TrialPanorama/TrialPanorama-database huggingface dataset:
Study: NCT00316017

Adverse event: Hypernatremia that required therapeutic intervention
Serious: yes
Organ System: Blood and lymphatic system disorders
Notes: Serum sodium\>160 mEq/L requiring therapeutic intervention
Frequency: 2 affected / 220 at risk

Adverse event: Increased intracranial hemorrrhage
Serious: yes
Organ System: Nervous system disorders
Notes: Evidence observed on serial head CT scanning
Frequency: 12 affected / 220 at risk

Adverse event: Hypernatremia that did not required therapeutic intervention
Serious: yes
Organ System: Blood and lymphatic system disorders
Notes: Serum sodium\>160 mEq/L that did not require therapeutic intervention
Frequency: 7 affected / 220 at risk

Adverse event: Seizure activity
Serious: no
Organ System: Nervous system disorders
Notes: Observed in prehospital setting during 7.5% hypertonic saline/6% dextran-70 (HSD) fluid administration
Frequency: 1 affected / 220 at risk

Adverse event: Hypernatremia that required therapeutic intervention
Serious: yes
Organ System: Blood and lymphatic system disorders
Notes: Serum sodium\>160 mEq/L requiring therapeutic intervention
Frequency: 5 affected / 256 at risk

Adverse event: Increased intracranial hemorrrhage
Serious: yes
Organ System: Nervous system disorders
Notes: Evidence observed on serial head CT scanning
Frequency: 14 affected / 256 at risk

Adverse event: Hypernatremia that did not required therapeutic intervention
Serious: yes
Organ System: Blood and lymphatic system disorders
Notes: Serum sodium\>160 mEq/L that did not require therapeutic intervention
Frequency: 6 affected / 256 at risk

Adverse event: Complete placental abruption leading to fetal demise
Serious: no
Organ System: Pregnancy, puerperium and perinatal conditions
Notes: Protocol violation: enrolled obviously pregnant woman, 6 months gestation
Frequency: 1 affected / 256 at risk

Adverse event: Hypernatremia that required therapeutic intervention
Serious: yes
Organ System: Blood and lymphatic system disorders
Notes: Serum sodium\>160 mEq/L requiring therapeutic intervention
Frequency: 5 affected / 376 at risk

Adverse event: Increased intracranial hemorrrhage
Serious: yes
Organ System: Nervous system disorders
Notes: Evidence observed on serial head CT scanning
Frequency: 15 affected / 376 at risk

Adverse event: Hypernatremia that did not required therapeutic intervention
Serious: yes
Organ System: Blood and lymphatic system disorders
Notes: Serum sodium\>160 mEq/L that did not require therapeutic intervention
Frequency: 1 affected / 376 at risk

Adverse event: Pain, rash, hypotension secondary to a transfusion reaction
Serious: no
Organ System: Blood and lymphatic system disorders
Notes: 200 cc red blood cells typed for another patient and not felt to be related to study intervention
Frequency: 1 affected / 376 at risk
Study: NCT00316355

Adverse event: increased anxiety impairing functioning
Serious: no
Organ System: Psychiatric disorders
Frequency: 1 affected / 18 at risk
Study: NCT00317109

Adverse event: Febrile convulsion
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 82 at risk

Adverse event: Gastroenteritis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 82 at risk

Adverse event: Thermal burn
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 82 at risk

Adverse event: Tonsillitis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 82 at risk

Adverse event: Upper respiratory tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 5 affected / 84 at risk

Adverse event: Pain
Serious: no
Organ System: General disorders
Frequency: 21 affected / 84 at risk

Adverse event: Erythema
Serious: no
Organ System: General disorders
Frequency: 20 affected / 84 at risk

Adverse event: Swelling
Serious: no
Organ System: General disorders
Frequency: 13 affected / 84 at risk

Adverse event: Somnolence
Serious: no
Organ System: General disorders
Frequency: 14 affected / 84 at risk

