Trial Outcomes & Findings for Phase IIA Study of the HDAC Inhibitor ITF2357 in Patients With JAK-2 V617F Positive Chronic Myeloproliferative Diseases (NCT NCT00606307)
NCT ID: NCT00606307
Last Updated: 2019-12-03
Results Overview
Patients with Objective Response were defined as those patients achieving a complete, major, moderate or minor (only for Myelofibrosis patients) response during the experimental treatment course. The "best response" is reported hereunder by intensity of response.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
29 participants
Primary outcome timeframe
Every single week from week 1 to week 24 of treatment
Results posted on
2019-12-03
Participant Flow
Participant milestones
| Measure |
ITF2357
Initial dose of 50 mg b.i.d. that was subsequently escalated to 50 mg t.i.d in case of lack of significant toxicity.
ITF2357: 50 mg b.i.d. PO every day. More precisely, ITF2357 was supplied as 50 mg hard gelatine capsules for oral administration.
|
|---|---|
|
Overall Study
STARTED
|
29
|
|
Overall Study
COMPLETED
|
18
|
|
Overall Study
NOT COMPLETED
|
11
|
Reasons for withdrawal
| Measure |
ITF2357
Initial dose of 50 mg b.i.d. that was subsequently escalated to 50 mg t.i.d in case of lack of significant toxicity.
ITF2357: 50 mg b.i.d. PO every day. More precisely, ITF2357 was supplied as 50 mg hard gelatine capsules for oral administration.
|
|---|---|
|
Overall Study
Adverse Event
|
2
|
|
Overall Study
Withdrawal by Subject
|
2
|
|
Overall Study
Disease progression
|
6
|
|
Overall Study
QTc prolongation
|
1
|
Baseline Characteristics
Phase IIA Study of the HDAC Inhibitor ITF2357 in Patients With JAK-2 V617F Positive Chronic Myeloproliferative Diseases
Baseline characteristics by cohort
| Measure |
ITF2357
n=29 Participants
Initial dose of 50 mg b.i.d. that was subsequently escalated to 50 mg t.i.d in case of lack of significant toxicity.
ITF2357: 50 mg b.i.d. PO every day. More precisely, ITF2357 was supplied as 50 mg hard gelatine capsules for oral administration.
|
|---|---|
|
Age, Continuous
|
55.6 years
STANDARD_DEVIATION 10.7 • n=5 Participants
|
|
Sex: Female, Male
Female
|
14.0 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
15.0 Participants
n=5 Participants
|
|
Region of Enrollment
Italy
|
29 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Every single week from week 1 to week 24 of treatmentPopulation: ITT population: all recruited patients who received study medication and for whom at least one on-study tumour evaluation is available.
Patients with Objective Response were defined as those patients achieving a complete, major, moderate or minor (only for Myelofibrosis patients) response during the experimental treatment course. The "best response" is reported hereunder by intensity of response.
Outcome measures
| Measure |
ITF2357
n=29 Participants
Initial dose of 50 mg b.i.d. that was subsequently escalated to 50 mg t.i.d in case of lack of significant toxicity.
ITF2357: 50 mg b.i.d. PO every day. More precisely, ITF2357 was supplied as 50 mg hard gelatine capsules for oral administration.
|
|---|---|
|
Number of Patients With Objective Responses (Complete, Major, Moderate or Minor Responses), in Terms of Best Overall Response
complete responders
|
2 Participants
|
|
Number of Patients With Objective Responses (Complete, Major, Moderate or Minor Responses), in Terms of Best Overall Response
major responders
|
12 Participants
|
|
Number of Patients With Objective Responses (Complete, Major, Moderate or Minor Responses), in Terms of Best Overall Response
moderate responders
|
2 Participants
|
|
Number of Patients With Objective Responses (Complete, Major, Moderate or Minor Responses), in Terms of Best Overall Response
minor responders
|
1 Participants
|
|
Number of Patients With Objective Responses (Complete, Major, Moderate or Minor Responses), in Terms of Best Overall Response
non responders
|
12 Participants
|
SECONDARY outcome
Timeframe: At screening, at week 12, at week 24, at the end of treatment (EOT) visitPopulation: Intent-to-treat population: all recruited patients who received study medication and for whom at least one on-study tumour evaluation is available.
