Study: NCT03568708

Adverse event: Otoralgia
Serious: no
Organ System: Ear and labyrinth disorders
Frequency: 2 affected / 9 at risk

Adverse event: Folliculitis
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 9 at risk

Adverse event: Tympanoplasty
Serious: no
Organ System: Surgical and medical procedures
Notes: Outpatient procedure for cholesteatoma
Frequency: 1 affected / 9 at risk

Adverse event: Viral Illness
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 9 at risk

Adverse event: Headache
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 9 at risk

Adverse event: Road traffic accident
Serious: no
Organ System: General disorders
Frequency: 1 affected / 9 at risk

Adverse event: Abdominal pain
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 9 at risk

Adverse event: Deep vein thrombosis
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 10 at risk

Adverse event: Diabetic ketoacidosis (DKA) hospitalization
Serious: yes
Organ System: Endocrine disorders
Frequency: 1 affected / 10 at risk

Adverse event: Suicidality
Serious: yes
Organ System: Psychiatric disorders
Frequency: 1 affected / 10 at risk

Adverse event: Pain/irritation at patch site
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 3 affected / 10 at risk

Adverse event: Limb injury
Serious: no
Organ System: Injury, poisoning and procedural complications
Notes: No fracture identified
Frequency: 3 affected / 10 at risk

Adverse event: Bronchitis
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 10 at risk

Adverse event: Breast mass
Serious: no
Organ System: Reproductive system and breast disorders
Notes: Fibroglandular tissue, normal ultrasound
Frequency: 1 affected / 10 at risk

Adverse event: Vasovagal Syncope
Serious: no
Organ System: General disorders
Notes: During blood draw
Frequency: 1 affected / 10 at risk

Adverse event: Dental extraction
Serious: no
Organ System: Surgical and medical procedures
Notes: Removal of wisdom teeth
Frequency: 1 affected / 10 at risk

Adverse event: Motor Tics
Serious: no
Organ System: Nervous system disorders
Notes: Patient with prior diagnosis of simple motor tics reported increased frequency of these events during course of participation in the study.
Frequency: 1 affected / 10 at risk

Adverse event: Diabetic ketoacidosis (DKA)
Serious: no
Organ System: Endocrine disorders
Notes: Patient with known Type 1 Diabetes treated for DKA in emergency room setting. Did not require hospitalization.
Frequency: 1 affected / 10 at risk

Adverse event: Insulin pump site malfunction
Serious: no
Organ System: Endocrine disorders
Notes: Patient with known Type 1 Diabetes seen in local emergency department for insulin pump site malfunction. Resolved with typical care. She was not in DKA.
Frequency: 1 affected / 10 at risk

Adverse event: Weight decreased
Serious: no
Organ System: General disorders
Frequency: 1 affected / 10 at risk

Adverse event: Metatarsal fracture
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 10 at risk

Adverse event: Mood Changes
Serious: no
Organ System: Social circumstances
Notes: Experienced when not wearing estrogen patch consistently
Frequency: 1 affected / 10 at risk

Adverse event: Excessive menstrual bleeding
Serious: no
Organ System: Reproductive system and breast disorders
Notes: Menstrual bleeding stopped with norethindrone. Additional cycles were shorter in duration and lighter in flow.
Frequency: 1 affected / 10 at risk