Trial Outcomes & Findings for The Effectiveness of rTMS in Depressed VA Patients (NCT NCT01191333)

NCT ID: NCT01191333

Last Updated: 2018-03-09

Results Overview

The primary outcome is a proportion of participants achieving remission from depression based on the HRSD24 less than or equal to 10 at the end of the acute treatment phase. 24 item Instrument with overall score range from 0 - 76. High values represent a worse outcome.

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 164 participants
• Primary outcome timeframe: End of acute treatment 4-6 weeks
• Results posted on: 2018-03-09

Participant Flow

Participant milestones

Measure	Active rTMS Those receiving experimental treatment will receive 20 to 30 sessions of rTMS in blocks of 5 sessions. The treatment will be delivered by trained medical personnel. rTMS: Repetitive Transcranial Magnetic Stimulation	Sham rTMS Those receiving the sham rTMS will receive 20 to 30 sessions of sham rTMS in blocks of 5 sessions. The treatment will be delivered by trained medical personnel. Sham Device: Placebo Device that simulates active rTMS treatment
Overall Study STARTED	81	83
Overall Study COMPLETED	60	65
Overall Study NOT COMPLETED	21	18

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Missing values

Baseline characteristics by cohort

Measure	Active rTMS n=81 Participants Those receiving experimental treatment will receive 20 to 30 sessions of rTMS in blocks of 5 sessions. The treatment will be delivered by trained medical personnel. rTMS: Repetitive Transcranial Magnetic Stimulation	Sham rTMS n=83 Participants Those receiving the sham rTMS will receive 20 to 30 sessions of sham rTMS in blocks of 5 sessions. The treatment will be delivered by trained medical personnel. Sham Device: Placebo Device that simulates active rTMS treatment	Total n=164 Participants Total of all reporting groups
Age, Continuous	55.6 years STANDARD_DEVIATION 12.2 • n=81 Participants	54.8 years STANDARD_DEVIATION 12.6 • n=83 Participants	55.2 years STANDARD_DEVIATION 12.4 • n=164 Participants
Sex: Female, Male Female	14 Participants n=81 Participants	18 Participants n=83 Participants	32 Participants n=164 Participants
Sex: Female, Male Male	67 Participants n=81 Participants	65 Participants n=83 Participants	132 Participants n=164 Participants
Race (NIH/OMB) American Indian or Alaska Native	2 Participants n=81 Participants	0 Participants n=83 Participants	2 Participants n=164 Participants
Race (NIH/OMB) Asian	1 Participants n=81 Participants	3 Participants n=83 Participants	4 Participants n=164 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=81 Participants	0 Participants n=83 Participants	0 Participants n=164 Participants
Race (NIH/OMB) Black or African American	12 Participants n=81 Participants	14 Participants n=83 Participants	26 Participants n=164 Participants
Race (NIH/OMB) White	63 Participants n=81 Participants	63 Participants n=83 Participants	126 Participants n=164 Participants
Race (NIH/OMB) More than one race	3 Participants n=81 Participants	2 Participants n=83 Participants	5 Participants n=164 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=81 Participants	1 Participants n=83 Participants	1 Participants n=164 Participants
Region of Enrollment United States	81 Participants n=81 Participants	83 Participants n=83 Participants	164 Participants n=164 Participants
Beck Scale for Suicide Ideation (BSI)	3.7 units on a scale STANDARD_DEVIATION 6.0 • n=77 Participants • Missing values	5.6 units on a scale STANDARD_DEVIATION 6.7 • n=82 Participants • Missing values	4.7 units on a scale STANDARD_DEVIATION 6.5 • n=159 Participants • Missing values
Beck Depression Inventory (BDI)	22.6 units on a scale STANDARD_DEVIATION 10.3 • n=78 Participants • Missing values	26.5 units on a scale STANDARD_DEVIATION 10.0 • n=77 Participants • Missing values	24.5 units on a scale STANDARD_DEVIATION 10.3 • n=155 Participants • Missing values
VR-36 Mental Component Summary (MCS)	27.2 units on a scale STANDARD_DEVIATION 11.6 • n=81 Participants • Missing value	25.1 units on a scale STANDARD_DEVIATION 10.0 • n=82 Participants • Missing value	26.2 units on a scale STANDARD_DEVIATION 10.8 • n=163 Participants • Missing value
VR-36 Physical Component Summary (PCS)	42.4 units on a scale STANDARD_DEVIATION 11.5 • n=81 Participants • Missing value	40.2 units on a scale STANDARD_DEVIATION 10.0 • n=82 Participants • Missing value	41.3 units on a scale STANDARD_DEVIATION 10.8 • n=163 Participants • Missing value
Montgomery Asberg Depression Rating Scale (MADRS)	24.7 units on a scale STANDARD_DEVIATION 7.6 • n=81 Participants	26.2 units on a scale STANDARD_DEVIATION 6.9 • n=83 Participants	25.5 units on a scale STANDARD_DEVIATION 7.3 • n=164 Participants

PRIMARY outcome

Timeframe: End of acute treatment 4-6 weeks

Population: ITT

The primary outcome is a proportion of participants achieving remission from depression based on the HRSD24 less than or equal to 10 at the end of the acute treatment phase. 24 item Instrument with overall score range from 0 - 76. High values represent a worse outcome.

Outcome measures

Measure	Active rTMS n=81 Participants Those receiving experimental treatment will receive 20 to 30 sessions of rTMS in blocks of 5 sessions. The treatment will be delivered by trained medical personnel. rTMS: Repetitive Transcranial Magnetic Stimulation	Sham rTMS n=83 Participants Those receiving the sham rTMS will receive 20 to 30 sessions of sham rTMS in blocks of 5 sessions. The treatment will be delivered by trained medical personnel. Sham Device: Placebo Device that simulates active rTMS treatment
The Proportion of Participants Achieving Remission From Depression as Assessed by Hamilton Rating Scale for Depression	33 Participants	31 Participants

SECONDARY outcome

Timeframe: End of acute treatment 4-6 weeks, then end of F/U 6 months

Population: ITT minus participants with missing values

To help clinicians screen psychiatric patients for suicidal ideation, the Beck Scale for Suicide Ideation was developed, and is herein referred to as the BSS. This self-report measure consists of 21 items with overall score range from 0 - 38, with the last two items not counted in scoring. A high score represents a worse outcome.

Outcome measures

Measure	Active rTMS n=67 Participants Those receiving experimental treatment will receive 20 to 30 sessions of rTMS in blocks of 5 sessions. The treatment will be delivered by trained medical personnel. rTMS: Repetitive Transcranial Magnetic Stimulation	Sham rTMS n=72 Participants Those receiving the sham rTMS will receive 20 to 30 sessions of sham rTMS in blocks of 5 sessions. The treatment will be delivered by trained medical personnel. Sham Device: Placebo Device that simulates active rTMS treatment
Mean Suicidal Ideation Score as Assessed by Beck Scale for Suicide Ideation (BSS) End of Acute Treatment	2.0 units on a scale Standard Deviation 4.6	2.7 units on a scale Standard Deviation 4.9
Mean Suicidal Ideation Score as Assessed by Beck Scale for Suicide Ideation (BSS) End of F/U	1.5 units on a scale Standard Deviation 4.2	2.5 units on a scale Standard Deviation 4.9

SECONDARY outcome

Timeframe: Baseline - end of acute treatment 4-6 weeks, then end of F/U 6 months

Population: ITT minus participants with missing values

This measure is a 21-item self-report test presented in a multiple choice format which measures presence and extent of depression with overall score range from 0 - 63. A higher score represents a worse outcome. Each of the 21 items addresses a specific symptom or attitude that pertains to depressed patients, and which are consistent with descriptions of the depression within the peer-reviewed literature. While generally deemed less reliable than scales score by a trained rater (for example, the HRSD), the Beck scale is easy to administer, and provides convenient means by which patients can effectively communicate their own perception of their mood state.

