Trial Outcomes & Findings for Placebo-Controlled Study to Investigate the Efficacy & Safety of Injectafer in the Treatment of RLS (NCT NCT02397057)
NCT ID: NCT02397057
Last Updated: 2021-10-12
Results Overview
Summary of the actual values of IRLS total score on baseline and Day 42, and the change from baseline to Day 42. Eligible subjects were to have met the following requirements prior to receiving additional treatment: A baseline score ≥ 15 on the International Restless Legs Syndrome (IRLS) Rating Scale. The minimum score is 15 with the maximum of 40. A score of less than 15 is not an indicator of RLS. However, a score of 15 or greater is an indicator of RLS. Further increase indicates more severe disease.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
209 participants
Primary outcome timeframe
Baseline and Day 42
Results posted on
2021-10-12
Participant Flow
Participant milestones
| Measure |
Injectafer
Two doses of Injectafer 750 mg undiluted dose at 100 mg/minute given 5 days apart for a total of 1500 mgs.
Injectafer
|
Normal Saline
IV Placebo (15ml of Normal Saline) IV push at 2ml/minute
Placebo
|
|---|---|---|
|
Overall Study
STARTED
|
105
|
104
|
|
Overall Study
COMPLETED
|
94
|
91
|
|
Overall Study
NOT COMPLETED
|
11
|
13
|
Reasons for withdrawal
| Measure |
Injectafer
Two doses of Injectafer 750 mg undiluted dose at 100 mg/minute given 5 days apart for a total of 1500 mgs.
Injectafer
|
Normal Saline
IV Placebo (15ml of Normal Saline) IV push at 2ml/minute
Placebo
|
|---|---|---|
|
Overall Study
Withdrawal by Subject
|
6
|
7
|
|
Overall Study
Lost to Follow-up
|
4
|
3
|
|
Overall Study
Death
|
1
|
0
|
|
Overall Study
Adverse Event
|
0
|
1
|
|
Overall Study
Physician Decision
|
0
|
1
|
|
Overall Study
Subject did not receive study drug
|
0
|
1
|
Baseline Characteristics
One subject did not receive study drug and was excluded from the safety and full analysis population.
Baseline characteristics by cohort
| Measure |
Injectafer
n=105 Participants
Two doses of Injectafer 750 mg undiluted dose at 100 mg/minute given 5 days apart for a total of 1500 mgs.
Injectafer
|
Normal Saline
n=103 Participants
IV Placebo (15ml of Normal Saline) IV push at 2ml/minute
Placebo
|
Total
n=208 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
58.3 Years
STANDARD_DEVIATION 12.31 • n=5 Participants
|
56.9 Years
STANDARD_DEVIATION 13.73 • n=7 Participants
|
57.6 Years
STANDARD_DEVIATION 13.01 • n=5 Participants
|
|
Sex: Female, Male
Female
|
69 Participants
n=5 Participants • One subject did not receive study drug and was excluded from the safety and full analysis population.
|
71 Participants
n=7 Participants • One subject did not receive study drug and was excluded from the safety and full analysis population.
|
140 Participants
n=5 Participants • One subject did not receive study drug and was excluded from the safety and full analysis population.
|
|
Sex: Female, Male
Male
|
36 Participants
n=5 Participants • One subject did not receive study drug and was excluded from the safety and full analysis population.
|
32 Participants
n=7 Participants • One subject did not receive study drug and was excluded from the safety and full analysis population.
|
68 Participants
n=5 Participants • One subject did not receive study drug and was excluded from the safety and full analysis population.
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
12 Participants
n=5 Participants • One subject did not receive study drug and was excluded from the safety and full analysis population.
|
9 Participants
n=7 Participants • One subject did not receive study drug and was excluded from the safety and full analysis population.
|
21 Participants
n=5 Participants • One subject did not receive study drug and was excluded from the safety and full analysis population.
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
93 Participants
n=5 Participants • One subject did not receive study drug and was excluded from the safety and full analysis population.
|
94 Participants
n=7 Participants • One subject did not receive study drug and was excluded from the safety and full analysis population.
|
187 Participants
n=5 Participants • One subject did not receive study drug and was excluded from the safety and full analysis population.
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants • One subject did not receive study drug and was excluded from the safety and full analysis population.
|
0 Participants
n=7 Participants • One subject did not receive study drug and was excluded from the safety and full analysis population.
|
0 Participants
n=5 Participants • One subject did not receive study drug and was excluded from the safety and full analysis population.
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants • One subject did not receive study drug and was excluded from the safety and full analysis population.
|
0 Participants
n=7 Participants • One subject did not receive study drug and was excluded from the safety and full analysis population.
|
0 Participants
n=5 Participants • One subject did not receive study drug and was excluded from the safety and full analysis population.
|
|
Race (NIH/OMB)
Asian
|
1 Participants
n=5 Participants • One subject did not receive study drug and was excluded from the safety and full analysis population.
|
0 Participants
n=7 Participants • One subject did not receive study drug and was excluded from the safety and full analysis population.
|
1 Participants
n=5 Participants • One subject did not receive study drug and was excluded from the safety and full analysis population.
