants affected / at risk | 1/5 (20.00%) | 0/13 (0.00%) | 1/8 (12.50%) | 0/8 (0.00%) | 0/7 (0.00%) | 0/7 (0.00%) | 0/9 (0.00%) | 0/8 (0.00%) | 0/8 (0.00%) | 0/5 (0.00%) | 0/8 (0.00%) |
| # events | 1 | 0 | 1 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| Erectile dysfunction † 1 | |||||||||||
| # participants affected / at risk | 0/5 (0.00%) | 1/13 (7.69%) | 0/8 (0.00%) | 0/8 (0.00%) | 0/7 (0.00%) | 0/7 (0.00%) | 0/9 (0.00%) | 0/8 (0.00%) | 0/8 (0.00%) | 0/5 (0.00%) | 0/8 (0.00%) |
| # events | 0 | 1 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| Respiratory, thoracic and mediastinal disorders | |||||||||||
| Allergic sinusitis † 1 | |||||||||||
| # participants affected / at risk | 0/5 (0.00%) | 0/13 (0.00%) | 1/8 (12.50%) | 0/8 (0.00%) | 0/7 (0.00%) | 0/7 (0.00%) | 0/9 (0.00%) | 0/8 (0.00%) | 0/8 (0.00%) | 0/5 (0.00%) | 0/8 (0.00%) |
| # events | 0 | 0 | 2 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| Asthma † 1 | |||||||||||
| # participants affected / at risk | 0/5 (0.00%) | 0/13 (0.00%) | 0/8 (0.00%) | 0/8 (0.00%) | 0/7 (0.00%) | 0/7 (0.00%) | 1/9 (11.11%) | 0/8 (0.00%) | 0/8 (0.00%) | 0/5 (0.00%) | 0/8 (0.00%) |
| # events | 0 | 0 | 0 | 0 | 0 | 0 | 1 | 0 | 0 | 0 | 0 |
| Cough † 1 | |||||||||||
| # participants affected / at risk | 0/5 (0.00%) | 0/13 (0.00%) | 0/8 (0.00%) | 1/8 (12.50%) | 1/7 (14.29%) | 0/7 (0.00%) | 0/9 (0.00%) | 1/8 (12.50%) | 0/8 (0.00%) | 1/5 (20.00%) | 0/8 (0.00%) |
| # events | 0 | 0 | 0 | 1 | 1 | 0 | 0 | 1 | 0 | 1 | 0 |
| Epistaxis † 1 | |||||||||||
| # participants affected / at risk | 0/5 (0.00%) | 0/13 (0.00%) | 1/8 (12.50%) | 1/8 (12.50%) | 0/7 (0.00%) | 0/7 (0.00%) | 0/9 (0.00%) | 0/8 (0.00%) | 0/8 (0.00%) | 0/5 (0.00%) | 0/8 (0.00%) |
| # events | 0 | 0 | 1 | 1 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| Hiccups † 1 | |||||||||||
| # participants affected / at risk | 0/5 (0.00%) | 0/13 (0.00%) | 1/8 (12.50%) | 0/8 (0.00%) | 0/7 (0.00%) | 0/7 (0.00%) | 0/9 (0.00%) | 0/8 (0.00%) | 0/8 (0.00%) | 0/5 (0.00%) | 0/8 (0.00%) |
| # events | 0 | 0 | 1 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| Nasal congestion † 1 | |||||||||||
| # participants affected / at risk | 0/5 (0.00%) | 0/13 (0.00%) | 0/8 (0.00%) | 0/8 (0.00%) | 0/7 (0.00%) | 0/7 (0.00%) | 0/9 (0.00%) | 0/8 (0.00%) | 0/8 (0.00%) | 1/5 (20.00%) | 0/8 (0.00%) |
| # events | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 1 | 0 |
| Nasal discomfort † 1 | |||||||||||
| # participants affected / at risk | 0/5 (0.00%) | 0/13 (0.00%) | 0/8 (0.00%) | 0/8 (0.00%) | 0/7 (0.00%) | 0/7 (0.00%) | 1/9 (11.11%) | 0/8 (0.00%) | 0/8 (0.00%) | 0/5 (0.00%) | 0/8 (0.00%) |
| # events | 0 | 0 | 0 | 0 | 0 | 0 | 1 | 0 | 0 | 0 | 0 |
| Productive cough † 1 | |||||||||||