Outcome measures

Measure	Active rTMS n=66 Participants Those receiving experimental treatment will receive 20 to 30 sessions of rTMS in blocks of 5 sessions. The treatment will be delivered by trained medical personnel. rTMS: Repetitive Transcranial Magnetic Stimulation	Sham rTMS n=72 Participants Those receiving the sham rTMS will receive 20 to 30 sessions of sham rTMS in blocks of 5 sessions. The treatment will be delivered by trained medical personnel. Sham Device: Placebo Device that simulates active rTMS treatment
Mean Depression Score as Assessed by Beck Depression Inventory (BDI) End of Acute Treatment	14.2 units on a scale Standard Deviation 10.9	13.0 units on a scale Standard Deviation 9.5
Mean Depression Score as Assessed by Beck Depression Inventory (BDI) End of F/U	9.0 units on a scale Standard Deviation 8.3	12.8 units on a scale Standard Deviation 10.8

SECONDARY outcome

Timeframe: End of acute treatment 4-6 weeks, then end of F/U 6 months

Population: ITT minus participants with missing values

The VR-36 is a self-administered survey that measures eight dimensions of health: physical functioning, role limitations due to physical health, bodily pain, general health perceptions, vitality, social functioning, role limitations due to emotional problems, and mental health. It yields scale scores for each of these eight health domains, and two summary measures of physical and mental health: the Physical Component Summary (PCS) and Mental Component Summary (MCS). MCS is analyzed in this section. Standardized scoring ranging from 0-100. A higher score represents a better outcome.

Outcome measures

Measure	Active rTMS n=68 Participants Those receiving experimental treatment will receive 20 to 30 sessions of rTMS in blocks of 5 sessions. The treatment will be delivered by trained medical personnel. rTMS: Repetitive Transcranial Magnetic Stimulation	Sham rTMS n=73 Participants Those receiving the sham rTMS will receive 20 to 30 sessions of sham rTMS in blocks of 5 sessions. The treatment will be delivered by trained medical personnel. Sham Device: Placebo Device that simulates active rTMS treatment
Mean Mental Component Score as Assessed by VR-36 Mental Component Summary (MCS) End of Acute Treatment	35.1 units on a scale Standard Deviation 14.3	36.0 units on a scale Standard Deviation 14.7
Mean Mental Component Score as Assessed by VR-36 Mental Component Summary (MCS) End of F/U	34.5 units on a scale Standard Deviation 12.8	34.8 units on a scale Standard Deviation 13.4

SECONDARY outcome

Timeframe: End of acute treatment 4-6 weeks, then end of F/U 6 months

Population: ITT minus participants with missing values

The VR-36 is a self-administered survey that measures eight dimensions of health: physical functioning, role limitations due to physical health, bodily pain, general health perceptions, vitality, social functioning, role limitations due to emotional problems, and mental health. It yields scale scores for each of these eight health domains, and two summary measures of physical and mental health: the Physical Component Summary (PCS) and Mental Component Summary (MCS). PCS is analyzed in this section. Standardized scoring ranging from 0-100. A higher score represents a better outcome.

Outcome measures

Measure	Active rTMS n=68 Participants Those receiving experimental treatment will receive 20 to 30 sessions of rTMS in blocks of 5 sessions. The treatment will be delivered by trained medical personnel. rTMS: Repetitive Transcranial Magnetic Stimulation	Sham rTMS n=73 Participants Those receiving the sham rTMS will receive 20 to 30 sessions of sham rTMS in blocks of 5 sessions. The treatment will be delivered by trained medical personnel. Sham Device: Placebo Device that simulates active rTMS treatment
Mean Physical Component Score as Assessed by VR-36 Physical Component Summary (PCS) End of Acute Treatment	41.9 units on a scale Standard Deviation 10.9	41.2 units on a scale Standard Deviation 11.9
Mean Physical Component Score as Assessed by VR-36 Physical Component Summary (PCS) End of F/U	42.8 units on a scale Standard Deviation 10.8	40.1 units on a scale Standard Deviation 12.3

SECONDARY outcome

Timeframe: End of acute treatment 4-6 weeks, then end of F/U 6 months

Population: ITT minus participants with missing values

As another measure of depression, the Montgomery-Asberg Depression Rating Scale (MADRS) has been used with increasing frequency in recent years to measure outcome in antidepressant efficacy trials. It offers an alternative view of depressive illness, and may be sensitive to depressive symptoms that are not easily captured in the context of the HRSD, such as hypersomnia, increased appetite, and concentration/indecision. The MADRS is a 10-item clinician rating of depressive symptoms. Each item is scored on a 7-point scale (0 to 6) (range 0-60). A high score represents a worse outcome.

Outcome measures

Measure	Active rTMS n=70 Participants Those receiving experimental treatment will receive 20 to 30 sessions of rTMS in blocks of 5 sessions. The treatment will be delivered by trained medical personnel. rTMS: Repetitive Transcranial Magnetic Stimulation	Sham rTMS n=74 Participants Those receiving the sham rTMS will receive 20 to 30 sessions of sham rTMS in blocks of 5 sessions. The treatment will be delivered by trained medical personnel. Sham Device: Placebo Device that simulates active rTMS treatment
Mean Depression Score as Assessed by the Montgomery Asberg Depression Rating Scale (MADRS) End of Acute Treatment	14.3 units on a scale Standard Deviation 11.1	13.1 units on a scale Standard Deviation 10.5
Mean Depression Score as Assessed by the Montgomery Asberg Depression Rating Scale (MADRS) End of F/U	13.7 units on a scale Standard Deviation 10.2	15.0 units on a scale Standard Deviation 9.7

