Trial Outcomes & Findings for Safety and Efficacy of Deferasirox in Patients With Transfusion Dependent Iron Overload - a Non-comparative Extension Study (NCT NCT01033747)
NCT ID: NCT01033747
Last Updated: 2011-08-11
Results Overview
The mean percentage change in liver iron content (LIC) as assessed by superconducting quantum interference device (SQUID) was evaluated by comparing the LIC at the start of Deferasirox treatment to the LIC at the end of the 5 year extension study for participants who were treated with Deferasirox for more than 3.5 years. LIC is expressed in milligrams of iron per gram of liver dry weight (mgFe/g dw). Relative change = 1- (Change in LIC from Baseline/Baseline level) x 100.
Recruitment status
COMPLETED
Study phase
PHASE2/PHASE3
Target enrollment
70 participants
Primary outcome timeframe
Baseline to 7 Years
Results posted on
2011-08-11
Participant Flow
This 5 year extension study includes participants treated in one or more studies: a 1 year main study to evaluate the safety,tolerability and the effects of 2 doses of deferasirox on liver iron content in comparison to standard chelation therapy with DFO, a 3 week food effect sub-study and a 12-21 month prolongation phase(NCT00379483).
Participant milestones
| Measure |
Deferasirox
Deferasirox group consists of all participants who were initially randomized to 10 mg/kg or 20 mg/kg deferasirox orally daily in the main study and remained on deferasirox treatment during the comparative prolongation study (NCT00379483) and at the beginning of the 5-year non-comparative extension study
|
Deferasirox Crossover
Deferasirox Crossover group consists of participants who were initially randomized to 40 mg/kg/day deferoxamine (DFO) subcutaneously in the main study and comparative prolongation study and crossed over to 5 mg to 30 mg/kg/day deferasirox orally daily at the beginning of the 5-year non-comparative extension study
|
|---|---|---|
|
Overall Study
STARTED
|
51
|
19
|
|
Overall Study
COMPLETED
|
14
|
4
|
|
Overall Study
NOT COMPLETED
|
37
|
15
|
Reasons for withdrawal
| Measure |
Deferasirox
Deferasirox group consists of all participants who were initially randomized to 10 mg/kg or 20 mg/kg deferasirox orally daily in the main study and remained on deferasirox treatment during the comparative prolongation study (NCT00379483) and at the beginning of the 5-year non-comparative extension study
|
Deferasirox Crossover
Deferasirox Crossover group consists of participants who were initially randomized to 40 mg/kg/day deferoxamine (DFO) subcutaneously in the main study and comparative prolongation study and crossed over to 5 mg to 30 mg/kg/day deferasirox orally daily at the beginning of the 5-year non-comparative extension study
|
|---|---|---|
|
Overall Study
Adverse Event
|
9
|
4
|
|
Overall Study
Abnormal Laboratory Value
|
1
|
0
|
|
Overall Study
Abnormal test procedure
|
0
|
1
|
|
Overall Study
Unsatisfactory therapeutic effect
|
14
|
4
|
|
Overall Study
Protocol Violation
|
1
|
0
|
|
Overall Study
Withdrawal by Subject
|
9
|
6
|
|
Overall Study
Stopped at end of prolongation visit 1
|
1
|
0
|
|
Overall Study
Stopped at end of Extension 1
|
2
|
0
|
Baseline Characteristics
Safety and Efficacy of Deferasirox in Patients With Transfusion Dependent Iron Overload - a Non-comparative Extension Study
Baseline characteristics by cohort
| Measure |
Deferasirox
n=51 Participants
Deferasirox group consists of all participants who were initially randomized to 10 mg/kg or 20 mg/kg deferasirox orally daily in the main study and remained on deferasirox treatment during the comparative prolongation study (NCT00379483) and at the beginning of the 5-year non-comparative extension study
|
Deferasirox Crossover
n=19 Participants
Deferasirox Crossover group consists of participants who were initially randomized to 40 mg/kg/day deferoxamine (DFO) subcutaneously in the main study and comparative prolongation study and crossed over to 5 mg to 30 mg/kg/day deferasirox orally daily at the beginning of the 5-year non-comparative extension study
|
Total
n=70 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age Continuous
|
24.7 years
STANDARD_DEVIATION 5.43 • n=99 Participants
|
23.8 years
STANDARD_DEVIATION 3.76 • n=107 Participants
|
24.5 years
STANDARD_DEVIATION 5.02 • n=206 Participants
|
|
Age, Customized
16 to 49
|
50 participants
n=99 Participants
|
19 participants
n=107 Participants
|
69 participants
n=206 Participants
|
|
Age, Customized
50 to 65 years
|
1 participants
n=99 Participants
|
0 participants
n=107 Participants
|
1 participants
n=206 Participants
|
|
Sex: Female, Male
Female
|
35 Participants
n=99 Participants
|
10 Participants
n=107 Participants
|
45 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
16 Participants
n=99 Participants
|
9 Participants
n=107 Participants
|
25 Participants
n=206 Participants
|
|
Region of Enrollment
Italy
|
51 participants
n=99 Participants
|
19 participants
n=107 Participants
|
70 participants
n=206 Participants
|
PRIMARY outcome
Timeframe: Baseline to 7 YearsPopulation: All participants in the full analysis set treated with deferasirox for more than 3.5 years.
