Trial Outcomes & Findings for Intravenous (IV) Iron vs. No Iron as the Treatment of Anemia in Cancer Patients Undergoing Chemotherapy and Erythropoietin Therapy (NCT NCT00236951)
NCT ID: NCT00236951
Last Updated: 2018-02-20
Results Overview
The hemoglobin baseline was defined as the average of the last 2 hemoglobin values during stage 1 (through week 8).
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
224 participants
Primary outcome timeframe
During Stage 2 (week 9 through week 21)
Results posted on
2018-02-20
Participant Flow
July 18, 2003 - October 27, 2005 Locations: Hospitals and Medical Clinics (33 total sites)
Anemia defined as a hemoglobin level \< or = to 10.0 g/dL.
Participant milestones
| Measure |
Group A: Erythropoietin + Venofer (Responders)
Subjects who at any time during Stage 1 (8-week duration) showed a \> or = 1 g/dL increase in hemoglobin over baseline. These subjects received 100mcg of weekly Erythropoietin and up to three 500mg doses of Venofer at intervals of 2 to 3 weeks with last dose no later than Week 9 of Stage 2.
|
Group B: Erythropoietin Only (Responders)
Subjects who at any time during Stage 1 (8-week duration) showed a \> or = 1 g/dL increase in hemoglobin over baseline. These subjects received 100mcg of weekly Erythropoietin only.
|
Group C: Erythropoietin + Venofer (Non-responders)
Subjects whose maximum hemoglobin increase was \< 1 g/dL over baseline were designated as Stage 1 (8-week duration) non-responders. These subjects received 100mcg of weekly Erythropoietin and up to three 500mg doses of Venofer at intervals of 2 to 3 weeks with last dose no later than Week 9 of Stage 2.
|
Group D: Erythropoietin Only (Non-responders)
Subjects whose maximum hemoglobin increase was \< 1 g/dL over baseline were designated as Stage 1 (8-week duration) non-responders. These subjects received 100mcg of weekly Erythropoietin only.
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
59
|
77
|
40
|
48
|
|
Overall Study
COMPLETED
|
33
|
46
|
21
|
17
|
|
Overall Study
NOT COMPLETED
|
26
|
31
|
19
|
31
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Intravenous (IV) Iron vs. No Iron as the Treatment of Anemia in Cancer Patients Undergoing Chemotherapy and Erythropoietin Therapy
Baseline characteristics by cohort
| Measure |
Group A: Erythropoietin + Venofer (Responders)
n=59 Participants
Subjects who at any time during Stage 1 (8-week duration) showed a \> or = 1 g/dL increase in hemoglobin over baseline. These subjects received 100mcg of weekly Erythropoietin and up to three 500mg doses of Venofer at intervals of 2 to 3 weeks with last dose no later than Week 9 of Stage 2.
|
Group B: Erythropoietin Only (Responders)
n=77 Participants
Subjects who at any time during Stage 1 (8-week duration) showed a \> or = 1 g/dL increase in hemoglobin over baseline. These subjects received 100mcg of weekly Erythropoietin only.
|
Group C: Erythropoietin + Venofer (Non-responders)
n=40 Participants
Subjects whose maximum hemoglobin increase was \< 1 g/dL over baseline were designated as Stage 1 (8-week duration) non-responders. These subjects received 100mcg of weekly Erythropoietin and up to three 500mg doses of Venofer at intervals of 2 to 3 weeks with last dose no later than Week 9 of Stage 2.
|
Group D: Erythropoietin Only (Non-responders)
n=48 Participants
Subjects whose maximum hemoglobin increase was \< 1 g/dL over baseline were designated as Stage 1 (8-week duration) non-responders. These subjects received 100mcg of weekly Erythropoietin only.
|
Total
n=224 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Categorical
Between 18 and 65 years
|
34 Participants
n=5 Participants
|
42 Participants
n=7 Participants
|
23 Participants
n=5 Participants
|
25 Participants
n=4 Participants
|
124 Participants
n=21 Participants
|
|
Age, Categorical
>=65 years
|
25 Participants
n=5 Participants
|
35 Participants
n=7 Participants
|
17 Participants
n=5 Participants
|
23 Participants
n=4 Participants
|
100 Participants
n=21 Participants
|
|
Sex: Female, Male
Female
|
39 Participants
n=5 Participants
|
49 Participants
n=7 Participants
|
28 Participants
n=5 Participants
|
31 Participants
n=4 Participants
|
147 Participants
n=21 Participants
|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Sex: Female, Male
Male
|
20 Participants
n=5 Participants
|
28 Participants
n=7 Participants
|
12 Participants
n=5 Participants
|
17 Participants
n=4 Participants
|
77 Participants
n=21 Participants
|
PRIMARY outcome
Timeframe: During Stage 2 (week 9 through week 21)Population: intention to treat (ITT)
The hemoglobin baseline was defined as the average of the last 2 hemoglobin values during stage 1 (through week 8).
