Table 3 Participants time line and follow up data sheet over study period
−7 days | 0 days | 7 days | 14 days | 21 days | 1 month | 4 months | 8 months | 8 months 1 wk | 12 months | 16 months | 16 months 1 wk | 24 months | Close out | |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
BMI for age Z score | Enrolment | Allocation & intervention | – | – | – | – | – | |||||||
Height for age Z score | – | – | – | – | – | |||||||||
If on Oral Steroid, Dose (Mg/kg alternate day) | ||||||||||||||
Cumulative prednisolone dose during study period (mg/kg) | – | – | – | – | – | – | – | |||||||
If on MMF, dose (mg/kg) | ||||||||||||||
Number of Rituximab injection received | ||||||||||||||
Total B Lymphocyte count: | ||||||||||||||
Any Relapse during this period | ||||||||||||||
Time to first relapse (weeks) | ||||||||||||||
Albumin (g/dl) | – | – | ||||||||||||
Urine protein-creatinine ratio | – | – | ||||||||||||
Blood leucoocyte count (n/mm3) | – | – | – | |||||||||||
Blood leucocyte differential count (n/mm3) | – | – | – | |||||||||||
Blood Platelet count (n/mm3) | – | – | – | |||||||||||
Haemoglobin (g/dl) | – | – | – | |||||||||||
Serum Sodium (meq/l) | – | – | – | – | – | |||||||||
Serum Potasium (meq/l) | – | – | – | – | – | |||||||||
Serum Calcium (mg/dl) | – | – | – | – | – | |||||||||
Aspartate transaminase (IU) | – | – | – | – | – | |||||||||
Alanine transaminase (IU) | – | – | – | – | – | |||||||||
Alkaline phosphatase (IU) | – | – | – | – | – | |||||||||
Fasting blood glucose (mg/dl) | – | – | – | – | – | |||||||||
Immunoglobulin exam | ||||||||||||||
Cholesterol (mg/dl) | – | – | ||||||||||||
Estimated GFR, ml/min/1.73 m2 | – | – | ||||||||||||
Use of any other drugs | ||||||||||||||
Clinical exam (if specific abnormal –describe below) (Hypertension-Y/N) | ||||||||||||||
Any adverse report yes/no (if yes –describe in full detail) | ||||||||||||||
Study discontinuation or withdrawal (If Yes weeks of discontinuation & reason for discontinuation) Treatment related (yes/no) |