Study: NCT01144286

Adverse event: tonsilitis
Serious: no
Organ System: Infections and infestations
Notes: moderate, not related,recovered
Frequency: 1 affected / 57 at risk

Adverse event: Chamydial infection
Serious: no
Organ System: Infections and infestations
Notes: mild, not related, recovering
Frequency: 1 affected / 57 at risk

Adverse event: Heat stroke
Serious: no
Organ System: Injury, poisoning and procedural complications
Notes: mild, not related, recovered
Frequency: 1 affected / 57 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Notes: mild, not related, recovered
Frequency: 1 affected / 57 at risk

Adverse event: Vulvovaginal burning sensation
Serious: no
Organ System: Reproductive system and breast disorders
Notes: mild, possible related, recovered
Frequency: 1 affected / 57 at risk

Adverse event: Pruritus
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: mild, not related, recovered
Frequency: 1 affected / 57 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Notes: mild, not related, recovered
Frequency: 2 affected / 58 at risk

Adverse event: Pruritus
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: mild, not related, recovered
Frequency: 1 affected / 58 at risk

Adverse event: Abdominal distension
Serious: no
Organ System: Gastrointestinal disorders
Notes: mild, possible related, recovered
Frequency: 1 affected / 58 at risk

Adverse event: Vaginal infection
Serious: no
Organ System: Infections and infestations
Notes: mild, not related, recovered
Frequency: 1 affected / 58 at risk

Adverse event: Nasopharyngitis
Serious: no
Organ System: Infections and infestations
Notes: mild, not related, recovered
Frequency: 1 affected / 58 at risk

Adverse event: Respiratory tract infection
Serious: no
Organ System: Infections and infestations
Notes: mild, not related, recovered
Frequency: 1 affected / 58 at risk

Adverse event: Rhinitis
Serious: no
Organ System: Infections and infestations
Notes: mild, not related, recovered
Frequency: 1 affected / 58 at risk

Adverse event: Pain in extremity
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Notes: moderate, unlikely, recovered
Frequency: 1 affected / 58 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Notes: mild, not related, recovered
Frequency: 3 affected / 58 at risk

Adverse event: Pain in extremity
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Notes: moderate, unlikely, recovered
Frequency: 1 affected / 58 at risk

Adverse event: Arrhythmia
Serious: no
Organ System: Cardiac disorders
Notes: mild, unlikely, recovered
Frequency: 1 affected / 58 at risk

Adverse event: Vertigo
Serious: no
Organ System: Ear and labyrinth disorders
Notes: mild, unlikely, recovered
Frequency: 1 affected / 58 at risk

Adverse event: Bloody discharge
Serious: no
Organ System: General disorders
Notes: mild, possible related, recovered
Frequency: 1 affected / 58 at risk

Adverse event: Influenza
Serious: no
Organ System: Infections and infestations
Notes: mild-moderate, not related, recovered
Frequency: 2 affected / 58 at risk

Adverse event: electrocardiogram TWave decreased
Serious: no
Organ System: Investigations
Notes: moderate, not assessable, recovered
Frequency: 1 affected / 58 at risk

Adverse event: Pregnancy
Serious: no
Organ System: Pregnancy, puerperium and perinatal conditions
Notes: There were 2 pregnancy cases. Patient exposed to 600 mg Arasertaconazole delivered healthy boy at 38th week gestation. Investigator last report received patient exposed to 300 mg Arasertaconazole: Ultrasound at 20th week of gestation was normal.
Frequency: 1 affected / 58 at risk

Adverse event: Vulvovaginal discomfort
Serious: no
Organ System: Reproductive system and breast disorders
Notes: severe, probable related, recovered
Frequency: 1 affected / 58 at risk

Adverse event: Dyspareunia
Serious: no
Organ System: Reproductive system and breast disorders
Notes: moderate, not related, recovered
Frequency: 1 affected / 58 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Notes: mild, not related, recovered
Frequency: 2 affected / 56 at risk

Adverse event: Vulvovaginal burning sensation
Serious: no
Organ System: Reproductive system and breast disorders
Notes: mild, possible related, recovered
Frequency: 1 affected / 56 at risk

Adverse event: Pregnancy
Serious: no
Organ System: Pregnancy, puerperium and perinatal conditions
Notes: There were 2 pregnancy cases. Patient exposed to 600 mg Arasertaconazole delivered healthy boy at 38th week gestation. Investigator last report received patient exposed to 300 mg Arasertaconazole: Ultrasound at 20th week of gestation was normal.
Frequency: 1 affected / 56 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Notes: mild, not related, recovered
Frequency: 1 affected / 56 at risk

Adverse event: Bacterial vulvovaginitis
Serious: no
Organ System: Infections and infestations
Notes: mild, not related, recovered
Frequency: 1 affected / 56 at risk

Adverse event: blood bilirrubin increased
Serious: no
Organ System: Investigations
Notes: mild, not related, not recovered
Frequency: 1 affected / 56 at risk

Adverse event: Migraine
Serious: no
Organ System: Nervous system disorders
Notes: mild, not related, recovered
Frequency: 1 affected / 56 at risk

Adverse event: Urinary incontinence
Serious: no
Organ System: Renal and urinary disorders
Notes: moderate, possible related, recovered
Frequency: 1 affected / 56 at risk

Adverse event: Pelvic pain
Serious: no
Organ System: Reproductive system and breast disorders
Notes: moderate, not related, recovered
Frequency: 1 affected / 56 at risk

Adverse event: Uterine haemorrhage
Serious: no
Organ System: Reproductive system and breast disorders
Notes: mild, possible related, recovered
Frequency: 1 affected / 56 at risk

Adverse event: Oropharyngeal pain
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: mild, not related, recovered
Frequency: 1 affected / 56 at risk

Adverse event: Rhinitis allergic
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: mild, not related, recovered
Frequency: 1 affected / 56 at risk