Time Frame |
[Not Specified]
|
Adverse Event Reporting Description |
[Not Specified]
|
|
Arm/Group Title
|
Valsartan + Antihypertensive Group
|
Valsartan Alone
|
CKD Patients: Valsartan + Antihypertensive Group
|
CKD Patients: Valsartan Alone
|
Non-CKD Patients: Valsartan + Antihypertensive Group
|
Non-CKD Patients: Valsartan Alone
|
Arm/Group Description |
Valsartan starting dose: ≥18 kg to ...
|
Valsartan starting dose: ≥18 kg to ...
|
CKD Patients - Valsartan starting d...
|
CKD Patients - Valsartan starting d...
|
Non-CKD patients-Valsartan starting...
|
Non-CKD patients-Valsartan starting...
|
Arm/Group Description |
Valsartan starting dose: ≥18 kg to <35 kg is 40 mg, ≥35 kg to <80 kg is 80 mg, ≥80 kg to ≤160 kg is 160 mg for 1 week then Valsartan maintenance dose: ≥18 kg to <35 kg is 80 mg, ≥35 kg to <80 kg is 160 mg, ≥80 kg to ≤160 kg is 320 mg after Week 8 if the Mean Sitting Systolic Blood Pressure (MSSBP) and/or Mean Sitting Diastolic Blood Pressure (MSDBP) was higher than 95th percentile for age, gender and height under the maintenance valsartan dose then add amlodipine and/or Hydrochlorothiazide (HCTZ). The valsartan +antihypertensive group includes patients who received background antihypertensive medication or received antihypertensive medication including amlodipine or HCTZ during the study.
|
Valsartan starting dose: ≥18 kg to <35 kg is 40 mg, ≥35 kg to <80 kg is 80 mg, ≥80 kg to ≤160 kg is 160 mg for 1 week then Valsartan maintenance dose: ≥18 kg to <35 kg is 80 mg, ≥35 kg to <80 kg is 160 mg, ≥80 kg to ≤160 kg is 320 mg.
|
CKD Patients - Valsartan starting dose: ≥18 kg to <35 kg is 40 mg, ≥35 kg to <80 kg is 80 mg, ≥80 kg to ≤160 kg is 160 mg for 1 week then Valsartan maintenance dose: ≥18 kg to <35 kg is 80 mg, ≥35 kg to <80 kg is 160 mg, ≥80 kg to ≤160 kg is 320 mg after Week 8 if the Mean Sitting Systolic Blood Pressure (MSSBP) and/or Mean Sitting Diastolic Blood Pressure (MSDBP) was higher than 95th percentile for age, gender and height under the maintenance valsartan dose then add amlodipine and/or Hydrochlorothiazide (HCTZ). The valsartan +antihypertensive group includes patients who received background antihypertensive medication or received antihypertensive medication including amlodipine or HCTZ during the study.
|
CKD Patients - Valsartan starting dose: ≥18 kg to <35 kg is 40 mg, ≥35 kg to <80 kg is 80 mg, ≥80 kg to ≤160 kg is 160 mg for 1 week then Valsartan maintenance dose: ≥18 kg to <35 kg is 80 mg, ≥35 kg to <80 kg is 160 mg, ≥80 kg to ≤160 kg is 320 mg.
|
Non-CKD patients-Valsartan starting dose: ≥18 kg to <35 kg is 40 mg, ≥35 kg to <80 kg is 80 mg, ≥80 kg to ≤160 kg is 160 mg for 1 week then Valsartan maintenance dose: ≥18 kg to <35 kg is 80 mg, ≥35 kg to <80 kg is 160 mg, ≥80 kg to ≤160 kg is 320 mg after Week 8 if the Mean Sitting Systolic Blood Pressure (MSSBP) and/or Mean Sitting Diastolic Blood Pressure (MSDBP) was higher than 95th percentile for age, gender and height under the maintenance valsartan dose then add amlodipine and/or Hydrochlorothiazide (HCTZ). The valsartan +antihypertensive group includes patients who received background antihypertensive medication or received antihypertensive medication including amlodipine or HCTZ during the study.
|
Non-CKD patients-Valsartan starting dose: ≥18 kg to <35 kg is 40 mg, ≥35 kg to <80 kg is 80 mg, ≥80 kg to ≤160 kg is 160 mg for 1 week then Valsartan maintenance dose: ≥18 kg to <35 kg is 80 mg, ≥35 kg to <80 kg is 160 mg, ≥80 kg to ≤160 kg is 320 mg.
