TrialPanorama/TrialPanorama-database huggingface dataset:
Study: NCT00762502

Adverse event: Non-Significant Events
Serious: no
Organ System: Eye disorders
Notes: These were reported non-specifically as a single category of non-significant events.
Frequency: 13 affected / 87 at risk

Adverse event: Microbial Karatitis
Serious: yes
Organ System: Eye disorders
Frequency: 1 affected / 76 at risk

Adverse event: Non-Significant Events
Serious: no
Organ System: Eye disorders
Notes: These were reported non-specifically as a single category of non-significant events.
Frequency: 9 affected / 76 at risk
Study: NCT00762528

Adverse event: chest cold, upper respiratory infection
Serious: no
Organ System: General disorders
Notes: 2 subjects reported having a cold
Frequency: 1 affected / 24 at risk

Adverse event: Teeth Sensitive to cold
Serious: no
Organ System: General disorders
Notes: 2 subjects reported tooth sensitivity to cold.
Frequency: 2 affected / 25 at risk

Adverse event: Oral Irritation
Serious: no
Organ System: General disorders
Notes: subject reported oral irritation
Frequency: 1 affected / 25 at risk

Adverse event: chest cold, upper respiratory infection
Serious: no
Organ System: General disorders
Notes: 2 subjects reported having a cold
Frequency: 1 affected / 25 at risk

Adverse event: Pulled muscle in back
Serious: no
Organ System: General disorders
Notes: subject reported having a pulled muscle in their back.
Frequency: 1 affected / 25 at risk

Adverse event: Fever, chills & sore throat
Serious: no
Organ System: General disorders
Notes: subject reported experiencing a fever, chills and sore throat.
Frequency: 1 affected / 25 at risk
Study: NCT00762606

Adverse event: Posterior Capsular Rupture
Serious: no
Organ System: Eye disorders
Frequency: 2 affected / 55 at risk

Adverse event: Posterior Capsular Rupture
Serious: no
Organ System: Eye disorders
Frequency: 3 affected / 51 at risk

Adverse event: Conjunctival hyperaemia
Serious: no
Organ System: Eye disorders
Frequency: 1 affected / 51 at risk

Adverse event: Femoral Fracture
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 51 at risk

Adverse event: Zonular Rupture
Serious: no
Organ System: Eye disorders
Frequency: 1 affected / 51 at risk
Study: NCT00762710

Adverse event: Medical hospitalization
Serious: yes
Organ System: Infections and infestations
Notes: prazosin participant admitted to hospital for infected wisdom tooth
Frequency: 1 affected / 48 at risk

Adverse event: inpatient alcohol detoxification
Serious: yes
Organ System: Psychiatric disorders
Notes: two prazosin participants were hospitalized for acute alcohol withdrawal
Frequency: 2 affected / 48 at risk

Adverse event: Somnolence
Serious: no
Organ System: General disorders
Frequency: 28 affected / 48 at risk

Adverse event: Death
Serious: yes
Organ System: Psychiatric disorders
Notes: Placebo participant committed suicide.
Frequency: 1 affected / 44 at risk

Adverse event: medical hospitalization
Serious: yes
Organ System: Gastrointestinal disorders
Notes: placebo participant hospitalized for acute pancreatitis
Frequency: 1 affected / 44 at risk

Adverse event: Somnolence
Serious: no
Organ System: General disorders
Frequency: 15 affected / 44 at risk
Study: NCT00762723

Adverse event: Intervertebral disc disorder
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Notes: Pt. developed cervical disc disease, had surgery for cervical fusion
Frequency: 1 affected / 5 at risk

Adverse event: Illeus
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 5 at risk

Adverse event: Fall
Serious: no
Organ System: General disorders
Frequency: 2 affected / 5 at risk

Adverse event: Back pain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 5 at risk

Adverse event: Spinal stenosis
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 5 at risk

Adverse event: Fall
Serious: no
Organ System: General disorders
Frequency: 1 affected / 11 at risk

Adverse event: Back pain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 2 affected / 11 at risk