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
1 Participants
n=5 Participants • One subject did not receive study drug and was excluded from the safety and full analysis population.
|
0 Participants
n=7 Participants • One subject did not receive study drug and was excluded from the safety and full analysis population.
|
1 Participants
n=5 Participants • One subject did not receive study drug and was excluded from the safety and full analysis population.
|
|
Race (NIH/OMB)
Black or African American
|
2 Participants
n=5 Participants • One subject did not receive study drug and was excluded from the safety and full analysis population.
|
4 Participants
n=7 Participants • One subject did not receive study drug and was excluded from the safety and full analysis population.
|
6 Participants
n=5 Participants • One subject did not receive study drug and was excluded from the safety and full analysis population.
|
|
Race (NIH/OMB)
White
|
101 Participants
n=5 Participants • One subject did not receive study drug and was excluded from the safety and full analysis population.
|
99 Participants
n=7 Participants • One subject did not receive study drug and was excluded from the safety and full analysis population.
|
200 Participants
n=5 Participants • One subject did not receive study drug and was excluded from the safety and full analysis population.
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants • One subject did not receive study drug and was excluded from the safety and full analysis population.
|
0 Participants
n=7 Participants • One subject did not receive study drug and was excluded from the safety and full analysis population.
|
0 Participants
n=5 Participants • One subject did not receive study drug and was excluded from the safety and full analysis population.
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants • One subject did not receive study drug and was excluded from the safety and full analysis population.
|
0 Participants
n=7 Participants • One subject did not receive study drug and was excluded from the safety and full analysis population.
|
0 Participants
n=5 Participants • One subject did not receive study drug and was excluded from the safety and full analysis population.
|
|
Region of Enrollment
United States
|
42 participants
n=5 Participants
|
34 participants
n=7 Participants
|
76 participants
n=5 Participants
|
|
Region of Enrollment
Europe
|
65 participants
n=5 Participants
|
67 participants
n=7 Participants
|
132 participants
n=5 Participants
|
|
Height
|
167.6 cm
STANDARD_DEVIATION 9.4 • n=5 Participants
|
167 cm
STANDARD_DEVIATION 9.4 • n=7 Participants
|
167.3 cm
STANDARD_DEVIATION 9.4 • n=5 Participants
|
|
Weight
|
82.8 kg
STANDARD_DEVIATION 21.4 • n=5 Participants
|
79.1 kg
STANDARD_DEVIATION 20.8 • n=7 Participants
|
81 kg
STANDARD_DEVIATION 21.1 • n=5 Participants
|
|
Iron intolerance
No
|
104 Participants
n=5 Participants • One subject did not receive study drug and was excluded from the safety and full analysis population.
|
103 Participants
n=7 Participants • One subject did not receive study drug and was excluded from the safety and full analysis population.
|
207 Participants
n=5 Participants • One subject did not receive study drug and was excluded from the safety and full analysis population.
|
|
Iron intolerance
Yes
|
1 Participants
n=5 Participants • One subject did not receive study drug and was excluded from the safety and full analysis population.
|
0 Participants
n=7 Participants • One subject did not receive study drug and was excluded from the safety and full analysis population.
|
1 Participants
n=5 Participants • One subject did not receive study drug and was excluded from the safety and full analysis population.
|
|
RLS Medication-Related Augmentation
No augmentation
|
51 Participants
n=5 Participants • One participate did not receive study drug and was excluded from the safety and full analysis set population.
|
53 Participants
n=7 Participants • One participate did not receive study drug and was excluded from the safety and full analysis set population.
|
104 Participants
n=5 Participants • One participate did not receive study drug and was excluded from the safety and full analysis set population.
|
|
RLS Medication-Related Augmentation
Uncertain augmentation
|
31 Participants
n=5 Participants • One participate did not receive study drug and was excluded from the safety and full analysis set population.
|
33 Participants
n=7 Participants • One participate did not receive study drug and was excluded from the safety and full analysis set population.
|
64 Participants
n=5 Participants • One participate did not receive study drug and was excluded from the safety and full analysis set population.
|
|
RLS Medication-Related Augmentation
Definitive augmentation
|
23 Participants
n=5 Participants • One participate did not receive study drug and was excluded from the safety and full analysis set population.
|
17 Participants
n=7 Participants • One participate did not receive study drug and was excluded from the safety and full analysis set population.
|
40 Participants
n=5 Participants • One participate did not receive study drug and was excluded from the safety and full analysis set population.
|
PRIMARY outcome
Timeframe: Baseline and Day 42Population: One subject did not receive study drug and was excluded from the safety and Full analysis set population.
