Study: NCT01161420

Adverse event: Device Revision - resuture to secure IPG
Serious: yes
Organ System: Surgical and medical procedures
Frequency: 1 affected / 126 at risk

Adverse event: Atrial fibrillation
Serious: yes
Organ System: Cardiac disorders
Notes: pre-existing or independent condition unrelated to Inspire procedure or therapy.
Frequency: 2 affected / 126 at risk

Adverse event: Death
Serious: yes
Organ System: Cardiac disorders
Notes: pre-existing or independent condition unrelated to Inspire procedure or therapy.
Frequency: 1 affected / 126 at risk

Adverse event: Chest Pressure and/or Pain
Serious: yes
Organ System: Cardiac disorders
Notes: pre-existing or independent condition unrelated to Inspire procedure or therapy.
Frequency: 2 affected / 126 at risk

Adverse event: Recurring Syncope
Serious: yes
Organ System: Surgical and medical procedures
Notes: pre-existing or independent condition unrelated to Inspire procedure or therapy.
Frequency: 1 affected / 126 at risk

Adverse event: Coronary artery disease
Serious: yes
Organ System: Cardiac disorders
Notes: pre-existing or independent condition unrelated to Inspire procedure or therapy.
Frequency: 1 affected / 126 at risk

Adverse event: Rotator cuff syndrome
Serious: yes
Organ System: Injury, poisoning and procedural complications
Notes: pre-existing or independent condition unrelated to Inspire procedure or therapy.
Frequency: 1 affected / 126 at risk

Adverse event: Joint injury
Serious: yes
Organ System: Injury, poisoning and procedural complications
Notes: pre-existing or independent condition unrelated to Inspire procedure or therapy.
Frequency: 1 affected / 126 at risk

Adverse event: Acute Entercolitis
Serious: yes
Organ System: Gastrointestinal disorders
Notes: pre-existing or independent condition unrelated to Inspire procedure or therapy.
Frequency: 1 affected / 126 at risk

Adverse event: Road traffic accident
Serious: yes
Organ System: Injury, poisoning and procedural complications
Notes: pre-existing or independent condition unrelated to Inspire procedure or therapy.
Frequency: 1 affected / 126 at risk

Adverse event: Heart Catheter Procedure
Serious: yes
Organ System: Cardiac disorders
Notes: pre-existing or independent condition unrelated to Inspire procedure or therapy.
Frequency: 1 affected / 126 at risk

Adverse event: Accident
Serious: yes
Organ System: Injury, poisoning and procedural complications
Notes: pre-existing or independent condition unrelated to Inspire procedure or therapy.
Frequency: 1 affected / 126 at risk

Adverse event: Hernia
Serious: yes
Organ System: Injury, poisoning and procedural complications
Notes: pre-existing or independent condition unrelated to Inspire procedure or therapy.
Frequency: 1 affected / 126 at risk

Adverse event: Entercolitis
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 126 at risk

Adverse event: Events specifically related to an incision
Serious: no
Organ System: Surgical and medical procedures
Notes: Since the Inspire device is implanted under general anesthesia and requires three skin incisions, several types of AEs can be expected with this type of surgical procedure.
Frequency: 32 affected / 126 at risk

Adverse event: Post-operative discomfort independent of any surgical incision
Serious: no
Organ System: Surgical and medical procedures
Notes: The events reported in this category are common post-operative experiences from surgery such as pain, numbness, swelling or other post-operative discomfort that was not related to a specific surgical incision.
Frequency: 31 affected / 126 at risk

Adverse event: Temporary tongue weakness
Serious: no
Organ System: Surgical and medical procedures
Notes: The events reported in this category describe a temporary tongue weakness as evidenced by tongue numbness, tongue weakness or reduction in movement, tongue pain or discomfort, minor effect on speech, or swelling in the area.
Frequency: 23 affected / 126 at risk

Adverse event: Intubation Effects
Serious: no
Organ System: Surgical and medical procedures
Notes: All subjects were intubated during the surgical procedure, and therefore it was expected that subjects may experience the common effects of intubation, including sore throat, swallowing discomfort, or general soreness.
Frequency: 15 affected / 126 at risk

Adverse event: Post-op Headache
Serious: no
Organ System: Nervous system disorders
Notes: There were 8 reports of a post-implant headache in 8 (6%) subjects. All 8 events have been fully resolved with medication (5), medication and massage/acupuncture (1), or no intervention (2).
Frequency: 8 affected / 126 at risk

