TrialPanorama/TrialPanorama-database huggingface dataset:
Study: NCT00565370

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

Adverse event: Febrile neutropenia
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 21 at risk

Adverse event: Deep vein thrombosis
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 2 affected / 21 at risk

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

Adverse event: Neutropenia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 14 affected / 21 at risk

Adverse event: Leukopenia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 2 affected / 21 at risk

Adverse event: Febrile neutropenia
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: 2 affected / 21 at risk

Adverse event: Thrombocytopenia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 4 affected / 21 at risk

Adverse event: Decreased appetite
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 16 affected / 21 at risk

Adverse event: Vomiting
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 12 affected / 21 at risk

Adverse event: Asthenia
Serious: no
Organ System: General disorders
Frequency: 13 affected / 21 at risk

Adverse event: Stomatitis
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 13 affected / 21 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 13 affected / 21 at risk

Adverse event: Peripheral sensory neuropathy
Serious: no
Organ System: Nervous system disorders
Frequency: 18 affected / 21 at risk

Adverse event: Rash
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 9 affected / 21 at risk

Adverse event: Hand-foot syndrome
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 17 affected / 21 at risk

Adverse event: Hypertension
Serious: no
Organ System: Cardiac disorders
Frequency: 6 affected / 21 at risk
Study: NCT00565604

Adverse event: Deep vein thrombosis
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 6 affected / 43 at risk

Adverse event: Paraesthesia
Serious: no
Organ System: Nervous system disorders
Frequency: 11 affected / 43 at risk
Study: NCT00565617

Adverse event: Infection
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 5 at risk

Adverse event: Hospitalizations
Serious: yes
Organ System: Psychiatric disorders
Notes: All 5 participants did have hospitalizations for periods of worsening depression and suicidality or inability to care for self. They were all successfully stabilized inpatient and subsequently discharged. This was reported to the FDA. All stable now.
Frequency: 5 affected / 5 at risk
Study: NCT00565643

Adverse event: Readmission for Infection
Serious: yes
Organ System: Infections and infestations
Frequency: 2 affected / 380 at risk

Adverse event: Readmission for Intra-abdominal complication
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 380 at risk

Adverse event: Readmission for obstetrical complications
Serious: yes
Organ System: Pregnancy, puerperium and perinatal conditions
Notes: Delayed Postpartum hemorrhage
Frequency: 1 affected / 380 at risk

Adverse event: Readmission for Infection
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 373 at risk

Adverse event: Readmission for Central nervous system problem
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 373 at risk
Study: NCT00565721

Adverse event: Anaemia
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 25 at risk

Adverse event: Glioblastoma Multiforme (GBM)
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 25 at risk

Adverse event: Idiopathic Thrombocytopenic Purpura (ITP)
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 25 at risk

Adverse event: Pneumothorax
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 25 at risk

Adverse event: Renal injury
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 25 at risk

Adverse event: Subcutaneous emphysema
Serious: yes
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 25 at risk

Adverse event: Gastrointestinal Disorders
Serious: no
Organ System: Gastrointestinal disorders
Notes: AEs were described by system organ class.
Frequency: 3 affected / 25 at risk

Adverse event: General disorders and administration site conditions
Serious: no
Organ System: General disorders
Notes: AEs were described by system organ class.
Frequency: 5 affected / 25 at risk

Adverse event: Infections and Infestations
Serious: no
Organ System: Infections and infestations
Notes: AEs were described by system organ class.
Frequency: 3 affected / 25 at risk

Adverse event: Investigations
Serious: no
Organ System: Investigations
Notes: AEs were described by system organ class.
Frequency: 3 affected / 25 at risk

Adverse event: Respiratory
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: AEs were described by system organ class.
Frequency: 2 affected / 25 at risk
Study: NCT00565747

Adverse event: Ovarian hyperstimulation syndrome
Serious: yes
Organ System: Reproductive system and breast disorders
Frequency: 2 affected / 654 at risk

