An Open Label Study of Romiplostim in Adult Thrombocytopenic Subjects With ITP
Sponsor
Amgen (Industry)
Overall Status
Completed
CT.gov ID
NCT00508820
Collaborator
(none)
407
1
72.9
Study Details
Study Description
Brief Summary
This protocol will provide open label romiplostim to adult thrombocytopenic subjects. Romiplostim will be administered by subcutaneous injection once per week. Dose adjustment will be based on platelet counts, and will be allowed throughout the duration of the study. Rescue therapies are allowed at any time during the study. Reductions in concurrent ITP therapies may occur at any time when platelet counts are > 50,000.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 3 |
Study Design
Study Type:
Interventional
Actual Enrollment
:
407 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
An Open Label Study of Romiplostim in Adult Thrombocytopenic Subjects With Immune (Idiopathic) Thrombocytopenic Purpura (ITP)
Actual Study Start Date
:
Feb 1, 2005
Actual Primary Completion Date
:
Jan 1, 2011
Actual Study Completion Date
:
Mar 1, 2011
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: 1 Romiplostim |
Biological: Romiplostim
Romiplostim will be administered subcutaneously QW. Romiplostim will be manufactured and packaged and distributed using Amgen's clinical study investigational product distribution procedures. Romiplostim is presented as a lyophilized, white powder in 5.0 mL glass vials.
|
Outcome Measures
Primary Outcome Measures
- Adverse Events [Duration of Treatment plus 30 days or End of Study (whichever is later). Approximately 205 weeks.]
One or more occurences of one or more adverse events within the participant during the study. Participants with more than one event were only counted once
Secondary Outcome Measures
- Platelet Response (Definition 1) [Duration of treatment (up to 201 weeks)]
Platelet response using definition1 . (a doubling of baseline platelet count and a platelet count of >=50 x 10^9/L
- Platelet Response (Definition 2) [Duration of treatment (up to 201 weeks)]
Platelet response using definition 2 (a platelet count increase of >=20 x 109/L from baseline)
Eligibility Criteria
Criteria
Ages Eligible for Study:
18 Years
and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:
-
Subject is ≥ 18 years of age
-
Subject has a diagnosis of immune (idiopathic) thrombocytopenic purpura per the American Society of Hematology guidelines
-
If Subject is > 60 years of age, subject has a written bone marrow aspiration and/or biopsy report consistent with a diagnosis of ITP
-
Subject has received at least 1 prior therapy for ITP
-
Subject's platelet count is ≤ 30,000 or the subject is experiencing bleeding that is uncontrolled with conventional therapies
-
Subject (or legally-acceptable representative) is willing and able to provide written informed consent
Exclusion Criteria:
-
