TrialPanorama/TrialPanorama-database huggingface dataset:
Study: NCT01970306

Adverse event: Abdominal pain
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 78 at risk

Adverse event: Acute kidney injury
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 1 affected / 78 at risk

Adverse event: Atrial fibrillation
Serious: yes
Organ System: Cardiac disorders
Frequency: 2 affected / 78 at risk

Adverse event: Death
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 78 at risk

Adverse event: Gastrointestinal anastomotic leak
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 7 affected / 78 at risk

Adverse event: Oesophageal stenosis
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 3 affected / 78 at risk

Adverse event: Gastrointestinal anastomotic leak
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 78 at risk

Adverse event: Gastrointestinal necrosis
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 78 at risk

Adverse event: Cardiac failure
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 78 at risk

Adverse event: Hepatic infection
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 78 at risk

Adverse event: Ileus
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 78 at risk

Adverse event: Pneumonia
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 78 at risk

Adverse event: Myocardial infarction
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 78 at risk

Adverse event: Pleural effusion
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 78 at risk

Adverse event: Pneumothorax
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 78 at risk

Adverse event: Respiratory failure
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 2 affected / 78 at risk

Adverse event: Tracheal fistula
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 78 at risk

Adverse event: Ventricular arrhythmia
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 78 at risk

Adverse event: Abdominal pain upper
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 5 affected / 78 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 78 at risk

Adverse event: Dysphagia
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 78 at risk

Adverse event: Wound infection
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 78 at risk
Study: NCT01970345

Adverse event: Increased appetite
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 2 at risk

Adverse event: Sleep disorder
Serious: no
Organ System: General disorders
Frequency: 2 affected / 2 at risk

Adverse event: Irritability
Serious: no
Organ System: Psychiatric disorders
Frequency: 1 affected / 2 at risk

Adverse event: Increased energy
Serious: no
Organ System: General disorders
Frequency: 1 affected / 2 at risk

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

Adverse event: Decreased appetite
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 2 at risk

Adverse event: Congestion/allergies
Serious: no
Organ System: General disorders
Frequency: 2 affected / 2 at risk

Adverse event: Fever/congestion
Serious: no
Organ System: General disorders
Frequency: 2 affected / 2 at risk

Adverse event: Anxiety
Serious: no
Organ System: Psychiatric disorders
Frequency: 1 affected / 2 at risk

Adverse event: Increased appetite
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 2 at risk

Adverse event: Sleep disorder
Serious: no
Organ System: General disorders
Frequency: 1 affected / 2 at risk

Adverse event: Irritability
Serious: no
Organ System: Psychiatric disorders
Frequency: 2 affected / 2 at risk

Adverse event: Bruising easily
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 2 at risk

Adverse event: Increased energy
Serious: no
Organ System: General disorders
Frequency: 1 affected / 2 at risk

Adverse event: Aggression towards others
Serious: no
Organ System: Psychiatric disorders
Frequency: 2 affected / 2 at risk

Adverse event: oppositional behavior
Serious: no
Organ System: Psychiatric disorders
Frequency: 1 affected / 2 at risk

Adverse event: Eye blinking
Serious: no
Organ System: Eye disorders
Frequency: 1 affected / 2 at risk

Adverse event: Aphthous ulcer
Serious: no
Organ System: General disorders
Frequency: 1 affected / 2 at risk
Study: NCT01970397

Adverse event: Injection site bruise
Serious: no
Organ System: General disorders
Frequency: 5 affected / 68 at risk

Adverse event: Injection site induration
Serious: no
Organ System: General disorders
Frequency: 4 affected / 68 at risk

Adverse event: Injection site bruise
Serious: no
Organ System: General disorders
Frequency: 9 affected / 68 at risk

Adverse event: Injection site induration
Serious: no
Organ System: General disorders
Frequency: 1 affected / 68 at risk
Study: NCT01970592

Adverse event: Medical DIagnosis
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: Lung cancer diagnosis
Frequency: 1 affected / 56 at risk

Adverse event: Participant Fall
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Notes: Minor injuries resulting from non-study related falls
Frequency: 3 affected / 56 at risk
Study: NCT01970787

