Trial Outcomes & Findings for A Phase III Safety Study of Ferumoxytol Compared to Ferric Carboxymaltose for the Treatment of Iron Deficiency Anemia (IDA) (NCT NCT02694978)
NCT ID: NCT02694978
Last Updated: 2023-07-25
Results Overview
All IV iron formulations carry some risk of serious hypersensitivity reactions or anaphylaxis. Signs and symptoms potentially representing hypersensitivity were recorded and adjudicated by a blinded Clinical Events Committee (CEC). Hypotension is defined as a \>30% drop in systolic blood pressure from baseline or decrease of \>20 mmHg for systolic blood pressure. Statistical analysis was only performed on composite data. A summary of serious and all other non-serious adverse events regardless of causality is located in the Reported Adverse Events module.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
2014 participants
Primary outcome timeframe
Day 1 (after first dosing) through Week 5
Results posted on
2023-07-25
Participant Flow
Participants with iron deficiency anemia (IDA), \<12.0 grams (g) per deciliter (dL) for females and \<14.0 g/dL for males within 60 days of dosing and transferrin saturation (TSAT) \<20% or Ferritin ≤100 nanograms (ng) per milliliter (mL) within 60 days of dosing and a history of unsatisfactory oral iron therapy or in whom oral iron could not be used.
Participant milestones
| Measure |
Ferumoxytol
Participants received an IV infusion of ferumoxytol 510 milligram (mg) diluted (17 milliliter \[mL\]) in 233 mL 0.9% sodium chloride injection, United States Pharmacopeia (USP) (normal saline) (final volume 250 mL) over at least 15 minutes with a second dose 7-8 days after the first dose, for a total cumulative dose of 1.020 g.
|
Ferric Carboxymaltose (FCM)
Participants received an IV infusion of FCM 750 mg diluted (15 mL) in 235 mL 0.9% sodium chloride injection, USP (normal saline) (final volume 250 mL) over at least 15 minutes with a second dose 7-8 days after the first dose, for a total cumulative dose of 1.500 g.
|
|---|---|---|
|
Overall Study
STARTED
|
1006
|
1008
|
|
Overall Study
Received at Least 1 Dose of Study Drug
|
997
|
1000
|
|
Overall Study
COMPLETED
|
935
|
948
|
|
Overall Study
NOT COMPLETED
|
71
|
60
|
Reasons for withdrawal
| Measure |
Ferumoxytol
Participants received an IV infusion of ferumoxytol 510 milligram (mg) diluted (17 milliliter \[mL\]) in 233 mL 0.9% sodium chloride injection, United States Pharmacopeia (USP) (normal saline) (final volume 250 mL) over at least 15 minutes with a second dose 7-8 days after the first dose, for a total cumulative dose of 1.020 g.
|
Ferric Carboxymaltose (FCM)
Participants received an IV infusion of FCM 750 mg diluted (15 mL) in 235 mL 0.9% sodium chloride injection, USP (normal saline) (final volume 250 mL) over at least 15 minutes with a second dose 7-8 days after the first dose, for a total cumulative dose of 1.500 g.
|
|---|---|---|
|
Overall Study
Adverse Event
|
10
|
9
|
|
Overall Study
Withdrawal by Subject
|
22
|
19
|
|
Overall Study
Lost to Follow-up
|
14
|
17
|
|
Overall Study
Death
|
4
|
1
|
|
Overall Study
Other-Decision of Participant
|
6
|
1
|
|
Overall Study
Other-Investigator's decision
|
1
|
0
|
|
Overall Study
Other-Unable to be reached
|
0
|
1
|
|
Overall Study
Other-Protocol noncompliant
|
2
|
1
|
|
Overall Study
Other-Personal reasons
|
3
|
3
|
|
Overall Study
Other-Withdrew prior to dosing
|
9
|
8
|
Baseline Characteristics
A Phase III Safety Study of Ferumoxytol Compared to Ferric Carboxymaltose for the Treatment of Iron Deficiency Anemia (IDA)
Baseline characteristics by cohort
| Measure |
Ferumoxytol
n=997 Participants
Participants received an IV infusion of ferumoxytol 510 mg diluted (17 mL) in 233 mL 0.9% sodium chloride injection, USP (normal saline) (final volume 250 mL) over at least 15 minutes with a second dose 7-8 days after the first dose, for a total cumulative dose of 1.020 g.
