TrialPanorama/TrialPanorama-database huggingface dataset:
Study: NCT03134209

Adverse event: Wound drainage
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 2 affected / 53 at risk

Adverse event: Revision Surgery
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 54 at risk

Adverse event: Wound drainage
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 54 at risk

Adverse event: Revision Surgery
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 53 at risk

Adverse event: Wound drainage
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 53 at risk
Study: NCT03134911

Adverse event: Upper gastrointestinal haemorrhage
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 261 at risk
Study: NCT03134989

Adverse event: SUDDEN ONSET ROTARY VERTIGO
Serious: yes
Organ System: Surgical and medical procedures
Notes: PATIENT EXPERIENCED DIZZINESS, NAUSEA AND VOMITING AFTER POST-OP STENVERS X-RAY PROCEDURE DUE TO MANIPULATION TO GET GOOD IMAGE. DIZZINESS SETTLED AFTER ABOUT 1 HOUR. NAUSEA MAY BE RELATED TO CLINDAMYCIN POST-OP DOSE, DOSAGE CORRECTED.
Frequency: 2 affected / 61 at risk

Adverse event: Nasopharyngitis
Serious: no
Organ System: General disorders
Frequency: 1 affected / 61 at risk

Adverse event: UNDISPLACED FRACTURE OF THE MEDIAL FEMORAL CONDYLE
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 61 at risk

Adverse event: DELAYED FACIAL PARALYSIS
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 61 at risk

Adverse event: VERTIGO AND NAUSEA
Serious: no
Organ System: General disorders
Frequency: 4 affected / 61 at risk

Adverse event: Bronchitis
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 61 at risk

Adverse event: Otitis media
Serious: no
Organ System: Ear and labyrinth disorders
Frequency: 1 affected / 61 at risk

Adverse event: OTITIS EXTERNA DURING SURGERY
Serious: no
Organ System: Ear and labyrinth disorders
Frequency: 1 affected / 61 at risk

Adverse event: INTRAOPERATIVE HORIZONTAL CANAL DEFECT resulted in 'SEVERE VERTIGO EXPERIENCED DURING AUDIOMETRY, TY
Serious: no
Organ System: General disorders
Frequency: 1 affected / 61 at risk

Adverse event: Tinnitus
Serious: no
Organ System: Ear and labyrinth disorders
Frequency: 1 affected / 61 at risk

Adverse event: PAIN AND INFLAMATION POST SURGERY
Serious: no
Organ System: Ear and labyrinth disorders
Frequency: 1 affected / 61 at risk

Adverse event: EXACERBATION MENIERE'S DISEASE
Serious: no
Organ System: Ear and labyrinth disorders
Frequency: 1 affected / 61 at risk

Adverse event: BLOOD/FLUID STILL BEHIND EAR; NO PAIN REPORTED BY PATIENT
Serious: no
Organ System: Ear and labyrinth disorders
Frequency: 1 affected / 61 at risk
Study: NCT03135067

Adverse event: Intimate partner violence and social harms
Serious: no
Organ System: Social circumstances
Notes: Individuals who reported ever experiencing intimate partner violence (IPV) while participating in the study, that may or may not have been related to study participation.
Frequency: 241 affected / 1017 at risk

Adverse event: Intimate partner violence and social harms
Serious: no
Organ System: Social circumstances
Notes: Individuals who reported ever experiencing intimate partner violence (IPV) while participating in the study, that may or may not have been related to study participation.
Frequency: 210 affected / 985 at risk
Study: NCT03135431

Adverse event: Seizure
Serious: yes
Organ System: Nervous system disorders
Notes: Grade 1
Frequency: 1 affected / 18 at risk

Adverse event: Anaemia
Serious: yes
Organ System: Blood and lymphatic system disorders
Notes: Grade 2
Frequency: 1 affected / 18 at risk

Adverse event: Uterine haemorrhage
Serious: yes
Organ System: Reproductive system and breast disorders
Notes: Grade 1
Frequency: 2 affected / 18 at risk

Adverse event: Upper respiratory tract infection
Serious: no
Organ System: Infections and infestations
Notes: Grade 2
Frequency: 1 affected / 18 at risk

Adverse event: Other, post-operative pain score above goal
Serious: no
Organ System: Surgical and medical procedures
Notes: Grade 1
Frequency: 1 affected / 20 at risk

Adverse event: Breast pain
Serious: no
Organ System: Reproductive system and breast disorders
Notes: Grade 2
Frequency: 1 affected / 20 at risk
Study: NCT03135522

Adverse event: Pancreatitis
Serious: yes
Organ System: Gastrointestinal disorders
Notes: Participant admitted to hospital with acute pancreatitis. Participant had prior history of pancreatitis; underwent pancreatic resection and splenectomy about 6 weeks after initial presentation.
Frequency: 1 affected / 17 at risk

