TrialPanorama/TrialPanorama-database huggingface dataset:
Study: NCT05894577

Adverse event: Pneumonia
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 628 at risk

Adverse event: Cellulitis
Serious: yes
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 628 at risk

Adverse event: Adnexal torsion
Serious: yes
Organ System: Reproductive system and breast disorders
Frequency: 1 affected / 628 at risk

Adverse event: Atrial fibrillation
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 628 at risk

Adverse event: Skin injury
Serious: yes
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 628 at risk

Adverse event: Febrile neutropenia
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 628 at risk

Adverse event: Ankle fracture
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 628 at risk

Adverse event: Foot fracture
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 628 at risk

Adverse event: Paraesthesia
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 628 at risk

Adverse event: Pneumonia
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 622 at risk

Adverse event: Appendicitis
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 622 at risk

Adverse event: Suicidal ideation
Serious: yes
Organ System: Psychiatric disorders
Frequency: 1 affected / 622 at risk

Adverse event: Suicide attempt
Serious: yes
Organ System: Psychiatric disorders
Frequency: 1 affected / 622 at risk
Study: NCT05896696

Adverse event: Hysterectomy
Serious: yes
Organ System: Surgical and medical procedures
Frequency: 1 affected / 72 at risk

Adverse event: Nasopharyngitis
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 72 at risk

Adverse event: Stress
Serious: no
Organ System: Psychiatric disorders
Frequency: 1 affected / 72 at risk

Adverse event: Uterine leiomyoma
Serious: no
Organ System: Reproductive system and breast disorders
Frequency: 1 affected / 72 at risk

Adverse event: Application site bruise / Purpura
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 11 affected / 72 at risk

Adverse event: Erythema
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 34 affected / 72 at risk

Adverse event: Hyperaesthesia
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 72 at risk

Adverse event: Skin oedema
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 2 affected / 72 at risk
Study: NCT05896748

Adverse event: Passed away due to unknown reasons
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 94 at risk

Adverse event: Injection site pain
Serious: no
Organ System: General disorders
Frequency: 29 affected / 94 at risk

Adverse event: Injection site nodule
Serious: no
Organ System: General disorders
Frequency: 3 affected / 94 at risk

Adverse event: Injection site pruritus
Serious: no
Organ System: General disorders
Frequency: 2 affected / 94 at risk

Adverse event: Upper respiratory tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 2 affected / 94 at risk

Adverse event: Injection site pain
Serious: no
Organ System: General disorders
Frequency: 69 affected / 93 at risk

Adverse event: Injection site nodule
Serious: no
Organ System: General disorders
Frequency: 60 affected / 93 at risk

Adverse event: Injection site erythema
Serious: no
Organ System: General disorders
Frequency: 48 affected / 93 at risk

Adverse event: Injection site swelling
Serious: no
Organ System: General disorders
Frequency: 29 affected / 93 at risk

Adverse event: Injection site induration
Serious: no
Organ System: General disorders
Frequency: 24 affected / 93 at risk

Adverse event: Injection site pruritus
Serious: no
Organ System: General disorders
Frequency: 19 affected / 93 at risk

Adverse event: Injection site warmth
Serious: no
Organ System: General disorders
Frequency: 11 affected / 93 at risk

Adverse event: Injection site haematoma
Serious: no
Organ System: General disorders
Frequency: 7 affected / 93 at risk

Adverse event: Injection site bruising
Serious: no
Organ System: General disorders
Frequency: 6 affected / 93 at risk

Adverse event: Injection site discolouration
Serious: no
Organ System: General disorders
Frequency: 6 affected / 93 at risk

Adverse event: Upper respiratory tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 5 affected / 93 at risk

Adverse event: Injection site pain
Serious: no
Organ System: General disorders
Frequency: 30 affected / 93 at risk

Adverse event: Injection site nodule
Serious: no
Organ System: General disorders
Frequency: 9 affected / 93 at risk