The mean percentage change in liver iron content (LIC) as assessed by superconducting quantum interference device (SQUID) was evaluated by comparing the LIC at the start of Deferasirox treatment to the LIC at the end of the 5 year extension study for participants who were treated with Deferasirox for more than 3.5 years. LIC is expressed in milligrams of iron per gram of liver dry weight (mgFe/g dw). Relative change = 1- (Change in LIC from Baseline/Baseline level) x 100.
Outcome measures
| Measure |
Deferasirox
n=36 Participants
Deferasirox group consists of all participants who were initially randomized to 10 mg/kg or 20 mg/kg deferasirox orally daily in the main study and remained on deferasirox treatment during the comparative prolongation study (NCT00379483) and at the beginning of the 5-year non-comparative extension study
|
Deferasirox Crossover
n=8 Participants
Deferasirox Crossover group consists of participants who were initially randomized to 40 mg/kg/day deferoxamine (DFO) subcutaneously in the main study and comparative prolongation study and crossed over to 5 mg to 30 mg/kg/day deferasirox orally daily at the beginning of the 5-year non-comparative extension study
|
|---|---|---|
|
The Relative Change From Baseline in Liver Iron Content (LIC) After Prolonged Use of Deferasirox
|
-21.9 Percent change
Full Range 47.11 • Interval -97.1 to 124.6
|
-23.1 Percent change
Full Range 33.38 • Interval -62.2 to 18.8
|
SECONDARY outcome
Timeframe: Baseline to 3.5 yearsPopulation: All participants comprised of the full analysis set were evaluated for the change in serum ferritin.
The mean percentage change in serum ferritin was evaluated by comparing the serum ferritin level at the start of Deferasirox treatment to the serum ferritin level collected 18 months following the start of the extension study. Serum ferritin is measured in micrograms per Liter. Relative Change = 1- (Change in ferritin level from Baseline/Baseline level) x 100.
Outcome measures
| Measure |
Deferasirox
n=51 Participants
Deferasirox group consists of all participants who were initially randomized to 10 mg/kg or 20 mg/kg deferasirox orally daily in the main study and remained on deferasirox treatment during the comparative prolongation study (NCT00379483) and at the beginning of the 5-year non-comparative extension study
|
Deferasirox Crossover
n=19 Participants
Deferasirox Crossover group consists of participants who were initially randomized to 40 mg/kg/day deferoxamine (DFO) subcutaneously in the main study and comparative prolongation study and crossed over to 5 mg to 30 mg/kg/day deferasirox orally daily at the beginning of the 5-year non-comparative extension study
|
|---|---|---|
|
Relative Change in Serum Ferritin From Baseline to 3.5 Years
|
32.4 Percent change
Interval -68.8 to 152.7
|
33.2 Percent change
Interval -10.0 to 99.8
|
Adverse Events
Deferasirox
Serious events: 18 serious events
Other events: 50 other events
Deaths: 0 deaths
Deferasirox Crossover
Serious events: 2 serious events
Other events: 19 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Deferasirox
n=51 participants at risk
Deferasirox group consists of all participants who were initially randomized to 10 mg/kg or 20 mg/kg deferasirox orally daily in the main study and remained on the same deferasirox treatment during the comparative prolongation study(NCT00379483)and at the beginning of the 5-year non-comparative extension study
|
Deferasirox Crossover
n=19 participants at risk
Deferasirox Crossover group consists of participants who were initially randomized to 40 mg/kg/day deferoxamine (DFO)subcutaneously in the main study and comparative prolongation study and crossed over to 5 mg/kg to 30 mg/kg deferasirox orally daily at the beginning of the 5-year non-comparative extension study.
