TrialPanorama/TrialPanorama-database huggingface dataset:
Study: NCT03945266

Adverse event: Fetal Growth and Abnormalities
Serious: no
Organ System: Pregnancy, puerperium and perinatal conditions
Notes: Ultrasounds were performed on a monthly basis. Study team physicians review each ultrasound for any issues. If flagged, participant's physicians are notified and provided additional medical screening/care, if necessary. All non-study related.
Frequency: 8 affected / 15 at risk

Adverse event: Depressive Symptoms
Serious: no
Organ System: Psychiatric disorders
Notes: All women complete the CESD. If scores \>16, women are provided a consult with a study nurse practitioner. All participants are provided with local psychological care resources.
Frequency: 1 affected / 15 at risk

Adverse event: Gestational diabetes
Serious: no
Organ System: Metabolism and nutrition disorders
Notes: Participants self-report GDM diagnoses during study participation or GDM diagnoses determined through electronic health record extraction. Participants are still able to participate but study staff are in contact with physicians.
Frequency: 1 affected / 15 at risk

Adverse event: Maternal Blood Draw and Anemia
Serious: no
Organ System: Blood and lymphatic system disorders
Notes: Pre and post blood draws are monitored for any bruising, blood flow, or anemia concerns. Follow-ups with physicians are required for each event.
Frequency: 2 affected / 15 at risk

Adverse event: Depressive Symptoms
Serious: no
Organ System: Psychiatric disorders
Notes: All women complete the CESD. If scores \>16, women are provided a consult with a study nurse practitioner. All participants are provided with local psychological care resources.
Frequency: 3 affected / 16 at risk

Adverse event: Gestational diabetes
Serious: no
Organ System: Metabolism and nutrition disorders
Notes: Participants self-report GDM diagnoses during study participation or GDM diagnoses determined through electronic health record extraction. Participants are still able to participate but study staff are in contact with physicians.
Frequency: 3 affected / 16 at risk

Adverse event: Maternal Blood Draw and Anemia
Serious: no
Organ System: Blood and lymphatic system disorders
Notes: Pre and post blood draws are monitored for any bruising, blood flow, or anemia concerns. Follow-ups with physicians are required for each event.
Frequency: 1 affected / 16 at risk
Study: NCT03945357

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

Adverse event: Haematoma
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 2 affected / 124 at risk

Adverse event: Respiratory failure
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 124 at risk

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

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

Adverse event: Wound infection
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 124 at risk

Adverse event: Lethargy
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 124 at risk

Adverse event: Leukocytosis
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 124 at risk

Adverse event: Ileus
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 13 affected / 124 at risk

Adverse event: Intestinal obstruction
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 126 at risk

Adverse event: Respiratory failure
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 3 affected / 126 at risk

Adverse event: Pneumonia
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 126 at risk

Adverse event: Ileus
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 7 affected / 126 at risk
Study: NCT03946124

Adverse event: Side effects
Serious: no
Organ System: Gastrointestinal disorders
Notes: Patients who experienced expected side effects of medication, including constipation, dry eyes, and dry mouth
Frequency: 6 affected / 74 at risk

Adverse event: Dizziness, edema
Serious: no
Organ System: Vascular disorders
Notes: Patients who reported side effects not typically associated with fesoterodine, such as dizziness and edema. One subject experienced both AEs concurrently.
Frequency: 1 affected / 74 at risk
Study: NCT03946748

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 9 affected / 24 at risk

Adverse event: Abdominal pain
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 3 affected / 24 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 24 at risk

Adverse event: Nasopharyngitis
Serious: no
Organ System: Infections and infestations
Frequency: 3 affected / 24 at risk

Adverse event: Upper respiratory tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 2 affected / 24 at risk

Adverse event: Injection site reaction
Serious: no
Organ System: General disorders
Frequency: 3 affected / 24 at risk
Study: NCT03948334

Adverse event: Prostatitis
Serious: yes
Organ System: Reproductive system and breast disorders
Frequency: 1 affected / 60 at risk