Adverse Events

Active rTMS

Serious events: 22 serious events

Other events: 71 other events

Deaths: 0 deaths

Sham rTMS

Serious events: 18 serious events

Other events: 69 other events

Deaths: 0 deaths

Serious adverse events

Measure	Active rTMS n=81 participants at risk Those receiving experimental treatment will receive 20 to 30 sessions of rTMS in blocks of 5 sessions. The treatment will be delivered by trained medical personnel. rTMS: Repetitive Transcranial Magnetic Stimulation	Sham rTMS n=83 participants at risk Those receiving the sham rTMS will receive 20 to 30 sessions of sham rTMS in blocks of 5 sessions. The treatment will be delivered by trained medical personnel. Sham Device: Placebo Device that simulates active rTMS treatment
Psychiatric disorders Suicidal ideation	4.9% 4/81 • Number of events 4 • From informed consent until termination. 7-8 months.	4.8% 4/83 • Number of events 4 • From informed consent until termination. 7-8 months.
Psychiatric disorders Depression	1.2% 1/81 • Number of events 1 • From informed consent until termination. 7-8 months.	2.4% 2/83 • Number of events 2 • From informed consent until termination. 7-8 months.
Psychiatric disorders Suicide attempt	1.2% 1/81 • Number of events 1 • From informed consent until termination. 7-8 months.	1.2% 1/83 • Number of events 1 • From informed consent until termination. 7-8 months.
Psychiatric disorders Anxiety	0.00% 0/81 • From informed consent until termination. 7-8 months.	1.2% 1/83 • Number of events 1 • From informed consent until termination. 7-8 months.
Psychiatric disorders Depressed mood	1.2% 1/81 • Number of events 1 • From informed consent until termination. 7-8 months.	0.00% 0/83 • From informed consent until termination. 7-8 months.
Psychiatric disorders Depression suicidal	0.00% 0/81 • From informed consent until termination. 7-8 months.	1.2% 1/83 • Number of events 1 • From informed consent until termination. 7-8 months.
Psychiatric disorders Mania	1.2% 1/81 • Number of events 1 • From informed consent until termination. 7-8 months.	0.00% 0/83 • From informed consent until termination. 7-8 months.
Psychiatric disorders Obsessive-compulsive disorder	0.00% 0/81 • From informed consent until termination. 7-8 months.	1.2% 1/83 • Number of events 1 • From informed consent until termination. 7-8 months.
Psychiatric disorders Persistent depressive disorder	1.2% 1/81 • Number of events 1 • From informed consent until termination. 7-8 months.	0.00% 0/83 • From informed consent until termination. 7-8 months.
Psychiatric disorders Post-traumatic stress disorder	0.00% 0/81 • From informed consent until termination. 7-8 months.	1.2% 1/83 • Number of events 1 • From informed consent until termination. 7-8 months.
Investigations Acoustic stimulation tests abnormal	4.9% 4/81 • Number of events 4 • From informed consent until termination. 7-8 months.	6.0% 5/83 • Number of events 5 • From informed consent until termination. 7-8 months.
Injury, poisoning and procedural complications Alcohol poisoning	2.5% 2/81 • Number of events 2 • From informed consent until termination. 7-8 months.	0.00% 0/83 • From informed consent until termination. 7-8 months.
Injury, poisoning and procedural complications Accidental overdose	0.00% 0/81 • From informed consent until termination. 7-8 months.	1.2% 1/83 • Number of events 1 • From informed consent until termination. 7-8 months.
Injury, poisoning and procedural complications Fall	0.00% 0/81 • From informed consent until termination. 7-8 months.	1.2% 1/83 • Number of events 1 • From informed consent until termination. 7-8 months.
Injury, poisoning and procedural complications Road traffic accident	1.2% 1/81 • Number of events 1 • From informed consent until termination. 7-8 months.	0.00% 0/83 • From informed consent until termination. 7-8 months.
Ear and labyrinth disorders Hypoacusis	2.5% 2/81 • Number of events 2 • From informed consent until termination. 7-8 months.	2.4% 2/83 • Number of events 2 • From informed consent until termination. 7-8 months.
General disorders Chest discomfort	1.2% 1/81 • Number of events 1 • From informed consent until termination. 7-8 months.	0.00% 0/83 • From informed consent until termination. 7-8 months.
General disorders Chest pain	0.00% 0/81 • From informed consent until termination. 7-8 months.	1.2% 1/83 • Number of events 1 • From informed consent until termination. 7-8 months.
General disorders Drug withdrawal syndrome	0.00% 0/81 • From informed consent until termination. 7-8 months.	1.2% 1/83 • Number of events 1 • From informed consent until termination. 7-8 months.
General disorders Hernia	1.2% 1/81 • Number of events 1 • From informed consent until termination. 7-8 months.	0.00% 0/83 • From informed consent until termination. 7-8 months.
Infections and infestations Gastroenteritis viral	0.00% 0/81 • From informed consent until termination. 7-8 months.	1.2% 1/83 • Number of events 1 • From informed consent until termination. 7-8 months.
Infections and infestations Orchitis	0.00% 0/81 • From informed consent until termination. 7-8 months.	1.2% 1/83 • Number of events 1 • From informed consent until termination. 7-8 months.
Infections and infestations Staphylococcal infection	1.2% 1/81 • Number of events 1 • From informed consent until termination. 7-8 months.	0.00% 0/83 • From informed consent until termination. 7-8 months.
Infections and infestations Viral infection	0.00% 0/81 • From informed consent until termination. 7-8 months.	1.2% 1/83 • Number of events 1 • From informed consent until termination. 7-8 months.
Cardiac disorders Arrhythmia	0.00% 0/81 • From informed consent until termination. 7-8 months.	1.2% 1/83 • Number of events 1 • From informed consent until termination. 7-8 months.
Cardiac disorders Coronary artery disease	0.00% 0/81 • From informed consent until termination. 7-8 months.	1.2% 1/83 • Number of events 1 • From informed consent until termination. 7-8 months.
Gastrointestinal disorders Pancreatitis	1.2% 1/81 • Number of events 2 • From informed consent until termination. 7-8 months.	0.00% 0/83 • From informed consent until termination. 7-8 months.
Respiratory, thoracic and mediastinal disorders Pleuritic pain	1.2% 1/81 • Number of events 1 • From informed consent until termination. 7-8 months.	0.00% 0/83 • From informed consent until termination. 7-8 months.
Respiratory, thoracic and mediastinal disorders Pulmonary embolism	0.00% 0/81 • From informed consent until termination. 7-8 months.	1.2% 1/83 • Number of events 1 • From informed consent until termination. 7-8 months.
Hepatobiliary disorders Gallbladder disorder	1.2% 1/81 • Number of events 1 • From informed consent until termination. 7-8 months.	0.00% 0/83 • From informed consent until termination. 7-8 months.
Immune system disorders Allergy to arthropod sting	1.2% 1/81 • Number of events 1 • From informed consent until termination. 7-8 months.	0.00% 0/83 • From informed consent until termination. 7-8 months.
Metabolism and nutrition disorders Hyperglycaemia	0.00% 0/81 • From informed consent until termination. 7-8 months.	1.2% 1/83 • Number of events 1 • From informed consent until termination. 7-8 months.
Musculoskeletal and connective tissue disorders Arthralgia	1.2% 1/81 • Number of events 1 • From informed consent until termination. 7-8 months.	0.00% 0/83 • From informed consent until termination. 7-8 months.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Clear cell renal cell carcinoma	0.00% 0/81 • From informed consent until termination. 7-8 months.	1.2% 1/83 • Number of events 1 • From informed consent until termination. 7-8 months.
Nervous system disorders Transient ischaemic attack	0.00% 0/81 • From informed consent until termination. 7-8 months.	1.2% 1/83 • Number of events 1 • From informed consent until termination. 7-8 months.
Vascular disorders Hypotension	1.2% 1/81 • Number of events 1 • From informed consent until termination. 7-8 months.	0.00% 0/83 • From informed consent until termination. 7-8 months.

