Trial Outcomes & Findings for Immunotherapy For Men With Objective Disease Progression On Protocol D9902 Part B (NCT00065442) (NCT NCT00849290)
NCT ID: NCT00849290
Last Updated: 2023-11-29
Results Overview
All subjects who received at least one infusion of APC8015F (N = 109) were included in the safety analysis set and were followed for safety. Refer to Serious Adverse Events and Other Adverse Events.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
113 participants
Primary outcome timeframe
periodically over 24 months
Results posted on
2023-11-29
Participant Flow
Participants were registered between April 2004 and January 2009 across 52 clinical trial sites.
Participants who had objective disease progression on Dendreon's Phase 3 trial D9902B (NCT00065442)and who were determined to have received placebo were screened for evaluation of subject eligibility and performance of baseline tests/procedures.
Participant milestones
| Measure |
APC8015F
APC8015F (cryopreserved autologous PBMCs, including APCs, that have been thawed and then activated in vitro with a recombinant fusion protein). Each dose contains a minimum of 3 X 10\^6 CD54+ cells administered intravenously; treatment is 3 doses approximately 2 weeks apart.
|
|---|---|
|
Overall Study
STARTED
|
113
|
|
Overall Study
COMPLETED
|
58
|
|
Overall Study
NOT COMPLETED
|
55
|
Reasons for withdrawal
| Measure |
APC8015F
APC8015F (cryopreserved autologous PBMCs, including APCs, that have been thawed and then activated in vitro with a recombinant fusion protein). Each dose contains a minimum of 3 X 10\^6 CD54+ cells administered intravenously; treatment is 3 doses approximately 2 weeks apart.
|
|---|---|
|
Overall Study
Adverse Event
|
3
|
|
Overall Study
Death
|
14
|
|
Overall Study
Withdrawal by Subject
|
11
|
|
Overall Study
Lost to Follow-up
|
2
|
|
Overall Study
Protocol Violation
|
5
|
|
Overall Study
Disease Progression
|
20
|
Baseline Characteristics
Immunotherapy For Men With Objective Disease Progression On Protocol D9902 Part B (NCT00065442)
Baseline characteristics by cohort
| Measure |
APC8015F
n=113 Participants
Subjects receiving APC8015F
|
|---|---|
|
Age, Continuous
|
70.0 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
113 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: periodically over 24 monthsPopulation: All participants who received at least one infusion of APC8015F
All subjects who received at least one infusion of APC8015F (N = 109) were included in the safety analysis set and were followed for safety. Refer to Serious Adverse Events and Other Adverse Events.
Outcome measures
| Measure |
APC8015F
n=109 Participants
Subjects receiving at least one infusion of APC8015F
|
|---|---|
|
Safety of APC8015F by Review of Reported Adverse Events
|
109 Participants
|
Adverse Events
APC8015F
Serious events: 32 serious events
Other events: 101 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
APC8015F
n=109 participants at risk
Subjects receiving at least one infusion of APC8015F
|
|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
2.8%
3/109 • 4 years, 9 months
All subjects who received at least 1 infusion of APC8015F (N=109) were followed for safety. Total no. affected (32) = the number of subjects who experienced at least one serious adverse event (SAE). Subjects may have had \> 1 SAE. Total no. of SAEs may exceed the no. affected. Subjects with \<1 occurrence of the same event are counted only once.
|
|
Gastrointestinal disorders
Abdominal pain
|
0.92%
1/109 • 4 years, 9 months
All subjects who received at least 1 infusion of APC8015F (N=109) were followed for safety. Total no. affected (32) = the number of subjects who experienced at least one serious adverse event (SAE). Subjects may have had \> 1 SAE. Total no. of SAEs may exceed the no. affected. Subjects with \<1 occurrence of the same event are counted only once.
|
|
Gastrointestinal disorders
Abdominal pain lower
|
0.92%
1/109 • 4 years, 9 months
All subjects who received at least 1 infusion of APC8015F (N=109) were followed for safety. Total no. affected (32) = the number of subjects who experienced at least one serious adverse event (SAE). Subjects may have had \> 1 SAE. Total no. of SAEs may exceed the no. affected. Subjects with \<1 occurrence of the same event are counted only once.
