Trial Outcomes & Findings for A Trial Comparing Ferumoxytol With Iron Sucrose for the Treatment of Iron Deficiency Anemia (NCT NCT01114204)
NCT ID: NCT01114204
Last Updated: 2022-04-21
Results Overview
Participants who achieved a ≥2.0 g/dL increase in hemoglobin at any time from Baseline up to Week 5 are presented. Increase in hemoglobin at any time from Baseline up to Week 5 was calculated for each participant based on: Hemoglobin Change = Hemoglobin (Week X) - Hemoglobin (Baseline), where Week X was any post-Baseline visit up to and including Week 5. 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. Participants with no post-Baseline hemoglobin values were classified as not achieving a ≥2.0 g/dL increase. Statistical analysis was performed for data up to Week 5 only.
COMPLETED
PHASE3
605 participants
Baseline (Day 1) through Week 5
2022-04-21
Participant Flow
The study was open to enrollment for adult participants with iron deficiency anemia (IDA), defined as hemoglobin \<10.0 grams (g)/deciliter (dL) and transferrin saturation (TSAT) \<20%, and a history of unsatisfactory oral iron therapy or in whom oral iron could not be used.
Participant milestones
| Measure |
Ferumoxytol
Participants received a total of 2 doses of intravenous (IV) ferumoxytol 510 milligrams (mg) (17 milliliters \[mL\]). The first IV 510 mg dose was administered on Day 1 (Baseline) and second dose 2 to 8 (5±3) days after the first dose, for a total cumulative dose of 1.02 g.
|
Iron Sucrose
Participants received an IV injection or infusion of iron sucrose 200 mg (10 mL) on Day 1 (Baseline) and on 4 other non-consecutive days over a 14-day period, for a total cumulative dose of 1.0 g. Participants receiving their first ever exposure to IV iron sucrose, received a test dose on Day 1 prior to receiving the remainder of the first dose, as prescribed in the package insert for some countries.
|
|---|---|---|
|
Overall Study
STARTED
|
406
|
199
|
|
Overall Study
Received at Least 1 Dose of Study Drug
|
406
|
199
|
|
Overall Study
COMPLETED
|
385
|
191
|
|
Overall Study
NOT COMPLETED
|
21
|
8
|
Reasons for withdrawal
| Measure |
Ferumoxytol
Participants received a total of 2 doses of intravenous (IV) ferumoxytol 510 milligrams (mg) (17 milliliters \[mL\]). The first IV 510 mg dose was administered on Day 1 (Baseline) and second dose 2 to 8 (5±3) days after the first dose, for a total cumulative dose of 1.02 g.
|
Iron Sucrose
Participants received an IV injection or infusion of iron sucrose 200 mg (10 mL) on Day 1 (Baseline) and on 4 other non-consecutive days over a 14-day period, for a total cumulative dose of 1.0 g. Participants receiving their first ever exposure to IV iron sucrose, received a test dose on Day 1 prior to receiving the remainder of the first dose, as prescribed in the package insert for some countries.
|
|---|---|---|
|
Overall Study
Adverse Event
|
3
|
2
|
|
Overall Study
Lost to Follow-up
|
1
|
0
|
|
Overall Study
Withdrawal by Subject
|
10
|
6
|
|
Overall Study
Death
|
1
|
0
|
|
Overall Study
Other-Personal reasons
|
2
|
0
|
|
Overall Study
Other-Medical monitor request
|
1
|
0
|
|
Overall Study
Other-Participant request
|
2
|
0
|
|
Overall Study
Other-Protocol Violation
|
1
|
0
|
Baseline Characteristics
A Trial Comparing Ferumoxytol With Iron Sucrose for the Treatment of Iron Deficiency Anemia
Baseline characteristics by cohort
| Measure |
Ferumoxytol
n=406 Participants
Participants received a total of 2 doses of IV ferumoxytol 510 mg (17 mL). The first IV 510 mg dose was administered on Day 1 (Baseline) and second dose 2 to 8 (5±3) days after the first dose, for a total cumulative dose of 1.02 g.