Other adverse events

Measure	Active rTMS n=81 participants at risk Those receiving experimental treatment will receive 20 to 30 sessions of rTMS in blocks of 5 sessions. The treatment will be delivered by trained medical personnel. rTMS: Repetitive Transcranial Magnetic Stimulation	Sham rTMS n=83 participants at risk Those receiving the sham rTMS will receive 20 to 30 sessions of sham rTMS in blocks of 5 sessions. The treatment will be delivered by trained medical personnel. Sham Device: Placebo Device that simulates active rTMS treatment
Psychiatric disorders Dissociation	1.2% 1/81 • Number of events 1 • From informed consent until termination. 7-8 months.	0.00% 0/83 • From informed consent until termination. 7-8 months.
Psychiatric disorders Flashback	1.2% 1/81 • Number of events 1 • From informed consent until termination. 7-8 months.	0.00% 0/83 • From informed consent until termination. 7-8 months.
Infections and infestations Nasopharyngitis	9.9% 8/81 • Number of events 8 • From informed consent until termination. 7-8 months.	9.6% 8/83 • Number of events 12 • From informed consent until termination. 7-8 months.
Infections and infestations Upper respiratory tract infection	4.9% 4/81 • Number of events 4 • From informed consent until termination. 7-8 months.	4.8% 4/83 • Number of events 5 • From informed consent until termination. 7-8 months.
Infections and infestations Gastroenteritis	4.9% 4/81 • Number of events 5 • From informed consent until termination. 7-8 months.	1.2% 1/83 • Number of events 1 • From informed consent until termination. 7-8 months.
Infections and infestations Sinusitis	1.2% 1/81 • Number of events 2 • From informed consent until termination. 7-8 months.	3.6% 3/83 • Number of events 3 • From informed consent until termination. 7-8 months.
Infections and infestations Influenza	1.2% 1/81 • Number of events 2 • From informed consent until termination. 7-8 months.	2.4% 2/83 • Number of events 2 • From informed consent until termination. 7-8 months.
Infections and infestations Bronchitis	2.5% 2/81 • Number of events 2 • From informed consent until termination. 7-8 months.	1.2% 1/83 • Number of events 1 • From informed consent until termination. 7-8 months.
Infections and infestations Carbuncle	0.00% 0/81 • From informed consent until termination. 7-8 months.	2.4% 2/83 • Number of events 3 • From informed consent until termination. 7-8 months.
Infections and infestations Cellulitis	1.2% 1/81 • Number of events 1 • From informed consent until termination. 7-8 months.	2.4% 2/83 • Number of events 2 • From informed consent until termination. 7-8 months.
Infections and infestations Tooth abscess	2.5% 2/81 • Number of events 2 • From informed consent until termination. 7-8 months.	1.2% 1/83 • Number of events 1 • From informed consent until termination. 7-8 months.
Infections and infestations Urinary tract infection	0.00% 0/81 • From informed consent until termination. 7-8 months.	3.6% 3/83 • Number of events 3 • From informed consent until termination. 7-8 months.
Infections and infestations Epididymitis	1.2% 1/81 • Number of events 2 • From informed consent until termination. 7-8 months.	0.00% 0/83 • From informed consent until termination. 7-8 months.
Infections and infestations Pilonidal cyst	1.2% 1/81 • Number of events 1 • From informed consent until termination. 7-8 months.	1.2% 1/83 • Number of events 1 • From informed consent until termination. 7-8 months.
Infections and infestations Bacterial infection	0.00% 0/81 • From informed consent until termination. 7-8 months.	1.2% 1/83 • Number of events 1 • From informed consent until termination. 7-8 months.
Infections and infestations Conjunctivitis	0.00% 0/81 • From informed consent until termination. 7-8 months.	1.2% 1/83 • Number of events 1 • From informed consent until termination. 7-8 months.
Infections and infestations Folliculitis	1.2% 1/81 • Number of events 1 • From informed consent until termination. 7-8 months.	0.00% 0/83 • From informed consent until termination. 7-8 months.
Infections and infestations Furuncle	0.00% 0/81 • From informed consent until termination. 7-8 months.	1.2% 1/83 • Number of events 1 • From informed consent until termination. 7-8 months.
Infections and infestations Hordeolum	1.2% 1/81 • Number of events 1 • From informed consent until termination. 7-8 months.	0.00% 0/83 • From informed consent until termination. 7-8 months.
Infections and infestations Infection	1.2% 1/81 • Number of events 1 • From informed consent until termination. 7-8 months.	0.00% 0/83 • From informed consent until termination. 7-8 months.
Infections and infestations Laryngitis	1.2% 1/81 • Number of events 1 • From informed consent until termination. 7-8 months.	0.00% 0/83 • From informed consent until termination. 7-8 months.
Infections and infestations Oral bacterial infection	0.00% 0/81 • From informed consent until termination. 7-8 months.	1.2% 1/83 • Number of events 1 • From informed consent until termination. 7-8 months.
Infections and infestations Oral herpes	0.00% 0/81 • From informed consent until termination. 7-8 months.	1.2% 1/83 • Number of events 1 • From informed consent until termination. 7-8 months.
Infections and infestations Pharyngitis streptococcal	0.00% 0/81 • From informed consent until termination. 7-8 months.	1.2% 1/83 • Number of events 1 • From informed consent until termination. 7-8 months.
Infections and infestations Pneumonia	0.00% 0/81 • From informed consent until termination. 7-8 months.	1.2% 1/83 • Number of events 1 • From informed consent until termination. 7-8 months.
Infections and infestations Respiratory tract infection	1.2% 1/81 • Number of events 1 • From informed consent until termination. 7-8 months.	0.00% 0/83 • From informed consent until termination. 7-8 months.
Infections and infestations Skin infection	1.2% 1/81 • Number of events 1 • From informed consent until termination. 7-8 months.	0.00% 0/83 • From informed consent until termination. 7-8 months.
Infections and infestations Tooth infection	0.00% 0/81 • From informed consent until termination. 7-8 months.	1.2% 1/83 • Number of events 1 • From informed consent until termination. 7-8 months.
Infections and infestations Vaginitis gardnerella	0.00% 0/81 • From informed consent until termination. 7-8 months.	1.2% 1/83 • Number of events 1 • From informed consent until termination. 7-8 months.
Infections and infestations Viral infection	0.00% 0/81 • From informed consent until termination. 7-8 months.	1.2% 1/83 • Number of events 1 • From informed consent until termination. 7-8 months.
Infections and infestations Viral upper respiratory tract infection	0.00% 0/81 • From informed consent until termination. 7-8 months.	1.2% 1/83 • Number of events 1 • From informed consent until termination. 7-8 months.
Nervous system disorders Headache	18.5% 15/81 • Number of events 25 • From informed consent until termination. 7-8 months.	19.3% 16/83 • Number of events 25 • From informed consent until termination. 7-8 months.
Nervous system disorders Dizziness	2.5% 2/81 • Number of events 2 • From informed consent until termination. 7-8 months.	3.6% 3/83 • Number of events 3 • From informed consent until termination. 7-8 months.
Nervous system disorders Balance disorder	0.00% 0/81 • From informed consent until termination. 7-8 months.	2.4% 2/83 • Number of events 2 • From informed consent until termination. 7-8 months.
Nervous system disorders Sinus headache	1.2% 1/81 • Number of events 1 • From informed consent until termination. 7-8 months.	1.2% 1/83 • Number of events 1 • From informed consent until termination. 7-8 months.
Nervous system disorders Ataxia	1.2% 1/81 • Number of events 1 • From informed consent until termination. 7-8 months.	0.00% 0/83 • From informed consent until termination. 7-8 months.
Nervous system disorders Facial paralysis	0.00% 0/81 • From informed consent until termination. 7-8 months.	1.2% 1/83 • Number of events 1 • From informed consent until termination. 7-8 months.
Nervous system disorders Hypoaesthesia	0.00% 0/81 • From informed consent until termination. 7-8 months.	1.2% 1/83 • Number of events 1 • From informed consent until termination. 7-8 months.
Nervous system disorders Loss of consciousness	1.2% 1/81 • Number of events 1 • From informed consent until termination. 7-8 months.	0.00% 0/83 • From informed consent until termination. 7-8 months.
Nervous system disorders Memory impairment	0.00% 0/81 • From informed consent until termination. 7-8 months.	1.2% 1/83 • Number of events 1 • From informed consent until termination. 7-8 months.
Nervous system disorders Migraine	0.00% 0/81 • From informed consent until termination. 7-8 months.	1.2% 1/83 • Number of events 1 • From informed consent until termination. 7-8 months.
Nervous system disorders Mononeuropathy	1.2% 1/81 • Number of events 1 • From informed consent until termination. 7-8 months.	0.00% 0/83 • From informed consent until termination. 7-8 months.
Nervous system disorders Paraesthesia	1.2% 1/81 • Number of events 1 • From informed consent until termination. 7-8 months.	0.00% 0/83 • From informed consent until termination. 7-8 months.
