Trial Outcomes & Findings for An Extension Trial to Assess the Safety of Re-dosing of Iron Isomaltoside/Ferric Derisomaltose (Monofer®/Monoferric®) (NCT NCT02962648)
NCT ID: NCT02962648
Last Updated: 2020-03-10
Results Overview
Safety Evaluate the number of subjects with adverse drug reactions (ADRs), defined as AEs that were assessed by the investigator as related or possible related to the investigational product.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
103 participants
Primary outcome timeframe
Baseline to week 26
Results posted on
2020-03-10
Participant Flow
A total of 193 subjects were screened and 103 subjects were enrolled into the trial.
Subjects enrolled in this extension trial had previously participated in the lead-in trials IDA-03 (52%, NCT02940886), CKD-04 (32%, NCT02940860), and IDA-01 (16%, NCT02130063).
Participant milestones
| Measure |
Iron Isomaltoside/Ferric Derisomaltose
Iron isomaltoside/ferric derisomaltose (Monofer®/Monoferric®; 100 mg/mL) was the test product in this trial.
Subjects received iron isomaltoside/ferric derisomaltose (Monofer®/Monoferric®; 100 mg/mL) as a single IV infusion of 1000 mg at the baseline visit.
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|---|---|
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Overall Study
STARTED
|
103
|
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Overall Study
COMPLETED
|
94
|
|
Overall Study
NOT COMPLETED
|
9
|
Reasons for withdrawal
| Measure |
Iron Isomaltoside/Ferric Derisomaltose
Iron isomaltoside/ferric derisomaltose (Monofer®/Monoferric®; 100 mg/mL) was the test product in this trial.
Subjects received iron isomaltoside/ferric derisomaltose (Monofer®/Monoferric®; 100 mg/mL) as a single IV infusion of 1000 mg at the baseline visit.
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|---|---|
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Overall Study
Withdrawal by Subject
|
3
|
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Overall Study
Lost to Follow-up
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3
|
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Overall Study
Physician Decision
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1
|
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Overall Study
Subject had problems with transportation
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2
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Baseline Characteristics
An Extension Trial to Assess the Safety of Re-dosing of Iron Isomaltoside/Ferric Derisomaltose (Monofer®/Monoferric®)
Baseline characteristics by cohort
| Measure |
Iron Isomaltoside/Ferric Derisomaltose
n=103 Participants
Iron isomaltoside/ferric derisomaltose, administered IV
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
82 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
21 Participants
n=5 Participants
|
|
Age, Continuous
|
49.9 years
STANDARD_DEVIATION 15.7 • n=5 Participants
|
|
Age, Customized
18-64 years
|
82 Participants
n=5 Participants
|
|
Age, Customized
65-84 years
|
18 Participants
n=5 Participants
|
|
Age, Customized
>84 years
|
3 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
87 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
16 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
46 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
57 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
41 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
60 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
United States
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103 participants
n=5 Participants
|
|
Current smoker
Yes
|
8 Participants
n=5 Participants
|
|
Current smoker
No
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95 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Baseline to week 26Population: Safety analysis set: included all subjects who received at least one dose of the investigational product.
Safety Evaluate the number of subjects with adverse drug reactions (ADRs), defined as AEs that were assessed by the investigator as related or possible related to the investigational product.
Outcome measures
| Measure |
Iron Isomaltoside/Ferric Derisomaltose
n=102 Participants
Iron isomaltoside/ferric derisomaltose, administered IV
|
|---|---|
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Number of Subjects With Adverse Drug Reactions (ADR)
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5 Participants
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SECONDARY outcome
Timeframe: Baseline to week 26Population: Safety analysis set: included all subjects who received at least one dose of the investigational product.
Safety. For this endpoint, the number of participants with serious or severe hypersensitivity reactions were evaluated. The hypersensitivity terms that were included in the analysis were those that started or after the first dose of treatment (i.e. treatment emergent). The terms used to define hypersensitivity were those specified by the Standardised MedDRA Queries (SMQ) for hypersensitivity, plus four additional terms: Loss of consciousness; Seizure; Syncope; Unresponsiveness. The potential hypersensitivity AEs were adjudicated in a blinded fashion by an independent Clinical Endpoint Adjudication Committee (CEAC). Results show only those participants that had adjudicated and confirmed serious or severe hypersensitivity reactions.