Adverse event: Injection site erythema
Serious: no
Organ System: General disorders
Frequency: 1 affected / 93 at risk

Adverse event: Injection site swelling
Serious: no
Organ System: General disorders
Frequency: 1 affected / 93 at risk

Adverse event: Injection site induration
Serious: no
Organ System: General disorders
Frequency: 2 affected / 93 at risk

Adverse event: Injection site pruritus
Serious: no
Organ System: General disorders
Frequency: 1 affected / 93 at risk

Adverse event: Injection site haematoma
Serious: no
Organ System: General disorders
Frequency: 1 affected / 93 at risk

Adverse event: Injection site bruising
Serious: no
Organ System: General disorders
Frequency: 1 affected / 93 at risk

Adverse event: Upper respiratory tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 2 affected / 93 at risk
Study: NCT05896761

Adverse event: Injection site pain
Serious: no
Organ System: General disorders
Frequency: 38 affected / 54 at risk

Adverse event: Injection site discomfort
Serious: no
Organ System: General disorders
Frequency: 3 affected / 54 at risk

Adverse event: Injection site swelling
Serious: no
Organ System: General disorders
Frequency: 2 affected / 54 at risk

Adverse event: Fatigue
Serious: no
Organ System: General disorders
Frequency: 4 affected / 54 at risk

Adverse event: Pyrexia
Serious: no
Organ System: General disorders
Frequency: 3 affected / 54 at risk

Adverse event: COVID-19
Serious: no
Organ System: Infections and infestations
Frequency: 6 affected / 54 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 3 affected / 54 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 3 affected / 54 at risk

Adverse event: Cough
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 3 affected / 54 at risk

Adverse event: Injection site pain
Serious: no
Organ System: General disorders
Frequency: 43 affected / 64 at risk

Adverse event: Injection site discomfort
Serious: no
Organ System: General disorders
Frequency: 5 affected / 64 at risk

Adverse event: Injection site swelling
Serious: no
Organ System: General disorders
Frequency: 5 affected / 64 at risk

Adverse event: Fatigue
Serious: no
Organ System: General disorders
Frequency: 1 affected / 64 at risk

Adverse event: Pyrexia
Serious: no
Organ System: General disorders
Frequency: 1 affected / 64 at risk

Adverse event: COVID-19
Serious: no
Organ System: Infections and infestations
Frequency: 5 affected / 64 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 64 at risk

Adverse event: COVID-19
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 51 at risk

Adverse event: Injection site pain
Serious: no
Organ System: General disorders
Frequency: 3 affected / 51 at risk

Adverse event: COVID-19
Serious: no
Organ System: Infections and infestations
Frequency: 3 affected / 51 at risk

Adverse event: Injection site pain
Serious: no
Organ System: General disorders
Frequency: 9 affected / 61 at risk

Adverse event: COVID-19
Serious: no
Organ System: Infections and infestations
Frequency: 3 affected / 61 at risk
Study: NCT05898672

Adverse event: Abdominal pain
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 12 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 12 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 12 at risk

Adverse event: Pollakiuria
Serious: no
Organ System: Renal and urinary disorders
Frequency: 1 affected / 12 at risk

Adverse event: Haematoma
Serious: no
Organ System: Vascular disorders
Frequency: 4 affected / 12 at risk

Adverse event: Abdominal discomfort
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 12 at risk

Adverse event: Abdominal pain upper
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 12 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 12 at risk

Adverse event: Dysgeusia
Serious: no
Organ System: Nervous system disorders
Frequency: 10 affected / 12 at risk

Adverse event: Oropharyngeal pain
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 12 at risk
Study: NCT05907174

Adverse event: Death
Serious: yes
Organ System: General disorders
Notes: Death, cause unknown (family/friends reported they did not know the cause of death)
Frequency: 1 affected / 21 at risk