Nervous system disorders Phantom pain	1.2% 1/81 • Number of events 1 • From informed consent until termination. 7-8 months.	0.00% 0/83 • From informed consent until termination. 7-8 months.
Nervous system disorders Radiculopathy	1.2% 1/81 • Number of events 1 • From informed consent until termination. 7-8 months.	0.00% 0/83 • From informed consent until termination. 7-8 months.
Nervous system disorders Sensory disturbance	0.00% 0/81 • From informed consent until termination. 7-8 months.	1.2% 1/83 • Number of events 1 • From informed consent until termination. 7-8 months.
Nervous system disorders Speech disorder	1.2% 1/81 • Number of events 1 • From informed consent until termination. 7-8 months.	0.00% 0/83 • From informed consent until termination. 7-8 months.
Nervous system disorders Syncope	0.00% 0/81 • From informed consent until termination. 7-8 months.	1.2% 1/83 • Number of events 1 • From informed consent until termination. 7-8 months.
Nervous system disorders Tension headache	0.00% 0/81 • From informed consent until termination. 7-8 months.	1.2% 1/83 • Number of events 1 • From informed consent until termination. 7-8 months.
Nervous system disorders Tremor	1.2% 1/81 • Number of events 1 • From informed consent until termination. 7-8 months.	0.00% 0/83 • From informed consent until termination. 7-8 months.
Nervous system disorders Visual field defect	1.2% 1/81 • Number of events 1 • From informed consent until termination. 7-8 months.	0.00% 0/83 • From informed consent until termination. 7-8 months.
Musculoskeletal and connective tissue disorders Muscle spasms	2.5% 2/81 • Number of events 2 • From informed consent until termination. 7-8 months.	4.8% 4/83 • Number of events 5 • From informed consent until termination. 7-8 months.
Musculoskeletal and connective tissue disorders Arthralgia	4.9% 4/81 • Number of events 4 • From informed consent until termination. 7-8 months.	2.4% 2/83 • Number of events 2 • From informed consent until termination. 7-8 months.
Musculoskeletal and connective tissue disorders Back pain	2.5% 2/81 • Number of events 2 • From informed consent until termination. 7-8 months.	4.8% 4/83 • Number of events 4 • From informed consent until termination. 7-8 months.
Musculoskeletal and connective tissue disorders Arthritis	2.5% 2/81 • Number of events 2 • From informed consent until termination. 7-8 months.	1.2% 1/83 • Number of events 1 • From informed consent until termination. 7-8 months.
Musculoskeletal and connective tissue disorders Muscle twitching	1.2% 1/81 • Number of events 1 • From informed consent until termination. 7-8 months.	2.4% 2/83 • Number of events 2 • From informed consent until termination. 7-8 months.
Musculoskeletal and connective tissue disorders Pain in extremity	0.00% 0/81 • From informed consent until termination. 7-8 months.	3.6% 3/83 • Number of events 3 • From informed consent until termination. 7-8 months.
Musculoskeletal and connective tissue disorders Trigger finger	1.2% 1/81 • Number of events 1 • From informed consent until termination. 7-8 months.	2.4% 2/83 • Number of events 2 • From informed consent until termination. 7-8 months.
Musculoskeletal and connective tissue disorders Exostosis	1.2% 1/81 • Number of events 1 • From informed consent until termination. 7-8 months.	1.2% 1/83 • Number of events 1 • From informed consent until termination. 7-8 months.
Musculoskeletal and connective tissue disorders Flank pain	1.2% 1/81 • Number of events 1 • From informed consent until termination. 7-8 months.	1.2% 1/83 • Number of events 1 • From informed consent until termination. 7-8 months.
Musculoskeletal and connective tissue disorders Musculoskeletal pain	2.5% 2/81 • Number of events 2 • From informed consent until termination. 7-8 months.	0.00% 0/83 • From informed consent until termination. 7-8 months.
Musculoskeletal and connective tissue disorders Rotator cuff syndrome	2.5% 2/81 • Number of events 2 • From informed consent until termination. 7-8 months.	0.00% 0/83 • From informed consent until termination. 7-8 months.
Musculoskeletal and connective tissue disorders Bursitis	0.00% 0/81 • From informed consent until termination. 7-8 months.	1.2% 1/83 • Number of events 1 • From informed consent until termination. 7-8 months.
Musculoskeletal and connective tissue disorders Cervical spinal stenosis	1.2% 1/81 • Number of events 1 • From informed consent until termination. 7-8 months.	0.00% 0/83 • From informed consent until termination. 7-8 months.
Musculoskeletal and connective tissue disorders Chest wall mass	1.2% 1/81 • Number of events 1 • From informed consent until termination. 7-8 months.	0.00% 0/83 • From informed consent until termination. 7-8 months.
Musculoskeletal and connective tissue disorders Intervertebral disc degeneration	0.00% 0/81 • From informed consent until termination. 7-8 months.	1.2% 1/83 • Number of events 1 • From informed consent until termination. 7-8 months.
Musculoskeletal and connective tissue disorders Joint effusion	0.00% 0/81 • From informed consent until termination. 7-8 months.	1.2% 1/83 • Number of events 1 • From informed consent until termination. 7-8 months.
Musculoskeletal and connective tissue disorders Musculoskeletal chest pain	0.00% 0/81 • From informed consent until termination. 7-8 months.	1.2% 1/83 • Number of events 1 • From informed consent until termination. 7-8 months.
Musculoskeletal and connective tissue disorders Myalgia	1.2% 1/81 • Number of events 1 • From informed consent until termination. 7-8 months.	0.00% 0/83 • From informed consent until termination. 7-8 months.
Musculoskeletal and connective tissue disorders Neck pain	1.2% 1/81 • Number of events 1 • From informed consent until termination. 7-8 months.	0.00% 0/83 • From informed consent until termination. 7-8 months.
Musculoskeletal and connective tissue disorders Osteoarthritis	0.00% 0/81 • From informed consent until termination. 7-8 months.	1.2% 1/83 • Number of events 1 • From informed consent until termination. 7-8 months.
Musculoskeletal and connective tissue disorders Rhabdomyolysis	1.2% 1/81 • Number of events 1 • From informed consent until termination. 7-8 months.	0.00% 0/83 • From informed consent until termination. 7-8 months.
Musculoskeletal and connective tissue disorders Spinal osteoarthritis	0.00% 0/81 • From informed consent until termination. 7-8 months.	1.2% 1/83 • Number of events 1 • From informed consent until termination. 7-8 months.
Musculoskeletal and connective tissue disorders Synovial cyst	1.2% 1/81 • Number of events 1 • From informed consent until termination. 7-8 months.	0.00% 0/83 • From informed consent until termination. 7-8 months.
Musculoskeletal and connective tissue disorders Temporomandibular joint syndrome	0.00% 0/81 • From informed consent until termination. 7-8 months.	1.2% 1/83 • Number of events 1 • From informed consent until termination. 7-8 months.
Investigations Acoustic stimulation tests abnormal	19.8% 16/81 • Number of events 18 • From informed consent until termination. 7-8 months.	19.3% 16/83 • Number of events 19 • From informed consent until termination. 7-8 months.
Investigations Colonoscopy	2.5% 2/81 • Number of events 2 • From informed consent until termination. 7-8 months.	0.00% 0/83 • From informed consent until termination. 7-8 months.
Investigations Alanine aminotransferase increased	0.00% 0/81 • From informed consent until termination. 7-8 months.	1.2% 1/83 • Number of events 1 • From informed consent until termination. 7-8 months.
Investigations Blood thyroid stimulating hormone increased	1.2% 1/81 • Number of events 1 • From informed consent until termination. 7-8 months.	0.00% 0/83 • From informed consent until termination. 7-8 months.
Investigations Ejection fraction decreased	0.00% 0/81 • From informed consent until termination. 7-8 months.	1.2% 1/83 • Number of events 1 • From informed consent until termination. 7-8 months.
Investigations Hepatic enzyme increased	1.2% 1/81 • Number of events 1 • From informed consent until termination. 7-8 months.	0.00% 0/83 • From informed consent until termination. 7-8 months.
Investigations Protein total decreased	1.2% 1/81 • Number of events 1 • From informed consent until termination. 7-8 months.	0.00% 0/83 • From informed consent until termination. 7-8 months.
Gastrointestinal disorders Toothache	3.7% 3/81 • Number of events 3 • From informed consent until termination. 7-8 months.	2.4% 2/83 • Number of events 2 • From informed consent until termination. 7-8 months.
Gastrointestinal disorders Abdominal discomfort	1.2% 1/81 • Number of events 1 • From informed consent until termination. 7-8 months.	3.6% 3/83 • Number of events 3 • From informed consent until termination. 7-8 months.
Gastrointestinal disorders Diarrhoea	1.2% 1/81 • Number of events 1 • From informed consent until termination. 7-8 months.	2.4% 2/83 • Number of events 2 • From informed consent until termination. 7-8 months.
Gastrointestinal disorders Gastrooesophageal reflux disease	1.2% 1/81 • Number of events 1 • From informed consent until termination. 7-8 months.	2.4% 2/83 • Number of events 2 • From informed consent until termination. 7-8 months.
