TrialPanorama/TrialPanorama-database huggingface dataset:
Study: NCT01021956

Adverse event: Retinal vascular occlusion
Serious: yes
Organ System: Eye disorders
Frequency: 1 affected / 3 at risk

Adverse event: Eye pain
Serious: no
Organ System: Eye disorders
Frequency: 1 affected / 3 at risk

Adverse event: Visual Acuty reduced
Serious: no
Organ System: Eye disorders
Frequency: 2 affected / 3 at risk

Adverse event: Conjunctival haemorrhage
Serious: no
Organ System: Eye disorders
Frequency: 1 affected / 3 at risk

Adverse event: Ocular hyperaemia
Serious: no
Organ System: Eye disorders
Frequency: 1 affected / 3 at risk

Adverse event: Retinal pigment epitheliopathy
Serious: no
Organ System: Eye disorders
Frequency: 1 affected / 3 at risk

Adverse event: Macular ischaemia
Serious: no
Organ System: Eye disorders
Frequency: 1 affected / 3 at risk

Adverse event: Retinal vascular occlusion
Serious: yes
Organ System: Eye disorders
Frequency: 1 affected / 1 at risk

Adverse event: Macular ischaemia
Serious: no
Organ System: Eye disorders
Frequency: 1 affected / 1 at risk

Adverse event: Retinal haemorrhage
Serious: no
Organ System: Eye disorders
Frequency: 1 affected / 1 at risk

Adverse event: Retinal oedema
Serious: no
Organ System: Eye disorders
Frequency: 1 affected / 1 at risk
Study: NCT01022073

Adverse event: Hospitalisation
Serious: yes
Organ System: Surgical and medical procedures
Notes: Elective hospitalization are not medical events and are only scheduled to facilitate a safe study visit for the participants.
Frequency: 2 affected / 86 at risk

Adverse event: Hospitalisation
Serious: yes
Organ System: Surgical and medical procedures
Notes: Elective hospitalization are not medical events and are only scheduled to facilitate a safe study visit for the participants.
Frequency: 2 affected / 70 at risk
Study: NCT01022203

Adverse event: Aggression
Serious: no
Organ System: Psychiatric disorders
Notes: Veteran and his spouse became intoxicated and veteran was violent with spouse. No serious injury and no medical treatment required. The spouse ended her relationship with the veteran.
Frequency: 2 affected / 56 at risk
Study: NCT01022242

Adverse event: Tendon rupture
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 6 affected / 70 at risk

Adverse event: Syncope
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 70 at risk

Adverse event: adhesion (resulting in tenolysis)
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 2 affected / 70 at risk

Adverse event: Oedema peripheral
Serious: no
Organ System: General disorders
Frequency: 4 affected / 70 at risk

Adverse event: Nasopharyngitis
Serious: no
Organ System: Infections and infestations
Frequency: 8 affected / 70 at risk

Adverse event: Pain in extremity
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 6 affected / 70 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 2 affected / 70 at risk

Adverse event: Localised Infections
Serious: no
Organ System: Infections and infestations
Frequency: 2 affected / 70 at risk

Adverse event: Tendon rupture
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 5 affected / 65 at risk

Adverse event: Procedural pain
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 65 at risk

Adverse event: Urticaria
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 65 at risk

Adverse event: adhesion (resulting in tenolysis)
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 65 at risk

Adverse event: Accidental death
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 65 at risk

Adverse event: Myeloproliferative neoplasm
Serious: yes
Organ System: Immune system disorders
Frequency: 1 affected / 65 at risk

Adverse event: Cerebrovascular accident
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 65 at risk

Adverse event: Oedema peripheral
Serious: no
Organ System: General disorders
Frequency: 5 affected / 65 at risk

Adverse event: Nasopharyngitis
Serious: no
Organ System: Infections and infestations
Frequency: 7 affected / 65 at risk

Adverse event: Pain in extremity
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 2 affected / 65 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 4 affected / 65 at risk

Adverse event: Localised Infections
Serious: no
Organ System: Infections and infestations
Frequency: 4 affected / 65 at risk
Study: NCT01022359

Adverse event: Myocardial infarction
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 39 at risk

Adverse event: severe hemorrhagic stroke
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 39 at risk

Adverse event: metastatic malignancy that was diagnosed 9 months following CVC insertion
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 39 at risk

Adverse event: Sudden cardiac death
Serious: yes
Organ System: Cardiac disorders
Frequency: 2 affected / 41 at risk

Adverse event: Myocardial infarction
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 41 at risk

Adverse event: Pulmonary sepsis
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 41 at risk
Study: NCT01022502