Adverse event: Fever/(Rectally) (°C)
Serious: no
Organ System: General disorders
Frequency: 8 affected / 84 at risk

Adverse event: Irritability
Serious: no
Organ System: General disorders
Frequency: 15 affected / 84 at risk

Adverse event: Loss of appetite
Serious: no
Organ System: General disorders
Frequency: 13 affected / 84 at risk

Adverse event: Pneumonia
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 84 at risk

Adverse event: Upper respiratory tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 4 affected / 84 at risk

Adverse event: Pain
Serious: no
Organ System: General disorders
Frequency: 25 affected / 82 at risk

Adverse event: Erythema
Serious: no
Organ System: General disorders
Frequency: 16 affected / 82 at risk

Adverse event: Swelling
Serious: no
Organ System: General disorders
Frequency: 11 affected / 82 at risk

Adverse event: Somnolence
Serious: no
Organ System: General disorders
Frequency: 12 affected / 83 at risk

Adverse event: Fever/(Rectally) (°C)
Serious: no
Organ System: General disorders
Frequency: 5 affected / 83 at risk

Adverse event: Irritability
Serious: no
Organ System: General disorders
Frequency: 12 affected / 83 at risk

Adverse event: Loss of appetite
Serious: no
Organ System: General disorders
Frequency: 18 affected / 83 at risk
Study: NCT00317720

Adverse event: Anaemia
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 4 affected / 47 at risk

Adverse event: Lymphopenia
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 13 affected / 47 at risk

Adverse event: Neutropenia
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 9 affected / 47 at risk

Adverse event: Thrombocytopenia
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 4 affected / 47 at risk

Adverse event: Diarrhoea
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 9 affected / 47 at risk

Adverse event: Fatigue
Serious: yes
Organ System: General disorders
Frequency: 9 affected / 47 at risk

Adverse event: Hyperglycaemia
Serious: yes
Organ System: General disorders
Frequency: 13 affected / 47 at risk

Adverse event: Hypokalaemia
Serious: yes
Organ System: General disorders
Frequency: 6 affected / 47 at risk

Adverse event: Hyperlipidaemia
Serious: yes
Organ System: General disorders
Frequency: 4 affected / 47 at risk

Adverse event: Infection
Serious: yes
Organ System: General disorders
Frequency: 4 affected / 47 at risk

Adverse event: Mucosal inflammation
Serious: yes
Organ System: General disorders
Frequency: 9 affected / 47 at risk

Adverse event: Hypertransaminasaemia
Serious: yes
Organ System: General disorders
Frequency: 2 affected / 47 at risk

Adverse event: Thrombosis/embolism
Serious: yes
Organ System: Vascular disorders
Frequency: 2 affected / 47 at risk

Adverse event: Anaemia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 17 affected / 47 at risk

Adverse event: Lymphopenia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 13 affected / 47 at risk

Adverse event: Neutropenia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 13 affected / 47 at risk

Adverse event: Thrombocytopenia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 6 affected / 47 at risk

Adverse event: Fatigue
Serious: no
Organ System: General disorders
Frequency: 23 affected / 47 at risk

Adverse event: Hyperglycaemia
Serious: no
Organ System: General disorders
Frequency: 9 affected / 47 at risk

Adverse event: Hypokalaemia
Serious: no
Organ System: General disorders
Frequency: 6 affected / 47 at risk

Adverse event: Hyperlipidaemia
Serious: no
Organ System: General disorders
Frequency: 9 affected / 47 at risk

Adverse event: Infection
Serious: no
Organ System: General disorders
Frequency: 19 affected / 47 at risk

Adverse event: Mucosal inflammation
Serious: no
Organ System: General disorders
Frequency: 25 affected / 47 at risk

Adverse event: Rash
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 9 affected / 47 at risk

Adverse event: Hypertransaminasaemia
Serious: no
Organ System: General disorders
Frequency: 9 affected / 47 at risk
Study: NCT00318292