Adverse event: Anal pocket with purulent discharge
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 21 at risk

Adverse event: Pyrexia
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 21 at risk
Study: NCT01970982

Adverse event: Blood triglycerides increased
Serious: no
Organ System: Investigations
Frequency: 2 affected / 80 at risk

Adverse event: Blood triglycerides increased
Serious: no
Organ System: Investigations
Frequency: 2 affected / 40 at risk
Study: NCT01970995

Adverse event: Haemoglobin decreased
Serious: no
Organ System: Investigations
Frequency: 11 affected / 78 at risk

Adverse event: Neutrophil count decreased
Serious: no
Organ System: Investigations
Frequency: 5 affected / 78 at risk

Adverse event: Haemoglobin decreased
Serious: no
Organ System: Investigations
Frequency: 3 affected / 42 at risk

Adverse event: Neutrophil count decreased
Serious: no
Organ System: Investigations
Frequency: 1 affected / 42 at risk

Adverse event: Haemoglobin decreased
Serious: no
Organ System: Investigations
Frequency: 3 affected / 40 at risk

Adverse event: Neutrophil count decreased
Serious: no
Organ System: Investigations
Frequency: 2 affected / 40 at risk
Study: NCT01971008

Adverse event: Gastro-esophageal reflux
Serious: no
Organ System: Gastrointestinal disorders
Notes: One patient reported exacerbation of gastroesophageal reflux during the 4-weeks open-label follow-up: this might have been related to regular use of the abdominal binder.
Frequency: 1 affected / 13 at risk
Study: NCT01971203

Adverse event: Depression
Serious: no
Organ System: Psychiatric disorders
Frequency: 1 affected / 26 at risk

Adverse event: Blood clot
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 26 at risk

Adverse event: Sedation
Serious: no
Organ System: Nervous system disorders
Frequency: 24 affected / 26 at risk

Adverse event: Sedation
Serious: no
Organ System: Nervous system disorders
Frequency: 11 affected / 29 at risk
Study: NCT01971255

Adverse event: Oral disorder
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 25 at risk

Adverse event: Tooth disorder
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 25 at risk

Adverse event: Platelet count decreased
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 25 at risk

Adverse event: Viral infection
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 25 at risk

Adverse event: Skin laceration
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 25 at risk

Adverse event: Blood bilirubin increased
Serious: no
Organ System: Investigations
Frequency: 1 affected / 25 at risk

Adverse event: Blood creatine phosphokinase
Serious: no
Organ System: Investigations
Frequency: 2 affected / 25 at risk

Adverse event: Blood sodium increased
Serious: no
Organ System: Investigations
Frequency: 1 affected / 25 at risk

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

Adverse event: Rash pruritic
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 2 affected / 25 at risk

Adverse event: Lymphadenopathy
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 40 at risk

Adverse event: Ear discomfort
Serious: no
Organ System: Ear and labyrinth disorders
Frequency: 1 affected / 40 at risk

Adverse event: Blood thyroid stimulating hormone abnormal
Serious: no
Organ System: Investigations
Frequency: 1 affected / 40 at risk

Adverse event: Back pain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 40 at risk

Adverse event: Migraine
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 40 at risk
Study: NCT01971346

Adverse event: Post-Op Constipation
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 46 at risk

Adverse event: Nasal congestion
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 4 affected / 46 at risk

Adverse event: Injection site reaction
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 3 affected / 46 at risk

Adverse event: GI Distress
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 3 affected / 46 at risk
Study: NCT01971385

Adverse event: Non Serious Itching, Redness, or Swelling
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: Subjects who reported itching, redness, or swelling and were recorded as a non-serious AE
Frequency: 8 affected / 17 at risk

Adverse event: Other Non Serious AE
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: Other AEs that were reported by subjects but were non-serious
Frequency: 1 affected / 17 at risk

Adverse event: Non Serious Itching, Redness, or Swelling
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: Subjects who reported itching, redness, or swelling and were recorded as a non-serious AE
Frequency: 5 affected / 18 at risk

Adverse event: Other Non Serious AE
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: Other AEs that were reported by subjects but were non-serious
Frequency: 1 affected / 18 at risk