Gastrointestinal disorders Abdominal pain	0.00% 0/81 • From informed consent until termination. 7-8 months.	2.4% 2/83 • Number of events 2 • From informed consent until termination. 7-8 months.
Gastrointestinal disorders Constipation	2.5% 2/81 • Number of events 2 • From informed consent until termination. 7-8 months.	0.00% 0/83 • From informed consent until termination. 7-8 months.
Gastrointestinal disorders Dental caries	0.00% 0/81 • From informed consent until termination. 7-8 months.	2.4% 2/83 • Number of events 2 • From informed consent until termination. 7-8 months.
Gastrointestinal disorders Dyspepsia	0.00% 0/81 • From informed consent until termination. 7-8 months.	2.4% 2/83 • Number of events 2 • From informed consent until termination. 7-8 months.
Gastrointestinal disorders Nausea	1.2% 1/81 • Number of events 1 • From informed consent until termination. 7-8 months.	1.2% 1/83 • Number of events 1 • From informed consent until termination. 7-8 months.
Gastrointestinal disorders Vomiting	0.00% 0/81 • From informed consent until termination. 7-8 months.	2.4% 2/83 • Number of events 2 • From informed consent until termination. 7-8 months.
Gastrointestinal disorders Abdominal distension	0.00% 0/81 • From informed consent until termination. 7-8 months.	1.2% 1/83 • Number of events 1 • From informed consent until termination. 7-8 months.
Gastrointestinal disorders Abdominal hernia	1.2% 1/81 • Number of events 1 • From informed consent until termination. 7-8 months.	0.00% 0/83 • From informed consent until termination. 7-8 months.
Gastrointestinal disorders Anal fistula	1.2% 1/81 • Number of events 1 • From informed consent until termination. 7-8 months.	0.00% 0/83 • From informed consent until termination. 7-8 months.
Gastrointestinal disorders Aphthous ulcer	1.2% 1/81 • Number of events 1 • From informed consent until termination. 7-8 months.	0.00% 0/83 • From informed consent until termination. 7-8 months.
Gastrointestinal disorders Diverticulum intestinal	1.2% 1/81 • Number of events 1 • From informed consent until termination. 7-8 months.	0.00% 0/83 • From informed consent until termination. 7-8 months.
Gastrointestinal disorders Flatulence	0.00% 0/81 • From informed consent until termination. 7-8 months.	1.2% 1/83 • Number of events 1 • From informed consent until termination. 7-8 months.
Gastrointestinal disorders Gastrointestinal disorder	0.00% 0/81 • From informed consent until termination. 7-8 months.	1.2% 1/83 • Number of events 1 • From informed consent until termination. 7-8 months.
Gastrointestinal disorders Gastrointestinal pain	0.00% 0/81 • From informed consent until termination. 7-8 months.	1.2% 1/83 • Number of events 1 • From informed consent until termination. 7-8 months.
Gastrointestinal disorders Inguinal hernia	1.2% 1/81 • Number of events 1 • From informed consent until termination. 7-8 months.	0.00% 0/83 • From informed consent until termination. 7-8 months.
Gastrointestinal disorders Oesophageal achalasia	0.00% 0/81 • From informed consent until termination. 7-8 months.	1.2% 1/83 • Number of events 1 • From informed consent until termination. 7-8 months.
Gastrointestinal disorders Retching	0.00% 0/81 • From informed consent until termination. 7-8 months.	1.2% 1/83 • Number of events 1 • From informed consent until termination. 7-8 months.
Gastrointestinal disorders Umbilical hernia	0.00% 0/81 • From informed consent until termination. 7-8 months.	1.2% 1/83 • Number of events 1 • From informed consent until termination. 7-8 months.
Injury, poisoning and procedural complications Fall	3.7% 3/81 • Number of events 4 • From informed consent until termination. 7-8 months.	7.2% 6/83 • Number of events 6 • From informed consent until termination. 7-8 months.
Injury, poisoning and procedural complications Animal bite	0.00% 0/81 • From informed consent until termination. 7-8 months.	2.4% 2/83 • Number of events 3 • From informed consent until termination. 7-8 months.
Injury, poisoning and procedural complications Limb injury	1.2% 1/81 • Number of events 1 • From informed consent until termination. 7-8 months.	2.4% 2/83 • Number of events 2 • From informed consent until termination. 7-8 months.
Injury, poisoning and procedural complications Exposure to toxic agent	1.2% 1/81 • Number of events 2 • From informed consent until termination. 7-8 months.	0.00% 0/83 • From informed consent until termination. 7-8 months.
Injury, poisoning and procedural complications Ligament sprain	1.2% 1/81 • Number of events 1 • From informed consent until termination. 7-8 months.	1.2% 1/83 • Number of events 1 • From informed consent until termination. 7-8 months.
Injury, poisoning and procedural complications Road traffic accident	1.2% 1/81 • Number of events 1 • From informed consent until termination. 7-8 months.	1.2% 1/83 • Number of events 1 • From informed consent until termination. 7-8 months.
Injury, poisoning and procedural complications Animal scratch	0.00% 0/81 • From informed consent until termination. 7-8 months.	1.2% 1/83 • Number of events 1 • From informed consent until termination. 7-8 months.
Injury, poisoning and procedural complications Arthropod bite	0.00% 0/81 • From informed consent until termination. 7-8 months.	1.2% 1/83 • Number of events 1 • From informed consent until termination. 7-8 months.
Injury, poisoning and procedural complications Arthropod sting	1.2% 1/81 • Number of events 1 • From informed consent until termination. 7-8 months.	0.00% 0/83 • From informed consent until termination. 7-8 months.
Injury, poisoning and procedural complications Contusion	1.2% 1/81 • Number of events 1 • From informed consent until termination. 7-8 months.	0.00% 0/83 • From informed consent until termination. 7-8 months.
Injury, poisoning and procedural complications Ear canal abrasion	1.2% 1/81 • Number of events 1 • From informed consent until termination. 7-8 months.	0.00% 0/83 • From informed consent until termination. 7-8 months.
Injury, poisoning and procedural complications Fibula fracture	1.2% 1/81 • Number of events 1 • From informed consent until termination. 7-8 months.	0.00% 0/83 • From informed consent until termination. 7-8 months.
Injury, poisoning and procedural complications Foot fracture	0.00% 0/81 • From informed consent until termination. 7-8 months.	1.2% 1/83 • Number of events 1 • From informed consent until termination. 7-8 months.
Injury, poisoning and procedural complications Incorrect dosage administered	0.00% 0/81 • From informed consent until termination. 7-8 months.	1.2% 1/83 • Number of events 1 • From informed consent until termination. 7-8 months.
Injury, poisoning and procedural complications Laceration	0.00% 0/81 • From informed consent until termination. 7-8 months.	1.2% 1/83 • Number of events 1 • From informed consent until termination. 7-8 months.
Injury, poisoning and procedural complications Muscle strain	0.00% 0/81 • From informed consent until termination. 7-8 months.	1.2% 1/83 • Number of events 1 • From informed consent until termination. 7-8 months.
Injury, poisoning and procedural complications Penis injury	0.00% 0/81 • From informed consent until termination. 7-8 months.	1.2% 1/83 • Number of events 1 • From informed consent until termination. 7-8 months.
Injury, poisoning and procedural complications Post-traumatic neck syndrome	1.2% 1/81 • Number of events 1 • From informed consent until termination. 7-8 months.	0.00% 0/83 • From informed consent until termination. 7-8 months.
Injury, poisoning and procedural complications Stoma obstruction	0.00% 0/81 • From informed consent until termination. 7-8 months.	1.2% 1/83 • Number of events 1 • From informed consent until termination. 7-8 months.
Injury, poisoning and procedural complications Tooth injury	0.00% 0/81 • From informed consent until termination. 7-8 months.	1.2% 1/83 • Number of events 1 • From informed consent until termination. 7-8 months.
Injury, poisoning and procedural complications Upper limb fracture	1.2% 1/81 • Number of events 1 • From informed consent until termination. 7-8 months.	0.00% 0/83 • From informed consent until termination. 7-8 months.
Injury, poisoning and procedural complications Wound	1.2% 1/81 • Number of events 1 • From informed consent until termination. 7-8 months.	0.00% 0/83 • From informed consent until termination. 7-8 months.
Psychiatric disorders Depression	7.4% 6/81 • Number of events 7 • From informed consent until termination. 7-8 months.	2.4% 2/83 • Number of events 2 • From informed consent until termination. 7-8 months.
Psychiatric disorders Anxiety	4.9% 4/81 • Number of events 4 • From informed consent until termination. 7-8 months.	2.4% 2/83 • Number of events 2 • From informed consent until termination. 7-8 months.
Psychiatric disorders Insomnia	3.7% 3/81 • Number of events 3 • From informed consent until termination. 7-8 months.	1.2% 1/83 • Number of events 1 • From informed consent until termination. 7-8 months.
Psychiatric disorders Agitated depression	0.00% 0/81 • From informed consent until termination. 7-8 months.	1.2% 1/83 • Number of events 1 • From informed consent until termination. 7-8 months.