Adverse event: Asthma
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 60 at risk

Adverse event: Nasopharyngitis
Serious: no
Organ System: Infections and infestations
Frequency: 6 affected / 60 at risk

Adverse event: Dermatitis atopic
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 60 at risk

Adverse event: Abdominal pain
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 63 at risk

Adverse event: Bronchiolitis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 63 at risk

Adverse event: Bronchitis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 63 at risk

Adverse event: Ovarian cyst
Serious: yes
Organ System: Reproductive system and breast disorders
Frequency: 1 affected / 63 at risk

Adverse event: Pneumothorax spontaneous
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 63 at risk

Adverse event: Dermatitis atopic
Serious: yes
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 63 at risk

Adverse event: Nasopharyngitis
Serious: no
Organ System: Infections and infestations
Frequency: 4 affected / 63 at risk

Adverse event: Dermatitis atopic
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 4 affected / 63 at risk

Adverse event: Nasopharyngitis
Serious: no
Organ System: Infections and infestations
Frequency: 8 affected / 60 at risk

Adverse event: Dermatitis atopic
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 60 at risk

Adverse event: Steatohepatitis
Serious: yes
Organ System: Hepatobiliary disorders
Frequency: 1 affected / 63 at risk

Adverse event: Ankle fracture
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 63 at risk

Adverse event: Nasopharyngitis
Serious: no
Organ System: Infections and infestations
Frequency: 3 affected / 63 at risk

Adverse event: Dermatitis atopic
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 3 affected / 63 at risk
Study: NCT03948386

Adverse event: Transient neurologic symptoms
Serious: no
Organ System: Nervous system disorders
Notes: Response to the question ""Do you have any back pain that you didn't have before surgery that goes into your buttocks, thighs, hips, or lower legs?"
Frequency: 2 affected / 51 at risk

Adverse event: Transient neurologic symptoms
Serious: no
Organ System: Nervous system disorders
Notes: Response to the question ""Do you have any back pain that you didn't have before surgery that goes into your buttocks, thighs, hips, or lower legs?"
Frequency: 6 affected / 53 at risk

Adverse event: Transient neurologic symptoms
Serious: no
Organ System: Nervous system disorders
Notes: Response to the question ""Do you have any back pain that you didn't have before surgery that goes into your buttocks, thighs, hips, or lower legs?"
Frequency: 5 affected / 50 at risk
Study: NCT03948646

Adverse event: Appendicitis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 180 at risk

Adverse event: Application site pain
Serious: no
Organ System: General disorders
Frequency: 18 affected / 180 at risk

Adverse event: Application site erythema
Serious: no
Organ System: General disorders
Frequency: 14 affected / 180 at risk

Adverse event: Application site dermatitis
Serious: no
Organ System: General disorders
Frequency: 10 affected / 180 at risk

Adverse event: Application site irritation
Serious: no
Organ System: General disorders
Frequency: 6 affected / 180 at risk

Adverse event: Application Site Pruritis
Serious: no
Organ System: General disorders
Frequency: 4 affected / 180 at risk

Adverse event: Dry mouth
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 31 affected / 180 at risk

Adverse event: Constipation
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 4 affected / 180 at risk

Adverse event: Vision blurred
Serious: no
Organ System: Eye disorders
Frequency: 21 affected / 180 at risk

Adverse event: Mydriasis
Serious: no
Organ System: Eye disorders
Frequency: 9 affected / 180 at risk

Adverse event: Dry eye
Serious: no
Organ System: Eye disorders
Frequency: 6 affected / 180 at risk

Adverse event: Urinary retention
Serious: no
Organ System: Renal and urinary disorders
Frequency: 6 affected / 180 at risk

Adverse event: Urinary hesitation
Serious: no
Organ System: Renal and urinary disorders
Frequency: 4 affected / 180 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 4 affected / 180 at risk

Adverse event: Application site pain
Serious: no
Organ System: General disorders
Frequency: 2 affected / 171 at risk