|
Iron Sucrose
n=199 Participants
Participants received an IV injection or infusion of iron sucrose 200 mg (10 mL) on Day 1 (Baseline) and on 4 other non-consecutive days over a 14-day period for a total cumulative dose of 1.0 g. Participants receiving their first ever exposure to IV iron sucrose, received a test dose on Day 1 prior to receiving the remainder of the first dose, as prescribed in the package insert for some countries.
|
Total
n=605 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
48.0 years
STANDARD_DEVIATION 14.89 • n=5 Participants
|
48.9 years
STANDARD_DEVIATION 14.66 • n=7 Participants
|
48.2 years
STANDARD_DEVIATION 14.81 • n=5 Participants
|
|
Sex: Female, Male
Female
|
342 Participants
n=5 Participants
|
160 Participants
n=7 Participants
|
502 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
64 Participants
n=5 Participants
|
39 Participants
n=7 Participants
|
103 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Baseline (Day 1) through Week 5Population: ITT Population: Any randomized participant who had any exposure to study drug (ferumoxytol or iron sucrose) and was based upon randomized treatment assignment.
Participants who achieved a ≥2.0 g/dL increase in hemoglobin at any time from Baseline up to Week 5 are presented. Increase in hemoglobin at any time from Baseline up to Week 5 was calculated for each participant based on: Hemoglobin Change = Hemoglobin (Week X) - Hemoglobin (Baseline), where Week X was any post-Baseline visit up to and including Week 5. 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. Participants with no post-Baseline hemoglobin values were classified as not achieving a ≥2.0 g/dL increase. Statistical analysis was performed for data up to Week 5 only.
Outcome measures
| Measure |
Ferumoxytol
n=406 Participants
Participants received a total of 2 doses of IV ferumoxytol 510 mg (17 mL). The first IV 510 mg dose was administered on Day 1 (Baseline) and second dose 2 to 8 (5±3) days after the first dose, for a total cumulative dose of 1.02 g.
|
Iron Sucrose
n=199 Participants
Participants received an IV injection or infusion of iron sucrose 200 mg (10 mL) on Day 1 (Baseline) and on 4 other non-consecutive days over a 14-day period, for a total cumulative dose of 1.0 g. Participants receiving their first ever exposure to IV iron sucrose, received a test dose on Day 1 prior to receiving the remainder of the first dose, as prescribed in the package insert for some countries.
|
|---|---|---|
|
Participants Who Achieved A ≥2.0 g/dL Increase In Hemoglobin At Any Time From Baseline To Week 5
Up to Week 3
|
291 Participants
|
117 Participants
|
|
Participants Who Achieved A ≥2.0 g/dL Increase In Hemoglobin At Any Time From Baseline To Week 5
Up to Week 4
|
327 Participants
|
145 Participants
|
|
Participants Who Achieved A ≥2.0 g/dL Increase In Hemoglobin At Any Time From Baseline To Week 5
Up to Week 5
|
341 Participants
|
162 Participants
|
SECONDARY outcome
Timeframe: Baseline (Day 1), Week 5Population: ITT Population: Any randomized participant who had any exposure to study drug (ferumoxytol or iron sucrose) and was based upon 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. If the Week 5 hemoglobin value was missing, the change from Baseline was imputed to be zero.
Outcome measures
| Measure |
Ferumoxytol
n=406 Participants
Participants received a total of 2 doses of IV ferumoxytol 510 mg (17 mL). The first IV 510 mg dose was administered on Day 1 (Baseline) and second dose 2 to 8 (5±3) days after the first dose, for a total cumulative dose of 1.02 g.
|
Iron Sucrose
n=199 Participants
Participants received an IV injection or infusion of iron sucrose 200 mg (10 mL) on Day 1 (Baseline) and on 4 other non-consecutive days over a 14-day period, for a total cumulative dose of 1.0 g. Participants receiving their first ever exposure to IV iron sucrose, received a test dose on Day 1 prior to receiving the remainder of the first dose, as prescribed in the package insert for some countries.
|
|---|---|---|
|
Mean Change In Hemoglobin From Baseline To Week 5
|
2.9 g/dL
Standard Deviation 1.62
|
2.7 g/dL
Standard Deviation 1.30
|
SECONDARY outcome
Timeframe: Baseline (Day 1) through Week 5Population: ITT Population: Any randomized participant who had any exposure to study drug (ferumoxytol or iron sucrose) and was based upon randomized treatment assignment.
