Trial Outcomes & Findings for Safety and Efficacy Study of Romiplostim (AMG 531) to Treat ITP in Pediatric Subjects (NCT NCT00515203)
NCT ID: NCT00515203
Last Updated: 2014-07-25
Results Overview
Occurrence of one or more adverse events in the participant during the 12-week treatment period
Recruitment status
COMPLETED
Study phase
PHASE1/PHASE2
Target enrollment
22 participants
Primary outcome timeframe
12 weeks
Results posted on
2014-07-25
Participant Flow
Participants were enrolled from 19 Jul 2007 through 11 November 2008
Participant milestones
| Measure |
Romiplostim
Romiplostim by subcutaneous injection once weekly at a starting dose of 1 µg/kg, adjusted based on weekly platelet counts to a maximum weekly dose of 10 µg/kg
|
Placebo
Placebo by subcutaneous injection once weekly
|
|---|---|---|
|
Overall Study
STARTED
|
17
|
5
|
|
Overall Study
COMPLETED
|
17
|
5
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Safety and Efficacy Study of Romiplostim (AMG 531) to Treat ITP in Pediatric Subjects
Baseline characteristics by cohort
| Measure |
Romiplostim
n=17 Participants
Romiplostim by subcutaneous injection once weekly at a starting dose of 1 µg/kg, adjusted based on weekly platelet counts to a maximum weekly dose of 10 µg/kg
|
Placebo
n=5 Participants
Placebo by subcutaneous injection once weekly
|
Total
n=22 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
9.4 Years
STANDARD_DEVIATION 5.4 • n=5 Participants
|
9.8 Years
STANDARD_DEVIATION 4.6 • n=7 Participants
|
9.5 Years
STANDARD_DEVIATION 5.1 • n=5 Participants
|
|
Sex: Female, Male
Female
|
4 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
13 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
16 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
White or Caucasian
|
9 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
13 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Black or African American
|
5 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Hispanic or Latino
|
3 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Other
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 12 weeksPopulation: Safety Analysis Set, composed of all participants who received at least one dose of study medication
Occurrence of one or more adverse events in the participant during the 12-week treatment period
Outcome measures
| Measure |
Romiplostim
n=17 Participants
Romiplostim by subcutaneous injection once weekly at a starting dose of 1 µg/kg, adjusted based on weekly platelet counts to a maximum weekly dose of 10 µg/kg
|
Placebo
n=5 Participants
Placebo by subcutaneous injection once weekly
|
|---|---|---|
|
Adverse Events
|
16 Participants
|
5 Participants
|
SECONDARY outcome
Timeframe: 12-week treatment periodPopulation: Efficacy Analysis Set, composed of all randomized participants
The number of weeks with platelet count ≥ 50 x 10\^9/L during the 12 week treatment period.
Outcome measures
| Measure |
Romiplostim
n=17 Participants
Romiplostim by subcutaneous injection once weekly at a starting dose of 1 µg/kg, adjusted based on weekly platelet counts to a maximum weekly dose of 10 µg/kg
|
Placebo
n=5 Participants
Placebo by subcutaneous injection once weekly
|
|---|---|---|
|
Weeks With Platelet Count ≥ 50 x 10^9/L
|
5.65 Weeks
Standard Deviation 3.00
|
0.00 Weeks
Standard Deviation 0.00
|
SECONDARY outcome
Timeframe: 12-week treatment period (Weeks 2 - 13)Population: Efficacy Analysis Set, composed of all randomized participants
Total number of bleeding events (Grade 2 or higher, i.e., mild to life-threatening, as defined in the protocol) for each participant during Weeks 2-13 (end-of-study visit for non-responders)
Outcome measures
| Measure |
Romiplostim
n=17 Participants
Romiplostim by subcutaneous injection once weekly at a starting dose of 1 µg/kg, adjusted based on weekly platelet counts to a maximum weekly dose of 10 µg/kg
|
Placebo
n=5 Participants
Placebo by subcutaneous injection once weekly
|
|---|---|---|
|
Bleeding Events (Grade 2 or Higher)
|
0.41 Events per participant
Standard Deviation 1.00
|
0.00 Events per participant
Standard Deviation 0.00
|
SECONDARY outcome
Timeframe: 12-week treatment periodPopulation: Efficacy Analysis Set, composed of all randomized participants
Participant incidence of achieving a platelet count ≥50 x 10\^9/L for two consecutive weeks during the 12 week treatment period.
Outcome measures
| Measure |
Romiplostim
n=17 Participants
Romiplostim by subcutaneous injection once weekly at a starting dose of 1 µg/kg, adjusted based on weekly platelet counts to a maximum weekly dose of 10 µg/kg
|
Placebo
n=5 Participants
Placebo by subcutaneous injection once weekly
|
|---|---|---|
|
Platelet Count ≥ 50 x 10^9/L for Two Consecutive Weeks
|
15 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: 12-week treatment periodPopulation: Efficacy Analysis Set, composed of all randomized participants
Participant incidence of achieving an increase in platelet count ≥20 x 10\^9/L above baseline for two consecutive weeks during the 12 week treatment period.