Adverse event: Application site irritation
Serious: no
Organ System: General disorders
Frequency: 1 affected / 171 at risk

Adverse event: Application Site Pruritis
Serious: no
Organ System: General disorders
Frequency: 1 affected / 171 at risk

Adverse event: Dry mouth
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 171 at risk

Adverse event: Constipation
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 171 at risk

Adverse event: Vision blurred
Serious: no
Organ System: Eye disorders
Frequency: 1 affected / 171 at risk
Study: NCT03949335

Adverse event: Cystoid macular oedema
Serious: yes
Organ System: Eye disorders
Frequency: 1 affected / 135 at risk

Adverse event: Undesirable Optical Phenomena
Serious: yes
Organ System: Product Issues
Frequency: 1 affected / 135 at risk

Adverse event: Hospitalisation
Serious: yes
Organ System: General disorders
Notes: Due to high blood pressure and high blood sugar
Frequency: 1 affected / 135 at risk

Adverse event: Fractured right fibula and dislocated ankle requiring surgery
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 135 at risk

Adverse event: Abdominal Hernia requiring surgical repair
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 135 at risk

Adverse event: Hospitalisation
Serious: yes
Organ System: Infections and infestations
Notes: Due to pneumonia due to influenza
Frequency: 1 affected / 135 at risk

Adverse event: Undesirable Optical Phenomena
Serious: no
Organ System: Product Issues
Frequency: 10 affected / 135 at risk

Adverse event: Cystoid macular oedema
Serious: yes
Organ System: Eye disorders
Frequency: 1 affected / 137 at risk

Adverse event: Hospitalisation
Serious: yes
Organ System: Cardiac disorders
Notes: Exacerbation of congestive heart failure and atrial fibrillation
Frequency: 1 affected / 137 at risk

Adverse event: Cystoid macular oedema
Serious: yes
Organ System: Eye disorders
Frequency: 1 affected / 135 at risk

Adverse event: Macular hole
Serious: yes
Organ System: Eye disorders
Frequency: 1 affected / 135 at risk

Adverse event: Toxic anterior segment syndrome
Serious: yes
Organ System: Product Issues
Frequency: 1 affected / 135 at risk

Adverse event: Hypopyon
Serious: yes
Organ System: Product Issues
Frequency: 1 affected / 135 at risk

Adverse event: Retained lens material resulting in secondary surgical intervention
Serious: yes
Organ System: Surgical and medical procedures
Frequency: 1 affected / 135 at risk

Adverse event: Hospitalisation
Serious: yes
Organ System: General disorders
Notes: Due to high blood pressure and high blood sugar
Frequency: 1 affected / 135 at risk

Adverse event: Fractured right fibula and dislocated ankle requiring surgery
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 135 at risk

Adverse event: Abdominal Hernia requiring surgical repair
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 135 at risk

Adverse event: Hospitalisation
Serious: yes
Organ System: Infections and infestations
Notes: Due to pneumonia due to influenza
Frequency: 1 affected / 135 at risk

Adverse event: Retinal Detachment/tear
Serious: yes
Organ System: Eye disorders
Frequency: 1 affected / 137 at risk

Adverse event: Herpes Simplex Virus Keratitis
Serious: yes
Organ System: Eye disorders
Frequency: 1 affected / 137 at risk

Adverse event: Corneal Ulcers
Serious: yes
Organ System: Eye disorders
Frequency: 1 affected / 137 at risk

Adverse event: Hospitalisation
Serious: yes
Organ System: Cardiac disorders
Notes: Exacerbation of congestive heart failure and atrial fibrillation
Frequency: 1 affected / 137 at risk
Study: NCT03950440

Adverse event: All stroke
Serious: yes
Organ System: Nervous system disorders
Notes: According to VARC-2 criteria
Frequency: 9 affected / 84 at risk

Adverse event: Rehospitalization
Serious: yes
Organ System: General disorders
Frequency: 9 affected / 84 at risk

Adverse event: NYHA 3/44
Serious: yes
Organ System: Cardiac disorders
Notes: According to VARC-2 criteria
Frequency: 11 affected / 84 at risk