Adverse event: Other post-op symptoms
Serious: no
Organ System: Surgical and medical procedures
Notes: Fourteen (11%) subjects experienced a total of 22 events of post-operative symptoms including nausea, vomiting, drug reactions or miscellaneous pain or body soreness.
Frequency: 14 affected / 126 at risk

Adverse event: Procedure related Infection (mild or moderate)
Serious: no
Organ System: Infections and infestations
Notes: Procedure-related infections are categorized as mild or moderate (within 0-30 days post-procedure).
Frequency: 1 affected / 126 at risk

Adverse event: Discomfort due to electrical stimulation
Serious: no
Organ System: General disorders
Notes: The reports of discomfort due to the upper airway stimulation includes tongue pain, tongue movement limitations, neck/jaw discomfort or patient waking up due to stimulation strength.
Frequency: 42 affected / 126 at risk

Adverse event: Tongue abrasion
Serious: no
Organ System: General disorders
Notes: During the STAR trial, subjects reported symptoms of a sore tongue or tongue discomfort, including several with visible abrasions.
Frequency: 20 affected / 126 at risk

Adverse event: Mouth dryness
Serious: no
Organ System: General disorders
Notes: Mouth dryness is often associated with OSA due to subject having their mouth open during the night.
Frequency: 9 affected / 126 at risk

Adverse event: Mechanical pain associated with presence of device
Serious: no
Organ System: General disorders
Notes: Six (5%) subjects experienced 6 events resulting from discomfort or pain associated with the presence of the device, most commonly associated with the IPG.
Frequency: 6 affected / 126 at risk

Adverse event: Temporary internal device usability or functionality complaint
Serious: no
Organ System: Investigations
Notes: There were 9 adverse events reported where the cause was attributed to the operation of the Inspire system in 8 (6%) subjects.
Frequency: 8 affected / 126 at risk

Adverse event: Temporary external device usability or functionality
Serious: no
Organ System: Investigations
Notes: There were 3 events related to the operation of the external components and in all 3 cases, this was attributed to the subject's use of the patient programmer.
Frequency: 3 affected / 126 at risk

Adverse event: Other acute symptoms
Serious: no
Organ System: Surgical and medical procedures
Notes: This device-related adverse event code was created to include various event descriptions such as headaches, coughing, choking, dysphagia and speech.
Frequency: 14 affected / 126 at risk

Adverse event: Device related infection
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 126 at risk

Adverse event: Abdominal incisional pain
Serious: no
Organ System: General disorders
Frequency: 1 affected / 126 at risk

Adverse event: Abdominal pain/faecal incontinence
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 126 at risk

Adverse event: Abnormal pap smear/HPV
Serious: no
Organ System: Reproductive system and breast disorders
Frequency: 1 affected / 126 at risk

Adverse event: Abnormal x-ray
Serious: no
Organ System: General disorders
Frequency: 1 affected / 126 at risk

Adverse event: Acid reflux
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 126 at risk

Adverse event: Acute gastro-enteritis
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 126 at risk

Adverse event: Prostatitis
Serious: no
Organ System: Reproductive system and breast disorders
Frequency: 1 affected / 126 at risk

Adverse event: Allgeric reaction to Diamox
Serious: no
Organ System: Immune system disorders
Notes: Allergic reaction to Diamox
Frequency: 1 affected / 126 at risk

Adverse event: Allergic reaction to post-op antibiotics
Serious: no
Organ System: Immune system disorders
Frequency: 1 affected / 126 at risk

Adverse event: Anxiety
Serious: no
Organ System: Nervous system disorders
Frequency: 3 affected / 126 at risk

Adverse event: Awakening from sleep gasping for air
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: Patient calling and describes awakening from sleep with a sense of gasping for air. She reports experiencing this in the past when she was not adaquately using her CPAP prior to implant
Frequency: 1 affected / 126 at risk

Adverse event: Back pain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Notes: lateral
Frequency: 1 affected / 126 at risk

Adverse event: Back pain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 5 affected / 126 at risk

Adverse event: Benign fibrous papule and chronic folliculitis
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 126 at risk

Adverse event: Bilateral swelling of neck
Serious: no
Organ System: General disorders
Frequency: 1 affected / 126 at risk

Adverse event: Blood in ejaculate
Serious: no
Organ System: Reproductive system and breast disorders
Frequency: 1 affected / 126 at risk

Adverse event: Blood in sputum
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 126 at risk

Adverse event: Bone spurs
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 126 at risk