Adverse event: Adnexal torsion
Serious: yes
Organ System: Reproductive system and breast disorders
Frequency: 2 affected / 654 at risk

Adverse event: Ectopic pregnancy
Serious: yes
Organ System: Reproductive system and breast disorders
Frequency: 2 affected / 654 at risk

Adverse event: Miscarriage (missed abortion)
Serious: yes
Organ System: Pregnancy, puerperium and perinatal conditions
Frequency: 3 affected / 654 at risk

Adverse event: Foetus or child born with malformations
Serious: yes
Organ System: General disorders
Frequency: 4 affected / 654 at risk

Adverse event: Abortion spontaneous
Serious: no
Organ System: Pregnancy, puerperium and perinatal conditions
Frequency: 6 affected / 654 at risk

Adverse event: Abdominal haemorrhage after oocyte pick-up.
Serious: yes
Organ System: Reproductive system and breast disorders
Frequency: 1 affected / 678 at risk

Adverse event: Ovarian hyperstimulation syndrome
Serious: yes
Organ System: Reproductive system and breast disorders
Frequency: 1 affected / 678 at risk

Adverse event: Uterine retension, haematuria and cystitis
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 678 at risk

Adverse event: Miscarriage (missed abortion)
Serious: yes
Organ System: Pregnancy, puerperium and perinatal conditions
Frequency: 1 affected / 678 at risk

Adverse event: Foetus or child born with malformations
Serious: yes
Organ System: General disorders
Frequency: 4 affected / 678 at risk

Adverse event: Abortion spontaneous
Serious: no
Organ System: Pregnancy, puerperium and perinatal conditions
Frequency: 6 affected / 678 at risk
Study: NCT00565773

Adverse event: Herpes zoster
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 2 affected / 40 at risk

Adverse event: HHV-8/Kaposi's sarcoma
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 40 at risk

Adverse event: Incisional hernia
Serious: no
Organ System: Surgical and medical procedures
Frequency: 2 affected / 40 at risk

Adverse event: Mouth ulcers (sirolimus-associated)
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 9 affected / 40 at risk

Adverse event: Pericardial effusion
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 40 at risk

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

Adverse event: Arthralgia
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 2 affected / 40 at risk
Study: NCT00565864

Adverse event: Medication error
Serious: no
Organ System: Product Issues
Notes: medication delivered to wrong participant or wrong dose
Frequency: 2 affected / 46 at risk

Adverse event: Medication error
Serious: no
Organ System: Product Issues
Notes: medication delivered to wrong participant or wrong dose
Frequency: 1 affected / 47 at risk

Adverse event: symptoms
Serious: no
Organ System: Endocrine disorders
Notes: two patients developed symptoms unrelated to study and withdrew
Frequency: 1 affected / 47 at risk

Adverse event: Medication error
Serious: no
Organ System: Product Issues
Notes: medication delivered to wrong participant or wrong dose
Frequency: 2 affected / 45 at risk

Adverse event: symptoms
Serious: no
Organ System: Endocrine disorders
Notes: two patients developed symptoms unrelated to study and withdrew
Frequency: 1 affected / 45 at risk
Study: NCT00566020

Adverse event: Gastric cancer
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 92 at risk

Adverse event: Mania
Serious: yes
Organ System: Psychiatric disorders
Frequency: 4 affected / 92 at risk

Adverse event: Depression
Serious: yes
Organ System: Psychiatric disorders
Frequency: 2 affected / 92 at risk

Adverse event: Delirium
Serious: yes
Organ System: Psychiatric disorders
Frequency: 1 affected / 92 at risk

Adverse event: Self-destructive behaviour
Serious: yes
Organ System: Psychiatric disorders
Frequency: 1 affected / 92 at risk

Adverse event: Suicidal ideation
Serious: yes
Organ System: Psychiatric disorders
Frequency: 1 affected / 92 at risk