Adverse event: Non Serious Itching, Redness, or Swelling
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: Subjects who reported itching, redness, or swelling and were recorded as a non-serious AE
Frequency: 2 affected / 19 at risk

Adverse event: Other Non Serious AE
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: Other AEs that were reported by subjects but were non-serious
Frequency: 1 affected / 19 at risk
Study: NCT01971463

Adverse event: IV infiltration
Serious: no
Organ System: Vascular disorders
Frequency: 1 affected / 81 at risk

Adverse event: Elevated systolic blood pressure
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 81 at risk

Adverse event: Tachycardia
Serious: no
Organ System: Cardiac disorders
Notes: Subject was in atrial fibrillation at start of monitoring session, developed tachycardia during monitoring due to rapid ventricular response
Frequency: 1 affected / 81 at risk
Study: NCT01971567

Adverse event: Change in sleep
Serious: no
Organ System: General disorders
Notes: Change in sleep beyond baseline threshold
Frequency: 2 affected / 56 at risk

Adverse event: Change in emotions or awareness of feelings
Serious: no
Organ System: Social circumstances
Frequency: 1 affected / 56 at risk

Adverse event: Head discomfort
Serious: no
Organ System: General disorders
Notes: Mild headache
Frequency: 3 affected / 56 at risk

Adverse event: Change in sleep
Serious: no
Organ System: General disorders
Notes: Change in sleep beyond baseline threshold
Frequency: 2 affected / 51 at risk

Adverse event: Change in emotions or awareness of feelings
Serious: no
Organ System: Social circumstances
Frequency: 2 affected / 51 at risk

Adverse event: Head discomfort
Serious: no
Organ System: General disorders
Notes: Mild headache
Frequency: 2 affected / 51 at risk

Adverse event: Skin irritation at scalp sensor site
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 51 at risk
Study: NCT01971580

Adverse event: Gastroenteritis and acidosis
Serious: yes
Organ System: Gastrointestinal disorders
Notes: Subject developed a viral gastroenteritis not related to drug therapy which provoked drug discontinuation and hospitalization. The subject was still interested in participating and after recovering restarted the study protocol without problems.
Frequency: 1 affected / 19 at risk

Adverse event: Rhinitis or Pharyngitis
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 6 affected / 19 at risk

Adverse event: Oedema
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 3 affected / 19 at risk

Adverse event: Rash
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 2 affected / 19 at risk

Adverse event: cough/dyspnea
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 4 affected / 19 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 4 affected / 19 at risk

Adverse event: Fatigue
Serious: no
Organ System: General disorders
Frequency: 1 affected / 19 at risk

Adverse event: Abdominal pain
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 19 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 19 at risk

Adverse event: Rhinitis or Pharyngitis
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 8 affected / 19 at risk

Adverse event: Oedema
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 2 affected / 19 at risk

Adverse event: Rash
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 3 affected / 19 at risk

Adverse event: Arthralgia
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 19 at risk

Adverse event: cough/dyspnea
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 3 affected / 19 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 19 at risk

Adverse event: Chest pain
Serious: no
Organ System: Cardiac disorders
Frequency: 2 affected / 19 at risk

Adverse event: Fatigue
Serious: no
Organ System: General disorders
Frequency: 1 affected / 19 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 19 at risk
Study: NCT01971593

Adverse event: Leg cramping
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 26 at risk

Adverse event: Dizziness
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 26 at risk

Adverse event: Hyperkalaemia
Serious: no
Organ System: Renal and urinary disorders
Frequency: 1 affected / 26 at risk

Adverse event: Oedema
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 2 affected / 26 at risk

Adverse event: Chest pain
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 26 at risk

Adverse event: Hypotension
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 26 at risk
Study: NCT01971645

Adverse event: emergence delerium
Serious: no
Organ System: Injury, poisoning and procedural complications
Notes: An abnormal mental state that develops as a result of anesthesia administration during the transition from unconsciousness to complete wakefulness.
Frequency: 1 affected / 25 at risk
Study: NCT01971723

Adverse event: Libido increased
Serious: no
Organ System: Reproductive system and breast disorders
Notes: Subjects reported increased libidos
Frequency: 2 affected / 14 at risk

