Study: NCT02568215

Adverse event: Urinary tract infection bacterial
Serious: no
Organ System: Infections and infestations
Frequency: 19 affected / 1287 at risk

Adverse event: Urinary tract infection enterococcal
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 1287 at risk

Adverse event: Urogenital infection fungal
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 1287 at risk

Adverse event: Urogenital trichomoniasis
Serious: no
Organ System: Infections and infestations
Frequency: 44 affected / 1287 at risk

Adverse event: Vaginal infection
Serious: no
Organ System: Infections and infestations
Frequency: 14 affected / 1287 at risk

Adverse event: Vaginitis chlamydial
Serious: no
Organ System: Infections and infestations
Frequency: 3 affected / 1287 at risk

Adverse event: Varicella
Serious: no
Organ System: Infections and infestations
Frequency: 6 affected / 1287 at risk

Adverse event: Viral infection
Serious: no
Organ System: Infections and infestations
Frequency: 6 affected / 1287 at risk

Adverse event: Viral rhinitis
Serious: no
Organ System: Infections and infestations
Frequency: 4 affected / 1287 at risk

Adverse event: Viral upper respiratory tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 31 affected / 1287 at risk

Adverse event: Vulval abscess
Serious: no
Organ System: Infections and infestations
Frequency: 6 affected / 1287 at risk

Adverse event: Vulvovaginal candidiasis
Serious: no
Organ System: Infections and infestations
Frequency: 97 affected / 1287 at risk

Adverse event: Vulvovaginal mycotic infection
Serious: no
Organ System: Infections and infestations
Frequency: 2 affected / 1287 at risk

Adverse event: Vulvovaginitis
Serious: no
Organ System: Infections and infestations
Frequency: 16 affected / 1287 at risk

Adverse event: Vulvovaginitis gonococcal
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 1287 at risk

Adverse event: Vulvovaginitis trichomonal
Serious: no
Organ System: Infections and infestations
Frequency: 88 affected / 1287 at risk

Adverse event: Wound infection
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 1287 at risk

Adverse event: Wound infection bacterial
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 1287 at risk

Adverse event: Wound sepsis
Serious: no
Organ System: Infections and infestations
Frequency: 3 affected / 1287 at risk

Adverse event: Any Event in SOC
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 184 affected / 1287 at risk

Adverse event: Ankle fracture
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 2 affected / 1287 at risk

Adverse event: Arthropod bite
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 20 affected / 1287 at risk

Adverse event: Bite
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 1287 at risk

Adverse event: Burns first degree
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 1287 at risk

Adverse event: Chemical burns of eye
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 1287 at risk

Adverse event: Contusion
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 10 affected / 1287 at risk

Adverse event: Corneal abrasion
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 1287 at risk

Adverse event: Eye contusion
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 4 affected / 1287 at risk

Adverse event: Eye injury
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 2 affected / 1287 at risk

Adverse event: Face injury
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 8 affected / 1287 at risk

Adverse event: Foot fracture
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 3 affected / 1287 at risk

Adverse event: Forearm fracture
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 2 affected / 1287 at risk

Adverse event: Foreign body in eye
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 1287 at risk

Adverse event: Foreign body in reproductive tract
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 1287 at risk

Adverse event: Human bite
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 8 affected / 1287 at risk

Adverse event: Induced abortion haemorrhage
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 1287 at risk

Adverse event: Infusion related reaction
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 37 affected / 1287 at risk

Adverse event: Injection related reaction
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 1287 at risk

Adverse event: Injury
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 1287 at risk

Adverse event: Jaw fracture
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 1287 at risk

Adverse event: Joint dislocation
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 1287 at risk

Adverse event: Joint injury
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 4 affected / 1287 at risk

Adverse event: Ligament injury
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 1287 at risk

Adverse event: Ligament sprain
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 9 affected / 1287 at risk

Adverse event: Limb injury
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 12 affected / 1287 at risk

Adverse event: Lip injury
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 2 affected / 1287 at risk

Adverse event: Lower limb fracture
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 1287 at risk

Adverse event: Mouth injury
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 1287 at risk