|
|
Gastrointestinal disorders
Gastrointestinal haemorrhage
|
0.92%
1/109 • 4 years, 9 months
All subjects who received at least 1 infusion of APC8015F (N=109) were followed for safety. Total no. affected (32) = the number of subjects who experienced at least one serious adverse event (SAE). Subjects may have had \> 1 SAE. Total no. of SAEs may exceed the no. affected. Subjects with \<1 occurrence of the same event are counted only once.
|
|
Gastrointestinal disorders
Oesophagitis
|
0.92%
1/109 • 4 years, 9 months
All subjects who received at least 1 infusion of APC8015F (N=109) were followed for safety. Total no. affected (32) = the number of subjects who experienced at least one serious adverse event (SAE). Subjects may have had \> 1 SAE. Total no. of SAEs may exceed the no. affected. Subjects with \<1 occurrence of the same event are counted only once.
|
|
Gastrointestinal disorders
Vomiting
|
0.92%
1/109 • 4 years, 9 months
All subjects who received at least 1 infusion of APC8015F (N=109) were followed for safety. Total no. affected (32) = the number of subjects who experienced at least one serious adverse event (SAE). Subjects may have had \> 1 SAE. Total no. of SAEs may exceed the no. affected. Subjects with \<1 occurrence of the same event are counted only once.
|
|
General disorders
Multi-organ failure
|
0.92%
1/109 • 4 years, 9 months
All subjects who received at least 1 infusion of APC8015F (N=109) were followed for safety. Total no. affected (32) = the number of subjects who experienced at least one serious adverse event (SAE). Subjects may have had \> 1 SAE. Total no. of SAEs may exceed the no. affected. Subjects with \<1 occurrence of the same event are counted only once.
|
|
General disorders
Pain
|
1.8%
2/109 • 4 years, 9 months
All subjects who received at least 1 infusion of APC8015F (N=109) were followed for safety. Total no. affected (32) = the number of subjects who experienced at least one serious adverse event (SAE). Subjects may have had \> 1 SAE. Total no. of SAEs may exceed the no. affected. Subjects with \<1 occurrence of the same event are counted only once.
|
|
General disorders
Puncture site haemorrhage
|
0.92%
1/109 • 4 years, 9 months
All subjects who received at least 1 infusion of APC8015F (N=109) were followed for safety. Total no. affected (32) = the number of subjects who experienced at least one serious adverse event (SAE). Subjects may have had \> 1 SAE. Total no. of SAEs may exceed the no. affected. Subjects with \<1 occurrence of the same event are counted only once.
|
|
Infections and infestations
Sepsis
|
0.92%
1/109 • 4 years, 9 months
All subjects who received at least 1 infusion of APC8015F (N=109) were followed for safety. Total no. affected (32) = the number of subjects who experienced at least one serious adverse event (SAE). Subjects may have had \> 1 SAE. Total no. of SAEs may exceed the no. affected. Subjects with \<1 occurrence of the same event are counted only once.
|
|
Infections and infestations
Staphylococcal sepsis
|
0.92%
1/109 • 4 years, 9 months
All subjects who received at least 1 infusion of APC8015F (N=109) were followed for safety. Total no. affected (32) = the number of subjects who experienced at least one serious adverse event (SAE). Subjects may have had \> 1 SAE. Total no. of SAEs may exceed the no. affected. Subjects with \<1 occurrence of the same event are counted only once.
|
|
Infections and infestations
Urosepsis
|
0.92%
1/109 • 4 years, 9 months
All subjects who received at least 1 infusion of APC8015F (N=109) were followed for safety. Total no. affected (32) = the number of subjects who experienced at least one serious adverse event (SAE). Subjects may have had \> 1 SAE. Total no. of SAEs may exceed the no. affected. Subjects with \<1 occurrence of the same event are counted only once.
|
|
Injury, poisoning and procedural complications
Femur fracture
|
0.92%
1/109 • 4 years, 9 months
All subjects who received at least 1 infusion of APC8015F (N=109) were followed for safety. Total no. affected (32) = the number of subjects who experienced at least one serious adverse event (SAE). Subjects may have had \> 1 SAE. Total no. of SAEs may exceed the no. affected. Subjects with \<1 occurrence of the same event are counted only once.