|
|
|
Valsartan + Antihypertensive Group
|
Valsartan Alone
|
CKD Patients: Valsartan + Antihypertensive Group
|
CKD Patients: Valsartan Alone
|
Non-CKD Patients: Valsartan + Antihypertensive Group
|
Non-CKD Patients: Valsartan Alone
|
|
Affected / at Risk (%) |
Affected / at Risk (%) |
Affected / at Risk (%) |
Affected / at Risk (%) |
Affected / at Risk (%) |
Affected / at Risk (%) |
Total |
--/-- |
--/-- |
--/-- |
--/-- |
--/-- |
--/-- |
|
|
Valsartan + Antihypertensive Group
|
Valsartan Alone
|
CKD Patients: Valsartan + Antihypertensive Group
|
CKD Patients: Valsartan Alone
|
Non-CKD Patients: Valsartan + Antihypertensive Group
|
Non-CKD Patients: Valsartan Alone
|
|
Affected / at Risk (%) |
Affected / at Risk (%) |
Affected / at Risk (%) |
Affected / at Risk (%) |
Affected / at Risk (%) |
Affected / at Risk (%) |
Total |
8/41 (19.51%) |
7/109 (6.42%) |
7/23 (30.43%) |
4/52 (7.69%) |
1/18 (5.56%) |
3/57 (5.26%) |
Blood and lymphatic system disorders |
|
|
|
|
|
|
Febrile neutropenia |
1/41 (2.44%) |
0/109 (0.00%) |
1/23 (4.35%) |
0/52 (0.00%) |
0/18 (0.00%) |
0/57 (0.00%) |
Gastrointestinal disorders |
|
|
|
|
|
|
Oesophageal polyp |
1/41 (2.44%) |
0/109 (0.00%) |
1/23 (4.35%) |
0/52 (0.00%) |
0/18 (0.00%) |
0/57 (0.00%) |
General disorders |
|
|
|
|
|
|
Face oedema |
1/41 (2.44%) |
0/109 (0.00%) |
1/23 (4.35%) |
0/52 (0.00%) |
0/18 (0.00%) |
0/57 (0.00%) |
Oedema peripheral |
1/41 (2.44%) |
0/109 (0.00%) |
1/23 (4.35%) |
0/52 (0.00%) |
0/18 (0.00%) |
0/57 (0.00%) |
Hepatobiliary disorders |
|
|
|
|
|
|
Cholelithiasis |
0/41 (0.00%) |
1/109 (0.92%) |
0/23 (0.00%) |
0/52 (0.00%) |
0/18 (0.00%) |
1/57 (1.75%) |
Infections and infestations |
|
|
|
|
|
|
Gastroenteritis |
1/41 (2.44%) |
0/109 (0.00%) |
1/23 (4.35%) |
0/52 (0.00%) |
0/18 (0.00%) |
0/57 (0.00%) |
Pneumonia |
1/41 (2.44%) |
1/109 (0.92%) |
1/23 (4.35%) |
1/52 (1.92%) |
0/18 (0.00%) |
0/57 (0.00%) |
Urinary tract infection |
0/41 (0.00%) |
1/109 (0.92%) |
0/23 (0.00%) |
1/52 (1.92%) |
0/18 (0.00%) |
0/57 (0.00%) |
Viral upper respiratory tract infection |
0/41 (0.00%) |
1/109 (0.92%) |
0/23 (0.00%) |
0/52 (0.00%) |
0/18 (0.00%) |
1/57 (1.75%) |
Investigations |
|
|
|
|
|
|
Glomerular filtration rate decreased |
1/41 (2.44%) |
0/109 (0.00%) |
1/23 (4.35%) |
0/52 (0.00%) |
0/18 (0.00%) |
0/57 (0.00%) |
Musculoskeletal and connective tissue disorders |
|
|
|
|
|
|
Synovitis |
1/41 (2.44%) |
0/109 (0.00%) |
1/23 (4.35%) |
0/52 (0.00%) |
0/18 (0.00%) |
0/57 (0.00%) |
Nervous system disorders |