Adverse event: Multiple injuries
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 3 affected / 1287 at risk

Adverse event: Muscle strain
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 3 affected / 1287 at risk

Adverse event: Musculoskeletal injury
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 1287 at risk

Adverse event: Periorbital haematoma
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 1287 at risk

Adverse event: Periorbital haemorrhage
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 1287 at risk

Adverse event: Post procedural inflammation
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 1287 at risk

Adverse event: Post procedural swelling
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 1287 at risk

Adverse event: Traumatic pain
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 4 affected / 1287 at risk

Adverse event: Procedural dizziness
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 2 affected / 1287 at risk

Adverse event: Procedural pain
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 12 affected / 1287 at risk

Adverse event: Skin abrasion
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 7 affected / 1287 at risk

Adverse event: Skin laceration
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 10 affected / 1287 at risk

Adverse event: Skin wound
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 1287 at risk

Adverse event: Soft tissue injury
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 17 affected / 1287 at risk

Adverse event: Splinter
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 1287 at risk

Adverse event: Stab wound
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 1287 at risk

Adverse event: Thermal burn
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 9 affected / 1287 at risk

Adverse event: Tooth fracture
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 2 affected / 1287 at risk

Adverse event: Traumatic ulcer
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 1287 at risk

Adverse event: Wound
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 1287 at risk

Adverse event: Wrist fracture
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 1287 at risk

Adverse event: Any Event in SOC
Serious: no
Organ System: Investigations
Frequency: 447 affected / 1287 at risk

Adverse event: Alanine aminotransferase increased
Serious: no
Organ System: Investigations
Frequency: 98 affected / 1287 at risk

Adverse event: Amylase increased
Serious: no
Organ System: Investigations
Frequency: 2 affected / 1287 at risk

Adverse event: Aspartate aminotransferase increased
Serious: no
Organ System: Investigations
Frequency: 5 affected / 1287 at risk

Adverse event: Bilirubin conjugated increased
Serious: no
Organ System: Investigations
Frequency: 3 affected / 1287 at risk

Adverse event: Bilirubin urine present
Serious: no
Organ System: Investigations
Frequency: 1 affected / 1287 at risk

Adverse event: Blood alkaline phosphatase increased
Serious: no
Organ System: Investigations
Frequency: 1 affected / 1287 at risk

Adverse event: Blood bicarbonate decreased
Serious: no
Organ System: Investigations
Frequency: 1 affected / 1287 at risk

Adverse event: Blood bilirubin increased
Serious: no
Organ System: Investigations
Frequency: 1 affected / 1287 at risk

Adverse event: Blood creatine increased
Serious: no
Organ System: Investigations
Frequency: 3 affected / 1287 at risk

Adverse event: Blood creatinine increased
Serious: no
Organ System: Investigations
Frequency: 187 affected / 1287 at risk

Adverse event: Blood glucose increased
Serious: no
Organ System: Investigations
Frequency: 2 affected / 1287 at risk

Adverse event: Blood pressure decreased
Serious: no
Organ System: Investigations
Frequency: 13 affected / 1287 at risk

Adverse event: Blood pressure increased
Serious: no
Organ System: Investigations
Frequency: 90 affected / 1287 at risk

Adverse event: Body temperature decreased
Serious: no
Organ System: Investigations
Frequency: 1 affected / 1287 at risk

Adverse event: Body temperature increased
Serious: no
Organ System: Investigations
Frequency: 1 affected / 1287 at risk

Adverse event: CD4 lymphocytes decreased
Serious: no
Organ System: Investigations
Frequency: 1 affected / 1287 at risk

Adverse event: Carbon dioxide decreased
Serious: no
Organ System: Investigations
Frequency: 1 affected / 1287 at risk

Adverse event: Cardiac murmur
Serious: no
Organ System: Investigations
Frequency: 1 affected / 1287 at risk

Adverse event: Creatinine renal clearance decreased
Serious: no
Organ System: Investigations
Frequency: 2 affected / 1287 at risk

Adverse event: Fungal test positive
Serious: no
Organ System: Investigations
Frequency: 1 affected / 1287 at risk