|
Ferric Carboxymaltose (FCM)
n=1000 Participants
Participants received an IV infusion of FCM 750 mg diluted (15 mL) in 235 mL 0.9% sodium chloride injection, USP (normal saline) (final volume 250 mL) over at least 15 minutes with a second dose 7-8 days after the first dose, for a total cumulative dose of 1.500 g.
|
Total
n=1997 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
55.6 years
STANDARD_DEVIATION 17.30 • n=5 Participants
|
54.8 years
STANDARD_DEVIATION 17.02 • n=7 Participants
|
55.2 years
STANDARD_DEVIATION 17.16 • n=5 Participants
|
|
Sex: Female, Male
Female
|
743 Participants
n=5 Participants
|
776 Participants
n=7 Participants
|
1519 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
254 Participants
n=5 Participants
|
224 Participants
n=7 Participants
|
478 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Day 1 (after first dosing) through Week 5Population: The safety population included any randomized participant who received any amount of study drug. Treatment group was based on actual treatment.
All IV iron formulations carry some risk of serious hypersensitivity reactions or anaphylaxis. Signs and symptoms potentially representing hypersensitivity were recorded and adjudicated by a blinded Clinical Events Committee (CEC). Hypotension is defined as a \>30% drop in systolic blood pressure from baseline or decrease of \>20 mmHg for systolic blood pressure. Statistical analysis was only performed on composite data. A summary of serious and all other non-serious adverse events regardless of causality is located in the Reported Adverse Events module.
Outcome measures
| Measure |
Ferumoxytol
n=997 Participants
Participants received an IV infusion of ferumoxytol 510 mg diluted (17 mL) in 233 mL 0.9% sodium chloride injection, USP (normal saline) (final volume 250 mL) over at least 15 minutes with a second dose 7-8 days after the first dose, for a total cumulative dose of 1.020 g.
|
Ferric Carboxymaltose (FCM)
n=1000 Participants
Participants received an IV infusion of FCM 750 mg diluted (15 mL) in 235 mL 0.9% sodium chloride injection, USP (normal saline) (final volume 250 mL) over at least 15 minutes with a second dose 7-8 days after the first dose, for a total cumulative dose of 1.500 g.
|
|---|---|---|
|
Participants With Treatment-Emergent (TE) Moderate To Severe Hypersensitivity Reactions (Rxns), Including Anaphylaxis, Or Moderate To Severe Hypotension
Any TE moderate to severe hypersensitivity rxn
|
6 Participants
|
7 Participants
|
|
Participants With Treatment-Emergent (TE) Moderate To Severe Hypersensitivity Reactions (Rxns), Including Anaphylaxis, Or Moderate To Severe Hypotension
Moderate hypersensitivity reaction
|
3 Participants
|
6 Participants
|
|
Participants With Treatment-Emergent (TE) Moderate To Severe Hypersensitivity Reactions (Rxns), Including Anaphylaxis, Or Moderate To Severe Hypotension
Severe hypersensitivity reaction
|
1 Participants
|
0 Participants
|
|
Participants With Treatment-Emergent (TE) Moderate To Severe Hypersensitivity Reactions (Rxns), Including Anaphylaxis, Or Moderate To Severe Hypotension
Anaphylaxis
|
0 Participants
|
0 Participants
|
|
Participants With Treatment-Emergent (TE) Moderate To Severe Hypersensitivity Reactions (Rxns), Including Anaphylaxis, Or Moderate To Severe Hypotension
Moderate hypotension
|
2 Participants
|
1 Participants
|
|
Participants With Treatment-Emergent (TE) Moderate To Severe Hypersensitivity Reactions (Rxns), Including Anaphylaxis, Or Moderate To Severe Hypotension
Severe hypotension
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Day 1 (after first dosing) through Week 5Population: The safety population included any randomized participant who received any amount of study drug. Treatment group was based on actual treatment.
All IV iron formulations carry some risk of serious hypersensitivity reactions or anaphylaxis. Signs and symptoms potentially representing hypersensitivity were recorded and adjudicated by a blinded Clinical Events Committee (CEC). A summary of serious and all other non-serious adverse events regardless of causality is located in the Reported Adverse Events module.