Adverse event: Valve dysfunction
Serious: yes
Organ System: Cardiac disorders
Notes: According to VARC-2 criteria
Frequency: 13 affected / 84 at risk

Adverse event: Early safety at 30 days
Serious: no
Organ System: General disorders
Notes: According to VARC-2 criteria
Frequency: 28 affected / 84 at risk

Adverse event: All stroke
Serious: yes
Organ System: Nervous system disorders
Notes: According to VARC-2 criteria
Frequency: 3 affected / 82 at risk

Adverse event: Rehospitalization
Serious: yes
Organ System: General disorders
Frequency: 7 affected / 82 at risk

Adverse event: NYHA 3/44
Serious: yes
Organ System: Cardiac disorders
Notes: According to VARC-2 criteria
Frequency: 8 affected / 82 at risk

Adverse event: Valve dysfunction
Serious: yes
Organ System: Cardiac disorders
Notes: According to VARC-2 criteria
Frequency: 4 affected / 82 at risk

Adverse event: Early safety at 30 days
Serious: no
Organ System: General disorders
Notes: According to VARC-2 criteria
Frequency: 18 affected / 82 at risk

Adverse event: All stroke
Serious: yes
Organ System: Nervous system disorders
Notes: According to VARC-2 criteria
Frequency: 3 affected / 84 at risk

Adverse event: Rehospitalization
Serious: yes
Organ System: General disorders
Frequency: 10 affected / 84 at risk

Adverse event: NYHA 3/44
Serious: yes
Organ System: Cardiac disorders
Notes: According to VARC-2 criteria
Frequency: 8 affected / 84 at risk

Adverse event: Valve dysfunction
Serious: yes
Organ System: Cardiac disorders
Notes: According to VARC-2 criteria
Frequency: 2 affected / 84 at risk

Adverse event: Early safety at 30 days
Serious: no
Organ System: General disorders
Notes: According to VARC-2 criteria
Frequency: 18 affected / 84 at risk
Study: NCT03950791

Adverse event: Suicidal ideation
Serious: yes
Organ System: Psychiatric disorders
Notes: Not associated with the study or the intervention
Frequency: 1 affected / 108 at risk
Study: NCT03950973

Adverse event: Hospitalisation
Serious: yes
Organ System: Infections and infestations
Frequency: 15 affected / 301 at risk

Adverse event: Hospitalisation
Serious: yes
Organ System: Surgical and medical procedures
Frequency: 12 affected / 301 at risk

Adverse event: Hospitalisation
Serious: yes
Organ System: Blood and lymphatic system disorders
Notes: Blood Pressure
Frequency: 1 affected / 301 at risk

Adverse event: Hospitalisation
Serious: yes
Organ System: Metabolism and nutrition disorders
Notes: Blood sugar
Frequency: 4 affected / 301 at risk

Adverse event: Hospitalisation
Serious: yes
Organ System: General disorders
Notes: Organ System related or Other
Frequency: 10 affected / 301 at risk

Adverse event: Hospitalisation
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: COVID
Frequency: 7 affected / 301 at risk

Adverse event: Death
Serious: yes
Organ System: General disorders
Frequency: 2 affected / 301 at risk

Adverse event: Other Serious Event
Serious: yes
Organ System: General disorders
Frequency: 87 affected / 301 at risk

Adverse event: Hospitalisation
Serious: yes
Organ System: General disorders
Notes: Other
Frequency: 9 affected / 301 at risk

Adverse event: Other Non-Serious Adverse Events
Serious: no
Organ System: General disorders
Notes: Includes unexpected/unrelated, expected/unrelated, expected/related, and unexpected/related (all non-serious) adverse events
Frequency: 75 affected / 301 at risk

Adverse event: Hospitalisation
Serious: yes
Organ System: Infections and infestations
Frequency: 10 affected / 299 at risk

Adverse event: Hospitalisation
Serious: yes
Organ System: Surgical and medical procedures
Frequency: 12 affected / 299 at risk