Adverse event: Intervertebral disc protrusion
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Notes: Participant admitted to hospital for emergent back surgery to treat a herniated lumbar disc.
Frequency: 1 affected / 17 at risk

Adverse event: Rash
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: Participant developed skin rash on left arm. Rash treated with ointment prescribed by dermatologist; participant reported rash gone after 2 weeks.
Frequency: 1 affected / 17 at risk

Adverse event: Urosepsis
Serious: yes
Organ System: Renal and urinary disorders
Notes: Participant admitted to hospital with bronchitis, fever, and urinary tract infection; treated with oral and IV antibiotics and released. Participant had not started study medication at the time of event.
Frequency: 1 affected / 17 at risk

Adverse event: Rash
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: Participant experienced rash and itching during titration phase of treatment. Participant stopped study drug and returned study drug to clinic.
Frequency: 1 affected / 17 at risk

Adverse event: Elevated copper level
Serious: no
Organ System: Blood and lymphatic system disorders
Notes: Serum copper level above upper limit of normal. Study physician informed participant of result.
Frequency: 2 affected / 17 at risk
Study: NCT03135899

Adverse event: Procedural complication
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 35 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 6 affected / 35 at risk

Adverse event: Cough
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 4 affected / 35 at risk

Adverse event: Nasopharyngitis
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 35 at risk

Adverse event: Procedural complication
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 35 at risk

Adverse event: Dysgeusia
Serious: no
Organ System: Nervous system disorders
Frequency: 5 affected / 35 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 7 affected / 35 at risk

Adverse event: Cough
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 14 affected / 35 at risk

Adverse event: Chest discomfort
Serious: no
Organ System: General disorders
Frequency: 2 affected / 36 at risk

Adverse event: Nasopharyngitis
Serious: no
Organ System: Infections and infestations
Frequency: 2 affected / 36 at risk

Adverse event: Procedural complication
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 36 at risk

Adverse event: Dysgeusia
Serious: no
Organ System: Nervous system disorders
Frequency: 12 affected / 36 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 3 affected / 36 at risk

Adverse event: Cough
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 11 affected / 36 at risk

Adverse event: Chest discomfort
Serious: no
Organ System: General disorders
Frequency: 11 affected / 36 at risk

Adverse event: Nasopharyngitis
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 36 at risk

Adverse event: Procedural complication
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 2 affected / 36 at risk

Adverse event: Dysgeusia
Serious: no
Organ System: Nervous system disorders
Frequency: 15 affected / 36 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 3 affected / 36 at risk

Adverse event: Cough
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 15 affected / 36 at risk
Study: NCT03136068

Adverse event: pregnancy labor
Serious: no
Organ System: Pregnancy, puerperium and perinatal conditions
Notes: patient went into labor prior to D\&E (Dilation and evacuation), had D\&C (Dilation and curettage)
Frequency: 1 affected / 86 at risk

Adverse event: severe nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 86 at risk

Adverse event: hemmorhage
Serious: no
Organ System: Blood and lymphatic system disorders
Notes: 1 post-D\&E hemorrhage (requiring vag pack and med tx)

1 intra-op hemorrhage requiring Foley and med tx
Frequency: 2 affected / 86 at risk

Adverse event: cramping
Serious: no
Organ System: Reproductive system and breast disorders
Notes: extreme cramping pain following injection severe cramping pain post D\&E requiring medications
Frequency: 1 affected / 86 at risk

Adverse event: Pyrexia
Serious: no
Organ System: General disorders
Frequency: 1 affected / 86 at risk

Adverse event: Vomiting
Serious: no
Organ System: Gastrointestinal disorders
Notes: extreme nausea/vomiting following injection
Frequency: 1 affected / 86 at risk

Adverse event: Transfusion
Serious: yes
Organ System: Blood and lymphatic system disorders
Notes: Post-D\&E hemorrhage, patient admitted for transfusion
Frequency: 1 affected / 89 at risk

Adverse event: Anxiety
Serious: no
Organ System: Nervous system disorders
Notes: severe anxiety/pain post D\&E requiring medications
Frequency: 1 affected / 89 at risk

Adverse event: cramping
Serious: no
Organ System: Reproductive system and breast disorders
Notes: extreme cramping pain following injection severe cramping pain post D\&E requiring medications
Frequency: 1 affected / 89 at risk

Adverse event: Mass
Serious: no
Organ System: Reproductive system and breast disorders
Notes: MD identified uterine mass, pt transferred to hospital
Frequency: 1 affected / 89 at risk
Study: NCT03136159

Adverse event: Pruritus
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: itching at dressing
Frequency: 3 affected / 185 at risk
Study: NCT03136380

Adverse event: Viral upper respiratory tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 18 at risk

Adverse event: Herpes zoster
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 11 at risk

Adverse event: Blood uric acid increased
Serious: no
Organ System: Investigations
Frequency: 1 affected / 16 at risk
Study: NCT03136705

Adverse event: Hypophosphataemia
Serious: no
Organ System: Metabolism and nutrition disorders
Notes: Hypophosphatemia, with serum phosphate level below the limit of normal, was reported in 1 participant.