Adverse event: Benign prostatic hyperplasia
Serious: no
Organ System: Reproductive system and breast disorders
Frequency: 1 affected / 126 at risk

Adverse event: Broken teeth
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 126 at risk

Adverse event: Bronchitis
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 3 affected / 126 at risk

Adverse event: Burning, pinching, mildly tender at IPG site
Serious: no
Organ System: General disorders
Notes: Baseball moves
Frequency: 1 affected / 126 at risk

Adverse event: Chest pain
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: Patient complaint of pain in chest after waking up. This occurs only if patient takes a deep breath. This complaint was also there before the implant and has had it for years. However patient had not notified this before the implant date.
Frequency: 1 affected / 126 at risk

Adverse event: Nasopharyngitis
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 8 affected / 126 at risk

Adverse event: Cough
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 4 affected / 126 at risk

Adverse event: Cytomegalovirus
Serious: no
Organ System: Immune system disorders
Frequency: 1 affected / 126 at risk

Adverse event: Depression
Serious: no
Organ System: Immune system disorders
Frequency: 2 affected / 126 at risk

Adverse event: Device stimulation not felt during the night
Serious: no
Organ System: General disorders
Frequency: 1 affected / 126 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 126 at risk

Adverse event: Dysuria
Serious: no
Organ System: Renal and urinary disorders
Frequency: 1 affected / 126 at risk

Adverse event: Dilated cardiomyopathy
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 126 at risk

Adverse event: Diverticulitis
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 126 at risk

Adverse event: Dizziness
Serious: no
Organ System: Nervous system disorders
Frequency: 2 affected / 126 at risk

Adverse event: Drowsiness after Zolpidem administration
Serious: no
Organ System: General disorders
Frequency: 1 affected / 126 at risk

Adverse event: Drug reaction
Serious: no
Organ System: Immune system disorders
Frequency: 1 affected / 126 at risk

Adverse event: Dry throat
Serious: no
Organ System: General disorders
Frequency: 1 affected / 126 at risk

Adverse event: Dysphagia
Serious: no
Organ System: General disorders
Notes: Likely postoperative edema, mild. History of a Schatzki Ring dilation in the past.
Frequency: 1 affected / 126 at risk

Adverse event: Dyspnoea
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 126 at risk

Adverse event: Ear pain
Serious: no
Organ System: General disorders
Notes: Ear infection
Frequency: 1 affected / 126 at risk

Adverse event: Elevated triglycerides & blood sugar
Serious: no
Organ System: Blood and lymphatic system disorders
Notes: Hyperglycemia - unspecified Hypertriglycerides - unspecified
Frequency: 1 affected / 126 at risk

Adverse event: Enlarged lymphnodes
Serious: no
Organ System: Immune system disorders
Notes: possible viral infection
Frequency: 1 affected / 126 at risk

Adverse event: Fatigue related to B12 deficiency
Serious: no
Organ System: General disorders
Frequency: 1 affected / 126 at risk

Adverse event: Patient fall
Serious: no
Organ System: General disorders
Notes: Bicycle, ladder, general
Frequency: 4 affected / 126 at risk

Adverse event: Influenza
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 4 affected / 126 at risk

Adverse event: Grastic pain
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 126 at risk

Adverse event: Gastroenteritis
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 126 at risk

Adverse event: Gastrointestinal discomfort with nausea and mild diarrhea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 126 at risk

Adverse event: Malaise
Serious: no
Organ System: General disorders
Frequency: 1 affected / 126 at risk

Adverse event: Pruritus
Serious: no
Organ System: General disorders
Frequency: 1 affected / 126 at risk

Adverse event: Generalized neuropathy
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 126 at risk

Adverse event: Gastrooesophageal reflux disease
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 126 at risk

Adverse event: Abdominal discomfort
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 126 at risk

Adverse event: Hangover symptoms with associated nausea and vomiting
Serious: no
Organ System: General disorders
Frequency: 1 affected / 126 at risk

Adverse event: Nasopharyngitis
Serious: no
Organ System: General disorders
Frequency: 1 affected / 126 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 2 affected / 126 at risk

Adverse event: Heavy menstrual bleeding
Serious: no
Organ System: Reproductive system and breast disorders
Frequency: 1 affected / 126 at risk

Adverse event: Herpes Zoster (Shingles)
Serious: no
Organ System: Nervous system disorders
Frequency: 2 affected / 126 at risk

Adverse event: Hyperhidrosis
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 126 at risk