Adverse event: Gamma-glutamyltransferase increased
Serious: no
Organ System: Investigations
Frequency: 1 affected / 1287 at risk

Adverse event: Haemoglobin decreased
Serious: no
Organ System: Investigations
Frequency: 82 affected / 1287 at risk

Adverse event: Heart rate increased
Serious: no
Organ System: Investigations
Frequency: 1 affected / 1287 at risk

Adverse event: Lymphocyte count decreased
Serious: no
Organ System: Investigations
Frequency: 6 affected / 1287 at risk

Adverse event: Neutrophil count decreased
Serious: no
Organ System: Investigations
Frequency: 22 affected / 1287 at risk

Adverse event: Platelet count decreased
Serious: no
Organ System: Investigations
Frequency: 20 affected / 1287 at risk

Adverse event: Protein urine present
Serious: no
Organ System: Investigations
Frequency: 1 affected / 1287 at risk

Adverse event: Red blood cell count increased
Serious: no
Organ System: Investigations
Frequency: 1 affected / 1287 at risk

Adverse event: Serum ferritin decreased
Serious: no
Organ System: Investigations
Frequency: 1 affected / 1287 at risk

Adverse event: Smear vaginal abnormal
Serious: no
Organ System: Investigations
Frequency: 1 affected / 1287 at risk

Adverse event: Weight decreased
Serious: no
Organ System: Investigations
Frequency: 9 affected / 1287 at risk

Adverse event: Weight increased
Serious: no
Organ System: Investigations
Frequency: 1 affected / 1287 at risk

Adverse event: White blood cell count decreased
Serious: no
Organ System: Investigations
Frequency: 6 affected / 1287 at risk

Adverse event: White blood cell count increased
Serious: no
Organ System: Investigations
Frequency: 1 affected / 1287 at risk

Adverse event: Any Event in SOC
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 80 affected / 1287 at risk

Adverse event: Abnormal loss of weight
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 22 affected / 1287 at risk

Adverse event: Decreased appetite
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 42 affected / 1287 at risk

Adverse event: Glucose tolerance impaired
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 1287 at risk

Adverse event: Hyperlipidaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 1287 at risk

Adverse event: Increased appetite
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 3 affected / 1287 at risk

Adverse event: Iron deficiency
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 11 affected / 1287 at risk

Adverse event: Polydipsia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 2 affected / 1287 at risk

Adverse event: Vitamin B12 deficiency
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 1287 at risk

Adverse event: Any Event in SOC
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 249 affected / 1287 at risk

Adverse event: Arthralgia
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 46 affected / 1287 at risk

Adverse event: Axillary mass
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 1287 at risk

Adverse event: Back pain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 106 affected / 1287 at risk

Adverse event: Bone swelling
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 1287 at risk

Adverse event: Costochondritis
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 5 affected / 1287 at risk

Adverse event: Fibromyalgia
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 3 affected / 1287 at risk

Adverse event: Flank pain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 4 affected / 1287 at risk

Adverse event: Joint swelling
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 2 affected / 1287 at risk

Adverse event: Limb mass
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 2 affected / 1287 at risk

Adverse event: Muscle spasms
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 7 affected / 1287 at risk

Adverse event: Muscular weakness
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 1287 at risk

Adverse event: Musculoskeletal chest pain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 25 affected / 1287 at risk

Adverse event: Musculoskeletal discomfort
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 1287 at risk

Adverse event: Musculoskeletal pain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 27 affected / 1287 at risk

Adverse event: Musculoskeletal stiffness
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 1287 at risk

Adverse event: Myalgia
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 25 affected / 1287 at risk

Adverse event: Myalgia intercostal
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 1287 at risk

Adverse event: Neck mass
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 1287 at risk

Adverse event: Neck pain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 14 affected / 1287 at risk

Adverse event: Osteoarthritis
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 1287 at risk

Adverse event: Pain in extremity
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 33 affected / 1287 at risk

Adverse event: Pain in jaw
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 1287 at risk

Adverse event: Plantar fasciitis
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 1287 at risk