Adverse event: Infection
Serious: no
Organ System: Infections and infestations
Notes: Incision site infection
Frequency: 1 affected / 11 at risk
Study: NCT00762892

Adverse event: MAI infection, multi-organ failure, death
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 1 affected / 14 at risk
Study: NCT00762931

Adverse event: Hospitalization for chest pain associated with cocaine use
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 25 at risk

Adverse event: Hospitalization for asthma exacerbation
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 4 affected / 25 at risk

Adverse event: Hospitalization for persistant asthma symptoms
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 2 affected / 25 at risk

Adverse event: Death at 15 days post treatment
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 25 at risk

Adverse event: Hospitalization for observation; respiratory
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 25 at risk

Adverse event: Hospitalization for pneumonia
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 25 at risk

Adverse event: Hospitalization for continuation of asthma exacerbation
Serious: yes
Organ System: Reproductive system and breast disorders
Frequency: 1 affected / 25 at risk

Adverse event: Muscle twitching in neck
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 3 affected / 25 at risk

Adverse event: Sweating during attempted lead advancement
Serious: no
Organ System: Endocrine disorders
Frequency: 1 affected / 25 at risk

Adverse event: Lead displacement
Serious: no
Organ System: Surgical and medical procedures
Frequency: 1 affected / 25 at risk

Adverse event: Neck pain for 2 days post treatment
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 25 at risk

Adverse event: Haematoma
Serious: no
Organ System: Vascular disorders
Frequency: 1 affected / 25 at risk

Adverse event: Bleeding at insertion site
Serious: no
Organ System: Vascular disorders
Frequency: 1 affected / 25 at risk

Adverse event: Asthma exacerbation
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 25 at risk
Study: NCT00763035

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Notes: Severe headache that persisted for 2 days.
Frequency: 1 affected / 3 at risk

Adverse event: Abdominal Complaints
Serious: no
Organ System: Gastrointestinal disorders
Notes: Abdominal complaints, reminiscence of reactivation of Irritable Bowel Syndrome. Referred to specialist
Frequency: 1 affected / 3 at risk
Study: NCT00763139

Adverse event: liver function tests elevated
Serious: no
Organ System: Hepatobiliary disorders
Frequency: 2 affected / 34 at risk

Adverse event: Oedema peripheral
Serious: no
Organ System: General disorders
Frequency: 3 affected / 34 at risk

Adverse event: Upper respiratory tract infection
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 2 affected / 34 at risk

Adverse event: Pregnancy
Serious: yes
Organ System: Pregnancy, puerperium and perinatal conditions
Notes: Placebo Arm: 2 participants became pregnant, one when placebo was first intervention given, one when placebo was 2nd intervention given
Frequency: 2 affected / 34 at risk

Adverse event: liver function tests elevated
Serious: no
Organ System: Hepatobiliary disorders
Frequency: 1 affected / 34 at risk

Adverse event: Oedema peripheral
Serious: no
Organ System: General disorders
Frequency: 2 affected / 34 at risk

Adverse event: Upper respiratory tract infection
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 3 affected / 34 at risk
Study: NCT00763269

Adverse event: Burning sensation of mucosa
Serious: no
Organ System: General disorders
Notes: subject reported burning sensation on tongue, cheeks and lips. subject discontinued during the 4 weeks visit.
Frequency: 1 affected / 314 at risk

Adverse event: Redness in Perioral area (possible allergic reaction)
Serious: no
Organ System: General disorders
Notes: subject observed redness in perioral area. visited dermatologist who diagnosed a possible allergic reaction and recommended to discontinue study toothpaste.
Frequency: 1 affected / 314 at risk

Adverse event: Physical Accidents w/ injuries
Serious: no
Organ System: General disorders
Notes: Several subjects reported accident. 1 had a workplace accident and was put on bedrest. 1 fell and broke wrist while walking.1 fell in backyard and broke a bone in left foot. adn 1 subject reported 2 events(a foot sprain and a broken left foot bone.
Frequency: 1 affected / 314 at risk