Outcome measures
| Measure |
Iron Isomaltoside/Ferric Derisomaltose
n=102 Participants
Iron isomaltoside/ferric derisomaltose, administered IV
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|---|---|
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Incidence of Protocol-defined Serious or Severe Hypersensitivity Reactions
|
0 Participants
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SECONDARY outcome
Timeframe: Baseline to week 26Population: Safety analysis set: included all subjects who received at least one dose of the investigational product.
Safety Results show the composite cardiovascular AEs, that started on or after the first dose of treatment (i.e. treatment emergent) up to month 6. The reported potential cardiovascular AEs were adjudicated in a blinded fashion by an independent Clinical Endpoint Adjudication Committee (CEAC). The potential cardiovascular AEs included the following: * Death due to any cause * Non-fatal myocardial infarction * Non-fatal stroke * Unstable angina requiring hospitalisation * Congestive heart failure requiring hospitalisation or medical intervention * Arrhythmias * Hypertension * Hypotension Results show only those participants that had adjudicated and confirmed treatment-emergent composite cardiovascular AEs.
Outcome measures
| Measure |
Iron Isomaltoside/Ferric Derisomaltose
n=102 Participants
Iron isomaltoside/ferric derisomaltose, administered IV
|
|---|---|
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Composite Cardiovascular Adverse Events (AEs)
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6 Participants
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SECONDARY outcome
Timeframe: Baseline, week 2, 13, and 26Population: Safety analysis set: included all subjects who received at least one dose of the investigational product.
Safety Time to first composite cardiovascular AE was defined as the actual time in days from first dose of treatment until the date of the composite cardiovascular AE. For subjects not reporting a composite cardiovascular AE, the time was censored at the date of the last attended visit. Only the adjudicated and confirmed composite cardiovascular safety AEs, as judged by the Clinical Endpoint Adjudication Committee (CEAC), were considered for this endpoint. Time to first composite cardiovascular AE was defined as the actual time in days from first dose of treatment until the date of the composite cardiovascular AE. For subjects not reporting a composite cardiovascular AE, the time was censored at the date of the last attended visit.
Outcome measures
| Measure |
Iron Isomaltoside/Ferric Derisomaltose
n=102 Participants
Iron isomaltoside/ferric derisomaltose, administered IV
|
|---|---|
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Time to First Composite Cardiovascular Safety AE
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NA week
The number of adjudicated and confirmed composite cardiovascular safety AEs was too low (N=6) for estimation of median and 95 % CI.
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SECONDARY outcome
Timeframe: Baseline to week 26Population: Safety analysis set: included all subjects who received at least one dose of the investigational product.
Safety Results show the number of trial participants and their status of s-phosphate \<2 mg/dL, at any time from baseline to week 26.
Outcome measures
| Measure |
Iron Isomaltoside/Ferric Derisomaltose
n=102 Participants
Iron isomaltoside/ferric derisomaltose, administered IV
|
|---|---|
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S-phosphate <2 mg/dL at Any Time From Baseline to Week 26
Yes
|
8 Participants
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S-phosphate <2 mg/dL at Any Time From Baseline to Week 26
No
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94 Participants
|
SECONDARY outcome
Timeframe: Baseline, week 2, 13, and 26Population: Intention-to-treat (ITT) analysis set: included all subjects, except for screening failures and subjects withdrawn before visit 2 (baseline).
Efficacy. Change in Hb from baseline to week 2, 13, and 26.
Outcome measures
| Measure |
Iron Isomaltoside/Ferric Derisomaltose
n=103 Participants
Iron isomaltoside/ferric derisomaltose, administered IV
|
|---|---|
|
Change in Hb From Baseline to Week 2, 13, and 26
Week 2
|
1.23 g/dL
Standard Deviation 1.40
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Change in Hb From Baseline to Week 2, 13, and 26
Week 13
|
1.73 g/dL
Standard Deviation 1.83
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Change in Hb From Baseline to Week 2, 13, and 26
Week 26
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1.34 g/dL
Standard Deviation 1.93
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SECONDARY outcome
Timeframe: Baseline, week 2, 13, and 26Population: Intention-to-treat (ITT) analysis set: included all subjects, except for screening failures and subjects withdrawn before visit 2 (baseline).