Subject has a history of hematological malignancy, myeloproliferative disorder, myelodysplastic syndrome (MDS), or bone marrow stem cell disorder
-
Subject has participated in any study evaluating PEG-rHuMGDF, recombinant human thrombopoietin (rHuTPO), or related platelet product
-
Subject has a known hypersensitivity to any recombinant E coli-derived product
-
Subject has received any therapeutic drug or device that is not approved by the local regulatory health agency for any indication within 4 weeks of Screening
-
Subject is of reproductive potential and is not using adequate contraceptive precautions, in the judgment of the investigator
-
Subject is pregnant or breast feeding
-
Investigator has concerns regarding the subject's ability to comply with the protocol procedures
Contacts and Locations
Locations
No locations specified.Sponsors and Collaborators
- Amgen
Investigators
- Study Director: MD, Amgen
Study Documents (Full-Text)
None provided.More Information
Additional Information:
Publications
Responsible Party:
Amgen
ClinicalTrials.gov Identifier:
NCT00508820
Other Study ID Numbers:
- 20040209
First Posted:
Jul 30, 2007
Last Update Posted:
May 9, 2019
Last Verified:
May 1, 2019
Keywords provided by Amgen
Additional relevant MeSH terms:
Study Results
Participant Flow
| Recruitment Details | First Subject Enrolled: 24Feb2005 Last Subject Enrolled: 05Jan2010 |
|---|---|
| Pre-assignment Detail |
| Arm/Group Title | Romiplostim (AMG 531) Cohort 1 | Romiplostim (AMG 531) Cohort 2 |
|---|---|---|
| Arm/Group Description | Romiplostim administered to participants subcutaneously weekly based on platelet counts. Participants were enrolled under the original protocol or protocol amendments 1-3 where starting dose was 3mcg/kg. | Romiplostim administered to participants subcutaneously weekly based on platelet counts. Participants were enrolled under protocol amendments 4 where starting dose was 1mcg/kg. |
| Period Title: Overall Study | ||
| STARTED | 168 | 239 |
| COMPLETED | 113 | 175 |
| NOT COMPLETED | 55 | 64 |
Baseline Characteristics
| Arm/Group Title | Romiplostim (AMG 531) Cohort 1 | Romiplostim (AMG 531) Cohort 2 | Total |
|---|---|---|---|
| Arm/Group Description | Romiplostim administered to participants subcutaneously weekly based on platelet counts. Participants were enrolled under the original protocol or protocol amendments 1-3 where starting dose was 3mcg/kg. | Romiplostim administered to participants subcutaneously weekly based on platelet counts. Participants were enrolled under protocol amendments 4 where starting dose was 1mcg/kg. | Total of all reporting groups |
| Overall Participants | 168 | 239 | 407 |
| Age (years) [Mean (Standard Deviation) ] | |||
| Mean (Standard Deviation) [years] |
53.6
(17)
|
54.1
(18)
|
53.9
(17.6)
|
| Sex: Female, Male (Count of Participants) | |||
| Female |
94
56%
|
150
62.8%
|
244
60%
|
| Male |
74
44%