|
|---|---|---|
|
Blood and lymphatic system disorders
Extramedullary haemopoiesis
|
2.0%
1/51
|
0.00%
0/19
|
|
Cardiac disorders
Arrhythmia
|
2.0%
1/51
|
0.00%
0/19
|
|
Cardiac disorders
Atrial fibrillation
|
2.0%
1/51
|
0.00%
0/19
|
|
Gastrointestinal disorders
Abdominal pain
|
3.9%
2/51
|
0.00%
0/19
|
|
General disorders
Chest pain
|
2.0%
1/51
|
0.00%
0/19
|
|
General disorders
Oedema peripheral
|
2.0%
1/51
|
0.00%
0/19
|
|
General disorders
Pyrexia
|
2.0%
1/51
|
0.00%
0/19
|
|
Hepatobiliary disorders
Cholecystitis
|
2.0%
1/51
|
0.00%
0/19
|
|
Infections and infestations
Bacterial infection
|
2.0%
1/51
|
0.00%
0/19
|
|
Infections and infestations
Bronchitis
|
2.0%
1/51
|
0.00%
0/19
|
|
Infections and infestations
Bronchopneumonia
|
2.0%
1/51
|
0.00%
0/19
|
|
Infections and infestations
Gastroenteritis
|
0.00%
0/51
|
5.3%
1/19
|
|
Infections and infestations
Nasal abscess
|
2.0%
1/51
|
0.00%
0/19
|
|
Infections and infestations
Pyelonephritis
|
2.0%
1/51
|
0.00%
0/19
|
|
Injury, poisoning and procedural complications
Femur fracture
|
2.0%
1/51
|
0.00%
0/19
|
|
Injury, poisoning and procedural complications
Head injury
|
2.0%
1/51
|
0.00%
0/19
|
|
Injury, poisoning and procedural complications
Injury
|
2.0%
1/51
|
0.00%
0/19
|
|
Injury, poisoning and procedural complications
Neck injury
|
2.0%
1/51
|
0.00%
0/19
|
|
Injury, poisoning and procedural complications
Radius fracture
|
2.0%
1/51
|
0.00%
0/19
|
|
Injury, poisoning and procedural complications
Tendon injury
|
0.00%
0/51
|
5.3%
1/19
|
|
Investigations
Electrocardiogram QT prolonged
|
2.0%
1/51
|
0.00%
0/19
|
|
Metabolism and nutrition disorders
Diabetic ketoacidosis
|
2.0%
1/51
|
0.00%
0/19
|
|
Metabolism and nutrition disorders
Metabolic acidosis
|
2.0%
1/51
|
0.00%
0/19
|
|
Metabolism and nutrition disorders
Metabolic disorder
|
2.0%
1/51
|
0.00%
0/19
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
3.9%
2/51
|
0.00%
0/19
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
2.0%
1/51
|
0.00%
0/19
|
|
Musculoskeletal and connective tissue disorders
Bone pain
|
2.0%
1/51
|
0.00%
0/19
|
|
Musculoskeletal and connective tissue disorders
Tendon disorder
|
2.0%
1/51
|
0.00%
0/19
|
|
Nervous system disorders
Headache
|
0.00%
0/51
|
5.3%
1/19
|
|
Nervous system disorders
Monoparesis
|
2.0%
1/51
|
0.00%
0/19
|
|
Nervous system disorders
Paraesthesia
|
0.00%
0/51
|
5.3%
1/19
|
|
Pregnancy, puerperium and perinatal conditions
Pregnancy
|
2.0%
1/51
|
0.00%
0/19
|
|
Renal and urinary disorders
Renal colic
|
5.9%
3/51
|
0.00%
0/19
|
|
Respiratory, thoracic and mediastinal disorders
Asthma
|
2.0%
1/51
|
0.00%
0/19
|
|
Respiratory, thoracic and mediastinal disorders
Nasal septum deviation
|
2.0%
1/51
|
0.00%
0/19
|
|
Respiratory, thoracic and mediastinal disorders
Nasal turbinate hypertrophy
|
2.0%
1/51
|
0.00%
0/19