|
|
|
|
|
|
Somnolence |
0/41 (0.00%) |
1/109 (0.92%) |
0/23 (0.00%) |
0/52 (0.00%) |
0/18 (0.00%) |
1/57 (1.75%) |
Psychiatric disorders |
|
|
|
|
|
|
Drug abuse |
0/41 (0.00%) |
1/109 (0.92%) |
0/23 (0.00%) |
0/52 (0.00%) |
0/18 (0.00%) |
1/57 (1.75%) |
Renal and urinary disorders |
|
|
|
|
|
|
Chronic kidney disease |
1/41 (2.44%) |
0/109 (0.00%) |
1/23 (4.35%) |
0/52 (0.00%) |
0/18 (0.00%) |
0/57 (0.00%) |
IgA nephropathy |
0/41 (0.00%) |
1/109 (0.92%) |
0/23 (0.00%) |
1/52 (1.92%) |
0/18 (0.00%) |
0/57 (0.00%) |
Lupus nephritis |
3/41 (7.32%) |
1/109 (0.92%) |
3/23 (13.04%) |
1/52 (1.92%) |
0/18 (0.00%) |
0/57 (0.00%) |
Nephrotic syndrome |
0/41 (0.00%) |
1/109 (0.92%) |
0/23 (0.00%) |
1/52 (1.92%) |
0/18 (0.00%) |
0/57 (0.00%) |
Neurogenic bladder |
0/41 (0.00%) |
1/109 (0.92%) |
0/23 (0.00%) |
1/52 (1.92%) |
0/18 (0.00%) |
0/57 (0.00%) |
Proteinuria |
1/41 (2.44%) |
0/109 (0.00%) |
1/23 (4.35%) |
0/52 (0.00%) |
0/18 (0.00%) |
0/57 (0.00%) |
Vascular disorders |
|
|
|
|
|
|
Hypertension |
1/41 (2.44%) |
0/109 (0.00%) |
0/23 (0.00%) |
0/52 (0.00%) |
1/18 (5.56%) |
0/57 (0.00%) |
Hypotension |
0/41 (0.00%) |
1/109 (0.92%) |
0/23 (0.00%) |
0/52 (0.00%) |
0/18 (0.00%) |
1/57 (1.75%) |
Indicates events were collected by systematic assessment
Term from vocabulary, MedDRA 18.1
|
|
Frequency Threshold for Reporting Other Adverse Events
|
5%
|
|
Valsartan + Antihypertensive Group
|
Valsartan Alone
|
CKD Patients: Valsartan + Antihypertensive Group
|
CKD Patients: Valsartan Alone
|
Non-CKD Patients: Valsartan + Antihypertensive Group
|
Non-CKD Patients: Valsartan Alone
|
|
Affected / at Risk (%) |
Affected / at Risk (%) |
Affected / at Risk (%) |
Affected / at Risk (%) |
Affected / at Risk (%) |
Affected / at Risk (%) |
Total |
34/41 (82.93%) |
68/109 (62.39%) |
18/23 (78.26%) |
36/52 (69.23%) |
16/18 (88.89%) |
32/57 (56.14%) |
Blood and lymphatic system disorders |
|
|
|
|
|
|
Lymphadenopathy |
1/41 (2.44%) |
0/109 (0.00%) |
0/23 (0.00%) |
0/52 (0.00%) |
1/18 (5.56%) |
0/57 (0.00%) |
Eye disorders |
|
|
|
|
|
|
Myopia |
1/41 (2.44%) |
1/109 (0.92%) |
0/23 (0.00%) |
0/52 (0.00%) |
1/18 (5.56%) |
1/57 (1.75%) |
Retinal vascular disorder |
1/41 (2.44%) |
0/109 (0.00%) |
0/23 (0.00%) |
0/52 (0.00%) |
1/18 (5.56%) |
0/57 (0.00%) |
Vision blurred |
2/41 (4.88%) |
0/109 (0.00%) |
1/23 (4.35%) |
0/52 (0.00%) |
1/18 (5.56%) |
0/57 (0.00%) |
Gastrointestinal disorders |
|
|
|
|
|
|
Abdominal pain |
4/41 (9.76%) |
7/109 (6.42%) |
2/23 (8.70%) |