Adverse event: Sinus node dysfunction
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 92 at risk

Adverse event: Pharyngitis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 92 at risk

Adverse event: Abortion spontaneous
Serious: yes
Organ System: Pregnancy, puerperium and perinatal conditions
Frequency: 1 affected / 92 at risk

Adverse event: Ovarian haemorrhage
Serious: yes
Organ System: Reproductive system and breast disorders
Frequency: 1 affected / 92 at risk

Adverse event: Asthma
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 92 at risk

Adverse event: Nasopharyngitis
Serious: no
Organ System: Infections and infestations
Frequency: 36 affected / 92 at risk

Adverse event: Abdominal pain upper
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 14 affected / 92 at risk

Adverse event: Stomatitis
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 11 affected / 92 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 7 affected / 92 at risk

Adverse event: Vomiting
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 7 affected / 92 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 6 affected / 92 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 6 affected / 92 at risk

Adverse event: Anaemia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 5 affected / 92 at risk

Adverse event: Back pain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 5 affected / 92 at risk
Study: NCT00566111

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

Adverse event: Difficulty Concentrating
Serious: no
Organ System: General disorders
Frequency: 2 affected / 2 at risk

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

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

Adverse event: Tremors
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 2 at risk

Adverse event: Somnolence
Serious: no
Organ System: General disorders
Frequency: 1 affected / 3 at risk

Adverse event: Difficulty Concentrating
Serious: no
Organ System: General disorders
Frequency: 2 affected / 3 at risk

Adverse event: Poor Coordination
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 3 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 3 at risk
Study: NCT00566228

Adverse event: Haemoglobin decreased
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 5 affected / 57 at risk

Adverse event: Atrial fibrillation
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 57 at risk

Adverse event: Atrial tachycardia
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 57 at risk

Adverse event: Contusion
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 11 affected / 57 at risk

Adverse event: Platelet count decreased
Serious: no
Organ System: Investigations
Frequency: 6 affected / 57 at risk

Adverse event: Peripheral sensory neuropathy
Serious: no
Organ System: Nervous system disorders
Frequency: 5 affected / 57 at risk

Adverse event: Haemoglobin decreased
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 4 affected / 57 at risk

Adverse event: Injection site reaction
Serious: no
Organ System: General disorders
Frequency: 3 affected / 57 at risk

Adverse event: Contusion
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 9 affected / 57 at risk

Adverse event: Platelet count decreased
Serious: no
Organ System: Investigations
Frequency: 4 affected / 57 at risk

Adverse event: Peripheral sensory neuropathy
Serious: no
Organ System: Nervous system disorders
Frequency: 6 affected / 57 at risk
Study: NCT00566254

Adverse event: Focal dyscognitive seizures
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 100 at risk

Adverse event: Somnolence
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 100 at risk

Adverse event: Vomiting
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 100 at risk

Adverse event: Nasopharyngitis
Serious: no
Organ System: Infections and infestations
Frequency: 9 affected / 100 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 7 affected / 100 at risk

Adverse event: Abdominal pain upper
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 6 affected / 100 at risk

Adverse event: Decreased appetite
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 4 affected / 100 at risk

Adverse event: Status epilepticus
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 107 at risk

Adverse event: Abdominal pain
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 107 at risk

Adverse event: Cholelithiasis
Serious: yes
Organ System: Hepatobiliary disorders
Frequency: 1 affected / 107 at risk

Adverse event: Blood glucose decreased
Serious: yes
Organ System: Investigations
Frequency: 1 affected / 107 at risk

Adverse event: Weight decreased
Serious: yes
Organ System: Investigations
Frequency: 1 affected / 107 at risk

Adverse event: Dehydration
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 107 at risk

Adverse event: Nasopharyngitis
Serious: no
Organ System: Infections and infestations
Frequency: 6 affected / 107 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 7 affected / 107 at risk