Outcome measures
| Measure |
Group A: Erythropoietin + Venofer (Responders)
n=59 Participants
Subjects who at any time during Stage 1 (8-week duration) showed a \> or = 1 g/dL increase in hemoglobin over baseline. These subjects received 100mcg of weekly Erythropoietin and up to three 500mg doses of Venofer at intervals of 2 to 3 weeks with last dose no later than Week 9 of Stage 2.
|
Group B: Erythropoietin Only (Responders)
n=77 Participants
Subjects who at any time during Stage 1 (8-week duration) showed a \> or = 1 g/dL increase in hemoglobin over baseline. These subjects received 100mcg of weekly Erythropoietin only.
|
Group C: Erythropoietin + Venofer (Non-responders)
n=40 Participants
Subjects whose maximum hemoglobin increase was \< 1 g/dL over baseline were designated as Stage 1 (8-week duration) non-responders. These subjects received 100mcg of weekly Erythropoietin and up to three 500mg doses of Venofer at intervals of 2 to 3 weeks with last dose no later than Week 9 of Stage 2.
|
Group D: Erythropoietin Only (Non-responders)
n=48 Participants
Subjects whose maximum hemoglobin increase was \< 1 g/dL over baseline were designated as Stage 1 (8-week duration) non-responders. These subjects received 100mcg of weekly Erythropoietin only.
|
|---|---|---|---|---|
|
Change From Baseline to the Maximum Hemoglobin Level During Stage 2 (Week 9 Through Week 21).
|
2.6 g/dL
Standard Deviation 1.59
|
1.8 g/dL
Standard Deviation 1.39
|
2.5 g/dL
Standard Deviation 1.88
|
1.3 g/dL
Standard Deviation 1.73
|
Adverse Events
Group A: Erythropoietin + Venofer (Responders)
Serious events: 13 serious events
Other events: 50 other events
Deaths: 0 deaths
Group B: Erythropoietin Only (Responders)
Serious events: 14 serious events
Other events: 48 other events
Deaths: 0 deaths
Group C: Erythropoietin + Venofer (Non-responders)
Serious events: 11 serious events
Other events: 32 other events
Deaths: 0 deaths
Group D: Erythropoietin Only (Non-responders)
Serious events: 11 serious events
Other events: 35 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Group A: Erythropoietin + Venofer (Responders)
n=59 participants at risk
Subjects who at any time during Stage 1 (8-week duration) showed a \> or = 1 g/dL increase in hemoglobin over baseline. These subjects received 100mcg of weekly Erythropoietin and up to three 500mg doses of Venofer at intervals of 2 to 3 weeks with last dose no later than Week 9 of Stage 2.
|
Group B: Erythropoietin Only (Responders)
n=77 participants at risk
Subjects who at any time during Stage 1 (8-week duration) showed a \> or = 1 g/dL increase in hemoglobin over baseline. These subjects received 100mcg of weekly Erythropoietin only.
|
Group C: Erythropoietin + Venofer (Non-responders)
n=40 participants at risk
Subjects whose maximum hemoglobin increase was \< 1 g/dL over baseline were designated as Stage 1 (8-week duration) non-responders. These subjects received 100mcg of weekly Erythropoietin and up to three 500mg doses of Venofer at intervals of 2 to 3 weeks with last dose no later than Week 9 of Stage 2.
|
Group D: Erythropoietin Only (Non-responders)
n=48 participants at risk
Subjects whose maximum hemoglobin increase was \< 1 g/dL over baseline were designated as Stage 1 (8-week duration) non-responders. These subjects received 100mcg of weekly Erythropoietin only.
|
|---|---|---|---|---|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure
|
1.7%
1/59 • Number of events 1 • 2 years and 3 months
|
0.00%
0/77 • 2 years and 3 months
|
0.00%
0/40 • 2 years and 3 months
|
0.00%
0/48 • 2 years and 3 months
|
|
Renal and urinary disorders
Urinary retention
|
0.00%
0/59 • 2 years and 3 months
|
1.3%
1/77 • Number of events 1 • 2 years and 3 months
|
0.00%
0/40 • 2 years and 3 months
|
0.00%
0/48 • 2 years and 3 months
|
|
Infections and infestations
Sepsis NOS
|
1.7%
1/59 • Number of events 2 • 2 years and 3 months
|
1.3%
1/77 • Number of events 1 • 2 years and 3 months
|
2.5%
1/40 • Number of events 1 • 2 years and 3 months
|
2.1%
1/48 • Number of events 1 • 2 years and 3 months
|
|
Infections and infestations
Septic Shock
|
1.7%
1/59 • Number of events 1 • 2 years and 3 months
|
0.00%
0/77 • 2 years and 3 months
|
0.00%