4/52 (7.69%) |
2/18 (11.11%) |
3/57 (5.26%) |
Abdominal pain upper |
2/41 (4.88%) |
5/109 (4.59%) |
2/23 (8.70%) |
2/52 (3.85%) |
0/18 (0.00%) |
3/57 (5.26%) |
Constipation |
1/41 (2.44%) |
0/109 (0.00%) |
0/23 (0.00%) |
0/52 (0.00%) |
1/18 (5.56%) |
0/57 (0.00%) |
Diarrhoea |
2/41 (4.88%) |
8/109 (7.34%) |
1/23 (4.35%) |
5/52 (9.62%) |
1/18 (5.56%) |
3/57 (5.26%) |
Nausea |
2/41 (4.88%) |
3/109 (2.75%) |
2/23 (8.70%) |
2/52 (3.85%) |
0/18 (0.00%) |
1/57 (1.75%) |
Toothache |
3/41 (7.32%) |
1/109 (0.92%) |
2/23 (8.70%) |
0/52 (0.00%) |
1/18 (5.56%) |
1/57 (1.75%) |
Vomiting |
5/41 (12.20%) |
4/109 (3.67%) |
4/23 (17.39%) |
3/52 (5.77%) |
1/18 (5.56%) |
1/57 (1.75%) |
General disorders |
|
|
|
|
|
|
Asthenia |
2/41 (4.88%) |
1/109 (0.92%) |
1/23 (4.35%) |
0/52 (0.00%) |
1/18 (5.56%) |
1/57 (1.75%) |
Chest pain |
1/41 (2.44%) |
0/109 (0.00%) |
0/23 (0.00%) |
0/52 (0.00%) |
1/18 (5.56%) |
0/57 (0.00%) |
Pyrexia |
12/41 (29.27%) |
18/109 (16.51%) |
8/23 (34.78%) |
12/52 (23.08%) |
4/18 (22.22%) |
6/57 (10.53%) |
Infections and infestations |
|
|
|
|
|
|
Acarodermatitis |
1/41 (2.44%) |
1/109 (0.92%) |
0/23 (0.00%) |
1/52 (1.92%) |
1/18 (5.56%) |
0/57 (0.00%) |
Enterobiasis |
1/41 (2.44%) |
1/109 (0.92%) |
0/23 (0.00%) |
0/52 (0.00%) |
1/18 (5.56%) |
1/57 (1.75%) |
Influenza |
3/41 (7.32%) |
1/109 (0.92%) |
1/23 (4.35%) |
0/52 (0.00%) |
2/18 (11.11%) |
1/57 (1.75%) |
Mycoplasma infection |
1/41 (2.44%) |
0/109 (0.00%) |
0/23 (0.00%) |
0/52 (0.00%) |
1/18 (5.56%) |
0/57 (0.00%) |
Nasopharyngitis |
11/41 (26.83%) |
22/109 (20.18%) |
7/23 (30.43%) |
14/52 (26.92%) |
4/18 (22.22%) |
8/57 (14.04%) |
Pharyngitis |
2/41 (4.88%) |
0/109 (0.00%) |
2/23 (8.70%) |
0/52 (0.00%) |
0/18 (0.00%) |
0/57 (0.00%) |
Respiratory tract infection |
2/41 (4.88%) |
4/109 (3.67%) |
1/23 (4.35%) |
0/52 (0.00%) |
1/18 (5.56%) |
4/57 (7.02%) |
Rhinitis |
0/41 (0.00%) |
3/109 (2.75%) |
0/23 (0.00%) |
0/52 (0.00%) |
0/18 (0.00%) |
3/57 (5.26%) |
Upper respiratory tract infection |
2/41 (4.88%) |
17/109 (15.60%) |
1/23 (4.35%) |
12/52 (23.08%) |
1/18 (5.56%) |
5/57 (8.77%) |
Urinary tract infection |
2/41 (4.88%) |
3/109 (2.75%) |
2/23 (8.70%) |
2/52 (3.85%) |
0/18 (0.00%) |
1/57 (1.75%) |
Metabolism and nutrition disorders |
|
|
|
|
|
|
Hyperkalaemia |
1/41 (2.44%) |
4/109 (3.67%) |
1/23 (4.35%) |
4/52 (7.69%) |
0/18 (0.00%) |
0/57 (0.00%) |
Hyperphosphataemia |
1/41 (2.44%) |
0/109 (0.00%) |
0/23 (0.00%) |
0/52 (0.00%) |
1/18 (5.56%) |
0/57 (0.00%) |
