Trial Outcomes & Findings for Study of PRO 140 by Subcutaneous Administration in Adult Subjects With HIV -1 Infection (NCT NCT00642707)
NCT ID: NCT00642707
Last Updated: 2016-01-14
Results Overview
The primary end point was the maximum change from baseline in viral load following initiation of treatment, defined as HIV-1 copies/mL, measured by the Roche Amplicor HIV-1 Monitor UltraSensitive™ Test (lower limit of detection \[LLD\] = 48 copies/mL).
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
44 participants
Primary outcome timeframe
59 days
Results posted on
2016-01-14
Participant Flow
Recruitment started March 2008 and ended November 2008
There was a screening period of up to 12 weeks. Subjects had to be infected with CCR5-tropic human immunodeficiency virus type 1 (HIV-1)or they were excluded from the study.
Participant milestones
| Measure |
Arm 1
PRO 140 - 162 mg for three single SC doses: Days 1, 8, and 15
|
Arm 2
PRO 140 - 324 mg for three single SC doses: Days 1, 8 and 15
|
Arm 3
PRO 140 - 324 mg for two single SC doses: Days 1 and 15 plus one SC dose of placebo at Day 8
|
Arm 4
Placebo for three single SC doses: Days 1, 8 and 15
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
11
|
11
|
12
|
10
|
|
Overall Study
COMPLETED
|
10
|
11
|
12
|
8
|
|
Overall Study
NOT COMPLETED
|
1
|
0
|
0
|
2
|
Reasons for withdrawal
| Measure |
Arm 1
PRO 140 - 162 mg for three single SC doses: Days 1, 8, and 15
|
Arm 2
PRO 140 - 324 mg for three single SC doses: Days 1, 8 and 15
|
Arm 3
PRO 140 - 324 mg for two single SC doses: Days 1 and 15 plus one SC dose of placebo at Day 8
|
Arm 4
Placebo for three single SC doses: Days 1, 8 and 15
|
|---|---|---|---|---|
|
Overall Study
Adverse Event
|
0
|
0
|
0
|
2
|
|
Overall Study
Withdrawal by Subject
|
1
|
0
|
0
|
0
|
Baseline Characteristics
Study of PRO 140 by Subcutaneous Administration in Adult Subjects With HIV -1 Infection
Baseline characteristics by cohort
| Measure |
Arm 1
n=11 Participants
PRO 140 - 162 mg for three single SC doses: Days 1, 8, and 15
|
Arm 2
n=11 Participants
PRO 140 - 324 mg for three single SC doses: Days 1, 8 and 15
|
Arm 3
n=12 Participants
PRO 140 - 324 mg for two single SC doses: Days 1 and 15 plus one SC dose of placebo at Day 8
|
Arm 4
n=10 Participants
Placebo for three single SC doses: Days 1, 8 and 15
|
Total
n=44 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
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
|
|
Age, Categorical
Between 18 and 65 years
|
11 Participants
n=5 Participants
|
11 Participants
n=7 Participants
|
12 Participants
n=5 Participants
|
10 Participants
n=4 Participants
|
44 Participants
n=21 Participants
|
|
Age, Categorical
>=65 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
|
|
Age, Continuous
|
38.5 years
STANDARD_DEVIATION 5.13 • n=5 Participants
|
41.9 years
STANDARD_DEVIATION 5.46 • n=7 Participants
|
46.4 years
STANDARD_DEVIATION 8.18 • n=5 Participants
|
42.4 years
STANDARD_DEVIATION 7.44 • n=4 Participants
|
42.4 years
STANDARD_DEVIATION 7.09 • n=21 Participants
|
|
Sex: Female, Male
Female
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
4 Participants
n=21 Participants
|
|
Sex: Female, Male
Male
|
10 Participants
n=5 Participants
|
10 Participants
n=7 Participants
|
11 Participants
n=5 Participants
|
9 Participants
n=4 Participants
|
40 Participants
n=21 Participants
|
|
Region of Enrollment
United States
|
11 participants
n=5 Participants
|
11 participants
n=7 Participants
|
12 participants
n=5 Participants
|
10 participants
n=4 Participants
|
44 participants
n=21 Participants
|
PRIMARY outcome
Timeframe: 59 daysPopulation: All randomized subjects who received one dose of study drug were considered intent-to-treat (ITT) subjects and were analyzed for efficacy.