Efficacy. Change in s-ferritin from baseline to week 2, 13, and 26.
Outcome measures
| Measure |
Iron Isomaltoside/Ferric Derisomaltose
n=103 Participants
Iron isomaltoside/ferric derisomaltose, administered IV
|
|---|---|
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Change in S-ferritin From Baseline to Week 2, 13, and 26
Week 2
|
255.6 ng/mL
Standard Deviation 177.9
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Change in S-ferritin From Baseline to Week 2, 13, and 26
Week 13
|
87.9 ng/mL
Standard Deviation 123.6
|
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Change in S-ferritin From Baseline to Week 2, 13, and 26
Week 26
|
93.9 ng/mL
Standard Deviation 180.4
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SECONDARY outcome
Timeframe: Baseline, week 2, 13, and 26Population: Intention-to-treat (ITT) analysis set: included all subjects, except for screening failures and subjects withdrawn before visit 2 (baseline).
Efficacy Change in transferrin saturation (TSAT) from baseline to week 2, 13, and 26. TSAT is the value of serum iron divided by the total iron-binding capacity and the unit is %, which referrers to % of iron-binding sites of transferrin being occupied by iron.
Outcome measures
| Measure |
Iron Isomaltoside/Ferric Derisomaltose
n=103 Participants
Iron isomaltoside/ferric derisomaltose, administered IV
|
|---|---|
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Change in Transferrin Saturation (TSAT) From Baseline to Week 2, 13, and 26
Week 2
|
8.16 percentage of saturation
Standard Deviation 11.87
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Change in Transferrin Saturation (TSAT) From Baseline to Week 2, 13, and 26
Week 13
|
4.42 percentage of saturation
Standard Deviation 10.81
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Change in Transferrin Saturation (TSAT) From Baseline to Week 2, 13, and 26
Week 26
|
1.78 percentage of saturation
Standard Deviation 10.63
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SECONDARY outcome
Timeframe: Baseline, week 2, 13, and 26Population: Intention-to-treat (ITT) analysis set: included all subjects, except for screening failures and subjects withdrawn before visit 2 (baseline).
Efficacy. Change in s-iron from baseline to week 2, 13, and 26.
Outcome measures
| Measure |
Iron Isomaltoside/Ferric Derisomaltose
n=103 Participants
Iron isomaltoside/ferric derisomaltose, administered IV
|
|---|---|
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Change in S-iron From Baseline to Week 2, 13, and 26
Week 2
|
21.1 μg/dL
Standard Deviation 50.5
|
|
Change in S-iron From Baseline to Week 2, 13, and 26
Week 13
|
10.7 μg/dL
Standard Deviation 45.4
|
|
Change in S-iron From Baseline to Week 2, 13, and 26
Week 26
|
4.0 μg/dL
Standard Deviation 44.1
|
Adverse Events
Iron Isomaltoside/Ferric Derisomaltose
Serious events: 13 serious events
Other events: 17 other events
Deaths: 1 deaths
Serious adverse events
| Measure |
Iron Isomaltoside/Ferric Derisomaltose
n=102 participants at risk
Iron isomaltoside/ferric derisomaltose, administered IV
|
|---|---|
|
Infections and infestations
Appendicitis
|
0.98%
1/102 • Number of events 1 • From the time subjects signed the informed consent form (CRF) until they completed the trial, all adverse events (AEs) or serious adverse events (SAEs) were recorded in the CRF. The actual study duration was 6 months (or shorted if the trial was discontinued). Overall, eligible subjects participated in the trial for approximately 6.5 months (including a 14-day screening period).