Outcome measures
| Measure |
Ferumoxytol
n=997 Participants
Participants received an IV infusion of ferumoxytol 510 mg diluted (17 mL) in 233 mL 0.9% sodium chloride injection, USP (normal saline) (final volume 250 mL) over at least 15 minutes with a second dose 7-8 days after the first dose, for a total cumulative dose of 1.020 g.
|
Ferric Carboxymaltose (FCM)
n=1000 Participants
Participants received an IV infusion of FCM 750 mg diluted (15 mL) in 235 mL 0.9% sodium chloride injection, USP (normal saline) (final volume 250 mL) over at least 15 minutes with a second dose 7-8 days after the first dose, for a total cumulative dose of 1.500 g.
|
|---|---|---|
|
Participants With Moderate To Severe Hypersensitivity Reactions, Including Anaphylaxis, Serious Cardiovascular Events, And Death
Moderate hypersensitivity reaction
|
3 Participants
|
6 Participants
|
|
Participants With Moderate To Severe Hypersensitivity Reactions, Including Anaphylaxis, Serious Cardiovascular Events, And Death
Severe hypersensitivity reaction
|
1 Participants
|
0 Participants
|
|
Participants With Moderate To Severe Hypersensitivity Reactions, Including Anaphylaxis, Serious Cardiovascular Events, And Death
Anaphylaxis
|
0 Participants
|
0 Participants
|
|
Participants With Moderate To Severe Hypersensitivity Reactions, Including Anaphylaxis, Serious Cardiovascular Events, And Death
Serious cardiovascular event
|
6 Participants
|
13 Participants
|
|
Participants With Moderate To Severe Hypersensitivity Reactions, Including Anaphylaxis, Serious Cardiovascular Events, And Death
Death
|
4 Participants
|
2 Participants
|
|
Participants With Moderate To Severe Hypersensitivity Reactions, Including Anaphylaxis, Serious Cardiovascular Events, And Death
Any moderate to severe hypersensitivity rxn
|
13 Participants
|
20 Participants
|
SECONDARY outcome
Timeframe: Baseline (Day 1), Week 5Population: Intent-to-treat (ITT) population: any randomized participant who had any exposure to study drug, based on randomized treatment assignment.
Mean change in hemoglobin from Baseline to Week 5 was calculated for each participant as: Hemoglobin Change = Hemoglobin (Week 5) - Hemoglobin (Baseline). Baseline was defined as the Day 1 value (prior to injection of study drug). The screening or most recent value prior to Day 1 was used for any participant with missing Day 1 information.
Outcome measures
| Measure |
Ferumoxytol
n=997 Participants
Participants received an IV infusion of ferumoxytol 510 mg diluted (17 mL) in 233 mL 0.9% sodium chloride injection, USP (normal saline) (final volume 250 mL) over at least 15 minutes with a second dose 7-8 days after the first dose, for a total cumulative dose of 1.020 g.
|
Ferric Carboxymaltose (FCM)
n=1000 Participants
Participants received an IV infusion of FCM 750 mg diluted (15 mL) in 235 mL 0.9% sodium chloride injection, USP (normal saline) (final volume 250 mL) over at least 15 minutes with a second dose 7-8 days after the first dose, for a total cumulative dose of 1.500 g.
|
|---|---|---|
|
Mean Change In Hemoglobin From Baseline To Week 5
|
1.38 g/dL
Standard Deviation 1.351
|
1.63 g/dL
Standard Deviation 1.535
|
SECONDARY outcome
Timeframe: Baseline (Day 1), Week 5Population: ITT population: any randomized participant who had any exposure to study drug, based on randomized treatment assignment.
Mean change in hemoglobin per g of iron administered from Baseline (Day 1) to Week 5 was calculated for each participant as: Hemoglobin Change = Hemoglobin (Week 5) - Hemoglobin (Baseline). Baseline was defined as the Day 1 value (prior to injection of study drug). The screening or most recent value prior to Day 1 was used for any participant with missing Day 1 information.