This outcome was assessed by quantitative real time Polymerase Chain Reaction (RT PCR). At each time point, the number of patients is the following: Screening: N=29 Week 12: N=20 Week 24: N=18 EOT: N=24. End of treatment corresponds to the last visit performed before treatment discontinuation.
Outcome measures
| Measure |
ITF2357
n=29 Participants
Initial dose of 50 mg b.i.d. that was subsequently escalated to 50 mg t.i.d in case of lack of significant toxicity.
ITF2357: 50 mg b.i.d. PO every day. More precisely, ITF2357 was supplied as 50 mg hard gelatine capsules for oral administration.
|
|---|---|
|
Change in JAK2 Mutated Allele Burden
screening
|
54.0 percentage of change in allele burden
Standard Deviation 19.7
|
|
Change in JAK2 Mutated Allele Burden
week 12
|
49.4 percentage of change in allele burden
Standard Deviation 20.1
|
|
Change in JAK2 Mutated Allele Burden
week 24
|
47.1 percentage of change in allele burden
Standard Deviation 20.0
|
|
Change in JAK2 Mutated Allele Burden
EOT
|
49.0 percentage of change in allele burden
Standard Deviation 21.5
|
SECONDARY outcome
Timeframe: At weekly visits (Days 8, 15, 22, 36, 43, 50, 64, 71, 78, 99, 127, 155); At monthly visits (Days 29, 57, 85 113, 141,169); at end of treatment visitPopulation: safety population: all recruited patients who received at least one dose of the study medication.
An adverse event (AE) is any untoward occurrence in a patient or clinical investigation subject administered with a pharmaceutical product and which does not necessarily have to have a causal relationship with the treatment. An AE can therefore be any unfavourable and unintended sign, symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. The adverse events must to be followed to the end of study (28 days after the last study drug intake). A serious AE (SAE) is defined as an untoward (unfavourable) medical occurrence that at any dose results in death, or is life-threatening or requires inpatient hospitalisation or prolongation of existing hospitalisation, or results in persistent or significant disability/incapacity or is a congenital anomaly/birth defect.
Outcome measures
| Measure |
ITF2357
n=29 Participants
Initial dose of 50 mg b.i.d. that was subsequently escalated to 50 mg t.i.d in case of lack of significant toxicity.
ITF2357: 50 mg b.i.d. PO every day. More precisely, ITF2357 was supplied as 50 mg hard gelatine capsules for oral administration.
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|---|---|
|
Number of Subject Experiencing an Adverse Event
number of patients with AE
|
29 Participants
|
|
Number of Subject Experiencing an Adverse Event
number of patients with serious AE
|
3 Participants
|
Adverse Events
ITF2357
Serious events: 3 serious events
Other events: 29 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
ITF2357
n=29 participants at risk
Initial dose of 50 mg b.i.d. that was subsequently escalated to 50 mg t.i.d in case of lack of significant toxicity.
ITF2357: 50 mg b.i.d. PO every day. More precisely, ITF2357 was supplied as 50 mg hard gelatine capsules for oral administration.
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|---|---|
|
Infections and infestations
Cellulitis
|
3.4%
1/29 • Number of events 1 • At weekly visits (Days 8, 15, 22, 36, 43, 50, 64, 71, 78, 99, 127, 155); At monthly visits (Days 29, 57, 85 113, 141,169); at three-monthly visit (Day 85)
|
|
Infections and infestations
Localised infection
|
3.4%
1/29 • Number of events 1 • At weekly visits (Days 8, 15, 22, 36, 43, 50, 64, 71, 78, 99, 127, 155); At monthly visits (Days 29, 57, 85 113, 141,169); at three-monthly visit (Day 85)
|
|
Gastrointestinal disorders
Melena
|
3.4%
1/29 • Number of events 1 • At weekly visits (Days 8, 15, 22, 36, 43, 50, 64, 71, 78, 99, 127, 155); At monthly visits (Days 29, 57, 85 113, 141,169); at three-monthly visit (Day 85)
|
|
General disorders
Disease progression
|
3.4%
1/29 • Number of events 1 • At weekly visits (Days 8, 15, 22, 36, 43, 50, 64, 71, 78, 99, 127, 155); At monthly visits (Days 29, 57, 85 113, 141,169); at three-monthly visit (Day 85)
|
Other adverse events
| Measure |
ITF2357
n=29 participants at risk
Initial dose of 50 mg b.i.d. that was subsequently escalated to 50 mg t.i.d in case of lack of significant toxicity.