Adverse event: Burning sensation of mucosa
Serious: no
Organ System: General disorders
Notes: subject reported burning sensation on tongue, cheeks and lips. subject discontinued during the 4 weeks visit.
Frequency: 1 affected / 312 at risk

Adverse event: Physical Accidents w/ injuries
Serious: no
Organ System: General disorders
Notes: Several subjects reported accident. 1 had a workplace accident and was put on bedrest. 1 fell and broke wrist while walking.1 fell in backyard and broke a bone in left foot. adn 1 subject reported 2 events(a foot sprain and a broken left foot bone.
Frequency: 3 affected / 312 at risk
Study: NCT00763282

Adverse event: Death
Serious: yes
Organ System: Investigations
Notes: Cause of death was not systematically tracked throughout study, and deaths were unrelated to the study intervention.
Frequency: 4 affected / 72 at risk

Adverse event: Death
Serious: yes
Organ System: Investigations
Notes: Cause of death was not systematically tracked throughout study, and deaths were unrelated to the study intervention.
Frequency: 3 affected / 72 at risk
Study: NCT00763321

Adverse event: Acute kidney injury
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 1 affected / 285 at risk

Adverse event: Constipation
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 85 affected / 285 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 70 affected / 285 at risk

Adverse event: Vomiting
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 21 affected / 285 at risk

Adverse event: Dizziness
Serious: no
Organ System: Nervous system disorders
Frequency: 17 affected / 285 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 19 affected / 285 at risk

Adverse event: Somnolence
Serious: no
Organ System: Nervous system disorders
Frequency: 23 affected / 285 at risk

Adverse event: Pruritus
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 21 affected / 285 at risk

Adverse event: Obstruction gastric
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 109 at risk

Adverse event: Constipation
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 4 affected / 109 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 17 affected / 109 at risk

Adverse event: Vomiting
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 6 affected / 109 at risk

Adverse event: Dizziness
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 109 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 9 affected / 109 at risk

Adverse event: Somnolence
Serious: no
Organ System: Nervous system disorders
Frequency: 4 affected / 109 at risk

Adverse event: Pruritus
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 2 affected / 109 at risk

Adverse event: Haemorrhoids
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 113 at risk

Adverse event: Proctalgia
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 113 at risk

Adverse event: Constipation
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 4 affected / 113 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 4 affected / 113 at risk

Adverse event: Vomiting
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 113 at risk

Adverse event: Dizziness
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 113 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 9 affected / 113 at risk
Study: NCT00763555

Adverse event: Coronary artery disease
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 44 at risk

Adverse event: Nasopharyngitis
Serious: no
Organ System: Infections and infestations
Frequency: 3 affected / 44 at risk

Adverse event: Pharyngitis
Serious: no
Organ System: Infections and infestations
Frequency: 2 affected / 44 at risk

Adverse event: Gastroenteritis
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 44 at risk

Adverse event: Sinusitis
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 44 at risk

Adverse event: Upper respiratory tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 44 at risk

Adverse event: Blood calcium increased
Serious: no
Organ System: Investigations
Frequency: 1 affected / 44 at risk

Adverse event: Blood cholesterol increased
Serious: no
Organ System: Investigations
Frequency: 1 affected / 44 at risk

Adverse event: Blood pressure increased
Serious: no
Organ System: Investigations
Frequency: 1 affected / 44 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 44 at risk

Adverse event: Heavy menstrual bleeding
Serious: no
Organ System: Reproductive system and breast disorders
Frequency: 1 affected / 44 at risk

Adverse event: Psoriasis
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 44 at risk

Adverse event: Pleural effusion
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 44 at risk

Adverse event: Nasopharyngitis
Serious: no
Organ System: Infections and infestations
Frequency: 2 affected / 44 at risk

Adverse event: Upper respiratory tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 44 at risk

Adverse event: Pneumonia
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 44 at risk

Adverse event: Urinary tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 44 at risk

Adverse event: Aspartate aminotransferase increased
Serious: no
Organ System: Investigations
Frequency: 1 affected / 44 at risk

Adverse event: Skin burning sensation
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 44 at risk