Outcome measures
| Measure |
Ferumoxytol
n=997 Participants
Participants received an IV infusion of ferumoxytol 510 mg diluted (17 mL) in 233 mL 0.9% sodium chloride injection, USP (normal saline) (final volume 250 mL) over at least 15 minutes with a second dose 7-8 days after the first dose, for a total cumulative dose of 1.020 g.
|
Ferric Carboxymaltose (FCM)
n=1000 Participants
Participants received an IV infusion of FCM 750 mg diluted (15 mL) in 235 mL 0.9% sodium chloride injection, USP (normal saline) (final volume 250 mL) over at least 15 minutes with a second dose 7-8 days after the first dose, for a total cumulative dose of 1.500 g.
|
|---|---|---|
|
Mean Change In Hemoglobin Per Gram Of Iron Administered From Baseline To Week 5
|
1.35 g/dL
Standard Deviation 1.353
|
1.10 g/dL
Standard Deviation 1.050
|
Adverse Events
Ferumoxytol
Serious events: 36 serious events
Other events: 186 other events
Deaths: 0 deaths
Ferric Carboxymaltose (FCM)
Serious events: 35 serious events
Other events: 245 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Ferumoxytol
n=997 participants at risk
Participants received an IV infusion of ferumoxytol 510 mg diluted (17 mL) in 233 mL 0.9% sodium chloride injection, USP (normal saline) (final volume 250 mL) over at least 15 minutes with a second dose 7-8 days after the first dose, for a total cumulative dose of 1.020 g.
|
Ferric Carboxymaltose (FCM)
n=1000 participants at risk
Participants received an IV infusion of FCM 750 mg diluted (15 mL) in 235 mL 0.9% sodium chloride injection, USP (normal saline) (final volume 250 mL) over at least 15 minutes with a second dose 7-8 days after the first dose, for a total cumulative dose of 1.500 g.
|
|---|---|---|
|
Nervous system disorders
Seizure
|
0.20%
2/997
|
0.00%
0/1000
|
|
Nervous system disorders
Syncope
|
0.30%
3/997
|
0.30%
3/1000
|
|
Infections and infestations
Gastroenteritis
|
0.30%
3/997
|
0.10%
1/1000
|
|
Infections and infestations
Pneumonia
|
0.20%
2/997
|
0.00%
0/1000
|
|
Blood and lymphatic system disorders
Haemorrhagic anaemia
|
0.20%
2/997
|
0.00%
0/1000
|
|
Infections and infestations
Osteomyelitis chronic
|
0.10%
1/997
|
0.00%
0/1000
|
|
Renal and urinary disorders
Acute kidney injury
|
0.20%
2/997
|
0.00%
0/1000
|
|
Gastrointestinal disorders
Gastric ulcer haemorrhage
|
0.10%
1/997
|
0.10%
1/1000
|
|
Blood and lymphatic system disorders
Anaemia vitamin B12 deficiency
|
0.10%
1/997
|
0.00%
0/1000
|
|
Cardiac disorders
Cardiac failure congestive
|
0.10%
1/997
|
0.30%
3/1000
|
|
Cardiac disorders
Cardiorespiratory arrest
|
0.10%
1/997
|
0.00%
0/1000
|
|
Cardiac disorders
Left ventricular failure
|
0.10%
1/997
|
0.00%
0/1000
|
|
Gastrointestinal disorders
Abdominal pain
|
0.10%
1/997
|
0.00%
0/1000
|
|
Gastrointestinal disorders
Ascites
|
0.10%
1/997
|
0.00%
0/1000
|
|
Infections and infestations
Joint abscess
|
0.10%
1/997
|
0.00%
0/1000
|
|
Gastrointestinal disorders
Pancreatitis acute
|
0.10%
1/997
|
0.00%
0/1000
|
|
Immune system disorders
Anaphylactic reaction
|
0.10%
1/997
|
0.00%
0/1000
|
|
Infections and infestations
Anal abscess
|
0.10%
1/997
|
0.00%
0/1000
|
|
Infections and infestations
Cellulitis
|
0.10%
1/997
|
0.10%
1/1000
|
|
Infections and infestations
Sepsis
|
0.10%
1/997
|
0.00%
0/1000
|
|
Infections and infestations
Sepsis syndrome
|
0.10%
1/997
|
0.00%
0/1000
|
|