| # participants affected / at risk | 0/5 (0.00%) | 0/13 (0.00%) | 0/8 (0.00%) | 0/8 (0.00%) | 0/7 (0.00%) | 0/7 (0.00%) | 0/9 (0.00%) | 0/8 (0.00%) | 0/8 (0.00%) | 1/5 (20.00%) | 0/8 (0.00%) |
| # events | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 1 | 0 |
| Respiratory tract congestion † 1 | |||||||||||
| # participants affected / at risk | 0/5 (0.00%) | 0/13 (0.00%) | 0/8 (0.00%) | 0/8 (0.00%) | 1/7 (14.29%) | 0/7 (0.00%) | 0/9 (0.00%) | 0/8 (0.00%) | 1/8 (12.50%) | 0/5 (0.00%) | 0/8 (0.00%) |
| # events | 0 | 0 | 0 | 0 | 1 | 0 | 0 | 0 | 1 | 0 | 0 |
| Rhinitis allergic † 1 | |||||||||||
| # participants affected / at risk | 1/5 (20.00%) | 0/13 (0.00%) | 1/8 (12.50%) | 1/8 (12.50%) | 0/7 (0.00%) | 0/7 (0.00%) | 0/9 (0.00%) | 0/8 (0.00%) | 0/8 (0.00%) | 0/5 (0.00%) | 0/8 (0.00%) |
| # events | 1 | 0 | 1 | 1 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| Rhinorrhoea † 1 | |||||||||||
| # participants affected / at risk | 0/5 (0.00%) | 0/13 (0.00%) | 0/8 (0.00%) | 1/8 (12.50%) | 0/7 (0.00%) | 0/7 (0.00%) | 0/9 (0.00%) | 1/8 (12.50%) | 0/8 (0.00%) | 0/5 (0.00%) | 0/8 (0.00%) |
| # events | 0 | 0 | 0 | 1 | 0 | 0 | 0 | 1 | 0 | 0 | 0 |
| Sinus congestion † 1 | |||||||||||
| # participants affected / at risk | 0/5 (0.00%) | 1/13 (7.69%) | 0/8 (0.00%) | 0/8 (0.00%) | 0/7 (0.00%) | 0/7 (0.00%) | 0/9 (0.00%) | 0/8 (0.00%) | 0/8 (0.00%) | 1/5 (20.00%) | 0/8 (0.00%) |
| # events | 0 | 2 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 3 | 0 |
| Upper respiratory tract congestion † 1 | |||||||||||
| # participants affected / at risk | 1/5 (20.00%) | 0/13 (0.00%) | 0/8 (0.00%) | 0/8 (0.00%) | 0/7 (0.00%) | 0/7 (0.00%) | 0/9 (0.00%) | 0/8 (0.00%) | 0/8 (0.00%) | 0/5 (0.00%) | 0/8 (0.00%) |
| # events | 1 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| Upper-airway cough syndrome † 1 | |||||||||||
| # participants affected / at risk | 0/5 (0.00%) | 0/13 (0.00%) | 0/8 (0.00%) | 0/8 (0.00%) | 0/7 (0.00%) | 0/7 (0.00%) | 1/9 (11.11%) | 0/8 (0.00%) | 0/8 (0.00%) | 0/5 (0.00%) | 0/8 (0.00%) |
| # events | 0 | 0 | 0 | 0 | 0 | 0 | 1 | 0 | 0 | 0 | 0 |
| Skin and subcutaneous tissue disorders | |||||||||||
| Alopecia † 1 | |||||||||||
| # participants affected / at risk | 0/5 (0.00%) | 0/13 (0.00%) | 0/8 (0.00%) | 0/8 (0.00%) | 0/7 (0.00%) | 0/7 (0.00%) | 1/9 (11.11%) | 0/8 (0.00%) | 0/8 (0.00%) | 0/5 (0.00%) | 0/8 (0.00%) |
| # events | 0 | 0 | 0 | 0 | 0 | 0 | 1 | 0 | 0 | 0 | 0 |
| Dermatitis † 1 | |||||||||||
| # participants affected / at risk | 0/5 (0.00%) | 1/13 (7.69%) | 0/8 (0.00%) | 0/8 (0.00%) | 0/7 (0.00%) | 0/7 (0.00%) | 0/9 (0.00%) | 0/8 (0.00%) | 0/8 (0.00%) | 0/5 (0.00%) | 0/8 (0.00%) |
| # events | 0 | 1 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| Dermatitis contact † 1 | |||||||||||