Adverse event: Hypertension
Serious: no
Organ System: Vascular disorders
Frequency: 3 affected / 126 at risk

Adverse event: Itchy right ear
Serious: no
Organ System: General disorders
Notes: Otitis externa
Frequency: 1 affected / 126 at risk

Adverse event: Tooth impacted
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 126 at risk

Adverse event: Incontinence
Serious: no
Organ System: Renal and urinary disorders
Frequency: 1 affected / 126 at risk

Adverse event: Infection of the throat
Serious: no
Organ System: Infections and infestations
Notes: Intercurrent Infection (Viral)
Frequency: 1 affected / 126 at risk

Adverse event: Inflammation
Serious: no
Organ System: General disorders
Notes: Light inflammation of the wound in the neck. Probably caused by shaving.
Frequency: 1 affected / 126 at risk

Adverse event: Insomnia
Serious: no
Organ System: General disorders
Frequency: 3 affected / 126 at risk

Adverse event: Jolting sensation of whole body
Serious: no
Organ System: General disorders
Notes: brief jerk/jolt of whole body and sense of falling immediately upon drifting to sleep with naps during the day. Not at night with use of Inspire therapy
Frequency: 1 affected / 126 at risk

Adverse event: Arthralgia
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 2 affected / 126 at risk

Adverse event: Left hip/groin pain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 126 at risk

Adverse event: Left middle finger smashed
Serious: no
Organ System: General disorders
Frequency: 1 affected / 126 at risk

Adverse event: Low grade headache
Serious: no
Organ System: General disorders
Frequency: 1 affected / 126 at risk

Adverse event: Lower back muscle pull
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 126 at risk

Adverse event: Mould infection (mouth)
Serious: no
Organ System: General disorders
Notes: Candida infection in mouth.
Frequency: 1 affected / 126 at risk

Adverse event: Nasal allergies
Serious: no
Organ System: Immune system disorders
Frequency: 1 affected / 126 at risk

Adverse event: Nasal congestion
Serious: no
Organ System: General disorders
Frequency: 1 affected / 126 at risk

Adverse event: Nightmare
Serious: no
Organ System: General disorders
Frequency: 1 affected / 126 at risk

Adverse event: Non-cardiac chest pain
Serious: no
Organ System: Nervous system disorders
Notes: anxiety
Frequency: 1 affected / 126 at risk

Adverse event: Obesitas
Serious: no
Organ System: General disorders
Frequency: 1 affected / 126 at risk

Adverse event: Otitis media
Serious: no
Organ System: Ear and labyrinth disorders
Notes: Patient reports L ear fullness with worsening allergies.
Frequency: 1 affected / 126 at risk

Adverse event: Pain after tooth extraction
Serious: no
Organ System: General disorders
Frequency: 1 affected / 126 at risk

Adverse event: Pain below right shoulder
Serious: no
Organ System: General disorders
Frequency: 1 affected / 126 at risk

Adverse event: Pain in esophagus
Serious: no
Organ System: General disorders
Frequency: 1 affected / 126 at risk

Adverse event: Pain in right ear
Serious: no
Organ System: General disorders
Notes: Slight infection
Frequency: 1 affected / 126 at risk

Adverse event: Pain in shoulder
Serious: no
Organ System: General disorders
Frequency: 1 affected / 126 at risk

Adverse event: Painful back muscles
Serious: no
Organ System: General disorders
Frequency: 1 affected / 126 at risk

Adverse event: Painful big toe
Serious: no
Organ System: General disorders
Notes: bruised big toe
Frequency: 1 affected / 126 at risk

Adverse event: Painful hip
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Notes: muscle strain
Frequency: 1 affected / 126 at risk

Adverse event: Painful right arm
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Notes: muscle strain
Frequency: 1 affected / 126 at risk

Adverse event: Painful right index finger
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Notes: flexor tendinitis
Frequency: 1 affected / 126 at risk

Adverse event: Personal and work related problems
Serious: no
Organ System: General disorders
Frequency: 1 affected / 126 at risk

Adverse event: Pharyngitis
Serious: no
Organ System: General disorders
Frequency: 2 affected / 126 at risk

Adverse event: Problems with jaw joint
Serious: no
Organ System: General disorders
Frequency: 1 affected / 126 at risk

Adverse event: Rash
Serious: no
Organ System: Immune system disorders
Notes: allergic reaction to penicillin
Frequency: 2 affected / 126 at risk

Adverse event: Prostatism
Serious: no
Organ System: Reproductive system and breast disorders
Frequency: 1 affected / 126 at risk