Adverse event: Death
Serious: yes
Organ System: General disorders
Notes: Death, cause unknown (family/friends reported they did not know the cause of death)
Frequency: 3 affected / 25 at risk

Adverse event: Hospitalisation
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: 5-day hospitalization due to pulmonary tuberculosis (diagnosed during hospital stay).
Frequency: 1 affected / 25 at risk

Adverse event: Birth in hospital, infant death
Serious: no
Organ System: Pregnancy, puerperium and perinatal conditions
Notes: Pt admitted to hospital to give birth (planned). Infant did not survive. Pt discharged from hospital shortly after.
Frequency: 1 affected / 25 at risk

Adverse event: Suicidal Thoughts
Serious: no
Organ System: Psychiatric disorders
Notes: Pt reported suicidal thoughts during a qualitative interview. Study staff accompanied pt to clinic to meet with a psychologist.
Frequency: 1 affected / 25 at risk
Study: NCT05908344

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

Adverse event: Cystitis
Serious: no
Organ System: Renal and urinary disorders
Frequency: 1 affected / 10 at risk

Adverse event: Aching, Discomfort, or Pain (various)
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 3 affected / 10 at risk

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

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

Adverse event: Cornea tear
Serious: no
Organ System: Eye disorders
Frequency: 1 affected / 10 at risk

Adverse event: Aching, Discomfort, or Pain (various)
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 10 at risk

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

Adverse event: Hordeolum
Serious: no
Organ System: Eye disorders
Frequency: 1 affected / 10 at risk
Study: NCT05918822

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

Adverse event: Facial pain
Serious: no
Organ System: General disorders
Frequency: 1 affected / 18 at risk

Adverse event: Skin abrasion
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 18 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 2 affected / 18 at risk

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

Adverse event: Pain in extremity
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 14 at risk

Adverse event: Throat irritation
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 14 at risk

Adverse event: Dysuria
Serious: no
Organ System: Renal and urinary disorders
Frequency: 1 affected / 14 at risk

Adverse event: Urine odour abnormal
Serious: no
Organ System: Renal and urinary disorders
Frequency: 1 affected / 14 at risk
Study: NCT05919082

Adverse event: Patella fracture
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 300 at risk

Adverse event: Gastrointestinal haemorrhage
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 300 at risk

Adverse event: Appendicitis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 300 at risk

Adverse event: Psoriasis
Serious: yes
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 300 at risk

Adverse event: Upper respiratory tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 14 affected / 300 at risk

Adverse event: Folliculitis
Serious: no
Organ System: Infections and infestations
Frequency: 7 affected / 300 at risk

Adverse event: Tinea versicolour
Serious: no
Organ System: Infections and infestations
Frequency: 4 affected / 300 at risk

Adverse event: Fungal infection
Serious: no
Organ System: Infections and infestations
Frequency: 3 affected / 300 at risk

Adverse event: Cortisol decreased
Serious: no
Organ System: Investigations
Frequency: 7 affected / 300 at risk

Adverse event: Urine calcium/creatinine ratio increased
Serious: no
Organ System: Investigations
Frequency: 6 affected / 300 at risk

Adverse event: Application site pain
Serious: no
Organ System: General disorders
Frequency: 3 affected / 300 at risk

Adverse event: Application site pruritus
Serious: no
Organ System: General disorders
Frequency: 3 affected / 300 at risk

Adverse event: Pyrexia
Serious: no
Organ System: General disorders
Frequency: 3 affected / 300 at risk

Adverse event: Application site paraesthesia
Serious: no
Organ System: General disorders
Frequency: 3 affected / 300 at risk

Adverse event: Upper respiratory tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 18 affected / 301 at risk

Adverse event: Folliculitis
Serious: no
Organ System: Infections and infestations
Frequency: 4 affected / 301 at risk

Adverse event: Tinea versicolour
Serious: no
Organ System: Infections and infestations
Frequency: 3 affected / 301 at risk