Injury, poisoning and procedural complications
Anastomotic ulcer
|
0.10%
1/997
|
0.00%
0/1000
|
|
Injury, poisoning and procedural complications
Intentional overdose
|
0.10%
1/997
|
0.00%
0/1000
|
|
Metabolism and nutrition disorders
Fluid overload
|
0.10%
1/997
|
0.10%
1/1000
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Adenocarcinoma of colon
|
0.10%
1/997
|
0.10%
1/1000
|
|
Nervous system disorders
Cerebrovascular accident
|
0.10%
1/997
|
0.00%
0/1000
|
|
Metabolism and nutrition disorders
Hyperkalaemia
|
0.10%
1/997
|
0.00%
0/1000
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
0.10%
1/997
|
0.00%
0/1000
|
|
Musculoskeletal and connective tissue disorders
Haemarthrosis
|
0.10%
1/997
|
0.00%
0/1000
|
|
Pregnancy, puerperium and perinatal conditions
Abortion spontaneous
|
0.13%
1/743
|
0.00%
0/776
|
|
Pregnancy, puerperium and perinatal conditions
Ectopic pregnancy
|
0.13%
1/743
|
0.00%
0/776
|
|
Psychiatric disorders
Completed suicide
|
0.10%
1/997
|
0.00%
0/1000
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
0.10%
1/997
|
0.00%
0/1000
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory distress
|
0.10%
1/997
|
0.00%
0/1000
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure
|
0.10%
1/997
|
0.00%
0/1000
|
|
Skin and subcutaneous tissue disorders
Rash maculopapular
|
0.10%
1/997
|
0.00%
0/1000
|
|
Vascular disorders
Aortic stenosis
|
0.10%
1/997
|
0.00%
0/1000
|
|
Vascular disorders
Hypertensive crisis
|
0.10%
1/997
|
0.00%
0/1000
|
|
Cardiac disorders
Angina pectoris
|
0.00%
0/997
|
0.20%
2/1000
|
|
Cardiac disorders
Atrial fibrillation
|
0.00%
0/997
|
0.20%
2/1000
|
|
Psychiatric disorders
Bipolar disorder
|
0.00%
0/997
|
0.10%
1/1000
|
|
Nervous system disorders
Restless legs syndrome
|
0.00%
0/997
|
0.10%
1/1000
|
|
Cardiac disorders
Cardiac failure
|
0.00%
0/997
|
0.10%
1/1000
|
|
Cardiac disorders
Cardiac failure chronic
|
0.00%
0/997
|
0.10%
1/1000
|
|
Gastrointestinal disorders
Gastric haemorrhage
|
0.00%
0/997
|
0.10%
1/1000
|
|
Gastrointestinal disorders
Gastroduodenal ulcer
|
0.00%
0/997
|
0.10%
1/1000
|
|
Gastrointestinal disorders
Gastrointestinal haemorrhage
|
0.00%
0/997
|
0.10%
1/1000
|
|
Gastrointestinal disorders
Impaired gastric emptying
|
0.00%
0/997
|
0.10%
1/1000
|
|
Gastrointestinal disorders
Pancreatitis chronic
|
0.00%
0/997
|
0.10%
1/1000
|
|
General disorders
Chest pain
|
0.00%
0/997
|
0.10%
1/1000
|
|
Hepatobiliary disorders
Hepatitis acute
|
0.00%
0/997
|
0.10%
1/1000
|
|
Infections and infestations
Osteomyelitis
|
0.00%
0/997
|
0.10%
1/1000
|
|
Injury, poisoning and procedural complications
Fall
|
0.00%
0/997
|
0.10%
1/1000
|
|
Injury, poisoning and procedural complications
Post-procedural haemorrhage
|
0.00%
0/997
|
0.10%
1/1000
|
|
Injury, poisoning and procedural complications
Wound dehiscence
|
0.00%
0/997
|
0.10%
1/1000
|
|
Musculoskeletal and connective tissue disorders
Arthritis
|
0.00%
0/997
|
0.10%
1/1000
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Bladder cancer
|
0.00%
0/997
|
0.10%
1/1000
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Breast cancer metastatic
|
0.00%
0/997
|
0.10%
1/1000
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastatic uterine cancer
|
0.00%
0/743
|
0.13%
1/776
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Mixed hepatocellular cholangiocarcinoma
|
0.00%
0/997
|
0.10%