0/40 • 2 years and 3 months
|
0.00%
0/48 • 2 years and 3 months
|
|
Gastrointestinal disorders
Small intestinal obstruction NOS
|
0.00%
0/59 • 2 years and 3 months
|
0.00%
0/77 • 2 years and 3 months
|
0.00%
0/40 • 2 years and 3 months
|
2.1%
1/48 • Number of events 1 • 2 years and 3 months
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Squamous cell carcinoma
|
0.00%
0/59 • 2 years and 3 months
|
0.00%
0/77 • 2 years and 3 months
|
2.5%
1/40 • Number of events 1 • 2 years and 3 months
|
0.00%
0/48 • 2 years and 3 months
|
|
Nervous system disorders
Status epilepticus
|
0.00%
0/59 • 2 years and 3 months
|
1.3%
1/77 • Number of events 1 • 2 years and 3 months
|
0.00%
0/40 • 2 years and 3 months
|
0.00%
0/48 • 2 years and 3 months
|
|
Gastrointestinal disorders
Abdominal Pain NOS
|
0.00%
0/59 • 2 years and 3 months
|
1.3%
1/77 • Number of events 1 • 2 years and 3 months
|
0.00%
0/40 • 2 years and 3 months
|
0.00%
0/48 • 2 years and 3 months
|
|
Gastrointestinal disorders
Abdominal pain upper
|
1.7%
1/59 • Number of events 1 • 2 years and 3 months
|
0.00%
0/77 • 2 years and 3 months
|
0.00%
0/40 • 2 years and 3 months
|
0.00%
0/48 • 2 years and 3 months
|
|
Infections and infestations
Abscess limb
|
0.00%
0/59 • 2 years and 3 months
|
0.00%
0/77 • 2 years and 3 months
|
2.5%
1/40 • Number of events 1 • 2 years and 3 months
|
0.00%
0/48 • 2 years and 3 months
|
|
General disorders
Asthenia
|
0.00%
0/59 • 2 years and 3 months
|
0.00%
0/77 • 2 years and 3 months
|
2.5%
1/40 • Number of events 1 • 2 years and 3 months
|
0.00%
0/48 • 2 years and 3 months
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.00%
0/59 • 2 years and 3 months
|
0.00%
0/77 • 2 years and 3 months
|
2.5%
1/40 • Number of events 1 • 2 years and 3 months
|
0.00%
0/48 • 2 years and 3 months
|
|
Musculoskeletal and connective tissue disorders
Bone pain
|
0.00%
0/59 • 2 years and 3 months
|
1.3%
1/77 • Number of events 1 • 2 years and 3 months
|
0.00%
0/40 • 2 years and 3 months
|
0.00%
0/48 • 2 years and 3 months
|
|
Infections and infestations
Bronchitis acute NOS
|
0.00%
0/59 • 2 years and 3 months
|
0.00%
0/77 • 2 years and 3 months
|
0.00%
0/40 • 2 years and 3 months
|
2.1%
1/48 • Number of events 1 • 2 years and 3 months
|
|
Cardiac disorders
Cardio-respiratory arrest
|
0.00%
0/59 • 2 years and 3 months
|
1.3%
1/77 • Number of events 1 • 2 years and 3 months
|
0.00%
0/40 • 2 years and 3 months
|
0.00%
0/48 • 2 years and 3 months
|
|
Nervous system disorders
Cerebral haemorrhage
|
1.7%
1/59 • Number of events 1 • 2 years and 3 months
|
0.00%
0/77 • 2 years and 3 months
|
0.00%
0/40 • 2 years and 3 months
|
0.00%
0/48 • 2 years and 3 months
|
|
Nervous system disorders
Cerebrovascular accident
|
0.00%
0/59 • 2 years and 3 months
|
0.00%
0/77 • 2 years and 3 months
|
0.00%
0/40 • 2 years and 3 months
|
2.1%
1/48 • Number of events 1 • 2 years and 3 months
|
|
General disorders
Chest pain
|
1.7%
1/59 • Number of events 1 • 2 years and 3 months
|
0.00%
0/77 • 2 years and 3 months
|
0.00%
0/40 • 2 years and 3 months
|
0.00%
0/48 • 2 years and 3 months
|
|
Respiratory, thoracic and mediastinal disorders
Chronic obstructive airways disease exacerbated
|
0.00%
0/59 • 2 years and 3 months
|
0.00%
0/77 • 2 years and 3 months
|
0.00%
0/40 • 2 years and 3 months
|
4.2%
2/48 • Number of events 2 • 2 years and 3 months
|
|
Surgical and medical procedures
Colostomy
|
0.00%
0/59 • 2 years and 3 months
|
0.00%
0/77 • 2 years and 3 months
|
2.5%
1/40 • Number of events 1 • 2 years and 3 months
|
0.00%
0/48 • 2 years and 3 months
|
|
Vascular disorders
Deep vein thrombosis
|
0.00%
0/59 • 2 years and 3 months
|
1.3%
1/77 • Number of events 1 • 2 years and 3 months
|
2.5%
1/40 • Number of events 1 • 2 years and 3 months
|
0.00%
0/48 • 2 years and 3 months
|
|
Metabolism and nutrition disorders
Dehydration
|
1.7%
1/59 • Number of events 1 • 2 years and 3 months
|
0.00%
0/77 • 2 years and 3 months
|
2.5%
1/40 • Number of events 1 • 2 years and 3 months
|
0.00%
0/48 • 2 years and 3 months
|
|
Eye disorders
Diplopia
|
0.00%
0/59 • 2 years and 3 months
|
0.00%
0/77 • 2 years and 3 months
|
2.5%
1/40 • Number of events 1 • 2 years and 3 months
|
0.00%
0/48 • 2 years and 3 months
|
|
Gastrointestinal disorders