Outcome measures
| Measure |
Romiplostim
n=17 Participants
Romiplostim by subcutaneous injection once weekly at a starting dose of 1 µg/kg, adjusted based on weekly platelet counts to a maximum weekly dose of 10 µg/kg
|
Placebo
n=5 Participants
Placebo by subcutaneous injection once weekly
|
|---|---|---|
|
Increase in Platelet Count ≥ 20 x 10^9/L Above Baseline for Two Consecutive Weeks
|
15 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: 12-week treatment periodPopulation: Efficacy Analysis Set, composed of all randomized participants
Participant required rescue therapy (as defined per protocol) during the 12 week treatment period.
Outcome measures
| Measure |
Romiplostim
n=17 Participants
Romiplostim by subcutaneous injection once weekly at a starting dose of 1 µg/kg, adjusted based on weekly platelet counts to a maximum weekly dose of 10 µg/kg
|
Placebo
n=5 Participants
Placebo by subcutaneous injection once weekly
|
|---|---|---|
|
Requirement for Rescue Therapy (as Defined Per Protocol)
|
2 Participants
|
2 Participants
|
Adverse Events
Placebo
Serious events: 0 serious events
Other events: 5 other events
Deaths: 0 deaths
Romiplostim
Serious events: 1 serious events
Other events: 16 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Placebo
n=5 participants at risk
|
Romiplostim
n=17 participants at risk
|
|---|---|---|
|
Infections and infestations
Influenza
|
0.00%
0/5 • 12 week treatment period
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
5.9%
1/17 • 12 week treatment period
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Infections and infestations
Sepsis
|
0.00%
0/5 • 12 week treatment period
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
5.9%
1/17 • 12 week treatment period
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
Other adverse events
| Measure |
Placebo
n=5 participants at risk
|
Romiplostim
n=17 participants at risk
|
|---|---|---|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
0.00%
0/5 • 12 week treatment period
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
5.9%
1/17 • 12 week treatment period
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Gastrointestinal disorders
Abdominal pain
|
20.0%
1/5 • 12 week treatment period
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
5.9%
1/17 • 12 week treatment period
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Gastrointestinal disorders
Abdominal pain upper
|
0.00%
0/5 • 12 week treatment period
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
17.6%
3/17 • 12 week treatment period
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Gastrointestinal disorders
Chapped lips
|
0.00%
0/5 • 12 week treatment period
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
5.9%
1/17 • 12 week treatment period
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Gastrointestinal disorders
Diarrhoea
|
0.00%
0/5 • 12 week treatment period
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
5.9%
1/17 • 12 week treatment period
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Gastrointestinal disorders
Mouth haemorrhage
|
0.00%
0/5 • 12 week treatment period
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
5.9%
1/17 • 12 week treatment period
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Gastrointestinal disorders
Toothache
|
0.00%
0/5 • 12 week treatment period
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
5.9%
1/17 • 12 week treatment period
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Gastrointestinal disorders
Vomiting
|
40.0%
2/5 • 12 week treatment period
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
11.8%
2/17 • 12 week treatment period
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
General disorders
Chest discomfort
|
0.00%
0/5 • 12 week treatment period
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
5.9%
1/17 • 12 week treatment period
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
General disorders
Injection site haematoma
|
20.0%
1/5 • 12 week treatment period
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/17 • 12 week treatment period
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
General disorders
Malaise
|
20.0%
1/5 • 12 week treatment period
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/17 • 12 week treatment period
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
General disorders
Pyrexia
|
0.00%
0/5 • 12 week treatment period
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
23.5%
4/17 • 12 week treatment period
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Immune system disorders
Hypersensitivity
|
20.0%
1/5 • 12 week treatment period
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/17 • 12 week treatment period
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Infections and infestations
Ear infection
|
0.00%
0/5 • 12 week treatment period
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
5.9%
1/17 • 12 week treatment period
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Infections and infestations
Herpes simplex
|
20.0%
1/5 • 12 week treatment period
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/17 • 12 week treatment period
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Infections and infestations
Nasopharyngitis
|
0.00%
0/5 • 12 week treatment period
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
11.8%
2/17 • 12 week treatment period
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Infections and infestations
Otitis media
|
0.00%
0/5 • 12 week treatment period
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
5.9%
1/17 • 12 week treatment period
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Infections and infestations
Sinusitis
|
0.00%
0/5 • 12 week treatment period
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
5.9%
1/17 • 12 week treatment period
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Infections and infestations
Upper respiratory tract infection
|
20.0%
1/5 • 12 week treatment period
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
11.8%
2/17 • 12 week treatment period
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Infections and infestations
Urinary tract infection
|
0.00%
0/5 • 12 week treatment period
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
5.9%
1/17 • 12 week treatment period
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Injury, poisoning and procedural complications
Contusion
|
20.0%
1/5 • 12 week treatment period
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
17.6%
3/17 • 12 week treatment period
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Injury, poisoning and procedural complications
Fall
|
0.00%
0/5 • 12 week treatment period
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
5.9%
1/17 • 12 week treatment period
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Injury, poisoning and procedural complications
Scratch
|
20.0%
1/5 • 12 week treatment period
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/17 • 12 week treatment period
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Injury, poisoning and procedural complications
Skin laceration
|
20.0%
1/5 • 12 week treatment period