| # participants affected / at risk | 0/5 (0.00%) | 0/13 (0.00%) | 0/8 (0.00%) | 0/8 (0.00%) | 0/7 (0.00%) | 0/7 (0.00%) | 0/9 (0.00%) | 1/8 (12.50%) | 0/8 (0.00%) | 0/5 (0.00%) | 0/8 (0.00%) |
| # events | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 1 | 0 | 0 | 0 |
| Dry skin † 1 | |||||||||||
| # participants affected / at risk | 0/5 (0.00%) | 0/13 (0.00%) | 0/8 (0.00%) | 0/8 (0.00%) | 0/7 (0.00%) | 0/7 (0.00%) | 0/9 (0.00%) | 0/8 (0.00%) | 1/8 (12.50%) | 0/5 (0.00%) | 0/8 (0.00%) |
| # events | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 1 | 0 | 0 |
| Ecchymosis † 1 | |||||||||||
| # participants affected / at risk | 0/5 (0.00%) | 0/13 (0.00%) | 0/8 (0.00%) | 0/8 (0.00%) | 0/7 (0.00%) | 0/7 (0.00%) | 1/9 (11.11%) | 0/8 (0.00%) | 0/8 (0.00%) | 1/5 (20.00%) | 0/8 (0.00%) |
| # events | 0 | 0 | 0 | 0 | 0 | 0 | 1 | 0 | 0 | 2 | 0 |
| Hair disorder † 1 | |||||||||||
| # participants affected / at risk | 0/5 (0.00%) | 1/13 (7.69%) | 0/8 (0.00%) | 0/8 (0.00%) | 0/7 (0.00%) | 0/7 (0.00%) | 0/9 (0.00%) | 0/8 (0.00%) | 0/8 (0.00%) | 0/5 (0.00%) | 0/8 (0.00%) |
| # events | 0 | 1 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| Hypertrichosis † 1 | |||||||||||
| # participants affected / at risk | 0/5 (0.00%) | 1/13 (7.69%) | 0/8 (0.00%) | 0/8 (0.00%) | 0/7 (0.00%) | 0/7 (0.00%) | 0/9 (0.00%) | 0/8 (0.00%) | 0/8 (0.00%) | 0/5 (0.00%) | 0/8 (0.00%) |
| # events | 0 | 1 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| Petechiae † 1 | |||||||||||
| # participants affected / at risk | 0/5 (0.00%) | 0/13 (0.00%) | 0/8 (0.00%) | 0/8 (0.00%) | 0/7 (0.00%) | 0/7 (0.00%) | 1/9 (11.11%) | 0/8 (0.00%) | 0/8 (0.00%) | 0/5 (0.00%) | 0/8 (0.00%) |
| # events | 0 | 0 | 0 | 0 | 0 | 0 | 1 | 0 | 0 | 0 | 0 |
| Pruritus † 1 | |||||||||||
| # participants affected / at risk | 0/5 (0.00%) | 1/13 (7.69%) | 0/8 (0.00%) | 0/8 (0.00%) | 0/7 (0.00%) | 0/7 (0.00%) | 0/9 (0.00%) | 0/8 (0.00%) | 0/8 (0.00%) | 0/5 (0.00%) | 0/8 (0.00%) |
| # events | 0 | 1 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| Pruritus generalised † 1 | |||||||||||
| # participants affected / at risk | 0/5 (0.00%) | 1/13 (7.69%) | 0/8 (0.00%) | 0/8 (0.00%) | 0/7 (0.00%) | 0/7 (0.00%) | 0/9 (0.00%) | 0/8 (0.00%) | 0/8 (0.00%) | 0/5 (0.00%) | 0/8 (0.00%) |
| # events | 0 | 1 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| Psoriasis † 1 | |||||||||||
| # participants affected / at risk | 0/5 (0.00%) | 0/13 (0.00%) | 0/8 (0.00%) | 0/8 (0.00%) | 0/7 (0.00%) | 0/7 (0.00%) | 1/9 (11.11%) | 0/8 (0.00%) | 0/8 (0.00%) | 0/5 (0.00%) | 0/8 (0.00%) |
| # events | 0 | 0 | 0 | 0 | 0 | 0 | 1 | 0 | 0 | 0 | 0 |
| Rash † 1 | |||||||||||
| # participants affected / at risk | 0/5 (0.00%) | 0/13 (0.00%) | 0/8 (0.00%) | 1/8 (12.50%) | 0/7 (0.00%) | 0/7 (0.00%) | 0/9 (0.00%) | 0/8 (0.00%) | 0/8 (0.00%) | 0/5 (0.00%) | 0/8 (0.00%) |