Psychiatric disorders Bipolar disorder	1.2% 1/81 • Number of events 1 • From informed consent until termination. 7-8 months.	0.00% 0/83 • From informed consent until termination. 7-8 months.
Psychiatric disorders Confusional state	0.00% 0/81 • From informed consent until termination. 7-8 months.	1.2% 1/83 • Number of events 1 • From informed consent until termination. 7-8 months.
Psychiatric disorders Derealisation	1.2% 1/81 • Number of events 1 • From informed consent until termination. 7-8 months.	0.00% 0/83 • From informed consent until termination. 7-8 months.
Psychiatric disorders Mood altered	1.2% 1/81 • Number of events 1 • From informed consent until termination. 7-8 months.	0.00% 0/83 • From informed consent until termination. 7-8 months.
Psychiatric disorders Panic attack	1.2% 1/81 • Number of events 1 • From informed consent until termination. 7-8 months.	0.00% 0/83 • From informed consent until termination. 7-8 months.
Psychiatric disorders Parasomnia	1.2% 1/81 • Number of events 1 • From informed consent until termination. 7-8 months.	0.00% 0/83 • From informed consent until termination. 7-8 months.
Psychiatric disorders Post-traumatic stress disorder	0.00% 0/81 • From informed consent until termination. 7-8 months.	1.2% 1/83 • Number of events 1 • From informed consent until termination. 7-8 months.
Psychiatric disorders Suicidal ideation	0.00% 0/81 • From informed consent until termination. 7-8 months.	1.2% 1/83 • Number of events 1 • From informed consent until termination. 7-8 months.
General disorders Pain	3.7% 3/81 • Number of events 3 • From informed consent until termination. 7-8 months.	4.8% 4/83 • Number of events 4 • From informed consent until termination. 7-8 months.
General disorders Adverse drug reaction	2.5% 2/81 • Number of events 2 • From informed consent until termination. 7-8 months.	2.4% 2/83 • Number of events 2 • From informed consent until termination. 7-8 months.
General disorders Chest pain	3.7% 3/81 • Number of events 3 • From informed consent until termination. 7-8 months.	1.2% 1/83 • Number of events 1 • From informed consent until termination. 7-8 months.
General disorders Fatigue	2.5% 2/81 • Number of events 2 • From informed consent until termination. 7-8 months.	1.2% 1/83 • Number of events 1 • From informed consent until termination. 7-8 months.
General disorders Influenza like illness	2.5% 2/81 • Number of events 2 • From informed consent until termination. 7-8 months.	0.00% 0/83 • From informed consent until termination. 7-8 months.
General disorders Pyrexia	1.2% 1/81 • Number of events 1 • From informed consent until termination. 7-8 months.	1.2% 1/83 • Number of events 1 • From informed consent until termination. 7-8 months.
General disorders Drug withdrawal syndrome	1.2% 1/81 • Number of events 1 • From informed consent until termination. 7-8 months.	0.00% 0/83 • From informed consent until termination. 7-8 months.
General disorders Nodule	0.00% 0/81 • From informed consent until termination. 7-8 months.	1.2% 1/83 • Number of events 1 • From informed consent until termination. 7-8 months.
General disorders Sensation of blood flow	0.00% 0/81 • From informed consent until termination. 7-8 months.	1.2% 1/83 • Number of events 1 • From informed consent until termination. 7-8 months.
General disorders Sensation of foreign body	1.2% 1/81 • Number of events 1 • From informed consent until termination. 7-8 months.	0.00% 0/83 • From informed consent until termination. 7-8 months.
General disorders Swelling	0.00% 0/81 • From informed consent until termination. 7-8 months.	1.2% 1/83 • Number of events 1 • From informed consent until termination. 7-8 months.
General disorders Ulcer	1.2% 1/81 • Number of events 1 • From informed consent until termination. 7-8 months.	0.00% 0/83 • From informed consent until termination. 7-8 months.
Ear and labyrinth disorders Hypoacusis	1.2% 1/81 • Number of events 1 • From informed consent until termination. 7-8 months.	4.8% 4/83 • Number of events 4 • From informed consent until termination. 7-8 months.
Ear and labyrinth disorders Tinnitus	1.2% 1/81 • Number of events 1 • From informed consent until termination. 7-8 months.	2.4% 2/83 • Number of events 3 • From informed consent until termination. 7-8 months.
Ear and labyrinth disorders Ear pain	1.2% 1/81 • Number of events 1 • From informed consent until termination. 7-8 months.	2.4% 2/83 • Number of events 2 • From informed consent until termination. 7-8 months.
Ear and labyrinth disorders Vertigo	1.2% 1/81 • Number of events 1 • From informed consent until termination. 7-8 months.	2.4% 2/83 • Number of events 2 • From informed consent until termination. 7-8 months.
Ear and labyrinth disorders Deafness neurosensory	0.00% 0/81 • From informed consent until termination. 7-8 months.	1.2% 1/83 • Number of events 1 • From informed consent until termination. 7-8 months.
Respiratory, thoracic and mediastinal disorders Dyspnoea	1.2% 1/81 • Number of events 1 • From informed consent until termination. 7-8 months.	1.2% 1/83 • Number of events 1 • From informed consent until termination. 7-8 months.
Respiratory, thoracic and mediastinal disorders Epistaxis	1.2% 1/81 • Number of events 1 • From informed consent until termination. 7-8 months.	1.2% 1/83 • Number of events 1 • From informed consent until termination. 7-8 months.
Respiratory, thoracic and mediastinal disorders Oropharyngeal pain	2.5% 2/81 • Number of events 2 • From informed consent until termination. 7-8 months.	0.00% 0/83 • From informed consent until termination. 7-8 months.
Respiratory, thoracic and mediastinal disorders Sleep apnoea syndrome	2.5% 2/81 • Number of events 2 • From informed consent until termination. 7-8 months.	0.00% 0/83 • From informed consent until termination. 7-8 months.
Respiratory, thoracic and mediastinal disorders Chronic obstructive pulmonary disease	1.2% 1/81 • Number of events 1 • From informed consent until termination. 7-8 months.	0.00% 0/83 • From informed consent until termination. 7-8 months.
Respiratory, thoracic and mediastinal disorders Cough	1.2% 1/81 • Number of events 1 • From informed consent until termination. 7-8 months.	0.00% 0/83 • From informed consent until termination. 7-8 months.
Respiratory, thoracic and mediastinal disorders Haemoptysis	0.00% 0/81 • From informed consent until termination. 7-8 months.	1.2% 1/83 • Number of events 1 • From informed consent until termination. 7-8 months.
Respiratory, thoracic and mediastinal disorders Hiccups	0.00% 0/81 • From informed consent until termination. 7-8 months.	1.2% 1/83 • Number of events 1 • From informed consent until termination. 7-8 months.
Respiratory, thoracic and mediastinal disorders Nasal congestion	1.2% 1/81 • Number of events 1 • From informed consent until termination. 7-8 months.	0.00% 0/83 • From informed consent until termination. 7-8 months.
Respiratory, thoracic and mediastinal disorders Respiratory tract congestion	0.00% 0/81 • From informed consent until termination. 7-8 months.	1.2% 1/83 • Number of events 1 • From informed consent until termination. 7-8 months.
Respiratory, thoracic and mediastinal disorders Rhinorrhoea	0.00% 0/81 • From informed consent until termination. 7-8 months.	1.2% 1/83 • Number of events 1 • From informed consent until termination. 7-8 months.
Skin and subcutaneous tissue disorders Rash	1.2% 1/81 • Number of events 1 • From informed consent until termination. 7-8 months.	1.2% 1/83 • Number of events 1 • From informed consent until termination. 7-8 months.
Skin and subcutaneous tissue disorders Urticaria	1.2% 1/81 • Number of events 2 • From informed consent until termination. 7-8 months.	0.00% 0/83 • From informed consent until termination. 7-8 months.
Skin and subcutaneous tissue disorders Dermatitis contact	1.2% 1/81 • Number of events 1 • From informed consent until termination. 7-8 months.	0.00% 0/83 • From informed consent until termination. 7-8 months.
Skin and subcutaneous tissue disorders Ecchymosis	1.2% 1/81 • Number of events 1 • From informed consent until termination. 7-8 months.	0.00% 0/83 • From informed consent until termination. 7-8 months.
Skin and subcutaneous tissue disorders Eczema	1.2% 1/81 • Number of events 1 • From informed consent until termination. 7-8 months.	0.00% 0/83 • From informed consent until termination. 7-8 months.
Skin and subcutaneous tissue disorders Ingrowing nail	1.2% 1/81 • Number of events 1 • From informed consent until termination. 7-8 months.	0.00% 0/83 • From informed consent until termination. 7-8 months.
Skin and subcutaneous tissue disorders Pain of skin	1.2% 1/81 • Number of events 1 • From informed consent until termination. 7-8 months.	0.00% 0/83 • From informed consent until termination. 7-8 months.
Skin and subcutaneous tissue disorders Rash pruritic	1.2% 1/81 • Number of events 1 • From informed consent until termination. 7-8 months.	0.00% 0/83 • From informed consent until termination. 7-8 months.