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/17 • 12 week treatment period
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Investigations
Spleen palpable
|
0.00%
0/5 • 12 week treatment period
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
5.9%
1/17 • 12 week treatment period
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
20.0%
1/5 • 12 week treatment period
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/17 • 12 week treatment period
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
20.0%
1/5 • 12 week treatment period
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
5.9%
1/17 • 12 week treatment period
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Musculoskeletal and connective tissue disorders
Inguinal mass
|
0.00%
0/5 • 12 week treatment period
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
5.9%
1/17 • 12 week treatment period
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
20.0%
1/5 • 12 week treatment period
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
5.9%
1/17 • 12 week treatment period
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Nervous system disorders
Dizziness
|
20.0%
1/5 • 12 week treatment period
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/17 • 12 week treatment period
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Nervous system disorders
Headache
|
40.0%
2/5 • 12 week treatment period
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
35.3%
6/17 • 12 week treatment period
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Psychiatric disorders
Emotional disorder
|
0.00%
0/5 • 12 week treatment period
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
5.9%
1/17 • 12 week treatment period
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Renal and urinary disorders
Dysuria
|
0.00%
0/5 • 12 week treatment period
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
5.9%
1/17 • 12 week treatment period
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Renal and urinary disorders
Urethral disorder
|
0.00%
0/5 • 12 week treatment period
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
5.9%
1/17 • 12 week treatment period
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Reproductive system and breast disorders
Genital haemorrhage
|
0.00%
0/5 • 12 week treatment period
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
5.9%
1/17 • 12 week treatment period
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Reproductive system and breast disorders
Vaginal discharge
|
0.00%
0/5 • 12 week treatment period
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
5.9%
1/17 • 12 week treatment period
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Respiratory, thoracic and mediastinal disorders
Asthma
|
0.00%
0/5 • 12 week treatment period
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
5.9%
1/17 • 12 week treatment period
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
40.0%
2/5 • 12 week treatment period
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
11.8%
2/17 • 12 week treatment period
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea exertional
|
0.00%
0/5 • 12 week treatment period
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
5.9%
1/17 • 12 week treatment period
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
20.0%
1/5 • 12 week treatment period
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
35.3%
6/17 • 12 week treatment period
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
40.0%
2/5 • 12 week treatment period
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/17 • 12 week treatment period
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
0.00%
0/5 • 12 week treatment period
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
23.5%
4/17 • 12 week treatment period
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Respiratory, thoracic and mediastinal disorders
Pharyngeal erythema
|
20.0%
1/5 • 12 week treatment period
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/17 • 12 week treatment period
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory tract congestion
|
0.00%
0/5 • 12 week treatment period
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
5.9%
1/17 • 12 week treatment period
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Respiratory, thoracic and mediastinal disorders
Rhinorrhoea
|
20.0%
1/5 • 12 week treatment period
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/17 • 12 week treatment period
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Respiratory, thoracic and mediastinal disorders
Wheezing
|
0.00%
0/5 • 12 week treatment period
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
5.9%
1/17 • 12 week treatment period
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Skin and subcutaneous tissue disorders
Erythema
|
0.00%
0/5 • 12 week treatment period
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
5.9%
1/17 • 12 week treatment period
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Skin and subcutaneous tissue disorders
Hyperhidrosis
|
20.0%
1/5 • 12 week treatment period
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/17 • 12 week treatment period
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Skin and subcutaneous tissue disorders
Petechiae
|
20.0%
1/5 • 12 week treatment period
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
11.8%
2/17 • 12 week treatment period
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
0.00%
0/5 • 12 week treatment period
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
5.9%
1/17 • 12 week treatment period
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Skin and subcutaneous tissue disorders
Rash
|
0.00%
0/5 • 12 week treatment period
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
17.6%
3/17 • 12 week treatment period
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Skin and subcutaneous tissue disorders
Rash macular
|
0.00%
0/5 • 12 week treatment period
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
5.9%
1/17 • 12 week treatment period
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Vascular disorders
Haematoma
|
0.00%
0/5 • 12 week treatment period
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
5.9%
1/17 • 12 week treatment period
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Vascular disorders
Haemorrhage
|
0.00%
0/5 • 12 week treatment period
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
5.9%
1/17 • 12 week treatment period
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
Additional Information
Study Director
Amgen Inc.
Phone: 866-572-6436
Results disclosure agreements
- Principal investigator is a sponsor employee The Clinical Trial Agreement generally does not restrict an investigator's discussion of trial results after completion. The Agreement permits Amgen a limited period of time to review material discussing trial results (typically up to 45 days and possible extension). Amgen may remove confidential information, but authors have final control and approval of publication content. For multi-center studies, the investigator agrees not to publish any results before the first multi-center publication.
- Publication restrictions are in place
Restriction type: OTHER