ITF2357: 50 mg b.i.d. PO every day. More precisely, ITF2357 was supplied as 50 mg hard gelatine capsules for oral administration.
|
|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
20.7%
6/29 • Number of events 6 • At weekly visits (Days 8, 15, 22, 36, 43, 50, 64, 71, 78, 99, 127, 155); At monthly visits (Days 29, 57, 85 113, 141,169); at three-monthly visit (Day 85)
|
|
Blood and lymphatic system disorders
Leukopenia
|
3.4%
1/29 • Number of events 1 • At weekly visits (Days 8, 15, 22, 36, 43, 50, 64, 71, 78, 99, 127, 155); At monthly visits (Days 29, 57, 85 113, 141,169); at three-monthly visit (Day 85)
|
|
Blood and lymphatic system disorders
Neutropenia
|
3.4%
1/29 • Number of events 1 • At weekly visits (Days 8, 15, 22, 36, 43, 50, 64, 71, 78, 99, 127, 155); At monthly visits (Days 29, 57, 85 113, 141,169); at three-monthly visit (Day 85)
|
|
Cardiac disorders
Thrombocytopenia
|
10.3%
3/29 • Number of events 3 • At weekly visits (Days 8, 15, 22, 36, 43, 50, 64, 71, 78, 99, 127, 155); At monthly visits (Days 29, 57, 85 113, 141,169); at three-monthly visit (Day 85)
|
|
Cardiac disorders
Palpitation
|
3.4%
1/29 • Number of events 1 • At weekly visits (Days 8, 15, 22, 36, 43, 50, 64, 71, 78, 99, 127, 155); At monthly visits (Days 29, 57, 85 113, 141,169); at three-monthly visit (Day 85)
|
|
Cardiac disorders
Tachycardia
|
3.4%
1/29 • Number of events 1 • At weekly visits (Days 8, 15, 22, 36, 43, 50, 64, 71, 78, 99, 127, 155); At monthly visits (Days 29, 57, 85 113, 141,169); at three-monthly visit (Day 85)
|
|
Gastrointestinal disorders
Abdominal pain
|
20.7%
6/29 • Number of events 6 • At weekly visits (Days 8, 15, 22, 36, 43, 50, 64, 71, 78, 99, 127, 155); At monthly visits (Days 29, 57, 85 113, 141,169); at three-monthly visit (Day 85)
|
|
Gastrointestinal disorders
Abdominal pain upper
|
10.3%
3/29 • Number of events 3 • At weekly visits (Days 8, 15, 22, 36, 43, 50, 64, 71, 78, 99, 127, 155); At monthly visits (Days 29, 57, 85 113, 141,169); at three-monthly visit (Day 85)
|
|
Gastrointestinal disorders
Constipation
|
3.4%
1/29 • Number of events 1 • At weekly visits (Days 8, 15, 22, 36, 43, 50, 64, 71, 78, 99, 127, 155); At monthly visits (Days 29, 57, 85 113, 141,169); at three-monthly visit (Day 85)
|
|
Gastrointestinal disorders
Diarrhoea
|
62.1%
18/29 • Number of events 18 • At weekly visits (Days 8, 15, 22, 36, 43, 50, 64, 71, 78, 99, 127, 155); At monthly visits (Days 29, 57, 85 113, 141,169); at three-monthly visit (Day 85)
|
|
Gastrointestinal disorders
Dyspepsia
|
3.4%
1/29 • Number of events 1 • At weekly visits (Days 8, 15, 22, 36, 43, 50, 64, 71, 78, 99, 127, 155); At monthly visits (Days 29, 57, 85 113, 141,169); at three-monthly visit (Day 85)
|
|
Gastrointestinal disorders
Flatulence
|
3.4%
1/29 • Number of events 1 • At weekly visits (Days 8, 15, 22, 36, 43, 50, 64, 71, 78, 99, 127, 155); At monthly visits (Days 29, 57, 85 113, 141,169); at three-monthly visit (Day 85)
|
|
Gastrointestinal disorders
Gingival bleeding
|
3.4%
1/29 • Number of events 1 • At weekly visits (Days 8, 15, 22, 36, 43, 50, 64, 71, 78, 99, 127, 155); At monthly visits (Days 29, 57, 85 113, 141,169); at three-monthly visit (Day 85)
|
|