Dysphagia
|
0.00%
0/59 • 2 years and 3 months
|
1.3%
1/77 • Number of events 1 • 2 years and 3 months
|
0.00%
0/40 • 2 years and 3 months
|
0.00%
0/48 • 2 years and 3 months
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
0.00%
0/59 • 2 years and 3 months
|
0.00%
0/77 • 2 years and 3 months
|
2.5%
1/40 • Number of events 1 • 2 years and 3 months
|
0.00%
0/48 • 2 years and 3 months
|
|
Injury, poisoning and procedural complications
Fall
|
0.00%
0/59 • 2 years and 3 months
|
0.00%
0/77 • 2 years and 3 months
|
0.00%
0/40 • 2 years and 3 months
|
2.1%
1/48 • Number of events 1 • 2 years and 3 months
|
|
General disorders
Fatigue
|
1.7%
1/59 • Number of events 1 • 2 years and 3 months
|
0.00%
0/77 • 2 years and 3 months
|
0.00%
0/40 • 2 years and 3 months
|
0.00%
0/48 • 2 years and 3 months
|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
1.7%
1/59 • Number of events 1 • 2 years and 3 months
|
1.3%
1/77 • Number of events 1 • 2 years and 3 months
|
0.00%
0/40 • 2 years and 3 months
|
0.00%
0/48 • 2 years and 3 months
|
|
Injury, poisoning and procedural complications
Femur Fracture
|
0.00%
0/59 • 2 years and 3 months
|
1.3%
1/77 • Number of events 1 • 2 years and 3 months
|
0.00%
0/40 • 2 years and 3 months
|
0.00%
0/48 • 2 years and 3 months
|
|
Nervous system disorders
Headache
|
0.00%
0/59 • 2 years and 3 months
|
0.00%
0/77 • 2 years and 3 months
|
2.5%
1/40 • Number of events 1 • 2 years and 3 months
|
0.00%
0/48 • 2 years and 3 months
|
|
Investigations
Hemoglobin decreased
|
0.00%
0/59 • 2 years and 3 months
|
0.00%
0/77 • 2 years and 3 months
|
2.5%
1/40 • Number of events 1 • 2 years and 3 months
|
0.00%
0/48 • 2 years and 3 months
|
|
Injury, poisoning and procedural complications
Hip fracture
|
0.00%
0/59 • 2 years and 3 months
|
1.3%
1/77 • Number of events 1 • 2 years and 3 months
|
0.00%
0/40 • 2 years and 3 months
|
0.00%
0/48 • 2 years and 3 months
|
|
Immune system disorders
Hypersensitivity NOS
|
1.7%
1/59 • Number of events 1 • 2 years and 3 months
|
0.00%
0/77 • 2 years and 3 months
|
0.00%
0/40 • 2 years and 3 months
|
0.00%
0/48 • 2 years and 3 months
|
|
Metabolism and nutrition disorders
Hypokalemia
|
0.00%
0/59 • 2 years and 3 months
|
0.00%
0/77 • 2 years and 3 months
|
2.5%
1/40 • Number of events 1 • 2 years and 3 months
|
0.00%
0/48 • 2 years and 3 months
|
|
Metabolism and nutrition disorders
Hypomagnesaemia
|
1.7%
1/59 • Number of events 1 • 2 years and 3 months
|
0.00%
0/77 • 2 years and 3 months
|
0.00%
0/40 • 2 years and 3 months
|
0.00%
0/48 • 2 years and 3 months
|
|
Vascular disorders
Hypotension NOS
|
1.7%
1/59 • Number of events 1 • 2 years and 3 months
|
0.00%
0/77 • 2 years and 3 months
|
0.00%
0/40 • 2 years and 3 months
|
0.00%
0/48 • 2 years and 3 months
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
0.00%
0/59 • 2 years and 3 months
|
0.00%
0/77 • 2 years and 3 months
|
2.5%
1/40 • Number of events 1 • 2 years and 3 months
|
0.00%
0/48 • 2 years and 3 months
|
|
Gastrointestinal disorders
Intestinal obstruction NOS
|
1.7%
1/59 • Number of events 1 • 2 years and 3 months
|
0.00%
0/77 • 2 years and 3 months
|
0.00%
0/40 • 2 years and 3 months
|
0.00%
0/48 • 2 years and 3 months
|
|
Blood and lymphatic system disorders
Leukopenia NOS
|
0.00%
0/59 • 2 years and 3 months
|
0.00%
0/77 • 2 years and 3 months
|
2.5%
1/40 • Number of events 1 • 2 years and 3 months
|
0.00%
0/48 • 2 years and 3 months
|
|
General disorders
Malaise
|
1.7%
1/59 • Number of events 1 • 2 years and 3 months
|
0.00%
0/77 • 2 years and 3 months
|
0.00%
0/40 • 2 years and 3 months
|
0.00%
0/48 • 2 years and 3 months
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Malignant neoplasm NOS
|
0.00%
0/59 • 2 years and 3 months
|
0.00%
0/77 • 2 years and 3 months
|
0.00%
0/40 • 2 years and 3 months
|
2.1%
1/48 • Number of events 1 • 2 years and 3 months
|
|
Cardiac disorders
Myocardial infarction
|
0.00%
0/59 • 2 years and 3 months
|
1.3%
1/77 • Number of events 1 • 2 years and 3 months
|
2.5%
1/40 • Number of events 1 • 2 years and 3 months
|
0.00%
0/48 • 2 years and 3 months
|
|
Gastrointestinal disorders
Nausea
|
1.7%
1/59 • Number of events 1 • 2 years and 3 months
|
0.00%
0/77 • 2 years and 3 months
|
0.00%
0/40 • 2 years and 3 months