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

Adverse event: Hypoxia
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 45 at risk

Adverse event: Postoperative Pain Requiring Readmission
Serious: yes
Organ System: Surgical and medical procedures
Frequency: 2 affected / 45 at risk

Adverse event: Pulmonary embolism
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 45 at risk

Adverse event: Pneumonia
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 2 affected / 45 at risk

Adverse event: Proctalgia
Serious: no
Organ System: Surgical and medical procedures
Frequency: 1 affected / 45 at risk

Adverse event: Urinary retention
Serious: no
Organ System: Renal and urinary disorders
Frequency: 16 affected / 45 at risk

Adverse event: Bacterial infection
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 45 at risk

Adverse event: Pneumonia
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 45 at risk

Adverse event: Postoperative Nausea and Vomiting Requiring Readmission
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 45 at risk

Adverse event: Urinary retention
Serious: no
Organ System: Renal and urinary disorders
Frequency: 22 affected / 45 at risk
Study: NCT00318474

Adverse event: Injury
Serious: yes
Organ System: General disorders
Notes: motor vehicle accident (mva)
Frequency: 1 affected / 25 at risk

Adverse event: Back pain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 6 affected / 25 at risk

Adverse event: Nasopharyngitis
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 5 affected / 25 at risk

Adverse event: Cough
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 9 affected / 25 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 4 affected / 25 at risk

Adverse event: Oedema
Serious: no
Organ System: General disorders
Frequency: 5 affected / 25 at risk

Adverse event: Dyspepsia
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 5 affected / 25 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 8 affected / 25 at risk

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

Adverse event: Upper respiratory tract infection
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 5 affected / 25 at risk

Adverse event: Malignant melanoma
Serious: yes
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 27 at risk

Adverse event: Back pain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 6 affected / 27 at risk

Adverse event: Nasopharyngitis
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 7 affected / 27 at risk

Adverse event: Cough
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 9 affected / 27 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 6 affected / 27 at risk

Adverse event: Oedema
Serious: no
Organ System: General disorders
Frequency: 3 affected / 27 at risk

Adverse event: Dyspepsia
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 27 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 4 affected / 27 at risk

Adverse event: Oropharyngeal pain
Serious: no
Organ System: Infections and infestations
Frequency: 7 affected / 27 at risk

Adverse event: Upper respiratory tract infection
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 5 affected / 27 at risk
Study: NCT00318565

Adverse event: Pulmonary embolism
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 267 at risk

Adverse event: Atrioventricular block complete
Serious: yes
Organ System: Cardiac disorders
Frequency: 2 affected / 267 at risk

Adverse event: Acute myocardial infarction
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 267 at risk

Adverse event: Adverse Events within 7 Days- Device Related
Serious: no
Organ System: General disorders
Frequency: 1 affected / 267 at risk

Adverse event: Adverse Events within 7 Days- Procedure Related
Serious: no
Organ System: General disorders
Frequency: 18 affected / 267 at risk

Adverse event: Adverse Events within 7 Days- Possibly Procedure Related
Serious: no
Organ System: General disorders
Frequency: 12 affected / 267 at risk

Adverse event: Adverse Events within 7 Days- Unrelated to Device or Procedure
Serious: no
Organ System: General disorders
Frequency: 24 affected / 267 at risk

Adverse event: Adverse Events Greater than 7 Days- Procedure Related
Serious: no
Organ System: General disorders
Frequency: 2 affected / 267 at risk

Adverse event: Adverse Events Greater than 7 Days- Unrelated to Device or Procedure
Serious: no
Organ System: General disorders
Frequency: 28 affected / 267 at risk
Study: NCT00318591

Adverse event: Urinary tract infection
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 1 affected / 105 at risk

Adverse event: Diarrhoea
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 105 at risk

Adverse event: Suicidal ideation
Serious: yes
Organ System: Psychiatric disorders
Frequency: 1 affected / 105 at risk