Gastrointestinal disorders
Intestinal polyp
|
3.4%
1/29 • Number of events 1 • At weekly visits (Days 8, 15, 22, 36, 43, 50, 64, 71, 78, 99, 127, 155); At monthly visits (Days 29, 57, 85 113, 141,169); at three-monthly visit (Day 85)
|
|
Gastrointestinal disorders
Nausea
|
10.3%
3/29 • Number of events 3 • At weekly visits (Days 8, 15, 22, 36, 43, 50, 64, 71, 78, 99, 127, 155); At monthly visits (Days 29, 57, 85 113, 141,169); at three-monthly visit (Day 85)
|
|
Gastrointestinal disorders
Rectal Haemorrhage
|
6.9%
2/29 • Number of events 2 • At weekly visits (Days 8, 15, 22, 36, 43, 50, 64, 71, 78, 99, 127, 155); At monthly visits (Days 29, 57, 85 113, 141,169); at three-monthly visit (Day 85)
|
|
General disorders
Vomiting
|
3.4%
1/29 • Number of events 1 • At weekly visits (Days 8, 15, 22, 36, 43, 50, 64, 71, 78, 99, 127, 155); At monthly visits (Days 29, 57, 85 113, 141,169); at three-monthly visit (Day 85)
|
|
General disorders
Asthenia
|
31.0%
9/29 • Number of events 9 • At weekly visits (Days 8, 15, 22, 36, 43, 50, 64, 71, 78, 99, 127, 155); At monthly visits (Days 29, 57, 85 113, 141,169); at three-monthly visit (Day 85)
|
|
General disorders
Chest pain
|
3.4%
1/29 • Number of events 1 • At weekly visits (Days 8, 15, 22, 36, 43, 50, 64, 71, 78, 99, 127, 155); At monthly visits (Days 29, 57, 85 113, 141,169); at three-monthly visit (Day 85)
|
|
General disorders
Chills
|
3.4%
1/29 • Number of events 1 • At weekly visits (Days 8, 15, 22, 36, 43, 50, 64, 71, 78, 99, 127, 155); At monthly visits (Days 29, 57, 85 113, 141,169); at three-monthly visit (Day 85)
|
|
General disorders
Fatigue
|
10.3%
3/29 • Number of events 3 • At weekly visits (Days 8, 15, 22, 36, 43, 50, 64, 71, 78, 99, 127, 155); At monthly visits (Days 29, 57, 85 113, 141,169); at three-monthly visit (Day 85)
|
|
Hepatobiliary disorders
Oedema peripheral
|
6.9%
2/29 • Number of events 2 • At weekly visits (Days 8, 15, 22, 36, 43, 50, 64, 71, 78, 99, 127, 155); At monthly visits (Days 29, 57, 85 113, 141,169); at three-monthly visit (Day 85)
|
|
Hepatobiliary disorders
Pyrexia
|
27.6%
8/29 • Number of events 8 • At weekly visits (Days 8, 15, 22, 36, 43, 50, 64, 71, 78, 99, 127, 155); At monthly visits (Days 29, 57, 85 113, 141,169); at three-monthly visit (Day 85)
|
|
Hepatobiliary disorders
Hypertransaminasaemia
|
6.9%
2/29 • Number of events 2 • At weekly visits (Days 8, 15, 22, 36, 43, 50, 64, 71, 78, 99, 127, 155); At monthly visits (Days 29, 57, 85 113, 141,169); at three-monthly visit (Day 85)
|
|
Hepatobiliary disorders
Portal vein thrombosis
|
3.4%
1/29 • Number of events 1 • At weekly visits (Days 8, 15, 22, 36, 43, 50, 64, 71, 78, 99, 127, 155); At monthly visits (Days 29, 57, 85 113, 141,169); at three-monthly visit (Day 85)
|
|
Infections and infestations
Bronchitis
|
3.4%
1/29 • Number of events 1 • At weekly visits (Days 8, 15, 22, 36, 43, 50, 64, 71, 78, 99, 127, 155); At monthly visits (Days 29, 57, 85 113, 141,169); at three-monthly visit (Day 85)
|
|
Infections and infestations
Cystitis
|
6.9%
2/29 • Number of events 2 • At weekly visits (Days 8, 15, 22, 36, 43, 50, 64, 71, 78, 99, 127, 155); At monthly visits (Days 29, 57, 85 113, 141,169); at three-monthly visit (Day 85)
|