|
|
Metabolism and nutrition disorders
Anorexia
|
0.92%
1/109 • 4 years, 9 months
All subjects who received at least 1 infusion of APC8015F (N=109) were followed for safety. Total no. affected (32) = the number of subjects who experienced at least one serious adverse event (SAE). Subjects may have had \> 1 SAE. Total no. of SAEs may exceed the no. affected. Subjects with \<1 occurrence of the same event are counted only once.
|
|
Metabolism and nutrition disorders
Dehydration
|
1.8%
2/109 • 4 years, 9 months
All subjects who received at least 1 infusion of APC8015F (N=109) were followed for safety. Total no. affected (32) = the number of subjects who experienced at least one serious adverse event (SAE). Subjects may have had \> 1 SAE. Total no. of SAEs may exceed the no. affected. Subjects with \<1 occurrence of the same event are counted only once.
|
|
Metabolism and nutrition disorders
Failure to thrive
|
0.92%
1/109 • 4 years, 9 months
All subjects who received at least 1 infusion of APC8015F (N=109) were followed for safety. Total no. affected (32) = the number of subjects who experienced at least one serious adverse event (SAE). Subjects may have had \> 1 SAE. Total no. of SAEs may exceed the no. affected. Subjects with \<1 occurrence of the same event are counted only once.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
1.8%
2/109 • 4 years, 9 months
All subjects who received at least 1 infusion of APC8015F (N=109) were followed for safety. Total no. affected (32) = the number of subjects who experienced at least one serious adverse event (SAE). Subjects may have had \> 1 SAE. Total no. of SAEs may exceed the no. affected. Subjects with \<1 occurrence of the same event are counted only once.
|
|
Musculoskeletal and connective tissue disorders
Bone pain
|
0.92%
1/109 • 4 years, 9 months
All subjects who received at least 1 infusion of APC8015F (N=109) were followed for safety. Total no. affected (32) = the number of subjects who experienced at least one serious adverse event (SAE). Subjects may have had \> 1 SAE. Total no. of SAEs may exceed the no. affected. Subjects with \<1 occurrence of the same event are counted only once.
|
|
Musculoskeletal and connective tissue disorders
Muscular weakness
|
1.8%
2/109 • 4 years, 9 months
All subjects who received at least 1 infusion of APC8015F (N=109) were followed for safety. Total no. affected (32) = the number of subjects who experienced at least one serious adverse event (SAE). Subjects may have had \> 1 SAE. Total no. of SAEs may exceed the no. affected. Subjects with \<1 occurrence of the same event are counted only once.
|
|
Musculoskeletal and connective tissue disorders
Osteoarthritis
|
0.92%
1/109 • 4 years, 9 months
All subjects who received at least 1 infusion of APC8015F (N=109) were followed for safety. Total no. affected (32) = the number of subjects who experienced at least one serious adverse event (SAE). Subjects may have had \> 1 SAE. Total no. of SAEs may exceed the no. affected. Subjects with \<1 occurrence of the same event are counted only once.
|
|
Musculoskeletal and connective tissue disorders
Pathological fracture
|
0.92%
1/109 • 4 years, 9 months
All subjects who received at least 1 infusion of APC8015F (N=109) were followed for safety. Total no. affected (32) = the number of subjects who experienced at least one serious adverse event (SAE). Subjects may have had \> 1 SAE. Total no. of SAEs may exceed the no. affected. Subjects with \<1 occurrence of the same event are counted only once.
|
|
Musculoskeletal and connective tissue disorders
Spondylolisthesis
|
0.92%
1/109 • 4 years, 9 months
All subjects who received at least 1 infusion of APC8015F (N=109) were followed for safety. Total no. affected (32) = the number of subjects who experienced at least one serious adverse event (SAE). Subjects may have had \> 1 SAE. Total no. of SAEs may exceed the no. affected. Subjects with \<1 occurrence of the same event are counted only once.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastases to central nervous system
|
0.92%
1/109 • 4 years, 9 months
All subjects who received at least 1 infusion of APC8015F (N=109) were followed for safety. Total no. affected (32) = the number of subjects who experienced at least one serious adverse event (SAE). Subjects may have had \> 1 SAE. Total no. of SAEs may exceed the no. affected. Subjects with \<1 occurrence of the same event are counted only once.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Prostate cancer metastatic
|
3.7%
4/109 • 4 years, 9 months
All subjects who received at least 1 infusion of APC8015F (N=109) were followed for safety. Total no. affected (32) = the number of subjects who experienced at least one serious adverse event (SAE). Subjects may have had \> 1 SAE. Total no. of SAEs may exceed the no. affected. Subjects with \<1 occurrence of the same event are counted only once.