Skin and subcutaneous tissue disorders Skin discolouration	0.00% 0/81 • From informed consent until termination. 7-8 months.	1.2% 1/83 • Number of events 1 • From informed consent until termination. 7-8 months.
Skin and subcutaneous tissue disorders Skin discomfort	1.2% 1/81 • Number of events 1 • From informed consent until termination. 7-8 months.	0.00% 0/83 • From informed consent until termination. 7-8 months.
Skin and subcutaneous tissue disorders Skin reaction	0.00% 0/81 • From informed consent until termination. 7-8 months.	1.2% 1/83 • Number of events 1 • From informed consent until termination. 7-8 months.
Skin and subcutaneous tissue disorders Skin ulcer	1.2% 1/81 • Number of events 1 • From informed consent until termination. 7-8 months.	0.00% 0/83 • From informed consent until termination. 7-8 months.
Eye disorders Vision blurred	3.7% 3/81 • Number of events 3 • From informed consent until termination. 7-8 months.	0.00% 0/83 • From informed consent until termination. 7-8 months.
Eye disorders Blindness	1.2% 1/81 • Number of events 1 • From informed consent until termination. 7-8 months.	0.00% 0/83 • From informed consent until termination. 7-8 months.
Eye disorders Conjunctivitis allergic	1.2% 1/81 • Number of events 1 • From informed consent until termination. 7-8 months.	0.00% 0/83 • From informed consent until termination. 7-8 months.
Eye disorders Diabetic retinopathy	0.00% 0/81 • From informed consent until termination. 7-8 months.	1.2% 1/83 • Number of events 1 • From informed consent until termination. 7-8 months.
Eye disorders Episcleritis	1.2% 1/81 • Number of events 1 • From informed consent until termination. 7-8 months.	0.00% 0/83 • From informed consent until termination. 7-8 months.
Eye disorders Glaucoma	1.2% 1/81 • Number of events 1 • From informed consent until termination. 7-8 months.	0.00% 0/83 • From informed consent until termination. 7-8 months.
Eye disorders Photophobia	0.00% 0/81 • From informed consent until termination. 7-8 months.	1.2% 1/83 • Number of events 1 • From informed consent until termination. 7-8 months.
Eye disorders Photopsia	0.00% 0/81 • From informed consent until termination. 7-8 months.	1.2% 1/83 • Number of events 1 • From informed consent until termination. 7-8 months.
Eye disorders Visual impairment	1.2% 1/81 • Number of events 1 • From informed consent until termination. 7-8 months.	0.00% 0/83 • From informed consent until termination. 7-8 months.
Renal and urinary disorders Incontinence	2.5% 2/81 • Number of events 3 • From informed consent until termination. 7-8 months.	0.00% 0/83 • From informed consent until termination. 7-8 months.
Renal and urinary disorders Dysuria	1.2% 1/81 • Number of events 1 • From informed consent until termination. 7-8 months.	1.2% 1/83 • Number of events 1 • From informed consent until termination. 7-8 months.
Renal and urinary disorders Urinary retention	1.2% 1/81 • Number of events 1 • From informed consent until termination. 7-8 months.	1.2% 1/83 • Number of events 1 • From informed consent until termination. 7-8 months.
Renal and urinary disorders Acute kidney injury	1.2% 1/81 • Number of events 1 • From informed consent until termination. 7-8 months.	0.00% 0/83 • From informed consent until termination. 7-8 months.
Renal and urinary disorders Nephrolithiasis	0.00% 0/81 • From informed consent until termination. 7-8 months.	1.2% 1/83 • Number of events 1 • From informed consent until termination. 7-8 months.
Renal and urinary disorders Urinary incontinence	1.2% 1/81 • Number of events 1 • From informed consent until termination. 7-8 months.	0.00% 0/83 • From informed consent until termination. 7-8 months.
Renal and urinary disorders Urinary tract obstruction	1.2% 1/81 • Number of events 1 • From informed consent until termination. 7-8 months.	0.00% 0/83 • From informed consent until termination. 7-8 months.
Metabolism and nutrition disorders Hypoglycaemia	1.2% 1/81 • Number of events 1 • From informed consent until termination. 7-8 months.	2.4% 2/83 • Number of events 2 • From informed consent until termination. 7-8 months.
Metabolism and nutrition disorders Dehydration	0.00% 0/81 • From informed consent until termination. 7-8 months.	2.4% 2/83 • Number of events 2 • From informed consent until termination. 7-8 months.
Metabolism and nutrition disorders Gout	2.5% 2/81 • Number of events 2 • From informed consent until termination. 7-8 months.	0.00% 0/83 • From informed consent until termination. 7-8 months.
Metabolism and nutrition disorders Diabetes mellitus inadequate control	0.00% 0/81 • From informed consent until termination. 7-8 months.	1.2% 1/83 • Number of events 1 • From informed consent until termination. 7-8 months.
Surgical and medical procedures Tooth extraction	1.2% 1/81 • Number of events 1 • From informed consent until termination. 7-8 months.	1.2% 1/83 • Number of events 1 • From informed consent until termination. 7-8 months.
Surgical and medical procedures Dental care	1.2% 1/81 • Number of events 1 • From informed consent until termination. 7-8 months.	0.00% 0/83 • From informed consent until termination. 7-8 months.
Surgical and medical procedures Elective procedure	0.00% 0/81 • From informed consent until termination. 7-8 months.	1.2% 1/83 • Number of events 1 • From informed consent until termination. 7-8 months.
Surgical and medical procedures Papilloma excision	1.2% 1/81 • Number of events 1 • From informed consent until termination. 7-8 months.	0.00% 0/83 • From informed consent until termination. 7-8 months.
Surgical and medical procedures Shoulder operation	1.2% 1/81 • Number of events 1 • From informed consent until termination. 7-8 months.	0.00% 0/83 • From informed consent until termination. 7-8 months.
Immune system disorders Seasonal allergy	1.2% 1/81 • Number of events 1 • From informed consent until termination. 7-8 months.	2.4% 2/83 • Number of events 2 • From informed consent until termination. 7-8 months.
Immune system disorders Hypersensitivity	1.2% 1/81 • Number of events 1 • From informed consent until termination. 7-8 months.	1.2% 1/83 • Number of events 1 • From informed consent until termination. 7-8 months.
Vascular disorders Deep vein thrombosis	0.00% 0/81 • From informed consent until termination. 7-8 months.	1.2% 1/83 • Number of events 1 • From informed consent until termination. 7-8 months.
Vascular disorders Hypertension	0.00% 0/81 • From informed consent until termination. 7-8 months.	1.2% 1/83 • Number of events 1 • From informed consent until termination. 7-8 months.
Vascular disorders Lymphoedema	0.00% 0/81 • From informed consent until termination. 7-8 months.	1.2% 1/83 • Number of events 1 • From informed consent until termination. 7-8 months.
Vascular disorders Orthostatic hypotension	1.2% 1/81 • Number of events 1 • From informed consent until termination. 7-8 months.	0.00% 0/83 • From informed consent until termination. 7-8 months.
Congenital, familial and genetic disorders Arnold-Chiari malformation	1.2% 1/81 • Number of events 3 • From informed consent until termination. 7-8 months.	0.00% 0/83 • From informed consent until termination. 7-8 months.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Malignant melanoma in situ	0.00% 0/81 • From informed consent until termination. 7-8 months.	1.2% 1/83 • Number of events 1 • From informed consent until termination. 7-8 months.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Pituitary tumour benign	1.2% 1/81 • Number of events 1 • From informed consent until termination. 7-8 months.	0.00% 0/83 • From informed consent until termination. 7-8 months.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Skin cancer	1.2% 1/81 • Number of events 1 • From informed consent until termination. 7-8 months.	0.00% 0/83 • From informed consent until termination. 7-8 months.
Hepatobiliary disorders Biliary dyskinesia	1.2% 1/81 • Number of events 1 • From informed consent until termination. 7-8 months.	0.00% 0/83 • From informed consent until termination. 7-8 months.
Hepatobiliary disorders Hepatocellular injury	0.00% 0/81 • From informed consent until termination. 7-8 months.	1.2% 1/83 • Number of events 1 • From informed consent until termination. 7-8 months.
Blood and lymphatic system disorders Lymphadenopathy	0.00% 0/81 • From informed consent until termination. 7-8 months.	1.2% 1/83 • Number of events 1 • From informed consent until termination. 7-8 months.
Cardiac disorders Arrhythmia	0.00% 0/81 • From informed consent until termination. 7-8 months.	1.2% 1/83 • Number of events 1 • From informed consent until termination. 7-8 months.
Endocrine disorders Thyroid mass	1.2% 1/81 • Number of events 1 • From informed consent until termination. 7-8 months.	0.00% 0/83 • From informed consent until termination. 7-8 months.
Reproductive system and breast disorders Erectile dysfunction	0.00% 0/81 • From informed consent until termination. 7-8 months.	1.2% 1/83 • Number of events 1 • From informed consent until termination. 7-8 months.

Additional Information

Jerome Yesavage, MD

Director, VISN21 MIRECC, Department of Veterans Affairs

Phone: 650-852-3287

Email: Jerome.Yesavage@va.gov

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place