Trial Outcomes & Findings for Combined PD-1 and CCR5 Inhibition for the Treatment of Refractory Microsatellite Stable mCRC (NCT NCT03274804)
NCT ID: NCT03274804
Last Updated: 2022-06-07
Results Overview
Defined as the rate of patients receiving the protocol treatment according to the planned schedule without occurrence of at least one of the following events: Study treatment-related Grade ≥ 3 immune-related abnormalities; Study treatment-related Grade ≥ 4 AEs of any aetiology; Any toxic event leading to the premature withdrawal of protocol treatment
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
20 participants
Primary outcome timeframe
After core treatment period of 8 cycles (each cycle is 21 days)
Results posted on
2022-06-07
Participant Flow
Participant milestones
| Measure |
Single Arm, Prospective, Open-label Trial
Eligible subjects will receive pembrolizumab beginning on Day 1 of each 3-week dosing cycle (d1, qd22) together with maraviroc administered perorally on day 1 to 21 of each cycle (d1-21; qd22).
Pembrolizumab: Eligible subjects will receive pembrolizumab beginning on Day 1 of each 3-week dosing cycle (d1, qd22)
Maraviroc: Maraviroc will be administered perorally on day 1 to 21 of each cycle (d1-21; qd22)
|
|---|---|
|
Overall Study
STARTED
|
20
|
|
Overall Study
COMPLETED
|
20
|
|
Overall Study
NOT COMPLETED
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Combined PD-1 and CCR5 Inhibition for the Treatment of Refractory Microsatellite Stable mCRC
Baseline characteristics by cohort
| Measure |
Study Treatment Arm
n=20 Participants
All enrolled subjects received pembrolizumab 200 mg IV on day one every three weeks (d1, qd22; Q3W) plus maraviroc 2 x 300 mg p.o. daily as combination therapy in an unblinded fashion.
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
11 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
9 Participants
n=5 Participants
|
|
Age, Continuous
|
61 years
STANDARD_DEVIATION 8.94 • n=5 Participants
|
|
Sex: Female, Male
Female
|
13 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
7 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
19 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
Germany
|
20 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: After core treatment period of 8 cycles (each cycle is 21 days)Defined as the rate of patients receiving the protocol treatment according to the planned schedule without occurrence of at least one of the following events: Study treatment-related Grade ≥ 3 immune-related abnormalities; Study treatment-related Grade ≥ 4 AEs of any aetiology; Any toxic event leading to the premature withdrawal of protocol treatment
Outcome measures
| Measure |
Single Arm, Prospective, Open-label Trial
n=19 Participants
All enrolled subjects received pembrolizumab 200 mg IV on day one every three weeks (d1, qd22; Q3W) plus maraviroc 2 x 300 mg p.o. daily as combination therapy in an unblinded fashion.
|
|---|---|
|
Feasibility Rate of a Combined Therapy
|
18 Participants
|
SECONDARY outcome
Timeframe: After core treatment period of 8 cycles (each cycle is 21 days)The primary safety analysis will be based on subjects who experienced toxicities as defined by the current National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE, v4.0; Section 11.2). The attribution to drug, time-of-onset, duration of the event, its resolution, and any concomitant medications administered will be recorded.
Outcome measures
| Measure |
Single Arm, Prospective, Open-label Trial
n=20 Participants
All enrolled subjects received pembrolizumab 200 mg IV on day one every three weeks (d1, qd22; Q3W) plus maraviroc 2 x 300 mg p.o. daily as combination therapy in an unblinded fashion.
|
|---|---|
|
Safety and Toxicity of a Combined Therapy Based on Subjects Who Experienced Toxicities
|
20 Participants
|
SECONDARY outcome
Timeframe: through study completion (20 months)Determine DCR defined as percentage of patients displaying CR/PR or SD as best response according to the RECIST criteria version 1.1.