1/1000
|
|
Renal and urinary disorders
End stage renal disease
|
0.00%
0/997
|
0.10%
1/1000
|
|
Renal and urinary disorders
Haematuria
|
0.00%
0/997
|
0.10%
1/1000
|
|
Respiratory, thoracic and mediastinal disorders
Asthma
|
0.00%
0/997
|
0.10%
1/1000
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
0.00%
0/997
|
0.10%
1/1000
|
|
Vascular disorders
Aortic aneurysm
|
0.00%
0/997
|
0.10%
1/1000
|
|
Vascular disorders
Hypertensive emergency
|
0.00%
0/997
|
0.10%
1/1000
|
|
Vascular disorders
Hypotension
|
0.00%
0/997
|
0.10%
1/1000
|
|
Cardiac disorders
Acute myocardial infarction
|
0.00%
0/997
|
0.10%
1/1000
|
Other adverse events
| Measure |
Ferumoxytol
n=997 participants at risk
Participants received an IV infusion of ferumoxytol 510 mg diluted (17 mL) in 233 mL 0.9% sodium chloride injection, USP (normal saline) (final volume 250 mL) over at least 15 minutes with a second dose 7-8 days after the first dose, for a total cumulative dose of 1.020 g.
|
Ferric Carboxymaltose (FCM)
n=1000 participants at risk
Participants received an IV infusion of FCM 750 mg diluted (15 mL) in 235 mL 0.9% sodium chloride injection, USP (normal saline) (final volume 250 mL) over at least 15 minutes with a second dose 7-8 days after the first dose, for a total cumulative dose of 1.500 g.
|
|---|---|---|
|
Gastrointestinal disorders
Nausea
|
3.5%
35/997
|
6.0%
60/1000
|
|
Gastrointestinal disorders
Diarrhoea
|
2.9%
29/997
|
3.3%
33/1000
|
|
Gastrointestinal disorders
Abdominal pain
|
1.7%
17/997
|
2.1%
21/1000
|
|
Gastrointestinal disorders
Constipation
|
1.4%
14/997
|
1.3%
13/1000
|
|
Gastrointestinal disorders
Vomiting
|
1.1%
11/997
|
1.3%
13/1000
|
|
General disorders
Fatigue
|
3.0%
30/997
|
3.6%
36/1000
|
|
General disorders
Chest discomfort
|
0.80%
8/997
|
1.1%
11/1000
|
|
General disorders
Pyrexia
|
0.70%
7/997
|
2.2%
22/1000
|
|
Metabolism and nutrition disorders
Hypophosphataemia
|
0.00%
0/997
|
1.8%
18/1000
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
1.9%
19/997
|
1.6%
16/1000
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
1.4%
14/997
|
1.2%
12/1000
|
|
Nervous system disorders
Headache
|
6.0%
60/997
|
8.2%
82/1000
|
|
Nervous system disorders
Dizziness
|
2.5%
25/997
|
4.0%
40/1000
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
1.5%
15/997
|
1.3%
13/1000
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
1.1%
11/997
|
1.8%
18/1000
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
1.2%
12/997
|
1.1%
11/1000
|
|
Vascular disorders
Flushing
|
1.1%
11/997
|
1.6%
16/1000
|
|
Vascular disorders
Hypertension
|
0.70%
7/997
|
1.5%
15/1000
|
|
General disorders
Chest pain
|
1.0%
10/997
|
0.40%
4/1000
|
|
Skin and subcutaneous tissue disorders
Urticaria
|
0.30%
3/997
|
1.3%
13/1000
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee If there is no multi-site publication within 18 months after the Study has been completed or terminated at all Study sites, and all data have been received by Sponsor, the Site, and SMO shall have the right to publish its results from the Study for non-commercial purposes, if submitted to Sponsor for review 60 days prior to submission of publication. Publication must remove all confidential information and may be delayed by up to 180 days to allow Sponsor to protect its interests.
- Publication restrictions are in place
Restriction type: OTHER