Alkem

Subject ID *

Subject Initials *

Investigator *

Centre *

Date of Assessment *

Subject Initials *

Age (in Years) *

Height (in cm) *

Weight (in Kg) *

Patients with confirmed case of Endometriosis *

Yes No

Clinical Signs and Symptoms *

Clinical Diagnosis *

Stage of Endometriosis*

Duration of current illness *

Duration of menstrual cycle *

EAPP Score, if available

Previous analgesics or any other hormonal medications used (if any)

Complete the Laboratory data on Page 7 (if available)

Concomitant Disease	Duration of Disease	Medication	Dose	Frequency

Ultrasound (USG)

Transvaginal Abdominal

Size of endometrioma

Clinical Impression

PULSE (Bpm)

BP (mmhg)

RR (pm)

TEMPERATURE (ºF)

SPO2 (%)

Specify others (if available)

Dydrogesterone 10 mg IR or 20/30 mg SR tablets prescribed*

Yes No

Brand Name *

Generic name *

Formulation (IR or SR) *

Dose *

Frequency *

Duration *

Regimen*

Cyclic Continuous

Other medications prescribed for T/t (including analgesics and/or any other hormonal medications for endometriosis)

Medication	Dose	Frequency	Duration

Date of Assessment *

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

Clinical Signs and Symptoms (if any)

Stage of Endometriosis *

Duration of menstrual cycle *

EAPP Score, if available

Complete the Laboratory data on Page 7 (if available)

Ultrasound (USG)

Transvaginal Abdominal

Size of endometrioma

Clinical Impression

PULSE (Bpm)

BP (mmhg)

RR (pm)

TEMPERATURE (ºF)

SPO2 (%)

Specify others (if available)

Need of rescue analgesics beside Dydrogesterone *

Yes No

Rescue medications prescribed for T/t (if yes)

Medication	Dose	Frequency	Duration

Reports	Baseline	Follow-up visit
Hb (gm/dL)
RBC(Millions/cumm)
WBC (/cumm)
Platelets (/cumm)
CRP (mg/L)
TNF-α (pg/mL)
IL-6 (pg/mL)
IgG (g/L)
IgM (g/L)
C3 (Compliment Level) mg/dL
C4 (Compliment Level) mg/dL
Specify Others (if any)

Adverse events noted due to study medication *

Yes No {{-- If, Yes --}}

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
Severity: 1- Mild; 2- Moderate; 3- Severe; +Action Taken: 1- No Change in IP, 2- IP Temporarily Interrupted, 3- IP Permanently Discontinued, 4- Other, specify *If 'Treatment given 'is ticked as 'Yes' then relevant information should be captured on Prior and concomitant Medication Form. Relationship: 1= Related, 2= Not Related ++Outcome: 1 = Resolved, 2= Recovered/ Resolved with Sequelae, 3= Recovering/ Resolving, 4=Not Recovered/ Not Resolved, 5= Fatal/ result in death, 6= Unknown

Dydrogesterone Endometriosis

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

TREATMENT OF CURRENT MEDICAL ILLNESS

LABORATORY PARAMETERS (as available)

ADVERSE EVENTS