Outcome measures
| Measure |
Single Arm, Prospective, Open-label Trial
n=19 Participants
All enrolled subjects received pembrolizumab 200 mg IV on day one every three weeks (d1, qd22; Q3W) plus maraviroc 2 x 300 mg p.o. daily as combination therapy in an unblinded fashion.
|
|---|---|
|
Efficacy Endpoint: Disease Control Rate
|
1 Participants
|
SECONDARY outcome
Timeframe: through study completion (20 months)ORR and immune related (ir) ORR (irORR) will be analyzed.
Outcome measures
| Measure |
Single Arm, Prospective, Open-label Trial
n=19 Participants
All enrolled subjects received pembrolizumab 200 mg IV on day one every three weeks (d1, qd22; Q3W) plus maraviroc 2 x 300 mg p.o. daily as combination therapy in an unblinded fashion.
|
|---|---|
|
Efficacy Endpoint: Objective Response Rate
|
1 Participants
|
SECONDARY outcome
Timeframe: through study completion (20 months)Individual PFS will be analyzed.
Outcome measures
| Measure |
Single Arm, Prospective, Open-label Trial
n=19 Participants
All enrolled subjects received pembrolizumab 200 mg IV on day one every three weeks (d1, qd22; Q3W) plus maraviroc 2 x 300 mg p.o. daily as combination therapy in an unblinded fashion.
|
|---|---|
|
Efficacy Endpoint: Progression-free Survival
|
9 weeks
Interval 7.0 to 10.0
|
SECONDARY outcome
Timeframe: through study completion (20 months)Individual OS will be analyzed.
Outcome measures
| Measure |
Single Arm, Prospective, Open-label Trial
n=19 Participants
All enrolled subjects received pembrolizumab 200 mg IV on day one every three weeks (d1, qd22; Q3W) plus maraviroc 2 x 300 mg p.o. daily as combination therapy in an unblinded fashion.
|
|---|---|
|
Overall Survival
|
9 Time until event, month
Interval 6.0 to 20.0
|
Adverse Events
Study Treatment Arm
Serious events: 4 serious events
Other events: 20 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Study Treatment Arm
n=20 participants at risk
The primary safety analysis will be based on subjects who experienced toxicities as defined by the current National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE, v4.0; Section 11.2). The attribution to drug, time-of-onset, duration of the event, its resolution, and any concomitant medications administered will be recorded.
|
|---|---|
|
Infections and infestations
Infections and infestations - Other
|
5.0%
1/20 • Number of events 1 • From the time of treatment allocation through 30 days following discontinuation of treatment, up to 20 months, all adverse events must be reported by the investigator.
|
|
Infections and infestations
Catheter related infection
|
5.0%
1/20 • Number of events 1 • From the time of treatment allocation through 30 days following discontinuation of treatment, up to 20 months, all adverse events must be reported by the investigator.
|
|
Metabolism and nutrition disorders
Hyperglycemia
|
5.0%
1/20 • Number of events 1 • From the time of treatment allocation through 30 days following discontinuation of treatment, up to 20 months, all adverse events must be reported by the investigator.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
5.0%
1/20 • Number of events 1 • From the time of treatment allocation through 30 days following discontinuation of treatment, up to 20 months, all adverse events must be reported by the investigator.
|
Other adverse events
| Measure |
Study Treatment Arm
n=20 participants at risk
The primary safety analysis will be based on subjects who experienced toxicities as defined by the current National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE, v4.0; Section 11.2). The attribution to drug, time-of-onset, duration of the event, its resolution, and any concomitant medications administered will be recorded.
|
|---|---|
|
Gastrointestinal disorders
Abdominal pain
|
5.0%
1/20 • From the time of treatment allocation through 30 days following discontinuation of treatment, up to 20 months, all adverse events must be reported by the investigator.
|
|
Investigations
Alanine aminotransferase increased
|
5.0%
1/20 • From the time of treatment allocation through 30 days following discontinuation of treatment, up to 20 months, all adverse events must be reported by the investigator.
|
|
Respiratory, thoracic and mediastinal disorders
Allergic rhinitis
|
5.0%
1/20 • From the time of treatment allocation through 30 days following discontinuation of treatment, up to 20 months, all adverse events must be reported by the investigator.