Participants who achieved a ≥12.0 g/dL hemoglobin level at any time from Baseline up to Week 5 are presented. Increase in hemoglobin at any time from Baseline up to Week 5 was calculated for each participant based on: Hemoglobin Change = Hemoglobin (Week X) - Hemoglobin (Baseline), where Week X was any post-Baseline visit up to and including Week 5. 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. Participants without any post-Baseline hemoglobin values were treated as non-responders.
Outcome measures
| Measure |
Ferumoxytol
n=406 Participants
Participants received a total of 2 doses of IV ferumoxytol 510 mg (17 mL). The first IV 510 mg dose was administered on Day 1 (Baseline) and second dose 2 to 8 (5±3) days after the first dose, for a total cumulative dose of 1.02 g.
|
Iron Sucrose
n=199 Participants
Participants received an IV injection or infusion of iron sucrose 200 mg (10 mL) on Day 1 (Baseline) and on 4 other non-consecutive days over a 14-day period, for a total cumulative dose of 1.0 g. Participants receiving their first ever exposure to IV iron sucrose, received a test dose on Day 1 prior to receiving the remainder of the first dose, as prescribed in the package insert for some countries.
|
|---|---|---|
|
Participants Achieving A Hemoglobin Level ≥12.0 g/dL At Any Time From Baseline To Week 5
Up to Week 3
|
123 Participants
|
33 Participants
|
|
Participants Achieving A Hemoglobin Level ≥12.0 g/dL At Any Time From Baseline To Week 5
Up to Week 4
|
210 Participants
|
67 Participants
|
|
Participants Achieving A Hemoglobin Level ≥12.0 g/dL At Any Time From Baseline To Week 5
Up to Week 5
|
271 Participants
|
96 Participants
|
SECONDARY outcome
Timeframe: Baseline (Day 1), Week 5Population: ITT Population: Any randomized participant who had any exposure to study drug (ferumoxytol or iron sucrose) and was based upon randomized treatment assignment.
Mean change in TSAT from Baseline to Week 5 was calculated for each participant as: TSAT Change = TSAT (Week 5) - TSAT (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. If the Week 5 TSAT value was missing, the change from Baseline was imputed to be zero.
Outcome measures
| Measure |
Ferumoxytol
n=406 Participants
Participants received a total of 2 doses of IV ferumoxytol 510 mg (17 mL). The first IV 510 mg dose was administered on Day 1 (Baseline) and second dose 2 to 8 (5±3) days after the first dose, for a total cumulative dose of 1.02 g.
|
Iron Sucrose
n=199 Participants
Participants received an IV injection or infusion of iron sucrose 200 mg (10 mL) on Day 1 (Baseline) and on 4 other non-consecutive days over a 14-day period, for a total cumulative dose of 1.0 g. Participants receiving their first ever exposure to IV iron sucrose, received a test dose on Day 1 prior to receiving the remainder of the first dose, as prescribed in the package insert for some countries.
|
|---|---|---|
|
Mean Change In TSAT From Baseline To Week 5
|
15.7 percentage of saturation
Standard Deviation 16.80
|
11.9 percentage of saturation
Standard Deviation 14.41
|
SECONDARY outcome
Timeframe: Baseline (Day 1), Week 5Population: ITT Population: Any randomized participant who had any exposure to study drug (ferumoxytol or iron sucrose) and was based upon randomized treatment assignment.