Summary of the actual values of IRLS total score on baseline and Day 42, and the change from baseline to Day 42. Eligible subjects were to have met the following requirements prior to receiving additional treatment: A baseline score ≥ 15 on the International Restless Legs Syndrome (IRLS) Rating Scale. The minimum score is 15 with the maximum of 40. A score of less than 15 is not an indicator of RLS. However, a score of 15 or greater is an indicator of RLS. Further increase indicates more severe disease.
Outcome measures
| Measure |
Injectafer
n=105 Participants
Two doses of Injectafer 750 mg undiluted dose at 100 mg/minute given 5 days apart for a total of 1500 mgs.
Injectafer
|
Normal Saline
n=103 Participants
IV Placebo (15ml of Normal Saline) IV push at 2ml/minute
Placebo
|
|---|---|---|
|
International Restless Legs Syndrome (IRLS) Total Score Change From Baseline on Day 42
Baseline
|
24.1 score on a scale
Standard Deviation 6.27
|
24.5 score on a scale
Standard Deviation 6.05
|
|
International Restless Legs Syndrome (IRLS) Total Score Change From Baseline on Day 42
Day 42
|
15.6 score on a scale
Standard Deviation 8.69
|
18.7 score on a scale
Standard Deviation 8.94
|
|
International Restless Legs Syndrome (IRLS) Total Score Change From Baseline on Day 42
Change from Baseline to Day 42
|
-8.7 score on a scale
Standard Deviation 8.44
|
-5.9 score on a scale
Standard Deviation 9.07
|
PRIMARY outcome
Timeframe: Day 42Population: Responder(a), n/m(b) : a : Responder was defined as subjects rated as much or very much improved with the CGI-I. b : n is the number of responders; m is number of subjects who had non-missing results at the visit.
Responder is defined as subjects rated as much or very much improved with the CGI-I on Day 42. Summary of the number (percentage) of CGI-I responder. Per the protocol, the he CGI is a 3-item observer-rated scale that measures illness severity (CGIS), global improvement or change (CGIC) and therapeutic response. The scale requires the clinician to assess how much the patient's illness has improved or worsened relative to a baseline state at the beginning of the intervention.
Outcome measures
| Measure |
Injectafer
n=87 Participants
Two doses of Injectafer 750 mg undiluted dose at 100 mg/minute given 5 days apart for a total of 1500 mgs.
Injectafer
|
Normal Saline
n=70 Participants
IV Placebo (15ml of Normal Saline) IV push at 2ml/minute
Placebo
|
|---|---|---|
|
Proportion of Patients Rated as Much or Very Much Improved With the Clinical Global Impression (CGI) Performed by Investigator (CGI-I)
|
38 Participants
|
25 Participants
|
SECONDARY outcome
Timeframe: Day 42Population: Observed cases (n/m(a) \[%\]) a: n is the number of subjects of the category, m is number of subjects who have non-missing results at the visit.
Similar to the CGI-I except this is self-reported, 7-item scale for assessment of symptoms after treatment with the rating as: 1, very much improved; 2, much improved; 3, minimally improved; 4, no change; 5, minimally worse; 6, much worse; or 7, very much worse.
Outcome measures
| Measure |
Injectafer
n=87 Participants
Two doses of Injectafer 750 mg undiluted dose at 100 mg/minute given 5 days apart for a total of 1500 mgs.
Injectafer
|
Normal Saline
n=70 Participants
IV Placebo (15ml of Normal Saline) IV push at 2ml/minute
Placebo
|
|---|---|---|
|
Clinical Global Impression-Improvement (CGI-S) by Subject
Minimally worse
|
2 Participants
|
11 Participants
|
|
Clinical Global Impression-Improvement (CGI-S) by Subject
Very much improved
|
10 Participants
|
7 Participants
|
|
Clinical Global Impression-Improvement (CGI-S) by Subject
Much improved
|
30 Participants
|
19 Participants
|
|
Clinical Global Impression-Improvement (CGI-S) by Subject
Minimal change
|
31 Participants
|
16 Participants
|
|
Clinical Global Impression-Improvement (CGI-S) by Subject
No Change
|
10 Participants
|
12 Participants
|
|
Clinical Global Impression-Improvement (CGI-S) by Subject
Much worse
|
3 Participants
|
4 Participants
|
|
Clinical Global Impression-Improvement (CGI-S) by Subject
Very much worse
|
1 Participants
|
1 Participants
|
SECONDARY outcome
Timeframe: Baseline and Day 42Population: One subject did not receive study drug and was excluded from the Safety and Full Analysis Set Populations.