|
0.00%
0/48 • 2 years and 3 months
|
|
Blood and lymphatic system disorders
Neutropenia
|
0.00%
0/59 • 2 years and 3 months
|
0.00%
0/77 • 2 years and 3 months
|
2.5%
1/40 • Number of events 1 • 2 years and 3 months
|
0.00%
0/48 • 2 years and 3 months
|
|
Vascular disorders
Orthostatic hypotension
|
0.00%
0/59 • 2 years and 3 months
|
0.00%
0/77 • 2 years and 3 months
|
0.00%
0/40 • 2 years and 3 months
|
2.1%
1/48 • Number of events 1 • 2 years and 3 months
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Pancreatic carcinoma metastatic
|
0.00%
0/59 • 2 years and 3 months
|
1.3%
1/77 • Number of events 1 • 2 years and 3 months
|
0.00%
0/40 • 2 years and 3 months
|
0.00%
0/48 • 2 years and 3 months
|
|
Gastrointestinal disorders
Pancreatitis NOS
|
1.7%
1/59 • Number of events 1 • 2 years and 3 months
|
0.00%
0/77 • 2 years and 3 months
|
0.00%
0/40 • 2 years and 3 months
|
0.00%
0/48 • 2 years and 3 months
|
|
Gastrointestinal disorders
Pancreatitis acute
|
1.7%
1/59 • Number of events 1 • 2 years and 3 months
|
0.00%
0/77 • 2 years and 3 months
|
0.00%
0/40 • 2 years and 3 months
|
0.00%
0/48 • 2 years and 3 months
|
|
Nervous system disorders
Peripheral neuropathy NOS
|
0.00%
0/59 • 2 years and 3 months
|
0.00%
0/77 • 2 years and 3 months
|
0.00%
0/40 • 2 years and 3 months
|
2.1%
1/48 • Number of events 1 • 2 years and 3 months
|
|
Infections and infestations
Pneumonia NOS
|
5.1%
3/59 • Number of events 3 • 2 years and 3 months
|
2.6%
2/77 • Number of events 2 • 2 years and 3 months
|
2.5%
1/40 • Number of events 1 • 2 years and 3 months
|
2.1%
1/48 • Number of events 1 • 2 years and 3 months
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonia aspiration
|
0.00%
0/59 • 2 years and 3 months
|
1.3%
1/77 • Number of events 1 • 2 years and 3 months
|
0.00%
0/40 • 2 years and 3 months
|
0.00%
0/48 • 2 years and 3 months
|
|
Respiratory, thoracic and mediastinal disorders
Pneumothorax NOS
|
0.00%
0/59 • 2 years and 3 months
|
1.3%
1/77 • Number of events 1 • 2 years and 3 months
|
0.00%
0/40 • 2 years and 3 months
|
0.00%
0/48 • 2 years and 3 months
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
0.00%
0/59 • 2 years and 3 months
|
1.3%
1/77 • Number of events 1 • 2 years and 3 months
|
0.00%
0/40 • 2 years and 3 months
|
0.00%
0/48 • 2 years and 3 months
|
|
General disorders
Pyrexia
|
1.7%
1/59 • Number of events 1 • 2 years and 3 months
|
0.00%
0/77 • 2 years and 3 months
|
0.00%
0/40 • 2 years and 3 months
|
0.00%
0/48 • 2 years and 3 months
|
|
Gastrointestinal disorders
Rectal hemorrhage
|
0.00%
0/59 • 2 years and 3 months
|
1.3%
1/77 • Number of events 1 • 2 years and 3 months
|
0.00%
0/40 • 2 years and 3 months
|
0.00%
0/48 • 2 years and 3 months
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Rectal neoplasm NOS
|
0.00%
0/59 • 2 years and 3 months
|
1.3%
1/77 • Number of events 1 • 2 years and 3 months
|
0.00%
0/40 • 2 years and 3 months
|
0.00%
0/48 • 2 years and 3 months
|
|
Surgical and medical procedures
Resection of Rectum
|
0.00%
0/59 • 2 years and 3 months
|
0.00%
0/77 • 2 years and 3 months
|
2.5%
1/40 • Number of events 1 • 2 years and 3 months
|
0.00%
0/48 • 2 years and 3 months
|
|
Infections and infestations
Urinary tract infection NOS
|
1.7%
1/59 • Number of events 1 • 2 years and 3 months
|
0.00%
0/77 • 2 years and 3 months
|
0.00%
0/40 • 2 years and 3 months
|
0.00%
0/48 • 2 years and 3 months
|
|
Surgical and medical procedures
Vaginectomy
|
0.00%
0/59 • 2 years and 3 months
|
0.00%
0/77 • 2 years and 3 months
|
2.5%
1/40 • Number of events 1 • 2 years and 3 months
|
0.00%
0/48 • 2 years and 3 months
|
|
Gastrointestinal disorders
Vomiting NOS
|
1.7%
1/59 • Number of events 1 • 2 years and 3 months
|
0.00%
0/77 • 2 years and 3 months
|
0.00%
0/40 • 2 years and 3 months
|
0.00%
0/48 • 2 years and 3 months
|
Other adverse events
| Measure |
Group A: Erythropoietin + Venofer (Responders)
n=59 participants at risk
Subjects who at any time during Stage 1 (8-week duration) showed a \> or = 1 g/dL increase in hemoglobin over baseline. These subjects received 100mcg of weekly Erythropoietin and up to three 500mg doses of Venofer at intervals of 2 to 3 weeks with last dose no later than Week 9 of Stage 2.