|
|
Surgical and medical procedures
Cholecystectomy
|
2.0%
1/51
|
0.00%
0/19
|
|
Surgical and medical procedures
Splenectomy
|
2.0%
1/51
|
0.00%
0/19
|
|
Surgical and medical procedures
Surgery
|
2.0%
1/51
|
0.00%
0/19
|
|
Vascular disorders
Thrombophlebitis
|
3.9%
2/51
|
0.00%
0/19
|
|
Vascular disorders
Venous thrombosis
|
2.0%
1/51
|
0.00%
0/19
|
Other adverse events
| Measure |
Deferasirox
n=51 participants at risk
Deferasirox group consists of all participants who were initially randomized to 10 mg/kg or 20 mg/kg deferasirox orally daily in the main study and remained on the same deferasirox treatment during the comparative prolongation study(NCT00379483)and at the beginning of the 5-year non-comparative extension study
|
Deferasirox Crossover
n=19 participants at risk
Deferasirox Crossover group consists of participants who were initially randomized to 40 mg/kg/day deferoxamine (DFO)subcutaneously in the main study and comparative prolongation study and crossed over to 5 mg/kg to 30 mg/kg deferasirox orally daily at the beginning of the 5-year non-comparative extension study.
|
|---|---|---|
|
Blood and lymphatic system disorders
Lymphadenopathy
|
5.9%
3/51
|
0.00%
0/19
|
|
Cardiac disorders
Cardiac failure
|
3.9%
2/51
|
5.3%
1/19
|
|
Cardiac disorders
Palpitations
|
13.7%
7/51
|
5.3%
1/19
|
|
Cardiac disorders
Tachycardia
|
11.8%
6/51
|
26.3%
5/19
|
|
Ear and labyrinth disorders
Ear pain
|
9.8%
5/51
|
10.5%
2/19
|
|
Ear and labyrinth disorders
Vertigo
|
17.6%
9/51
|
21.1%
4/19
|
|
Endocrine disorders
Hypogonadism
|
9.8%
5/51
|
0.00%
0/19
|
|
Eye disorders
Chalazion
|
5.9%
3/51
|
0.00%
0/19
|
|
Eye disorders
Conjunctivitis
|
5.9%
3/51
|
0.00%
0/19
|
|
Eye disorders
Conjunctivitis allergic
|
9.8%
5/51
|
10.5%
2/19
|
|
Eye disorders
Eyelid oedema
|
0.00%
0/51
|
5.3%
1/19
|
|
Eye disorders
Scotoma
|
0.00%
0/51
|
5.3%
1/19
|
|
Gastrointestinal disorders
Abdominal distension
|
2.0%
1/51
|
15.8%
3/19
|
|
Gastrointestinal disorders
Abdominal pain
|
47.1%
24/51
|
26.3%
5/19
|
|
Gastrointestinal disorders
Abdominal pain upper
|
43.1%
22/51
|
31.6%
6/19
|
|
Gastrointestinal disorders
Aphthous stomatitis
|
0.00%
0/51
|
5.3%
1/19
|
|
Gastrointestinal disorders
Colitis
|
2.0%
1/51
|
5.3%
1/19
|
|
Gastrointestinal disorders
Constipation
|
5.9%
3/51
|
21.1%
4/19
|
|
Gastrointestinal disorders
Diarrhoea
|
39.2%
20/51
|
42.1%
8/19
|
|
Gastrointestinal disorders
Dyspepsia
|
17.6%
9/51
|
10.5%
2/19
|
|
Gastrointestinal disorders
Enteritis
|
15.7%
8/51
|
15.8%
3/19
|
|
Gastrointestinal disorders
Gastritis
|
11.8%
6/51
|
10.5%
2/19
|
|
Gastrointestinal disorders
Nausea
|
37.3%
19/51
|
21.1%
4/19
|
|
Gastrointestinal disorders
Rectal prolapse
|
0.00%
0/51
|
5.3%
1/19
|
|
Gastrointestinal disorders
Toothache
|
15.7%
8/51
|
5.3%
1/19
|
|
Gastrointestinal disorders
Vomiting
|
31.4%
16/51