|
|
Nervous system disorders
Spinal cord compression
|
6.4%
7/109 • 4 years, 9 months
All subjects who received at least 1 infusion of APC8015F (N=109) were followed for safety. Total no. affected (32) = the number of subjects who experienced at least one serious adverse event (SAE). Subjects may have had \> 1 SAE. Total no. of SAEs may exceed the no. affected. Subjects with \<1 occurrence of the same event are counted only once.
|
|
Renal and urinary disorders
Hydronephrosis
|
1.8%
2/109 • 4 years, 9 months
All subjects who received at least 1 infusion of APC8015F (N=109) were followed for safety. Total no. affected (32) = the number of subjects who experienced at least one serious adverse event (SAE). Subjects may have had \> 1 SAE. Total no. of SAEs may exceed the no. affected. Subjects with \<1 occurrence of the same event are counted only once.
|
|
Renal and urinary disorders
Obstructive uropathy
|
2.8%
3/109 • 4 years, 9 months
All subjects who received at least 1 infusion of APC8015F (N=109) were followed for safety. Total no. affected (32) = the number of subjects who experienced at least one serious adverse event (SAE). Subjects may have had \> 1 SAE. Total no. of SAEs may exceed the no. affected. Subjects with \<1 occurrence of the same event are counted only once.
|
|
Renal and urinary disorders
Renal failure
|
0.92%
1/109 • 4 years, 9 months
All subjects who received at least 1 infusion of APC8015F (N=109) were followed for safety. Total no. affected (32) = the number of subjects who experienced at least one serious adverse event (SAE). Subjects may have had \> 1 SAE. Total no. of SAEs may exceed the no. affected. Subjects with \<1 occurrence of the same event are counted only once.
|
|
Renal and urinary disorders
Renal failure acute
|
3.7%
4/109 • 4 years, 9 months
All subjects who received at least 1 infusion of APC8015F (N=109) were followed for safety. Total no. affected (32) = the number of subjects who experienced at least one serious adverse event (SAE). Subjects may have had \> 1 SAE. Total no. of SAEs may exceed the no. affected. Subjects with \<1 occurrence of the same event are counted only once.
|
|
Renal and urinary disorders
Ureteric obstruction
|
0.92%
1/109 • 4 years, 9 months
All subjects who received at least 1 infusion of APC8015F (N=109) were followed for safety. Total no. affected (32) = the number of subjects who experienced at least one serious adverse event (SAE). Subjects may have had \> 1 SAE. Total no. of SAEs may exceed the no. affected. Subjects with \<1 occurrence of the same event are counted only once.
|
|
Renal and urinary disorders
Urinary retention
|
0.92%
1/109 • 4 years, 9 months
All subjects who received at least 1 infusion of APC8015F (N=109) were followed for safety. Total no. affected (32) = the number of subjects who experienced at least one serious adverse event (SAE). Subjects may have had \> 1 SAE. Total no. of SAEs may exceed the no. affected. Subjects with \<1 occurrence of the same event are counted only once.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.92%
1/109 • 4 years, 9 months
All subjects who received at least 1 infusion of APC8015F (N=109) were followed for safety. Total no. affected (32) = the number of subjects who experienced at least one serious adverse event (SAE). Subjects may have had \> 1 SAE. Total no. of SAEs may exceed the no. affected. Subjects with \<1 occurrence of the same event are counted only once.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
0.92%
1/109 • 4 years, 9 months
All subjects who received at least 1 infusion of APC8015F (N=109) were followed for safety. Total no. affected (32) = the number of subjects who experienced at least one serious adverse event (SAE). Subjects may have had \> 1 SAE. Total no. of SAEs may exceed the no. affected. Subjects with \<1 occurrence of the same event are counted only once.
|
|
Vascular disorders
Deep vein thrombosis
|
1.8%
2/109 • 4 years, 9 months
All subjects who received at least 1 infusion of APC8015F (N=109) were followed for safety. Total no. affected (32) = the number of subjects who experienced at least one serious adverse event (SAE). Subjects may have had \> 1 SAE. Total no. of SAEs may exceed the no. affected. Subjects with \<1 occurrence of the same event are counted only once.