|
Group B: Erythropoietin Only (Responders)
n=77 participants at risk
Subjects who at any time during Stage 1 (8-week duration) showed a \> or = 1 g/dL increase in hemoglobin over baseline. These subjects received 100mcg of weekly Erythropoietin only.
|
Group C: Erythropoietin + Venofer (Non-responders)
n=40 participants at risk
Subjects whose maximum hemoglobin increase was \< 1 g/dL over baseline were designated as Stage 1 (8-week duration) non-responders. These subjects received 100mcg of weekly Erythropoietin and up to three 500mg doses of Venofer at intervals of 2 to 3 weeks with last dose no later than Week 9 of Stage 2.
|
Group D: Erythropoietin Only (Non-responders)
n=48 participants at risk
Subjects whose maximum hemoglobin increase was \< 1 g/dL over baseline were designated as Stage 1 (8-week duration) non-responders. These subjects received 100mcg of weekly Erythropoietin only.
|
|---|---|---|---|---|
|
General disorders
Oedema peripheral
|
11.9%
7/59 • Number of events 7 • 2 years and 3 months
|
7.8%
6/77 • Number of events 6 • 2 years and 3 months
|
10.0%
4/40 • Number of events 5 • 2 years and 3 months
|
4.2%
2/48 • Number of events 2 • 2 years and 3 months
|
|
General disorders
Pain NOS
|
6.8%
4/59 • Number of events 4 • 2 years and 3 months
|
0.00%
0/77 • 2 years and 3 months
|
2.5%
1/40 • Number of events 1 • 2 years and 3 months
|
0.00%
0/48 • 2 years and 3 months
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
3.4%
2/59 • Number of events 2 • 2 years and 3 months
|
2.6%
2/77 • Number of events 2 • 2 years and 3 months
|
2.5%
1/40 • Number of events 1 • 2 years and 3 months
|
6.2%
3/48 • Number of events 3 • 2 years and 3 months
|
|
Gastrointestinal disorders
Abdominal pain NOS
|
8.5%
5/59 • Number of events 5 • 2 years and 3 months
|
3.9%
3/77 • Number of events 4 • 2 years and 3 months
|
2.5%
1/40 • Number of events 1 • 2 years and 3 months
|
2.1%
1/48 • Number of events 1 • 2 years and 3 months
|
|
Nervous system disorders
Paraesthesia
|
5.1%
3/59 • Number of events 3 • 2 years and 3 months
|
2.6%
2/77 • Number of events 2 • 2 years and 3 months
|
5.0%
2/40 • Number of events 2 • 2 years and 3 months
|
2.1%
1/48 • Number of events 1 • 2 years and 3 months
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
3.4%
2/59 • Number of events 2 • 2 years and 3 months
|
7.8%
6/77 • Number of events 6 • 2 years and 3 months
|
10.0%
4/40 • Number of events 4 • 2 years and 3 months
|
6.2%
3/48 • Number of events 3 • 2 years and 3 months
|
|
Metabolism and nutrition disorders
Anorexia
|
6.8%
4/59 • Number of events 4 • 2 years and 3 months
|
1.3%
1/77 • Number of events 1 • 2 years and 3 months
|
0.00%
0/40 • 2 years and 3 months
|
4.2%
2/48 • Number of events 2 • 2 years and 3 months
|
|
Nervous system disorders
Peripheral neuropathy NOS
|
3.4%
2/59 • Number of events 2 • 2 years and 3 months
|
6.5%
5/77 • Number of events 5 • 2 years and 3 months
|
0.00%
0/40 • 2 years and 3 months
|
2.1%
1/48 • Number of events 1 • 2 years and 3 months
|
|
Metabolism and nutrition disorders
Appetite decreased NOS
|
1.7%
1/59 • Number of events 1 • 2 years and 3 months
|
2.6%
2/77 • Number of events 2 • 2 years and 3 months
|
0.00%
0/40 • 2 years and 3 months
|
6.2%
3/48 • Number of events 3 • 2 years and 3 months
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
10.2%
6/59 • Number of events 8 • 2 years and 3 months
|
7.8%
6/77 • Number of events 7 • 2 years and 3 months
|
7.5%
3/40 • Number of events 3 • 2 years and 3 months
|
4.2%
2/48 • Number of events 2 • 2 years and 3 months
|
|
General disorders
Asthenia
|
3.4%
2/59 • Number of events 2 • 2 years and 3 months
|
3.9%
3/77 • Number of events 3 • 2 years and 3 months
|
7.5%
3/40 • Number of events 3 • 2 years and 3 months
|
4.2%
2/48 • Number of events 3 • 2 years and 3 months
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
15.3%
9/59 • Number of events 9 • 2 years and 3 months
|
7.8%
6/77 • Number of events 6 • 2 years and 3 months
|
7.5%
3/40 • Number of events 3 • 2 years and 3 months
|
10.4%
5/48 • Number of events 5 • 2 years and 3 months
|
|
Musculoskeletal and connective tissue disorders
Bone pain
|
