TrialPanorama/TrialPanorama-database huggingface dataset:
Study: NCT01541371

Adverse event: Depression
Serious: yes
Organ System: Psychiatric disorders
Frequency: 1 affected / 403 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 15 affected / 403 at risk

Adverse event: Vomiting
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 8 affected / 403 at risk

Adverse event: Salivary hypersecretion
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 7 affected / 403 at risk

Adverse event: Constipation
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 6 affected / 403 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 6 affected / 403 at risk

Adverse event: Fatigue
Serious: no
Organ System: General disorders
Frequency: 11 affected / 403 at risk

Adverse event: Hepatic function abnormal
Serious: no
Organ System: Hepatobiliary disorders
Frequency: 6 affected / 403 at risk

Adverse event: Upper respiratory tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 15 affected / 403 at risk

Adverse event: Weight increased
Serious: no
Organ System: Investigations
Frequency: 17 affected / 403 at risk

Adverse event: Transaminases increased
Serious: no
Organ System: Investigations
Frequency: 9 affected / 403 at risk

Adverse event: Blood prolactin increased
Serious: no
Organ System: Investigations
Frequency: 6 affected / 403 at risk

Adverse event: Obesity
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 8 affected / 403 at risk

Adverse event: Increased appetite
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 6 affected / 403 at risk

Adverse event: Tremor
Serious: no
Organ System: Nervous system disorders
Frequency: 52 affected / 403 at risk

Adverse event: Dystonia
Serious: no
Organ System: Nervous system disorders
Frequency: 35 affected / 403 at risk

Adverse event: Extrapyramidal disorder
Serious: no
Organ System: Nervous system disorders
Frequency: 24 affected / 403 at risk

Adverse event: Dizziness
Serious: no
Organ System: Nervous system disorders
Frequency: 17 affected / 403 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 7 affected / 403 at risk

Adverse event: Akathisia
Serious: no
Organ System: Psychiatric disorders
Frequency: 74 affected / 403 at risk

Adverse event: Somnolence
Serious: no
Organ System: Psychiatric disorders
Frequency: 32 affected / 403 at risk

Adverse event: Insomnia
Serious: no
Organ System: Psychiatric disorders
Frequency: 26 affected / 403 at risk

Adverse event: Sleep disorder
Serious: no
Organ System: Psychiatric disorders
Frequency: 9 affected / 403 at risk

Adverse event: Menstrual disorders
Serious: no
Organ System: Reproductive system and breast disorders
Frequency: 7 affected / 403 at risk
Study: NCT01541553

Adverse event: Basal cell carcinoma
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 2 affected / 167 at risk

Adverse event: Malignant melanoma
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 167 at risk

Adverse event: Squamous cell carcinoma
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 3 affected / 167 at risk

Adverse event: Syncope
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 167 at risk

Adverse event: Basal cell carcinoma
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 162 at risk

Adverse event: Malignant melanoma
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 162 at risk

Adverse event: Squamous cell carcinoma
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 162 at risk

Adverse event: Transient ischeamic
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 162 at risk
Study: NCT01541748

Adverse event: Haematoma
Serious: yes
Organ System: Surgical and medical procedures
Notes: Retroperitoneal pelvic hematoma resulting in severe anemia, responded to 4 units of blood transfused.
Frequency: 1 affected / 68 at risk

Adverse event: Wound dehiscence
Serious: yes
Organ System: Surgical and medical procedures
Notes: Wound dehiscence with fever, bilateral abscess drained. Wound breakdown, repaired. Possible mechanical trauma caused both compartments wound breakdown.
Frequency: 1 affected / 68 at risk

Adverse event: Pelvic abscess.
Serious: yes
Organ System: Infections and infestations
Notes: Post-operative pelvic abscess. Drained by Interventional Radiology. No evidence of fistula.
Frequency: 1 affected / 68 at risk

Adverse event: Pain (Lasting > 6 weeks post-operatively)
Serious: no
Organ System: Surgical and medical procedures
Notes: Procedure related pelvic pain
Frequency: 3 affected / 68 at risk

Adverse event: Wound dehiscence
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: One participant had a perineal separation. One participant had a superficial separation of incision. One participant had a 1 cm vaginal exposure. One participant had a vaginal posterior separation 1 x 2 cm.
Frequency: 4 affected / 68 at risk
Study: NCT01541891

Adverse event: Cephalea
Serious: no
Organ System: Investigations
Notes: An adverse event was present (mild-intensity cephalea at visit 1 that did not need medications for its relief) in the CS/XG group, but it was not related to the treatment.
Frequency: 1 affected / 14 at risk
Study: NCT01541930

