Comprehensive Individual Patient Profile

1 Subject : 01-701-1015

1.1 Demographic

Gender

F

Race

WHITE

Ethnicity

HISPANIC OR LATINO

Treatment Arm

Placebo

Country

USA

Site ID

701

Treatment Start Date

2014-01-02

Treatment End Date

2014-07-02

1.2 Medical History (Start - End)

Body System or Organ Class

Dictionary-Derived Term

Start Date/Time of Medical History Event

End Date/Time of Medical History Event

2010-04-30

2011-03-20

HEPATOBILIARY DISORDERS

CHOLELITHIASIS

2012

GASTROINTESTINAL DISORDERS

DYSPEPSIA

NERVOUS SYSTEM DISORDERS

HEADACHE

NERVOUS SYSTEM DISORDERS

HYPOAESTHESIA

SURGICAL AND MEDICAL PROCEDURES

HYSTERECTOMY

1986

CARDIAC DISORDERS

PALPITATIONS

RESPIRATORY, THORACIC AND MEDIASTINAL DISORDERS

PHARYNGOLARYNGEAL PAIN

2013-12

SURGICAL AND MEDICAL PROCEDURES

THYROIDECTOMY PARTIAL

1973

EAR AND LABYRINTH DISORDERS

TINNITUS

SURGICAL AND MEDICAL PROCEDURES

TONSILLECTOMY

1973

1.3 Concomitant Medications

1.4 Treatment Exposure

1.5 Adverse Events

1.6 Laboratory Test Measurements