The Restless Legs Syndrome Quality of Life (RLS-QLI) instrument, a self-assessment, 17-item questionnaire with four scales identified through factor analysis: Daily Function, Social Function, Sleep Quality, and Emotional Well-Being, developed to facilitate clinical research on RLS. Scoring Instructions below: 1. Social Function = Sum (Items 1, 2, 3, 4), subtract 4, divide by 16, multiply by 100 2. Daily Function = Sum (Items 5, 6, 13,14, 15, 16), subtract 6, divide by 24, multiply by 100 3. Sleep Quality = Sum (Item 7, 8, 9, 17), subtract 4, divide by 18, multiply by 100 4. Emotional Well-being = Sum (Items 10, 11, 12), subtract 3, divide by 12, multiply by 100 Note: Resulting scores range between 0-100. Higher scores on the RLS-QLI indicate a lower quality of life. Lower scores indicate a higher quality of life.
Outcome measures
| Measure |
Injectafer
n=105 Participants
Two doses of Injectafer 750 mg undiluted dose at 100 mg/minute given 5 days apart for a total of 1500 mgs.
Injectafer
|
Normal Saline
n=103 Participants
IV Placebo (15ml of Normal Saline) IV push at 2ml/minute
Placebo
|
|---|---|---|
|
Restless Legs Syndrome Quality of Life (RLS-QLI) Change From Baseline to Day 42.
Baseline
|
55.6 units on a scale
Standard Deviation 15.0
|
54.3 units on a scale
Standard Deviation 13.08
|
|
Restless Legs Syndrome Quality of Life (RLS-QLI) Change From Baseline to Day 42.
Day 42
|
65.2 units on a scale
Standard Deviation 15.49
|
62.8 units on a scale
Standard Deviation 14.90
|
|
Restless Legs Syndrome Quality of Life (RLS-QLI) Change From Baseline to Day 42.
Change from Baseline to Day 42
|
9.0 units on a scale
Standard Deviation 12.48
|
8.7 units on a scale
Standard Deviation 14.61
|
SECONDARY outcome
Timeframe: Baseline and Day 42Population: One subject did not receive study drug and was excluded from the Safety and Full Analysis Set Populations.
The Fatigue Linear Analog Scale is a self-assessment scale in which a 100 mm line is used to measure the severity of fatigue and its effect on a person's activities and lifestyle. The scale severity measure ranges from No Fatigue to Worst Possible Fatigue.
Outcome measures
| Measure |
Injectafer
n=104 Participants
Two doses of Injectafer 750 mg undiluted dose at 100 mg/minute given 5 days apart for a total of 1500 mgs.
Injectafer
|
Normal Saline
n=103 Participants
IV Placebo (15ml of Normal Saline) IV push at 2ml/minute
Placebo
|
|---|---|---|
|
Fatigue Linear Analog Scale Change From Baseline
Change from Baseline to Day 42
|
-9.98 units on a scale
Standard Deviation 27.55
|
-16.50 units on a scale
Standard Deviation 28.32
|
|
Fatigue Linear Analog Scale Change From Baseline
Baseline
|
49.78 units on a scale
Standard Deviation 26.32
|
57.34 units on a scale
Standard Deviation 23.61
|
|
Fatigue Linear Analog Scale Change From Baseline
Day 42
|
38.90 units on a scale
Standard Deviation 26.25
|
42.57 units on a scale
Standard Deviation 27.13
|
SECONDARY outcome
Timeframe: Change from Baseline and Day 42.Population: Only participants with Sleep disturbance are included.
The MOS-Sleep scale, is a 12-item standardized, validated questionnaire for assessing sleep disturbance, sleep adequacy, somnolence, quantity of sleep, snoring, and awakening short of breath or with a headache which has been demonstrated to be sensitive to RLS treatment effects. This questionnaire provides information about sleep quality. Individual questions can be used for analysis but summary or index scores of a group of questions, is more commonly used in analysis. The "quantity of sleep" dimension is the average number of hours of sleep per night reported by the patient and the "optimal sleep" is a dichotomized version that is "yes" when the number of hours of sleep is 7 or 8. The scores of the dimensions and of the sleep problem index were converted to a 0 to 100 scale, with higher scores reflecting more of the attribute implied by the name (e.g. greater sleep disturbance, greater adequacy of sleep).
Outcome measures
| Measure |
Injectafer
n=105 Participants
Two doses of Injectafer 750 mg undiluted dose at 100 mg/minute given 5 days apart for a total of 1500 mgs.
Injectafer
|
Normal Saline
n=103 Participants
IV Placebo (15ml of Normal Saline) IV push at 2ml/minute
Placebo
|
|---|---|---|
|
Medical Outcomes Study(MOS) Sleep Scale Change From Baseline to Day 42
|
-13.086 score on a scale
Standard Error 1.829
|
-9.015 score on a scale
Standard Error 1.902
|
SECONDARY outcome
Timeframe: Time from Day 5 to Day 365Population: Full Analysis Set Population. Subjects who discontinued or completed the study before an intervention were censored at the last study visit. Subjects Receiving RLS Intervention after Day 5.