Adverse event: Subdural haematoma
Serious: yes
Organ System: General disorders
Notes: not device-related
Frequency: 1 affected / 105 at risk

Adverse event: Deep vein thrombosis
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 105 at risk

Adverse event: renal and urinary disorders
Serious: no
Organ System: Renal and urinary disorders
Frequency: 16 affected / 105 at risk

Adverse event: Urinary tract infection
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 3 affected / 114 at risk

Adverse event: Pneumonia
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 2 affected / 114 at risk

Adverse event: Urosepsis
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 1 affected / 114 at risk

Adverse event: perforated bladder/cystitis/decreased oxygen saturation
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 1 affected / 114 at risk

Adverse event: renal and urinary disorders
Serious: no
Organ System: Renal and urinary disorders
Frequency: 13 affected / 114 at risk

Adverse event: reproductive system and breast disorders
Serious: no
Organ System: Reproductive system and breast disorders
Frequency: 1 affected / 114 at risk
Study: NCT00318708

Adverse event: respiratory infections
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 5 affected / 47 at risk

Adverse event: gastrointestinal events
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 7 affected / 47 at risk

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

Adverse event: gastrointestinal events
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 3 affected / 45 at risk
Study: NCT00318812

Adverse event: Constipation
Serious: no
Organ System: Gastrointestinal disorders
Notes: Gastrointestinal complaints were the most common adverse effects in both groups with constipation and abdominal cramps being the most common in HIP group and constipation in IV sucrose group
Frequency: 5 affected / 18 at risk

Adverse event: Abdominal pain
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 5 affected / 18 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 18 at risk

Adverse event: Dyspepsia
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 18 at risk

Adverse event: Rash
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 18 at risk

Adverse event: Muscle spasms
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 5 affected / 18 at risk

Adverse event: Constipation
Serious: no
Organ System: Gastrointestinal disorders
Notes: Gastrointestinal complaints were the most common adverse effects in both groups with constipation and abdominal cramps being the most common in HIP group and constipation in IV sucrose group
Frequency: 4 affected / 22 at risk

Adverse event: Abdominal pain
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 3 affected / 22 at risk

Adverse event: Symptomatic Hypotension
Serious: no
Organ System: Cardiac disorders
Notes: symptomatic hypotesnion was seen in 3 patients in the IV sucrose arm and 0 patients in the HIP arm
Frequency: 3 affected / 22 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 3 affected / 22 at risk

Adverse event: Dyspepsia
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 3 affected / 22 at risk

Adverse event: Muscle spasms
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 2 affected / 22 at risk
Study: NCT00319449

Adverse event: Cardiac failure congestive
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 10 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 10 at risk

Adverse event: Arthralgia
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 10 at risk

Adverse event: Myalgia
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 10 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 10 at risk

Adverse event: Pruritus
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 10 at risk

Adverse event: Decreased appetite
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 12 at risk

Adverse event: Back pain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 12 at risk

Adverse event: Musculoskeletal stiffness
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 12 at risk
Study: NCT00319553

Adverse event: Solicited injection site Pain
Serious: no
Organ System: General disorders
Frequency: 270 affected / 320 at risk

Adverse event: Solicited injection site Erythema
Serious: no
Organ System: General disorders
Frequency: 75 affected / 320 at risk

Adverse event: Solicited injection site Swelling
Serious: no
Organ System: General disorders
Frequency: 61 affected / 320 at risk

Adverse event: Solicited Fever
Serious: no
Organ System: General disorders
Frequency: 18 affected / 320 at risk

Adverse event: Solicited Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 136 affected / 320 at risk

Adverse event: Solicited Malaise
Serious: no
Organ System: General disorders
Frequency: 91 affected / 320 at risk

Adverse event: Solicited Myalgia
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 167 affected / 320 at risk

Adverse event: Solicited injection site Pain
Serious: no
Organ System: General disorders
Frequency: 257 affected / 317 at risk