Study medications were held temporarily and the serum phosphate improved.
Frequency: 1 affected / 10 at risk
Study: NCT03137082

Adverse event: Pelvic pain
Serious: yes
Organ System: Reproductive system and breast disorders
Notes: participant admitted to ED and diagnosed with ovarian cysts
Frequency: 1 affected / 8 at risk

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

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

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

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

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

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

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

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

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

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

Adverse event: Headaches
Serious: no
Organ System: General disorders
Frequency: 1 affected / 7 at risk

Adverse event: Dry mouth
Serious: no
Organ System: General disorders
Frequency: 1 affected / 7 at risk

Adverse event: Tremor
Serious: no
Organ System: General disorders
Frequency: 1 affected / 7 at risk

Adverse event: Urinary tract infection
Serious: no
Organ System: General disorders
Frequency: 1 affected / 7 at risk
Study: NCT03137121

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 3 affected / 15 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 6 affected / 14 at risk
Study: NCT03137160

Adverse event: Sepsis
Serious: yes
Organ System: Blood and lymphatic system disorders
Notes: Sepsis due to LLE wound infection
Frequency: 1 affected / 4 at risk

Adverse event: Infection
Serious: yes
Organ System: Infections and infestations
Notes: Bilateral Infection of Pyoderma Gangrenosum
Frequency: 1 affected / 4 at risk

Adverse event: Sepsis
Serious: yes
Organ System: Blood and lymphatic system disorders
Notes: Severe Sepsis secondary to Pneumonia
Frequency: 1 affected / 4 at risk

Adverse event: Hypotension
Serious: no
Organ System: Cardiac disorders
Frequency: 2 affected / 4 at risk

Adverse event: Pyrexia
Serious: no
Organ System: Immune system disorders
Frequency: 2 affected / 4 at risk

Adverse event: vomitting
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 4 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 4 at risk

Adverse event: infection of ulcer
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 4 at risk

Adverse event: Pneumonia
Serious: no
Organ System: Immune system disorders
Frequency: 1 affected / 4 at risk

Adverse event: h influenza
Serious: no
Organ System: Immune system disorders
Frequency: 1 affected / 4 at risk

Adverse event: low WBC
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 4 at risk

Adverse event: low igG levels
Serious: no
Organ System: Immune system disorders
Frequency: 1 affected / 4 at risk
Study: NCT03137407

Adverse event: Flank pain
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 30 at risk

Adverse event: Injection site haemorrhage
Serious: no
Organ System: General disorders
Frequency: 3 affected / 30 at risk

Adverse event: Injection site pain
Serious: no
Organ System: General disorders
Frequency: 6 affected / 30 at risk

Adverse event: Injection site bruising
Serious: no
Organ System: General disorders
Frequency: 2 affected / 30 at risk

Adverse event: Paronychia
Serious: no
Organ System: Infections and infestations
Frequency: 2 affected / 30 at risk

Adverse event: Arthropod bite
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 2 affected / 30 at risk

Adverse event: Contusion
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 2 affected / 30 at risk

Adverse event: Muscle tightness
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 2 affected / 30 at risk

Adverse event: Muscular weakness
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 2 affected / 30 at risk

Adverse event: Pain in extremity
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 6 affected / 30 at risk

Adverse event: Hypoaesthesia
Serious: no
Organ System: Nervous system disorders
Frequency: 4 affected / 30 at risk

Adverse event: Atrioventricular block first degree
Serious: no
Organ System: Cardiac disorders
Frequency: 2 affected / 29 at risk

Adverse event: Injection site haemorrhage
Serious: no
Organ System: General disorders
Frequency: 2 affected / 29 at risk

Adverse event: Injection site pain
Serious: no
Organ System: General disorders
Frequency: 6 affected / 29 at risk

Adverse event: Injection site bruising
Serious: no
Organ System: General disorders
Frequency: 1 affected / 29 at risk

Adverse event: Injection site oedema
Serious: no
Organ System: General disorders
Frequency: 2 affected / 29 at risk

Adverse event: Injection site erythema
Serious: no
Organ System: General disorders
Frequency: 2 affected / 29 at risk