The primary end point was the maximum change from baseline in viral load following initiation of treatment, defined as HIV-1 copies/mL, measured by the Roche Amplicor HIV-1 Monitor UltraSensitive™ Test (lower limit of detection \[LLD\] = 48 copies/mL).
Outcome measures
| Measure |
Arm 1
n=11 Participants
PRO 140 - 162 mg for three single SC doses: Days 1, 8, and 15
|
Arm 2
n=11 Participants
PRO 140 - 324 mg for three single SC doses: Days 1, 8 and 15
|
Arm 3
n=12 Participants
PRO 140 - 324 mg for two single SC doses: Days 1 and 15 plus one SC dose of placebo at Day 8
|
Arm 4
n=10 Participants
Placebo for three single SC doses: Days 1, 8 and 15
|
|---|---|---|---|---|
|
Maximum Change in Viral Load Following Initiation of Treatment (Viral Load is Defined as HIV-1 Copies/mL and Expressed as log10 Copies/mL).
|
-0.99 Log10copies/HIV-1 RNA/mL
Standard Deviation 0.558
|
-1.65 Log10copies/HIV-1 RNA/mL
Standard Deviation 0.571
|
-1.37 Log10copies/HIV-1 RNA/mL
Standard Deviation 0.891
|
-0.23 Log10copies/HIV-1 RNA/mL
Standard Deviation 0.285
|
Adverse Events
Arm 1
Serious events: 0 serious events
Other events: 9 other events
Deaths: 0 deaths
Arm 2
Serious events: 0 serious events
Other events: 10 other events
Deaths: 0 deaths
Arm 3
Serious events: 3 serious events
Other events: 11 other events
Deaths: 0 deaths
Arm 4
Serious events: 0 serious events
Other events: 10 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Arm 1
n=11 participants at risk
PRO 140 - 162 mg for three single SC doses: Days 1, 8, and 15
|
Arm 2
n=11 participants at risk
PRO 140 - 324 mg for three single SC doses: Days 1, 8 and 15
|
Arm 3
n=12 participants at risk
PRO 140 - 324 mg for two single SC doses: Days 1 and 15 plus one SC dose of placebo at Day 8
|
Arm 4
n=10 participants at risk
Placebo for three single SC doses: Days 1, 8 and 15
|
|---|---|---|---|---|
|
Infections and infestations
Meningitis viral
|
0.00%
0/11
|
0.00%
0/11
|
100.0%
1/1 • Number of events 1
|
0.00%
0/10
|
|
Infections and infestations
Scrotal abscess
|
0.00%
0/11
|
0.00%
0/11
|
100.0%
1/1 • Number of events 1
|
0.00%
0/10
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Anal cancer stage I
|
0.00%
0/11
|
0.00%
0/11
|
100.0%
1/1 • Number of events 1
|
0.00%
0/10
|
Other adverse events
| Measure |
Arm 1
n=11 participants at risk
PRO 140 - 162 mg for three single SC doses: Days 1, 8, and 15
|
Arm 2
n=11 participants at risk
PRO 140 - 324 mg for three single SC doses: Days 1, 8 and 15
|
Arm 3
n=12 participants at risk
PRO 140 - 324 mg for two single SC doses: Days 1 and 15 plus one SC dose of placebo at Day 8
|
Arm 4
n=10 participants at risk
Placebo for three single SC doses: Days 1, 8 and 15
|
|---|---|---|---|---|
|
Blood and lymphatic system disorders
Lymphadenopathy
|
27.3%
3/11 • Number of events 4
|
9.1%
1/11 • Number of events 1
|
8.3%
1/12 • Number of events 1
|
0.00%
0/10
|
|
Cardiac disorders
Tachycardia
|
9.1%
1/11 • Number of events 1
|
0.00%
0/11
|
0.00%
0/12
|
20.0%
2/10 • Number of events 2
|
|
Ear and labyrinth disorders
Ear pain
|
0.00%
0/11
|
0.00%
0/11