Adverse event: Solicited injection site Erythema
Serious: no
Organ System: General disorders
Frequency: 67 affected / 316 at risk

Adverse event: Solicited injection site Swelling
Serious: no
Organ System: General disorders
Frequency: 44 affected / 316 at risk

Adverse event: Solicited Fever
Serious: no
Organ System: General disorders
Frequency: 9 affected / 316 at risk

Adverse event: Solicited Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 108 affected / 317 at risk

Adverse event: Solicited Malaise
Serious: no
Organ System: General disorders
Frequency: 78 affected / 317 at risk

Adverse event: Solicited Myalgia
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 166 affected / 317 at risk
Study: NCT00319644

Adverse event: Transient Desaturation
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 16 at risk

Adverse event: Agitation
Serious: no
Organ System: Psychiatric disorders
Frequency: 1 affected / 16 at risk
Study: NCT00319748

Adverse event: Abdominal pain
Serious: yes
Organ System: Gastrointestinal disorders
Notes: Grade 3, severe
Frequency: 1 affected / 13 at risk

Adverse event: Acute idiopathic cardiomyopathy
Serious: yes
Organ System: Cardiac disorders
Notes: Grade 3, severe
Frequency: 1 affected / 13 at risk

Adverse event: Decreased appetite
Serious: yes
Organ System: Gastrointestinal disorders
Notes: Grade 3, severe
Frequency: 1 affected / 13 at risk

Adverse event: Cardiac left ventricular function
Serious: yes
Organ System: Cardiac disorders
Notes: Grade 2, moderate
Frequency: 1 affected / 13 at risk

Adverse event: Cardiac troponin levels increased
Serious: yes
Organ System: Cardiac disorders
Notes: Grade 4, life-threatening
Frequency: 1 affected / 13 at risk

Adverse event: Death due to Progressive Disease
Serious: yes
Organ System: General disorders
Notes: Grade 5, death
Frequency: 1 affected / 13 at risk

Adverse event: Dehydration
Serious: yes
Organ System: Gastrointestinal disorders
Notes: Grade 3, severe
Frequency: 3 affected / 13 at risk

Adverse event: Hepatic enzyme increased
Serious: yes
Organ System: Hepatobiliary disorders
Notes: Grade 4, life-threatening
Frequency: 1 affected / 13 at risk

Adverse event: Fatigue
Serious: yes
Organ System: General disorders
Notes: Grade 3, severe
Frequency: 1 affected / 13 at risk

Adverse event: Gastrointestinal symptoms
Serious: yes
Organ System: Gastrointestinal disorders
Notes: Grade 3, severe
Frequency: 1 affected / 13 at risk

Adverse event: Infection/Febrile Neutropenia
Serious: yes
Organ System: Blood and lymphatic system disorders
Notes: Grade 3, severe
Frequency: 3 affected / 13 at risk

Adverse event: Nausea
Serious: yes
Organ System: Gastrointestinal disorders
Notes: Grade 3, severe
Frequency: 1 affected / 13 at risk

Adverse event: Pain
Serious: yes
Organ System: General disorders
Notes: Grade 3, severe
Frequency: 3 affected / 13 at risk

Adverse event: Renal failure
Serious: yes
Organ System: Renal and urinary disorders
Notes: Grade 3, severe
Frequency: 1 affected / 13 at risk

Adverse event: Renal, other
Serious: yes
Organ System: Renal and urinary disorders
Notes: Grade 3, severe
Frequency: 1 affected / 13 at risk

Adverse event: Vomiting
Serious: yes
Organ System: Gastrointestinal disorders
Notes: Grade 3, severe
Frequency: 1 affected / 13 at risk
Study: NCT00319839

Adverse event: Influenza Grade III
Serious: yes
Organ System: General disorders
Notes: Hospital admission for fever, chills, cough with sputum, and WBC count of 1,000/mcl.
Frequency: 1 affected / 7 at risk

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

Adverse event: Difficulty Breathing and Swallowing
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 7 at risk