Adverse event: Hospitalisation
Serious: yes
Organ System: Blood and lymphatic system disorders
Notes: Blood Pressure
Frequency: 2 affected / 299 at risk

Adverse event: Hospitalisation
Serious: yes
Organ System: Metabolism and nutrition disorders
Notes: Blood sugar
Frequency: 6 affected / 299 at risk

Adverse event: Hospitalisation
Serious: yes
Organ System: General disorders
Notes: Organ System related or Other
Frequency: 15 affected / 299 at risk

Adverse event: Hospitalisation
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: COVID
Frequency: 3 affected / 299 at risk

Adverse event: Death
Serious: yes
Organ System: General disorders
Frequency: 2 affected / 299 at risk

Adverse event: Other Serious Event
Serious: yes
Organ System: General disorders
Frequency: 99 affected / 299 at risk

Adverse event: Hospitalisation
Serious: yes
Organ System: General disorders
Notes: Other
Frequency: 15 affected / 299 at risk

Adverse event: Other Non-Serious Adverse Events
Serious: no
Organ System: General disorders
Notes: Includes unexpected/unrelated, expected/unrelated, expected/related, and unexpected/related (all non-serious) adverse events
Frequency: 86 affected / 299 at risk
Study: NCT03951649

Adverse event: Pre-term Birth
Serious: no
Organ System: Pregnancy, puerperium and perinatal conditions
Notes: PTB, Sev SiPreE, not related to study
Frequency: 1 affected / 31 at risk

Adverse event: Injection Site Complication
Serious: no
Organ System: Injury, poisoning and procedural complications
Notes: Patients reported pain at injection site of treatment.
Frequency: 2 affected / 31 at risk
Study: NCT03951805

Adverse event: Angina pectoris
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 51 at risk

Adverse event: Choroid neoplasm
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 51 at risk

Adverse event: Metastasis
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 51 at risk

Adverse event: Transitional cell carcinoma
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 51 at risk

Adverse event: Back pain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 5 affected / 51 at risk

Adverse event: Nasopharyngitis
Serious: no
Organ System: Infections and infestations
Frequency: 5 affected / 51 at risk

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

Adverse event: Back pain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 2 affected / 51 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 3 affected / 51 at risk

Adverse event: Nasopharyngitis
Serious: no
Organ System: Infections and infestations
Frequency: 7 affected / 51 at risk

Adverse event: Back pain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 52 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 5 affected / 52 at risk

Adverse event: Nasopharyngitis
Serious: no
Organ System: Infections and infestations
Frequency: 2 affected / 52 at risk

Adverse event: Knee arthroplasty
Serious: yes
Organ System: Surgical and medical procedures
Frequency: 1 affected / 51 at risk

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

Adverse event: Back pain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 51 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 2 affected / 51 at risk

Adverse event: Nasopharyngitis
Serious: no
Organ System: Infections and infestations
Frequency: 6 affected / 51 at risk
Study: NCT03952546

Adverse event: Wound infection
Serious: no
Organ System: Infections and infestations
Notes: Patients were assessed for 90 days postoperatively for any wound infections.
Frequency: 1 affected / 82 at risk

Adverse event: Wound infection
Serious: no
Organ System: Infections and infestations
Notes: Patients were assessed for 90 days postoperatively for any wound infections.
Frequency: 3 affected / 82 at risk
Study: NCT03953183

Adverse event: Blood bilirubin increased
Serious: no
Organ System: Investigations
Frequency: 2 affected / 30 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 2 affected / 30 at risk

Adverse event: Cough
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 30 at risk

Adverse event: Throat irritation
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 2 affected / 30 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 2 affected / 30 at risk

Adverse event: Cough
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 2 affected / 30 at risk

Adverse event: Throat irritation
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 30 at risk
Study: NCT03953508

Adverse event: Other
Serious: no
Organ System: Gastrointestinal disorders
Notes: Participant vomited after smoking a study cigarette in the laboratory.
Frequency: 1 affected / 61 at risk