An AE was described as follows: the nature of the event was described in precise, standard medical terminology (i.e. not necessarily the exact words used by the subject). If known, a specific diagnosis was stated. Furthermore, the Investigator described an AE regarding seriousness, severity, relatedness, and outcome.
|
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Infections and infestations
Cellulitis
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0.98%
1/102 • Number of events 1 • From the time subjects signed the informed consent form (CRF) until they completed the trial, all adverse events (AEs) or serious adverse events (SAEs) were recorded in the CRF. The actual study duration was 6 months (or shorted if the trial was discontinued). Overall, eligible subjects participated in the trial for approximately 6.5 months (including a 14-day screening period).
An AE was described as follows: the nature of the event was described in precise, standard medical terminology (i.e. not necessarily the exact words used by the subject). If known, a specific diagnosis was stated. Furthermore, the Investigator described an AE regarding seriousness, severity, relatedness, and outcome.
|
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Infections and infestations
Endometritis
|
0.98%
1/102 • Number of events 1 • From the time subjects signed the informed consent form (CRF) until they completed the trial, all adverse events (AEs) or serious adverse events (SAEs) were recorded in the CRF. The actual study duration was 6 months (or shorted if the trial was discontinued). Overall, eligible subjects participated in the trial for approximately 6.5 months (including a 14-day screening period).
An AE was described as follows: the nature of the event was described in precise, standard medical terminology (i.e. not necessarily the exact words used by the subject). If known, a specific diagnosis was stated. Furthermore, the Investigator described an AE regarding seriousness, severity, relatedness, and outcome.
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Renal and urinary disorders
Chronic kidney disease
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2.0%
2/102 • Number of events 2 • From the time subjects signed the informed consent form (CRF) until they completed the trial, all adverse events (AEs) or serious adverse events (SAEs) were recorded in the CRF. The actual study duration was 6 months (or shorted if the trial was discontinued). Overall, eligible subjects participated in the trial for approximately 6.5 months (including a 14-day screening period).
An AE was described as follows: the nature of the event was described in precise, standard medical terminology (i.e. not necessarily the exact words used by the subject). If known, a specific diagnosis was stated. Furthermore, the Investigator described an AE regarding seriousness, severity, relatedness, and outcome.
|
|
Cardiac disorders
Cardiac failure congestive
|
0.98%
1/102 • Number of events 1 • From the time subjects signed the informed consent form (CRF) until they completed the trial, all adverse events (AEs) or serious adverse events (SAEs) were recorded in the CRF. The actual study duration was 6 months (or shorted if the trial was discontinued). Overall, eligible subjects participated in the trial for approximately 6.5 months (including a 14-day screening period).
An AE was described as follows: the nature of the event was described in precise, standard medical terminology (i.e. not necessarily the exact words used by the subject). If known, a specific diagnosis was stated. Furthermore, the Investigator described an AE regarding seriousness, severity, relatedness, and outcome.
|
|
General disorders
Chest pain
|
0.98%
1/102 • Number of events 1 • From the time subjects signed the informed consent form (CRF) until they completed the trial, all adverse events (AEs) or serious adverse events (SAEs) were recorded in the CRF. The actual study duration was 6 months (or shorted if the trial was discontinued). Overall, eligible subjects participated in the trial for approximately 6.5 months (including a 14-day screening period).
An AE was described as follows: the nature of the event was described in precise, standard medical terminology (i.e. not necessarily the exact words used by the subject). If known, a specific diagnosis was stated. Furthermore, the Investigator described an AE regarding seriousness, severity, relatedness, and outcome.
|
|
Injury, poisoning and procedural complications
Fall
|
0.98%
1/102 • Number of events 1 • From the time subjects signed the informed consent form (CRF) until they completed the trial, all adverse events (AEs) or serious adverse events (SAEs) were recorded in the CRF. The actual study duration was 6 months (or shorted if the trial was discontinued). Overall, eligible subjects participated in the trial for approximately 6.5 months (including a 14-day screening period).
An AE was described as follows: the nature of the event was described in precise, standard medical terminology (i.e. not necessarily the exact words used by the subject). If known, a specific diagnosis was stated. Furthermore, the Investigator described an AE regarding seriousness, severity, relatedness, and outcome.
|
|
Metabolism and nutrition disorders
Hypocalcaemia
|
0.98%
1/102 • Number of events 1 • From the time subjects signed the informed consent form (CRF) until they completed the trial, all adverse events (AEs) or serious adverse events (SAEs) were recorded in the CRF. The actual study duration was 6 months (or shorted if the trial was discontinued). Overall, eligible subjects participated in the trial for approximately 6.5 months (including a 14-day screening period).