Adverse event: Restless legs syndrome
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 126 at risk

Adverse event: Right shoulder arm pain
Serious: no
Organ System: General disorders
Frequency: 3 affected / 126 at risk

Adverse event: Right thigh hematoma
Serious: no
Organ System: General disorders
Frequency: 1 affected / 126 at risk

Adverse event: Sciatic nerve aggravated
Serious: no
Organ System: General disorders
Frequency: 1 affected / 126 at risk

Adverse event: Sinusitis
Serious: no
Organ System: General disorders
Frequency: 3 affected / 126 at risk

Adverse event: Sinus/allergy symptoms
Serious: no
Organ System: General disorders
Frequency: 1 affected / 126 at risk

Adverse event: Skin infection
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 126 at risk

Adverse event: Soft tissue pain; back/ribs
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 126 at risk

Adverse event: Stiff neck pain
Serious: no
Organ System: General disorders
Frequency: 1 affected / 126 at risk

Adverse event: Stress
Serious: no
Organ System: General disorders
Frequency: 2 affected / 126 at risk

Adverse event: Stuffy nose
Serious: no
Organ System: General disorders
Frequency: 2 affected / 126 at risk

Adverse event: Submandibular gland pain
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 126 at risk

Adverse event: Syncope
Serious: no
Organ System: Nervous system disorders
Frequency: 3 affected / 126 at risk

Adverse event: TBI with no LOC
Serious: no
Organ System: General disorders
Frequency: 1 affected / 126 at risk

Adverse event: Throat ache
Serious: no
Organ System: General disorders
Frequency: 1 affected / 126 at risk

Adverse event: Pharyngitis
Serious: no
Organ System: General disorders
Frequency: 1 affected / 126 at risk

Adverse event: Oropharyngeal pain
Serious: no
Organ System: General disorders
Frequency: 1 affected / 126 at risk

Adverse event: Throat tightness
Serious: no
Organ System: General disorders
Frequency: 1 affected / 126 at risk

Adverse event: Tinnitus
Serious: no
Organ System: General disorders
Frequency: 2 affected / 126 at risk

Adverse event: Tongue biting
Serious: no
Organ System: General disorders
Frequency: 1 affected / 126 at risk

Adverse event: Tongue haematoma
Serious: no
Organ System: General disorders
Frequency: 1 affected / 126 at risk

Adverse event: Glossodynia
Serious: no
Organ System: General disorders
Frequency: 1 affected / 126 at risk

Adverse event: Toothache
Serious: no
Organ System: General disorders
Frequency: 1 affected / 126 at risk

Adverse event: Tooth infection
Serious: no
Organ System: General disorders
Frequency: 1 affected / 126 at risk

Adverse event: Tooth removed
Serious: no
Organ System: General disorders
Frequency: 1 affected / 126 at risk

Adverse event: Torticollis
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 126 at risk

Adverse event: Trigger fingers
Serious: no
Organ System: General disorders
Frequency: 1 affected / 126 at risk

Adverse event: Type ll Diabetes
Serious: no
Organ System: Endocrine disorders
Frequency: 1 affected / 126 at risk

Adverse event: Umbilical hernia
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 126 at risk

Adverse event: Upper respiratory tract infection
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 4 affected / 126 at risk

Adverse event: Urinary tract infection
Serious: no
Organ System: Renal and urinary disorders
Frequency: 2 affected / 126 at risk

Adverse event: Vaginal dermititis
Serious: no
Organ System: Reproductive system and breast disorders
Frequency: 1 affected / 126 at risk

Adverse event: Vertigo
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 126 at risk

Adverse event: Worsening arrhythmia - bigeminy
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 126 at risk

Adverse event: Worsening occasional difficulty with speech
Serious: no
Organ System: General disorders
Notes: Patient describes being "tongue tied" occasionally. States he has had this since TMJ surgery in 1994, but has noticed an increase in the last six months.
Frequency: 1 affected / 126 at risk

Adverse event: Worsening dry mouth
Serious: no
Organ System: General disorders
Frequency: 1 affected / 126 at risk

Adverse event: Worsening urinary incontinence
Serious: no
Organ System: Renal and urinary disorders
Frequency: 1 affected / 126 at risk

Adverse event: Worsening RLS
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 126 at risk

Adverse event: Worsening sinusitis
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 126 at risk

Adverse event: Wound on top of thumb
Serious: no
Organ System: General disorders
Frequency: 1 affected / 126 at risk