Adverse event: Diarrhoea
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 21 at risk

Adverse event: Fatigue
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 21 at risk

Adverse event: Skin neoplasm bleeding
Serious: no
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 3 affected / 21 at risk

Adverse event: Somnolence
Serious: no
Organ System: Nervous system disorders
Frequency: 2 affected / 21 at risk

Adverse event: Fatigue
Serious: no
Organ System: General disorders
Frequency: 3 affected / 21 at risk

Adverse event: Gamma-glutamyltransferase increased
Serious: no
Organ System: Investigations
Frequency: 2 affected / 21 at risk

Adverse event: Nasopharyngitis
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 21 at risk

Adverse event: Anaemia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 21 at risk

Adverse event: Decreased appetite
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 21 at risk

Adverse event: Peripheral sensory neuropathy
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 21 at risk

Adverse event: Flushing
Serious: no
Organ System: Vascular disorders
Frequency: 1 affected / 21 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 21 at risk

Adverse event: Vomiting
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 21 at risk

Adverse event: Hepatic function abnormal
Serious: no
Organ System: Hepatobiliary disorders
Frequency: 1 affected / 21 at risk

Adverse event: Alopecia
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 21 at risk

Adverse event: Rash
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 21 at risk

Adverse event: Dysuria
Serious: no
Organ System: Renal and urinary disorders
Frequency: 1 affected / 21 at risk

Adverse event: Pollakiuria
Serious: no
Organ System: Renal and urinary disorders
Frequency: 1 affected / 21 at risk

Adverse event: Oedema peripheral
Serious: no
Organ System: General disorders
Frequency: 1 affected / 21 at risk

Adverse event: Pyrexia
Serious: no
Organ System: General disorders
Frequency: 1 affected / 21 at risk

Adverse event: White blood cell count decreased
Serious: no
Organ System: Investigations
Frequency: 1 affected / 21 at risk

Adverse event: Procedural pain
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 21 at risk
Study: NCT01541969

Adverse event: Tinnitus worsened
Serious: no
Organ System: Ear and labyrinth disorders
Notes: In Acoustic CR Neuromodulation group AE reported by 2 participants during 12 week RCT phase, and 2 participants in the LTE phase (weeks 13 to 36). In the Tinnitus Masking group AE reported by 3 participants in the LTE phase (after crossover).
Frequency: 4 affected / 50 at risk

Adverse event: Tinnitus worsened
Serious: no
Organ System: Ear and labyrinth disorders
Notes: In Acoustic CR Neuromodulation group AE reported by 2 participants during 12 week RCT phase, and 2 participants in the LTE phase (weeks 13 to 36). In the Tinnitus Masking group AE reported by 3 participants in the LTE phase (after crossover).
Frequency: 3 affected / 50 at risk
Study: NCT01542229

Adverse event: psychiatric hospitalization
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 66 at risk
Study: NCT01542307

Adverse event: Dry mouth
Serious: no
Organ System: General disorders
Frequency: 1 affected / 22 at risk

Adverse event: Paraesthesia
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 22 at risk

Adverse event: Significant worsening of migraine headache
Serious: no
Organ System: Nervous system disorders
Frequency: 2 affected / 22 at risk
Study: NCT01542502

Adverse event: Injection site reactions
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: Mild injection site reaction - not requiring cessation of therapy
Frequency: 3 affected / 12 at risk
Study: NCT01542528

Adverse event: Minor incidents (scratches, bumped knees, etc)
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 8 affected / 59 at risk

Adverse event: Disruptive behaviors
Serious: no
Organ System: Social circumstances
Frequency: 5 affected / 59 at risk
Study: NCT01542684

Adverse event: Pyrexia
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 8 at risk

Adverse event: Injection site reaction
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 8 at risk

Adverse event: Urinary tract infection
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 8 at risk

Adverse event: Bone pain
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 8 at risk

Adverse event: Pyrexia
Serious: no
Organ System: General disorders
Frequency: 4 affected / 8 at risk

Adverse event: Nausea/Vomiting
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 4 affected / 8 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 8 at risk

Adverse event: Chest pain
Serious: no
Organ System: General disorders
Frequency: 1 affected / 8 at risk

Adverse event: Consipation
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 3 affected / 8 at risk

Adverse event: Fatigue
Serious: no
Organ System: General disorders
Frequency: 4 affected / 8 at risk

Adverse event: Dyspnoea
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 2 affected / 8 at risk

Adverse event: Dizziness
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 8 at risk

Adverse event: Memory Change
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 8 at risk

Adverse event: Vision blurred
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 8 at risk