|
Infections and infestations
Cystitis escherichia
|
3.4%
1/29 • Number of events 1 • At weekly visits (Days 8, 15, 22, 36, 43, 50, 64, 71, 78, 99, 127, 155); At monthly visits (Days 29, 57, 85 113, 141,169); at three-monthly visit (Day 85)
|
|
Infections and infestations
Ear infection
|
3.4%
1/29 • Number of events 1 • At weekly visits (Days 8, 15, 22, 36, 43, 50, 64, 71, 78, 99, 127, 155); At monthly visits (Days 29, 57, 85 113, 141,169); at three-monthly visit (Day 85)
|
|
Infections and infestations
Fungal infection
|
3.4%
1/29 • Number of events 1 • At weekly visits (Days 8, 15, 22, 36, 43, 50, 64, 71, 78, 99, 127, 155); At monthly visits (Days 29, 57, 85 113, 141,169); at three-monthly visit (Day 85)
|
|
Infections and infestations
Gastritis bacterial
|
3.4%
1/29 • Number of events 1 • At weekly visits (Days 8, 15, 22, 36, 43, 50, 64, 71, 78, 99, 127, 155); At monthly visits (Days 29, 57, 85 113, 141,169); at three-monthly visit (Day 85)
|
|
Infections and infestations
Gastroenteritis
|
3.4%
1/29 • Number of events 1 • At weekly visits (Days 8, 15, 22, 36, 43, 50, 64, 71, 78, 99, 127, 155); At monthly visits (Days 29, 57, 85 113, 141,169); at three-monthly visit (Day 85)
|
|
Infections and infestations
Influenza
|
17.2%
5/29 • Number of events 5 • At weekly visits (Days 8, 15, 22, 36, 43, 50, 64, 71, 78, 99, 127, 155); At monthly visits (Days 29, 57, 85 113, 141,169); at three-monthly visit (Day 85)
|
|
Infections and infestations
Oral candidiasis
|
3.4%
1/29 • Number of events 1 • At weekly visits (Days 8, 15, 22, 36, 43, 50, 64, 71, 78, 99, 127, 155); At monthly visits (Days 29, 57, 85 113, 141,169); at three-monthly visit (Day 85)
|
|
Infections and infestations
Pneumonia
|
3.4%
1/29 • Number of events 1 • At weekly visits (Days 8, 15, 22, 36, 43, 50, 64, 71, 78, 99, 127, 155); At monthly visits (Days 29, 57, 85 113, 141,169); at three-monthly visit (Day 85)
|
|
Infections and infestations
Tooth infection
|
3.4%
1/29 • Number of events 1 • At weekly visits (Days 8, 15, 22, 36, 43, 50, 64, 71, 78, 99, 127, 155); At monthly visits (Days 29, 57, 85 113, 141,169); at three-monthly visit (Day 85)
|
|
Injury, poisoning and procedural complications
Injury
|
3.4%
1/29 • Number of events 1 • At weekly visits (Days 8, 15, 22, 36, 43, 50, 64, 71, 78, 99, 127, 155); At monthly visits (Days 29, 57, 85 113, 141,169); at three-monthly visit (Day 85)
|
|
Investigations
Alanine aminotransferase
|
3.4%
1/29 • Number of events 1 • At weekly visits (Days 8, 15, 22, 36, 43, 50, 64, 71, 78, 99, 127, 155); At monthly visits (Days 29, 57, 85 113, 141,169); at three-monthly visit (Day 85)
|
|
Investigations
Aspertate aminotransferase
|
3.4%
1/29 • Number of events 1 • At weekly visits (Days 8, 15, 22, 36, 43, 50, 64, 71, 78, 99, 127, 155); At monthly visits (Days 29, 57, 85 113, 141,169); at three-monthly visit (Day 85)
|
|
Investigations
Blood uric acid increased
|
3.4%
1/29 • Number of events 1 • At weekly visits (Days 8, 15, 22, 36, 43, 50, 64, 71, 78, 99, 127, 155); At monthly visits (Days 29, 57, 85 113, 141,169); at three-monthly visit (Day 85)
|
|
Investigations
Electrocardiogram QT prolonged
|
17.2%