Adverse event: Cortisol decreased
Serious: no
Organ System: Investigations
Frequency: 6 affected / 301 at risk

Adverse event: Urine calcium/creatinine ratio increased
Serious: no
Organ System: Investigations
Frequency: 5 affected / 301 at risk

Adverse event: Application site pain
Serious: no
Organ System: General disorders
Frequency: 1 affected / 301 at risk

Adverse event: Application site pruritus
Serious: no
Organ System: General disorders
Frequency: 1 affected / 301 at risk

Adverse event: Pyrexia
Serious: no
Organ System: General disorders
Frequency: 1 affected / 301 at risk
Study: NCT05919888

Adverse event: Infection
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 20 at risk

Adverse event: Hypoxia
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 20 at risk

Adverse event: Infection
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 20 at risk

Adverse event: Myocardial infarction
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 20 at risk

Adverse event: Joint dislocation
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 20 at risk

Adverse event: Atrial fibrillation
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 20 at risk

Adverse event: Readmission for Social Reasons
Serious: yes
Organ System: Social circumstances
Frequency: 1 affected / 20 at risk
Study: NCT05927753

Adverse event: Hordeolum
Serious: no
Organ System: Eye disorders
Frequency: 1 affected / 53 at risk

Adverse event: Lacrimation decreased
Serious: no
Organ System: Eye disorders
Frequency: 1 affected / 53 at risk

Adverse event: Vital dye staining cornea present
Serious: no
Organ System: Investigations
Frequency: 1 affected / 53 at risk

Adverse event: Contact lens intolerance
Serious: no
Organ System: Eye disorders
Frequency: 1 affected / 26 at risk

Adverse event: Vision blurred
Serious: no
Organ System: Eye disorders
Frequency: 1 affected / 26 at risk
Study: NCT05930782

Adverse event: Heart rate increased
Serious: no
Organ System: Investigations
Frequency: 1 affected / 12 at risk

Adverse event: Upper respiratory tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 12 at risk

Adverse event: Migraine
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 12 at risk
Study: NCT05933772

Adverse event: Inflammated skin due to eye make-up spread in eye
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 49 at risk

Adverse event: Red Eye (No Discomfort)
Serious: no
Organ System: Eye disorders
Frequency: 1 affected / 49 at risk

Adverse event: Botox Injection
Serious: no
Organ System: General disorders
Frequency: 1 affected / 49 at risk

Adverse event: Sinusitis
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 49 at risk

Adverse event: Pneumonia
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 49 at risk

Adverse event: Gum Graft Surgery
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 49 at risk

Adverse event: Bronchitis
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 49 at risk

Adverse event: Insomnolence
Serious: no
Organ System: General disorders
Frequency: 1 affected / 49 at risk

Adverse event: Stuffy nose and sneezing
Serious: no
Organ System: General disorders
Frequency: 1 affected / 49 at risk
Study: NCT05934292

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

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

Adverse event: Animal bite
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 8 at risk

Adverse event: Orthostatic hypotension
Serious: no
Organ System: Vascular disorders
Frequency: 1 affected / 8 at risk

Adverse event: Hypervolaemia
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 9 at risk
Study: NCT05934942

Adverse event: Nasopharyngitis
Serious: no
Organ System: Infections and infestations
Frequency: 3 affected / 28 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 4 affected / 28 at risk

Adverse event: Heavy menstrual bleeding
Serious: no
Organ System: Reproductive system and breast disorders
Frequency: 2 affected / 28 at risk
Study: NCT05940194

Adverse event: BRAIN CONCUSSION (DUE TO TRAFFIC ACCIDENT)
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 124 at risk

Adverse event: Leukaemia
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 124 at risk

Adverse event: Intestinal obstruction
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 124 at risk

Adverse event: CHRONIC INFLAMMATION OF THE SALIVARY GLANDS
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 124 at risk