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
5.0%
1/20 • From the time of treatment allocation through 30 days following discontinuation of treatment, up to 20 months, all adverse events must be reported by the investigator.
|
|
Gastrointestinal disorders
Anal hemorrhage
|
5.0%
1/20 • From the time of treatment allocation through 30 days following discontinuation of treatment, up to 20 months, all adverse events must be reported by the investigator.
|
|
Blood and lymphatic system disorders
Anemia
|
5.0%
1/20 • From the time of treatment allocation through 30 days following discontinuation of treatment, up to 20 months, all adverse events must be reported by the investigator.
|
|
Metabolism and nutrition disorders
Anorexia
|
5.0%
1/20 • From the time of treatment allocation through 30 days following discontinuation of treatment, up to 20 months, all adverse events must be reported by the investigator.
|
|
Gastrointestinal disorders
Ascites
|
5.0%
1/20 • From the time of treatment allocation through 30 days following discontinuation of treatment, up to 20 months, all adverse events must be reported by the investigator.
|
|
Investigations
Aspartate aminotransferase increased
|
5.0%
1/20 • From the time of treatment allocation through 30 days following discontinuation of treatment, up to 20 months, all adverse events must be reported by the investigator.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
5.0%
1/20 • From the time of treatment allocation through 30 days following discontinuation of treatment, up to 20 months, all adverse events must be reported by the investigator.
|
|
Gastrointestinal disorders
Bloating
|
5.0%
1/20 • From the time of treatment allocation through 30 days following discontinuation of treatment, up to 20 months, all adverse events must be reported by the investigator.
|
|
Blood and lymphatic system disorders
Blood and lymphatic system disorders - Other, specify
|
5.0%
1/20 • From the time of treatment allocation through 30 days following discontinuation of treatment, up to 20 months, all adverse events must be reported by the investigator.
|
|
Investigations
Blood bilirubin increased
|
5.0%
1/20 • From the time of treatment allocation through 30 days following discontinuation of treatment, up to 20 months, all adverse events must be reported by the investigator.
|
|
Musculoskeletal and connective tissue disorders
Bone pain
|
5.0%
1/20 • From the time of treatment allocation through 30 days following discontinuation of treatment, up to 20 months, all adverse events must be reported by the investigator.
|
|
Infections and infestations
Bronchial infection
|
5.0%
1/20 • From the time of treatment allocation through 30 days following discontinuation of treatment, up to 20 months, all adverse events must be reported by the investigator.
|
|
Infections and infestations
Catheter related infection
|
5.0%
1/20 • From the time of treatment allocation through 30 days following discontinuation of treatment, up to 20 months, all adverse events must be reported by the investigator.
|
|
Musculoskeletal and connective tissue disorders
Chest wall pain
|
5.0%
1/20 • From the time of treatment allocation through 30 days following discontinuation of treatment, up to 20 months, all adverse events must be reported by the investigator.
|
|
General disorders
Chills
|
5.0%
1/20 • From the time of treatment allocation through 30 days following discontinuation of treatment, up to 20 months, all adverse events must be reported by the investigator.
|
|
Eye disorders
Conjunctivitis
|
5.0%
1/20 • From the time of treatment allocation through 30 days following discontinuation of treatment, up to 20 months, all adverse events must be reported by the investigator.
|
|
Gastrointestinal disorders
Constipation
|
5.0%
1/20 • From the time of treatment allocation through 30 days following discontinuation of treatment, up to 20 months, all adverse events must be reported by the investigator.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
5.0%
1/20 • From the time of treatment allocation through 30 days following discontinuation of treatment, up to 20 months, all adverse events must be reported by the investigator.
|
|
Investigations
Creatinine increased
|
5.0%
1/20 • From the time of treatment allocation through 30 days following discontinuation of treatment, up to 20 months, all adverse events must be reported by the investigator.
|
|
Metabolism and nutrition disorders
Dehydration
|
5.0%
1/20 • From the time of treatment allocation through 30 days following discontinuation of treatment, up to 20 months, all adverse events must be reported by the investigator.
|
|
Gastrointestinal disorders
Diarrhea
|
5.0%
1/20 • From the time of treatment allocation through 30 days following discontinuation of treatment, up to 20 months, all adverse events must be reported by the investigator.