An AE was described as follows: the nature of the event was described in precise, standard medical terminology (i.e. not necessarily the exact words used by the subject). If known, a specific diagnosis was stated. Furthermore, the Investigator described an AE regarding seriousness, severity, relatedness, and outcome.
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
0.98%
1/102 • Number of events 1 • From the time subjects signed the informed consent form (CRF) until they completed the trial, all adverse events (AEs) or serious adverse events (SAEs) were recorded in the CRF. The actual study duration was 6 months (or shorted if the trial was discontinued). Overall, eligible subjects participated in the trial for approximately 6.5 months (including a 14-day screening period).
An AE was described as follows: the nature of the event was described in precise, standard medical terminology (i.e. not necessarily the exact words used by the subject). If known, a specific diagnosis was stated. Furthermore, the Investigator described an AE regarding seriousness, severity, relatedness, and outcome.
|
|
Reproductive system and breast disorders
Menorrhagia
|
0.98%
1/102 • Number of events 1 • From the time subjects signed the informed consent form (CRF) until they completed the trial, all adverse events (AEs) or serious adverse events (SAEs) were recorded in the CRF. The actual study duration was 6 months (or shorted if the trial was discontinued). Overall, eligible subjects participated in the trial for approximately 6.5 months (including a 14-day screening period).
An AE was described as follows: the nature of the event was described in precise, standard medical terminology (i.e. not necessarily the exact words used by the subject). If known, a specific diagnosis was stated. Furthermore, the Investigator described an AE regarding seriousness, severity, relatedness, and outcome.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
0.98%
1/102 • Number of events 1 • From the time subjects signed the informed consent form (CRF) until they completed the trial, all adverse events (AEs) or serious adverse events (SAEs) were recorded in the CRF. The actual study duration was 6 months (or shorted if the trial was discontinued). Overall, eligible subjects participated in the trial for approximately 6.5 months (including a 14-day screening period).
An AE was described as follows: the nature of the event was described in precise, standard medical terminology (i.e. not necessarily the exact words used by the subject). If known, a specific diagnosis was stated. Furthermore, the Investigator described an AE regarding seriousness, severity, relatedness, and outcome.
|
|
Vascular disorders
Hypertensive crisis
|
0.98%
1/102 • Number of events 1 • From the time subjects signed the informed consent form (CRF) until they completed the trial, all adverse events (AEs) or serious adverse events (SAEs) were recorded in the CRF. The actual study duration was 6 months (or shorted if the trial was discontinued). Overall, eligible subjects participated in the trial for approximately 6.5 months (including a 14-day screening period).
An AE was described as follows: the nature of the event was described in precise, standard medical terminology (i.e. not necessarily the exact words used by the subject). If known, a specific diagnosis was stated. Furthermore, the Investigator described an AE regarding seriousness, severity, relatedness, and outcome.
|
Other adverse events
| Measure |
Iron Isomaltoside/Ferric Derisomaltose
n=102 participants at risk
Iron isomaltoside/ferric derisomaltose, administered IV
|
|---|---|
|
General disorders
Fatigue
|
2.9%
3/102 • Number of events 3 • From the time subjects signed the informed consent form (CRF) until they completed the trial, all adverse events (AEs) or serious adverse events (SAEs) were recorded in the CRF. The actual study duration was 6 months (or shorted if the trial was discontinued). Overall, eligible subjects participated in the trial for approximately 6.5 months (including a 14-day screening period).
An AE was described as follows: the nature of the event was described in precise, standard medical terminology (i.e. not necessarily the exact words used by the subject). If known, a specific diagnosis was stated. Furthermore, the Investigator described an AE regarding seriousness, severity, relatedness, and outcome.
|
|
Gastrointestinal disorders
Abdominal pain
|
2.9%
3/102 • Number of events 3 • From the time subjects signed the informed consent form (CRF) until they completed the trial, all adverse events (AEs) or serious adverse events (SAEs) were recorded in the CRF. The actual study duration was 6 months (or shorted if the trial was discontinued). Overall, eligible subjects participated in the trial for approximately 6.5 months (including a 14-day screening period).