|
89
37.2%
|
163
40%
|
| Race/Ethnicity, Customized (participants) [Number] | |||
| White or Caucasian |
149
88.7%
|
232
97.1%
|
381
93.6%
|
| Black or African American |
5
3%
|
1
0.4%
|
6
1.5%
|
| Hispanic or Latino |
7
4.2%
|
2
0.8%
|
9
2.2%
|
| Asian |
5
3%
|
3
1.3%
|
8
2%
|
| Other |
1
0.6%
|
1
0.4%
|
2
0.5%
|
| Native Hawaiian or Other Pacific Islander |
1
0.6%
|
0
0%
|
1
0.2%
|
Outcome Measures
| Title | Adverse Events |
|---|---|
| Description | One or more occurences of one or more adverse events within the participant during the study. Participants with more than one event were only counted once |
| Time Frame | Duration of Treatment plus 30 days or End of Study (whichever is later). Approximately 205 weeks. |
Outcome Measure Data
| Analysis Population Description |
|---|
| Safety Analysis Set, comprised of all participants who received at least one dose of romiplostim |
| Arm/Group Title | Romiplostim (AMG 531) Cohort 1 | Romiplostim (AMG 531) Cohort 2 |
|---|---|---|
| Arm/Group Description | Romiplostim administered to participants subcutaneously weekly based on platelet counts. Participants were enrolled under the original protocol or protocol amendments 1-3 where starting dose was 3mcg/kg. | Romiplostim administered to participants subcutaneously weekly based on platelet counts. Participants were enrolled under protocol amendments 4 where starting dose was 1mcg/kg. |
| Measure Participants | 168 | 239 |
| Number [participants] |
162
96.4%
|
215
90%
|
| Title | Platelet Response (Definition 1) |
|---|---|
| Description | Platelet response using definition1 . (a doubling of baseline platelet count and a platelet count of >=50 x 10^9/L |
| Time Frame | Duration of treatment (up to 201 weeks) |
Outcome Measure Data
| Analysis Population Description |
|---|
| Full Analysis Set, all enrolled participants |
| Arm/Group Title | Romiplostim (AMG 531) Cohort 1 | Romiplostim (AMG 531) Cohort 2 |
|---|---|---|
| Arm/Group Description | Romiplostim administered to participants subcutaneously weekly based on platelet counts. Participants were enrolled under the original protocol or protocol amendments 1-3 where starting dose was 3mcg/kg. | Romiplostim administered to participants subcutaneously weekly based on platelet counts. Participants were enrolled under protocol amendments 4 where starting dose was 1mcg/kg. |
| Measure Participants | 168 | 239 |
| Number [Participants] |
156
92.9%
|
214
89.5%
|
| Title | Platelet Response (Definition 2) |
|---|---|
| Description | Platelet response using definition 2 (a platelet count increase of >=20 x 109/L from baseline) |
| Time Frame | Duration of treatment (up to 201 weeks) |
Outcome Measure Data
| Analysis Population Description |
|---|
| Full Analysis Set, all enrolled participants |
| Arm/Group Title | Romiplostim (AMG 531) Cohort 1 | Romiplostim (AMG 531) Cohort 2 |
|---|---|---|