|
|
Vascular disorders
Hypotension
|
0.92%
1/109 • 4 years, 9 months
All subjects who received at least 1 infusion of APC8015F (N=109) were followed for safety. Total no. affected (32) = the number of subjects who experienced at least one serious adverse event (SAE). Subjects may have had \> 1 SAE. Total no. of SAEs may exceed the no. affected. Subjects with \<1 occurrence of the same event are counted only once.
|
|
Vascular disorders
Poor venous access
|
0.92%
1/109 • 4 years, 9 months
All subjects who received at least 1 infusion of APC8015F (N=109) were followed for safety. Total no. affected (32) = the number of subjects who experienced at least one serious adverse event (SAE). Subjects may have had \> 1 SAE. Total no. of SAEs may exceed the no. affected. Subjects with \<1 occurrence of the same event are counted only once.
|
Other adverse events
| Measure |
APC8015F
n=109 participants at risk
Subjects receiving at least one infusion of APC8015F
|
|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
15.6%
17/109 • 4 years, 9 months
All subjects who received at least 1 infusion of APC8015F (N=109) were followed for safety. Total no. affected (32) = the number of subjects who experienced at least one serious adverse event (SAE). Subjects may have had \> 1 SAE. Total no. of SAEs may exceed the no. affected. Subjects with \<1 occurrence of the same event are counted only once.
|
|
Gastrointestinal disorders
Abdominal pain
|
6.4%
7/109 • 4 years, 9 months
All subjects who received at least 1 infusion of APC8015F (N=109) were followed for safety. Total no. affected (32) = the number of subjects who experienced at least one serious adverse event (SAE). Subjects may have had \> 1 SAE. Total no. of SAEs may exceed the no. affected. Subjects with \<1 occurrence of the same event are counted only once.
|
|
Gastrointestinal disorders
Constipation
|
19.3%
21/109 • 4 years, 9 months
All subjects who received at least 1 infusion of APC8015F (N=109) were followed for safety. Total no. affected (32) = the number of subjects who experienced at least one serious adverse event (SAE). Subjects may have had \> 1 SAE. Total no. of SAEs may exceed the no. affected. Subjects with \<1 occurrence of the same event are counted only once.
|
|
Gastrointestinal disorders
Diarrhoea
|
11.9%
13/109 • 4 years, 9 months
All subjects who received at least 1 infusion of APC8015F (N=109) were followed for safety. Total no. affected (32) = the number of subjects who experienced at least one serious adverse event (SAE). Subjects may have had \> 1 SAE. Total no. of SAEs may exceed the no. affected. Subjects with \<1 occurrence of the same event are counted only once.
|
|
Gastrointestinal disorders
Nausea
|
26.6%
29/109 • 4 years, 9 months
All subjects who received at least 1 infusion of APC8015F (N=109) were followed for safety. Total no. affected (32) = the number of subjects who experienced at least one serious adverse event (SAE). Subjects may have had \> 1 SAE. Total no. of SAEs may exceed the no. affected. Subjects with \<1 occurrence of the same event are counted only once.
|
|
Gastrointestinal disorders
Vomiting
|
17.4%
19/109 • 4 years, 9 months
All subjects who received at least 1 infusion of APC8015F (N=109) were followed for safety. Total no. affected (32) = the number of subjects who experienced at least one serious adverse event (SAE). Subjects may have had \> 1 SAE. Total no. of SAEs may exceed the no. affected. Subjects with \<1 occurrence of the same event are counted only once.
|
|
General disorders
Asthenia
|
7.3%
8/109 • 4 years, 9 months
All subjects who received at least 1 infusion of APC8015F (N=109) were followed for safety. Total no. affected (32) = the number of subjects who experienced at least one serious adverse event (SAE). Subjects may have had \> 1 SAE. Total no. of SAEs may exceed the no. affected. Subjects with \<1 occurrence of the same event are counted only once.
|
|
General disorders
Chills
|
23.9%
26/109 • 4 years, 9 months
All subjects who received at least 1 infusion of APC8015F (N=109) were followed for safety. Total no. affected (32) = the number of subjects who experienced at least one serious adverse event (SAE). Subjects may have had \> 1 SAE. Total no. of SAEs may exceed the no. affected. Subjects with \<1 occurrence of the same event are counted only once.