Musculoskeletal and connective tissue disorders |
|
|
|
|
|
|
Back pain |
1/41 (2.44%) |
4/109 (3.67%) |
1/23 (4.35%) |
3/52 (5.77%) |
0/18 (0.00%) |
1/57 (1.75%) |
Neck pain |
2/41 (4.88%) |
0/109 (0.00%) |
0/23 (0.00%) |
0/52 (0.00%) |
2/18 (11.11%) |
0/57 (0.00%) |
Pain in extremity |
3/41 (7.32%) |
0/109 (0.00%) |
2/23 (8.70%) |
0/52 (0.00%) |
1/18 (5.56%) |
0/57 (0.00%) |
Nervous system disorders |
|
|
|
|
|
|
Dizziness |
8/41 (19.51%) |
17/109 (15.60%) |
4/23 (17.39%) |
6/52 (11.54%) |
4/18 (22.22%) |
11/57 (19.30%) |
Headache |
14/41 (34.15%) |
23/109 (21.10%) |
8/23 (34.78%) |
11/52 (21.15%) |
6/18 (33.33%) |
12/57 (21.05%) |
Hypoaesthesia |
1/41 (2.44%) |
1/109 (0.92%) |
0/23 (0.00%) |
1/52 (1.92%) |
1/18 (5.56%) |
0/57 (0.00%) |
Renal and urinary disorders |
|
|
|
|
|
|
Micturition urgency |
1/41 (2.44%) |
1/109 (0.92%) |
0/23 (0.00%) |
0/52 (0.00%) |
1/18 (5.56%) |
1/57 (1.75%) |
Respiratory, thoracic and mediastinal disorders |
|
|
|
|
|
|
Cough |
18/41 (43.90%) |
18/109 (16.51%) |
12/23 (52.17%) |
12/52 (23.08%) |
6/18 (33.33%) |
6/57 (10.53%) |
Dyspnoea |
1/41 (2.44%) |
2/109 (1.83%) |
0/23 (0.00%) |
2/52 (3.85%) |
1/18 (5.56%) |
0/57 (0.00%) |
Epistaxis |
2/41 (4.88%) |
1/109 (0.92%) |
1/23 (4.35%) |
0/52 (0.00%) |
1/18 (5.56%) |
1/57 (1.75%) |
Nasal congestion |
3/41 (7.32%) |
1/109 (0.92%) |
1/23 (4.35%) |
1/52 (1.92%) |
2/18 (11.11%) |
0/57 (0.00%) |
Oropharyngeal pain |
2/41 (4.88%) |
2/109 (1.83%) |
1/23 (4.35%) |
1/52 (1.92%) |
1/18 (5.56%) |
1/57 (1.75%) |
Rhinitis allergic |
2/41 (4.88%) |
0/109 (0.00%) |
1/23 (4.35%) |
0/52 (0.00%) |
1/18 (5.56%) |
0/57 (0.00%) |
Rhinorrhoea |
4/41 (9.76%) |
3/109 (2.75%) |
3/23 (13.04%) |
2/52 (3.85%) |
1/18 (5.56%) |
1/57 (1.75%) |
Skin and subcutaneous tissue disorders |
|
|
|
|
|
|
Acne |
1/41 (2.44%) |
2/109 (1.83%) |
0/23 (0.00%) |
1/52 (1.92%) |
1/18 (5.56%) |
1/57 (1.75%) |
Papule |
1/41 (2.44%) |
0/109 (0.00%) |
0/23 (0.00%) |
0/52 (0.00%) |
1/18 (5.56%) |
0/57 (0.00%) |
Pruritus |
0/41 (0.00%) |
3/109 (2.75%) |
0/23 (0.00%) |
3/52 (5.77%) |
0/18 (0.00%) |
0/57 (0.00%) |
Vascular disorders |
|
|
|
|
|
|
Hypertension |
1/41 (2.44%) |
0/109 (0.00%) |
0/23 (0.00%) |
0/52 (0.00%) |
1/18 (5.56%) |
0/57 (0.00%) |
Hypotension |
2/41 (4.88%) |
2/109 (1.83%) |
2/23 (8.70%) |
2/52 (3.85%) |
0/18 (0.00%) |
0/57 (0.00%) |
Pallor |
1/41 (2.44%) |
0/109 (0.00%) |
0/23 (0.00%) |
0/52 (0.00%) |
1/18 (5.56%) |
0/57 (0.00%) |
Indicates events were collected by systematic assessment
Term from vocabulary, MedDRA 18.1
|