| Arm/Group Description | Romiplostim administered to participants subcutaneously weekly based on platelet counts. Participants were enrolled under the original protocol or protocol amendments 1-3 where starting dose was 3mcg/kg. | Romiplostim administered to participants subcutaneously weekly based on platelet counts. Participants were enrolled under protocol amendments 4 where starting dose was 1mcg/kg. |
| Measure Participants | 168 | 239 |
| Number [Participants] |
160
95.2%
|
220
92.1%
|
Adverse Events
| Time Frame | Average duration: cohort 1 52 wks; cohort 2 42 wks. | |||
|---|---|---|---|---|
| Adverse Event Reporting Description | The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. | |||
| Arm/Group Title | Romiplostim Cohort 1 | Romiplostim Cohort 2 | ||
| Arm/Group Description | ||||
All Cause Mortality |
||||
| Romiplostim Cohort 1 | Romiplostim Cohort 2 | |||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | / (NaN) | / (NaN) | ||
Serious Adverse Events |
||||
| Romiplostim Cohort 1 | Romiplostim Cohort 2 | |||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 61/168 (36.3%) | 61/239 (25.5%) | ||
| Blood and lymphatic system disorders | ||||
| Anaemia | 2/168 (1.2%) | 0/239 (0%) | ||
| Aplasia pure red cell | 0/168 (0%) | 1/239 (0.4%) | ||
| Aplastic anaemia | 1/168 (0.6%) | 0/239 (0%) | ||
| Bone marrow disorder | 0/168 (0%) | 1/239 (0.4%) | ||
| Bone marrow reticulin fibrosis | 1/168 (0.6%) | 1/239 (0.4%) | ||
| Febrile neutropenia | 0/168 (0%) | 1/239 (0.4%) | ||
| Haemolysis | 1/168 (0.6%) | 0/239 (0%) | ||
| Idiopathic thrombocytopenic purpura | 5/168 (3%) | 2/239 (0.8%) | ||
| Leukocytosis | 1/168 (0.6%) | 0/239 (0%) | ||
| Lymphadenopathy | 0/168 (0%) | 1/239 (0.4%) | ||
| Neutropenia | 1/168 (0.6%) | 0/239 (0%) | ||
| Splenomegaly | 1/168 (0.6%) | 0/239 (0%) | ||
| Thrombocytopenia | 10/168 (6%) | 10/239 (4.2%) | ||
| Cardiac disorders | ||||
| Acute coronary syndrome | 0/168 (0%) | 1/239 (0.4%) | ||
| Cardiac disorder | 0/168 (0%) | 1/239 (0.4%) | ||
| Cardiac failure | 0/168 (0%) | 1/239 (0.4%) | ||
| Coronary artery stenosis | 0/168 (0%) | 1/239 (0.4%) | ||
| Myocardial infarction | 1/168 (0.6%) | 0/239 (0%) | ||
| Ear and labyrinth disorders | ||||
| Deafness | 0/168 (0%) | 1/239 (0.4%) | ||
| Tinnitus | 0/168 (0%) | 1/239 (0.4%) | ||
| Eye disorders | ||||
| Visual impairment | 0/168 (0%) | 1/239 (0.4%) | ||
| Gastrointestinal disorders | ||||
| Abdominal pain | 1/168 (0.6%) | 3/239 (1.3%) | ||
| Diarrhoea | 1/168 (0.6%) | 0/239 (0%) | ||
| Diarrhoea haemorrhagic | 0/168 (0%) | 1/239 (0.4%) | ||
| Enterocolitis haemorrhagic | 1/168 (0.6%) | 0/239 (0%) | ||
| Gastric perforation | 0/168 (0%) | 1/239 (0.4%) | ||
| Gastritis | 1/168 (0.6%) | 0/239 (0%) | ||
| Gastrointestinal haemorrhage | 5/168 (3%) | 0/239 (0%) | ||
| Haemorrhoids | 0/168 (0%) | 1/239 (0.4%) | ||
| Inguinal hernia | 0/168 (0%) | 1/239 (0.4%) | ||