Adverse event: Polyarthritis
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 1287 at risk

Adverse event: Any Event in SOC
Serious: no
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 11 affected / 1287 at risk

Adverse event: Anogenital warts
Serious: no
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 4 affected / 1287 at risk

Adverse event: Lipoma
Serious: no
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 2 affected / 1287 at risk

Adverse event: Skin papilloma
Serious: no
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 1287 at risk

Adverse event: Vulvovaginal warts
Serious: no
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 4 affected / 1287 at risk

Adverse event: Any Event in SOC
Serious: no
Organ System: Nervous system disorders
Frequency: 288 affected / 1287 at risk

Adverse event: Dizziness
Serious: no
Organ System: Nervous system disorders
Frequency: 35 affected / 1287 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 241 affected / 1287 at risk

Adverse event: Hypersomnia
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 1287 at risk

Adverse event: Hypoaesthesia
Serious: no
Organ System: Nervous system disorders
Frequency: 2 affected / 1287 at risk

Adverse event: Hyposmia
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 1287 at risk

Adverse event: Meningism
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 1287 at risk

Adverse event: Migraine
Serious: no
Organ System: Nervous system disorders
Frequency: 4 affected / 1287 at risk

Adverse event: Neuropathy peripheral
Serious: no
Organ System: Nervous system disorders
Frequency: 3 affected / 1287 at risk

Adverse event: Paraesthesia
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 1287 at risk

Adverse event: Presyncope
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 1287 at risk

Adverse event: Sciatica
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 1287 at risk

Adverse event: Seizure
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 1287 at risk

Adverse event: Sensory disturbance
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 1287 at risk

Adverse event: Somnolence
Serious: no
Organ System: Nervous system disorders
Frequency: 3 affected / 1287 at risk

Adverse event: Syncope
Serious: no
Organ System: Nervous system disorders
Frequency: 4 affected / 1287 at risk

Adverse event: Tension headache
Serious: no
Organ System: Nervous system disorders
Frequency: 15 affected / 1287 at risk

Adverse event: Any Event in SOC
Serious: no
Organ System: Pregnancy, puerperium and perinatal conditions
Frequency: 23 affected / 1287 at risk

Adverse event: Abortion complete
Serious: no
Organ System: Pregnancy, puerperium and perinatal conditions
Frequency: 1 affected / 1287 at risk

Adverse event: Abortion incomplete
Serious: no
Organ System: Pregnancy, puerperium and perinatal conditions
Frequency: 2 affected / 1287 at risk

Adverse event: Abortion spontaneous
Serious: no
Organ System: Pregnancy, puerperium and perinatal conditions
Frequency: 19 affected / 1287 at risk

Adverse event: Complication of pregnancy
Serious: no
Organ System: Pregnancy, puerperium and perinatal conditions
Frequency: 1 affected / 1287 at risk

Adverse event: Threatened labour
Serious: no
Organ System: Pregnancy, puerperium and perinatal conditions
Frequency: 1 affected / 1287 at risk

Adverse event: Any Event in SOC
Serious: no
Organ System: Psychiatric disorders
Frequency: 38 affected / 1287 at risk

Adverse event: Acute stress disorder
Serious: no
Organ System: Psychiatric disorders
Frequency: 1 affected / 1287 at risk

Adverse event: Alcohol use disorder
Serious: no
Organ System: Psychiatric disorders
Frequency: 1 affected / 1287 at risk

Adverse event: Anxiety
Serious: no
Organ System: Psychiatric disorders
Frequency: 8 affected / 1287 at risk

Adverse event: Depression
Serious: no
Organ System: Psychiatric disorders
Frequency: 8 affected / 1287 at risk

Adverse event: Emotional distress
Serious: no
Organ System: Psychiatric disorders
Frequency: 2 affected / 1287 at risk

Adverse event: Insomnia
Serious: no
Organ System: Psychiatric disorders
Frequency: 10 affected / 1287 at risk

Adverse event: Loss of libido
Serious: no
Organ System: Psychiatric disorders
Frequency: 1 affected / 1287 at risk