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
5.0%
1/20 • From the time of treatment allocation through 30 days following discontinuation of treatment, up to 20 months, all adverse events must be reported by the investigator.
|
|
Gastrointestinal disorders
Dysphagia
|
5.0%
1/20 • From the time of treatment allocation through 30 days following discontinuation of treatment, up to 20 months, all adverse events must be reported by the investigator.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
5.0%
1/20 • From the time of treatment allocation through 30 days following discontinuation of treatment, up to 20 months, all adverse events must be reported by the investigator.
|
|
Ear and labyrinth disorders
Ear and labyrinth disorders - Other, specify
|
5.0%
1/20 • From the time of treatment allocation through 30 days following discontinuation of treatment, up to 20 months, all adverse events must be reported by the investigator.
|
|
General disorders
Edema limbs
|
5.0%
1/20 • From the time of treatment allocation through 30 days following discontinuation of treatment, up to 20 months, all adverse events must be reported by the investigator.
|
|
Eye disorders
Eye disorders - Other, specify
|
5.0%
1/20 • From the time of treatment allocation through 30 days following discontinuation of treatment, up to 20 months, all adverse events must be reported by the investigator.
|
|
General disorders
Fatigue
|
5.0%
1/20 • From the time of treatment allocation through 30 days following discontinuation of treatment, up to 20 months, all adverse events must be reported by the investigator.
|
|
General disorders
Fever
|
5.0%
1/20 • From the time of treatment allocation through 30 days following discontinuation of treatment, up to 20 months, all adverse events must be reported by the investigator.
|
|
Musculoskeletal and connective tissue disorders
Flank pain
|
5.0%
1/20 • From the time of treatment allocation through 30 days following discontinuation of treatment, up to 20 months, all adverse events must be reported by the investigator.
|
|
Vascular disorders
Flushing
|
5.0%
1/20 • From the time of treatment allocation through 30 days following discontinuation of treatment, up to 20 months, all adverse events must be reported by the investigator.
|
|
Hepatobiliary disorders
Gallbladder obstruction
|
5.0%
1/20 • From the time of treatment allocation through 30 days following discontinuation of treatment, up to 20 months, all adverse events must be reported by the investigator.
|
|
Gastrointestinal disorders
Gastrointestinal disorders - Other, specify
|
5.0%
1/20 • From the time of treatment allocation through 30 days following discontinuation of treatment, up to 20 months, all adverse events must be reported by the investigator.
|
|
General disorders
General disorders and administration site conditions - Other, specify
|
5.0%
1/20 • From the time of treatment allocation through 30 days following discontinuation of treatment, up to 20 months, all adverse events must be reported by the investigator.
|
|
Nervous system disorders
Headache
|
5.0%
1/20 • From the time of treatment allocation through 30 days following discontinuation of treatment, up to 20 months, all adverse events must be reported by the investigator.
|
|
Gastrointestinal disorders
Hemorrhoidal hemorrhage
|
5.0%
1/20 • From the time of treatment allocation through 30 days following discontinuation of treatment, up to 20 months, all adverse events must be reported by the investigator.
|
|
Vascular disorders
Hot flashes
|
5.0%
1/20 • From the time of treatment allocation through 30 days following discontinuation of treatment, up to 20 months, all adverse events must be reported by the investigator.
|
|
Metabolism and nutrition disorders
Hyperglycemia
|
5.0%
1/20 • From the time of treatment allocation through 30 days following discontinuation of treatment, up to 20 months, all adverse events must be reported by the investigator.
|
|
Metabolism and nutrition disorders
Hypernatremia
|
5.0%
1/20 • From the time of treatment allocation through 30 days following discontinuation of treatment, up to 20 months, all adverse events must be reported by the investigator.
|
|
Vascular disorders
Hypertension
|
5.0%
1/20 • From the time of treatment allocation through 30 days following discontinuation of treatment, up to 20 months, all adverse events must be reported by the investigator.