Adverse event: Skin irritation
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 44 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 44 at risk

Adverse event: Rales
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 44 at risk
Study: NCT00763698

Adverse event: Cardiac vein thrombus
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 86 at risk

Adverse event: Haematoma
Serious: yes
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 86 at risk

Adverse event: Right ventricular lead dislodgement/migration
Serious: yes
Organ System: Surgical and medical procedures
Frequency: 1 affected / 86 at risk

Adverse event: Right ventricular lead cardiac perforation
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 86 at risk

Adverse event: Cardiac vein thrombus
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 86 at risk

Adverse event: Haematoma
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 4 affected / 86 at risk

Adverse event: High defibrillation threshold
Serious: no
Organ System: Cardiac disorders
Frequency: 3 affected / 86 at risk

Adverse event: Hypotension
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 86 at risk

Adverse event: Left ventricular lead dislodgement/migration
Serious: no
Organ System: Surgical and medical procedures
Frequency: 1 affected / 86 at risk

Adverse event: Elevated left ventricular pacing threshold
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 86 at risk

Adverse event: Phrenic Nerve/Diaphragmatic Nerve stimulation
Serious: no
Organ System: Surgical and medical procedures
Frequency: 10 affected / 86 at risk

Adverse event: Right atrial lead undersensing
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 86 at risk

Adverse event: Device pocket stimulation
Serious: no
Organ System: Surgical and medical procedures
Frequency: 1 affected / 86 at risk

Adverse event: Therapy for non-ventricular rhythm
Serious: no
Organ System: Cardiac disorders
Frequency: 3 affected / 86 at risk

Adverse event: Arrhythmia supraventricular
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 86 at risk
Study: NCT00763750

Adverse event: PLT gr 4, ANC 4, HGB 3 F/U: ANC to gr3, HGB and PLT to gr 2
Serious: yes
Organ System: Investigations
Frequency: 1 affected / 25 at risk

Adverse event: gr 4 PLT, ANC 3, HGB2 & FU: death
Serious: yes
Organ System: Investigations
Frequency: 1 affected / 25 at risk

Adverse event: Plt gr4, ANC4, weakness/failure to thrive gr 3 & FU:gr 4 Leuko, gr 3 HGB, Anorexia gr 3, death
Serious: yes
Organ System: Investigations
Frequency: 1 affected / 25 at risk

Adverse event: weakness (gr 3)
Serious: yes
Organ System: Investigations
Frequency: 1 affected / 25 at risk

Adverse event: seizure - no grade
Serious: yes
Organ System: Investigations
Frequency: 1 affected / 25 at risk

Adverse event: gr 3 dehydration, gr 3 weakness, gr 3 Anorexia
Serious: yes
Organ System: Investigations
Frequency: 1 affected / 25 at risk

Adverse event: Rash
Serious: no
Organ System: Investigations
Frequency: 5 affected / 25 at risk

Adverse event: infection normal ANC (thrush included)
Serious: no
Organ System: Investigations
Frequency: 8 affected / 25 at risk

Adverse event: Fatigue
Serious: no
Organ System: Investigations
Frequency: 7 affected / 25 at risk

Adverse event: Seizure
Serious: no
Organ System: Investigations
Frequency: 3 affected / 25 at risk

Adverse event: Headache
Serious: no
Organ System: Investigations
Frequency: 3 affected / 25 at risk

Adverse event: Insomnia
Serious: no
Organ System: Investigations
Frequency: 2 affected / 25 at risk

Adverse event: Vomiting
Serious: no
Organ System: Investigations
Frequency: 2 affected / 25 at risk

Adverse event: Nausea
Serious: no
Organ System: Investigations
Frequency: 2 affected / 25 at risk

Adverse event: Alopecia
Serious: no
Organ System: Investigations
Frequency: 4 affected / 25 at risk

Adverse event: Constipation
Serious: no
Organ System: Investigations
Frequency: 3 affected / 25 at risk

Adverse event: Blood glucose
Serious: no
Organ System: Investigations
Frequency: 5 affected / 25 at risk