Adverse event: Erythema
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: Erythematous changes occurred at the beginning of treatment and resolved after a couple of days. Patch test results revealed no allergic responses, while monitoring tests for hematology, liver and renal function showed no significant findings.
Frequency: 3 affected / 38 at risk

Adverse event: Erythema
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: Erythematous changes occurred at the beginning of treatment and resolved after a couple of days. Patch test results revealed no allergic responses, while monitoring tests for hematology, liver and renal function showed no significant findings.
Frequency: 1 affected / 38 at risk
Study: NCT01022567

Adverse event: Overall morbidity
Serious: no
Organ System: Infections and infestations
Frequency: 45 affected / 273 at risk

Adverse event: Overall morbidity
Serious: no
Organ System: Infections and infestations
Frequency: 6 affected / 257 at risk
Study: NCT01022580

Adverse event: Death
Serious: yes
Organ System: Investigations
Frequency: 29 affected / 252 at risk

Adverse event: IVH New or Worsened
Serious: no
Organ System: General disorders
Notes: Evaluation of new or worsened IVH after enrollment.
Frequency: 33 affected / 252 at risk

Adverse event: PDA Requiring Treatment
Serious: no
Organ System: Cardiac disorders
Notes: Incidence of infants who's PDA worsened to the point of needing treatment.
Frequency: 89 affected / 252 at risk

Adverse event: NEC
Serious: no
Organ System: Gastrointestinal disorders
Notes: Incidence of new or worsened NEC after enrollment.
Frequency: 27 affected / 252 at risk

Adverse event: Sepsis
Serious: no
Organ System: Infections and infestations
Notes: Incidence new episodes of culture proven sepsis after enrollment.
Frequency: 141 affected / 252 at risk

Adverse event: ROP Class 4-5 or surgery
Serious: no
Organ System: Eye disorders
Frequency: 34 affected / 252 at risk

Adverse event: Death
Serious: yes
Organ System: Investigations
Frequency: 24 affected / 259 at risk

Adverse event: IVH New or Worsened
Serious: no
Organ System: General disorders
Notes: Evaluation of new or worsened IVH after enrollment.
Frequency: 35 affected / 259 at risk

Adverse event: PDA Requiring Treatment
Serious: no
Organ System: Cardiac disorders
Notes: Incidence of infants who's PDA worsened to the point of needing treatment.
Frequency: 95 affected / 259 at risk

Adverse event: NEC
Serious: no
Organ System: Gastrointestinal disorders
Notes: Incidence of new or worsened NEC after enrollment.
Frequency: 24 affected / 259 at risk

Adverse event: Sepsis
Serious: no
Organ System: Infections and infestations
Notes: Incidence new episodes of culture proven sepsis after enrollment.
Frequency: 153 affected / 259 at risk

Adverse event: ROP Class 4-5 or surgery
Serious: no
Organ System: Eye disorders
Frequency: 29 affected / 259 at risk
Study: NCT01022762

Adverse event: Haemorrhoidal haemorrhage
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 216 at risk

Adverse event: Intervertebral disc protrusion
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 216 at risk

Adverse event: Gall bladder cancer
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 216 at risk
Study: NCT01023022

Adverse event: Death
Serious: yes
Organ System: Cardiac disorders
Notes: exacerbation of cardiac insufficiency
Frequency: 3 affected / 176 at risk

Adverse event: Death
Serious: yes
Organ System: Gastrointestinal disorders
Notes: peritonitis due to malignant sigmoid tumour
Frequency: 1 affected / 176 at risk

Adverse event: Death
Serious: yes
Organ System: General disorders
Notes: cause not determined
Frequency: 1 affected / 176 at risk
Study: NCT01023061

Adverse event: Lymphopenia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 19 affected / 22 at risk

Adverse event: Hypertension
Serious: no
Organ System: Cardiac disorders
Frequency: 8 affected / 22 at risk

Adverse event: ALT and AST: increased
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 7 affected / 22 at risk

Adverse event: Fatigue
Serious: no
Organ System: General disorders
Frequency: 15 affected / 22 at risk

Adverse event: hypokalemia syndrome
Serious: no
Organ System: Investigations
Frequency: 12 affected / 22 at risk

Adverse event: Hot flush
Serious: no
Organ System: Vascular disorders
Frequency: 15 affected / 22 at risk

Adverse event: Hyperbilirubinaemia
Serious: no
Organ System: Hepatobiliary disorders
Frequency: 5 affected / 22 at risk

Adverse event: Insomnia
Serious: no
Organ System: General disorders
Frequency: 3 affected / 22 at risk

Adverse event: Erectile dysfunction
Serious: no
Organ System: Reproductive system and breast disorders
Frequency: 7 affected / 22 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 9 affected / 22 at risk

Adverse event: Urinary tract discomfort
Serious: no
Organ System: Renal and urinary disorders
Frequency: 19 affected / 22 at risk
Study: NCT01023217