|
|
Metabolism and nutrition disorders
Hypokalemia
|
5.0%
1/20 • From the time of treatment allocation through 30 days following discontinuation of treatment, up to 20 months, all adverse events must be reported by the investigator.
|
|
Endocrine disorders
Hypothyroidism
|
5.0%
1/20 • From the time of treatment allocation through 30 days following discontinuation of treatment, up to 20 months, all adverse events must be reported by the investigator.
|
|
Infections and infestations
Infections and infestations - Other, specify
|
5.0%
1/20 • From the time of treatment allocation through 30 days following discontinuation of treatment, up to 20 months, all adverse events must be reported by the investigator.
|
|
Psychiatric disorders
Insomnia
|
5.0%
1/20 • From the time of treatment allocation through 30 days following discontinuation of treatment, up to 20 months, all adverse events must be reported by the investigator.
|
|
Investigations
Investigations - Other, specify
|
5.0%
1/20 • From the time of treatment allocation through 30 days following discontinuation of treatment, up to 20 months, all adverse events must be reported by the investigator.
|
|
Eye disorders
Keratitis
|
5.0%
1/20 • From the time of treatment allocation through 30 days following discontinuation of treatment, up to 20 months, all adverse events must be reported by the investigator.
|
|
General disorders
Localized edema
|
5.0%
1/20 • From the time of treatment allocation through 30 days following discontinuation of treatment, up to 20 months, all adverse events must be reported by the investigator.
|
|
Metabolism and nutrition disorders
Metabolism and nutrition disorders - Other, specify
|
5.0%
1/20 • From the time of treatment allocation through 30 days following discontinuation of treatment, up to 20 months, all adverse events must be reported by the investigator.
|
|
Gastrointestinal disorders
Mucositis oral
|
5.0%
1/20 • From the time of treatment allocation through 30 days following discontinuation of treatment, up to 20 months, all adverse events must be reported by the investigator.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal and connective tissue disorder - Other, specify
|
5.0%
1/20 • From the time of treatment allocation through 30 days following discontinuation of treatment, up to 20 months, all adverse events must be reported by the investigator.
|
|
Infections and infestations
Nail infection
|
5.0%
1/20 • From the time of treatment allocation through 30 days following discontinuation of treatment, up to 20 months, all adverse events must be reported by the investigator.
|
|
Gastrointestinal disorders
Nausea
|
5.0%
1/20 • From the time of treatment allocation through 30 days following discontinuation of treatment, up to 20 months, all adverse events must be reported by the investigator.
|
|
General disorders
Non-cardiac chest pain
|
5.0%
1/20 • From the time of treatment allocation through 30 days following discontinuation of treatment, up to 20 months, all adverse events must be reported by the investigator.
|
|
General disorders
Pain
|
5.0%
1/20 • From the time of treatment allocation through 30 days following discontinuation of treatment, up to 20 months, all adverse events must be reported by the investigator.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
5.0%
1/20 • From the time of treatment allocation through 30 days following discontinuation of treatment, up to 20 months, all adverse events must be reported by the investigator.
|
|
Nervous system disorders
Peripheral sensory neuropathy
|
5.0%
1/20 • From the time of treatment allocation through 30 days following discontinuation of treatment, up to 20 months, all adverse events must be reported by the investigator.
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
5.0%
1/20 • From the time of treatment allocation through 30 days following discontinuation of treatment, up to 20 months, all adverse events must be reported by the investigator.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonitis
|
5.0%
1/20 • From the time of treatment allocation through 30 days following discontinuation of treatment, up to 20 months, all adverse events must be reported by the investigator.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
5.0%
1/20 • From the time of treatment allocation through 30 days following discontinuation of treatment, up to 20 months, all adverse events must be reported by the investigator.
|
|
Skin and subcutaneous tissue disorders
Rash acneiform
|
5.0%
1/20 • From the time of treatment allocation through 30 days following discontinuation of treatment, up to 20 months, all adverse events must be reported by the investigator.