5.1%
3/59 • Number of events 4 • 2 years and 3 months
|
1.3%
1/77 • Number of events 1 • 2 years and 3 months
|
0.00%
0/40 • 2 years and 3 months
|
0.00%
0/48 • 2 years and 3 months
|
|
Infections and infestations
Canidal infection NOS
|
0.00%
0/59 • 2 years and 3 months
|
1.3%
1/77 • Number of events 1 • 2 years and 3 months
|
5.0%
2/40 • Number of events 2 • 2 years and 3 months
|
2.1%
1/48 • Number of events 1 • 2 years and 3 months
|
|
General disorders
Chest pain
|
6.8%
4/59 • Number of events 5 • 2 years and 3 months
|
3.9%
3/77 • Number of events 4 • 2 years and 3 months
|
7.5%
3/40 • Number of events 3 • 2 years and 3 months
|
6.2%
3/48 • Number of events 3 • 2 years and 3 months
|
|
Gastrointestinal disorders
Constipation
|
13.6%
8/59 • Number of events 8 • 2 years and 3 months
|
9.1%
7/77 • Number of events 7 • 2 years and 3 months
|
10.0%
4/40 • Number of events 4 • 2 years and 3 months
|
2.1%
1/48 • Number of events 1 • 2 years and 3 months
|
|
Investigations
Prothrombin time prolonged
|
0.00%
0/59 • 2 years and 3 months
|
0.00%
0/77 • 2 years and 3 months
|
5.0%
2/40 • Number of events 2 • 2 years and 3 months
|
0.00%
0/48 • 2 years and 3 months
|
|
Skin and subcutaneous tissue disorders
Contusion
|
5.1%
3/59 • Number of events 3 • 2 years and 3 months
|
0.00%
0/77 • 2 years and 3 months
|
2.5%
1/40 • Number of events 1 • 2 years and 3 months
|
2.1%
1/48 • Number of events 1 • 2 years and 3 months
|
|
Metabolism and nutrition disorders
Dehydration
|
6.8%
4/59 • Number of events 5 • 2 years and 3 months
|
2.6%
2/77 • Number of events 2 • 2 years and 3 months
|
0.00%
0/40 • 2 years and 3 months
|
8.3%
4/48 • Number of events 6 • 2 years and 3 months
|
|
Psychiatric disorders
Depression
|
1.7%
1/59 • Number of events 1 • 2 years and 3 months
|
2.6%
2/77 • Number of events 2 • 2 years and 3 months
|
5.0%
2/40 • Number of events 2 • 2 years and 3 months
|
6.2%
3/48 • Number of events 3 • 2 years and 3 months
|
|
Gastrointestinal disorders
Diarrhea NOS
|
13.6%
8/59 • Number of events 8 • 2 years and 3 months
|
11.7%
9/77 • Number of events 10 • 2 years and 3 months
|
15.0%
6/40 • Number of events 6 • 2 years and 3 months
|
12.5%
6/48 • Number of events 9 • 2 years and 3 months
|
|
General disorders
Pyrexia
|
1.7%
1/59 • Number of events 1 • 2 years and 3 months
|
1.3%
1/77 • Number of events 1 • 2 years and 3 months
|
7.5%
3/40 • Number of events 3 • 2 years and 3 months
|
4.2%
2/48 • Number of events 2 • 2 years and 3 months
|
|
Nervous system disorders
Dizziness
|
10.2%
6/59 • Number of events 6 • 2 years and 3 months
|
3.9%
3/77 • Number of events 4 • 2 years and 3 months
|
2.5%
1/40 • Number of events 1 • 2 years and 3 months
|
2.1%
1/48 • Number of events 1 • 2 years and 3 months
|
|
Nervous system disorders
Dysgeusia
|
11.9%
7/59 • Number of events 7 • 2 years and 3 months
|
10.4%
8/77 • Number of events 8 • 2 years and 3 months
|
2.5%
1/40 • Number of events 1 • 2 years and 3 months
|
8.3%
4/48 • Number of events 4 • 2 years and 3 months
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
10.2%
6/59 • Number of events 7 • 2 years and 3 months
|
5.2%
4/77 • Number of events 4 • 2 years and 3 months
|
7.5%
3/40 • Number of events 4 • 2 years and 3 months
|
2.1%
1/48 • Number of events 1 • 2 years and 3 months
|
|
Skin and subcutaneous tissue disorders
Rash NOS
|
5.1%
3/59 • Number of events 4 • 2 years and 3 months
|
7.8%
6/77 • Number of events 8 • 2 years and 3 months
|
5.0%
2/40 • Number of events 2 • 2 years and 3 months
|
0.00%
0/48 • 2 years and 3 months
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea exertional
|
0.00%
0/59 • 2 years and 3 months
|
2.6%
2/77 • Number of events 2 • 2 years and 3 months
|
5.0%
2/40 • Number of events 2 • 2 years and 3 months
|
6.2%
3/48 • Number of events 3 • 2 years and 3 months
|
|
Gastrointestinal disorders
Stomatitis
|
5.1%
3/59 • Number of events 3 • 2 years and 3 months
|
1.3%
1/77 • Number of events 2 • 2 years and 3 months
|
0.00%
0/40 • 2 years and 3 months
|
8.3%
4/48 • Number of events 4 • 2 years and 3 months
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
3.4%
2/59 • Number of events 2 • 2 years and 3 months