Adverse event: Myalgia
Serious: no
Organ System: General disorders
Frequency: 3 affected / 8 at risk

Adverse event: Upper Respiratory Infecion
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 8 at risk

Adverse event: Cough
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 8 at risk

Adverse event: Oral pain
Serious: no
Organ System: General disorders
Frequency: 2 affected / 8 at risk

Adverse event: Bone pain
Serious: no
Organ System: General disorders
Frequency: 1 affected / 8 at risk

Adverse event: Vertigo
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 8 at risk

Adverse event: Dry eye
Serious: no
Organ System: General disorders
Frequency: 1 affected / 8 at risk

Adverse event: Injection site reaction
Serious: no
Organ System: General disorders
Frequency: 1 affected / 8 at risk

Adverse event: Verebral Fracture
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 8 at risk

Adverse event: Hypotension
Serious: no
Organ System: Vascular disorders
Frequency: 1 affected / 8 at risk
Study: NCT01542736

Adverse event: Death due to multi-system organ failure
Serious: yes
Organ System: Infections and infestations
Notes: Death was related to infection and occurred off-treatment.
Frequency: 1 affected / 8 at risk

Adverse event: Relapse
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 8 at risk
Study: NCT01543074

Adverse event: Abdominal discomfort
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 7 at risk

Adverse event: Abdominal discomfort
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 3 affected / 5 at risk

Adverse event: Abdominal discomfort
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 6 at risk
Study: NCT01543204

Adverse event: Colitis ischaemic
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 64 at risk

Adverse event: Diverticulitis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 64 at risk

Adverse event: Nasopharyngitis
Serious: no
Organ System: Infections and infestations
Frequency: 5 affected / 64 at risk

Adverse event: Vitamin D deficiency
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 5 affected / 64 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 6 affected / 64 at risk

Adverse event: Cough
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 6 affected / 64 at risk
Study: NCT01543256

Adverse event: Abdominal pain
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 5 affected / 80 at risk

Adverse event: Cholangitis/fever/jaundice
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 7 affected / 80 at risk

Adverse event: Cholecystitis
Serious: yes
Organ System: Gastrointestinal disorders
Notes: among patients with a gallbladder
Frequency: 3 affected / 69 at risk

Adverse event: Post-ERCP pancreatitis
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 80 at risk

Adverse event: Acute-on-chronic pancreatitis
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 80 at risk

Adverse event: Post-sphincterotomy bleed
Serious: yes
Organ System: Gastrointestinal disorders
Notes: among patients who had a sphincterotomy
Frequency: 1 affected / 77 at risk

Adverse event: Abdominal pain
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 3 affected / 80 at risk

Adverse event: Chronic Obstruction Pulmonary Disease
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 80 at risk

Adverse event: Neuropathy peripheral
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 80 at risk

Adverse event: Abdominal pain
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 5 affected / 84 at risk

Adverse event: Cholangitis/fever/jaundice
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 9 affected / 84 at risk

Adverse event: Cholecystitis
Serious: yes
Organ System: Gastrointestinal disorders
Notes: among patients with a gallbladder
Frequency: 1 affected / 72 at risk

Adverse event: Perforation of duodenum
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 84 at risk

Adverse event: Abdominal pain
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 4 affected / 84 at risk

Adverse event: Duodenal ulcer
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 84 at risk

Adverse event: Gastrointestinal oedema
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 84 at risk

Adverse event: Pancreatitis acute
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 84 at risk

Adverse event: Upper respiratory tract infection
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 84 at risk
Study: NCT01543490

Adverse event: Syncope
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 367 at risk

Adverse event: Transient global amnesia
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 367 at risk

Adverse event: Retinal detachment
Serious: yes
Organ System: Eye disorders
Frequency: 1 affected / 367 at risk

Adverse event: Cholecystitis
Serious: yes
Organ System: Hepatobiliary disorders
Frequency: 1 affected / 367 at risk

Adverse event: Cholelithiasis
Serious: yes
Organ System: Hepatobiliary disorders
Frequency: 1 affected / 367 at risk

Adverse event: Conjunctival hyperaemia
Serious: no
Organ System: Eye disorders
Frequency: 7 affected / 367 at risk

Adverse event: Conjunctival hyperaemia
Serious: no
Organ System: Eye disorders
Frequency: 5 affected / 188 at risk
Study: NCT01543568

Adverse event: Urinary tract infection
Serious: yes
Organ System: Infections and infestations
Frequency: 2 affected / 45 at risk

Adverse event: Death
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 45 at risk

Adverse event: Atrial fibrillation
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 45 at risk

Adverse event: Squamous cell carcinoma
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 2 affected / 45 at risk