|
8.3%
1/12 • Number of events 1
|
0.00%
0/10
|
|
Ear and labyrinth disorders
Tympanic membrane disorder
|
0.00%
0/11
|
9.1%
1/11 • Number of events 1
|
0.00%
0/12
|
0.00%
0/10
|
|
Gastrointestinal disorders
Constipation
|
9.1%
1/11 • Number of events 1
|
9.1%
1/11 • Number of events 1
|
8.3%
1/12 • Number of events 1
|
0.00%
0/10
|
|
Gastrointestinal disorders
Dental discomfort
|
0.00%
0/11
|
0.00%
0/11
|
8.3%
1/12 • Number of events 1
|
0.00%
0/10
|
|
Gastrointestinal disorders
Diarrhoea
|
9.1%
1/11 • Number of events 1
|
27.3%
3/11 • Number of events 3
|
16.7%
2/12 • Number of events 2
|
0.00%
0/10
|
|
Gastrointestinal disorders
Faeces pale
|
9.1%
1/11 • Number of events 1
|
0.00%
0/11
|
0.00%
0/12
|
0.00%
0/10
|
|
Gastrointestinal disorders
Flatulence
|
0.00%
0/11
|
9.1%
1/11 • Number of events 1
|
0.00%
0/12
|
0.00%
0/10
|
|
Gastrointestinal disorders
Gastritis
|
0.00%
0/11
|
0.00%
0/11
|
8.3%
1/12 • Number of events 1
|
0.00%
0/10
|
|
Gastrointestinal disorders
Intestinal mass
|
0.00%
0/11
|
0.00%
0/11
|
8.3%
1/12 • Number of events 1
|
0.00%
0/10
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/11
|
0.00%
0/11
|
16.7%
2/12 • Number of events 2
|
0.00%
0/10
|
|
Gastrointestinal disorders
Perianal erythema
|
9.1%
1/11 • Number of events 1
|
0.00%
0/11
|
0.00%
0/12
|
0.00%
0/10
|
|
Gastrointestinal disorders
Toothache
|
0.00%
0/11
|
0.00%
0/11
|
0.00%
0/12
|
10.0%
1/10 • Number of events 1
|
|
General disorders
Adverse drug reaction
|
0.00%
0/11
|
0.00%
0/11
|
8.3%
1/12 • Number of events 1
|
0.00%
0/10
|
|
General disorders
Asthenia
|
0.00%
0/11
|
0.00%
0/11
|
8.3%
1/12 • Number of events 1
|
0.00%
0/10
|
|
General disorders
Chills
|
0.00%
0/11
|
0.00%
0/11
|
8.3%
1/12 • Number of events 1
|
0.00%
0/10
|
|
General disorders
Fatigue
|
18.2%
2/11 • Number of events 2
|
0.00%
0/11
|
8.3%
1/12 • Number of events 1
|
0.00%
0/10
|
|
General disorders
Infusion site erythema
|
0.00%
0/11
|
0.00%
0/11
|
0.00%
0/12
|
10.0%
1/10 • Number of events 1
|
|
General disorders
Infusion site induration
|
9.1%
1/11 • Number of events 3
|
18.2%
2/11 • Number of events 5
|
25.0%
3/12 • Number of events 5
|
0.00%
0/10
|
|
General disorders
Infusion site inflammation
|
0.00%
0/11
|
0.00%
0/11
|
0.00%
0/12
|
10.0%
1/10 • Number of events 1
|
|
General disorders
Infusion site pain
|
0.00%
0/11
|
9.1%
1/11 • Number of events 1
|
16.7%
2/12 • Number of events 4
|
10.0%
1/10 • Number of events 1
|
|
General disorders
Injection site discomfort
|
9.1%
1/11 • Number of events 1
|
0.00%
0/11
|
0.00%
0/12
|
0.00%
0/10
|
|
General disorders
Injection site erythema
|
18.2%
2/11 • Number of events 5
|
0.00%
0/11
|
0.00%
0/12
|
0.00%
0/10
|
|
General disorders
Injection site haemorrhage
|
0.00%
0/11
|
0.00%
0/11
|
0.00%
0/12
|
10.0%
1/10 • Number of events 1
|
|
General disorders
Injection site induration
|
18.2%
2/11 • Number of events 5
|
9.1%
1/11 • Number of events 1
|
0.00%
0/12
|
0.00%
0/10
|
|
General disorders
Injection site irritation
|
9.1%
1/11 • Number of events 1
|
9.1%
1/11 • Number of events 2
|
8.3%
1/12 • Number of events 1