An AE was described as follows: the nature of the event was described in precise, standard medical terminology (i.e. not necessarily the exact words used by the subject). If known, a specific diagnosis was stated. Furthermore, the Investigator described an AE regarding seriousness, severity, relatedness, and outcome.
|
|
Infections and infestations
Urinary tract infection
|
2.9%
3/102 • Number of events 3 • From the time subjects signed the informed consent form (CRF) until they completed the trial, all adverse events (AEs) or serious adverse events (SAEs) were recorded in the CRF. The actual study duration was 6 months (or shorted if the trial was discontinued). Overall, eligible subjects participated in the trial for approximately 6.5 months (including a 14-day screening period).
An AE was described as follows: the nature of the event was described in precise, standard medical terminology (i.e. not necessarily the exact words used by the subject). If known, a specific diagnosis was stated. Furthermore, the Investigator described an AE regarding seriousness, severity, relatedness, and outcome.
|
|
Nervous system disorders
Dizziness
|
2.9%
3/102 • Number of events 3 • From the time subjects signed the informed consent form (CRF) until they completed the trial, all adverse events (AEs) or serious adverse events (SAEs) were recorded in the CRF. The actual study duration was 6 months (or shorted if the trial was discontinued). Overall, eligible subjects participated in the trial for approximately 6.5 months (including a 14-day screening period).
An AE was described as follows: the nature of the event was described in precise, standard medical terminology (i.e. not necessarily the exact words used by the subject). If known, a specific diagnosis was stated. Furthermore, the Investigator described an AE regarding seriousness, severity, relatedness, and outcome.
|
|
Nervous system disorders
Headache
|
2.9%
3/102 • Number of events 3 • From the time subjects signed the informed consent form (CRF) until they completed the trial, all adverse events (AEs) or serious adverse events (SAEs) were recorded in the CRF. The actual study duration was 6 months (or shorted if the trial was discontinued). Overall, eligible subjects participated in the trial for approximately 6.5 months (including a 14-day screening period).
An AE was described as follows: the nature of the event was described in precise, standard medical terminology (i.e. not necessarily the exact words used by the subject). If known, a specific diagnosis was stated. Furthermore, the Investigator described an AE regarding seriousness, severity, relatedness, and outcome.
|
|
Vascular disorders
Hypertension
|
2.9%
3/102 • Number of events 3 • From the time subjects signed the informed consent form (CRF) until they completed the trial, all adverse events (AEs) or serious adverse events (SAEs) were recorded in the CRF. The actual study duration was 6 months (or shorted if the trial was discontinued). Overall, eligible subjects participated in the trial for approximately 6.5 months (including a 14-day screening period).
An AE was described as follows: the nature of the event was described in precise, standard medical terminology (i.e. not necessarily the exact words used by the subject). If known, a specific diagnosis was stated. Furthermore, the Investigator described an AE regarding seriousness, severity, relatedness, and outcome.
|
|
Blood and lymphatic system disorders
Anaemia
|
2.9%
3/102 • Number of events 3 • From the time subjects signed the informed consent form (CRF) until they completed the trial, all adverse events (AEs) or serious adverse events (SAEs) were recorded in the CRF. The actual study duration was 6 months (or shorted if the trial was discontinued). Overall, eligible subjects participated in the trial for approximately 6.5 months (including a 14-day screening period).
An AE was described as follows: the nature of the event was described in precise, standard medical terminology (i.e. not necessarily the exact words used by the subject). If known, a specific diagnosis was stated. Furthermore, the Investigator described an AE regarding seriousness, severity, relatedness, and outcome.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee Institution may publish the study results. Before submission for publication or presentation, Institution shall allow Sponsor not less than 90 days to review any manuscript and not less than 30 days to review any poster presentation, abstract, or any other written or oral material which describes or discloses the study results. If sponsor so requests in writing, Institution shall withhold any publication or presentation for an additional 90 days.
- Publication restrictions are in place
Restriction type: OTHER