| # events | 0 | 0 | 0 | 1 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| Rash papular † 1 | |||||||||||
| # participants affected / at risk | 0/5 (0.00%) | 0/13 (0.00%) | 0/8 (0.00%) | 0/8 (0.00%) | 0/7 (0.00%) | 1/7 (14.29%) | 0/9 (0.00%) | 0/8 (0.00%) | 0/8 (0.00%) | 0/5 (0.00%) | 0/8 (0.00%) |
| # events | 0 | 0 | 0 | 0 | 0 | 1 | 0 | 0 | 0 | 0 | 0 |
| Skin lesion † 1 | |||||||||||
| # participants affected / at risk | 1/5 (20.00%) | 0/13 (0.00%) | 0/8 (0.00%) | 0/8 (0.00%) | 0/7 (0.00%) | 0/7 (0.00%) | 0/9 (0.00%) | 0/8 (0.00%) | 0/8 (0.00%) | 0/5 (0.00%) | 0/8 (0.00%) |
| # events | 1 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| Urticaria † 1 | |||||||||||
| # participants affected / at risk | 0/5 (0.00%) | 0/13 (0.00%) | 0/8 (0.00%) | 0/8 (0.00%) | 0/7 (0.00%) | 0/7 (0.00%) | 1/9 (11.11%) | 0/8 (0.00%) | 0/8 (0.00%) | 0/5 (0.00%) | 0/8 (0.00%) |
| # events | 0 | 0 | 0 | 0 | 0 | 0 | 1 | 0 | 0 | 0 | 0 |
| Vascular disorders | |||||||||||
| Haematoma † 1 | |||||||||||
| # participants affected / at risk | 0/5 (0.00%) | 0/13 (0.00%) | 0/8 (0.00%) | 0/8 (0.00%) | 0/7 (0.00%) | 0/7 (0.00%) | 0/9 (0.00%) | 1/8 (12.50%) | 0/8 (0.00%) | 0/5 (0.00%) | 0/8 (0.00%) |
| # events | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 1 | 0 | 0 | 0 |
| Hot flush † 1 | |||||||||||
| # participants affected / at risk | 0/5 (0.00%) | 1/13 (7.69%) | 0/8 (0.00%) | 0/8 (0.00%) | 0/7 (0.00%) | 0/7 (0.00%) | 0/9 (0.00%) | 0/8 (0.00%) | 0/8 (0.00%) | 0/5 (0.00%) | 0/8 (0.00%) |
| # events | 0 | 1 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| Hypertension † 1 | |||||||||||
| # participants affected / at risk | 0/5 (0.00%) | 1/13 (7.69%) | 0/8 (0.00%) | 0/8 (0.00%) | 1/7 (14.29%) | 0/7 (0.00%) | 2/9 (22.22%) | 0/8 (0.00%) | 0/8 (0.00%) | 0/5 (0.00%) | 0/8 (0.00%) |
| # events | 0 | 1 | 0 | 0 | 1 | 0 | 2 | 0 | 0 | 0 | 0 |
| † | Events were collected by systematic assessment |
|---|---|
| 1 | Term from vocabulary, MedDRA 14.1 |
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 |
|---|
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More Information
Certain Agreements:
Results Point of Contact:
| 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:
|
Results Point of Contact:
Name/Title: Senior Vice President, Global Clinical Development
Organization: Merck Sharp & Dohme Corp
phone: 1-800-672-6372
e-mail: ClinicalTrialsDisclosure@merck.com
Organization: Merck Sharp & Dohme Corp
phone: 1-800-672-6372
e-mail: ClinicalTrialsDisclosure@merck.com
| Responsible Party: | Merck Sharp & Dohme Corp. |
| ClinicalTrials.gov Identifier: | NCT00464334 History of Changes |
| Other Study ID Numbers: |
V950-001 2007_518 ( Other Identifier: Merck Registration ID ) |
| Study First Received: | April 20, 2007 |
| Results First Received: | November 19, 2012 |
| Last Updated: | September 24, 2015 |