|
|
General disorders
Fatigue
|
26.6%
29/109 • 4 years, 9 months
All subjects who received at least 1 infusion of APC8015F (N=109) were followed for safety. Total no. affected (32) = the number of subjects who experienced at least one serious adverse event (SAE). Subjects may have had \> 1 SAE. Total no. of SAEs may exceed the no. affected. Subjects with \<1 occurrence of the same event are counted only once.
|
|
General disorders
Pain
|
9.2%
10/109 • 4 years, 9 months
All subjects who received at least 1 infusion of APC8015F (N=109) were followed for safety. Total no. affected (32) = the number of subjects who experienced at least one serious adverse event (SAE). Subjects may have had \> 1 SAE. Total no. of SAEs may exceed the no. affected. Subjects with \<1 occurrence of the same event are counted only once.
|
|
General disorders
Pyrexia
|
17.4%
19/109 • 4 years, 9 months
All subjects who received at least 1 infusion of APC8015F (N=109) were followed for safety. Total no. affected (32) = the number of subjects who experienced at least one serious adverse event (SAE). Subjects may have had \> 1 SAE. Total no. of SAEs may exceed the no. affected. Subjects with \<1 occurrence of the same event are counted only once.
|
|
Infections and infestations
Urinary tract infection
|
6.4%
7/109 • 4 years, 9 months
All subjects who received at least 1 infusion of APC8015F (N=109) were followed for safety. Total no. affected (32) = the number of subjects who experienced at least one serious adverse event (SAE). Subjects may have had \> 1 SAE. Total no. of SAEs may exceed the no. affected. Subjects with \<1 occurrence of the same event are counted only once.
|
|
Investigations
Weight decreased
|
12.8%
14/109 • 4 years, 9 months
All subjects who received at least 1 infusion of APC8015F (N=109) were followed for safety. Total no. affected (32) = the number of subjects who experienced at least one serious adverse event (SAE). Subjects may have had \> 1 SAE. Total no. of SAEs may exceed the no. affected. Subjects with \<1 occurrence of the same event are counted only once.
|
|
Metabolism and nutrition disorders
Anorexia
|
14.7%
16/109 • 4 years, 9 months
All subjects who received at least 1 infusion of APC8015F (N=109) were followed for safety. Total no. affected (32) = the number of subjects who experienced at least one serious adverse event (SAE). Subjects may have had \> 1 SAE. Total no. of SAEs may exceed the no. affected. Subjects with \<1 occurrence of the same event are counted only once.
|
|
Metabolism and nutrition disorders
Decreased appetite
|
11.0%
12/109 • 4 years, 9 months
All subjects who received at least 1 infusion of APC8015F (N=109) were followed for safety. Total no. affected (32) = the number of subjects who experienced at least one serious adverse event (SAE). Subjects may have had \> 1 SAE. Total no. of SAEs may exceed the no. affected. Subjects with \<1 occurrence of the same event are counted only once.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
22.0%
24/109 • 4 years, 9 months
All subjects who received at least 1 infusion of APC8015F (N=109) were followed for safety. Total no. affected (32) = the number of subjects who experienced at least one serious adverse event (SAE). Subjects may have had \> 1 SAE. Total no. of SAEs may exceed the no. affected. Subjects with \<1 occurrence of the same event are counted only once.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
25.7%
28/109 • 4 years, 9 months
All subjects who received at least 1 infusion of APC8015F (N=109) were followed for safety. Total no. affected (32) = the number of subjects who experienced at least one serious adverse event (SAE). Subjects may have had \> 1 SAE. Total no. of SAEs may exceed the no. affected. Subjects with \<1 occurrence of the same event are counted only once.