|
0.00%
0/10
|
|
General disorders
Injection site pain
|
9.1%
1/11 • Number of events 3
|
0.00%
0/11
|
8.3%
1/12 • Number of events 1
|
0.00%
0/10
|
|
General disorders
Injection site reaction
|
0.00%
0/11
|
9.1%
1/11 • Number of events 1
|
0.00%
0/12
|
10.0%
1/10 • Number of events 1
|
|
General disorders
Pain
|
0.00%
0/11
|
9.1%
1/11 • Number of events 1
|
0.00%
0/12
|
10.0%
1/10 • Number of events 1
|
|
General disorders
Pyrexia
|
0.00%
0/11
|
9.1%
1/11 • Number of events 1
|
0.00%
0/12
|
0.00%
0/10
|
|
General disorders
Vessel puncture site haematoma
|
0.00%
0/11
|
0.00%
0/11
|
0.00%
0/12
|
10.0%
1/10 • Number of events 1
|
|
Infections and infestations
Chlamydial infection
|
9.1%
1/11 • Number of events 1
|
0.00%
0/11
|
0.00%
0/12
|
0.00%
0/10
|
|
Infections and infestations
Folliculitis
|
0.00%
0/11
|
0.00%
0/11
|
8.3%
1/12 • Number of events 1
|
0.00%
0/10
|
|
Infections and infestations
Gastroenteritis
|
0.00%
0/11
|
9.1%
1/11 • Number of events 1
|
0.00%
0/12
|
0.00%
0/10
|
|
Infections and infestations
Herpes simplex
|
9.1%
1/11 • Number of events 1
|
9.1%
1/11 • Number of events 1
|
0.00%
0/12
|
0.00%
0/10
|
|
Infections and infestations
Influenza
|
0.00%
0/11
|
0.00%
0/11
|
8.3%
1/12 • Number of events 1
|
0.00%
0/10
|
|
Infections and infestations
Meningitis viral
|
0.00%
0/11
|
0.00%
0/11
|
8.3%
1/12 • Number of events 1
|
0.00%
0/10
|
|
Infections and infestations
Nasopharyngitis
|
9.1%
1/11 • Number of events 1
|
0.00%
0/11
|
8.3%
1/12 • Number of events 2
|
0.00%
0/10
|
|
Infections and infestations
Oral herpes
|
0.00%
0/11
|
0.00%
0/11
|
0.00%
0/12
|
10.0%
1/10 • Number of events 1
|
|
Infections and infestations
Respiratory tract infection viral
|
0.00%
0/11
|
0.00%
0/11
|
8.3%
1/12 • Number of events 1
|
0.00%
0/10
|
|
Infections and infestations
Scrotal abscess
|
0.00%
0/11
|
0.00%
0/11
|
8.3%
1/12 • Number of events 4
|
0.00%
0/10
|
|
Infections and infestations
Skin infection
|
0.00%
0/11
|
9.1%
1/11 • Number of events 1
|
0.00%
0/12
|
0.00%
0/10
|
|
Infections and infestations
Staphylococcal infection
|
0.00%
0/11
|
9.1%
1/11 • Number of events 1
|
0.00%
0/12
|
0.00%
0/10
|
|
Infections and infestations
Subcutaneous abcess
|
0.00%
0/11
|
0.00%
0/11
|
8.3%
1/12 • Number of events 1
|
0.00%
0/10
|
|
Infections and infestations
Syphillis
|
0.00%
0/11
|
0.00%
0/11
|
8.3%
1/12 • Number of events 1
|
0.00%
0/10
|
|
Infections and infestations
Tinea cruris
|
0.00%
0/11
|
0.00%
0/11
|
8.3%
1/12 • Number of events 1
|
0.00%
0/10
|
|
Infections and infestations
Upper respiratory tract infection
|
0.00%
0/11
|
18.2%
2/11 • Number of events 2
|
8.3%
1/12 • Number of events 1
|
0.00%
0/10
|
|
Infections and infestations
Urethritis gonococcal
|
0.00%
0/11
|
0.00%
0/11
|
0.00%
0/12
|
10.0%
1/10 • Number of events 1
|
|
Infections and infestations
Vaginitis bacterial
|
9.1%
1/11 • Number of events 1
|
0.00%
0/11
|
0.00%
0/12
|
0.00%
0/10
|
|
Injury, poisoning and procedural complications
Arthropod bite
|
0.00%
0/11
|
0.00%
0/11
|
0.00%
0/12
|
20.0%
2/10 • Number of events 3
|
|
Injury, poisoning and procedural complications