5/29 • Number of events 5 • At weekly visits (Days 8, 15, 22, 36, 43, 50, 64, 71, 78, 99, 127, 155); At monthly visits (Days 29, 57, 85 113, 141,169); at three-monthly visit (Day 85)
|
|
Investigations
Weight decreased
|
41.4%
12/29 • Number of events 12 • At weekly visits (Days 8, 15, 22, 36, 43, 50, 64, 71, 78, 99, 127, 155); At monthly visits (Days 29, 57, 85 113, 141,169); at three-monthly visit (Day 85)
|
|
Metabolism and nutrition disorders
Anorexia
|
6.9%
2/29 • Number of events 2 • At weekly visits (Days 8, 15, 22, 36, 43, 50, 64, 71, 78, 99, 127, 155); At monthly visits (Days 29, 57, 85 113, 141,169); at three-monthly visit (Day 85)
|
|
Metabolism and nutrition disorders
Hyperkalaemia
|
3.4%
1/29 • Number of events 1 • At weekly visits (Days 8, 15, 22, 36, 43, 50, 64, 71, 78, 99, 127, 155); At monthly visits (Days 29, 57, 85 113, 141,169); at three-monthly visit (Day 85)
|
|
Metabolism and nutrition disorders
Hypertriglyceridaemia
|
3.4%
1/29 • Number of events 1 • At weekly visits (Days 8, 15, 22, 36, 43, 50, 64, 71, 78, 99, 127, 155); At monthly visits (Days 29, 57, 85 113, 141,169); at three-monthly visit (Day 85)
|
|
Metabolism and nutrition disorders
Hyperuricaemia
|
6.9%
2/29 • Number of events 2 • At weekly visits (Days 8, 15, 22, 36, 43, 50, 64, 71, 78, 99, 127, 155); At monthly visits (Days 29, 57, 85 113, 141,169); at three-monthly visit (Day 85)
|
|
Metabolism and nutrition disorders
Hypocalcaemia
|
3.4%
1/29 • Number of events 1 • At weekly visits (Days 8, 15, 22, 36, 43, 50, 64, 71, 78, 99, 127, 155); At monthly visits (Days 29, 57, 85 113, 141,169); at three-monthly visit (Day 85)
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
10.3%
3/29 • Number of events 3 • At weekly visits (Days 8, 15, 22, 36, 43, 50, 64, 71, 78, 99, 127, 155); At monthly visits (Days 29, 57, 85 113, 141,169); at three-monthly visit (Day 85)
|
|
Musculoskeletal and connective tissue disorders
Muscoloskeletal pain
|
6.9%
2/29 • Number of events 2 • At weekly visits (Days 8, 15, 22, 36, 43, 50, 64, 71, 78, 99, 127, 155); At monthly visits (Days 29, 57, 85 113, 141,169); at three-monthly visit (Day 85)
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
3.4%
1/29 • Number of events 1 • At weekly visits (Days 8, 15, 22, 36, 43, 50, 64, 71, 78, 99, 127, 155); At monthly visits (Days 29, 57, 85 113, 141,169); at three-monthly visit (Day 85)
|
|
Nervous system disorders
Dizziness
|
3.4%
1/29 • Number of events 1 • At weekly visits (Days 8, 15, 22, 36, 43, 50, 64, 71, 78, 99, 127, 155); At monthly visits (Days 29, 57, 85 113, 141,169); at three-monthly visit (Day 85)
|
|
Nervous system disorders
Headache
|
3.4%
1/29 • Number of events 1 • At weekly visits (Days 8, 15, 22, 36, 43, 50, 64, 71, 78, 99, 127, 155); At monthly visits (Days 29, 57, 85 113, 141,169); at three-monthly visit (Day 85)
|
|
Nervous system disorders
Neurological symptom
|
3.4%
1/29 • Number of events 1 • At weekly visits (Days 8, 15, 22, 36, 43, 50, 64, 71, 78, 99, 127, 155); At monthly visits (Days 29, 57, 85 113, 141,169); at three-monthly visit (Day 85)
|
|
Nervous system disorders
Paraesthesia
|
10.3%
3/29 • Number of events 3 • At weekly visits (Days 8, 15, 22, 36, 43, 50, 64, 71, 78, 99, 127, 155); At monthly visits (Days 29, 57, 85 113, 141,169); at three-monthly visit (Day 85)