|
|
Musculoskeletal and connective tissue disorders
Muscular weakness
|
5.5%
6/109 • 4 years, 9 months
All subjects who received at least 1 infusion of APC8015F (N=109) were followed for safety. Total no. affected (32) = the number of subjects who experienced at least one serious adverse event (SAE). Subjects may have had \> 1 SAE. Total no. of SAEs may exceed the no. affected. Subjects with \<1 occurrence of the same event are counted only once.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal pain
|
8.3%
9/109 • 4 years, 9 months
All subjects who received at least 1 infusion of APC8015F (N=109) were followed for safety. Total no. affected (32) = the number of subjects who experienced at least one serious adverse event (SAE). Subjects may have had \> 1 SAE. Total no. of SAEs may exceed the no. affected. Subjects with \<1 occurrence of the same event are counted only once.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
16.5%
18/109 • 4 years, 9 months
All subjects who received at least 1 infusion of APC8015F (N=109) were followed for safety. Total no. affected (32) = the number of subjects who experienced at least one serious adverse event (SAE). Subjects may have had \> 1 SAE. Total no. of SAEs may exceed the no. affected. Subjects with \<1 occurrence of the same event are counted only once.
|
|
Nervous system disorders
Dizziness
|
10.1%
11/109 • 4 years, 9 months
All subjects who received at least 1 infusion of APC8015F (N=109) were followed for safety. Total no. affected (32) = the number of subjects who experienced at least one serious adverse event (SAE). Subjects may have had \> 1 SAE. Total no. of SAEs may exceed the no. affected. Subjects with \<1 occurrence of the same event are counted only once.
|
|
Nervous system disorders
Spinal cord compression
|
7.3%
8/109 • 4 years, 9 months
All subjects who received at least 1 infusion of APC8015F (N=109) were followed for safety. Total no. affected (32) = the number of subjects who experienced at least one serious adverse event (SAE). Subjects may have had \> 1 SAE. Total no. of SAEs may exceed the no. affected. Subjects with \<1 occurrence of the same event are counted only once.
|
|
Psychiatric disorders
Depression
|
5.5%
6/109 • 4 years, 9 months
All subjects who received at least 1 infusion of APC8015F (N=109) were followed for safety. Total no. affected (32) = the number of subjects who experienced at least one serious adverse event (SAE). Subjects may have had \> 1 SAE. Total no. of SAEs may exceed the no. affected. Subjects with \<1 occurrence of the same event are counted only once.
|
|
Psychiatric disorders
Insomnia
|
6.4%
7/109 • 4 years, 9 months
All subjects who received at least 1 infusion of APC8015F (N=109) were followed for safety. Total no. affected (32) = the number of subjects who experienced at least one serious adverse event (SAE). Subjects may have had \> 1 SAE. Total no. of SAEs may exceed the no. affected. Subjects with \<1 occurrence of the same event are counted only once.
|
|
Renal and urinary disorders
Hydronephrosis
|
6.4%
7/109 • 4 years, 9 months
All subjects who received at least 1 infusion of APC8015F (N=109) were followed for safety. Total no. affected (32) = the number of subjects who experienced at least one serious adverse event (SAE). Subjects may have had \> 1 SAE. Total no. of SAEs may exceed the no. affected. Subjects with \<1 occurrence of the same event are counted only once.
|
|
Skin and subcutaneous tissue disorders
HYPERHIDROSIS
|
5.5%
6/109 • 4 years, 9 months
All subjects who received at least 1 infusion of APC8015F (N=109) were followed for safety. Total no. affected (32) = the number of subjects who experienced at least one serious adverse event (SAE). Subjects may have had \> 1 SAE. Total no. of SAEs may exceed the no. affected. Subjects with \<1 occurrence of the same event are counted only once.
|
|
Vascular disorders
HYPERTENSION
|
5.5%
6/109 • 4 years, 9 months
All subjects who received at least 1 infusion of APC8015F (N=109) were followed for safety. Total no. affected (32) = the number of subjects who experienced at least one serious adverse event (SAE). Subjects may have had \> 1 SAE. Total no. of SAEs may exceed the no. affected. Subjects with \<1 occurrence of the same event are counted only once.
|
|
Vascular disorders
HYPOTENSION
|
5.5%
6/109 • 4 years, 9 months
All subjects who received at least 1 infusion of APC8015F (N=109) were followed for safety. Total no. affected (32) = the number of subjects who experienced at least one serious adverse event (SAE). Subjects may have had \> 1 SAE. Total no. of SAEs may exceed the no. affected. Subjects with \<1 occurrence of the same event are counted only once.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee A provision provides for sponsor review up to 45 days with the right to request modification based on disclosure of confidential information; extendable by 60 days to file a patent application.
- Publication restrictions are in place
Restriction type: OTHER