Adverse event: Major depression
Serious: no
Organ System: Psychiatric disorders
Frequency: 2 affected / 1287 at risk

Adverse event: Panic attack
Serious: no
Organ System: Psychiatric disorders
Frequency: 1 affected / 1287 at risk

Adverse event: Pica
Serious: no
Organ System: Psychiatric disorders
Frequency: 1 affected / 1287 at risk

Adverse event: Post-traumatic stress disorder
Serious: no
Organ System: Psychiatric disorders
Frequency: 1 affected / 1287 at risk

Adverse event: Stress
Serious: no
Organ System: Psychiatric disorders
Frequency: 5 affected / 1287 at risk

Adverse event: Terminal insomnia
Serious: no
Organ System: Psychiatric disorders
Frequency: 1 affected / 1287 at risk

Adverse event: Any Event in SOC
Serious: no
Organ System: Renal and urinary disorders
Frequency: 140 affected / 1287 at risk

Adverse event: Crystalluria
Serious: no
Organ System: Renal and urinary disorders
Frequency: 1 affected / 1287 at risk

Adverse event: Dysuria
Serious: no
Organ System: Renal and urinary disorders
Frequency: 18 affected / 1287 at risk

Adverse event: Glycosuria
Serious: no
Organ System: Renal and urinary disorders
Frequency: 4 affected / 1287 at risk

Adverse event: Haematuria
Serious: no
Organ System: Renal and urinary disorders
Frequency: 40 affected / 1287 at risk

Adverse event: Ketonuria
Serious: no
Organ System: Renal and urinary disorders
Frequency: 1 affected / 1287 at risk

Adverse event: Nocturia
Serious: no
Organ System: Renal and urinary disorders
Frequency: 1 affected / 1287 at risk

Adverse event: Pollakiuria
Serious: no
Organ System: Renal and urinary disorders
Frequency: 4 affected / 1287 at risk

Adverse event: Polyuria
Serious: no
Organ System: Renal and urinary disorders
Frequency: 3 affected / 1287 at risk

Adverse event: Proteinuria
Serious: no
Organ System: Renal and urinary disorders
Frequency: 89 affected / 1287 at risk

Adverse event: Urge incontinence
Serious: no
Organ System: Renal and urinary disorders
Frequency: 1 affected / 1287 at risk

Adverse event: Urinary retention
Serious: no
Organ System: Renal and urinary disorders
Frequency: 1 affected / 1287 at risk

Adverse event: Any Event in SOC
Serious: no
Organ System: Reproductive system and breast disorders
Frequency: 316 affected / 1287 at risk

Adverse event: Abnormal uterine bleeding
Serious: no
Organ System: Reproductive system and breast disorders
Frequency: 92 affected / 1287 at risk

Adverse event: Adnexa uteri pain
Serious: no
Organ System: Reproductive system and breast disorders
Frequency: 3 affected / 1287 at risk

Adverse event: Bartholin's cyst
Serious: no
Organ System: Reproductive system and breast disorders
Frequency: 2 affected / 1287 at risk

Adverse event: Breast discharge
Serious: no
Organ System: Reproductive system and breast disorders
Frequency: 2 affected / 1287 at risk

Adverse event: Breast mass
Serious: no
Organ System: Reproductive system and breast disorders
Frequency: 4 affected / 1287 at risk

Adverse event: Breast pain
Serious: no
Organ System: Reproductive system and breast disorders
Frequency: 13 affected / 1287 at risk

Adverse event: Breast swelling
Serious: no
Organ System: Reproductive system and breast disorders
Frequency: 1 affected / 1287 at risk

Adverse event: Cervical dysplasia
Serious: no
Organ System: Reproductive system and breast disorders
Frequency: 3 affected / 1287 at risk

Adverse event: Coital bleeding
Serious: no
Organ System: Reproductive system and breast disorders
Frequency: 1 affected / 1287 at risk

Adverse event: Dysmenorrhoea
Serious: no
Organ System: Reproductive system and breast disorders
Frequency: 22 affected / 1287 at risk

Adverse event: Dyspareunia
Serious: no
Organ System: Reproductive system and breast disorders
Frequency: 4 affected / 1287 at risk