|
|
Renal and urinary disorders
Peripheral sensory neuropathy
|
3.4%
1/29 • Number of events 1 • At weekly visits (Days 8, 15, 22, 36, 43, 50, 64, 71, 78, 99, 127, 155); At monthly visits (Days 29, 57, 85 113, 141,169); at three-monthly visit (Day 85)
|
|
Renal and urinary disorders
sciatica
|
3.4%
1/29 • Number of events 1 • At weekly visits (Days 8, 15, 22, 36, 43, 50, 64, 71, 78, 99, 127, 155); At monthly visits (Days 29, 57, 85 113, 141,169); at three-monthly visit (Day 85)
|
|
Renal and urinary disorders
Renal failure
|
3.4%
1/29 • Number of events 1 • At weekly visits (Days 8, 15, 22, 36, 43, 50, 64, 71, 78, 99, 127, 155); At monthly visits (Days 29, 57, 85 113, 141,169); at three-monthly visit (Day 85)
|
|
Reproductive system and breast disorders
Breast discomfort
|
3.4%
1/29 • Number of events 1 • At weekly visits (Days 8, 15, 22, 36, 43, 50, 64, 71, 78, 99, 127, 155); At monthly visits (Days 29, 57, 85 113, 141,169); at three-monthly visit (Day 85)
|
|
Respiratory, thoracic and mediastinal disorders
Gynaecomastia
|
3.4%
1/29 • Number of events 1 • At weekly visits (Days 8, 15, 22, 36, 43, 50, 64, 71, 78, 99, 127, 155); At monthly visits (Days 29, 57, 85 113, 141,169); at three-monthly visit (Day 85)
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
3.4%
1/29 • Number of events 1 • At weekly visits (Days 8, 15, 22, 36, 43, 50, 64, 71, 78, 99, 127, 155); At monthly visits (Days 29, 57, 85 113, 141,169); at three-monthly visit (Day 85)
|
|
Skin and subcutaneous tissue disorders
Erythema
|
6.9%
2/29 • Number of events 2 • At weekly visits (Days 8, 15, 22, 36, 43, 50, 64, 71, 78, 99, 127, 155); At monthly visits (Days 29, 57, 85 113, 141,169); at three-monthly visit (Day 85)
|
|
Surgical and medical procedures
Pruritus
|
10.3%
3/29 • Number of events 3 • At weekly visits (Days 8, 15, 22, 36, 43, 50, 64, 71, 78, 99, 127, 155); At monthly visits (Days 29, 57, 85 113, 141,169); at three-monthly visit (Day 85)
|
|
Surgical and medical procedures
Rush
|
6.9%
2/29 • Number of events 2 • At weekly visits (Days 8, 15, 22, 36, 43, 50, 64, 71, 78, 99, 127, 155); At monthly visits (Days 29, 57, 85 113, 141,169); at three-monthly visit (Day 85)
|
|
Surgical and medical procedures
Astringent therapy
|
3.4%
1/29 • Number of events 1 • At weekly visits (Days 8, 15, 22, 36, 43, 50, 64, 71, 78, 99, 127, 155); At monthly visits (Days 29, 57, 85 113, 141,169); at three-monthly visit (Day 85)
|
|
Vascular disorders
Angiopathy
|
3.4%
1/29 • Number of events 1 • At weekly visits (Days 8, 15, 22, 36, 43, 50, 64, 71, 78, 99, 127, 155); At monthly visits (Days 29, 57, 85 113, 141,169); at three-monthly visit (Day 85)
|
|
Vascular disorders
Erythromelalgia
|
3.4%
1/29 • Number of events 1 • At weekly visits (Days 8, 15, 22, 36, 43, 50, 64, 71, 78, 99, 127, 155); At monthly visits (Days 29, 57, 85 113, 141,169); at three-monthly visit (Day 85)
|
|
Vascular disorders
Hypertension
|
3.4%
1/29 • Number of events 1 • At weekly visits (Days 8, 15, 22, 36, 43, 50, 64, 71, 78, 99, 127, 155); At monthly visits (Days 29, 57, 85 113, 141,169); at three-monthly visit (Day 85)
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place