Subjects could start tapering off pre-enrollment prescribed RLS medications after Day 5 until Day 365.
Outcome measures
| Measure |
Injectafer
n=105 Participants
Two doses of Injectafer 750 mg undiluted dose at 100 mg/minute given 5 days apart for a total of 1500 mgs.
Injectafer
|
Normal Saline
n=103 Participants
IV Placebo (15ml of Normal Saline) IV push at 2ml/minute
Placebo
|
|---|---|---|
|
Time Off Pre-Enrollment Prescribed Restless Legs Syndrome (RLS) Medications
|
34 days
Interval 34.0 to 164.0
|
61 days
Interval 61.0 to 183.0
|
Adverse Events
Injectafer
Serious events: 6 serious events
Other events: 72 other events
Deaths: 1 deaths
Normal Saline
Serious events: 4 serious events
Other events: 19 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Injectafer
n=107 participants at risk
Two doses of Injectafer 750 mg undiluted dose at 100 mg/minute given 5 days apart for a total of 1500 mgs.
Injectafer
|
Normal Saline
n=101 participants at risk
IV Placebo (15ml of Normal Saline) IV push at 2ml/minute
Placebo
|
|---|---|---|
|
Metabolism and nutrition disorders
Diabetes mellitus inadequate control
|
0.93%
1/107 • Number of events 1 • 2 years, I month
209 participants were randomized of whom 208 received study drug: 105 who were randomized to Injectafer and 103 who were randomized to placebo. Two participants randomized to Placebo received Injectafer. Therefore the Numbers at Risk comprised 107 for Injectafer 101 for placebo.
|
0.00%
0/101 • 2 years, I month
209 participants were randomized of whom 208 received study drug: 105 who were randomized to Injectafer and 103 who were randomized to placebo. Two participants randomized to Placebo received Injectafer. Therefore the Numbers at Risk comprised 107 for Injectafer 101 for placebo.
|
|
Metabolism and nutrition disorders
Gout
|
0.93%
1/107 • Number of events 1 • 2 years, I month
209 participants were randomized of whom 208 received study drug: 105 who were randomized to Injectafer and 103 who were randomized to placebo. Two participants randomized to Placebo received Injectafer. Therefore the Numbers at Risk comprised 107 for Injectafer 101 for placebo.
|
0.00%
0/101 • 2 years, I month
209 participants were randomized of whom 208 received study drug: 105 who were randomized to Injectafer and 103 who were randomized to placebo. Two participants randomized to Placebo received Injectafer. Therefore the Numbers at Risk comprised 107 for Injectafer 101 for placebo.
|
|
Metabolism and nutrition disorders
Hypophosphataemia
|
0.93%
1/107 • Number of events 1 • 2 years, I month
209 participants were randomized of whom 208 received study drug: 105 who were randomized to Injectafer and 103 who were randomized to placebo. Two participants randomized to Placebo received Injectafer. Therefore the Numbers at Risk comprised 107 for Injectafer 101 for placebo.
|
0.00%
0/101 • 2 years, I month
209 participants were randomized of whom 208 received study drug: 105 who were randomized to Injectafer and 103 who were randomized to placebo. Two participants randomized to Placebo received Injectafer. Therefore the Numbers at Risk comprised 107 for Injectafer 101 for placebo.
|
|
Nervous system disorders
Cerebral haemorrhage
|
0.93%
1/107 • Number of events 1 • 2 years, I month
209 participants were randomized of whom 208 received study drug: 105 who were randomized to Injectafer and 103 who were randomized to placebo. Two participants randomized to Placebo received Injectafer. Therefore the Numbers at Risk comprised 107 for Injectafer 101 for placebo.
|
0.00%
0/101 • 2 years, I month
209 participants were randomized of whom 208 received study drug: 105 who were randomized to Injectafer and 103 who were randomized to placebo. Two participants randomized to Placebo received Injectafer. Therefore the Numbers at Risk comprised 107 for Injectafer 101 for placebo.
|
|
Nervous system disorders
Syncope
|
0.93%
1/107 • Number of events 1 • 2 years, I month
209 participants were randomized of whom 208 received study drug: 105 who were randomized to Injectafer and 103 who were randomized to placebo. Two participants randomized to Placebo received Injectafer. Therefore the Numbers at Risk comprised 107 for Injectafer 101 for placebo.
|
0.00%
0/101 • 2 years, I month
209 participants were randomized of whom 208 received study drug: 105 who were randomized to Injectafer and 103 who were randomized to placebo. Two participants randomized to Placebo received Injectafer. Therefore the Numbers at Risk comprised 107 for Injectafer 101 for placebo.
|
|
Nervous system disorders
Haemorrhagic stroke
|
0.00%
0/107 • 2 years, I month
209 participants were randomized of whom 208 received study drug: 105 who were randomized to Injectafer and 103 who were randomized to placebo. Two participants randomized to Placebo received Injectafer. Therefore the Numbers at Risk comprised 107 for Injectafer 101 for placebo.
