Alkem

Subject ID *

Subject Initials *

Investigator *

Centre *

Date of Assessment *

Subject Initials *

Age (in Years) *

Gender *

Male Female

Height (in cm) *

Weight (in Kg) *

Patients with confirmed case of LPD *

Yes No

Presenting Signs and Symptoms *

Clinical Diagnosis *

Duration of current illness *

Complete the Laboratory data (if available)

@for ($i = 1; $i <= 4; $i++) @for ($j = 1; $j <= 5; $j++) @endfor @endfor

Concomitant Disease	Duration of Disease	Medication	Dose	Frequency

Ultrasound (USG)

Transvaginal Abdominal

Abdominal

PULSE (Bpm)

BP (mmhg)

RR (Bpm)

TEMPERATURE (ºF)

SPO2 (%)

Specify others (if available)

Dydrogesterone tablets prescribed *

Yes No

Brand Name *

Marketing Company Name *

Dose *

Frequency *

Duration *

Other medications prescribed for T/t

@for ($i = 1; $i <= 4; $i++) @endfor

Medication	Dose	Frequency	Duration

Date of Assessment *

Total Duration of Therapy (from baseline to follow-up visit date) (days) *

Improvement in clinical signs/symptoms (per treating gynecologist) *

If yes, kindly specify (in terms of regularization of menstrual cycles, pregnancy rate, reproductive outcomes)

Did patient conceive *

Yes No

Duration of dydrogesterone treatment *

Complete the Laboratory data (if available)

Ultrasound (USG)

Transvaginal Abdominal

Clinical Impression

PULSE (Bpm)

BP (mmhg)

RR (Bpm)

TEMPERATURE (ºF)

SPO2 (%)

Specify others (if available)

Adverse events noted due to study medication *

Yes No

ADVERSE EVENT(S)
AE. No	Adverse Event Term	Date of onset (DD/MM/YYYY)	Severity	Action Taken	Treatment given	Relationship with Study Drug	Outcome	Serious Adverse Event
1					Yes No			Yes No
2					Yes No			Yes No
3					Yes No			Yes No
4					Yes No			Yes No

@for ($i = 1; $i <= 10; $i++) @endfor

Reports	Baseline	Follow-up visit
@if ($i == 10) Specify Others (if any) @endif @if ($i == 10) @endif

LPD Protocol

ASSESSMENT 1 - START OF THERAPY

DEMOGRAPHICS and ANTHROPOMETRY

MEDICAL AND SURGICAL HISTORY

CONCOMITANT DISEASE and MEDICATION

USG DATA

VITALS

TREATMENT OF CURRENT MEDICAL ILLNESS

ASSESSMENT 2 - FOLLOW-UP VISIT

DATE OF ASSESSMENT

CLINICAL DATA

USG DATA

VITALS

ADVERSE EVENTS

LABORATORY PARAMETERS (as available)