| Intestinal infarction | 1/168 (0.6%) | 0/239 (0%) | ||
| Intestinal ischaemia | 0/168 (0%) | 1/239 (0.4%) | ||
| Mouth haemorrhage | 1/168 (0.6%) | 1/239 (0.4%) | ||
| Nausea | 2/168 (1.2%) | 3/239 (1.3%) | ||
| Pancreatic pseudocyst | 1/168 (0.6%) | 0/239 (0%) | ||
| Pancreatitis | 1/168 (0.6%) | 0/239 (0%) | ||
| Periodontitis | 1/168 (0.6%) | 0/239 (0%) | ||
| Peritonitis | 0/168 (0%) | 2/239 (0.8%) | ||
| Rectal haemorrhage | 2/168 (1.2%) | 1/239 (0.4%) | ||
| Rectal prolapse | 0/168 (0%) | 1/239 (0.4%) | ||
| Vomiting | 1/168 (0.6%) | 1/239 (0.4%) | ||
| General disorders | ||||
| Chest pain | 1/168 (0.6%) | 2/239 (0.8%) | ||
| Fatigue | 0/168 (0%) | 1/239 (0.4%) | ||
| General physical health deterioration | 0/168 (0%) | 1/239 (0.4%) | ||
| Generalised oedema | 0/168 (0%) | 1/239 (0.4%) | ||
| Hyperpyrexia | 0/168 (0%) | 1/239 (0.4%) | ||
| No therapeutic response | 1/168 (0.6%) | 0/239 (0%) | ||
| Polyp | 0/168 (0%) | 1/239 (0.4%) | ||
| Pyrexia | 2/168 (1.2%) | 2/239 (0.8%) | ||
| Sudden death | 0/168 (0%) | 1/239 (0.4%) | ||
| Thrombosis in device | 1/168 (0.6%) | 0/239 (0%) | ||
| Hepatobiliary disorders | ||||
| Cholecystitis acute | 1/168 (0.6%) | 1/239 (0.4%) | ||
| Hepatic haemorrhage | 1/168 (0.6%) | 0/239 (0%) | ||
| Portal vein thrombosis | 1/168 (0.6%) | 2/239 (0.8%) | ||
| Infections and infestations | ||||
| Acute tonsillitis | 1/168 (0.6%) | 0/239 (0%) | ||
| Bronchitis | 1/168 (0.6%) | 0/239 (0%) | ||
| Cellulitis | 1/168 (0.6%) | 0/239 (0%) | ||
| Cytomegalovirus infection | 0/168 (0%) | 1/239 (0.4%) | ||
| Erysipelas | 1/168 (0.6%) | 0/239 (0%) | ||
| Fungal sepsis | 1/168 (0.6%) | 0/239 (0%) | ||
| Gastroenteritis | 1/168 (0.6%) | 1/239 (0.4%) | ||
| Gastrointestinal infection | 1/168 (0.6%) | 0/239 (0%) | ||
| H1N1 influenza | 1/168 (0.6%) | 0/239 (0%) | ||
| Herpes virus infection | 1/168 (0.6%) | 0/239 (0%) | ||
| Infected cyst | 1/168 (0.6%) | 0/239 (0%) | ||
| Infection | 0/168 (0%) | 1/239 (0.4%) | ||
| Intervertebral discitis | 0/168 (0%) | 1/239 (0.4%) | ||
| Lower respiratory tract infection | 0/168 (0%) | 2/239 (0.8%) | ||
| Osteomyelitis | 1/168 (0.6%) | 0/239 (0%) | ||
| Pneumococcal sepsis | 1/168 (0.6%) | 0/239 (0%) | ||
| Pneumonia | 6/168 (3.6%) | 3/239 (1.3%) | ||
| Pseudomonal sepsis | 1/168 (0.6%) | 0/239 (0%) | ||
| Pyelonephritis | 0/168 (0%) | 1/239 (0.4%) | ||
| Respiratory syncytial virus infection | 1/168 (0.6%) | 0/239 (0%) | ||
| Respiratory tract infection | 0/168 (0%) | 1/239 (0.4%) | ||
| Sepsis | 0/168 (0%) | 2/239 (0.8%) | ||
| Septic shock | 0/168 (0%) | 1/239 (0.4%) | ||
| Tuberculous pleurisy | 1/168 (0.6%) | 0/239 (0%) | ||
| Upper respiratory tract infection | 1/168 (0.6%) | 0/239 (0%) | ||
| Urinary tract infection | 3/168 (1.8%) | 0/239 (0%) | ||
| Viral infection | 2/168 (1.2%) | 0/239 (0%) | ||
| Injury, poisoning and procedural complications | ||||