Adverse event: Arthropod bite
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 29 at risk

Adverse event: Muscular weakness
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 29 at risk

Adverse event: Myalgia
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 2 affected / 29 at risk

Adverse event: Pain in extremity
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 3 affected / 29 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 2 affected / 29 at risk
Study: NCT03137433

Adverse event: Suicide attempt
Serious: yes
Organ System: Psychiatric disorders
Frequency: 1 affected / 63 at risk

Adverse event: Overdose
Serious: yes
Organ System: Psychiatric disorders
Frequency: 1 affected / 63 at risk

Adverse event: Acquired pneumonia and E-cigarette associated lung injury (EVALI)
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 63 at risk

Adverse event: Self report of taking laxatives
Serious: no
Organ System: Psychiatric disorders
Notes: Taken from the Eating Disorder Examination-Questionnaire (EDEQ) question 17
Frequency: 7 affected / 63 at risk

Adverse event: Self induced vomiting
Serious: no
Organ System: Psychiatric disorders
Notes: Self report of making oneself sick based on the Eating Disorder Examination-Questionnaire, question 16.
Frequency: 9 affected / 63 at risk

Adverse event: Asthma
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: Hospitalization for asthma. Asthma was noted as a pre-existing condition at enrollment.
Frequency: 1 affected / 63 at risk

Adverse event: Self report of taking laxatives
Serious: no
Organ System: Psychiatric disorders
Notes: Taken from the Eating Disorder Examination-Questionnaire (EDEQ) question 17
Frequency: 6 affected / 63 at risk

Adverse event: Self induced vomiting
Serious: no
Organ System: Psychiatric disorders
Notes: Self report of making oneself sick based on the Eating Disorder Examination-Questionnaire, question 16.
Frequency: 6 affected / 63 at risk
Study: NCT03137537

Adverse event: Cardiac failure
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 12 at risk

Adverse event: Sinus bradycardia
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 12 at risk

Adverse event: Fatigue
Serious: no
Organ System: General disorders
Frequency: 1 affected / 12 at risk

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

Adverse event: Dyspnoea
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 11 at risk

Adverse event: Dizziness
Serious: no
Organ System: Ear and labyrinth disorders
Frequency: 1 affected / 11 at risk
Study: NCT03137693

Adverse event: Radiation skin injury
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 20 at risk

Adverse event: Pain
Serious: no
Organ System: General disorders
Frequency: 2 affected / 20 at risk

Adverse event: Infections and Infestations - Other
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 20 at risk
Study: NCT03137784

Adverse event: Patellofemoral pain syndrome
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 147 at risk

Adverse event: Nasopharyngitis
Serious: no
Organ System: Infections and infestations
Frequency: 2 affected / 147 at risk

Adverse event: Upper respiratory tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 147 at risk

Adverse event: Muscle strain
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 147 at risk

Adverse event: Dizziness
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 147 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 5 affected / 147 at risk

Adverse event: Oropharyngeal pain
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 147 at risk

Adverse event: Completed suicide
Serious: yes
Organ System: Psychiatric disorders
Frequency: 1 affected / 146 at risk

Adverse event: Nasopharyngitis
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 146 at risk

Adverse event: Upper respiratory tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 3 affected / 146 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 2 affected / 146 at risk

Adverse event: Asthma
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 2 affected / 146 at risk

Adverse event: Oropharyngeal pain
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 2 affected / 146 at risk

Adverse event: Dermatitis contact
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 2 affected / 146 at risk

Adverse event: Nasopharyngitis
Serious: no
Organ System: Infections and infestations
Frequency: 3 affected / 146 at risk

Adverse event: Upper respiratory tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 146 at risk

Adverse event: Muscle strain
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 2 affected / 146 at risk

Adverse event: Dizziness
Serious: no
Organ System: Nervous system disorders
Frequency: 2 affected / 146 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 2 affected / 146 at risk

Adverse event: Dermatitis contact
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 146 at risk
Study: NCT03138252

Adverse event: Peripartum Hysterectomy
Serious: yes
Organ System: Pregnancy, puerperium and perinatal conditions
Notes: Not study-related
Frequency: 1 affected / 90 at risk

Adverse event: Unanticipated neonatal intensive care unit admission
Serious: yes
Organ System: Pregnancy, puerperium and perinatal conditions
Notes: Not study related
Frequency: 1 affected / 90 at risk
Study: NCT03138369

Adverse event: Multi-resistant bacterial infection - Non-device related SAE
Serious: yes
Organ System: Immune system disorders
Notes: Non-device related SAE. Participant required hospitalisation and antibiotics.
Frequency: 1 affected / 11 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 4 affected / 11 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 3 affected / 11 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 3 affected / 11 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 11 at risk