Chemical poisoning
|
9.1%
1/11 • Number of events 1
|
0.00%
0/11
|
0.00%
0/12
|
0.00%
0/10
|
|
Injury, poisoning and procedural complications
Excoriation
|
9.1%
1/11 • Number of events 1
|
0.00%
0/11
|
0.00%
0/12
|
0.00%
0/10
|
|
Investigations
Blood creatine phosphokinase increased
|
0.00%
0/11
|
9.1%
1/11 • Number of events 1
|
0.00%
0/12
|
0.00%
0/10
|
|
Investigations
Blood pressure diastolic increased
|
0.00%
0/11
|
0.00%
0/11
|
8.3%
1/12 • Number of events 1
|
0.00%
0/10
|
|
Investigations
Blood pressure increased
|
0.00%
0/11
|
0.00%
0/11
|
8.3%
1/12 • Number of events 5
|
0.00%
0/10
|
|
Investigations
Cardiac murmur
|
9.1%
1/11 • Number of events 1
|
0.00%
0/11
|
0.00%
0/12
|
0.00%
0/10
|
|
Investigations
Electrocardiogram abnormal
|
0.00%
0/11
|
0.00%
0/11
|
0.00%
0/12
|
10.0%
1/10 • Number of events 1
|
|
Investigations
Herpes simplex serology positive
|
0.00%
0/11
|
0.00%
0/11
|
0.00%
0/12
|
10.0%
1/10 • Number of events 1
|
|
Investigations
Urine analysis abnormal
|
0.00%
0/11
|
9.1%
1/11 • Number of events 1
|
0.00%
0/12
|
0.00%
0/10
|
|
Investigations
Weight increased
|
0.00%
0/11
|
0.00%
0/11
|
0.00%
0/12
|
10.0%
1/10 • Number of events 1
|
|
Metabolism and nutrition disorders
Anorexia
|
0.00%
0/11
|
0.00%
0/11
|
16.7%
2/12 • Number of events 3
|
0.00%
0/10
|
|
Metabolism and nutrition disorders
Increased appetite
|
0.00%
0/11
|
9.1%
1/11 • Number of events 1
|
0.00%
0/12
|
0.00%
0/10
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.00%
0/11
|
0.00%
0/11
|
8.3%
1/12 • Number of events 1
|
0.00%
0/10
|
|
Musculoskeletal and connective tissue disorders
Clubbing
|
0.00%
0/11
|
0.00%
0/11
|
0.00%
0/12
|
10.0%
1/10 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal pain
|
0.00%
0/11
|
0.00%
0/11
|
8.3%
1/12 • Number of events 1
|
0.00%
0/10
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
0.00%
0/11
|
0.00%
0/11
|
16.7%
2/12 • Number of events 2
|
0.00%
0/10
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
0.00%
0/11
|
0.00%
0/11
|
16.7%
2/12 • Number of events 3
|
0.00%
0/10
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Anal cancer stage I
|
0.00%
0/11
|
0.00%
0/11
|
8.3%
1/12 • Number of events 1
|
0.00%
0/10
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lipoma
|
9.1%
1/11 • Number of events 1
|
0.00%
0/11
|
0.00%
0/12
|
0.00%
0/10
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Uterine leiomyoma
|
9.1%
1/11 • Number of events 1
|
0.00%
0/11
|
0.00%
0/12
|
0.00%
0/10
|
|
Nervous system disorders
Anaesthesia
|
0.00%
0/11
|
0.00%
0/11
|
8.3%
1/12 • Number of events 1
|
0.00%
0/10
|
|
Nervous system disorders
Dizziness
|
9.1%
1/11 • Number of events 1
|
0.00%
0/11
|
0.00%
0/12
|
0.00%
0/10
|
|
Nervous system disorders
Headache
|
27.3%
3/11 • Number of events 3
|
0.00%
0/11
|
16.7%
2/12 • Number of events 2
|
10.0%
1/10 • Number of events 2
|
|
Nervous system disorders
Sinus headache
|
0.00%
0/11
|
0.00%
0/11
|
0.00%
0/12
|
10.0%
1/10 • Number of events 1
|
|
Psychiatric disorders
Abnormal dreams
|
0.00%
0/11
|
0.00%
0/11
|
8.3%
1/12 • Number of events 1