Adverse event: INFECTION AFTER SURGERY
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 124 at risk

Adverse event: COVID-19
Serious: no
Organ System: Infections and infestations
Frequency: 25 affected / 124 at risk

Adverse event: Gastric cancer
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 125 at risk

Adverse event: COVID-19
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 125 at risk

Adverse event: Colon cancer
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 125 at risk

Adverse event: COVID-19
Serious: no
Organ System: Infections and infestations
Frequency: 22 affected / 125 at risk

Adverse event: COVID-19
Serious: no
Organ System: Infections and infestations
Frequency: 25 affected / 125 at risk
Study: NCT05941702

Adverse event: Psychological Distress
Serious: no
Organ System: Social circumstances
Notes: Stress caused by tuning into the body leading to greater perception of symptoms/distress associated with symptoms. In this instance,
Frequency: 1 affected / 8 at risk
Study: NCT05948670

Adverse event: New physical health condition
Serious: no
Organ System: General disorders
Frequency: 1 affected / 87 at risk

Adverse event: Worsening physical health condition
Serious: no
Organ System: General disorders
Frequency: 2 affected / 88 at risk

Adverse event: Worsening mental health condition
Serious: no
Organ System: Psychiatric disorders
Frequency: 3 affected / 88 at risk

Adverse event: New physical health condition
Serious: no
Organ System: General disorders
Frequency: 2 affected / 88 at risk
Study: NCT05949788

Adverse event: Death
Serious: yes
Organ System: Infections and infestations
Notes: In anemia group: Two died from late onset sepsis. In non-anemia group: Six died from late onset sepsis.
Frequency: 2 affected / 36 at risk

Adverse event: Death
Serious: yes
Organ System: Reproductive system and breast disorders
Notes: One in anemia group and two in non-anemia group were died from respiratory failure within 14 days after birth.One in anemia group and two in non-anemia group were died from pneumothorax within 14 days after birth.
Frequency: 2 affected / 36 at risk

Adverse event: Death
Serious: yes
Organ System: Gastrointestinal disorders
Notes: One in anemia group died from necrotizing enterocolitis.
Frequency: 1 affected / 36 at risk

Adverse event: Sepsis neonatal
Serious: no
Organ System: Infections and infestations
Notes: Neonatal sepsis diagnosis required positive culture along with clinical signs (fever; hypothermia; lethargy; tachypnea; apnea/bradycardia; cyanosis; and hypoglycemia not explained by other diagnoses) or laboratory signs of infection.
Frequency: 17 affected / 36 at risk

Adverse event: NEC
Serious: no
Organ System: Gastrointestinal disorders
Notes: NEC was defined as stage 2 or higher based on Bell's criteria.
Frequency: 3 affected / 36 at risk

Adverse event: Death
Serious: yes
Organ System: Infections and infestations
Notes: In anemia group: Two died from late onset sepsis. In non-anemia group: Six died from late onset sepsis.
Frequency: 6 affected / 110 at risk

Adverse event: Death
Serious: yes
Organ System: Reproductive system and breast disorders
Notes: One in anemia group and two in non-anemia group were died from respiratory failure within 14 days after birth.One in anemia group and two in non-anemia group were died from pneumothorax within 14 days after birth.
Frequency: 4 affected / 110 at risk

Adverse event: Sepsis neonatal
Serious: no
Organ System: Infections and infestations
Notes: Neonatal sepsis diagnosis required positive culture along with clinical signs (fever; hypothermia; lethargy; tachypnea; apnea/bradycardia; cyanosis; and hypoglycemia not explained by other diagnoses) or laboratory signs of infection.
Frequency: 39 affected / 110 at risk

Adverse event: NEC
Serious: no
Organ System: Gastrointestinal disorders
Notes: NEC was defined as stage 2 or higher based on Bell's criteria.
Frequency: 6 affected / 110 at risk