|
5.3%
1/19
|
|
General disorders
Asthenia
|
39.2%
20/51
|
21.1%
4/19
|
|
General disorders
Chest discomfort
|
2.0%
1/51
|
5.3%
1/19
|
|
General disorders
Chest pain
|
7.8%
4/51
|
10.5%
2/19
|
|
General disorders
Gravitational oedema
|
0.00%
0/51
|
5.3%
1/19
|
|
General disorders
Influenza like illness
|
17.6%
9/51
|
5.3%
1/19
|
|
General disorders
Oedema peripheral
|
19.6%
10/51
|
0.00%
0/19
|
|
General disorders
Pyrexia
|
60.8%
31/51
|
47.4%
9/19
|
|
Infections and infestations
Bronchitis
|
23.5%
12/51
|
5.3%
1/19
|
|
Infections and infestations
Cystitis
|
7.8%
4/51
|
10.5%
2/19
|
|
Infections and infestations
Dysentery
|
2.0%
1/51
|
5.3%
1/19
|
|
Infections and infestations
Ear infection
|
5.9%
3/51
|
10.5%
2/19
|
|
Infections and infestations
Fungal skin infection
|
3.9%
2/51
|
10.5%
2/19
|
|
Infections and infestations
Gastroenteritis
|
17.6%
9/51
|
10.5%
2/19
|
|
Infections and infestations
Hordeolum
|
5.9%
3/51
|
0.00%
0/19
|
|
Infections and infestations
Influenza
|
49.0%
25/51
|
36.8%
7/19
|
|
Infections and infestations
Localised infection
|
2.0%
1/51
|
5.3%
1/19
|
|
Infections and infestations
Nasopharyngitis
|
33.3%
17/51
|
26.3%
5/19
|
|
Infections and infestations
Oral herpes
|
5.9%
3/51
|
0.00%
0/19
|
|
Infections and infestations
Paronychia
|
0.00%
0/51
|
5.3%
1/19
|
|
Infections and infestations
Pharyngitis
|
66.7%
34/51
|
31.6%
6/19
|
|
Infections and infestations
Pharyngotonsillitis
|
3.9%
2/51
|
10.5%
2/19
|
|
Infections and infestations
Rhinitis
|
56.9%
29/51
|
36.8%
7/19
|
|
Infections and infestations
Sinusitis
|
11.8%
6/51
|
5.3%
1/19
|
|
Infections and infestations
Tonsillitis
|
13.7%
7/51
|
15.8%
3/19
|
|
Infections and infestations
Tooth abscess
|
17.6%
9/51
|
5.3%
1/19
|
|
Infections and infestations
Tooth infection
|
0.00%
0/51
|
5.3%
1/19
|
|
Infections and infestations
Tracheitis
|
11.8%
6/51
|
5.3%
1/19
|
|
Infections and infestations
Urinary tract infection
|
13.7%
7/51
|
15.8%
3/19
|
|
Infections and infestations
Vaginal infection
|
11.8%
6/51
|
0.00%
0/19
|
|
Infections and infestations
Vulvovaginal candidiasis
|
0.00%
0/51
|
5.3%
1/19
|
|
Infections and infestations
Vulvovaginal mycotic infection
|
0.00%
0/51
|
5.3%
1/19
|
|
Infections and infestations
Wound infection
|
0.00%
0/51
|
5.3%
1/19
|
|
Injury, poisoning and procedural complications
Limb injury
|
3.9%
2/51
|
5.3%
1/19
|
|
Injury, poisoning and procedural complications
Muscle strain
|
2.0%
1/51
|
5.3%
1/19
|
|
Injury, poisoning and procedural complications
Neck injury
|
0.00%
0/51
|
10.5%
2/19
|
|
Injury, poisoning and procedural complications
Pelvic fracture
|
0.00%
0/51
|
5.3%
1/19
|
|
Injury, poisoning and procedural complications
Skeletal injury
|
5.9%
3/51
|
0.00%
0/19
|
|
Injury, poisoning and procedural complications
Thermal burn
|
2.0%
1/51
|
5.3%
1/19
|
|