Adverse event: Deafness
Serious: yes
Organ System: Ear and labyrinth disorders
Frequency: 1 affected / 45 at risk

Adverse event: Thyroid cancer
Serious: yes
Organ System: Endocrine disorders
Frequency: 1 affected / 45 at risk

Adverse event: Upper respiratory tract infection
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 5 affected / 45 at risk

Adverse event: Intervertebral disc protrusion
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 45 at risk

Adverse event: Rib fracture
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 45 at risk

Adverse event: Upper respiratory tract infection
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 5 affected / 45 at risk
Study: NCT01023269

Adverse event: Infection of the device stimulator
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 17 at risk

Adverse event: Urinary tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 4 affected / 17 at risk

Adverse event: pain after surgery
Serious: no
Organ System: Surgical and medical procedures
Frequency: 1 affected / 17 at risk

Adverse event: Bronchitis
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 17 at risk

Adverse event: Battery empty at 07h30 and return of symptoms
Serious: no
Organ System: Investigations
Frequency: 1 affected / 17 at risk

Adverse event: Lead cut by the nurse
Serious: no
Organ System: Investigations
Frequency: 1 affected / 17 at risk
Study: NCT01023516

Adverse event: Bundle branch block right
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 313 at risk

Adverse event: Pneumonia
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 313 at risk

Adverse event: Pyelonephritis acute
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 313 at risk

Adverse event: Radius fracture
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 313 at risk

Adverse event: Lung neoplasm malignant
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 313 at risk

Adverse event: Chronic obstructive pulmonary disease
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 4 affected / 313 at risk

Adverse event: Myocardial ischaemia
Serious: yes
Organ System: Cardiac disorders
Frequency: 2 affected / 302 at risk

Adverse event: Acute myocardial infarction
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 302 at risk

Adverse event: Angina pectoris
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 302 at risk

Adverse event: Cardiac failure
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 302 at risk

Adverse event: Pneumonia
Serious: yes
Organ System: Infections and infestations
Frequency: 3 affected / 302 at risk

Adverse event: Post procedural infection
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 302 at risk

Adverse event: Tibia fracture
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 302 at risk

Adverse event: Laryngeal cancer
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 302 at risk

Adverse event: Squamous cell carcinoma of lung
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 302 at risk

Adverse event: Renal colic
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 1 affected / 302 at risk

Adverse event: Chronic obstructive pulmonary disease
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 302 at risk

Adverse event: Acute pulmonary oedema
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 302 at risk
Study: NCT01023672

Adverse event: Anxiety
Serious: no
Organ System: Psychiatric disorders
Frequency: 1 affected / 20 at risk

Adverse event: Blepharitis
Serious: no
Organ System: Eye disorders
Frequency: 1 affected / 20 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 20 at risk

Adverse event: ECG changes/prolonged QTc interval
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 20 at risk

Adverse event: Depression
Serious: no
Organ System: Psychiatric disorders
Frequency: 1 affected / 20 at risk

Adverse event: Ear pain
Serious: no
Organ System: Ear and labyrinth disorders
Frequency: 1 affected / 20 at risk
Study: NCT01023711

Adverse event: Upper respiratory tract infection
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 8 affected / 107 at risk

Adverse event: Fatigue
Serious: no
Organ System: General disorders
Frequency: 3 affected / 107 at risk

Adverse event: CONGESTION
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 3 affected / 107 at risk
Study: NCT01023776

Adverse event: Back pain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 20 at risk

Adverse event: Cholelithiasis
Serious: no
Organ System: Hepatobiliary disorders
Frequency: 1 affected / 20 at risk

Adverse event: Cough
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 20 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 20 at risk

Adverse event: Light Headed
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 20 at risk

Adverse event: Menstral Cramps
Serious: no
Organ System: Reproductive system and breast disorders
Frequency: 1 affected / 20 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 20 at risk

Adverse event: Epistaxis
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 2 affected / 20 at risk

Adverse event: Rhinorrhoea
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 2 affected / 20 at risk

Adverse event: Arthralgia
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 3 affected / 20 at risk

Adverse event: Oropharyngeal pain
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 4 affected / 20 at risk

Adverse event: Stuffy nose
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 20 at risk

Adverse event: Lymphadenopathy
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 2 affected / 20 at risk

Adverse event: Upper respiratory tract infection
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 20 at risk

Adverse event: Vomiting
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 20 at risk
Study: NCT01023841

Adverse event: Ovarian cyst ruptured
Serious: no
Organ System: Reproductive system and breast disorders
Frequency: 1 affected / 16 at risk
Study: NCT01024309

