Alkem

Date of Assessment *

Subject Initials *

Age (Completed years) *

Height (in cm) *

Weight (in Kg) *

Signs and Symptoms *

Clinical Diagnosis (if any)

Concomitant medication for current medical illness (If Any)

Gemcal XT prescribed ? *

Yes No

Condition of Female *

Pregnant Lactation

Dosing Frequency *

Total Duration of Therapy (weeks) *

Other medications prescribed for T/t

Medication	Dose	Frequency	Duration

Preeclampsia (in current pregnancy) *

Yes No

Gestational Diabetes *

Yes No

Gestational Hypertension *

Yes No

Serum Calcium Level (if available) (mg/dL)

Serum Vitamin D (25(OH)D) Level (ng/mL)

Mode of Delivery *

Vaginal C-section Instrumental

Gestational Age at Delivery (weeks) *

Birth Weight (grams) *

APGAR Score (if available) (1 min / 5 min)

Neonatal Complications (if any)

Yes No

Postnatal Gemcal XT Use

Yes No

Duration of Use (weeks postpartum) (weeks)

Breastfeeding Initiated

Yes No

Maternal Bone Pain / Fatigue Postpartum

Yes No Not recorded

Any Lactation-Related Complications

Yes No

Adverse events noted due to study medication *

Yes No

If yes, add details
AE. No	Adverse Event Term	Date of onset (DD/MM/YYYY)	Date of resolution (DD/MM/YYYY)	Severity	Action Taken (Specify)	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

Gemcal XT

ASSESSMENT 1 - THERAPY EVALUATION

DEMOGRAPHICS and ANTHROPOMETRY

MEDICAL AND SURGICAL HISTORY

TREATMENT OF CURRENT MEDICAL ILLNESS

CLINICAL DATA

Outcomes Maternal

Outcomes - Neonatal

Lactation Phase (If Applicable)

ADVERSE EVENTS