|
0.99%
1/101 • Number of events 1 • 2 years, I month
209 participants were randomized of whom 208 received study drug: 105 who were randomized to Injectafer and 103 who were randomized to placebo. Two participants randomized to Placebo received Injectafer. Therefore the Numbers at Risk comprised 107 for Injectafer 101 for placebo.
|
|
Gastrointestinal disorders
Diarrhoea
|
0.93%
1/107 • Number of events 1 • 2 years, I month
209 participants were randomized of whom 208 received study drug: 105 who were randomized to Injectafer and 103 who were randomized to placebo. Two participants randomized to Placebo received Injectafer. Therefore the Numbers at Risk comprised 107 for Injectafer 101 for placebo.
|
0.00%
0/101 • 2 years, I month
209 participants were randomized of whom 208 received study drug: 105 who were randomized to Injectafer and 103 who were randomized to placebo. Two participants randomized to Placebo received Injectafer. Therefore the Numbers at Risk comprised 107 for Injectafer 101 for placebo.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Colon cancer stage IV
|
0.93%
1/107 • Number of events 1 • 2 years, I month
209 participants were randomized of whom 208 received study drug: 105 who were randomized to Injectafer and 103 who were randomized to placebo. Two participants randomized to Placebo received Injectafer. Therefore the Numbers at Risk comprised 107 for Injectafer 101 for placebo.
|
0.00%
0/101 • 2 years, I month
209 participants were randomized of whom 208 received study drug: 105 who were randomized to Injectafer and 103 who were randomized to placebo. Two participants randomized to Placebo received Injectafer. Therefore the Numbers at Risk comprised 107 for Injectafer 101 for placebo.
|
|
Infections and infestations
Cellulitis
|
0.00%
0/107 • 2 years, I month
209 participants were randomized of whom 208 received study drug: 105 who were randomized to Injectafer and 103 who were randomized to placebo. Two participants randomized to Placebo received Injectafer. Therefore the Numbers at Risk comprised 107 for Injectafer 101 for placebo.
|
0.99%
1/101 • Number of events 1 • 2 years, I month
209 participants were randomized of whom 208 received study drug: 105 who were randomized to Injectafer and 103 who were randomized to placebo. Two participants randomized to Placebo received Injectafer. Therefore the Numbers at Risk comprised 107 for Injectafer 101 for placebo.
|
|
Injury, poisoning and procedural complications
Forearm fracture
|
0.00%
0/107 • 2 years, I month
209 participants were randomized of whom 208 received study drug: 105 who were randomized to Injectafer and 103 who were randomized to placebo. Two participants randomized to Placebo received Injectafer. Therefore the Numbers at Risk comprised 107 for Injectafer 101 for placebo.
|
0.99%
1/101 • Number of events 1 • 2 years, I month
209 participants were randomized of whom 208 received study drug: 105 who were randomized to Injectafer and 103 who were randomized to placebo. Two participants randomized to Placebo received Injectafer. Therefore the Numbers at Risk comprised 107 for Injectafer 101 for placebo.
|
|
Respiratory, thoracic and mediastinal disorders
Chronic obstructive pulmonary disease
|
0.00%
0/107 • 2 years, I month
209 participants were randomized of whom 208 received study drug: 105 who were randomized to Injectafer and 103 who were randomized to placebo. Two participants randomized to Placebo received Injectafer. Therefore the Numbers at Risk comprised 107 for Injectafer 101 for placebo.
|
0.99%
1/101 • Number of events 1 • 2 years, I month
209 participants were randomized of whom 208 received study drug: 105 who were randomized to Injectafer and 103 who were randomized to placebo. Two participants randomized to Placebo received Injectafer. Therefore the Numbers at Risk comprised 107 for Injectafer 101 for placebo.
|
Other adverse events
| Measure |
Injectafer
n=107 participants at risk
Two doses of Injectafer 750 mg undiluted dose at 100 mg/minute given 5 days apart for a total of 1500 mgs.
Injectafer
|
Normal Saline
n=101 participants at risk
IV Placebo (15ml of Normal Saline) IV push at 2ml/minute
Placebo
|
|---|---|---|
|
Gastrointestinal disorders
Nausea
|
9.3%
10/107 • Number of events 12 • 2 years, I month
209 participants were randomized of whom 208 received study drug: 105 who were randomized to Injectafer and 103 who were randomized to placebo. Two participants randomized to Placebo received Injectafer. Therefore the Numbers at Risk comprised 107 for Injectafer 101 for placebo.
|
0.99%
1/101 • Number of events 1 • 2 years, I month
209 participants were randomized of whom 208 received study drug: 105 who were randomized to Injectafer and 103 who were randomized to placebo. Two participants randomized to Placebo received Injectafer. Therefore the Numbers at Risk comprised 107 for Injectafer 101 for placebo.