Adverse event: Upper respiratory tract infection
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 5 affected / 45 at risk

Adverse event: Cataract Progression
Serious: no
Organ System: Eye disorders
Frequency: 3 affected / 45 at risk

Adverse event: Geographic atrophy progression
Serious: no
Organ System: Eye disorders
Frequency: 3 affected / 45 at risk
Study: NCT01543581

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

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

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

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

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

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

Adverse event: loss of taste sensation
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 1 at risk
Study: NCT01543828

Adverse event: Cough
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 2 affected / 40 at risk
Study: NCT01543958

Adverse event: Cellulitis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 40 at risk

Adverse event: Joint injury
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 40 at risk

Adverse event: Conjunctivitis
Serious: no
Organ System: Eye disorders
Frequency: 2 affected / 40 at risk

Adverse event: Abdominal pain
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 40 at risk

Adverse event: Constipation
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 40 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 40 at risk

Adverse event: Alanine aminotransferase increased
Serious: no
Organ System: Investigations
Frequency: 2 affected / 40 at risk

Adverse event: Blood bicarbonate decreased
Serious: no
Organ System: Investigations
Frequency: 9 affected / 40 at risk

Adverse event: Blood calcium decreased
Serious: no
Organ System: Investigations
Frequency: 8 affected / 40 at risk

Adverse event: Blood cholesterol increased
Serious: no
Organ System: Investigations
Frequency: 11 affected / 40 at risk

Adverse event: Blood glucose decreased
Serious: no
Organ System: Investigations
Frequency: 5 affected / 40 at risk

Adverse event: Blood glucose increased
Serious: no
Organ System: Investigations
Frequency: 9 affected / 40 at risk

Adverse event: Blood phosphorus decreased
Serious: no
Organ System: Investigations
Frequency: 10 affected / 40 at risk

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

Adverse event: Haemoglobin decreased
Serious: no
Organ System: Investigations
Frequency: 2 affected / 40 at risk

Adverse event: Low density lipoprotein increased
Serious: no
Organ System: Investigations
Frequency: 6 affected / 40 at risk

Adverse event: Neutrophil count decreased
Serious: no
Organ System: Investigations
Frequency: 2 affected / 40 at risk
Study: NCT01544088

Adverse event: hospitalization due to medical illness
Serious: yes
Organ System: Surgical and medical procedures
Notes: Medical hospitalization due to medical/surgical procedures
Frequency: 2 affected / 98 at risk

Adverse event: psychiatric hospitalization
Serious: yes
Organ System: Psychiatric disorders
Notes: hospitalization for substance-use related disorder, a condition that predated study entry. Moreover, hospitalization occurred during the follow up assessment phase of the study.
Frequency: 4 affected / 98 at risk

Adverse event: General disorders
Serious: yes
Organ System: General disorders
Notes: hospitalization for general disorders
Frequency: 2 affected / 98 at risk

Adverse event: Uninary disorder
Serious: yes
Organ System: Renal and urinary disorders
Notes: hospitalization due to renal or urinary disorder
Frequency: 1 affected / 98 at risk

Adverse event: Infection disease
Serious: yes
Organ System: Infections and infestations
Notes: hospitalization due to infectious disease
Frequency: 3 affected / 98 at risk

Adverse event: GI illness
Serious: yes
Organ System: Gastrointestinal disorders
Notes: hospitalization due to GI disorders
Frequency: 3 affected / 98 at risk

Adverse event: hospitalization due to medical illness
Serious: yes
Organ System: Surgical and medical procedures
Notes: Medical hospitalization due to medical/surgical procedures
Frequency: 4 affected / 100 at risk

Adverse event: psychiatric hospitalization
Serious: yes
Organ System: Psychiatric disorders
Notes: hospitalization for substance-use related disorder, a condition that predated study entry. Moreover, hospitalization occurred during the follow up assessment phase of the study.
Frequency: 9 affected / 100 at risk

Adverse event: General disorders
Serious: yes
Organ System: General disorders
Notes: hospitalization for general disorders
Frequency: 4 affected / 100 at risk

Adverse event: Uninary disorder
Serious: yes
Organ System: Renal and urinary disorders
Notes: hospitalization due to renal or urinary disorder
Frequency: 2 affected / 100 at risk

Adverse event: Infection disease
Serious: yes
Organ System: Infections and infestations
Notes: hospitalization due to infectious disease
Frequency: 2 affected / 100 at risk

Adverse event: GI illness
Serious: yes
Organ System: Gastrointestinal disorders
Notes: hospitalization due to GI disorders
Frequency: 1 affected / 100 at risk