| Alcohol poisoning | 0/168 (0%) | 1/239 (0.4%) | ||
| Contusion | 0/168 (0%) | 2/239 (0.8%) | ||
| Incision site haemorrhage | 1/168 (0.6%) | 0/239 (0%) | ||
| Incisional hernia | 0/168 (0%) | 1/239 (0.4%) | ||
| Post procedural haemorrhage | 0/168 (0%) | 1/239 (0.4%) | ||
| Stab wound | 0/168 (0%) | 1/239 (0.4%) | ||
| Thermal burn | 0/168 (0%) | 1/239 (0.4%) | ||
| Traumatic haematoma | 0/168 (0%) | 2/239 (0.8%) | ||
| Traumatic haemorrhage | 0/168 (0%) | 1/239 (0.4%) | ||
| Wound | 0/168 (0%) | 1/239 (0.4%) | ||
| Investigations | ||||
| Blood smear test abnormal | 0/168 (0%) | 1/239 (0.4%) | ||
| Electrocardiogram | 1/168 (0.6%) | 0/239 (0%) | ||
| Platelet count abnormal | 1/168 (0.6%) | 0/239 (0%) | ||
| Platelet count decreased | 1/168 (0.6%) | 2/239 (0.8%) | ||
| Troponin increased | 1/168 (0.6%) | 0/239 (0%) | ||
| Metabolism and nutrition disorders | ||||
| Dehydration | 1/168 (0.6%) | 0/239 (0%) | ||
| Hyperkalaemia | 1/168 (0.6%) | 0/239 (0%) | ||
| Hypoglycaemia | 1/168 (0.6%) | 0/239 (0%) | ||
| Hyponatraemia | 1/168 (0.6%) | 0/239 (0%) | ||
| Hypovolaemia | 0/168 (0%) | 1/239 (0.4%) | ||
| Musculoskeletal and connective tissue disorders | ||||
| Arthralgia | 1/168 (0.6%) | 0/239 (0%) | ||
| Back pain | 2/168 (1.2%) | 0/239 (0%) | ||
| Bone pain | 0/168 (0%) | 1/239 (0.4%) | ||
| Osteoarthritis | 1/168 (0.6%) | 0/239 (0%) | ||
| Osteonecrosis | 1/168 (0.6%) | 0/239 (0%) | ||
| Neoplasms benign, malignant and unspecified (incl cysts and polyps) | ||||
| Colon cancer | 1/168 (0.6%) | 0/239 (0%) | ||
| Juvenile melanoma benign | 0/168 (0%) | 1/239 (0.4%) | ||
| Metastases to lymph nodes | 0/168 (0%) | 1/239 (0.4%) | ||
| Squamous cell carcinoma | 1/168 (0.6%) | 0/239 (0%) | ||
| Nervous system disorders | ||||
| Amnesia | 1/168 (0.6%) | 0/239 (0%) | ||
| Brain oedema | 0/168 (0%) | 1/239 (0.4%) | ||
| Carpal tunnel syndrome | 1/168 (0.6%) | 0/239 (0%) | ||
| Cerebral haemorrhage | 1/168 (0.6%) | 0/239 (0%) | ||
| Cerebrovascular accident | 2/168 (1.2%) | 0/239 (0%) | ||
| Dementia | 1/168 (0.6%) | 0/239 (0%) | ||
| Encephalopathy | 1/168 (0.6%) | 0/239 (0%) | ||
| Haemorrhage intracranial | 0/168 (0%) | 1/239 (0.4%) | ||
| Headache | 2/168 (1.2%) | 2/239 (0.8%) | ||
| Intracranial aneurysm | 0/168 (0%) | 1/239 (0.4%) | ||
| Intracranial venous sinus thrombosis | 0/168 (0%) | 1/239 (0.4%) | ||
| Ischaemic stroke | 1/168 (0.6%) | 0/239 (0%) | ||
| Mononeuropathy multiplex | 0/168 (0%) | 1/239 (0.4%) | ||
| Neuralgia | 1/168 (0.6%) | 0/239 (0%) | ||
| Paraesthesia | 0/168 (0%) | 1/239 (0.4%) | ||
| Subarachnoid haemorrhage | 1/168 (0.6%) | 0/239 (0%) | ||
| Syncope | 2/168 (1.2%) | 1/239 (0.4%) | ||
| Temporal lobe epilepsy | 0/168 (0%) | 1/239 (0.4%) | ||
| Transient ischaemic attack | 0/168 (0%) | 2/239 (0.8%) | ||
| Psychiatric disorders | ||||
| Depression | 0/168 (0%) | 1/239 (0.4%) | ||
| Renal and urinary disorders | ||||