|
|
General disorders
Feeling hot
|
5.6%
6/107 • Number of events 6 • 2 years, I month
209 participants were randomized of whom 208 received study drug: 105 who were randomized to Injectafer and 103 who were randomized to placebo. Two participants randomized to Placebo received Injectafer. Therefore the Numbers at Risk comprised 107 for Injectafer 101 for placebo.
|
0.00%
0/101 • 2 years, I month
209 participants were randomized of whom 208 received study drug: 105 who were randomized to Injectafer and 103 who were randomized to placebo. Two participants randomized to Placebo received Injectafer. Therefore the Numbers at Risk comprised 107 for Injectafer 101 for placebo.
|
|
Investigations
Blood pressure increased
|
4.7%
5/107 • Number of events 5 • 2 years, I month
209 participants were randomized of whom 208 received study drug: 105 who were randomized to Injectafer and 103 who were randomized to placebo. Two participants randomized to Placebo received Injectafer. Therefore the Numbers at Risk comprised 107 for Injectafer 101 for placebo.
|
0.99%
1/101 • Number of events 1 • 2 years, I month
209 participants were randomized of whom 208 received study drug: 105 who were randomized to Injectafer and 103 who were randomized to placebo. Two participants randomized to Placebo received Injectafer. Therefore the Numbers at Risk comprised 107 for Injectafer 101 for placebo.
|
|
Investigations
Alanine aminotransferase increased
|
4.7%
5/107 • Number of events 5 • 2 years, I month
209 participants were randomized of whom 208 received study drug: 105 who were randomized to Injectafer and 103 who were randomized to placebo. Two participants randomized to Placebo received Injectafer. Therefore the Numbers at Risk comprised 107 for Injectafer 101 for placebo.
|
0.99%
1/101 • Number of events 1 • 2 years, I month
209 participants were randomized of whom 208 received study drug: 105 who were randomized to Injectafer and 103 who were randomized to placebo. Two participants randomized to Placebo received Injectafer. Therefore the Numbers at Risk comprised 107 for Injectafer 101 for placebo.
|
|
Investigations
Blood phosphorus decreased
|
2.8%
3/107 • Number of events 3 • 2 years, I month
209 participants were randomized of whom 208 received study drug: 105 who were randomized to Injectafer and 103 who were randomized to placebo. Two participants randomized to Placebo received Injectafer. Therefore the Numbers at Risk comprised 107 for Injectafer 101 for placebo.
|
0.00%
0/101 • 2 years, I month
209 participants were randomized of whom 208 received study drug: 105 who were randomized to Injectafer and 103 who were randomized to placebo. Two participants randomized to Placebo received Injectafer. Therefore the Numbers at Risk comprised 107 for Injectafer 101 for placebo.
|
|
Investigations
Aspartate aminotransferase increased
|
2.8%
3/107 • Number of events 3 • 2 years, I month
209 participants were randomized of whom 208 received study drug: 105 who were randomized to Injectafer and 103 who were randomized to placebo. Two participants randomized to Placebo received Injectafer. Therefore the Numbers at Risk comprised 107 for Injectafer 101 for placebo.
|
0.99%
1/101 • Number of events 1 • 2 years, I month
209 participants were randomized of whom 208 received study drug: 105 who were randomized to Injectafer and 103 who were randomized to placebo. Two participants randomized to Placebo received Injectafer. Therefore the Numbers at Risk comprised 107 for Injectafer 101 for placebo.
|
|
Investigations
Blood pressure systolic increased
|
4.7%
5/107 • Number of events 5 • 2 years, I month
209 participants were randomized of whom 208 received study drug: 105 who were randomized to Injectafer and 103 who were randomized to placebo. Two participants randomized to Placebo received Injectafer. Therefore the Numbers at Risk comprised 107 for Injectafer 101 for placebo.
|
0.99%
1/101 • Number of events 1 • 2 years, I month
209 participants were randomized of whom 208 received study drug: 105 who were randomized to Injectafer and 103 who were randomized to placebo. Two participants randomized to Placebo received Injectafer. Therefore the Numbers at Risk comprised 107 for Injectafer 101 for placebo.
|
|
Metabolism and nutrition disorders
Hypophosphataemia
|
7.5%
8/107 • Number of events 9 • 2 years, I month
209 participants were randomized of whom 208 received study drug: 105 who were randomized to Injectafer and 103 who were randomized to placebo. Two participants randomized to Placebo received Injectafer. Therefore the Numbers at Risk comprised 107 for Injectafer 101 for placebo.
|
0.99%
1/101 • Number of events 1 • 2 years, I month
209 participants were randomized of whom 208 received study drug: 105 who were randomized to Injectafer and 103 who were randomized to placebo. Two participants randomized to Placebo received Injectafer. Therefore the Numbers at Risk comprised 107 for Injectafer 101 for placebo.