The FACIT-Fatigue questionnaire is a 13 item questionnaire designed and validated to specifically assess the presence and impact of treatment on fatigue and related symptoms, such as tiredness, on health-related quality of life in anemic participants with cancer. The questionnaire has 13 items, each measured on a 4-point Likert scale. Scoring ranges from 0 (the most fatigued) to 52 (the least fatigued) points, with higher scores representing better functioning or less fatigue. Mean change in FACIT-Fatigue Score from Baseline to Week 5 was calculated for each participant as: FACIT-Fatigue Score Change = FACIT-Fatigue Score (Week 5) - FACIT-Fatigue Score (Baseline). Baseline was defined as the Day 1 value (prior to first dose of study drug).The screening or most recent value prior to Day 1 was used for any participant with missing Day 1 information. If the Week 5 FACIT-Fatigue Score value was missing, the change from Baseline was imputed to be zero.
Outcome measures
| Measure |
Ferumoxytol
n=399 Participants
Participants received a total of 2 doses of IV ferumoxytol 510 mg (17 mL). The first IV 510 mg dose was administered on Day 1 (Baseline) and second dose 2 to 8 (5±3) days after the first dose, for a total cumulative dose of 1.02 g.
|
Iron Sucrose
n=198 Participants
Participants received an IV injection or infusion of iron sucrose 200 mg (10 mL) on Day 1 (Baseline) and on 4 other non-consecutive days over a 14-day period, for a total cumulative dose of 1.0 g. Participants receiving their first ever exposure to IV iron sucrose, received a test dose on Day 1 prior to receiving the remainder of the first dose, as prescribed in the package insert for some countries.
|
|---|---|---|
|
Mean Change In Functional Assessment of Chronic Illness Therapy (FACIT)-Fatigue Score From Baseline To Week 5
|
13.1 units on a scale
Standard Deviation 11.78
|
12.4 units on a scale
Standard Deviation 11.22
|
SECONDARY outcome
Timeframe: From Baseline (Day 1) up to Week 5Population: ITT Population: Any randomized participant who had any exposure to study drug (ferumoxytol or iron sucrose) and was based upon randomized treatment assignment.
The time to hemoglobin increase of ≥2.0 g/dL or hemoglobin value of ≥12.0 g/dL was defined as the days from Baseline (Day 1) to the first time the participant had an increase in hemoglobin of ≥2.0 g/dL or hemoglobin value of ≥12.0 g/dL, and was calculated using a Kaplan-Meier curve. Participants who did not have a hemoglobin increase of ≥2.0 g/dL or to a hemoglobin level ≥12.0 g/dL were censored at their last visit day. Participants without any post-Baseline study visits were not included.
Outcome measures
| Measure |
Ferumoxytol
n=406 Participants
Participants received a total of 2 doses of IV ferumoxytol 510 mg (17 mL). The first IV 510 mg dose was administered on Day 1 (Baseline) and second dose 2 to 8 (5±3) days after the first dose, for a total cumulative dose of 1.02 g.
|
Iron Sucrose
n=199 Participants
Participants received an IV injection or infusion of iron sucrose 200 mg (10 mL) on Day 1 (Baseline) and on 4 other non-consecutive days over a 14-day period, for a total cumulative dose of 1.0 g. Participants receiving their first ever exposure to IV iron sucrose, received a test dose on Day 1 prior to receiving the remainder of the first dose, as prescribed in the package insert for some countries.
|
|---|---|---|
|
Time To Hemoglobin Increase Of ≥2.0 g/dL Or Hemoglobin Value Of ≥12.0 g/dL From Baseline
|
23.1 days
Interval 15.0 to 24.0
|
25.2 days
Interval 21.0 to 30.0
|
Adverse Events
Ferumoxytol
Iron Sucrose
Serious adverse events
| Measure |
Ferumoxytol
n=406 participants at risk
Participants received a total of 2 doses of IV ferumoxytol 510 mg (17 mL). The first IV 510 mg dose was administered on Day 1 (Baseline) and second dose 2 to 8 (5±3) days after the first dose, for a total cumulative dose of 1.02 g.