Adverse event: Chest pain and tightness
Serious: yes
Organ System: Cardiac disorders
Notes: Emergency Room Visit
Frequency: 1 affected / 27 at risk

Adverse event: Haematoma
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 27 at risk

Adverse event: Gallstone
Serious: yes
Organ System: Gastrointestinal disorders
Notes: Surgery
Frequency: 1 affected / 27 at risk

Adverse event: Calcar bone fracture
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 27 at risk

Adverse event: Dehydration and gastroenteritis
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 27 at risk

Adverse event: Medication Overdose
Serious: yes
Organ System: Injury, poisoning and procedural complications
Notes: Emergency Room Visit
Frequency: 1 affected / 27 at risk

Adverse event: Calcar bone fracture
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 27 at risk

Adverse event: Surgical incision complication
Serious: no
Organ System: Injury, poisoning and procedural complications
Notes: Capsular stitch popped
Frequency: 1 affected / 27 at risk
Study: NCT01024335

Adverse event: Dehydration
Serious: yes
Organ System: General disorders
Notes: One participant in the placebo arm was hospitalized for symptoms of dehydration during the first week of the outpatient phase.
Frequency: 1 affected / 20 at risk

Adverse event: Kidney infection and dislocated arm
Serious: yes
Organ System: General disorders
Notes: A participant in the placebo arm was hospitalized for treatment of a kidney infection and dislocated arm, which occurred 3 weeks after discontinuation of study participation
Frequency: 1 affected / 20 at risk

Adverse event: Insomnia
Serious: no
Organ System: Psychiatric disorders
Frequency: 7 affected / 20 at risk

Adverse event: Mood changes
Serious: no
Organ System: Psychiatric disorders
Frequency: 4 affected / 20 at risk

Adverse event: Increased/decreased appetite
Serious: no
Organ System: General disorders
Frequency: 2 affected / 20 at risk

Adverse event: Nausea/vomiting
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 20 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 20 at risk

Adverse event: Headache
Serious: no
Organ System: General disorders
Frequency: 2 affected / 20 at risk

Adverse event: Body Aches
Serious: no
Organ System: General disorders
Frequency: 1 affected / 20 at risk

Adverse event: GI Distress
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 3 affected / 20 at risk

Adverse event: Pruritis and facial swelling
Serious: yes
Organ System: General disorders
Notes: A participant in the dronabinol treatment arm developed symptoms of pruritis and facial swelling two days after receiving an injection of naltrexone. A dermatologist determined that the rash was most likely not related to the study medication.
Frequency: 1 affected / 40 at risk

Adverse event: Insomnia
Serious: no
Organ System: Psychiatric disorders
Frequency: 17 affected / 40 at risk

Adverse event: Mood changes
Serious: no
Organ System: Psychiatric disorders
Frequency: 5 affected / 40 at risk

Adverse event: Increased/decreased appetite
Serious: no
Organ System: General disorders
Frequency: 2 affected / 40 at risk

Adverse event: Nausea/vomiting
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 5 affected / 40 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 7 affected / 40 at risk

Adverse event: Headache
Serious: no
Organ System: General disorders
Frequency: 3 affected / 40 at risk

Adverse event: Body Aches
Serious: no
Organ System: General disorders
Frequency: 3 affected / 40 at risk

Adverse event: GI Distress
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 4 affected / 40 at risk

Adverse event: Sweating/chills
Serious: no
Organ System: General disorders
Frequency: 4 affected / 40 at risk
Study: NCT01024465

Adverse event: nausea/vomiting after discharge
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 4 affected / 26 at risk

Adverse event: gastric bloating
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 4 affected / 26 at risk

Adverse event: Abdominal pain upper
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 3 affected / 26 at risk

Adverse event: Gastrooesophageal reflux disease
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 3 affected / 26 at risk

Adverse event: ulcer at removal
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 3 affected / 26 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 26 at risk
Study: NCT01024569

Adverse event: Psychiatric Disorders
Serious: no
Organ System: Psychiatric disorders
Notes: At the Time 2 interview, subject mentioned that she had been thinking about harming herself and had been feeling this way for several weeks. The interviewer activated the study's crisis protocol and followed up with subject.
Frequency: 1 affected / 268 at risk

Adverse event: Psychiatric Disorders
Serious: no
Organ System: Psychiatric disorders
Notes: At the Time 1 interview, subject responded that she had been "a little bothered" by suicidal thoughts during the past week, due to the recent death of her daughter. The study's crisis protocol was activated and subject was followed up with.
Frequency: 1 affected / 251 at risk
Study: NCT01024608

Adverse event: Hypertensive crisis
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 167 at risk

Adverse event: Nasal discomfort
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 11 affected / 167 at risk

Adverse event: Nasal discomfort
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 10 affected / 171 at risk