|
|
Metabolism and nutrition disorders
Decreased appetite
|
3.7%
4/107 • Number of events 4 • 2 years, I month
209 participants were randomized of whom 208 received study drug: 105 who were randomized to Injectafer and 103 who were randomized to placebo. Two participants randomized to Placebo received Injectafer. Therefore the Numbers at Risk comprised 107 for Injectafer 101 for placebo.
|
0.00%
0/101 • 2 years, I month
209 participants were randomized of whom 208 received study drug: 105 who were randomized to Injectafer and 103 who were randomized to placebo. Two participants randomized to Placebo received Injectafer. Therefore the Numbers at Risk comprised 107 for Injectafer 101 for placebo.
|
|
Nervous system disorders
Dizziness
|
7.5%
8/107 • Number of events 8 • 2 years, I month
209 participants were randomized of whom 208 received study drug: 105 who were randomized to Injectafer and 103 who were randomized to placebo. Two participants randomized to Placebo received Injectafer. Therefore the Numbers at Risk comprised 107 for Injectafer 101 for placebo.
|
0.99%
1/101 • Number of events 1 • 2 years, I month
209 participants were randomized of whom 208 received study drug: 105 who were randomized to Injectafer and 103 who were randomized to placebo. Two participants randomized to Placebo received Injectafer. Therefore the Numbers at Risk comprised 107 for Injectafer 101 for placebo.
|
|
Nervous system disorders
Headache
|
4.7%
5/107 • Number of events 5 • 2 years, I month
209 participants were randomized of whom 208 received study drug: 105 who were randomized to Injectafer and 103 who were randomized to placebo. Two participants randomized to Placebo received Injectafer. Therefore the Numbers at Risk comprised 107 for Injectafer 101 for placebo.
|
5.9%
6/101 • Number of events 9 • 2 years, I month
209 participants were randomized of whom 208 received study drug: 105 who were randomized to Injectafer and 103 who were randomized to placebo. Two participants randomized to Placebo received Injectafer. Therefore the Numbers at Risk comprised 107 for Injectafer 101 for placebo.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
0.00%
0/107 • 2 years, I month
209 participants were randomized of whom 208 received study drug: 105 who were randomized to Injectafer and 103 who were randomized to placebo. Two participants randomized to Placebo received Injectafer. Therefore the Numbers at Risk comprised 107 for Injectafer 101 for placebo.
|
2.0%
2/101 • Number of events 2 • 2 years, I month
209 participants were randomized of whom 208 received study drug: 105 who were randomized to Injectafer and 103 who were randomized to placebo. Two participants randomized to Placebo received Injectafer. Therefore the Numbers at Risk comprised 107 for Injectafer 101 for placebo.
|
|
Vascular disorders
Hot flush
|
4.7%
5/107 • Number of events 5 • 2 years, I month
209 participants were randomized of whom 208 received study drug: 105 who were randomized to Injectafer and 103 who were randomized to placebo. Two participants randomized to Placebo received Injectafer. Therefore the Numbers at Risk comprised 107 for Injectafer 101 for placebo.
|
0.99%
1/101 • Number of events 1 • 2 years, I month
209 participants were randomized of whom 208 received study drug: 105 who were randomized to Injectafer and 103 who were randomized to placebo. Two participants randomized to Placebo received Injectafer. Therefore the Numbers at Risk comprised 107 for Injectafer 101 for placebo.
|
|
Vascular disorders
Flushing
|
5.6%
6/107 • Number of events 6 • 2 years, I month
209 participants were randomized of whom 208 received study drug: 105 who were randomized to Injectafer and 103 who were randomized to placebo. Two participants randomized to Placebo received Injectafer. Therefore the Numbers at Risk comprised 107 for Injectafer 101 for placebo.
|
0.00%
0/101 • 2 years, I month
209 participants were randomized of whom 208 received study drug: 105 who were randomized to Injectafer and 103 who were randomized to placebo. Two participants randomized to Placebo received Injectafer. Therefore the Numbers at Risk comprised 107 for Injectafer 101 for placebo.
|
|
Investigations
Gamma-Glutamyl Transferase Increase
|
2.8%
3/107 • Number of events 3 • 2 years, I month
209 participants were randomized of whom 208 received study drug: 105 who were randomized to Injectafer and 103 who were randomized to placebo. Two participants randomized to Placebo received Injectafer. Therefore the Numbers at Risk comprised 107 for Injectafer 101 for placebo.
|
3.0%
3/101 • Number of events 3 • 2 years, I month
209 participants were randomized of whom 208 received study drug: 105 who were randomized to Injectafer and 103 who were randomized to placebo. Two participants randomized to Placebo received Injectafer. Therefore the Numbers at Risk comprised 107 for Injectafer 101 for placebo.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: LTE60