| Acute prerenal failure | 0/168 (0%) | 1/239 (0.4%) | ||
| Renal colic | 1/168 (0.6%) | 0/239 (0%) | ||
| Renal disorder | 0/168 (0%) | 1/239 (0.4%) | ||
| Renal failure | 0/168 (0%) | 2/239 (0.8%) | ||
| Renal failure acute | 1/168 (0.6%) | 0/239 (0%) | ||
| Urogenital haemorrhage | 0/168 (0%) | 1/239 (0.4%) | ||
| Reproductive system and breast disorders | ||||
| Menorrhagia | 0/168 (0%) | 1/239 (0.4%) | ||
| Vaginal haemorrhage | 2/168 (1.2%) | 0/239 (0%) | ||
| Respiratory, thoracic and mediastinal disorders | ||||
| Acute respiratory distress syndrome | 3/168 (1.8%) | 0/239 (0%) | ||
| Dyspnoea | 1/168 (0.6%) | 0/239 (0%) | ||
| Epistaxis | 5/168 (3%) | 3/239 (1.3%) | ||
| Oropharyngeal pain | 0/168 (0%) | 1/239 (0.4%) | ||
| Pleural effusion | 0/168 (0%) | 1/239 (0.4%) | ||
| Pleurisy | 1/168 (0.6%) | 0/239 (0%) | ||
| Pneumothorax | 1/168 (0.6%) | 0/239 (0%) | ||
| Pulmonary alveolar haemorrhage | 1/168 (0.6%) | 0/239 (0%) | ||
| Pulmonary embolism | 5/168 (3%) | 1/239 (0.4%) | ||
| Pulmonary haemorrhage | 1/168 (0.6%) | 0/239 (0%) | ||
| Pulmonary oedema | 1/168 (0.6%) | 0/239 (0%) | ||
| Respiratory failure | 1/168 (0.6%) | 0/239 (0%) | ||
| Respiratory tract haemorrhage | 2/168 (1.2%) | 0/239 (0%) | ||
| Skin and subcutaneous tissue disorders | ||||
| Pemphigus | 0/168 (0%) | 1/239 (0.4%) | ||
| Petechiae | 2/168 (1.2%) | 2/239 (0.8%) | ||
| Purpura | 3/168 (1.8%) | 1/239 (0.4%) | ||
| Skin discolouration | 1/168 (0.6%) | 0/239 (0%) | ||
| Vascular disorders | ||||
| Aortic stenosis | 1/168 (0.6%) | 0/239 (0%) | ||
| Deep vein thrombosis | 3/168 (1.8%) | 1/239 (0.4%) | ||
| Haematoma | 0/168 (0%) | 1/239 (0.4%) | ||
| Haemorrhage | 3/168 (1.8%) | 2/239 (0.8%) | ||
| Hypertension | 0/168 (0%) | 1/239 (0.4%) | ||
| Hypotension | 1/168 (0.6%) | 0/239 (0%) | ||
| Peripheral ischaemia | 0/168 (0%) | 1/239 (0.4%) | ||
| Thrombophlebitis superficial | 1/168 (0.6%) | 0/239 (0%) | ||
| Thrombosis | 0/168 (0%) | 1/239 (0.4%) | ||
| Venous thrombosis | 0/168 (0%) | 1/239 (0.4%) | ||
| Venous thrombosis limb | 0/168 (0%) | 1/239 (0.4%) | ||
Other (Not Including Serious) Adverse Events |
||||
| Romiplostim Cohort 1 | Romiplostim Cohort 2 | |||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 155/168 (92.3%) | 188/239 (78.7%) | ||
| Blood and lymphatic system disorders | ||||
| Anaemia | 13/168 (7.7%) | 10/239 (4.2%) | ||
| Thrombocytopenia | 15/168 (8.9%) | 11/239 (4.6%) | ||
| Gastrointestinal disorders | ||||
| Abdominal pain | 18/168 (10.7%) | 11/239 (4.6%) | ||
| Constipation | 20/168 (11.9%) | 12/239 (5%) | ||
| Diarrhoea | 33/168 (19.6%) | 24/239 (10%) | ||
| Dyspepsia | 9/168 (5.4%) | 5/239 (2.1%) | ||
| Gingival bleeding | 14/168 (8.3%) | 5/239 (2.1%) | ||
| Mouth haemorrhage | 11/168 (6.5%) | 15/239 (6.3%) | ||
| Nausea | 32/168 (19%) | 38/239 (15.9%) | ||
| Vomiting | 12/168 (7.1%) | 11/239 (4.6%) | ||
| General disorders | ||||