Adverse event: Paraesthesia
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: Tingling of the skin
Frequency: 1 affected / 14 at risk

Adverse event: Acne
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: Subjects reported more acne than usual
Frequency: 2 affected / 14 at risk
Study: NCT01972152

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 5 affected / 28 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 28 at risk

Adverse event: Dizziness
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 28 at risk

Adverse event: Flushing
Serious: no
Organ System: Endocrine disorders
Frequency: 1 affected / 28 at risk

Adverse event: Gastrointestinal pain
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 28 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 2 affected / 28 at risk

Adverse event: Injection site reaction
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 21 affected / 28 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 4 affected / 29 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 29 at risk

Adverse event: Dizziness
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 29 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 2 affected / 29 at risk

Adverse event: Hot flush
Serious: no
Organ System: Endocrine disorders
Frequency: 1 affected / 29 at risk

Adverse event: Injection site reaction
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 24 affected / 29 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 13 affected / 28 at risk

Adverse event: Dizziness
Serious: no
Organ System: Nervous system disorders
Frequency: 2 affected / 28 at risk

Adverse event: Flushing
Serious: no
Organ System: Endocrine disorders
Frequency: 2 affected / 28 at risk

Adverse event: Gastrointestinal pain
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 28 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 2 affected / 28 at risk

Adverse event: Hot flush
Serious: no
Organ System: Endocrine disorders
Frequency: 3 affected / 28 at risk

Adverse event: Injection site reaction
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 11 affected / 28 at risk
Study: NCT01972204

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 3 affected / 58 at risk

Adverse event: Vomiting
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 58 at risk

Adverse event: Contusion
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 5 affected / 58 at risk

Adverse event: Decreased appetite
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 3 affected / 58 at risk

Adverse event: Back pain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 3 affected / 58 at risk

Adverse event: hypertention
Serious: no
Organ System: Vascular disorders
Frequency: 5 affected / 58 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 59 at risk

Adverse event: Vomiting
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 5 affected / 59 at risk

Adverse event: Contusion
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 3 affected / 59 at risk

Adverse event: Decreased appetite
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 4 affected / 59 at risk

Adverse event: hypertention
Serious: no
Organ System: Vascular disorders
Frequency: 1 affected / 59 at risk
Study: NCT01972282

Adverse event: Procedural Device/Procedure related Serious Adverse Events
Serious: yes
Organ System: Cardiac disorders
Notes: Bleeding; Hematoma; groin vascular damage; device embolization; incomplete seal at device release; pericardial effusion/tamponade; respiratory insufficiency; coronary air embolism; cerebral air embolism; hypotension; adverse reaction to anaesthesia
Frequency: 26 affected / 1020 at risk
Study: NCT01972438

Adverse event: Lymphadenopathy
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 18 at risk

Adverse event: Retinal vein occlusion
Serious: no
Organ System: Eye disorders
Frequency: 1 affected / 18 at risk

Adverse event: Macular oedema
Serious: no
Organ System: Eye disorders
Frequency: 1 affected / 18 at risk

Adverse event: Upper respiratory tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 18 at risk

Adverse event: Upper respiratory tract infection
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 18 at risk

Adverse event: Aspergillus infection
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 18 at risk

Adverse event: Pneumonia
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 18 at risk

Adverse event: Cataract subcapsular
Serious: no
Organ System: Eye disorders
Frequency: 1 affected / 18 at risk
Study: NCT01972464

Adverse event: Headache
Serious: no
Organ System: General disorders
Notes: headache
Frequency: 1 affected / 19 at risk

Adverse event: feeling Warm
Serious: no
Organ System: General disorders
Notes: feeling warm
Frequency: 1 affected / 19 at risk

Adverse event: Pruritus
Serious: no
Organ System: General disorders
Notes: Itching
Frequency: 1 affected / 19 at risk

Adverse event: abnormal pap smear
Serious: no
Organ System: Reproductive system and breast disorders
Notes: abnormal pap smear; repeat pap smear was negative
Frequency: 1 affected / 22 at risk

Adverse event: heavy menses
Serious: no
Organ System: Reproductive system and breast disorders
Notes: heavy menses during first cycle following delivery
Frequency: 1 affected / 22 at risk