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
5.0%
1/20 • From the time of treatment allocation through 30 days following discontinuation of treatment, up to 20 months, all adverse events must be reported by the investigator.
|
|
Infections and infestations
Rash pustular
|
5.0%
1/20 • From the time of treatment allocation through 30 days following discontinuation of treatment, up to 20 months, all adverse events must be reported by the investigator.
|
|
Gastrointestinal disorders
Rectal hemorrhage
|
5.0%
1/20 • From the time of treatment allocation through 30 days following discontinuation of treatment, up to 20 months, all adverse events must be reported by the investigator.
|
|
Renal and urinary disorders
Renal and urinary disorders - Other, specify
|
5.0%
1/20 • From the time of treatment allocation through 30 days following discontinuation of treatment, up to 20 months, all adverse events must be reported by the investigator.
|
|
Reproductive system and breast disorders
Reproductive system and breast disorders - Other, specify
|
5.0%
1/20 • From the time of treatment allocation through 30 days following discontinuation of treatment, up to 20 months, all adverse events must be reported by the investigator.
|
|
Infections and infestations
Salivary gland infection
|
5.0%
1/20 • From the time of treatment allocation through 30 days following discontinuation of treatment, up to 20 months, all adverse events must be reported by the investigator.
|
|
Skin and subcutaneous tissue disorders
Skin and subcutaneous tissue disorders - Other, specify
|
5.0%
1/20 • From the time of treatment allocation through 30 days following discontinuation of treatment, up to 20 months, all adverse events must be reported by the investigator.
|
|
Respiratory, thoracic and mediastinal disorders
Sore throat
|
5.0%
1/20 • From the time of treatment allocation through 30 days following discontinuation of treatment, up to 20 months, all adverse events must be reported by the investigator.
|
|
Gastrointestinal disorders
Stomach pain
|
5.0%
1/20 • From the time of treatment allocation through 30 days following discontinuation of treatment, up to 20 months, all adverse events must be reported by the investigator.
|
|
Infections and infestations
Tooth infection
|
5.0%
1/20 • From the time of treatment allocation through 30 days following discontinuation of treatment, up to 20 months, all adverse events must be reported by the investigator.
|
|
Nervous system disorders
Tremor
|
5.0%
1/20 • From the time of treatment allocation through 30 days following discontinuation of treatment, up to 20 months, all adverse events must be reported by the investigator.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Tumor pain
|
5.0%
1/20 • From the time of treatment allocation through 30 days following discontinuation of treatment, up to 20 months, all adverse events must be reported by the investigator.
|
|
Renal and urinary disorders
Urinary frequency
|
5.0%
1/20 • From the time of treatment allocation through 30 days following discontinuation of treatment, up to 20 months, all adverse events must be reported by the investigator.
|
|
Renal and urinary disorders
Urinary incontinence
|
5.0%
1/20 • From the time of treatment allocation through 30 days following discontinuation of treatment, up to 20 months, all adverse events must be reported by the investigator.
|
|
Renal and urinary disorders
Urinary retention
|
5.0%
1/20 • From the time of treatment allocation through 30 days following discontinuation of treatment, up to 20 months, all adverse events must be reported by the investigator.
|
|
Infections and infestations
Urinary tract infection
|
5.0%
1/20 • From the time of treatment allocation through 30 days following discontinuation of treatment, up to 20 months, all adverse events must be reported by the investigator.
|
|
Gastrointestinal disorders
Vomiting
|
5.0%
1/20 • From the time of treatment allocation through 30 days following discontinuation of treatment, up to 20 months, all adverse events must be reported by the investigator.
|
|
Investigations
Weight gain
|
5.0%
1/20 • From the time of treatment allocation through 30 days following discontinuation of treatment, up to 20 months, all adverse events must be reported by the investigator.
|
|
Respiratory, thoracic and mediastinal disorders
Wheezing
|
5.0%
1/20 • From the time of treatment allocation through 30 days following discontinuation of treatment, up to 20 months, all adverse events must be reported by the investigator.
|
Additional Information
Dr. Georg Martin Haag
Universitätsklinikum Heidelberg, NCT
Phone: +49 (0) 6221 56
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place