Adverse event: Abdominal pain upper
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 107 at risk

Adverse event: Decreased appetite
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 7 affected / 107 at risk
Study: NCT00566345

Adverse event: Death
Serious: yes
Organ System: Injury, poisoning and procedural complications
Notes: one subject died as a result of a massive open head trauma due to a single motorcycle collision
Frequency: 1 affected / 1829 at risk

Adverse event: Hypersensitivity
Serious: yes
Organ System: Immune system disorders
Notes: allergic reaction during administration of investigational product
Frequency: 1 affected / 1829 at risk

Adverse event: Acute disseminated encephalomyelitis
Serious: yes
Organ System: Skin and subcutaneous tissue disorders
Notes: subject developed injection site reaction, tingling, burning, itching and numbness after administration of investigational product
Frequency: 1 affected / 1829 at risk

Adverse event: Tenderness
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 848 affected / 1829 at risk

Adverse event: Injection site pain
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 598 affected / 1829 at risk

Adverse event: Headache
Serious: no
Organ System: General disorders
Frequency: 327 affected / 1829 at risk

Adverse event: Myalgia
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 275 affected / 1829 at risk

Adverse event: Fatigue
Serious: no
Organ System: General disorders
Frequency: 194 affected / 1829 at risk

Adverse event: Malaise
Serious: no
Organ System: General disorders
Frequency: 137 affected / 1829 at risk

Adverse event: Chills
Serious: no
Organ System: General disorders
Frequency: 101 affected / 1829 at risk

Adverse event: Arthralgia
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 96 affected / 1829 at risk

Adverse event: Tenderness
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 200 affected / 1841 at risk

Adverse event: Injection site pain
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 140 affected / 1841 at risk

Adverse event: Myalgia
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 99 affected / 1841 at risk

Adverse event: Fatigue
Serious: no
Organ System: General disorders
Frequency: 116 affected / 1841 at risk
Study: NCT00566462

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

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

Adverse event: Glossodynia
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 1 at risk
Study: NCT00566579

Adverse event: Cervical dysplasia
Serious: no
Organ System: Reproductive system and breast disorders
Notes: HSIL rates, found by LEEP after HSIL Pap smears in treated group and observed group, were both very low (3.4% vs. 6.5%, p=0.58 ).
Frequency: 1 affected / 29 at risk

Adverse event: Cervical dysplasia
Serious: no
Organ System: Reproductive system and breast disorders
Notes: HSIL rates, found by LEEP after HSIL Pap smears in treated group and observed group, were both very low (3.4% vs. 6.5%, p=0.58 ).
Frequency: 2 affected / 31 at risk
Study: NCT00566618

Adverse event: Anaemia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 3 affected / 25 at risk

Adverse event: Fatigue
Serious: no
Organ System: General disorders
Frequency: 9 affected / 25 at risk

Adverse event: Rash
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 9 affected / 25 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 6 affected / 25 at risk

Adverse event: Pain
Serious: no
Organ System: General disorders
Frequency: 9 affected / 25 at risk

Adverse event: Thrombocytopenia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 25 at risk

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

Adverse event: Pleural effusion
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 2 affected / 25 at risk

Adverse event: Vasomotor symptoms
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 4 affected / 25 at risk

Adverse event: Pruritus
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 25 at risk

Adverse event: Alopecia
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 4 affected / 25 at risk

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

Adverse event: Constipation
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 3 affected / 25 at risk

Adverse event: Dry mouth
Serious: no
Organ System: General disorders
Frequency: 2 affected / 25 at risk

Adverse event: Vomiting
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 3 affected / 25 at risk

Adverse event: Infections (non-neutropenic)
Serious: no
Organ System: Infections and infestations
Frequency: 3 affected / 25 at risk

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

Adverse event: Paraesthesia
Serious: no
Organ System: Nervous system disorders
Frequency: 3 affected / 25 at risk