|
0.00%
0/10
|
|
Psychiatric disorders
Depression
|
0.00%
0/11
|
9.1%
1/11 • Number of events 1
|
0.00%
0/12
|
0.00%
0/10
|
|
Psychiatric disorders
Drug abuse
|
0.00%
0/11
|
0.00%
0/11
|
0.00%
0/12
|
10.0%
1/10 • Number of events 1
|
|
Psychiatric disorders
Insomnia
|
0.00%
0/11
|
9.1%
1/11 • Number of events 1
|
8.3%
1/12 • Number of events 1
|
0.00%
0/10
|
|
Psychiatric disorders
Stress
|
0.00%
0/11
|
9.1%
1/11 • Number of events 1
|
—
0/0
|
0.00%
0/10
|
|
Renal and urinary disorders
Chromaturia
|
9.1%
1/11 • Number of events 1
|
0.00%
0/11
|
0.00%
0/12
|
0.00%
0/10
|
|
Renal and urinary disorders
Penile discharge
|
9.1%
1/11 • Number of events 1
|
0.00%
0/11
|
0.00%
0/12
|
0.00%
0/10
|
|
Renal and urinary disorders
Scrotal pain
|
0.00%
0/11
|
0.00%
0/11
|
8.3%
1/12 • Number of events 2
|
0.00%
0/10
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
9.1%
1/11 • Number of events 1
|
0.00%
0/11
|
0.00%
0/12
|
0.00%
0/10
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
0.00%
0/11
|
0.00%
0/11
|
0.00%
0/12
|
10.0%
1/10 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Nasal oedema
|
0.00%
0/11
|
0.00%
0/11
|
8.3%
1/12 • Number of events 1
|
0.00%
0/10
|
|
Respiratory, thoracic and mediastinal disorders
Rhinitis allergic
|
0.00%
0/11
|
0.00%
0/11
|
8.3%
1/12 • Number of events 1
|
10.0%
1/10 • Number of events 1
|
|
Skin and subcutaneous tissue disorders
Dermatitis
|
18.2%
2/11 • Number of events 2
|
0.00%
0/11
|
0.00%
0/12
|
0.00%
0/10
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
0.00%
0/11
|
9.1%
1/11 • Number of events 1
|
0.00%
0/12
|
0.00%
0/10
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
0.00%
0/11
|
0.00%
0/11
|
0.00%
0/12
|
10.0%
1/10 • Number of events 1
|
|
Skin and subcutaneous tissue disorders
Rash
|
0.00%
0/11
|
9.1%
1/11 • Number of events 1
|
0.00%
0/12
|
0.00%
0/10
|
|
Skin and subcutaneous tissue disorders
Skin hyperpigmentation
|
0.00%
0/11
|
0.00%
0/11
|
0.00%
0/12
|
10.0%
1/10 • Number of events 1
|
|
Skin and subcutaneous tissue disorders
Skin maceration
|
0.00%
0/11
|
9.1%
1/11 • Number of events 1
|
0.00%
0/12
|
0.00%
0/10
|
|
Skin and subcutaneous tissue disorders
Urticaria
|
0.00%
0/11
|
9.1%
1/11 • Number of events 1
|
0.00%
0/12
|
0.00%
0/10
|
|
Vascular disorders
Haematoma
|
0.00%
0/11
|
0.00%
0/11
|
0.00%
0/12
|
10.0%
1/10 • Number of events 1
|
|
Vascular disorders
Hypertension
|
0.00%
0/11
|
9.1%
1/11 • Number of events 2
|
8.3%
1/12 • Number of events 1
|
20.0%
2/10 • Number of events 2
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee Because the study is a multicenter study, the PI(s) can only publish after the aggregate results of all investigators and institutions participating in the study have been published, and the proposed publication is reviewed by Progenics. In the event that Progenics does not publish the results of the study within eighteen months from availability of final study analysis, the PI can publish provided that the proposed publication is reviewed by Progenics.
- Publication restrictions are in place
Restriction type: OTHER