|
Iron Sucrose
n=199 participants at risk
Participants received an IV injection or infusion of iron sucrose 200 mg (10 mL) on Day 1 (Baseline) and on 4 other non-consecutive days over a 14-day period for a total cumulative dose of 1.0 g. Participants receiving their first ever exposure to IV iron sucrose, received a test dose on Day 1 prior to receiving the remainder of the first dose, as prescribed in the package insert for some countries.
|
|---|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
0.25%
1/406
|
0.50%
1/199
|
|
Blood and lymphatic system disorders
Iron deficiency anaemia
|
0.25%
1/406
|
0.00%
0/199
|
|
Cardiac disorders
Atrioventricular block second degree
|
0.25%
1/406
|
0.00%
0/199
|
|
Cardiac disorders
Tachycardia
|
0.25%
1/406
|
0.00%
0/199
|
|
Gastrointestinal disorders
Gastric ulcer haemorrhage
|
0.25%
1/406
|
0.00%
0/199
|
|
Gastrointestinal disorders
Gastrointestinal obstruction
|
0.25%
1/406
|
0.00%
0/199
|
|
Gastrointestinal disorders
Nausea
|
0.25%
1/406
|
0.00%
0/199
|
|
General disorders
Asthenia
|
0.25%
1/406
|
0.00%
0/199
|
|
General disorders
Pyrexia
|
0.00%
0/406
|
0.50%
1/199
|
|
Hepatobiliary disorders
Hepatic cirrhosis
|
0.25%
1/406
|
0.00%
0/199
|
|
Immune system disorders
Anaphylactic reaction
|
0.25%
1/406
|
0.00%
0/199
|
|
Infections and infestations
Bartholin's abscess
|
0.00%
0/406
|
0.50%
1/199
|
|
Infections and infestations
Bronchopneumonia
|
0.00%
0/406
|
0.50%
1/199
|
|
Infections and infestations
Rectal abscess
|
0.25%
1/406
|
0.00%
0/199
|
|
Infections and infestations
Viraemia
|
0.25%
1/406
|
0.00%
0/199
|
|
Injury, poisoning and procedural complications
Road traffic accident
|
0.25%
1/406
|
0.00%
0/199
|
|
Musculoskeletal and connective tissue disorders
Spinal osteoarthritis
|
0.25%
1/406
|
0.00%
0/199
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lymphoma
|
0.25%
1/406
|
0.00%
0/199
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Myelodysplastic syndrome
|
0.00%
0/406
|
0.50%
1/199
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Neoplasm progression
|
0.00%
0/406
|
0.50%
1/199
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Tumour haemorrhage
|
0.25%
1/406
|
0.00%
0/199
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Uterine leiomyoma
|
0.29%
1/342
|
0.00%
0/160
|
|
Renal and urinary disorders
Dysuria
|
0.25%
1/406
|
0.00%
0/199
|
|
Reproductive system and breast disorders
Uterine haemorrhage
|
0.58%
2/342
|
0.00%
0/160
|
|
Skin and subcutaneous tissue disorders
Angioedema
|
0.25%
1/406
|
0.00%
0/199
|
|
Skin and subcutaneous tissue disorders
Urticaria
|
0.25%
1/406
|
0.00%
0/199
|
|
Vascular disorders
Hypertension
|
0.25%
1/406
|
0.00%
0/199
|
Other adverse events
| Measure |
Ferumoxytol
n=406 participants at risk
Participants received a total of 2 doses of IV ferumoxytol 510 mg (17 mL). The first IV 510 mg dose was administered on Day 1 (Baseline) and second dose 2 to 8 (5±3) days after the first dose, for a total cumulative dose of 1.02 g.
|
Iron Sucrose
n=199 participants at risk
Participants received an IV injection or infusion of iron sucrose 200 mg (10 mL) on Day 1 (Baseline) and on 4 other non-consecutive days over a 14-day period for a total cumulative dose of 1.0 g. Participants receiving their first ever exposure to IV iron sucrose, received a test dose on Day 1 prior to receiving the remainder of the first dose, as prescribed in the package insert for some countries.