| Asthenia | 13/168 (7.7%) | 18/239 (7.5%) | ||
| Chest pain | 10/168 (6%) | 7/239 (2.9%) | ||
| Chills | 11/168 (6.5%) | 4/239 (1.7%) | ||
| Fatigue | 50/168 (29.8%) | 25/239 (10.5%) | ||
| Influenza like illness | 11/168 (6.5%) | 8/239 (3.3%) | ||
| Oedema peripheral | 24/168 (14.3%) | 23/239 (9.6%) | ||
| Pain | 16/168 (9.5%) | 7/239 (2.9%) | ||
| Pyrexia | 19/168 (11.3%) | 13/239 (5.4%) | ||
| Infections and infestations | ||||
| Influenza | 9/168 (5.4%) | 25/239 (10.5%) | ||
| Nasopharyngitis | 38/168 (22.6%) | 31/239 (13%) | ||
| Rhinitis | 10/168 (6%) | 4/239 (1.7%) | ||
| Upper respiratory tract infection | 24/168 (14.3%) | 14/239 (5.9%) | ||
| Urinary tract infection | 11/168 (6.5%) | 8/239 (3.3%) | ||
| Viral infection | 15/168 (8.9%) | 1/239 (0.4%) | ||
| Injury, poisoning and procedural complications | ||||
| Contusion | 39/168 (23.2%) | 21/239 (8.8%) | ||
| Metabolism and nutrition disorders | ||||
| Decreased appetite | 16/168 (9.5%) | 6/239 (2.5%) | ||
| Musculoskeletal and connective tissue disorders | ||||
| Arthralgia | 46/168 (27.4%) | 34/239 (14.2%) | ||
| Back pain | 28/168 (16.7%) | 16/239 (6.7%) | ||
| Bone pain | 2/168 (1.2%) | 16/239 (6.7%) | ||
| Muscle spasms | 15/168 (8.9%) | 8/239 (3.3%) | ||
| Musculoskeletal pain | 18/168 (10.7%) | 10/239 (4.2%) | ||
| Myalgia | 21/168 (12.5%) | 15/239 (6.3%) | ||
| Pain in extremity | 27/168 (16.1%) | 28/239 (11.7%) | ||
| Nervous system disorders | ||||
| Dizziness | 28/168 (16.7%) | 15/239 (6.3%) | ||
| Headache | 57/168 (33.9%) | 61/239 (25.5%) | ||
| Hypoaesthesia | 9/168 (5.4%) | 0/239 (0%) | ||
| Paraesthesia | 10/168 (6%) | 16/239 (6.7%) | ||
| Psychiatric disorders | ||||
| Anxiety | 11/168 (6.5%) | 5/239 (2.1%) | ||
| Depression | 10/168 (6%) | 7/239 (2.9%) | ||
| Insomnia | 19/168 (11.3%) | 11/239 (4.6%) | ||
| Respiratory, thoracic and mediastinal disorders | ||||
| Cough | 35/168 (20.8%) | 22/239 (9.2%) | ||
| Dyspnoea | 17/168 (10.1%) | 8/239 (3.3%) | ||
| Epistaxis | 34/168 (20.2%) | 31/239 (13%) | ||
| Oropharyngeal pain | 17/168 (10.1%) | 14/239 (5.9%) | ||
| Skin and subcutaneous tissue disorders | ||||
| Ecchymosis | 9/168 (5.4%) | 3/239 (1.3%) | ||
| Petechiae | 29/168 (17.3%) | 31/239 (13%) | ||
| Pruritus | 14/168 (8.3%) | 12/239 (5%) | ||
| Rash | 17/168 (10.1%) | 8/239 (3.3%) | ||
| Vascular disorders | ||||
| Haematoma | 8/168 (4.8%) | 17/239 (7.1%) | ||
| Hypertension | 13/168 (7.7%) | 11/239 (4.6%) | ||
Limitations/Caveats
[Not Specified]
More Information
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
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.
Results Point of Contact
| Name/Title | Study Director |
|---|---|
| Organization | Amgen Inc. |
| Phone | 866-572-6436 |
Responsible Party:
Amgen
ClinicalTrials.gov Identifier:
NCT00508820
Other Study ID Numbers:
- 20040209
First Posted:
Jul 30, 2007
Last Update Posted:
May 9, 2019
Last Verified:
May 1, 2019