Adverse event: Blood albumin
Serious: no
Organ System: Investigations
Frequency: 4 affected / 25 at risk

Adverse event: Lymphopenia
Serious: no
Organ System: Investigations
Frequency: 14 affected / 25 at risk

Adverse event: PLT
Serious: no
Organ System: Investigations
Frequency: 4 affected / 25 at risk

Adverse event: ANC
Serious: no
Organ System: Investigations
Frequency: 4 affected / 25 at risk

Adverse event: White blood cell count
Serious: no
Organ System: Investigations
Frequency: 4 affected / 25 at risk

Adverse event: HGB
Serious: no
Organ System: Investigations
Frequency: 4 affected / 25 at risk
Study: NCT00763919

Adverse event: worsening mania
Serious: yes
Organ System: Psychiatric disorders
Frequency: 2 affected / 43 at risk

Adverse event: Death
Serious: yes
Organ System: Social circumstances
Notes: As of the last follow-up, the cause of the participant's death was under investigation by authorities.
Frequency: 1 affected / 43 at risk

Adverse event: worsening anxiety/panic attack
Serious: yes
Organ System: Psychiatric disorders
Frequency: 1 affected / 43 at risk

Adverse event: suicidal thoughts
Serious: yes
Organ System: Psychiatric disorders
Frequency: 2 affected / 43 at risk

Adverse event: incarcerated
Serious: yes
Organ System: Social circumstances
Notes: The participant was incarcerated for domestic violence.
Frequency: 1 affected / 43 at risk

Adverse event: boils beneath arms (hydronitis)
Serious: yes
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 43 at risk

Adverse event: Suicidal thoughts without plan
Serious: no
Organ System: Psychiatric disorders
Frequency: 1 affected / 43 at risk

Adverse event: mental instability
Serious: no
Organ System: Psychiatric disorders
Frequency: 1 affected / 43 at risk

Adverse event: Worsening depression
Serious: no
Organ System: Psychiatric disorders
Frequency: 1 affected / 43 at risk

Adverse event: Worsening mania
Serious: no
Organ System: Psychiatric disorders
Frequency: 1 affected / 43 at risk
Study: NCT00764491

Adverse event: Haematoma
Serious: yes
Organ System: Surgical and medical procedures
Notes: Hematoma requiring evacuation
Frequency: 1 affected / 123 at risk

Adverse event: Pseudoarthrosis
Serious: yes
Organ System: Surgical and medical procedures
Frequency: 7 affected / 123 at risk

Adverse event: Infection
Serious: yes
Organ System: Surgical and medical procedures
Notes: Infection requiring Intervention
Frequency: 2 affected / 123 at risk

Adverse event: Adjacent Level Degeneration
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Notes: Requiring Intervention
Frequency: 1 affected / 123 at risk

Adverse event: Screw Irritation
Serious: yes
Organ System: Surgical and medical procedures
Notes: Requiring Intervention
Frequency: 3 affected / 123 at risk

Adverse event: Disc Herniation
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Notes: Requiring Intervention
Frequency: 2 affected / 2 at risk

Adverse event: Lateral femoral cutaneous nerve injury secondary to intra-op positioning on table
Serious: no
Organ System: Surgical and medical procedures
Frequency: 10 affected / 123 at risk

Adverse event: Back pain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 9 affected / 123 at risk

Adverse event: Pseudoarthrosis
Serious: yes
Organ System: Surgical and medical procedures
Frequency: 1 affected / 33 at risk

Adverse event: Infection
Serious: yes
Organ System: Surgical and medical procedures
Notes: Infection requiring Intervention
Frequency: 1 affected / 33 at risk

Adverse event: Adjacent Level Degeneration
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Notes: Requiring Intervention
Frequency: 2 affected / 33 at risk

Adverse event: Disc Herniation
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Notes: Requiring Intervention
Frequency: 1 affected / 33 at risk

Adverse event: Spinal stenosis
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Notes: Requiring Intervention
Frequency: 2 affected / 33 at risk

Adverse event: Back pain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 6 affected / 33 at risk