Injury, poisoning and procedural complications
Transfusion reaction
|
7.8%
4/51
|
5.3%
1/19
|
|
Investigations
Beta 2 microglobulin increased
|
11.8%
6/51
|
0.00%
0/19
|
|
Investigations
Beta 2 microglobulin urine increased
|
7.8%
4/51
|
0.00%
0/19
|
|
Investigations
Blood folate decreased
|
3.9%
2/51
|
5.3%
1/19
|
|
Investigations
Blood phosphorus decreased
|
0.00%
0/51
|
5.3%
1/19
|
|
Investigations
Blood thyroid stimulating hormone increased
|
0.00%
0/51
|
5.3%
1/19
|
|
Investigations
Gamma-glutamyltransferase increased
|
5.9%
3/51
|
0.00%
0/19
|
|
Investigations
Transaminases increased
|
7.8%
4/51
|
5.3%
1/19
|
|
Investigations
Vitamin C decreased
|
15.7%
8/51
|
5.3%
1/19
|
|
Investigations
Vitamin E decreased
|
7.8%
4/51
|
0.00%
0/19
|
|
Metabolism and nutrition disorders
Diabetes mellitus
|
2.0%
1/51
|
5.3%
1/19
|
|
Metabolism and nutrition disorders
Hypocalcaemia
|
3.9%
2/51
|
5.3%
1/19
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
5.9%
3/51
|
5.3%
1/19
|
|
Metabolism and nutrition disorders
Metabolic acidosis
|
0.00%
0/51
|
5.3%
1/19
|
|
Metabolism and nutrition disorders
Zinc deficiency
|
7.8%
4/51
|
5.3%
1/19
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
31.4%
16/51
|
10.5%
2/19
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
56.9%
29/51
|
47.4%
9/19
|
|
Musculoskeletal and connective tissue disorders
Bone pain
|
15.7%
8/51
|
15.8%
3/19
|
|
Musculoskeletal and connective tissue disorders
Flank pain
|
7.8%
4/51
|
0.00%
0/19
|
|
Musculoskeletal and connective tissue disorders
Muscle spasms
|
7.8%
4/51
|
5.3%
1/19
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal chest pain
|
0.00%
0/51
|
10.5%
2/19
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal pain
|
13.7%
7/51
|
0.00%
0/19
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
5.9%
3/51
|
0.00%
0/19
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
13.7%
7/51
|
0.00%
0/19
|
|
Musculoskeletal and connective tissue disorders
Osteoporosis
|
5.9%
3/51
|
15.8%
3/19
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
19.6%
10/51
|
10.5%
2/19
|
|
Musculoskeletal and connective tissue disorders
Torticollis
|
3.9%
2/51
|
5.3%
1/19
|
|
Nervous system disorders
Dizziness
|
9.8%
5/51
|
5.3%
1/19
|
|
Nervous system disorders
Headache
|
56.9%
29/51
|
47.4%
9/19
|
|
Nervous system disorders
Hypoaesthesia
|
2.0%
1/51
|
5.3%
1/19
|
|
Nervous system disorders
Paraesthesia
|
3.9%
2/51
|
15.8%
3/19
|
|
Nervous system disorders
Presyncope
|
15.7%
8/51
|
5.3%
1/19
|
|
Nervous system disorders
Sciatica
|
9.8%
5/51
|
10.5%
2/19
|
|
Psychiatric disorders
Anxiety
|
7.8%
4/51
|
0.00%
0/19
|
|
Psychiatric disorders
Depression
|
7.8%
4/51
|
0.00%
0/19
|
|
Psychiatric disorders
Insomnia
|
7.8%
4/51
|
5.3%
1/19
|
|
Renal and urinary disorders
Dysuria
|
13.7%
7/51
|
5.3%
1/19
|
|
Renal and urinary disorders