Adverse event: Galactorrhoea
Serious: no
Organ System: Reproductive system and breast disorders
Frequency: 1 affected / 1287 at risk

Adverse event: Genital blister
Serious: no
Organ System: Reproductive system and breast disorders
Frequency: 1 affected / 1287 at risk

Adverse event: Genital pain
Serious: no
Organ System: Reproductive system and breast disorders
Frequency: 2 affected / 1287 at risk

Adverse event: Genital ulceration
Serious: no
Organ System: Reproductive system and breast disorders
Frequency: 6 affected / 1287 at risk

Adverse event: Heavy menstrual bleeding
Serious: no
Organ System: Reproductive system and breast disorders
Frequency: 8 affected / 1287 at risk

Adverse event: Intermenstrual bleeding
Serious: no
Organ System: Reproductive system and breast disorders
Frequency: 4 affected / 1287 at risk

Adverse event: Nipple inflammation
Serious: no
Organ System: Reproductive system and breast disorders
Frequency: 1 affected / 1287 at risk

Adverse event: Nipple pain
Serious: no
Organ System: Reproductive system and breast disorders
Frequency: 1 affected / 1287 at risk

Adverse event: Pelvic pain
Serious: no
Organ System: Reproductive system and breast disorders
Frequency: 10 affected / 1287 at risk

Adverse event: Polymenorrhoea
Serious: no
Organ System: Reproductive system and breast disorders
Frequency: 3 affected / 1287 at risk

Adverse event: Uterine cyst
Serious: no
Organ System: Reproductive system and breast disorders
Frequency: 1 affected / 1287 at risk

Adverse event: Uterine pain
Serious: no
Organ System: Reproductive system and breast disorders
Frequency: 3 affected / 1287 at risk

Adverse event: Vaginal discharge
Serious: no
Organ System: Reproductive system and breast disorders
Frequency: 160 affected / 1287 at risk

Adverse event: Vaginal haemorrhage
Serious: no
Organ System: Reproductive system and breast disorders
Frequency: 3 affected / 1287 at risk

Adverse event: Vulval ulceration
Serious: no
Organ System: Reproductive system and breast disorders
Frequency: 3 affected / 1287 at risk

Adverse event: Vulvovaginal pruritus
Serious: no
Organ System: Reproductive system and breast disorders
Frequency: 13 affected / 1287 at risk

Adverse event: Vulvovaginal rash
Serious: no
Organ System: Reproductive system and breast disorders
Frequency: 3 affected / 1287 at risk

Adverse event: Vulvovaginal swelling
Serious: no
Organ System: Reproductive system and breast disorders
Frequency: 1 affected / 1287 at risk

Adverse event: Vulvovaginal ulceration
Serious: no
Organ System: Reproductive system and breast disorders
Frequency: 1 affected / 1287 at risk

Adverse event: Withdrawal bleed
Serious: no
Organ System: Reproductive system and breast disorders
Frequency: 1 affected / 1287 at risk

Adverse event: Any Event in SOC
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 106 affected / 1287 at risk

Adverse event: Asthma
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 3 affected / 1287 at risk

Adverse event: Bronchiectasis
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 1287 at risk

Adverse event: Bronchospasm
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 1287 at risk

Adverse event: Cough
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 43 affected / 1287 at risk

Adverse event: Dry throat
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 1287 at risk

Adverse event: Dysphonia
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 1287 at risk

Adverse event: Dyspnoea
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 4 affected / 1287 at risk

Adverse event: Epistaxis
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 7 affected / 1287 at risk

Adverse event: Lower respiratory tract congestion
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 1287 at risk

Adverse event: Nasal congestion
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 8 affected / 1287 at risk

Adverse event: Oropharyngeal pain
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 18 affected / 1287 at risk

Adverse event: Pleurisy
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 1287 at risk

Adverse event: Productive cough
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 3 affected / 1287 at risk

Adverse event: Rhinitis allergic
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 15 affected / 1287 at risk

Adverse event: Rhinorrhoea
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 3 affected / 1287 at risk