|
2.6%
2/77 • Number of events 2 • 2 years and 3 months
|
2.5%
1/40 • Number of events 1 • 2 years and 3 months
|
6.2%
3/48 • Number of events 3 • 2 years and 3 months
|
|
Skin and subcutaneous tissue disorders
Erythema
|
5.1%
3/59 • Number of events 3 • 2 years and 3 months
|
1.3%
1/77 • Number of events 1 • 2 years and 3 months
|
0.00%
0/40 • 2 years and 3 months
|
0.00%
0/48 • 2 years and 3 months
|
|
General disorders
Fatigue
|
15.3%
9/59 • Number of events 9 • 2 years and 3 months
|
20.8%
16/77 • Number of events 17 • 2 years and 3 months
|
15.0%
6/40 • Number of events 8 • 2 years and 3 months
|
22.9%
11/48 • Number of events 12 • 2 years and 3 months
|
|
Renal and urinary disorders
Haematuria
|
0.00%
0/59 • 2 years and 3 months
|
2.6%
2/77 • Number of events 2 • 2 years and 3 months
|
2.5%
1/40 • Number of events 1 • 2 years and 3 months
|
6.2%
3/48 • Number of events 3 • 2 years and 3 months
|
|
Nervous system disorders
Headache
|
8.5%
5/59 • Number of events 5 • 2 years and 3 months
|
6.5%
5/77 • Number of events 5 • 2 years and 3 months
|
2.5%
1/40 • Number of events 1 • 2 years and 3 months
|
2.1%
1/48 • Number of events 1 • 2 years and 3 months
|
|
Nervous system disorders
Hypoaesthesia
|
3.4%
2/59 • Number of events 2 • 2 years and 3 months
|
5.2%
4/77 • Number of events 4 • 2 years and 3 months
|
10.0%
4/40 • Number of events 6 • 2 years and 3 months
|
2.1%
1/48 • Number of events 1 • 2 years and 3 months
|
|
Metabolism and nutrition disorders
Hypokalemia
|
5.1%
3/59 • Number of events 4 • 2 years and 3 months
|
2.6%
2/77 • Number of events 2 • 2 years and 3 months
|
2.5%
1/40 • Number of events 1 • 2 years and 3 months
|
4.2%
2/48 • Number of events 2 • 2 years and 3 months
|
|
Vascular disorders
Hypotension NOS
|
6.8%
4/59 • Number of events 4 • 2 years and 3 months
|
1.3%
1/77 • Number of events 1 • 2 years and 3 months
|
2.5%
1/40 • Number of events 1 • 2 years and 3 months
|
0.00%
0/48 • 2 years and 3 months
|
|
Psychiatric disorders
Insomnia
|
3.4%
2/59 • Number of events 2 • 2 years and 3 months
|
2.6%
2/77 • Number of events 2 • 2 years and 3 months
|
5.0%
2/40 • Number of events 2 • 2 years and 3 months
|
4.2%
2/48 • Number of events 2 • 2 years and 3 months
|
|
Musculoskeletal and connective tissue disorders
Muscle cramp
|
11.9%
7/59 • Number of events 8 • 2 years and 3 months
|
6.5%
5/77 • Number of events 5 • 2 years and 3 months
|
0.00%
0/40 • 2 years and 3 months
|
2.1%
1/48 • Number of events 1 • 2 years and 3 months
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
1.7%
1/59 • Number of events 1 • 2 years and 3 months
|
6.5%
5/77 • Number of events 5 • 2 years and 3 months
|
5.0%
2/40 • Number of events 2 • 2 years and 3 months
|
2.1%
1/48 • Number of events 1 • 2 years and 3 months
|
|
Gastrointestinal disorders
Nausea
|
30.5%
18/59 • Number of events 22 • 2 years and 3 months
|
20.8%
16/77 • Number of events 21 • 2 years and 3 months
|
25.0%
10/40 • Number of events 10 • 2 years and 3 months
|
16.7%
8/48 • Number of events 10 • 2 years and 3 months
|
|
General disorders
Oedema NOS
|
8.5%
5/59 • Number of events 5 • 2 years and 3 months
|
0.00%
0/77 • 2 years and 3 months
|
2.5%
1/40 • Number of events 1 • 2 years and 3 months
|
0.00%
0/48 • 2 years and 3 months
|
|
Infections and infestations
Upper respiratory infection NOS
|
5.1%
3/59 • Number of events 3 • 2 years and 3 months
|
3.9%
3/77 • Number of events 3 • 2 years and 3 months
|
2.5%
1/40 • Number of events 1 • 2 years and 3 months
|
4.2%
2/48 • Number of events 2 • 2 years and 3 months
|
|
Gastrointestinal disorders
Vomiting NOS
|
20.3%
12/59 • Number of events 14 • 2 years and 3 months
|
14.3%
11/77 • Number of events 14 • 2 years and 3 months
|
12.5%
5/40 • Number of events 7 • 2 years and 3 months
|
12.5%
6/48 • Number of events 6 • 2 years and 3 months
|
|
Investigations
Weight decreased
|
5.1%
3/59 • Number of events 3 • 2 years and 3 months
|
2.6%
2/77 • Number of events 2 • 2 years and 3 months
|
2.5%
1/40 • Number of events 1 • 2 years and 3 months
|
2.1%
1/48 • Number of events 1 • 2 years and 3 months
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: LTE60