|
|---|---|---|
|
Gastrointestinal disorders
Nausea
|
2.7%
11/406
|
3.5%
7/199
|
|
Gastrointestinal disorders
Dry mouth
|
1.5%
6/406
|
0.00%
0/199
|
|
Gastrointestinal disorders
Abdominal pain
|
0.99%
4/406
|
1.5%
3/199
|
|
Gastrointestinal disorders
Vomiting
|
0.74%
3/406
|
2.0%
4/199
|
|
General disorders
Chest discomfort
|
2.2%
9/406
|
1.0%
2/199
|
|
General disorders
Pyrexia
|
0.49%
2/406
|
3.0%
6/199
|
|
General disorders
Chills
|
0.00%
0/406
|
2.0%
4/199
|
|
Infections and infestations
Urinary tract infection
|
0.49%
2/406
|
1.5%
3/199
|
|
Infections and infestations
Cystitis
|
0.25%
1/406
|
1.5%
3/199
|
|
Investigations
Alanine aminotransferase increased
|
0.99%
4/406
|
2.0%
4/199
|
|
Investigations
Aspartate aminotransferase increased
|
0.74%
3/406
|
1.5%
3/199
|
|
Investigations
White blood cell count decreased
|
0.74%
3/406
|
1.5%
3/199
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
1.7%
7/406
|
0.50%
1/199
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
1.2%
5/406
|
0.00%
0/199
|
|
Nervous system disorders
Headache
|
4.7%
19/406
|
5.5%
11/199
|
|
Nervous system disorders
Dizziness
|
2.2%
9/406
|
1.5%
3/199
|
|
Nervous system disorders
Dysgeusia
|
2.2%
9/406
|
6.5%
13/199
|
|
Reproductive system and breast disorders
Dysmenorrhoea
|
0.88%
3/342
|
1.9%
3/160
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.74%
3/406
|
2.0%
4/199
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
0.00%
0/406
|
2.0%
4/199
|
|
Vascular disorders
Hypertension
|
0.99%
4/406
|
1.5%
3/199
|
|
Blood and lymphatic system disorders
Anaemia
|
0.25%
1/406
|
1.0%
2/199
|
|
Ear and labyrinth disorders
Vertigo
|
0.49%
2/406
|
1.0%
2/199
|
|
Gastrointestinal disorders
Constipation
|
0.99%
4/406
|
1.0%
2/199
|
|
General disorders
Fatigue
|
0.74%
3/406
|
1.0%
2/199
|
|
General disorders
Oedema peripheral
|
0.74%
3/406
|
1.0%
2/199
|
|
General disorders
Feeling hot
|
0.49%
2/406
|
1.0%
2/199
|
|
General disorders
Injection site pain
|
0.00%
0/406
|
1.0%
2/199
|
|
Immune system disorders
Hypersensitivity
|
0.74%
3/406
|
1.0%
2/199
|
|
Immune system disorders
Drug hypersensitivity
|
0.49%
2/406
|
1.0%
2/199
|
|
Infections and infestations
Influenza
|
0.99%
4/406
|
1.0%
2/199
|
|
Infections and infestations
Nasopharyngitis
|
0.49%
2/406
|
1.0%
2/199
|
|
Injury, poisoning and procedural complications
Fall
|
0.00%
0/406
|
1.0%
2/199
|
|
Investigations
Lymphocyte count decreased
|
0.99%
4/406
|
1.0%
2/199
|
|
Investigations
Gamma-glutamyltransferase increased
|
0.74%
3/406
|
1.0%
2/199
|
|
Investigations
Blood urea decreased
|
0.49%
2/406
|
1.0%
2/199
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
0.25%
1/406
|
1.0%
2/199
|
|
Nervous system disorders
Somnolence
|
0.00%
0/406
|
1.0%
2/199
|
|
Vascular disorders
Hypotension
|
0.25%
1/406
|
1.0%
2/199
|
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