Adverse event: Sinus congestion
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 1287 at risk

Adverse event: Throat irritation
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 1287 at risk

Adverse event: Tonsillar hypertrophy
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 1287 at risk

Adverse event: Upper-airway cough syndrome
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 1287 at risk

Adverse event: Any Event in SOC
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 268 affected / 1287 at risk

Adverse event: Acne
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 17 affected / 1287 at risk

Adverse event: Acne cystic
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 1287 at risk

Adverse event: Alopecia
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 1287 at risk

Adverse event: Blister
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 1287 at risk

Adverse event: Dandruff
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 1287 at risk

Adverse event: Dermatitis
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 11 affected / 1287 at risk

Adverse event: Dermatitis acneiform
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 2 affected / 1287 at risk

Adverse event: Dermatitis allergic
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 16 affected / 1287 at risk

Adverse event: Dermatitis atopic
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 5 affected / 1287 at risk

Adverse event: Dermatitis contact
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 18 affected / 1287 at risk

Adverse event: Drug eruption
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 1287 at risk

Adverse event: Dry skin
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 2 affected / 1287 at risk

Adverse event: Dyshidrotic eczema
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 1287 at risk

Adverse event: Eczema
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 23 affected / 1287 at risk

Adverse event: Eczema nummular
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 1287 at risk

Adverse event: Hidradenitis
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 2 affected / 1287 at risk

Adverse event: Ingrown hair
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 2 affected / 1287 at risk

Adverse event: Macule
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 2 affected / 1287 at risk

Adverse event: Miliaria
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 1287 at risk

Adverse event: Night sweats
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 6 affected / 1287 at risk

Adverse event: Papule
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 5 affected / 1287 at risk

Adverse event: Pityriasis
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 2 affected / 1287 at risk

Adverse event: Pityriasis alba
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 1287 at risk

Adverse event: Pruritus
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 56 affected / 1287 at risk

Adverse event: Rash
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 35 affected / 1287 at risk

Adverse event: Rash erythematous
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 3 affected / 1287 at risk

Adverse event: Rash macular
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 3 affected / 1287 at risk

Adverse event: Rash maculo-papular
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 6 affected / 1287 at risk

Adverse event: Rash papular
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 30 affected / 1287 at risk

Adverse event: Rash pruritic
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 15 affected / 1287 at risk

Adverse event: Rash vesicular
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 2 affected / 1287 at risk

Adverse event: Scar pain
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 1287 at risk

Adverse event: Seborrhoeic dermatitis
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 1287 at risk

Adverse event: Skin hyperpigmentation
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 1287 at risk

Adverse event: Skin hypopigmentation
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 1287 at risk

Adverse event: Skin irritation
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 1287 at risk

Adverse event: Skin mass
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 2 affected / 1287 at risk

Adverse event: Skin ulcer
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 3 affected / 1287 at risk

Adverse event: Solar dermatitis
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 2 affected / 1287 at risk

Adverse event: Urticaria
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 35 affected / 1287 at risk

Adverse event: Vitiligo
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 1287 at risk

Adverse event: Any Event in SOC
Serious: no
Organ System: Social circumstances
Frequency: 4 affected / 1287 at risk

Adverse event: Victim of sexual abuse
Serious: no
Organ System: Social circumstances
Frequency: 4 affected / 1287 at risk

Adverse event: Any Event in SOC
Serious: no
Organ System: Vascular disorders
Frequency: 25 affected / 1287 at risk

Adverse event: Haematoma
Serious: no
Organ System: Vascular disorders
Frequency: 1 affected / 1287 at risk

Adverse event: Hot flush
Serious: no
Organ System: Vascular disorders
Frequency: 2 affected / 1287 at risk

Adverse event: Hypertension
Serious: no
Organ System: Vascular disorders
Frequency: 20 affected / 1287 at risk

Adverse event: Superficial vein thrombosis
Serious: no
Organ System: Vascular disorders
Frequency: 1 affected / 1287 at risk

Adverse event: Vascular pain
Serious: no
Organ System: Vascular disorders
Frequency: 2 affected / 1287 at risk