Glycosuria
|
2.0%
1/51
|
5.3%
1/19
|
|
Renal and urinary disorders
Micturition disorder
|
0.00%
0/51
|
5.3%
1/19
|
|
Renal and urinary disorders
Nephrolithiasis
|
9.8%
5/51
|
0.00%
0/19
|
|
Renal and urinary disorders
Nephropathy toxic
|
2.0%
1/51
|
10.5%
2/19
|
|
Renal and urinary disorders
Nocturia
|
0.00%
0/51
|
5.3%
1/19
|
|
Renal and urinary disorders
Pollakiuria
|
0.00%
0/51
|
10.5%
2/19
|
|
Renal and urinary disorders
Proteinuria
|
0.00%
0/51
|
5.3%
1/19
|
|
Renal and urinary disorders
Renal colic
|
13.7%
7/51
|
5.3%
1/19
|
|
Renal and urinary disorders
Renal tubular disorder
|
0.00%
0/51
|
5.3%
1/19
|
|
Renal and urinary disorders
Strangury
|
3.9%
2/51
|
5.3%
1/19
|
|
Reproductive system and breast disorders
Amenorrhoea
|
7.8%
4/51
|
5.3%
1/19
|
|
Reproductive system and breast disorders
Dysmenorrhoea
|
5.9%
3/51
|
5.3%
1/19
|
|
Reproductive system and breast disorders
Genital discharge
|
2.0%
1/51
|
5.3%
1/19
|
|
Reproductive system and breast disorders
Genital haemorrhage
|
0.00%
0/51
|
10.5%
2/19
|
|
Reproductive system and breast disorders
Pruritus genital
|
0.00%
0/51
|
5.3%
1/19
|
|
Reproductive system and breast disorders
Vulvovaginal pruritus
|
3.9%
2/51
|
5.3%
1/19
|
|
Respiratory, thoracic and mediastinal disorders
Asthma
|
5.9%
3/51
|
0.00%
0/19
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
70.6%
36/51
|
36.8%
7/19
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
2.0%
1/51
|
5.3%
1/19
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
45.1%
23/51
|
36.8%
7/19
|
|
Respiratory, thoracic and mediastinal disorders
Rhinitis allergic
|
5.9%
3/51
|
0.00%
0/19
|
|
Skin and subcutaneous tissue disorders
Erythema
|
5.9%
3/51
|
0.00%
0/19
|
|
Skin and subcutaneous tissue disorders
Koilonychia
|
0.00%
0/51
|
5.3%
1/19
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
9.8%
5/51
|
10.5%
2/19
|
|
Skin and subcutaneous tissue disorders
Rash
|
3.9%
2/51
|
15.8%
3/19
|
|
Skin and subcutaneous tissue disorders
Rash papular
|
2.0%
1/51
|
5.3%
1/19
|
|
Skin and subcutaneous tissue disorders
Skin lesion
|
5.9%
3/51
|
0.00%
0/19
|
|
Skin and subcutaneous tissue disorders
Urticaria
|
7.8%
4/51
|
0.00%
0/19
|
|
Surgical and medical procedures
Tooth extraction
|
0.00%
0/51
|
5.3%
1/19
|
|
Vascular disorders
Hypotension
|
9.8%
5/51
|
10.5%
2/19
|
Additional Information
Study Director
Novartis Pharmaceuticals
Phone: 862 778-8300
Results disclosure agreements
- Principal investigator is a sponsor employee The terms and conditions of Novartis' agreements with its investigators may vary. However, Novartis does not prohibit any investigator from publishing. Any publications from a single-site are postponed until the publication of the pooled data (i.e., data from all sites) in the clinical trial.
- Publication restrictions are in place
Restriction type: OTHER